Pharmaceutical Industry’s Medicine Access Efforts Stall in Poor Nations, Watchdog Finds 21/11/2024 Stefan Anderson Lab technicians work in laboratories in Afrigen, a company in Cape Town selected as the WHO Vaccine Hub, in South Africa. Major pharmaceutical companies have made minimal progress in expanding access to essential medicines since the COVID-19 pandemic, according to an industry watchdog report released Tuesday. The 2024 Access to Medicine Index, which evaluates 20 of the world’s leading drugmakers, found that despite modest improvements from certain companies, the overall pace of change in improving availability of life-saving medicines remains slow across more than 100 low- and middle-income countries. The biennial rankings show major access initiatives launched by firms like Pfizer, Novo Nordisk and Bristol Myers Squibb to make treatments more affordable and available are operating in less than a quarter of their target countries. The 20 companies assessed by the index, which control over half of global pharmaceutical revenue, face mounting pressure to improve access amid growing threats from drug-resistant infections and future pandemics. Two billion people, particularly in the world’s poorest countries, still lack access to essential medicines accessible for decades in other parts of the world. “Companies could do a lot more to scale up their initiatives to make lifesaving treatments accessible and affordable everywhere they are needed,” said Dr Jayasree Iyer, CEO of the Access to Medicine Foundation. “Until that happens, many essential medicines and healthcare products will remain out of reach for billions of people living in low- and middle-income countries.” Nearly half of essential medicines – from treatments for diabetes and cancer to cardiovascular and infectious diseases – remain unregistered in countries where disease burdens are highest, the report found. As clinical trials continue to bypass low-income countries, and with most drugmakers having policies to seek approval only where they run trials, new treatments do too, the analysis showed. “We’ve seen what’s possible when global health becomes a priority, as it did during the COVID-19 pandemic,” Iyer said. “The tools exist, and so do the partnerships. What we need now is sustained commitment and deliberate action to reach those who have been left behind for far too long.” “Why create medical innovations if they’re out of reach to those who need them?” Iyer added. Clinical trial disparities widen access gap Over half of the 117 low- and middle-income countries covered by the Index have no active clinical trials. Clinical trials remain heavily skewed toward wealthy nations. While low- and middle-income countries are home to 80% of the world’s population, they host only 43% of trials for new medicines, with just 3.6% taking place in low-income nations, according to the report. Even within developing regions, trials cluster in a handful of upper-middle-income countries like China, Brazil and South Africa, leaving over 70 of the 113 nations covered by the Index with no active trials at all. This matters, as a majority of pharmaceutical companies covered in the index only file for drug approvals in countries where they run clinical trials, making early access planning critical for ensuring treatments reach patients in low-income regions after regulatory approval. “Since trials are conducted only in a few low- and middle-income countries, access plans are often confined to these regions, ultimately widening the access gaps instead of closing them,” Iyer explained. “This is a big problem.” Registration gaps leave the poorest nations behind The disparity in clinical trials has led companies to register products five times more frequently in upper-middle-income countries than in low-income ones. Of 179 products analysed in the Index, 87 are not registered in any of the top 10 countries with the highest disease burdens associated with the medications. While 85% of products have company-led programs to ensure availability and affordability in upper-middle-income countries through measures like equitable pricing and licensing agreements, this drops to just 39% for low-income nations. The proportion of products lacking any affordability or access programs in low-income countries has barely improved, falling to 61% from 65% in 2022. “This low overall registration coverage of countries with high disease burdens means that products may not be available where people need them the most,” the report found. Nearly half of innovative medicines approved in the past five years remain unregistered in any African country as a result, contributing to $2.4 trillion in annual costs from preventable disease across the region. “This imbalance is unacceptable,” Iyer said. “Every delay in expanding access to medicine translates to more lives lost and communities devastated.” Manufacturing gap widens as technology transfers stall Sub-Saharan Africa is largely overlooked by companies’ technology transfer efforts. As a result, 43% of innovative products approved within the past five years have not been registered in any African countries. The barriers to access are further compounded by stagnating efforts to boost local manufacturing capacity in low-income countries. Technology transfers, where companies share manufacturing knowledge with local producers, remain heavily concentrated in a handful of emerging markets. Like clinical trials, the majority of technology transfers undertaken by major pharmaceutical firms benefit a small share of upper-middle-income nations. Of 47 ongoing technology transfer initiatives identified, India hosts 11, Brazil nine, and China seven. Sub-Saharan Africa, which bears 20% of the global disease burden and relies on imports for up to 90% of its pharmaceutical products, sees minimal investment outside South Africa. The manufacturing gap is at its widest when it comes to vaccines, with Africa importing 99% of its doses. “Right now, these efforts are heavily skewed toward upper-middle-income countries like China and India, leaving Africa behind,” said Claudia Martinez, Research Director at the Access to Medicine Foundation. Progress in voluntary licencing agreements, which allow generic manufacturers to produce and distribute patented medicines at lower costs, has also slowed, with just two new agreements in 2024, down from six in 2022. “The infrastructure exists in places like South Africa, Nigeria, and Kenya,” Martinez said. “The challenge lies in companies’ willingness to expand their efforts and commit to long-term partnerships.” New access models show mixed early results Five companies – Novartis, Novo Nordisk, Sanofi, Pfizer, and Bristol Myers Squibb – have pledged to tackle systemic access barriers by making their products available in 102 countries through “inclusive business models” (IBMs), targeting all 48 low-income and least developed nations. Early results show varying progress. Bristol Myers Squibb’s ASPIRE program, launched this year, is active in 19 of its 85 target countries – an implementation rate of 22%. Pfizer’s Accord for a Healthier World, announced in 2022, has signed agreements with only eight of the 45 countries covered in the plan. Longer-running programs fare better. Novo Nordisk’s iCARE, launched in 2021, is active in 17 of 46 countries. Novartis, with the oldest program launched in 2019, states its products are available in “most” of its target countries but does not provide specific numbers. Sanofi is the only company providing specific patient numbers under its IBM, the report said. The drugmaker reached 261,977 patients with treatments for non-communicable diseases across 31 countries, while serving 23 countries for tuberculosis and 19 for malaria, though it doesn’t provide country-by-country breakdowns. New leader, slow pack Overall rankings of the 2024 Access to Medicines Index. The Index ranks companies on a five-point scale, measuring their efforts to improve medicine access in poorer nations. While Novartis claimed the top spot for the first time with a score of 3.78, displacing long-time leader GSK to second place, even these best performers remain well below the maximum score. The Index shows steady progress over its 15-year history, with the average scores across the 20 pharmaceutical companies rising more than a third since 2010 and the gap a steadily narrowing gap between the best and worst performers. Companies like GSK and Novartis have consistently maintained the top spots, while Gilead, despite its crucial role in HIV/AIDS and hepatitis treatments, has seen its score decline significantly. David Reddy, director of IFPMA, the pharmaceutical industry group representing most indexed companies, points to initiatives like tiered pricing models and voluntary licensing agreements as evidence of progress. “These efforts demonstrate the value of partnerships with governments, healthcare systems, and local organisations,” Reddy said. “Despite these strides, the report underscores the need for accelerated efforts to close persistent gaps in access, particularly in low-income countries.” Researchers at the United Nations University International Institute for Global Health have questioned the rankings’ reliability, noting they rely heavily on self-reported corporate data that cannot be independently verified. Image Credits: WHO. Sustainability is the Focus of WHO’s mRNA Vaccine Programme as Partners Look Beyond COVID 20/11/2024 Kerry Cullinan Afrigen’s Petro Terblanche at the progress meeting. CAPE TOWN – Sustainability is the priority for vaccine manufacturers that are part of the mRNA technology transfer programme established by the World Health Organization (WHO) and the Medicines Patent Pool (MPP). The programme was launched in 2020 to equip low and middle-income countries (LMIC) to make their own COVID-19 vaccines to address the inequity exposed by the pandemic – but few countries want or need these vaccines now. “The network was built on the premise of a COVID-19 vaccine market. What do the manufacturers do to stay alive?” asked Martin Friede, head of WHO’s vaccine development unit, at a three-day progress meeting in Cape Town. The immediate priority is to ensure that the 15 partners in the network can “make commercially viable products that they can sell and that there are people out there who want these products,” he added. Dengue, H5N1, malaria, cholera and Rift Valley fever (RVF) are some of the vaccines under research and development (R&D). Meanwhile, South Africa is putting much of its focus on trying to develop an mRNA vaccine for tuberculosis, the world’s biggest infectious disease. Some manufacturers also looking at vaccines for zoonotic diseases like leishmaniosis, which affects people and animals, and animal vaccines to keep their new facilities “warm” and ready for the next pandemic. MPP executive director Charles Gore said that manufacturers can also go beyond mRNA: “We need monoclonal antibodies and immune modulators.” But unless the manufacturers sell vaccines and other products to address the health challenges of their regions, they will either go bankrupt or move on to commercially viable products, and their new capacity will be lost by the next pandemic. In 2023, the South African government, which hosts the mRNA hub, opted to procure pneumococcal vaccines from an Indian company rather than local company Biovac, which is part of the programme, because they were cheaper. In the meantime, the vaccine platform, Gavi, has set aside money to assist up-and-coming vaccine manufacturers particularly in Africa to compete in a tight market. Amazing progress – and financial challenges Charles Gore, executive director of the Medicines Patent Pool. Despite the challenges, progress has been “really amazing,” said Gore of the programme that started in Cape Town, South Africa. “We are now poised to establish a sustainable mRNA vaccine production capacity that will benefit millions across the Global South, truly redefining what health equity can look like on a global scale,” added Gore. From zero mRNA manufacturing capabilities in LMICS at the launch, the initiative expects 11 state-of-the-art good manufacturing practices (GMP) certified mRNA manufacturing facilities to be launched in 10 countries by 2030 – two within the next year. Should this happen, the network will be able to make 60 million doses annually by 2030, with the potential to scale up to a maximum of two billion doses in the event of a pandemic. The initiative is supported by the governments of South Africa, France, Belgium, Canada, the European Union, Germany, Norway, and the ELMA Foundation. “Despite remarkable progress, additional funding is required to fully achieve the programme’s ambition. An estimated $200 million is needed to advance all manufacturers to GMP standards and continue to strengthen the R&D pipeline in support of at least 12 mRNA products currently in development,” the MPP noted in a statement on Wednesday. South Africa leads South Africa was chosen to lead the initiative because of its strong research community and manufacturing sector, according to Gore. Commercial company Afrigen was appointed as the “hub” of the programme. Within six months, its scientists had developed an mRNA vaccine based on the Moderna vaccine – although the drug company declined to offer any help. Afrigen has since trained 15 partners to develop mRNA vaccines from Argentina, Bangladesh, Brazil, Egypt, India, Indonesia, Kenya, Nigeria, Pakistan, Senegal, Serbia, Tunisia, Ukraine and Vietnam. Afrigen expects to be GMP-certified within the next year but it too is challenged by the need for commercially viable products, particularly as money for the mRNA initiative only runs to 2026. CEO Dr Petro Terblanche says her company and others in the network are exploring a variety of options to keep afloat including “blended finance” from governments, donors and development banks. South African manufacturer Biovac is the manufacturing arm of the country’s consortium. It is in the process of developing a cholera vaccine which enters clinical trials next year. Scaling up Some of the partners, such as BioFarma in Indonesia and Egypt’s BioGeneric are not only honing their ability to make vaccines but scaling up their manufacturing capacity to produce millions of vaccines per year. Biofarma’s Indra Rudiansyah said that the Indonesian company was expanding its site and had a candidate vaccine for rabies. BioGeneric has four vaccines in the pipeline including rabies and polio, and now has fill-and-finish capacity to make 30 million vaccine doses a year. It has invested $50 million in expansion. “But it’s very hard to know when we will reach profitability,” said Heba Wali, the company’s general manager. Companies that are government-funded have more security. Bio-Manguinhos, which falls under Brazil’s science foundation, makes vaccines for the country’s public health programme. “There is a very strong possibility that our government will use our mRNA COVID-19 vaccine,” said Patricia Neves of Bio-Manguinhos. Kenya’s Biovax is 100% state-owned, and its government has procured a $120 million loan from the World Bank for its expansion. However, it’s biggest challenge is that it is unable to compete with the salaries paid by commercial companies. Meanwhile, Senegal’s Institut Pasteur Dakar, have gone from three employees to 16 and still are far from ready to manufacture vaccines. Regional co-operation But, said Friede, “most of the vaccine manufacturers on earth are not research entities. They are manufacturing entities. They go and buy their research from universities or biotech companies. “How are we going to ensure that these manufacturers get access to a portfolio product that they can manufacture?” To assist with this, R&D consortia have been set up to lead product-orientated research. Most consortia are aimed at developing vaccine candidates for diseases that are priorities in their regions. The partners have organised themselves into R&D consortiums The consortia are bringing in experienced translational research groups like the International Vaccine Institute in Korea and Hilleman laboratories in Singapore and universities, said Friede. At least 13 of the 15 partners and the WHO have also signed a memorandum of understanding with Professor Drew Weissman at the University of Pennsylvania, who is assisting in building their research development capacity and they will get access to the portfolio of products coming out of this. Weissman and Katalin Karikó won the Nobel Prize for Medicine in 2023 for their work on mRNA. The Southeast Asia consortium is fairly advanced in its work on four mRNA vaccines for dengue, HPV, malaria and Enterovirus. Any vaccines developed through this initiative will be shared across participating LMICs. South East Asia consortium’s mRNA vaccine plan Moderna has around 5,000 scientists, which is hard to compete with, added Friede. But the consortia are enabling the network to start building “the critical mass that is necessary to ensure that LMICs can get a portfolio of products that have been taken to a certain point in development and then transferred over”. “The point of the network is sharing and collaborating,” said Gore, adding that those in the network will get preferential treatment and access to products. Image Credits: Kerry Cullinan, Rodger Bosch / Medicines Patent Pool. Residents in Delhi Advised to Wear Masks as Air Pollution Reaches ‘Severe Plus’ Levels 19/11/2024 Disha Shetty Delhi and its neighboring city of Gurgaon (pictured above) are engulfed in a layer of smog due to the high levels of air pollution. Schools were closed, vehicle entry restricted and India’s top court on Monday advised residents of Delhi’s metropolitan area to wear masks as the capital city was shrouded in “severe plus” levels of air pollution for the second day in a row. For the past week, Delhi’s air pollution has been in the “severe” category – dashing government claims that improved surveillance of rural crop burning and other measures to ease the annual pollution emergency are working. On Monday the PM2.5 air pollution levels – particles so small that they can be inhaled deep into the lungs and even into the bloodstream – were nearly 17 times the limit set by the World Health Organization (WHO). WHO limits for PM2.5 over a 24-hour time period is 25 micrograms per cubic meter of air (μg/m3), while some monitors in Delhi measured PM2.5 levels at 420 μg/m3. Air pollution is a year-long problem in Delhi, but the halt of monsoons in the autumn as well as low wind speeds – what the government calls “unfavourable meteorological conditions” – have long sent toxic levels of air pollution soaring in the late autumn. And the burning of rice stubble in surrounding rural states such as Haryana and Punjab continue to exacerbate conditions, said Delhi’s chief minister Atishi Marlena during a press interaction. The problem became much worse ever since 2008, when the national government ordered farmers to delay the planting of rice crops until later in the spring – thus delaying the harvest date and leaving farmers in a rush to plant a crop of winter wheat. On Monday, Delhi’s PM2.5 levels were 420 μg/m3 – nearly 17 times above the recommended WHO 24-average of 25 μg/m3. Farmers avoiding surveillance satellites While state governments claim to have clamped down on farmers who set their fields on fire to clear the paddy stubble, stepping up surveillance and fines, satellite images reveal something else. To avoid being detected, farmers are merely setting the stubble on fire later in the afternoon, after the satellite that the government uses for surveillance information passes, experts told Health Policy Watch. To improve enforcement, stationary satellites should be used instead, they said. See related story: Delhi Air Pollution: Is Government’s Satellite Monitoring Missing Stubble Fires? Aarti Khosla, Director of Delhi-based research consultancy Climate Trends said that rather than blaming only the rural areas, Delhi officials need to better manage the city’s background air pollution levels year-round. “Agricultural farm burning, contributes, on the days when it’s a peak, to 40% of Delhi’s air [poor] quality,” she said at a press conference on the sidelines of UN climate conference (COP29) in Baku. “And when, when it’s not a peak, it’s 2-3% of its problem.” Aarti Khosla, Director of Delhi-based research consultancy Climate Trends during a press conference at COP29. Short-term measures Along with the advise about masking, the government has ordered most schools to hold classes online, barring a few exceptions. Vehicles that do not meet pollution norms will not be allowed into the city. All construction activities have been halted given their contribution to increasing dust. Options to allow government employees to work from home or call in a reduced number of employees to the workplace are also being considered. The government has already deployed vehicles that are spraying mist on the streets and the trees nearby to reduce the dust. Experts though have been pointing out that such measures are short-term and will do little to reduce the city’s toxic levels of air pollution, or the autumn emergency that recurs annually. Air pollution is the biggest threat to health today & is not limited to a city, state or country. Needs a science-based approach with actions in multiple sectors – transport, construction, factories, cooking fuel, agriculture etc. We can solve the problem, other countries have. — Soumya Swaminathan (@doctorsoumya) November 18, 2024 ‘We want pollution levels to be down year-round’ “Ultimately, we want the pollution levels to be down year round and not just the extremes or winters,” Sarath Guttikunda, director of the Delhi-based Urban Emissions.Info that monitors and researches air pollution research, told Health Policy Watch, in an emailed comment. “Five items which need a long-term vision,” he added, “aggressive expansion and promotion of use of mass transport (especially buses), walking, and cycling modes; promotion of clean fuels like electricity or gas for heating during the winter months; strict enforcement of a ban on open waste burning; clear mandates for complying with emission norms for all industries including brick kilns; and management of road dust,” he said. He also said that the promotion of green spaces adds to a city’s air quality and ‘breathability’. Delhi is currently among the most polluted cities in the world. In rural areas, officials have long spoken about promoting alternatives to rice-stubble burning, such as machine crushing of stubble and expedited composting formulas. But these, too, have not been backed with sufficient levels of state or national government incentives – or enforcement for those who continue to burn. Shifting government subsidies away from rice production to support the cultivation of more nutritionally rich, indigenous grains, such as millet, has also been advocated by environmentalists to reduce stubble. They point out that the rice is now largely produced for export and is a heavy consumer of water, draining underground aquifers. However, the rural farm lobby in Punjab and Haryana is a powerful force and politicians have been generally fearful about changing the status quo. The high levels of air pollution in Delhi and its surrounding cities are a health hazard, warned health experts. Impacts on climate and health South Asia which has among the highest air pollution levels in the world reports an estimated two million deaths annually that are linked to air pollution. The Southeast Asia region typically suffers from the highest pollution levels in the world, with an estimated 2 million deaths annually, according to WHO. And the annual pollution emergencies that strike at Delhi, in fact affect the shared airshed of a much larger area – the sprawling Indo-Gangetic Plains and Himalayan Foothills region extending from eastern Pakistan, where crop-stubble burning also is widespread, across northern India and Nepal to Bangladesh. Satellite image shows smoke from a large number of small fires across the Indo-Gangetic plain and Himalayan foothills, a shared airshed across four countries. That has led to groups such as the World Bank to call for a broader, regional approach to air quality management. But so far attempts to trigger political cooperation across fraught borders have engaged scientists, but not always top political leaders. Reducing air pollution also reduces climate change – a “triple win” for health, climate and economic development, experts have maintained. Fossil fuel burning is directly responsible for a significant proportion of air pollution related deaths, so shifting to renewables has synergistic effects, noted Marina Romanello in the 30 October launch of the Lancet Countdown on Climate and Health. In addition, methane waste emissions and black carbon particles emitted by open crops, waste burning and household fuels are short-lived climate pollutants that exacerbate snow melt and warming temperatures. Speaking from Baku’s COP29, WHO’s Director for Environment and Climate Change Dr Maria Neira, too, drew attention to Delhi’s staggering levels of air pollution during a press conference. “The same causes that are responsible for global warming, the combustion of fossil fuels,… are the causes of air pollution as well,” she said. “At the moment we are talking here, people in one place in the world are breathing air with 400 micrograms/ per cubic meter of pm.2.5,” she said, displaying a WHO ‘BreatheLife’ gauge that reflects how Delhi’s annual air pollution levels exceed WHO guideline norms more than 12 fold. WHO’s Maria Neira displays WHO ‘BreatheLife’ gauge showing how Delhi’s annual air pollution levels exceed WHO guidelines more than 12 fold. The acutely high air pollution levels are a long-term term risk for health, with one-quarter to one-third of deaths from hypertension and other cardiovascular diseases, lung disease as well as lung cancer attributable to air pollution. But they are also a very immediate health emergency, said Dr Courtney Howard, vice-chair of the Global Climate and Health Alliance (GCHA), at the same COP press briefing. “So when air pollution levels are as high as they are in Delhi today, what we’ll be presenting to emergency departments are people with breathing problems from asthma, from chronic obstructive pulmonary disease. People will be coming in with chest pain due to heart attacks that get worse. Strokes are made worse by high levels of air pollution on a more chronic basis. It does increase risks to newborns,” said Howard. Image Credits: Chetan Bhattacharji, AQI, IQAir, Our World in Data, NASA, WHO. Health Secures Permanent Spot on COP Agenda – But Little Else 19/11/2024 Stefan Anderson After decades of advocacy, health secures a permanent spot on the UN climate summit agenda. The World Health Organization’s marquee event at COP29 in Baku produced a document that captures the growing frustration felt by delegates, civil society, and people across the globe with UN climate negotiations: a “letter of intent” to form a coalition to continue discussions about taking action. In stark contrast to the glitzy, Bill Gates-adorned fanfare of the inaugural COP Health Day in Dubai a year ago, the WHO-led high-level ministerial on Monday took place in a cramped, windowless meeting room – though, to be fair, the ground floor of Baku’s football stadium, the venue for COP29, has no windows. Seasoned UN observers sensed the event, billed as a “round table” emphasising “sharing best practices” and “reinforcing sustained action,” was unlikely to make headlines. While Dubai’s celebration drew VIPs and global attention, this year’s event peaked at just 18 guest attendees on a Microsoft Teams call attended by Health Policy Watch. The meeting resulted in the “Baku COP Presidencies Continuity Coalition for Climate and Health,” an acronym sure to catch on at the UN climate talks: BCPCCCH. Thank you @COP29_AZ Presidency for establishing the Baku COP Presidencies Continuity Coalition on Climate and Health. This initiative unites the visionary leadership of five COP presidencies that span this critical time for action, underscoring a commitment to elevate health… pic.twitter.com/QhDl91aeFN — Tedros Adhanom Ghebreyesus (@DrTedros) November 13, 2024 The new coalition, coordinated by Azerbaijan in partnership with previous COP hosts Egypt, the United Arab Emirates, the United Kingdom, and the next host, Brazil, commits COP presidencies to ensure health is a central agenda item at future UN climate summits. “By signing the Letter of Intent, we commit to a shared vision of a world where climate and health policies are not isolated but integrated into all aspects of governance and development,” Azerbaijan’s Minister of Health, Teymur Musayev, said in a press conference following the signing. Musayev said the coalition was “not created for dialogue alone,” though provided few specifics on objectives beyond strengthening health initiatives agreed upon at past COPs. ‘Significant milestone’ WHO hailed the letter of intent as a “significant milestone,” while its director-general, Tedros Adhanom Ghebreyesus, said it “unites the visionary leadership” of COP host countries and shows “a collective will to prioritize climate and health now and for the future.” Adding to the chorus of UN buzzwords, COP29 President Mukhtar Babayev called the coalition “another step towards synergistic action on climate and health.” The agreement falls short of making health a formal topic in UN climate negotiations – long considered the holy grail for the health community – despite evidence climate change-related developments, from air pollution to extreme weather, cost nearly ten million lives annually. While both the Azerbaijani presidency and WHO have issued press releases, the letter of intent itself has not been made public at the time of publication. “With the Continuity Coalition, there is now a mechanism to foster presidency-led, high-level attention to health as the norm,” Dr Jeni Miller, executive director of the Global Climate and Health Alliance, told Health Policy Watch. “What we will be looking for is how it makes that a reality.” Missing the mark Delegates celebrate the creation of the Baku coalition following the WHO-led Baku Coalition signing ceremony. For communities on the frontlines of the climate crisis, the pledge to have future discussions about potential actions to protect health – and the celebratory tone adopted by ministers like Babayev and Musayev – miss the mark. The loss of life from climate change and disease that could be prevented by nations living up to Paris Agreement Targets – an ambition so far absent at the midway mark in Baku – would save two million lives annually, WHO said in a report ahead of COP29. Civil society stakeholders from frontline countries are demanding $5 trillion in annual funding as the bare minimum outcome of the summit to cope with the damage already incurred and to adapt and mitigate future climate change. Nations are less ambitious than civil society in their demands, with most targets from developing countries, including the Arab and the African Groups, hovering around the $1-2 trillion range. As the summit enters its second week and UN climate negotiations near the three-decade mark, words on a page, absent any legally binding or financial backing, are ringing increasingly hollow. “I see a disconnect between the global conversation and discourse with the reality that countries are facing,” Nigeria’s Minister of Health, Mohammed Ali Pate, said following the signing ceremony including the countries that inaugurated the coalition. “Nigeria and other countries are pulling within their limited resources,” Pate said. “We need to reconcile this divergence between global rhetoric and real action backed by resources for those who are bearing the brunt of climate change.” What’s the point? WHO COP29 high-level ministerial in progress in Baku. For frontline communities, the Baku coalition’s non-binding ‘promises’ are pyrrhic victories. But for the WHO and health advocates, they represent hard-fought institutional progress. The fight for health to be recognised as a central concern in UN climate summit agendas has been an uphill battle, mirroring the decades-long struggle to force nations to acknowledge the role of fossil fuels in the climate crisis. Just as it took nearly three decades of UN climate negotiations for the global community to finally commit to “transitioning away” from fossil fuels in Dubai last year – making headlines across the globe – the inclusion of health in the climate agenda is a victory that was won over decades. The health breakthrough is also reminiscent of another recent milestone in global environmental negotiations. Just a month ago in Cali, Colombia, Indigenous communities were granted an official expert body seat in UN biodiversity negotiations after years of tireless advocacy, prompting emotional scenes from people and communities who fought relentlessly for recognition. “The place that we have gained over the years for health at the COPs is now secured,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “We don’t need to fight every year to obtain this space.” Indigenous delegates at COP16 in Cali, Colombia, celebrate victory as decades of advocacy and activism lead to official representation in international negotiations. The coalition’s key achievement, while bureaucratic, is significant: after decades of fighting, health advocates and WHO officials will no longer have to relitigate the importance of health as a central concern in climate talks. “Each victory has been a step forward in getting health into the climate conversation,” Miller said. “Negotiators and heads of state [now] recognise that when they are making decisions about climate action, they are making decisions about people’s lives.” WHO can also claim the establishment of the Baku Coalition meets its basic goal for the talks – ensuring delegates recognize they’re negotiating the health of eight billion people – though the 18 attendees on Teams suggest the message may not have reached many member states. That such a modest procedural win emerges as COP29’s headline health achievement however challenges WHO’s message, pushed through two decades of pre-COP media blitzes, that health – as the lived experience of climate change – would be “the argument” driving meaningful climate action. So far, the evidence from Baku suggests that national delegations still aren’t listening. Time saved? It remains to be seen whether the time saved on bureaucratic wrangling with COP presidencies can translate into more careful tracking of achievements or barriers to fulfilling health-related commitments made at previous COP summits. At Glasgow’s COP26, the Alliance for Transformative Action on Climate and Health (ATACH) was launched with a promise to transform health systems to be more climate resilient. The coalition now includes 91 nations – half of UN climate summit participants – after Azerbaijan joined on Monday. While WHO monitors commitments made by ATACH members to low-carbon and net-zero health systems, there is no oversight of whether these have translated into action. Limited international funding available for health has gone largely unnoticed, even by the only country receiving support from the world’s leading climate fund, the Green Climate Fund (GCF). Malawi is the sole recipient of a GCF grant targeting the health sector’s climate needs. Yet Malawi’s own climate minister, interviewed by Health Policy Watch this week, was unaware of the GCF-funded project in their country. GCF has not responded to a request for comment. Baby steps, urgent crisis Delegates convened for the first-ever Health Day at a UN climate summit in Dubai. Last year seemed to mark another step forward in health action, with 150 nations signing a Health and Climate declaration during the first dedicated Health Day in three decades of climate talks. The Dubai COP also featured a two-week series of climate side events at an expanded WHO Health Pavilion, highlighting the impacts of climate change on food systems, air pollution, household air pollution, energy, and biodiversity. But beyond the political rhetoric, it remains unclear the level of progress being made in getting health into formal adaptation and mitigation processes. Health-specific climate action remains severely underfunded, still capturing only 2% of adaptation funding and 0.5% of multilateral climate funding – unchanged since Glasgow five years ago. At COP29, health financing announcements have amounted to a single $10 million grant from the Islamic Development Bank to the WHO. WHO influence in jeopardy WHO kicked off a funding drive to fill its multi-billion budget shortfall in Berlin last month. The WHO’s influence in the funding arena is further complicated by its own financial instability. Already grappling with a multi-billion dollar budget shortfall, the organization faces additional uncertainty with the possibility of the US, its biggest single donor, cutting funds when President-Elect Donald Trump returns to office in 2025. Trump withdrew from WHO in his previous term, and many in his orbit expect the incoming president to do the same this time around. Top WHO officials told Health Policy Watch last month another Trump withdrawal of funding reinstated by Biden would result in a “dramatically bad crisis” for the UN health agency. Brazil offers a glimmer of hope The Amazon Rainforest, Brazil. The buzz in the health world ahead of talks in Baku was to not expect significant health outcomes from COP29. Finance was always going to dominate the agenda, and Azerbaijan – whose delegation has by some accounts never spoken at COPs before hosting this one – was unlikely to lead on the issue. Looking ahead, Brazil’s hosting of COP30 offers a glimmer of hope to many in the health world. Brazil’s president, Luiz Inácio Lula da Silva, has pledged to act on climate and protect the Amazon, reversing four years of the legacy left by his predecessor, Jair Bolsonaro, who denies climate change and allowed deforestation and exploitation of the tropical rainforest to expand at an unprecedented rate. Brazilian officials have also committed to prioritizing health initiatives on next year’s agenda, already participating in high-profile WHO events in Geneva and Berlin ahead of the summit. In Baku, Brazil’s health minister announced that equality will be a key focus of its upcoming COP presidency. And with universal health coverage deeply embedded in Brazil’s national identity, there’s cautious optimism that meaningful health and climate action might finally move from rhetoric to reality in Rio. Image Credits: COP16, WHO , CIFOR-ICRAF. Jeddah Conference Announces More Measures to Combat AMR – But Implementation Plans Are Still Vague 18/11/2024 Kerry Cullinan Saudi Health Minister Fahad Abdulrahman Aljalajil addresses the Ministerial Conference on Antimicrobial Resistance (AMR) in Jeddah. Government leaders from the health, environment and agriculture sectors in 57 countries adopted a 14-point plan to tackle antimicrobial resistance (AMR) at a meeting in Saudi Arabia that ended over the weekend. One of the undertakings of the Jeddah Commitment is support for the establishment of an independent panel to collect evidence about AMR. The United Nations (UN) High-Level Meeting on AMR had already committed to such a panel in September and gave the Quadripartite (Quad) organisations – the World Health Organization (WHO), Food and Agricultural Organization (FAO), UN Evironment Programme (UNEP) and World Organization for Animal Health (WOAH) – the authority to set up the panel. The ministerial conference resolved to support the Quad in a “timely, open and transparent process” to set up “an Independent Panel for Evidence on Action Against AMR”. However further details, including which UN agency should host the panel and its terms of reference, have not yet been resolved. The UK is believed to favour UNEP hosting the panel while other countries believe that the WHO is better equipped to do so as the global health body houses the Quad. The declaration also call for the creation of a new “biotech bridge” to boost research, development and innovation to find solutions to AMR. AMR happens when bacteria, viruses, fungi, and parasites develop resistance to medicines designed to kill them. This makes infections harder and more costly to treat. Drug-resistant pathogens can also spread between people, animals, and the environment. It is driven in large part by the misuse and overuse of antimicrobials, particularly in agriculture. AMR already causes an estimated 1.27 million deaths per year. From agricultural runoff to wastewater, #AntimicrobialResistance spreads through our land & water, threatening ecosystems & health. Effective handling of fertilizers, wastewater & proper hygiene practices can help reduce #AMR in the environment. More🔗https://t.co/7mtNh4ejnI pic.twitter.com/9416GlR4eX — FAO Knowledge (@FAOKnowledge) November 18, 2024 Saudi Arabia launches regional hubs Meanwhile, Saudi Arabia will launch a regional antibiotic access and logistics hub and an AMR One Health learning hub, the country’s health minister, Fahd bin Abdulrahman Al-Jalajel, told conference delegates. The access and logistics hub will initially operate as a pilot in the WHO’s Eastern Mediterranean Region (EMRO). Its purpose is to foster the sustainable procurement of antibiotics and diagnostics and improve end-to-end access to these. A conference participant told Health Policy Watch that the hub would stockpile antibiotics and establish distribution networks to ensure that they reach areas in need, particularly conflict zones. EMRO members include Palestine, Lebanon and Sudan. The One Health AMR Learning Hub will focus on sharing best practices and developing capabilities on how to implement national AMR action plans on AMR with specific national targets. ‘Misunderstanding’ of animal welfare Wendla-Antonia Beyer, policy officer at the farm animal welfare and public health organisation, Four Paws, said that while the Jeddah Commitment “shows there is momentum behind tackling AMR” it also shows that there is “insufficient understanding of how animal welfare impacts antibiotics use in farming”. Beyer said that “73% of our antibiotics are used in agriculture, often for growth-promotion or for diseases that could be prevented if farms had good animal welfare. “Farms where piglets spend more time with their mothers use less antibiotics. Farms with slower-growing chicken breeds use less antibiotics. The solutions are there, proven and viable — they only need to make it into policy and practice. With the Political Declaration and the Jeddah Commitment behind us, governments and global governance structures now need to make animal welfare an integral part of the One Health response to AMR.” Katherine Urbáez, who heads the Health Diplomacy Alliance (HDA), said her organisation would “continue to advocate to ensure the continued political and financial commitment and to tackle AMR”. “This includes the setting up of the panel with the scope and governance that allows the identification of the data and to advance the commitments in the HLM Policital Declaration”. HDA is based in Geneva and works with multi-stakeholders to advance health with diplomacy. This week is World AMR Awareness Week, which has its theme as “Educate. Advocate. Act now.” Image Credits: Health Ministry of Saudi Arabia. Pandemic Agreement Makes Progress But Still Plenty of Sticky Details to Address 15/11/2024 Kerry Cullinan INB co-chair Anne-Claire Amprou and the WHO’s Mike Ryan at the close of INB12. The latest draft of the World Health Organization’s (WHO) pandemic agreement is awash with green highlights – an indication that countries have reached consensus on much of the text. But the Intergovernmental Negotiating Body (INB) announced on Monday that it would not be possible to reach an agreement by December – and countries would push for the adoption of an agreement by the World Health Assembly (WHA) next May. During the past two weeks of the 12th meeting of the INB, progress has been made on research and development(Article 9), local production(Article 10) and regulatory systems strengthening (Article 14). Sticking points But Article 4 on prevention, which details countries’ pandemic prevention and surveillance obligations, is mostly highlighted in yellow. This means that countries have broad agreement on the text but much of the detail is not agreed. Many of the proposals are common sense – such as building the capacity to detect pathogens at the community level, routine immunisation, and prevention of zoonotic spillover. But these measures are a tall order for some low-income countries, which is partly where the resistance is coming from. Under-resourced countries are unsure of how much prevention will cost them and whether they will get help to implement the provisions. Wealthier countries want assurances that their poorer neighbours can contain outbreaks. The rapid spread of mpox in central Africa is an example. Several affected countries have been unable to confirm cases as they lack basic diagnostic laboratories and trained staff. Negotiators are considering a separate annex on prevention, much as the details of a Pathogen Access and Benefit Sharing (PABS) system may be accommodated in a separate annex. Sticking points also remain on technology transfer (Article 11), the PABS system (Article 12), the global supply chain and logistic (GSCL) system (Article 13) and sustainable financing (Article 20). However, the most tangible offering of the agreement is back on the table although not yet agreed: that 20% of vaccines, therapeutics and diagnostics produced to combat that pathogen during a pandemic will be allocated to the WHO for distribution with 10% given free and the remaining amount on yet-to-be determined terms. Earlier, there were reports that some members of the European Union wanted this requirement to be cut down to 10% and 5% respectively. ‘Crucial and delicate’ Tanzanian Ambassador Dr Abdallah Saleh Possi. Tanzanian Ambassador Dr Abdallah Saleh Possi, speaking for the 47 African member states and Egypt, expressed Africa’s disappointment that there was not sufficient consensus to call a special World Health Assembly next month. “Although we had such slow progress in this 12th session that did not realize the convening of a special session in December as anticipated, we all agree that the remaining issues are not many, but crucial and delicate, requiring decision-making and flexibility,” said Possi at the close of the two-week negotiations on Friday. “Significantly, the meeting has generated the commitment to finalize them. We thank all the delegations that organize informal meetings on some sticky areas. We support having informal sessions during inter-sessional period with a view to achieving consensus on key areas. The Africa group plus Egypt is happy to be amongst the groups seeking to find consensus on the remaining issues.” The Philippines on behalf of the Equity Group, expressed appreciation for both the “substantive progress” particularly on articles, 9,10 and 14, and “the cordiality displayed by delegations that helped bring about this progress”. However, warned the Philippines’ delegate, “much work needs to be done to achieve consensus on key articles that operationalize equity such as articles, 11,12, 13, 13 (bis) and 20.” Unlike the Africa Group, which wanted a December resolution, the Equity Group has always advocated for more time to deliberate on the agreement. The negotiators reconvene for a short INB session from 2-6 December, where they will decide on the programme of negotiations for 2025. RFK Jr Nominated as Top US Health Official 15/11/2024 Stefan Anderson & Sophia Samantaroy Robert F. Kennedy Jr, scion of America’s most prominent political family, is set to become the nation’s top health official under Trump. Donald Trump has named Robert F Kennedy Jr as his choice for US health secretary, putting the controversial anti-vaccine activist and environmental lawyer in line to control some of the world’s most influential health agencies. Kennedy shot to political prominence during the COVID-19 pandemic when his organisation, Children’s Health Defense, became a leading global voice questioning vaccine safety and efficacy. His appointment, which requires Senate confirmation, comes after Kennedy dropped his independent presidential bid to back Trump. “He’s going to help make America healthy again,” Trump said in a speech at Mar-a-Lago following his election victory. “He wants to do some things, and we’re going to let him get to it.” Trump described the role atop HHS as “the most important role of any administration”, adding that Kennedy “will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country”. I am thrilled to announce Robert F. Kennedy Jr. as The United States Secretary of Health and Human Services (HHS). For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it… — Donald J. Trump (@realDonaldTrump) November 14, 2024 If confirmed, Kennedy would oversee a sprawling $1.8 trillion department with 10 health agencies and three human services agencies. His leadership of HHS would include the administration of Medicare, Medicaid and the Affordable Care Act while setting priorities for America’s three most powerful health agencies: the Centers for Disease Control and Prevention (CDC), which tracks disease outbreaks and sets public health guidance; the Food and Drug Administration (FDA), which approves medicines and medical devices; and the National Institutes of Health (NIH), the world’s largest public funder of medical research. Kennedy, an environmental lawyer with no health experience, called his appointment “a generational opportunity” to realign US health policy and “put an end to the chronic disease epidemic” in a post accepting the nomination on X. He said Trump has instructed him to “reorganize” the U.S. constellation of federal health agencies. “I look forward to working with the more than 80,000 employees at HHS to free the agencies from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth,” Kennedy said. Global health fallout Beyond domestic agencies, the Trump administration is also expected to reshape America’s role in global health. In his last term, Trump withdrew funding from the World Health Organization over its COVID-19 response and slashed funding to UN agencies, leaving a multi-billion dollar gap in the UN health agency’s budget. With Kennedy – who has questioned global health orthodoxies – by his side, experts expect this isolationist stance to deepen. This could affect millions who rely on HIV/AIDS funding through PEPFAR, a $7 billion US program providing HIV treatment in over 50 countries, the CDC’s network of 65 international offices, and State Department health diplomacy efforts. WHO officials told Health Policy Watch last month they face “a huge fear factor” over potential US funding withdrawal, warning the agency would enter “a dramatically bad crisis” without American support. The Biden administration’s global health security team referred Health Policy Watch to the Trump transition team when asked for comment. Robert Kennedy Junior’s banner photo on X, formerly Twitter, where he boasts over 4.5 million followers. Beyond the mainstream Kennedy’s stated priorities for America’s health system veer from broadly supported reforms to debunked anti-scientific claims that have alarmed health experts. In recent weeks, he has called for removing fluoride from US drinking water – which he claims causes brain disease – reviewing vaccine safety data with an eye to withdrawing some from the market, eliminating “entire departments” at the FDA, and immediately dismissing 600 NIH employees. His controversial positions include claims repeatedly rejected by scientists: that vaccines cause autism in children, that AIDS is not caused by HIV, that antidepressants are responsible for mass school shootings, and that atrazine, a widely used herbicide, triggers gender dysphoria and has led to increases in young people identifying as transgender. Kennedy’s unconventional streak isn’t limited to medicine. In the run-up to November’s election, Kennedy said doctors found a worm had eaten part of his brain, video footage revealed him to be the key to a decade-old New York City mystery of a dead bear in Central Park – he dumped it there on his way to the airport – and came under investigation for decapitating a whale. Lawrence Gostin, a global health expert at Georgetown University, called the Kennedy pick “the darkest day for public health and science in my lifetime.” “Trump’s pick of RFK Jr as HHS Secretary is disastrous for public health,” Gostin said. “Having a person sceptical of science and evidence at HHS will make America unhealthy.” Public health victories at risk Public health victories like vaccines and drinking water fluoridation have led to dramatic increases in life expectancy. The World Health Organization estimates vaccines save five million lives annually, with global immunization efforts having saved at least 154 million lives over the past 50 years. Yet Kennedy has repeatedly challenged these achievements by questioning vaccine safety and stating that fluoride is linked to “neurodevelopmental disorders.” The real-world impact of vaccine scepticism is already visible in the US, with the CDC reporting vaccination rates for children dropping for all available vaccines last year and vaccine exemptions for religious reasons rising across the past decade. “Religion doesn’t change that fast,” said Dr Michael Mendoza, a former county Public Health Commissioner in New York State. “This is about ideology and misinformation – and we’re seeing a direct impact in the number of kids unvaccinated.” “We’re at risk of widespread distrust in evidence-based treatments and vaccines,” Mendoza added, noting how health misinformation has directly influenced the increase in risky medical decisions. “Our elected and appointed officials have an obligation to promote experts and guidelines that are grounded in established scientific evidence.” Within the federal workforce, many remain optimistic that little will change. Agencies like the Biomedical Advanced Research and Development Authority (BARDA), which funded the development of COVID-19 vaccines, traditionally receive bipartisan support, resulting in little change across administrations. An HHS employee, speaking to Health Policy Watch on the condition of anonymity to safeguard their job security, noted that the negative perception of the new administration has yet to filter into many agencies. Room for agreement Less controversial is Kennedy’s opposition to the well-documented “revolving door” between the industry and government, where officials frequently switch between regulating companies and working for them – a system he argues has led to the “corporate capture” of US health agencies. In a country that spends more on healthcare than any other developed nation, has one of the world’s highest obesity rates, and whose largest public health crisis – the opioid epidemic – was engineered by pharmaceutical giant Purdue Pharma, his critiques of the system have found resonance. The concern about industry influence has merit: since 2000, every FDA commissioner has taken industry positions after leaving office. Nine out of the last ten, representing 40 years of leadership, have done the same. The pattern continued with Trump’s previous HHS secretary, Scott Gottlieb, who departed to a board seat at Pfizer in 2020. Kennedy’s stance against pharmaceutical interests sets up a likely clash with fellow Republicans, many of whom receive significant industry funding. Several GOP lawmakers have already pledged to dismantle President Joe Biden’s signature Medicare drug price negotiation law, which allows the government to negotiate fairer prices on behalf of its senior citizens, claiming it stifles innovation. Yet Kennedy has promised a direct confrontation with the industry, causing shares of major vaccine makers to plunge after Trump’s announcement of Kennedy’s selection. “Together we will clean up corruption, stop the revolving door between industry and government,” Kennedy said. Kennedy’s promised crusade against chronic diseases and processed foods has also found broad support among public health officials – setting up yet another clash with a major industry traditionally aligned with Republican politics. His pledge to strip ultra-processed foods from school lunches and crack down on food dyes has drawn bipartisan backing, though industry groups warn such moves could increase grocery prices Trump has vowed to reduce. “Senators may say, well, RFK Jr has good ideas like tackling chronic disease and regulating Big Food, but RFK Jr is not to be trusted after a career of peddling falsehoods,” Gostin said. “What we need is nutritional warnings on unhealthy foods, bans on targeting kids, and reduced salt and sugar.” Even some nutrition advocates who oppose Kennedy’s broader agenda acknowledge the need for stricter oversight of the food industry. The FDA has identified concerns about ultra-processed foods’ health impacts, though the agency says more research is needed. The challenge, experts say, will be implementing evidence-based reforms while avoiding Kennedy’s tendency toward unproven theories about food safety. Environmental hero to anti-vaccine empire Headline published in the Defender, the news arm of Kennedy’s anti-vaccine outfit on November 7. Kennedy began his career as a celebrated environmental lawyer, fighting corporate polluters and championing indigenous communities whose lands had been poisoned by industry. His aggressive prosecution of polluters helped restore the Hudson River to health, earning him Time magazine’s “Hero for the Planet” designation. He maintains some of this environmental ethos, promising in his presidential campaign before bowing out to back Trump to tackle unsafe PFAS levels and microplastic contamination. But his path took a sharp turn in 2015 when he took over the struggling World Mercury Project, rebranding it as Children’s Health Defense (CHD) in 2018. Under Kennedy’s leadership, CHD became a global anti-vaccine juggernaut. The organization’s revenue skyrocketed from $1.1 million in 2018 to $23.5 million in 2022, with Kennedy himself earning more than $510,000 in 2022, the last year where filings are available. In mainstream interviews and congressional appearances, Kennedy has worked to promote his least controversial views. He has attempted to moderate his image, telling NBC News: “I’m not going to take away anybody’s vaccines, I’ve never been anti-vaccine.” Yet the organization he led until his presidential campaign – and where he remains a lawyer – continues to fund and promote numerous anti-scientific positions. Public tax filings show Kennedy made $550,000 in executive compensation from Children’s Health Defense in 2022, the last year where records are available. During the pandemic, CHD’s vaccine-related posts were shared more frequently on Twitter than content from CNN, Fox News, NPR and the CDC combined – occasionally eclipsing the readership of the New York Times and Washington Post. The Center for Countering Digital Hate named Kennedy one of the “Disinformation Dozen,” identifying him and CHD as among the top spreaders of vaccine misinformation online. CHD also played a role in coordinating international protests for anti-vaccine movements around the world – with deadly consequences. In 2019, Kennedy’s organization flooded American Samoa with vaccine misinformation and lobbied the government against the use of the MMR vaccine, resulting in a devastating measles outbreak. This week, CHD’s news arm, The Defender, published claims that COVID-19 vaccines pose a “112,000% greater risk of brain clots and strokes than flu shots” – research based on misuse of VAERS, a federal database that records unverified reports of adverse events. The study’s authors include supplement company affiliates and anti-vaccine activists who openly coordinate with Kennedy’s organization. One author chairs a Texas-based organization that tagged Kennedy in a Twitter post on Tuesday calling for the “immediate withdrawal of all COVID-19 vaccines from the market” and the “repeal of the 1986” national childhood vaccination act. In his 2021 book, which sold over a million copies and sat on the New York TImes bestseller list for 17 weeks, Kennedy expands on the ethos behind CDH, calling Anthony Fauci, who led the US response to the COVID-19 pandemic, “the powerful technocrat who helped orchestrate and execute 2020’s historic coup d’état against Western democracy,” claiming his “remedies” – including Covid vaccines – were “often more lethal than the diseases they pretend to treat.” The book also champions Alan Duesberg, praising as “elegant” and “compelling” the discredited scientist’s claims that AIDS is not caused by HIV. Such theories had deadly consequences: 330,000 people died prematurely after being denied life-saving HIV treatment when South Africa’s government embraced view championed by Duesberg in the early 2000s, according to Harvard researchers. Path to Senate confirmation .@RobertKennedyJr has championed issues like healthy foods and the need for greater transparency in our public health infrastructure. I look forward to learning more about his other policy positions and how they will support a conservative, pro-American agenda. — U.S. Senator Bill Cassidy, M.D. (@SenBillCassidy) November 14, 2024 Kennedy’s path to confirmation runs through a Republican-led Senate, where he needs a simple majority of 51 votes. While some Republicans have expressed cautious support, experts point to Trump’s other nominees as the President-elect’s “tests” for Senate loyalty, suggesting the incoming president may bypass the traditional confirmation process entirely. “Any Republican Senator seeking the coveted LEADERSHIP position in the United States Senate must agree to Recess Appointments (in the Senate!), without which we will not be able to get people confirmed in a timely manner,” Trump posted on Sunday. “We need positions filled IMMEDIATELY!” If the Republican-majority Senate agrees to recess appointments – where the President appoints officials when Congress is not in session – Trump’s cabinet picks could stay until the end of 2026. Kennedy joins other iconoclastic nominees. Trump tapped former Democratic Representative Tulsi Gabbard for Director of National Security, noted for her opposition to US support for Ukraine and promoting debunked Russian claims about US-funded biolabs there. He also named Florida Representative Matt Gaetz, who had been facing a congressional ethics investigation over allegations of sex trafficking a minor, as Attorney General. Image Credits: Gage Skidmore, European Union/Martin Matev. Breakthrough Research Promises Shorter Treatment for Multi-Drug-Resistant TB 15/11/2024 Disha Shetty Young Indonesians appeal for an end to TB at the Union’s World Lung Health conference in Bali. In a breakthrough for patients with multi-drug-resistant (MDR) tuberculosis (TB), researchers shared positive trial results for a shorter, tailored alternative at the World Conference on Lung Health in Bali, Indonesia. The insights came from the endTB-Q trial aimed at finding a simpler, less toxic, shorter regimen for fluoroquinolone-resistant MDR-TB. Fluoroquinolone is a common class of medicine used to treat MDR TB, and if patients become resistant, they are considered to be bordering on extensively drug-resistant (XDR) TB, which is extremely hard to treat and can take 18 months. The endTB-Q clinical trial enrolled 323 patients from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam to try to find alternatives to the current longer treatment regimen recommended by the World Health Organization (WHO). Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project “Our trial innovated in several important ways. Since we know that treatment for TB is not ‘one size fits all’, we tested a strategy that tailored treatment duration to disease severity and treatment response based on simple criteria,” said Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project and co-principal investigator of the trial. Researchers tried a combination of four TB drugs used to treat drug-resistant forms of TB – bedaquiline, clofazimine, delamanid and linezolid (BCDL). These drugs were given for six months and extended to nine months in case of delayed treatment response. Around 87% of patients were cured after the treatment in comparison to 89% of patients in the control arm of the trial that received the current WHO regime. But those 87% who did get better had less severe TB, according to the researchers. But for people with severe TB disease, BCDL for nine months was insufficient as they were at risk of TB returning and the longer regimen is still the best option. “Our conclusions are that this regimen, BCDL, given for six to nine months, is an excellent approach for those who don’t have severe disease at baseline. In this group, the success rate is almost 95% and it has a big advantage compared to the historical conventional treatment because it’s much shorter and less toxic,” said Guglielmetti. Researchers shared several breakthrough insights on tuberculosis care at the World Conference on Lung Health. Bedaquiline use in children found safe Researchers also shared updates from a separate trial that looked into whether children can take bedaquiline, which is used to treat drug-resistant TB. The trial found the drug to have a high degree of safety and tolerance for use in children. New data from a different trial funded by the US-research agency National Institute of Health (NIH) called IMPAACT that included experts from Stellenbosch University in South Africa found bedaquiline safe for use in the treatment of infants, children and adolescents with drug-resistant TB. This is a crucial finding as it will allow further optimising the use of bedaquiline in children with drug-resistant TB – an under-served population. “The P1108 trial [bedaquiline] has paved the way for access, finally, to effective, shorter and safer treatment for children with drug-resistant TB. For too long children with TB have been left behind,” said researcher Simon Schaaf. He said that children form nearly 12% of all TB cases or 1.3 million cases every year globally but despite bedaquiline being authorized for use since 2012, there wasn’t any trial for its use in children. Nearly 3,900 stakeholders including industry representatives, patient groups, and doctors from around 150 countries attended the conference. The week-long conference also saw the release of results from other TB trials in countries across Southeast Asia. In Indonesia, researchers found that using mobile chest X-ray screening proved to be a useful tool to find active TB cases in the community. This is especially helpful in cases where people do not show classic symptoms of TB like coughing. Day 2 at #UnionConf24 is underway! 👉 @FIT_eV present their research into active case finding among communities in Vietnam🇻🇳 “Community chest X-ray screening for TB among ethnic minority communities is more than just a health intervention—it’s a vital step toward equity”#EndTB pic.twitter.com/Hn0iAzpr1V — The Union (@TheUnion_TBLH) November 13, 2024 In Vietnam, researchers stressed the importance of active case finding in ethnic minorities and remote communities to ensure access to treatment. They also used mobile X-ray machines. In the Philippines, person-centred active case finding for TB was found to break down barriers to healthcare access for vulnerable populations. The screening was done as a part of a poverty alleviation programme which empowered community members to participate and take a leading role. Trust in community leaders aided the screening of TB. Researchers also shared results from a study that highlighted the need to optimize tests to check whether a patient was susceptible to a particular drug or not, and to expand access to new TB compounds for people with life-threatening TB. “Antimicrobial resistance is among the greatest global health threats we face today. For people at-risk of TB, this threat is multiplied,” said Dr Cassandra Kelly-Cirino, Executive Director of The International Union Against Tuberculosis and Lung Disease (The Union), which convened the conference. “The new research presented at the Union Conference this week represents an invaluable step in managing this challenge and in offering hope to patients of all ages living with extensively drug-resistant TB.” Image Credits: The Union, The Union. Make Clean Air Part of Climate Plans, Experts Say 15/11/2024 Chetan Bhattacharji Smog engulfs Lahore, Pakistan, on Thursday as air pollution levels hit record highs. Some pollutants reached nearly 100 times the World Health Organization’s recommended level, according to IQAir. BAKU, Azerbaijan — Global and Indian experts at COP29 produced new evidence Thursday calling for clean air standards to become part of nations’ climate commitments, as cities across South Asia’s heavily polluted air corridor battled record-breaking smog. In Delhi, authorities closed schools up to grade 5 and halted construction as pollution levels soared to almost twenty times the WHO’s safe daily limit. The crisis came just days after Lahore, Pakistan’s second-largest city just 25 kilometres from the Indian border, saw its highest-ever levels of air pollution. Under the clear skies of Azerbaijan’s capital, experts from the World Bank, WHO, and Indian health ministry were unanimous that air quality improvement should be included in the new Nationally Determined Contributions (NDCs), the self-determined climate targets nations set under the Paris Agreement. “Air quality targets and standards can be a perfect indicator of success if we are successful in targeting the causes of climate change,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “If we could select an indicator of how successful we are in achieving negotiations on climate change mitigation, I think we should use the levels of air quality that people around the world are breathing.” Health experts hope their evidence linking air pollution and climate change will strengthen calls for action at COP29. Supporting this call for action is a new report released by the Clean Air Fund that shows how tropospheric ozone – a little-discussed ‘super pollutant’ – is linked to 500,000 premature deaths and an estimated $500 billion in economic costs annually. Air pollution from all sources contributes to more than eight million premature deaths each year, with economic costs exceeding $8 trillion, the report found. The findings aim to support the push for including air quality standards in the third generation of NDCs – binding climate commitments due before COP30 next year under the Paris Agreement. Only a small fraction of countries currently include air pollution safety in their climate plans despite the health threat to millions worldwide. Clean Air Fund’s founder and CEO, Jane Burston, said tackling super pollutants provides “huge opportunities” for improving climate, health, economic development, and equity. “We know that developing countries are some of the few that have included things like black carbon in their nationally determined contributions, and that’s because a lot of these deaths and this exposure is happening in countries least able to afford action on it,” she added. Super-bad for children Protest by ‘Warrior Moms’, a group for clean air, in Delhi outside India’s health ministry, as air pollution turned ‘severe’ on 14th November, which is celebrated as Children’s Day in the country. Tropospheric ozone and its super-pollutant siblings – including methane, black carbon, nitrous oxide and fluorinated gases – are collectively responsible for nearly half of global warming to date. Unlike other pollutants, tropospheric ozone isn’t directly emitted but forms when sunlight interacts with pollutants from aviation, shipping, agriculture and other sectors. Its health impacts can be severe, from reduced lung function to complications in type 2 diabetes and cardiovascular disease. For children, this pollution poses an especially severe threat. “Young children have smaller lungs,” Dr Soumya Swaminathan, an advisor to the Indian health ministry and former chief scientist at the WHO, explained. “They breathe much faster than adults, and they are shorter, so they’re closer to the ground, where there are more pollutants, and get more respiratory infections.” Dr Valerie Hickey, who leads the World Bank’s environment department, also placed children at the centre of her argument. “Your kid got up coughing so bad they couldn’t go to school does not lead on CNN,” she said. “Though if there are huge floods in Valencia, it does. Both are terrible, but [air pollution] is a public health emergency.” Like climate change itself, air pollution’s threat isn’t only visible in extreme events such as Delhi’s current crisis, where PM2.5 levels have reached almost 300 micrograms per cubic metre. “Every unit you go above five, you actually have a health impact,” explained Swaminathan, who co-chairs Our Common Air. “Even at 20, 30, 40 you start getting effects on the heart, respiratory system, and brain. So we need to take action to keep it as low as possible.” “We have to be pragmatic and set interim targets and do a stepwise plan to reduce it,” she added. “That’s what the NDCs are all about.” ‘Smog diplomacy’ Delhi and Lahore, just 400 kilometres apart, face the world’s highest air pollution levels. Half of the ten most polluted places in the world today are in four countries of South Asia – Pakistan, India, Nepal and Bangladesh. Health experts often say that air pollution knows no borders, an adage now forcing cooperation between long-standing rivals in what’s come to be known as “smog diplomacy.” India and Pakistan, nations that have fought multiple wars since independence, are finding themselves pushed toward dialogue over their shared air crisis. This week, as their major cities Delhi and Lahore traded places as the world’s most polluted, officials in Punjab, Pakistan’s most populous province, drafted a letter to India seeking talks on air pollution. “This is an area of the world where there isn’t always great experience with international diplomacy,” Hickey said. “Countries don’t always like each other, but they’re actually seeing that smog diplomacy is something that can bring them to the table.” The outreach comes as hundreds of millions in both countries face severe health risks borne from common problems plaguing both nations: farmers burning agricultural waste, coal-fired power plants, heavy traffic, construction and windless days trapping emissions. The World Bank has launched a “multi-hundred billion dollar” to address this cross-border crisis, targeting the vast northern plains of South Asia, known as the Indo-Gangetic Plains, Hickey told Health Policy Watch. The Bank has already committed to several regional projects in India, including a $350 million clean air management initiative plus $5 million grant for Uttar Pradesh, reportedly approved by the state cabinet and a pending $300 million loan plus $5 million grant for Haryana. Similar programs are planned for Nepal, Pakistan and Bangladesh to address pollution that readily crosses borders due to the region’s geography and wind patterns. “We need climate diplomacy, as a regional and global issue,” Raja Jahangir Anwar, Punjab’s Secretary for Environment and Climate Change, told CNN. “We are suffering in Lahore due to the eastern wind corridor coming from India. We are not blaming anyone, it’s a natural phenomenon.” Image Credits: https://x.com/ThePeerAli/status/1856985454072963085/photo/1. As World’s Health Ministers Meet in Jeddah: Calls for Strong AMR Science Panel With Authority to ‘Challenge’ Sponsors 14/11/2024 Elaine Ruth Fletcher Thail lab technicians train in surveillance of antimicrobial resistance (AMR) in food-producing animals in Southeast Asia – an driver of AMR that was neglected in the recent UN High Level Meeting declaration. With plans underway for a new “Independent Panel” on Antimicrobial Resistance, endorsed at September’s UN High-Level AMR Meeting, the new body must become a strong scientific authority. It should have the power to “challenge” the agencies that create it and address both human and animal health factors driving drug-resistant pathogens. That was a key message from AMR experts in the lead up to the Fourth Ministerial Meeting on Antimicrobial Resistance, which begins Friday in Jeddah, Saudi Arabia. The Independent Panel “needs to be an inclusive process… listening to scientists… civil society, to industry and other actors. But you also need to make sure that that panel, even though hosted by a Quadripartite, can actually challenge the Quadripartite,” declared John Arne Røttingen, CEO of the UK-based Wellcome Trust, of the panel’s central importance to providing evidence on future AMR policies. The ‘Quadripartite’ includes the World Health Organization, as well as the global environment, food and animal health agencies, which are now formally collaborating to confront the AMR threat. John-Arne Røttingen, CEO of Wellcome Trust. Røttingen was among the more than two dozen experts convened for two high-level AMR sessions at Berlin’s World Health Summit in mid-October to discuss next steps for the battle against drug resistant pathogens in the lead-up to the Jeddah meeting. “Declarations are long. It’s hard to identify the real material commitments that have been made,” Røttingen said at a panel discussion on Milestones and Challenges in Tackling AMR, hosted by the German Ministry of Health. “So it’s great that we come to Jeddah for the ministerial meeting,” he said. “That should be a start of both countries’ [and development agencies] coming together as well as the multi stakeholder partnership platform coming together across sectors to make sure that we are keeping our commitments.” On the research front, meanwhile, new “pull incentives” recently developed in the United Kingdom, Italy and Canada to foster a sustainable market for next generation antibiotics are welcome, but they are not enough, industry experts asserted. Many more nations need to adopt supply-side incentives to ensure that badly-needed new drug candidates actually come to market. Jeddah should be the start of making good on the UN’s AMR Declaration FAO, UNEP, WHO and WOAH heads at September’s UN High Level Meeting that approved a set of new commitments for action on drug resistant pathogens. The health ministers’ confab in Saudi Arabia (15-16 November) is supposed to lay out next steps for delivering on promises made in the Declaration on Antimicrobial Resistance approved at the UN High Level Meeting, 26 September in New York City. September’s declaration was a major milestone in the battle to bring a long-ignored AMR epidemic to the forefront of global health policy. AMR is associated, directly or indirectly, a “silent, slow-motion pandemic” that could kill some 39 million people by 2050. The mandate to create an “independent panel for evidence for action against antimicrobial resistance in 2025” is embedded in a 15-page text, with 106 clauses. But it is widely perceived as a key next move to maintain strategic momentum on AMR threats. The science panel should “facilitate the generation and use of multisectoral, scientific evidence to support Member States in efforts to tackle antimicrobial resistance, making use of existing resources and avoiding duplication of on-going efforts, after an open and transparent consultation with all Member States on its composition, mandate, scope, and deliverables,” the AMR declaration stated. Final HLM declaration omitted target for reducing animal antibiotic consumption Asian meat-packing house. The science panel is supposed to be created and administered by the Quadripartite of agencies whose role in managing the AMR crisis was also formalized by the declaration. Along with WHO, the four-member body includes the UN Food and Agriculture Organization (FAO), the UN Environment Programme (UNEP), and the World Animal Health Organization (WOAH), a non-UN member state body. And that makes the panel’s mandate and composition a sensitive point, in light of the political pressures from big food and other interests that want to play down their role in fostering AMR risks, which some researchers say is the leading driver. Identified AMR hotspots often align with high volumes of antibiotics sales and use in livestock. Pressures from agri-businesses and meat producing nations already led to the deletion of a target for reducing animal antibiotic use by 30% by 2030 from the final HLM declaration. Now, the question is whether scientists can come together to articulate the evidence and agree on science-based policy recommendations. “Even though the declaration was positive, it also didn’t achieve agreement on things that I, from my professional background, …would say should have been agreed,” Røttingen observed. “And that speaks to the interests and the trade offs between different sectors… it speaks to agri-food businesses versus human health, and that’s why we believe a science panel is important.” He said, “We have the target of inverting AMR-related mortality [by 10% by 2030], but we need even more targets and more ambitious targets, so we have a lot to do,” he said. “In the climate sector, we have the IPCC (Intergovernmental Panel on Climate Change),” Røttingen continued. “We know how … contested the climate space is, but still, we have a collective international evidence base… We need authoritative evidence with scientists working in the human sector and the animal sector that can come together to actually give us that evidence base and give guidance. “ For animal health, as well, the ultimate aim is to curb abuse not essential use Arshnee Moodley, CGIAR-Kenya Worldwide, the overuse of such antibiotics in livestock production is widely regarded among experts as a leading, if not the leading, driver of pathogen resistance. But ultimately, the aim of new measures should be win-wins that ensure better access to vaccines and other measures to pre-empt antibiotic use and ensure animal health, panelists at the sessions also underlined. “You need to be able to communicate with the people who can change that [AMR trends],” said Dr. Arshnee Moodley, a Kenya-based lead of CGIAR, which works with farmers on animal health. “And for me, it’s the smallholder famer outside of Nairobi. I need to be able to tell him or her why they shouldn’t use antibiotics,” she said. “And that’s really critical because livestock is also part of the solution; it’s vital food for vulnerable groups,” she continued. “I worked every summer in my grandfather’s farm with three milk houses, from the age of 13. So I know about animal health and the need for small farmers, even in high income countries, to keep their herds healthy,” Røttingen countered. “When I’m concerned about the agricultural sector, it’s not really about the misuse of antibiotics among small scale farmers … it is about big food on several continents and making sure that they are … transparent and they are willing to engage in proper animal welfare, because that’s the starting point for ensuring animal health. Too often, measures related to vaccines and hygiene are bypassed, “by using antibiotics to treat herds that aren’t necessarily requisite,” he explained. Worst of all, is the use of antimicrobials or antibiotics “as growth promotion that has nothing to do with animal health. It’s not healthy for those who eat those animals, and it’s not healthy for the animals. “So … animal health is an important part, but I think the hardest question lies with the big food companies.” For human health – more prevention and better regulation are essential too Malawi’s Minister of Health Khumbize Kandodo Chiponda with Tamas Koncz, Pfizer Germany Much as with animals, infection prevention, appropriate access to drugs and better regulation need to be the operative goals for humans as well, panelists at a second high-level session on AMR agreed. That includes clean water, sanitation and hygiene that many communities and health facilities still lack, as well as stronger laboratory networks, and quality control of antimicrobials in settings were fake and substandard formulas often circulate. “Unfortunately for countries like us, we face challenges, because in terms of manufacturing… we have to get them [products] from outside. So in terms of the quality…. you cannot be 100% sure that what you’re getting really is the very, very good quality,” said Khumbize Kandodo Chiponda Minister of Health, Malawi, speaking at the panel hosted by the global non-profit antibiotic accelerator CARB-X and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Changing community behaviours and patterns can be a major lift, in light of the ease with which people can get antibiotics through more informal channels as well as the expense people might face in seeing a healthcare professional – who will in turn face challenges determining if antibiotics are needed or not – without adequate diagnostics equipment. Access to antibiotics is improving – but Africa is also becoming an AMR hotspot Buying antibiotics in India. Prescriptions are required but the rule is not always enforced. “Access to antibiotics [in LMICs] is improving and that is a good thing,” said Tamas Koncz, a vice-president of Pfizer’s operations in Germany. He pointed to data citing a 114% increase in antibiotic use in low- and middle-income countries between 2000-2015. Pfizer’s 2022 Accord for a Healthier World, which committed to providing all of its patented medicines and vaccines to 45 lower-income countries on a not-for-profit basis, has been one enabler of better access to common antimicrobials, he said. At the same time, weak enforcement of prescription drug rules, as well as a lack of health provider knowledge about which drugs to prescribe, are drivers of drug resistance. “If physicians are not using [the drugs] appropriately, then it’s going to lead to problems. So we need to fix the challenge of access. But I think what is even more important is the overall approach.” Africa, where sales of antibiotics by unlicensed vendors is often widespread, is also becoming a major AMR hotspot, he pointed out – highlighting the challenges of balancing access with judicious use. All-age rate of deaths attributable to/associated with antibiotic resistance, 2019. (Lancet, 2022) The landmark 2022 Lancet study that found 1.27 million deaths globally in 2019 were directly attributable to drug-resistant bacterial infections, including 860,000 in Africa. That same year, Africa saw 640,000 deaths from HIV. “We know from the recent communication from the African CDC and others, that it’s becoming probably the one of the biggest, if not the biggest, healthcare burden, superseding now HIV AIDs, maybe even malaria and tuberculosis,” said Koncz. ‘Pull’ incentives Florence Séjourné, Aurobac and Kevin Outterson, CARB-X. On the supply side of the equation, meanwhile, “more pull incentives” that can incentivize pharma developers of newer, pathogen-resistant antibiotics is a long-neglected topic now finally rising to the top of health ministers’ agendas. The challenge lies in the fact that new antibiotics capable of beating drug-resistant infections also need to used sparingly – to ensure that they, too, don’t fail prey to AMR. But that means companies that develop the drugs can’t count on revenues from blockbuster sales to pay back years of investment in clinical trials. “AMR innovation is in a broken business model right now, needing incentives.” said Florence Séjourné. She is the CEO of the Aurobac Therapeutics, a joint AMR R&D venture created by two leading European pharma firms as well as the founder of the BEAM Alliance association of AMR-focused biotechs. Products risk death in the pipeline While there are now 20 “highly innovative” antibiotics in the early stages of development globally, the number will have dwindled by 75% within eight years if the business model doesn’t change, warned Dr Kevin Outterson, head of CARB-X. “Within four years, we’ll have less than 10 in clinical development globally. And four more years after that, we’ll have less than five.” The of human capital” he added as large companies shut down programmes, and research is concentrated in underfinanced biotech startups. “There is absolutely no interest in private investors in the antibacterial field, which is complex,” added Séjourné. Of the startups, 60% of the BEAM Alliance members have less than a year of cash to fund their activities; 40% are firms of less than 9 employees. “The world is relying on micro companies, companies with less than 10 employees…That’s a very fragile base,” for developing urgently needed new drugs, Outterson added. On the cusp of a solution? Bacterial culture prepared for testing new antibiotic candidates. But, there are also some glimmers of hope on the horizon. The first was the launch of the United Kingdom’s new “subscription model” in May for antimicrobial drugs that need to be held in ‘reserve’ for drug resistant pathogens. This aims to guarantee innovators a return on new drugs, regardless of the quantities used, that can guarantee a market incentive for new drugs, even if they are carefully rationed. Séjourné praised the UK decision as “something to highlight has a good example for others to follow” – although she warned that until a larger number of countries get on board with such changes, “the broken business model will remain.” More recently, at the 10 October meeting of G7 health and finance ministers in Ancona, Italy’s Minister of Health, Orazio Schillaci announced a series of new “pull incentives” aimed at stimulating R&D and ensuring biotech firms a payback on their investment. Canada is also piloting an incentive programme, while other European Union members, as well as Japan, are considering similar moves. In light of those new developments, CARB-X’s Outterson sounds a note of cautious optimism. “At the G7 meeting, I made the economic case for a small, reasonable investment and push and mostly pull incentives, together, yields an amazing return on investment, both on the health side as well as the economic side,” Outterson said. “It was a rare opportunity to be able to speak not just to the health people, but also the finance people,” he said, noting that the issues raised at the meeting appeared to resonate with both sectors. “And so we have a problem, and we know that it’s desperate, and companies are filled with innovation, but not enough capital to move things forward. But we really are on the cusp of the solution as well.” IFPMA Director David Reddy “The UN meeting finished only a few weeks ago,” said IFPMA director David Reddy. “We’re moving towards the meeting in Saudi Arabia, which is the fourth AMR high level event. “I think one thing that is really important is that we are getting a common understanding of where we need to go, and what the challenges are,” he added. “We do need to make progress on the business model. The UK, Japan have already made good moves towards pull incentives, and a pilot has been put in place by Canada. There are a lot of remaining challenges, but I think the key message coming out of this is there is a real thirst to maintain momentum as we head into the meeting in Saudi Arabia.” But “it’s not just about financing,” he added, “it’s also about people and competencies.” “Access but having a really firm understanding of community needs on the ground is essential, because without that, we won’t make progress in the fight against AMR and in bringing antibiotics to those who need them.” Image Credits: USAID Asia/Flickr, USAID Asia , Health Policy Watch , Van Boeckel, Pires et al, 2019, WHO, The Lancet, 2022, AMR Industry Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. 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Sustainability is the Focus of WHO’s mRNA Vaccine Programme as Partners Look Beyond COVID 20/11/2024 Kerry Cullinan Afrigen’s Petro Terblanche at the progress meeting. CAPE TOWN – Sustainability is the priority for vaccine manufacturers that are part of the mRNA technology transfer programme established by the World Health Organization (WHO) and the Medicines Patent Pool (MPP). The programme was launched in 2020 to equip low and middle-income countries (LMIC) to make their own COVID-19 vaccines to address the inequity exposed by the pandemic – but few countries want or need these vaccines now. “The network was built on the premise of a COVID-19 vaccine market. What do the manufacturers do to stay alive?” asked Martin Friede, head of WHO’s vaccine development unit, at a three-day progress meeting in Cape Town. The immediate priority is to ensure that the 15 partners in the network can “make commercially viable products that they can sell and that there are people out there who want these products,” he added. Dengue, H5N1, malaria, cholera and Rift Valley fever (RVF) are some of the vaccines under research and development (R&D). Meanwhile, South Africa is putting much of its focus on trying to develop an mRNA vaccine for tuberculosis, the world’s biggest infectious disease. Some manufacturers also looking at vaccines for zoonotic diseases like leishmaniosis, which affects people and animals, and animal vaccines to keep their new facilities “warm” and ready for the next pandemic. MPP executive director Charles Gore said that manufacturers can also go beyond mRNA: “We need monoclonal antibodies and immune modulators.” But unless the manufacturers sell vaccines and other products to address the health challenges of their regions, they will either go bankrupt or move on to commercially viable products, and their new capacity will be lost by the next pandemic. In 2023, the South African government, which hosts the mRNA hub, opted to procure pneumococcal vaccines from an Indian company rather than local company Biovac, which is part of the programme, because they were cheaper. In the meantime, the vaccine platform, Gavi, has set aside money to assist up-and-coming vaccine manufacturers particularly in Africa to compete in a tight market. Amazing progress – and financial challenges Charles Gore, executive director of the Medicines Patent Pool. Despite the challenges, progress has been “really amazing,” said Gore of the programme that started in Cape Town, South Africa. “We are now poised to establish a sustainable mRNA vaccine production capacity that will benefit millions across the Global South, truly redefining what health equity can look like on a global scale,” added Gore. From zero mRNA manufacturing capabilities in LMICS at the launch, the initiative expects 11 state-of-the-art good manufacturing practices (GMP) certified mRNA manufacturing facilities to be launched in 10 countries by 2030 – two within the next year. Should this happen, the network will be able to make 60 million doses annually by 2030, with the potential to scale up to a maximum of two billion doses in the event of a pandemic. The initiative is supported by the governments of South Africa, France, Belgium, Canada, the European Union, Germany, Norway, and the ELMA Foundation. “Despite remarkable progress, additional funding is required to fully achieve the programme’s ambition. An estimated $200 million is needed to advance all manufacturers to GMP standards and continue to strengthen the R&D pipeline in support of at least 12 mRNA products currently in development,” the MPP noted in a statement on Wednesday. South Africa leads South Africa was chosen to lead the initiative because of its strong research community and manufacturing sector, according to Gore. Commercial company Afrigen was appointed as the “hub” of the programme. Within six months, its scientists had developed an mRNA vaccine based on the Moderna vaccine – although the drug company declined to offer any help. Afrigen has since trained 15 partners to develop mRNA vaccines from Argentina, Bangladesh, Brazil, Egypt, India, Indonesia, Kenya, Nigeria, Pakistan, Senegal, Serbia, Tunisia, Ukraine and Vietnam. Afrigen expects to be GMP-certified within the next year but it too is challenged by the need for commercially viable products, particularly as money for the mRNA initiative only runs to 2026. CEO Dr Petro Terblanche says her company and others in the network are exploring a variety of options to keep afloat including “blended finance” from governments, donors and development banks. South African manufacturer Biovac is the manufacturing arm of the country’s consortium. It is in the process of developing a cholera vaccine which enters clinical trials next year. Scaling up Some of the partners, such as BioFarma in Indonesia and Egypt’s BioGeneric are not only honing their ability to make vaccines but scaling up their manufacturing capacity to produce millions of vaccines per year. Biofarma’s Indra Rudiansyah said that the Indonesian company was expanding its site and had a candidate vaccine for rabies. BioGeneric has four vaccines in the pipeline including rabies and polio, and now has fill-and-finish capacity to make 30 million vaccine doses a year. It has invested $50 million in expansion. “But it’s very hard to know when we will reach profitability,” said Heba Wali, the company’s general manager. Companies that are government-funded have more security. Bio-Manguinhos, which falls under Brazil’s science foundation, makes vaccines for the country’s public health programme. “There is a very strong possibility that our government will use our mRNA COVID-19 vaccine,” said Patricia Neves of Bio-Manguinhos. Kenya’s Biovax is 100% state-owned, and its government has procured a $120 million loan from the World Bank for its expansion. However, it’s biggest challenge is that it is unable to compete with the salaries paid by commercial companies. Meanwhile, Senegal’s Institut Pasteur Dakar, have gone from three employees to 16 and still are far from ready to manufacture vaccines. Regional co-operation But, said Friede, “most of the vaccine manufacturers on earth are not research entities. They are manufacturing entities. They go and buy their research from universities or biotech companies. “How are we going to ensure that these manufacturers get access to a portfolio product that they can manufacture?” To assist with this, R&D consortia have been set up to lead product-orientated research. Most consortia are aimed at developing vaccine candidates for diseases that are priorities in their regions. The partners have organised themselves into R&D consortiums The consortia are bringing in experienced translational research groups like the International Vaccine Institute in Korea and Hilleman laboratories in Singapore and universities, said Friede. At least 13 of the 15 partners and the WHO have also signed a memorandum of understanding with Professor Drew Weissman at the University of Pennsylvania, who is assisting in building their research development capacity and they will get access to the portfolio of products coming out of this. Weissman and Katalin Karikó won the Nobel Prize for Medicine in 2023 for their work on mRNA. The Southeast Asia consortium is fairly advanced in its work on four mRNA vaccines for dengue, HPV, malaria and Enterovirus. Any vaccines developed through this initiative will be shared across participating LMICs. South East Asia consortium’s mRNA vaccine plan Moderna has around 5,000 scientists, which is hard to compete with, added Friede. But the consortia are enabling the network to start building “the critical mass that is necessary to ensure that LMICs can get a portfolio of products that have been taken to a certain point in development and then transferred over”. “The point of the network is sharing and collaborating,” said Gore, adding that those in the network will get preferential treatment and access to products. Image Credits: Kerry Cullinan, Rodger Bosch / Medicines Patent Pool. Residents in Delhi Advised to Wear Masks as Air Pollution Reaches ‘Severe Plus’ Levels 19/11/2024 Disha Shetty Delhi and its neighboring city of Gurgaon (pictured above) are engulfed in a layer of smog due to the high levels of air pollution. Schools were closed, vehicle entry restricted and India’s top court on Monday advised residents of Delhi’s metropolitan area to wear masks as the capital city was shrouded in “severe plus” levels of air pollution for the second day in a row. For the past week, Delhi’s air pollution has been in the “severe” category – dashing government claims that improved surveillance of rural crop burning and other measures to ease the annual pollution emergency are working. On Monday the PM2.5 air pollution levels – particles so small that they can be inhaled deep into the lungs and even into the bloodstream – were nearly 17 times the limit set by the World Health Organization (WHO). WHO limits for PM2.5 over a 24-hour time period is 25 micrograms per cubic meter of air (μg/m3), while some monitors in Delhi measured PM2.5 levels at 420 μg/m3. Air pollution is a year-long problem in Delhi, but the halt of monsoons in the autumn as well as low wind speeds – what the government calls “unfavourable meteorological conditions” – have long sent toxic levels of air pollution soaring in the late autumn. And the burning of rice stubble in surrounding rural states such as Haryana and Punjab continue to exacerbate conditions, said Delhi’s chief minister Atishi Marlena during a press interaction. The problem became much worse ever since 2008, when the national government ordered farmers to delay the planting of rice crops until later in the spring – thus delaying the harvest date and leaving farmers in a rush to plant a crop of winter wheat. On Monday, Delhi’s PM2.5 levels were 420 μg/m3 – nearly 17 times above the recommended WHO 24-average of 25 μg/m3. Farmers avoiding surveillance satellites While state governments claim to have clamped down on farmers who set their fields on fire to clear the paddy stubble, stepping up surveillance and fines, satellite images reveal something else. To avoid being detected, farmers are merely setting the stubble on fire later in the afternoon, after the satellite that the government uses for surveillance information passes, experts told Health Policy Watch. To improve enforcement, stationary satellites should be used instead, they said. See related story: Delhi Air Pollution: Is Government’s Satellite Monitoring Missing Stubble Fires? Aarti Khosla, Director of Delhi-based research consultancy Climate Trends said that rather than blaming only the rural areas, Delhi officials need to better manage the city’s background air pollution levels year-round. “Agricultural farm burning, contributes, on the days when it’s a peak, to 40% of Delhi’s air [poor] quality,” she said at a press conference on the sidelines of UN climate conference (COP29) in Baku. “And when, when it’s not a peak, it’s 2-3% of its problem.” Aarti Khosla, Director of Delhi-based research consultancy Climate Trends during a press conference at COP29. Short-term measures Along with the advise about masking, the government has ordered most schools to hold classes online, barring a few exceptions. Vehicles that do not meet pollution norms will not be allowed into the city. All construction activities have been halted given their contribution to increasing dust. Options to allow government employees to work from home or call in a reduced number of employees to the workplace are also being considered. The government has already deployed vehicles that are spraying mist on the streets and the trees nearby to reduce the dust. Experts though have been pointing out that such measures are short-term and will do little to reduce the city’s toxic levels of air pollution, or the autumn emergency that recurs annually. Air pollution is the biggest threat to health today & is not limited to a city, state or country. Needs a science-based approach with actions in multiple sectors – transport, construction, factories, cooking fuel, agriculture etc. We can solve the problem, other countries have. — Soumya Swaminathan (@doctorsoumya) November 18, 2024 ‘We want pollution levels to be down year-round’ “Ultimately, we want the pollution levels to be down year round and not just the extremes or winters,” Sarath Guttikunda, director of the Delhi-based Urban Emissions.Info that monitors and researches air pollution research, told Health Policy Watch, in an emailed comment. “Five items which need a long-term vision,” he added, “aggressive expansion and promotion of use of mass transport (especially buses), walking, and cycling modes; promotion of clean fuels like electricity or gas for heating during the winter months; strict enforcement of a ban on open waste burning; clear mandates for complying with emission norms for all industries including brick kilns; and management of road dust,” he said. He also said that the promotion of green spaces adds to a city’s air quality and ‘breathability’. Delhi is currently among the most polluted cities in the world. In rural areas, officials have long spoken about promoting alternatives to rice-stubble burning, such as machine crushing of stubble and expedited composting formulas. But these, too, have not been backed with sufficient levels of state or national government incentives – or enforcement for those who continue to burn. Shifting government subsidies away from rice production to support the cultivation of more nutritionally rich, indigenous grains, such as millet, has also been advocated by environmentalists to reduce stubble. They point out that the rice is now largely produced for export and is a heavy consumer of water, draining underground aquifers. However, the rural farm lobby in Punjab and Haryana is a powerful force and politicians have been generally fearful about changing the status quo. The high levels of air pollution in Delhi and its surrounding cities are a health hazard, warned health experts. Impacts on climate and health South Asia which has among the highest air pollution levels in the world reports an estimated two million deaths annually that are linked to air pollution. The Southeast Asia region typically suffers from the highest pollution levels in the world, with an estimated 2 million deaths annually, according to WHO. And the annual pollution emergencies that strike at Delhi, in fact affect the shared airshed of a much larger area – the sprawling Indo-Gangetic Plains and Himalayan Foothills region extending from eastern Pakistan, where crop-stubble burning also is widespread, across northern India and Nepal to Bangladesh. Satellite image shows smoke from a large number of small fires across the Indo-Gangetic plain and Himalayan foothills, a shared airshed across four countries. That has led to groups such as the World Bank to call for a broader, regional approach to air quality management. But so far attempts to trigger political cooperation across fraught borders have engaged scientists, but not always top political leaders. Reducing air pollution also reduces climate change – a “triple win” for health, climate and economic development, experts have maintained. Fossil fuel burning is directly responsible for a significant proportion of air pollution related deaths, so shifting to renewables has synergistic effects, noted Marina Romanello in the 30 October launch of the Lancet Countdown on Climate and Health. In addition, methane waste emissions and black carbon particles emitted by open crops, waste burning and household fuels are short-lived climate pollutants that exacerbate snow melt and warming temperatures. Speaking from Baku’s COP29, WHO’s Director for Environment and Climate Change Dr Maria Neira, too, drew attention to Delhi’s staggering levels of air pollution during a press conference. “The same causes that are responsible for global warming, the combustion of fossil fuels,… are the causes of air pollution as well,” she said. “At the moment we are talking here, people in one place in the world are breathing air with 400 micrograms/ per cubic meter of pm.2.5,” she said, displaying a WHO ‘BreatheLife’ gauge that reflects how Delhi’s annual air pollution levels exceed WHO guideline norms more than 12 fold. WHO’s Maria Neira displays WHO ‘BreatheLife’ gauge showing how Delhi’s annual air pollution levels exceed WHO guidelines more than 12 fold. The acutely high air pollution levels are a long-term term risk for health, with one-quarter to one-third of deaths from hypertension and other cardiovascular diseases, lung disease as well as lung cancer attributable to air pollution. But they are also a very immediate health emergency, said Dr Courtney Howard, vice-chair of the Global Climate and Health Alliance (GCHA), at the same COP press briefing. “So when air pollution levels are as high as they are in Delhi today, what we’ll be presenting to emergency departments are people with breathing problems from asthma, from chronic obstructive pulmonary disease. People will be coming in with chest pain due to heart attacks that get worse. Strokes are made worse by high levels of air pollution on a more chronic basis. It does increase risks to newborns,” said Howard. Image Credits: Chetan Bhattacharji, AQI, IQAir, Our World in Data, NASA, WHO. Health Secures Permanent Spot on COP Agenda – But Little Else 19/11/2024 Stefan Anderson After decades of advocacy, health secures a permanent spot on the UN climate summit agenda. The World Health Organization’s marquee event at COP29 in Baku produced a document that captures the growing frustration felt by delegates, civil society, and people across the globe with UN climate negotiations: a “letter of intent” to form a coalition to continue discussions about taking action. In stark contrast to the glitzy, Bill Gates-adorned fanfare of the inaugural COP Health Day in Dubai a year ago, the WHO-led high-level ministerial on Monday took place in a cramped, windowless meeting room – though, to be fair, the ground floor of Baku’s football stadium, the venue for COP29, has no windows. Seasoned UN observers sensed the event, billed as a “round table” emphasising “sharing best practices” and “reinforcing sustained action,” was unlikely to make headlines. While Dubai’s celebration drew VIPs and global attention, this year’s event peaked at just 18 guest attendees on a Microsoft Teams call attended by Health Policy Watch. The meeting resulted in the “Baku COP Presidencies Continuity Coalition for Climate and Health,” an acronym sure to catch on at the UN climate talks: BCPCCCH. Thank you @COP29_AZ Presidency for establishing the Baku COP Presidencies Continuity Coalition on Climate and Health. This initiative unites the visionary leadership of five COP presidencies that span this critical time for action, underscoring a commitment to elevate health… pic.twitter.com/QhDl91aeFN — Tedros Adhanom Ghebreyesus (@DrTedros) November 13, 2024 The new coalition, coordinated by Azerbaijan in partnership with previous COP hosts Egypt, the United Arab Emirates, the United Kingdom, and the next host, Brazil, commits COP presidencies to ensure health is a central agenda item at future UN climate summits. “By signing the Letter of Intent, we commit to a shared vision of a world where climate and health policies are not isolated but integrated into all aspects of governance and development,” Azerbaijan’s Minister of Health, Teymur Musayev, said in a press conference following the signing. Musayev said the coalition was “not created for dialogue alone,” though provided few specifics on objectives beyond strengthening health initiatives agreed upon at past COPs. ‘Significant milestone’ WHO hailed the letter of intent as a “significant milestone,” while its director-general, Tedros Adhanom Ghebreyesus, said it “unites the visionary leadership” of COP host countries and shows “a collective will to prioritize climate and health now and for the future.” Adding to the chorus of UN buzzwords, COP29 President Mukhtar Babayev called the coalition “another step towards synergistic action on climate and health.” The agreement falls short of making health a formal topic in UN climate negotiations – long considered the holy grail for the health community – despite evidence climate change-related developments, from air pollution to extreme weather, cost nearly ten million lives annually. While both the Azerbaijani presidency and WHO have issued press releases, the letter of intent itself has not been made public at the time of publication. “With the Continuity Coalition, there is now a mechanism to foster presidency-led, high-level attention to health as the norm,” Dr Jeni Miller, executive director of the Global Climate and Health Alliance, told Health Policy Watch. “What we will be looking for is how it makes that a reality.” Missing the mark Delegates celebrate the creation of the Baku coalition following the WHO-led Baku Coalition signing ceremony. For communities on the frontlines of the climate crisis, the pledge to have future discussions about potential actions to protect health – and the celebratory tone adopted by ministers like Babayev and Musayev – miss the mark. The loss of life from climate change and disease that could be prevented by nations living up to Paris Agreement Targets – an ambition so far absent at the midway mark in Baku – would save two million lives annually, WHO said in a report ahead of COP29. Civil society stakeholders from frontline countries are demanding $5 trillion in annual funding as the bare minimum outcome of the summit to cope with the damage already incurred and to adapt and mitigate future climate change. Nations are less ambitious than civil society in their demands, with most targets from developing countries, including the Arab and the African Groups, hovering around the $1-2 trillion range. As the summit enters its second week and UN climate negotiations near the three-decade mark, words on a page, absent any legally binding or financial backing, are ringing increasingly hollow. “I see a disconnect between the global conversation and discourse with the reality that countries are facing,” Nigeria’s Minister of Health, Mohammed Ali Pate, said following the signing ceremony including the countries that inaugurated the coalition. “Nigeria and other countries are pulling within their limited resources,” Pate said. “We need to reconcile this divergence between global rhetoric and real action backed by resources for those who are bearing the brunt of climate change.” What’s the point? WHO COP29 high-level ministerial in progress in Baku. For frontline communities, the Baku coalition’s non-binding ‘promises’ are pyrrhic victories. But for the WHO and health advocates, they represent hard-fought institutional progress. The fight for health to be recognised as a central concern in UN climate summit agendas has been an uphill battle, mirroring the decades-long struggle to force nations to acknowledge the role of fossil fuels in the climate crisis. Just as it took nearly three decades of UN climate negotiations for the global community to finally commit to “transitioning away” from fossil fuels in Dubai last year – making headlines across the globe – the inclusion of health in the climate agenda is a victory that was won over decades. The health breakthrough is also reminiscent of another recent milestone in global environmental negotiations. Just a month ago in Cali, Colombia, Indigenous communities were granted an official expert body seat in UN biodiversity negotiations after years of tireless advocacy, prompting emotional scenes from people and communities who fought relentlessly for recognition. “The place that we have gained over the years for health at the COPs is now secured,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “We don’t need to fight every year to obtain this space.” Indigenous delegates at COP16 in Cali, Colombia, celebrate victory as decades of advocacy and activism lead to official representation in international negotiations. The coalition’s key achievement, while bureaucratic, is significant: after decades of fighting, health advocates and WHO officials will no longer have to relitigate the importance of health as a central concern in climate talks. “Each victory has been a step forward in getting health into the climate conversation,” Miller said. “Negotiators and heads of state [now] recognise that when they are making decisions about climate action, they are making decisions about people’s lives.” WHO can also claim the establishment of the Baku Coalition meets its basic goal for the talks – ensuring delegates recognize they’re negotiating the health of eight billion people – though the 18 attendees on Teams suggest the message may not have reached many member states. That such a modest procedural win emerges as COP29’s headline health achievement however challenges WHO’s message, pushed through two decades of pre-COP media blitzes, that health – as the lived experience of climate change – would be “the argument” driving meaningful climate action. So far, the evidence from Baku suggests that national delegations still aren’t listening. Time saved? It remains to be seen whether the time saved on bureaucratic wrangling with COP presidencies can translate into more careful tracking of achievements or barriers to fulfilling health-related commitments made at previous COP summits. At Glasgow’s COP26, the Alliance for Transformative Action on Climate and Health (ATACH) was launched with a promise to transform health systems to be more climate resilient. The coalition now includes 91 nations – half of UN climate summit participants – after Azerbaijan joined on Monday. While WHO monitors commitments made by ATACH members to low-carbon and net-zero health systems, there is no oversight of whether these have translated into action. Limited international funding available for health has gone largely unnoticed, even by the only country receiving support from the world’s leading climate fund, the Green Climate Fund (GCF). Malawi is the sole recipient of a GCF grant targeting the health sector’s climate needs. Yet Malawi’s own climate minister, interviewed by Health Policy Watch this week, was unaware of the GCF-funded project in their country. GCF has not responded to a request for comment. Baby steps, urgent crisis Delegates convened for the first-ever Health Day at a UN climate summit in Dubai. Last year seemed to mark another step forward in health action, with 150 nations signing a Health and Climate declaration during the first dedicated Health Day in three decades of climate talks. The Dubai COP also featured a two-week series of climate side events at an expanded WHO Health Pavilion, highlighting the impacts of climate change on food systems, air pollution, household air pollution, energy, and biodiversity. But beyond the political rhetoric, it remains unclear the level of progress being made in getting health into formal adaptation and mitigation processes. Health-specific climate action remains severely underfunded, still capturing only 2% of adaptation funding and 0.5% of multilateral climate funding – unchanged since Glasgow five years ago. At COP29, health financing announcements have amounted to a single $10 million grant from the Islamic Development Bank to the WHO. WHO influence in jeopardy WHO kicked off a funding drive to fill its multi-billion budget shortfall in Berlin last month. The WHO’s influence in the funding arena is further complicated by its own financial instability. Already grappling with a multi-billion dollar budget shortfall, the organization faces additional uncertainty with the possibility of the US, its biggest single donor, cutting funds when President-Elect Donald Trump returns to office in 2025. Trump withdrew from WHO in his previous term, and many in his orbit expect the incoming president to do the same this time around. Top WHO officials told Health Policy Watch last month another Trump withdrawal of funding reinstated by Biden would result in a “dramatically bad crisis” for the UN health agency. Brazil offers a glimmer of hope The Amazon Rainforest, Brazil. The buzz in the health world ahead of talks in Baku was to not expect significant health outcomes from COP29. Finance was always going to dominate the agenda, and Azerbaijan – whose delegation has by some accounts never spoken at COPs before hosting this one – was unlikely to lead on the issue. Looking ahead, Brazil’s hosting of COP30 offers a glimmer of hope to many in the health world. Brazil’s president, Luiz Inácio Lula da Silva, has pledged to act on climate and protect the Amazon, reversing four years of the legacy left by his predecessor, Jair Bolsonaro, who denies climate change and allowed deforestation and exploitation of the tropical rainforest to expand at an unprecedented rate. Brazilian officials have also committed to prioritizing health initiatives on next year’s agenda, already participating in high-profile WHO events in Geneva and Berlin ahead of the summit. In Baku, Brazil’s health minister announced that equality will be a key focus of its upcoming COP presidency. And with universal health coverage deeply embedded in Brazil’s national identity, there’s cautious optimism that meaningful health and climate action might finally move from rhetoric to reality in Rio. Image Credits: COP16, WHO , CIFOR-ICRAF. Jeddah Conference Announces More Measures to Combat AMR – But Implementation Plans Are Still Vague 18/11/2024 Kerry Cullinan Saudi Health Minister Fahad Abdulrahman Aljalajil addresses the Ministerial Conference on Antimicrobial Resistance (AMR) in Jeddah. Government leaders from the health, environment and agriculture sectors in 57 countries adopted a 14-point plan to tackle antimicrobial resistance (AMR) at a meeting in Saudi Arabia that ended over the weekend. One of the undertakings of the Jeddah Commitment is support for the establishment of an independent panel to collect evidence about AMR. The United Nations (UN) High-Level Meeting on AMR had already committed to such a panel in September and gave the Quadripartite (Quad) organisations – the World Health Organization (WHO), Food and Agricultural Organization (FAO), UN Evironment Programme (UNEP) and World Organization for Animal Health (WOAH) – the authority to set up the panel. The ministerial conference resolved to support the Quad in a “timely, open and transparent process” to set up “an Independent Panel for Evidence on Action Against AMR”. However further details, including which UN agency should host the panel and its terms of reference, have not yet been resolved. The UK is believed to favour UNEP hosting the panel while other countries believe that the WHO is better equipped to do so as the global health body houses the Quad. The declaration also call for the creation of a new “biotech bridge” to boost research, development and innovation to find solutions to AMR. AMR happens when bacteria, viruses, fungi, and parasites develop resistance to medicines designed to kill them. This makes infections harder and more costly to treat. Drug-resistant pathogens can also spread between people, animals, and the environment. It is driven in large part by the misuse and overuse of antimicrobials, particularly in agriculture. AMR already causes an estimated 1.27 million deaths per year. From agricultural runoff to wastewater, #AntimicrobialResistance spreads through our land & water, threatening ecosystems & health. Effective handling of fertilizers, wastewater & proper hygiene practices can help reduce #AMR in the environment. More🔗https://t.co/7mtNh4ejnI pic.twitter.com/9416GlR4eX — FAO Knowledge (@FAOKnowledge) November 18, 2024 Saudi Arabia launches regional hubs Meanwhile, Saudi Arabia will launch a regional antibiotic access and logistics hub and an AMR One Health learning hub, the country’s health minister, Fahd bin Abdulrahman Al-Jalajel, told conference delegates. The access and logistics hub will initially operate as a pilot in the WHO’s Eastern Mediterranean Region (EMRO). Its purpose is to foster the sustainable procurement of antibiotics and diagnostics and improve end-to-end access to these. A conference participant told Health Policy Watch that the hub would stockpile antibiotics and establish distribution networks to ensure that they reach areas in need, particularly conflict zones. EMRO members include Palestine, Lebanon and Sudan. The One Health AMR Learning Hub will focus on sharing best practices and developing capabilities on how to implement national AMR action plans on AMR with specific national targets. ‘Misunderstanding’ of animal welfare Wendla-Antonia Beyer, policy officer at the farm animal welfare and public health organisation, Four Paws, said that while the Jeddah Commitment “shows there is momentum behind tackling AMR” it also shows that there is “insufficient understanding of how animal welfare impacts antibiotics use in farming”. Beyer said that “73% of our antibiotics are used in agriculture, often for growth-promotion or for diseases that could be prevented if farms had good animal welfare. “Farms where piglets spend more time with their mothers use less antibiotics. Farms with slower-growing chicken breeds use less antibiotics. The solutions are there, proven and viable — they only need to make it into policy and practice. With the Political Declaration and the Jeddah Commitment behind us, governments and global governance structures now need to make animal welfare an integral part of the One Health response to AMR.” Katherine Urbáez, who heads the Health Diplomacy Alliance (HDA), said her organisation would “continue to advocate to ensure the continued political and financial commitment and to tackle AMR”. “This includes the setting up of the panel with the scope and governance that allows the identification of the data and to advance the commitments in the HLM Policital Declaration”. HDA is based in Geneva and works with multi-stakeholders to advance health with diplomacy. This week is World AMR Awareness Week, which has its theme as “Educate. Advocate. Act now.” Image Credits: Health Ministry of Saudi Arabia. Pandemic Agreement Makes Progress But Still Plenty of Sticky Details to Address 15/11/2024 Kerry Cullinan INB co-chair Anne-Claire Amprou and the WHO’s Mike Ryan at the close of INB12. The latest draft of the World Health Organization’s (WHO) pandemic agreement is awash with green highlights – an indication that countries have reached consensus on much of the text. But the Intergovernmental Negotiating Body (INB) announced on Monday that it would not be possible to reach an agreement by December – and countries would push for the adoption of an agreement by the World Health Assembly (WHA) next May. During the past two weeks of the 12th meeting of the INB, progress has been made on research and development(Article 9), local production(Article 10) and regulatory systems strengthening (Article 14). Sticking points But Article 4 on prevention, which details countries’ pandemic prevention and surveillance obligations, is mostly highlighted in yellow. This means that countries have broad agreement on the text but much of the detail is not agreed. Many of the proposals are common sense – such as building the capacity to detect pathogens at the community level, routine immunisation, and prevention of zoonotic spillover. But these measures are a tall order for some low-income countries, which is partly where the resistance is coming from. Under-resourced countries are unsure of how much prevention will cost them and whether they will get help to implement the provisions. Wealthier countries want assurances that their poorer neighbours can contain outbreaks. The rapid spread of mpox in central Africa is an example. Several affected countries have been unable to confirm cases as they lack basic diagnostic laboratories and trained staff. Negotiators are considering a separate annex on prevention, much as the details of a Pathogen Access and Benefit Sharing (PABS) system may be accommodated in a separate annex. Sticking points also remain on technology transfer (Article 11), the PABS system (Article 12), the global supply chain and logistic (GSCL) system (Article 13) and sustainable financing (Article 20). However, the most tangible offering of the agreement is back on the table although not yet agreed: that 20% of vaccines, therapeutics and diagnostics produced to combat that pathogen during a pandemic will be allocated to the WHO for distribution with 10% given free and the remaining amount on yet-to-be determined terms. Earlier, there were reports that some members of the European Union wanted this requirement to be cut down to 10% and 5% respectively. ‘Crucial and delicate’ Tanzanian Ambassador Dr Abdallah Saleh Possi. Tanzanian Ambassador Dr Abdallah Saleh Possi, speaking for the 47 African member states and Egypt, expressed Africa’s disappointment that there was not sufficient consensus to call a special World Health Assembly next month. “Although we had such slow progress in this 12th session that did not realize the convening of a special session in December as anticipated, we all agree that the remaining issues are not many, but crucial and delicate, requiring decision-making and flexibility,” said Possi at the close of the two-week negotiations on Friday. “Significantly, the meeting has generated the commitment to finalize them. We thank all the delegations that organize informal meetings on some sticky areas. We support having informal sessions during inter-sessional period with a view to achieving consensus on key areas. The Africa group plus Egypt is happy to be amongst the groups seeking to find consensus on the remaining issues.” The Philippines on behalf of the Equity Group, expressed appreciation for both the “substantive progress” particularly on articles, 9,10 and 14, and “the cordiality displayed by delegations that helped bring about this progress”. However, warned the Philippines’ delegate, “much work needs to be done to achieve consensus on key articles that operationalize equity such as articles, 11,12, 13, 13 (bis) and 20.” Unlike the Africa Group, which wanted a December resolution, the Equity Group has always advocated for more time to deliberate on the agreement. The negotiators reconvene for a short INB session from 2-6 December, where they will decide on the programme of negotiations for 2025. RFK Jr Nominated as Top US Health Official 15/11/2024 Stefan Anderson & Sophia Samantaroy Robert F. Kennedy Jr, scion of America’s most prominent political family, is set to become the nation’s top health official under Trump. Donald Trump has named Robert F Kennedy Jr as his choice for US health secretary, putting the controversial anti-vaccine activist and environmental lawyer in line to control some of the world’s most influential health agencies. Kennedy shot to political prominence during the COVID-19 pandemic when his organisation, Children’s Health Defense, became a leading global voice questioning vaccine safety and efficacy. His appointment, which requires Senate confirmation, comes after Kennedy dropped his independent presidential bid to back Trump. “He’s going to help make America healthy again,” Trump said in a speech at Mar-a-Lago following his election victory. “He wants to do some things, and we’re going to let him get to it.” Trump described the role atop HHS as “the most important role of any administration”, adding that Kennedy “will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country”. I am thrilled to announce Robert F. Kennedy Jr. as The United States Secretary of Health and Human Services (HHS). For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it… — Donald J. Trump (@realDonaldTrump) November 14, 2024 If confirmed, Kennedy would oversee a sprawling $1.8 trillion department with 10 health agencies and three human services agencies. His leadership of HHS would include the administration of Medicare, Medicaid and the Affordable Care Act while setting priorities for America’s three most powerful health agencies: the Centers for Disease Control and Prevention (CDC), which tracks disease outbreaks and sets public health guidance; the Food and Drug Administration (FDA), which approves medicines and medical devices; and the National Institutes of Health (NIH), the world’s largest public funder of medical research. Kennedy, an environmental lawyer with no health experience, called his appointment “a generational opportunity” to realign US health policy and “put an end to the chronic disease epidemic” in a post accepting the nomination on X. He said Trump has instructed him to “reorganize” the U.S. constellation of federal health agencies. “I look forward to working with the more than 80,000 employees at HHS to free the agencies from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth,” Kennedy said. Global health fallout Beyond domestic agencies, the Trump administration is also expected to reshape America’s role in global health. In his last term, Trump withdrew funding from the World Health Organization over its COVID-19 response and slashed funding to UN agencies, leaving a multi-billion dollar gap in the UN health agency’s budget. With Kennedy – who has questioned global health orthodoxies – by his side, experts expect this isolationist stance to deepen. This could affect millions who rely on HIV/AIDS funding through PEPFAR, a $7 billion US program providing HIV treatment in over 50 countries, the CDC’s network of 65 international offices, and State Department health diplomacy efforts. WHO officials told Health Policy Watch last month they face “a huge fear factor” over potential US funding withdrawal, warning the agency would enter “a dramatically bad crisis” without American support. The Biden administration’s global health security team referred Health Policy Watch to the Trump transition team when asked for comment. Robert Kennedy Junior’s banner photo on X, formerly Twitter, where he boasts over 4.5 million followers. Beyond the mainstream Kennedy’s stated priorities for America’s health system veer from broadly supported reforms to debunked anti-scientific claims that have alarmed health experts. In recent weeks, he has called for removing fluoride from US drinking water – which he claims causes brain disease – reviewing vaccine safety data with an eye to withdrawing some from the market, eliminating “entire departments” at the FDA, and immediately dismissing 600 NIH employees. His controversial positions include claims repeatedly rejected by scientists: that vaccines cause autism in children, that AIDS is not caused by HIV, that antidepressants are responsible for mass school shootings, and that atrazine, a widely used herbicide, triggers gender dysphoria and has led to increases in young people identifying as transgender. Kennedy’s unconventional streak isn’t limited to medicine. In the run-up to November’s election, Kennedy said doctors found a worm had eaten part of his brain, video footage revealed him to be the key to a decade-old New York City mystery of a dead bear in Central Park – he dumped it there on his way to the airport – and came under investigation for decapitating a whale. Lawrence Gostin, a global health expert at Georgetown University, called the Kennedy pick “the darkest day for public health and science in my lifetime.” “Trump’s pick of RFK Jr as HHS Secretary is disastrous for public health,” Gostin said. “Having a person sceptical of science and evidence at HHS will make America unhealthy.” Public health victories at risk Public health victories like vaccines and drinking water fluoridation have led to dramatic increases in life expectancy. The World Health Organization estimates vaccines save five million lives annually, with global immunization efforts having saved at least 154 million lives over the past 50 years. Yet Kennedy has repeatedly challenged these achievements by questioning vaccine safety and stating that fluoride is linked to “neurodevelopmental disorders.” The real-world impact of vaccine scepticism is already visible in the US, with the CDC reporting vaccination rates for children dropping for all available vaccines last year and vaccine exemptions for religious reasons rising across the past decade. “Religion doesn’t change that fast,” said Dr Michael Mendoza, a former county Public Health Commissioner in New York State. “This is about ideology and misinformation – and we’re seeing a direct impact in the number of kids unvaccinated.” “We’re at risk of widespread distrust in evidence-based treatments and vaccines,” Mendoza added, noting how health misinformation has directly influenced the increase in risky medical decisions. “Our elected and appointed officials have an obligation to promote experts and guidelines that are grounded in established scientific evidence.” Within the federal workforce, many remain optimistic that little will change. Agencies like the Biomedical Advanced Research and Development Authority (BARDA), which funded the development of COVID-19 vaccines, traditionally receive bipartisan support, resulting in little change across administrations. An HHS employee, speaking to Health Policy Watch on the condition of anonymity to safeguard their job security, noted that the negative perception of the new administration has yet to filter into many agencies. Room for agreement Less controversial is Kennedy’s opposition to the well-documented “revolving door” between the industry and government, where officials frequently switch between regulating companies and working for them – a system he argues has led to the “corporate capture” of US health agencies. In a country that spends more on healthcare than any other developed nation, has one of the world’s highest obesity rates, and whose largest public health crisis – the opioid epidemic – was engineered by pharmaceutical giant Purdue Pharma, his critiques of the system have found resonance. The concern about industry influence has merit: since 2000, every FDA commissioner has taken industry positions after leaving office. Nine out of the last ten, representing 40 years of leadership, have done the same. The pattern continued with Trump’s previous HHS secretary, Scott Gottlieb, who departed to a board seat at Pfizer in 2020. Kennedy’s stance against pharmaceutical interests sets up a likely clash with fellow Republicans, many of whom receive significant industry funding. Several GOP lawmakers have already pledged to dismantle President Joe Biden’s signature Medicare drug price negotiation law, which allows the government to negotiate fairer prices on behalf of its senior citizens, claiming it stifles innovation. Yet Kennedy has promised a direct confrontation with the industry, causing shares of major vaccine makers to plunge after Trump’s announcement of Kennedy’s selection. “Together we will clean up corruption, stop the revolving door between industry and government,” Kennedy said. Kennedy’s promised crusade against chronic diseases and processed foods has also found broad support among public health officials – setting up yet another clash with a major industry traditionally aligned with Republican politics. His pledge to strip ultra-processed foods from school lunches and crack down on food dyes has drawn bipartisan backing, though industry groups warn such moves could increase grocery prices Trump has vowed to reduce. “Senators may say, well, RFK Jr has good ideas like tackling chronic disease and regulating Big Food, but RFK Jr is not to be trusted after a career of peddling falsehoods,” Gostin said. “What we need is nutritional warnings on unhealthy foods, bans on targeting kids, and reduced salt and sugar.” Even some nutrition advocates who oppose Kennedy’s broader agenda acknowledge the need for stricter oversight of the food industry. The FDA has identified concerns about ultra-processed foods’ health impacts, though the agency says more research is needed. The challenge, experts say, will be implementing evidence-based reforms while avoiding Kennedy’s tendency toward unproven theories about food safety. Environmental hero to anti-vaccine empire Headline published in the Defender, the news arm of Kennedy’s anti-vaccine outfit on November 7. Kennedy began his career as a celebrated environmental lawyer, fighting corporate polluters and championing indigenous communities whose lands had been poisoned by industry. His aggressive prosecution of polluters helped restore the Hudson River to health, earning him Time magazine’s “Hero for the Planet” designation. He maintains some of this environmental ethos, promising in his presidential campaign before bowing out to back Trump to tackle unsafe PFAS levels and microplastic contamination. But his path took a sharp turn in 2015 when he took over the struggling World Mercury Project, rebranding it as Children’s Health Defense (CHD) in 2018. Under Kennedy’s leadership, CHD became a global anti-vaccine juggernaut. The organization’s revenue skyrocketed from $1.1 million in 2018 to $23.5 million in 2022, with Kennedy himself earning more than $510,000 in 2022, the last year where filings are available. In mainstream interviews and congressional appearances, Kennedy has worked to promote his least controversial views. He has attempted to moderate his image, telling NBC News: “I’m not going to take away anybody’s vaccines, I’ve never been anti-vaccine.” Yet the organization he led until his presidential campaign – and where he remains a lawyer – continues to fund and promote numerous anti-scientific positions. Public tax filings show Kennedy made $550,000 in executive compensation from Children’s Health Defense in 2022, the last year where records are available. During the pandemic, CHD’s vaccine-related posts were shared more frequently on Twitter than content from CNN, Fox News, NPR and the CDC combined – occasionally eclipsing the readership of the New York Times and Washington Post. The Center for Countering Digital Hate named Kennedy one of the “Disinformation Dozen,” identifying him and CHD as among the top spreaders of vaccine misinformation online. CHD also played a role in coordinating international protests for anti-vaccine movements around the world – with deadly consequences. In 2019, Kennedy’s organization flooded American Samoa with vaccine misinformation and lobbied the government against the use of the MMR vaccine, resulting in a devastating measles outbreak. This week, CHD’s news arm, The Defender, published claims that COVID-19 vaccines pose a “112,000% greater risk of brain clots and strokes than flu shots” – research based on misuse of VAERS, a federal database that records unverified reports of adverse events. The study’s authors include supplement company affiliates and anti-vaccine activists who openly coordinate with Kennedy’s organization. One author chairs a Texas-based organization that tagged Kennedy in a Twitter post on Tuesday calling for the “immediate withdrawal of all COVID-19 vaccines from the market” and the “repeal of the 1986” national childhood vaccination act. In his 2021 book, which sold over a million copies and sat on the New York TImes bestseller list for 17 weeks, Kennedy expands on the ethos behind CDH, calling Anthony Fauci, who led the US response to the COVID-19 pandemic, “the powerful technocrat who helped orchestrate and execute 2020’s historic coup d’état against Western democracy,” claiming his “remedies” – including Covid vaccines – were “often more lethal than the diseases they pretend to treat.” The book also champions Alan Duesberg, praising as “elegant” and “compelling” the discredited scientist’s claims that AIDS is not caused by HIV. Such theories had deadly consequences: 330,000 people died prematurely after being denied life-saving HIV treatment when South Africa’s government embraced view championed by Duesberg in the early 2000s, according to Harvard researchers. Path to Senate confirmation .@RobertKennedyJr has championed issues like healthy foods and the need for greater transparency in our public health infrastructure. I look forward to learning more about his other policy positions and how they will support a conservative, pro-American agenda. — U.S. Senator Bill Cassidy, M.D. (@SenBillCassidy) November 14, 2024 Kennedy’s path to confirmation runs through a Republican-led Senate, where he needs a simple majority of 51 votes. While some Republicans have expressed cautious support, experts point to Trump’s other nominees as the President-elect’s “tests” for Senate loyalty, suggesting the incoming president may bypass the traditional confirmation process entirely. “Any Republican Senator seeking the coveted LEADERSHIP position in the United States Senate must agree to Recess Appointments (in the Senate!), without which we will not be able to get people confirmed in a timely manner,” Trump posted on Sunday. “We need positions filled IMMEDIATELY!” If the Republican-majority Senate agrees to recess appointments – where the President appoints officials when Congress is not in session – Trump’s cabinet picks could stay until the end of 2026. Kennedy joins other iconoclastic nominees. Trump tapped former Democratic Representative Tulsi Gabbard for Director of National Security, noted for her opposition to US support for Ukraine and promoting debunked Russian claims about US-funded biolabs there. He also named Florida Representative Matt Gaetz, who had been facing a congressional ethics investigation over allegations of sex trafficking a minor, as Attorney General. Image Credits: Gage Skidmore, European Union/Martin Matev. Breakthrough Research Promises Shorter Treatment for Multi-Drug-Resistant TB 15/11/2024 Disha Shetty Young Indonesians appeal for an end to TB at the Union’s World Lung Health conference in Bali. In a breakthrough for patients with multi-drug-resistant (MDR) tuberculosis (TB), researchers shared positive trial results for a shorter, tailored alternative at the World Conference on Lung Health in Bali, Indonesia. The insights came from the endTB-Q trial aimed at finding a simpler, less toxic, shorter regimen for fluoroquinolone-resistant MDR-TB. Fluoroquinolone is a common class of medicine used to treat MDR TB, and if patients become resistant, they are considered to be bordering on extensively drug-resistant (XDR) TB, which is extremely hard to treat and can take 18 months. The endTB-Q clinical trial enrolled 323 patients from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam to try to find alternatives to the current longer treatment regimen recommended by the World Health Organization (WHO). Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project “Our trial innovated in several important ways. Since we know that treatment for TB is not ‘one size fits all’, we tested a strategy that tailored treatment duration to disease severity and treatment response based on simple criteria,” said Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project and co-principal investigator of the trial. Researchers tried a combination of four TB drugs used to treat drug-resistant forms of TB – bedaquiline, clofazimine, delamanid and linezolid (BCDL). These drugs were given for six months and extended to nine months in case of delayed treatment response. Around 87% of patients were cured after the treatment in comparison to 89% of patients in the control arm of the trial that received the current WHO regime. But those 87% who did get better had less severe TB, according to the researchers. But for people with severe TB disease, BCDL for nine months was insufficient as they were at risk of TB returning and the longer regimen is still the best option. “Our conclusions are that this regimen, BCDL, given for six to nine months, is an excellent approach for those who don’t have severe disease at baseline. In this group, the success rate is almost 95% and it has a big advantage compared to the historical conventional treatment because it’s much shorter and less toxic,” said Guglielmetti. Researchers shared several breakthrough insights on tuberculosis care at the World Conference on Lung Health. Bedaquiline use in children found safe Researchers also shared updates from a separate trial that looked into whether children can take bedaquiline, which is used to treat drug-resistant TB. The trial found the drug to have a high degree of safety and tolerance for use in children. New data from a different trial funded by the US-research agency National Institute of Health (NIH) called IMPAACT that included experts from Stellenbosch University in South Africa found bedaquiline safe for use in the treatment of infants, children and adolescents with drug-resistant TB. This is a crucial finding as it will allow further optimising the use of bedaquiline in children with drug-resistant TB – an under-served population. “The P1108 trial [bedaquiline] has paved the way for access, finally, to effective, shorter and safer treatment for children with drug-resistant TB. For too long children with TB have been left behind,” said researcher Simon Schaaf. He said that children form nearly 12% of all TB cases or 1.3 million cases every year globally but despite bedaquiline being authorized for use since 2012, there wasn’t any trial for its use in children. Nearly 3,900 stakeholders including industry representatives, patient groups, and doctors from around 150 countries attended the conference. The week-long conference also saw the release of results from other TB trials in countries across Southeast Asia. In Indonesia, researchers found that using mobile chest X-ray screening proved to be a useful tool to find active TB cases in the community. This is especially helpful in cases where people do not show classic symptoms of TB like coughing. Day 2 at #UnionConf24 is underway! 👉 @FIT_eV present their research into active case finding among communities in Vietnam🇻🇳 “Community chest X-ray screening for TB among ethnic minority communities is more than just a health intervention—it’s a vital step toward equity”#EndTB pic.twitter.com/Hn0iAzpr1V — The Union (@TheUnion_TBLH) November 13, 2024 In Vietnam, researchers stressed the importance of active case finding in ethnic minorities and remote communities to ensure access to treatment. They also used mobile X-ray machines. In the Philippines, person-centred active case finding for TB was found to break down barriers to healthcare access for vulnerable populations. The screening was done as a part of a poverty alleviation programme which empowered community members to participate and take a leading role. Trust in community leaders aided the screening of TB. Researchers also shared results from a study that highlighted the need to optimize tests to check whether a patient was susceptible to a particular drug or not, and to expand access to new TB compounds for people with life-threatening TB. “Antimicrobial resistance is among the greatest global health threats we face today. For people at-risk of TB, this threat is multiplied,” said Dr Cassandra Kelly-Cirino, Executive Director of The International Union Against Tuberculosis and Lung Disease (The Union), which convened the conference. “The new research presented at the Union Conference this week represents an invaluable step in managing this challenge and in offering hope to patients of all ages living with extensively drug-resistant TB.” Image Credits: The Union, The Union. Make Clean Air Part of Climate Plans, Experts Say 15/11/2024 Chetan Bhattacharji Smog engulfs Lahore, Pakistan, on Thursday as air pollution levels hit record highs. Some pollutants reached nearly 100 times the World Health Organization’s recommended level, according to IQAir. BAKU, Azerbaijan — Global and Indian experts at COP29 produced new evidence Thursday calling for clean air standards to become part of nations’ climate commitments, as cities across South Asia’s heavily polluted air corridor battled record-breaking smog. In Delhi, authorities closed schools up to grade 5 and halted construction as pollution levels soared to almost twenty times the WHO’s safe daily limit. The crisis came just days after Lahore, Pakistan’s second-largest city just 25 kilometres from the Indian border, saw its highest-ever levels of air pollution. Under the clear skies of Azerbaijan’s capital, experts from the World Bank, WHO, and Indian health ministry were unanimous that air quality improvement should be included in the new Nationally Determined Contributions (NDCs), the self-determined climate targets nations set under the Paris Agreement. “Air quality targets and standards can be a perfect indicator of success if we are successful in targeting the causes of climate change,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “If we could select an indicator of how successful we are in achieving negotiations on climate change mitigation, I think we should use the levels of air quality that people around the world are breathing.” Health experts hope their evidence linking air pollution and climate change will strengthen calls for action at COP29. Supporting this call for action is a new report released by the Clean Air Fund that shows how tropospheric ozone – a little-discussed ‘super pollutant’ – is linked to 500,000 premature deaths and an estimated $500 billion in economic costs annually. Air pollution from all sources contributes to more than eight million premature deaths each year, with economic costs exceeding $8 trillion, the report found. The findings aim to support the push for including air quality standards in the third generation of NDCs – binding climate commitments due before COP30 next year under the Paris Agreement. Only a small fraction of countries currently include air pollution safety in their climate plans despite the health threat to millions worldwide. Clean Air Fund’s founder and CEO, Jane Burston, said tackling super pollutants provides “huge opportunities” for improving climate, health, economic development, and equity. “We know that developing countries are some of the few that have included things like black carbon in their nationally determined contributions, and that’s because a lot of these deaths and this exposure is happening in countries least able to afford action on it,” she added. Super-bad for children Protest by ‘Warrior Moms’, a group for clean air, in Delhi outside India’s health ministry, as air pollution turned ‘severe’ on 14th November, which is celebrated as Children’s Day in the country. Tropospheric ozone and its super-pollutant siblings – including methane, black carbon, nitrous oxide and fluorinated gases – are collectively responsible for nearly half of global warming to date. Unlike other pollutants, tropospheric ozone isn’t directly emitted but forms when sunlight interacts with pollutants from aviation, shipping, agriculture and other sectors. Its health impacts can be severe, from reduced lung function to complications in type 2 diabetes and cardiovascular disease. For children, this pollution poses an especially severe threat. “Young children have smaller lungs,” Dr Soumya Swaminathan, an advisor to the Indian health ministry and former chief scientist at the WHO, explained. “They breathe much faster than adults, and they are shorter, so they’re closer to the ground, where there are more pollutants, and get more respiratory infections.” Dr Valerie Hickey, who leads the World Bank’s environment department, also placed children at the centre of her argument. “Your kid got up coughing so bad they couldn’t go to school does not lead on CNN,” she said. “Though if there are huge floods in Valencia, it does. Both are terrible, but [air pollution] is a public health emergency.” Like climate change itself, air pollution’s threat isn’t only visible in extreme events such as Delhi’s current crisis, where PM2.5 levels have reached almost 300 micrograms per cubic metre. “Every unit you go above five, you actually have a health impact,” explained Swaminathan, who co-chairs Our Common Air. “Even at 20, 30, 40 you start getting effects on the heart, respiratory system, and brain. So we need to take action to keep it as low as possible.” “We have to be pragmatic and set interim targets and do a stepwise plan to reduce it,” she added. “That’s what the NDCs are all about.” ‘Smog diplomacy’ Delhi and Lahore, just 400 kilometres apart, face the world’s highest air pollution levels. Half of the ten most polluted places in the world today are in four countries of South Asia – Pakistan, India, Nepal and Bangladesh. Health experts often say that air pollution knows no borders, an adage now forcing cooperation between long-standing rivals in what’s come to be known as “smog diplomacy.” India and Pakistan, nations that have fought multiple wars since independence, are finding themselves pushed toward dialogue over their shared air crisis. This week, as their major cities Delhi and Lahore traded places as the world’s most polluted, officials in Punjab, Pakistan’s most populous province, drafted a letter to India seeking talks on air pollution. “This is an area of the world where there isn’t always great experience with international diplomacy,” Hickey said. “Countries don’t always like each other, but they’re actually seeing that smog diplomacy is something that can bring them to the table.” The outreach comes as hundreds of millions in both countries face severe health risks borne from common problems plaguing both nations: farmers burning agricultural waste, coal-fired power plants, heavy traffic, construction and windless days trapping emissions. The World Bank has launched a “multi-hundred billion dollar” to address this cross-border crisis, targeting the vast northern plains of South Asia, known as the Indo-Gangetic Plains, Hickey told Health Policy Watch. The Bank has already committed to several regional projects in India, including a $350 million clean air management initiative plus $5 million grant for Uttar Pradesh, reportedly approved by the state cabinet and a pending $300 million loan plus $5 million grant for Haryana. Similar programs are planned for Nepal, Pakistan and Bangladesh to address pollution that readily crosses borders due to the region’s geography and wind patterns. “We need climate diplomacy, as a regional and global issue,” Raja Jahangir Anwar, Punjab’s Secretary for Environment and Climate Change, told CNN. “We are suffering in Lahore due to the eastern wind corridor coming from India. We are not blaming anyone, it’s a natural phenomenon.” Image Credits: https://x.com/ThePeerAli/status/1856985454072963085/photo/1. As World’s Health Ministers Meet in Jeddah: Calls for Strong AMR Science Panel With Authority to ‘Challenge’ Sponsors 14/11/2024 Elaine Ruth Fletcher Thail lab technicians train in surveillance of antimicrobial resistance (AMR) in food-producing animals in Southeast Asia – an driver of AMR that was neglected in the recent UN High Level Meeting declaration. With plans underway for a new “Independent Panel” on Antimicrobial Resistance, endorsed at September’s UN High-Level AMR Meeting, the new body must become a strong scientific authority. It should have the power to “challenge” the agencies that create it and address both human and animal health factors driving drug-resistant pathogens. That was a key message from AMR experts in the lead up to the Fourth Ministerial Meeting on Antimicrobial Resistance, which begins Friday in Jeddah, Saudi Arabia. The Independent Panel “needs to be an inclusive process… listening to scientists… civil society, to industry and other actors. But you also need to make sure that that panel, even though hosted by a Quadripartite, can actually challenge the Quadripartite,” declared John Arne Røttingen, CEO of the UK-based Wellcome Trust, of the panel’s central importance to providing evidence on future AMR policies. The ‘Quadripartite’ includes the World Health Organization, as well as the global environment, food and animal health agencies, which are now formally collaborating to confront the AMR threat. John-Arne Røttingen, CEO of Wellcome Trust. Røttingen was among the more than two dozen experts convened for two high-level AMR sessions at Berlin’s World Health Summit in mid-October to discuss next steps for the battle against drug resistant pathogens in the lead-up to the Jeddah meeting. “Declarations are long. It’s hard to identify the real material commitments that have been made,” Røttingen said at a panel discussion on Milestones and Challenges in Tackling AMR, hosted by the German Ministry of Health. “So it’s great that we come to Jeddah for the ministerial meeting,” he said. “That should be a start of both countries’ [and development agencies] coming together as well as the multi stakeholder partnership platform coming together across sectors to make sure that we are keeping our commitments.” On the research front, meanwhile, new “pull incentives” recently developed in the United Kingdom, Italy and Canada to foster a sustainable market for next generation antibiotics are welcome, but they are not enough, industry experts asserted. Many more nations need to adopt supply-side incentives to ensure that badly-needed new drug candidates actually come to market. Jeddah should be the start of making good on the UN’s AMR Declaration FAO, UNEP, WHO and WOAH heads at September’s UN High Level Meeting that approved a set of new commitments for action on drug resistant pathogens. The health ministers’ confab in Saudi Arabia (15-16 November) is supposed to lay out next steps for delivering on promises made in the Declaration on Antimicrobial Resistance approved at the UN High Level Meeting, 26 September in New York City. September’s declaration was a major milestone in the battle to bring a long-ignored AMR epidemic to the forefront of global health policy. AMR is associated, directly or indirectly, a “silent, slow-motion pandemic” that could kill some 39 million people by 2050. The mandate to create an “independent panel for evidence for action against antimicrobial resistance in 2025” is embedded in a 15-page text, with 106 clauses. But it is widely perceived as a key next move to maintain strategic momentum on AMR threats. The science panel should “facilitate the generation and use of multisectoral, scientific evidence to support Member States in efforts to tackle antimicrobial resistance, making use of existing resources and avoiding duplication of on-going efforts, after an open and transparent consultation with all Member States on its composition, mandate, scope, and deliverables,” the AMR declaration stated. Final HLM declaration omitted target for reducing animal antibiotic consumption Asian meat-packing house. The science panel is supposed to be created and administered by the Quadripartite of agencies whose role in managing the AMR crisis was also formalized by the declaration. Along with WHO, the four-member body includes the UN Food and Agriculture Organization (FAO), the UN Environment Programme (UNEP), and the World Animal Health Organization (WOAH), a non-UN member state body. And that makes the panel’s mandate and composition a sensitive point, in light of the political pressures from big food and other interests that want to play down their role in fostering AMR risks, which some researchers say is the leading driver. Identified AMR hotspots often align with high volumes of antibiotics sales and use in livestock. Pressures from agri-businesses and meat producing nations already led to the deletion of a target for reducing animal antibiotic use by 30% by 2030 from the final HLM declaration. Now, the question is whether scientists can come together to articulate the evidence and agree on science-based policy recommendations. “Even though the declaration was positive, it also didn’t achieve agreement on things that I, from my professional background, …would say should have been agreed,” Røttingen observed. “And that speaks to the interests and the trade offs between different sectors… it speaks to agri-food businesses versus human health, and that’s why we believe a science panel is important.” He said, “We have the target of inverting AMR-related mortality [by 10% by 2030], but we need even more targets and more ambitious targets, so we have a lot to do,” he said. “In the climate sector, we have the IPCC (Intergovernmental Panel on Climate Change),” Røttingen continued. “We know how … contested the climate space is, but still, we have a collective international evidence base… We need authoritative evidence with scientists working in the human sector and the animal sector that can come together to actually give us that evidence base and give guidance. “ For animal health, as well, the ultimate aim is to curb abuse not essential use Arshnee Moodley, CGIAR-Kenya Worldwide, the overuse of such antibiotics in livestock production is widely regarded among experts as a leading, if not the leading, driver of pathogen resistance. But ultimately, the aim of new measures should be win-wins that ensure better access to vaccines and other measures to pre-empt antibiotic use and ensure animal health, panelists at the sessions also underlined. “You need to be able to communicate with the people who can change that [AMR trends],” said Dr. Arshnee Moodley, a Kenya-based lead of CGIAR, which works with farmers on animal health. “And for me, it’s the smallholder famer outside of Nairobi. I need to be able to tell him or her why they shouldn’t use antibiotics,” she said. “And that’s really critical because livestock is also part of the solution; it’s vital food for vulnerable groups,” she continued. “I worked every summer in my grandfather’s farm with three milk houses, from the age of 13. So I know about animal health and the need for small farmers, even in high income countries, to keep their herds healthy,” Røttingen countered. “When I’m concerned about the agricultural sector, it’s not really about the misuse of antibiotics among small scale farmers … it is about big food on several continents and making sure that they are … transparent and they are willing to engage in proper animal welfare, because that’s the starting point for ensuring animal health. Too often, measures related to vaccines and hygiene are bypassed, “by using antibiotics to treat herds that aren’t necessarily requisite,” he explained. Worst of all, is the use of antimicrobials or antibiotics “as growth promotion that has nothing to do with animal health. It’s not healthy for those who eat those animals, and it’s not healthy for the animals. “So … animal health is an important part, but I think the hardest question lies with the big food companies.” For human health – more prevention and better regulation are essential too Malawi’s Minister of Health Khumbize Kandodo Chiponda with Tamas Koncz, Pfizer Germany Much as with animals, infection prevention, appropriate access to drugs and better regulation need to be the operative goals for humans as well, panelists at a second high-level session on AMR agreed. That includes clean water, sanitation and hygiene that many communities and health facilities still lack, as well as stronger laboratory networks, and quality control of antimicrobials in settings were fake and substandard formulas often circulate. “Unfortunately for countries like us, we face challenges, because in terms of manufacturing… we have to get them [products] from outside. So in terms of the quality…. you cannot be 100% sure that what you’re getting really is the very, very good quality,” said Khumbize Kandodo Chiponda Minister of Health, Malawi, speaking at the panel hosted by the global non-profit antibiotic accelerator CARB-X and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Changing community behaviours and patterns can be a major lift, in light of the ease with which people can get antibiotics through more informal channels as well as the expense people might face in seeing a healthcare professional – who will in turn face challenges determining if antibiotics are needed or not – without adequate diagnostics equipment. Access to antibiotics is improving – but Africa is also becoming an AMR hotspot Buying antibiotics in India. Prescriptions are required but the rule is not always enforced. “Access to antibiotics [in LMICs] is improving and that is a good thing,” said Tamas Koncz, a vice-president of Pfizer’s operations in Germany. He pointed to data citing a 114% increase in antibiotic use in low- and middle-income countries between 2000-2015. Pfizer’s 2022 Accord for a Healthier World, which committed to providing all of its patented medicines and vaccines to 45 lower-income countries on a not-for-profit basis, has been one enabler of better access to common antimicrobials, he said. At the same time, weak enforcement of prescription drug rules, as well as a lack of health provider knowledge about which drugs to prescribe, are drivers of drug resistance. “If physicians are not using [the drugs] appropriately, then it’s going to lead to problems. So we need to fix the challenge of access. But I think what is even more important is the overall approach.” Africa, where sales of antibiotics by unlicensed vendors is often widespread, is also becoming a major AMR hotspot, he pointed out – highlighting the challenges of balancing access with judicious use. All-age rate of deaths attributable to/associated with antibiotic resistance, 2019. (Lancet, 2022) The landmark 2022 Lancet study that found 1.27 million deaths globally in 2019 were directly attributable to drug-resistant bacterial infections, including 860,000 in Africa. That same year, Africa saw 640,000 deaths from HIV. “We know from the recent communication from the African CDC and others, that it’s becoming probably the one of the biggest, if not the biggest, healthcare burden, superseding now HIV AIDs, maybe even malaria and tuberculosis,” said Koncz. ‘Pull’ incentives Florence Séjourné, Aurobac and Kevin Outterson, CARB-X. On the supply side of the equation, meanwhile, “more pull incentives” that can incentivize pharma developers of newer, pathogen-resistant antibiotics is a long-neglected topic now finally rising to the top of health ministers’ agendas. The challenge lies in the fact that new antibiotics capable of beating drug-resistant infections also need to used sparingly – to ensure that they, too, don’t fail prey to AMR. But that means companies that develop the drugs can’t count on revenues from blockbuster sales to pay back years of investment in clinical trials. “AMR innovation is in a broken business model right now, needing incentives.” said Florence Séjourné. She is the CEO of the Aurobac Therapeutics, a joint AMR R&D venture created by two leading European pharma firms as well as the founder of the BEAM Alliance association of AMR-focused biotechs. Products risk death in the pipeline While there are now 20 “highly innovative” antibiotics in the early stages of development globally, the number will have dwindled by 75% within eight years if the business model doesn’t change, warned Dr Kevin Outterson, head of CARB-X. “Within four years, we’ll have less than 10 in clinical development globally. And four more years after that, we’ll have less than five.” The of human capital” he added as large companies shut down programmes, and research is concentrated in underfinanced biotech startups. “There is absolutely no interest in private investors in the antibacterial field, which is complex,” added Séjourné. Of the startups, 60% of the BEAM Alliance members have less than a year of cash to fund their activities; 40% are firms of less than 9 employees. “The world is relying on micro companies, companies with less than 10 employees…That’s a very fragile base,” for developing urgently needed new drugs, Outterson added. On the cusp of a solution? Bacterial culture prepared for testing new antibiotic candidates. But, there are also some glimmers of hope on the horizon. The first was the launch of the United Kingdom’s new “subscription model” in May for antimicrobial drugs that need to be held in ‘reserve’ for drug resistant pathogens. This aims to guarantee innovators a return on new drugs, regardless of the quantities used, that can guarantee a market incentive for new drugs, even if they are carefully rationed. Séjourné praised the UK decision as “something to highlight has a good example for others to follow” – although she warned that until a larger number of countries get on board with such changes, “the broken business model will remain.” More recently, at the 10 October meeting of G7 health and finance ministers in Ancona, Italy’s Minister of Health, Orazio Schillaci announced a series of new “pull incentives” aimed at stimulating R&D and ensuring biotech firms a payback on their investment. Canada is also piloting an incentive programme, while other European Union members, as well as Japan, are considering similar moves. In light of those new developments, CARB-X’s Outterson sounds a note of cautious optimism. “At the G7 meeting, I made the economic case for a small, reasonable investment and push and mostly pull incentives, together, yields an amazing return on investment, both on the health side as well as the economic side,” Outterson said. “It was a rare opportunity to be able to speak not just to the health people, but also the finance people,” he said, noting that the issues raised at the meeting appeared to resonate with both sectors. “And so we have a problem, and we know that it’s desperate, and companies are filled with innovation, but not enough capital to move things forward. But we really are on the cusp of the solution as well.” IFPMA Director David Reddy “The UN meeting finished only a few weeks ago,” said IFPMA director David Reddy. “We’re moving towards the meeting in Saudi Arabia, which is the fourth AMR high level event. “I think one thing that is really important is that we are getting a common understanding of where we need to go, and what the challenges are,” he added. “We do need to make progress on the business model. The UK, Japan have already made good moves towards pull incentives, and a pilot has been put in place by Canada. There are a lot of remaining challenges, but I think the key message coming out of this is there is a real thirst to maintain momentum as we head into the meeting in Saudi Arabia.” But “it’s not just about financing,” he added, “it’s also about people and competencies.” “Access but having a really firm understanding of community needs on the ground is essential, because without that, we won’t make progress in the fight against AMR and in bringing antibiotics to those who need them.” Image Credits: USAID Asia/Flickr, USAID Asia , Health Policy Watch , Van Boeckel, Pires et al, 2019, WHO, The Lancet, 2022, AMR Industry Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. 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Residents in Delhi Advised to Wear Masks as Air Pollution Reaches ‘Severe Plus’ Levels 19/11/2024 Disha Shetty Delhi and its neighboring city of Gurgaon (pictured above) are engulfed in a layer of smog due to the high levels of air pollution. Schools were closed, vehicle entry restricted and India’s top court on Monday advised residents of Delhi’s metropolitan area to wear masks as the capital city was shrouded in “severe plus” levels of air pollution for the second day in a row. For the past week, Delhi’s air pollution has been in the “severe” category – dashing government claims that improved surveillance of rural crop burning and other measures to ease the annual pollution emergency are working. On Monday the PM2.5 air pollution levels – particles so small that they can be inhaled deep into the lungs and even into the bloodstream – were nearly 17 times the limit set by the World Health Organization (WHO). WHO limits for PM2.5 over a 24-hour time period is 25 micrograms per cubic meter of air (μg/m3), while some monitors in Delhi measured PM2.5 levels at 420 μg/m3. Air pollution is a year-long problem in Delhi, but the halt of monsoons in the autumn as well as low wind speeds – what the government calls “unfavourable meteorological conditions” – have long sent toxic levels of air pollution soaring in the late autumn. And the burning of rice stubble in surrounding rural states such as Haryana and Punjab continue to exacerbate conditions, said Delhi’s chief minister Atishi Marlena during a press interaction. The problem became much worse ever since 2008, when the national government ordered farmers to delay the planting of rice crops until later in the spring – thus delaying the harvest date and leaving farmers in a rush to plant a crop of winter wheat. On Monday, Delhi’s PM2.5 levels were 420 μg/m3 – nearly 17 times above the recommended WHO 24-average of 25 μg/m3. Farmers avoiding surveillance satellites While state governments claim to have clamped down on farmers who set their fields on fire to clear the paddy stubble, stepping up surveillance and fines, satellite images reveal something else. To avoid being detected, farmers are merely setting the stubble on fire later in the afternoon, after the satellite that the government uses for surveillance information passes, experts told Health Policy Watch. To improve enforcement, stationary satellites should be used instead, they said. See related story: Delhi Air Pollution: Is Government’s Satellite Monitoring Missing Stubble Fires? Aarti Khosla, Director of Delhi-based research consultancy Climate Trends said that rather than blaming only the rural areas, Delhi officials need to better manage the city’s background air pollution levels year-round. “Agricultural farm burning, contributes, on the days when it’s a peak, to 40% of Delhi’s air [poor] quality,” she said at a press conference on the sidelines of UN climate conference (COP29) in Baku. “And when, when it’s not a peak, it’s 2-3% of its problem.” Aarti Khosla, Director of Delhi-based research consultancy Climate Trends during a press conference at COP29. Short-term measures Along with the advise about masking, the government has ordered most schools to hold classes online, barring a few exceptions. Vehicles that do not meet pollution norms will not be allowed into the city. All construction activities have been halted given their contribution to increasing dust. Options to allow government employees to work from home or call in a reduced number of employees to the workplace are also being considered. The government has already deployed vehicles that are spraying mist on the streets and the trees nearby to reduce the dust. Experts though have been pointing out that such measures are short-term and will do little to reduce the city’s toxic levels of air pollution, or the autumn emergency that recurs annually. Air pollution is the biggest threat to health today & is not limited to a city, state or country. Needs a science-based approach with actions in multiple sectors – transport, construction, factories, cooking fuel, agriculture etc. We can solve the problem, other countries have. — Soumya Swaminathan (@doctorsoumya) November 18, 2024 ‘We want pollution levels to be down year-round’ “Ultimately, we want the pollution levels to be down year round and not just the extremes or winters,” Sarath Guttikunda, director of the Delhi-based Urban Emissions.Info that monitors and researches air pollution research, told Health Policy Watch, in an emailed comment. “Five items which need a long-term vision,” he added, “aggressive expansion and promotion of use of mass transport (especially buses), walking, and cycling modes; promotion of clean fuels like electricity or gas for heating during the winter months; strict enforcement of a ban on open waste burning; clear mandates for complying with emission norms for all industries including brick kilns; and management of road dust,” he said. He also said that the promotion of green spaces adds to a city’s air quality and ‘breathability’. Delhi is currently among the most polluted cities in the world. In rural areas, officials have long spoken about promoting alternatives to rice-stubble burning, such as machine crushing of stubble and expedited composting formulas. But these, too, have not been backed with sufficient levels of state or national government incentives – or enforcement for those who continue to burn. Shifting government subsidies away from rice production to support the cultivation of more nutritionally rich, indigenous grains, such as millet, has also been advocated by environmentalists to reduce stubble. They point out that the rice is now largely produced for export and is a heavy consumer of water, draining underground aquifers. However, the rural farm lobby in Punjab and Haryana is a powerful force and politicians have been generally fearful about changing the status quo. The high levels of air pollution in Delhi and its surrounding cities are a health hazard, warned health experts. Impacts on climate and health South Asia which has among the highest air pollution levels in the world reports an estimated two million deaths annually that are linked to air pollution. The Southeast Asia region typically suffers from the highest pollution levels in the world, with an estimated 2 million deaths annually, according to WHO. And the annual pollution emergencies that strike at Delhi, in fact affect the shared airshed of a much larger area – the sprawling Indo-Gangetic Plains and Himalayan Foothills region extending from eastern Pakistan, where crop-stubble burning also is widespread, across northern India and Nepal to Bangladesh. Satellite image shows smoke from a large number of small fires across the Indo-Gangetic plain and Himalayan foothills, a shared airshed across four countries. That has led to groups such as the World Bank to call for a broader, regional approach to air quality management. But so far attempts to trigger political cooperation across fraught borders have engaged scientists, but not always top political leaders. Reducing air pollution also reduces climate change – a “triple win” for health, climate and economic development, experts have maintained. Fossil fuel burning is directly responsible for a significant proportion of air pollution related deaths, so shifting to renewables has synergistic effects, noted Marina Romanello in the 30 October launch of the Lancet Countdown on Climate and Health. In addition, methane waste emissions and black carbon particles emitted by open crops, waste burning and household fuels are short-lived climate pollutants that exacerbate snow melt and warming temperatures. Speaking from Baku’s COP29, WHO’s Director for Environment and Climate Change Dr Maria Neira, too, drew attention to Delhi’s staggering levels of air pollution during a press conference. “The same causes that are responsible for global warming, the combustion of fossil fuels,… are the causes of air pollution as well,” she said. “At the moment we are talking here, people in one place in the world are breathing air with 400 micrograms/ per cubic meter of pm.2.5,” she said, displaying a WHO ‘BreatheLife’ gauge that reflects how Delhi’s annual air pollution levels exceed WHO guideline norms more than 12 fold. WHO’s Maria Neira displays WHO ‘BreatheLife’ gauge showing how Delhi’s annual air pollution levels exceed WHO guidelines more than 12 fold. The acutely high air pollution levels are a long-term term risk for health, with one-quarter to one-third of deaths from hypertension and other cardiovascular diseases, lung disease as well as lung cancer attributable to air pollution. But they are also a very immediate health emergency, said Dr Courtney Howard, vice-chair of the Global Climate and Health Alliance (GCHA), at the same COP press briefing. “So when air pollution levels are as high as they are in Delhi today, what we’ll be presenting to emergency departments are people with breathing problems from asthma, from chronic obstructive pulmonary disease. People will be coming in with chest pain due to heart attacks that get worse. Strokes are made worse by high levels of air pollution on a more chronic basis. It does increase risks to newborns,” said Howard. Image Credits: Chetan Bhattacharji, AQI, IQAir, Our World in Data, NASA, WHO. Health Secures Permanent Spot on COP Agenda – But Little Else 19/11/2024 Stefan Anderson After decades of advocacy, health secures a permanent spot on the UN climate summit agenda. The World Health Organization’s marquee event at COP29 in Baku produced a document that captures the growing frustration felt by delegates, civil society, and people across the globe with UN climate negotiations: a “letter of intent” to form a coalition to continue discussions about taking action. In stark contrast to the glitzy, Bill Gates-adorned fanfare of the inaugural COP Health Day in Dubai a year ago, the WHO-led high-level ministerial on Monday took place in a cramped, windowless meeting room – though, to be fair, the ground floor of Baku’s football stadium, the venue for COP29, has no windows. Seasoned UN observers sensed the event, billed as a “round table” emphasising “sharing best practices” and “reinforcing sustained action,” was unlikely to make headlines. While Dubai’s celebration drew VIPs and global attention, this year’s event peaked at just 18 guest attendees on a Microsoft Teams call attended by Health Policy Watch. The meeting resulted in the “Baku COP Presidencies Continuity Coalition for Climate and Health,” an acronym sure to catch on at the UN climate talks: BCPCCCH. Thank you @COP29_AZ Presidency for establishing the Baku COP Presidencies Continuity Coalition on Climate and Health. This initiative unites the visionary leadership of five COP presidencies that span this critical time for action, underscoring a commitment to elevate health… pic.twitter.com/QhDl91aeFN — Tedros Adhanom Ghebreyesus (@DrTedros) November 13, 2024 The new coalition, coordinated by Azerbaijan in partnership with previous COP hosts Egypt, the United Arab Emirates, the United Kingdom, and the next host, Brazil, commits COP presidencies to ensure health is a central agenda item at future UN climate summits. “By signing the Letter of Intent, we commit to a shared vision of a world where climate and health policies are not isolated but integrated into all aspects of governance and development,” Azerbaijan’s Minister of Health, Teymur Musayev, said in a press conference following the signing. Musayev said the coalition was “not created for dialogue alone,” though provided few specifics on objectives beyond strengthening health initiatives agreed upon at past COPs. ‘Significant milestone’ WHO hailed the letter of intent as a “significant milestone,” while its director-general, Tedros Adhanom Ghebreyesus, said it “unites the visionary leadership” of COP host countries and shows “a collective will to prioritize climate and health now and for the future.” Adding to the chorus of UN buzzwords, COP29 President Mukhtar Babayev called the coalition “another step towards synergistic action on climate and health.” The agreement falls short of making health a formal topic in UN climate negotiations – long considered the holy grail for the health community – despite evidence climate change-related developments, from air pollution to extreme weather, cost nearly ten million lives annually. While both the Azerbaijani presidency and WHO have issued press releases, the letter of intent itself has not been made public at the time of publication. “With the Continuity Coalition, there is now a mechanism to foster presidency-led, high-level attention to health as the norm,” Dr Jeni Miller, executive director of the Global Climate and Health Alliance, told Health Policy Watch. “What we will be looking for is how it makes that a reality.” Missing the mark Delegates celebrate the creation of the Baku coalition following the WHO-led Baku Coalition signing ceremony. For communities on the frontlines of the climate crisis, the pledge to have future discussions about potential actions to protect health – and the celebratory tone adopted by ministers like Babayev and Musayev – miss the mark. The loss of life from climate change and disease that could be prevented by nations living up to Paris Agreement Targets – an ambition so far absent at the midway mark in Baku – would save two million lives annually, WHO said in a report ahead of COP29. Civil society stakeholders from frontline countries are demanding $5 trillion in annual funding as the bare minimum outcome of the summit to cope with the damage already incurred and to adapt and mitigate future climate change. Nations are less ambitious than civil society in their demands, with most targets from developing countries, including the Arab and the African Groups, hovering around the $1-2 trillion range. As the summit enters its second week and UN climate negotiations near the three-decade mark, words on a page, absent any legally binding or financial backing, are ringing increasingly hollow. “I see a disconnect between the global conversation and discourse with the reality that countries are facing,” Nigeria’s Minister of Health, Mohammed Ali Pate, said following the signing ceremony including the countries that inaugurated the coalition. “Nigeria and other countries are pulling within their limited resources,” Pate said. “We need to reconcile this divergence between global rhetoric and real action backed by resources for those who are bearing the brunt of climate change.” What’s the point? WHO COP29 high-level ministerial in progress in Baku. For frontline communities, the Baku coalition’s non-binding ‘promises’ are pyrrhic victories. But for the WHO and health advocates, they represent hard-fought institutional progress. The fight for health to be recognised as a central concern in UN climate summit agendas has been an uphill battle, mirroring the decades-long struggle to force nations to acknowledge the role of fossil fuels in the climate crisis. Just as it took nearly three decades of UN climate negotiations for the global community to finally commit to “transitioning away” from fossil fuels in Dubai last year – making headlines across the globe – the inclusion of health in the climate agenda is a victory that was won over decades. The health breakthrough is also reminiscent of another recent milestone in global environmental negotiations. Just a month ago in Cali, Colombia, Indigenous communities were granted an official expert body seat in UN biodiversity negotiations after years of tireless advocacy, prompting emotional scenes from people and communities who fought relentlessly for recognition. “The place that we have gained over the years for health at the COPs is now secured,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “We don’t need to fight every year to obtain this space.” Indigenous delegates at COP16 in Cali, Colombia, celebrate victory as decades of advocacy and activism lead to official representation in international negotiations. The coalition’s key achievement, while bureaucratic, is significant: after decades of fighting, health advocates and WHO officials will no longer have to relitigate the importance of health as a central concern in climate talks. “Each victory has been a step forward in getting health into the climate conversation,” Miller said. “Negotiators and heads of state [now] recognise that when they are making decisions about climate action, they are making decisions about people’s lives.” WHO can also claim the establishment of the Baku Coalition meets its basic goal for the talks – ensuring delegates recognize they’re negotiating the health of eight billion people – though the 18 attendees on Teams suggest the message may not have reached many member states. That such a modest procedural win emerges as COP29’s headline health achievement however challenges WHO’s message, pushed through two decades of pre-COP media blitzes, that health – as the lived experience of climate change – would be “the argument” driving meaningful climate action. So far, the evidence from Baku suggests that national delegations still aren’t listening. Time saved? It remains to be seen whether the time saved on bureaucratic wrangling with COP presidencies can translate into more careful tracking of achievements or barriers to fulfilling health-related commitments made at previous COP summits. At Glasgow’s COP26, the Alliance for Transformative Action on Climate and Health (ATACH) was launched with a promise to transform health systems to be more climate resilient. The coalition now includes 91 nations – half of UN climate summit participants – after Azerbaijan joined on Monday. While WHO monitors commitments made by ATACH members to low-carbon and net-zero health systems, there is no oversight of whether these have translated into action. Limited international funding available for health has gone largely unnoticed, even by the only country receiving support from the world’s leading climate fund, the Green Climate Fund (GCF). Malawi is the sole recipient of a GCF grant targeting the health sector’s climate needs. Yet Malawi’s own climate minister, interviewed by Health Policy Watch this week, was unaware of the GCF-funded project in their country. GCF has not responded to a request for comment. Baby steps, urgent crisis Delegates convened for the first-ever Health Day at a UN climate summit in Dubai. Last year seemed to mark another step forward in health action, with 150 nations signing a Health and Climate declaration during the first dedicated Health Day in three decades of climate talks. The Dubai COP also featured a two-week series of climate side events at an expanded WHO Health Pavilion, highlighting the impacts of climate change on food systems, air pollution, household air pollution, energy, and biodiversity. But beyond the political rhetoric, it remains unclear the level of progress being made in getting health into formal adaptation and mitigation processes. Health-specific climate action remains severely underfunded, still capturing only 2% of adaptation funding and 0.5% of multilateral climate funding – unchanged since Glasgow five years ago. At COP29, health financing announcements have amounted to a single $10 million grant from the Islamic Development Bank to the WHO. WHO influence in jeopardy WHO kicked off a funding drive to fill its multi-billion budget shortfall in Berlin last month. The WHO’s influence in the funding arena is further complicated by its own financial instability. Already grappling with a multi-billion dollar budget shortfall, the organization faces additional uncertainty with the possibility of the US, its biggest single donor, cutting funds when President-Elect Donald Trump returns to office in 2025. Trump withdrew from WHO in his previous term, and many in his orbit expect the incoming president to do the same this time around. Top WHO officials told Health Policy Watch last month another Trump withdrawal of funding reinstated by Biden would result in a “dramatically bad crisis” for the UN health agency. Brazil offers a glimmer of hope The Amazon Rainforest, Brazil. The buzz in the health world ahead of talks in Baku was to not expect significant health outcomes from COP29. Finance was always going to dominate the agenda, and Azerbaijan – whose delegation has by some accounts never spoken at COPs before hosting this one – was unlikely to lead on the issue. Looking ahead, Brazil’s hosting of COP30 offers a glimmer of hope to many in the health world. Brazil’s president, Luiz Inácio Lula da Silva, has pledged to act on climate and protect the Amazon, reversing four years of the legacy left by his predecessor, Jair Bolsonaro, who denies climate change and allowed deforestation and exploitation of the tropical rainforest to expand at an unprecedented rate. Brazilian officials have also committed to prioritizing health initiatives on next year’s agenda, already participating in high-profile WHO events in Geneva and Berlin ahead of the summit. In Baku, Brazil’s health minister announced that equality will be a key focus of its upcoming COP presidency. And with universal health coverage deeply embedded in Brazil’s national identity, there’s cautious optimism that meaningful health and climate action might finally move from rhetoric to reality in Rio. Image Credits: COP16, WHO , CIFOR-ICRAF. Jeddah Conference Announces More Measures to Combat AMR – But Implementation Plans Are Still Vague 18/11/2024 Kerry Cullinan Saudi Health Minister Fahad Abdulrahman Aljalajil addresses the Ministerial Conference on Antimicrobial Resistance (AMR) in Jeddah. Government leaders from the health, environment and agriculture sectors in 57 countries adopted a 14-point plan to tackle antimicrobial resistance (AMR) at a meeting in Saudi Arabia that ended over the weekend. One of the undertakings of the Jeddah Commitment is support for the establishment of an independent panel to collect evidence about AMR. The United Nations (UN) High-Level Meeting on AMR had already committed to such a panel in September and gave the Quadripartite (Quad) organisations – the World Health Organization (WHO), Food and Agricultural Organization (FAO), UN Evironment Programme (UNEP) and World Organization for Animal Health (WOAH) – the authority to set up the panel. The ministerial conference resolved to support the Quad in a “timely, open and transparent process” to set up “an Independent Panel for Evidence on Action Against AMR”. However further details, including which UN agency should host the panel and its terms of reference, have not yet been resolved. The UK is believed to favour UNEP hosting the panel while other countries believe that the WHO is better equipped to do so as the global health body houses the Quad. The declaration also call for the creation of a new “biotech bridge” to boost research, development and innovation to find solutions to AMR. AMR happens when bacteria, viruses, fungi, and parasites develop resistance to medicines designed to kill them. This makes infections harder and more costly to treat. Drug-resistant pathogens can also spread between people, animals, and the environment. It is driven in large part by the misuse and overuse of antimicrobials, particularly in agriculture. AMR already causes an estimated 1.27 million deaths per year. From agricultural runoff to wastewater, #AntimicrobialResistance spreads through our land & water, threatening ecosystems & health. Effective handling of fertilizers, wastewater & proper hygiene practices can help reduce #AMR in the environment. More🔗https://t.co/7mtNh4ejnI pic.twitter.com/9416GlR4eX — FAO Knowledge (@FAOKnowledge) November 18, 2024 Saudi Arabia launches regional hubs Meanwhile, Saudi Arabia will launch a regional antibiotic access and logistics hub and an AMR One Health learning hub, the country’s health minister, Fahd bin Abdulrahman Al-Jalajel, told conference delegates. The access and logistics hub will initially operate as a pilot in the WHO’s Eastern Mediterranean Region (EMRO). Its purpose is to foster the sustainable procurement of antibiotics and diagnostics and improve end-to-end access to these. A conference participant told Health Policy Watch that the hub would stockpile antibiotics and establish distribution networks to ensure that they reach areas in need, particularly conflict zones. EMRO members include Palestine, Lebanon and Sudan. The One Health AMR Learning Hub will focus on sharing best practices and developing capabilities on how to implement national AMR action plans on AMR with specific national targets. ‘Misunderstanding’ of animal welfare Wendla-Antonia Beyer, policy officer at the farm animal welfare and public health organisation, Four Paws, said that while the Jeddah Commitment “shows there is momentum behind tackling AMR” it also shows that there is “insufficient understanding of how animal welfare impacts antibiotics use in farming”. Beyer said that “73% of our antibiotics are used in agriculture, often for growth-promotion or for diseases that could be prevented if farms had good animal welfare. “Farms where piglets spend more time with their mothers use less antibiotics. Farms with slower-growing chicken breeds use less antibiotics. The solutions are there, proven and viable — they only need to make it into policy and practice. With the Political Declaration and the Jeddah Commitment behind us, governments and global governance structures now need to make animal welfare an integral part of the One Health response to AMR.” Katherine Urbáez, who heads the Health Diplomacy Alliance (HDA), said her organisation would “continue to advocate to ensure the continued political and financial commitment and to tackle AMR”. “This includes the setting up of the panel with the scope and governance that allows the identification of the data and to advance the commitments in the HLM Policital Declaration”. HDA is based in Geneva and works with multi-stakeholders to advance health with diplomacy. This week is World AMR Awareness Week, which has its theme as “Educate. Advocate. Act now.” Image Credits: Health Ministry of Saudi Arabia. Pandemic Agreement Makes Progress But Still Plenty of Sticky Details to Address 15/11/2024 Kerry Cullinan INB co-chair Anne-Claire Amprou and the WHO’s Mike Ryan at the close of INB12. The latest draft of the World Health Organization’s (WHO) pandemic agreement is awash with green highlights – an indication that countries have reached consensus on much of the text. But the Intergovernmental Negotiating Body (INB) announced on Monday that it would not be possible to reach an agreement by December – and countries would push for the adoption of an agreement by the World Health Assembly (WHA) next May. During the past two weeks of the 12th meeting of the INB, progress has been made on research and development(Article 9), local production(Article 10) and regulatory systems strengthening (Article 14). Sticking points But Article 4 on prevention, which details countries’ pandemic prevention and surveillance obligations, is mostly highlighted in yellow. This means that countries have broad agreement on the text but much of the detail is not agreed. Many of the proposals are common sense – such as building the capacity to detect pathogens at the community level, routine immunisation, and prevention of zoonotic spillover. But these measures are a tall order for some low-income countries, which is partly where the resistance is coming from. Under-resourced countries are unsure of how much prevention will cost them and whether they will get help to implement the provisions. Wealthier countries want assurances that their poorer neighbours can contain outbreaks. The rapid spread of mpox in central Africa is an example. Several affected countries have been unable to confirm cases as they lack basic diagnostic laboratories and trained staff. Negotiators are considering a separate annex on prevention, much as the details of a Pathogen Access and Benefit Sharing (PABS) system may be accommodated in a separate annex. Sticking points also remain on technology transfer (Article 11), the PABS system (Article 12), the global supply chain and logistic (GSCL) system (Article 13) and sustainable financing (Article 20). However, the most tangible offering of the agreement is back on the table although not yet agreed: that 20% of vaccines, therapeutics and diagnostics produced to combat that pathogen during a pandemic will be allocated to the WHO for distribution with 10% given free and the remaining amount on yet-to-be determined terms. Earlier, there were reports that some members of the European Union wanted this requirement to be cut down to 10% and 5% respectively. ‘Crucial and delicate’ Tanzanian Ambassador Dr Abdallah Saleh Possi. Tanzanian Ambassador Dr Abdallah Saleh Possi, speaking for the 47 African member states and Egypt, expressed Africa’s disappointment that there was not sufficient consensus to call a special World Health Assembly next month. “Although we had such slow progress in this 12th session that did not realize the convening of a special session in December as anticipated, we all agree that the remaining issues are not many, but crucial and delicate, requiring decision-making and flexibility,” said Possi at the close of the two-week negotiations on Friday. “Significantly, the meeting has generated the commitment to finalize them. We thank all the delegations that organize informal meetings on some sticky areas. We support having informal sessions during inter-sessional period with a view to achieving consensus on key areas. The Africa group plus Egypt is happy to be amongst the groups seeking to find consensus on the remaining issues.” The Philippines on behalf of the Equity Group, expressed appreciation for both the “substantive progress” particularly on articles, 9,10 and 14, and “the cordiality displayed by delegations that helped bring about this progress”. However, warned the Philippines’ delegate, “much work needs to be done to achieve consensus on key articles that operationalize equity such as articles, 11,12, 13, 13 (bis) and 20.” Unlike the Africa Group, which wanted a December resolution, the Equity Group has always advocated for more time to deliberate on the agreement. The negotiators reconvene for a short INB session from 2-6 December, where they will decide on the programme of negotiations for 2025. RFK Jr Nominated as Top US Health Official 15/11/2024 Stefan Anderson & Sophia Samantaroy Robert F. Kennedy Jr, scion of America’s most prominent political family, is set to become the nation’s top health official under Trump. Donald Trump has named Robert F Kennedy Jr as his choice for US health secretary, putting the controversial anti-vaccine activist and environmental lawyer in line to control some of the world’s most influential health agencies. Kennedy shot to political prominence during the COVID-19 pandemic when his organisation, Children’s Health Defense, became a leading global voice questioning vaccine safety and efficacy. His appointment, which requires Senate confirmation, comes after Kennedy dropped his independent presidential bid to back Trump. “He’s going to help make America healthy again,” Trump said in a speech at Mar-a-Lago following his election victory. “He wants to do some things, and we’re going to let him get to it.” Trump described the role atop HHS as “the most important role of any administration”, adding that Kennedy “will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country”. I am thrilled to announce Robert F. Kennedy Jr. as The United States Secretary of Health and Human Services (HHS). For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it… — Donald J. Trump (@realDonaldTrump) November 14, 2024 If confirmed, Kennedy would oversee a sprawling $1.8 trillion department with 10 health agencies and three human services agencies. His leadership of HHS would include the administration of Medicare, Medicaid and the Affordable Care Act while setting priorities for America’s three most powerful health agencies: the Centers for Disease Control and Prevention (CDC), which tracks disease outbreaks and sets public health guidance; the Food and Drug Administration (FDA), which approves medicines and medical devices; and the National Institutes of Health (NIH), the world’s largest public funder of medical research. Kennedy, an environmental lawyer with no health experience, called his appointment “a generational opportunity” to realign US health policy and “put an end to the chronic disease epidemic” in a post accepting the nomination on X. He said Trump has instructed him to “reorganize” the U.S. constellation of federal health agencies. “I look forward to working with the more than 80,000 employees at HHS to free the agencies from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth,” Kennedy said. Global health fallout Beyond domestic agencies, the Trump administration is also expected to reshape America’s role in global health. In his last term, Trump withdrew funding from the World Health Organization over its COVID-19 response and slashed funding to UN agencies, leaving a multi-billion dollar gap in the UN health agency’s budget. With Kennedy – who has questioned global health orthodoxies – by his side, experts expect this isolationist stance to deepen. This could affect millions who rely on HIV/AIDS funding through PEPFAR, a $7 billion US program providing HIV treatment in over 50 countries, the CDC’s network of 65 international offices, and State Department health diplomacy efforts. WHO officials told Health Policy Watch last month they face “a huge fear factor” over potential US funding withdrawal, warning the agency would enter “a dramatically bad crisis” without American support. The Biden administration’s global health security team referred Health Policy Watch to the Trump transition team when asked for comment. Robert Kennedy Junior’s banner photo on X, formerly Twitter, where he boasts over 4.5 million followers. Beyond the mainstream Kennedy’s stated priorities for America’s health system veer from broadly supported reforms to debunked anti-scientific claims that have alarmed health experts. In recent weeks, he has called for removing fluoride from US drinking water – which he claims causes brain disease – reviewing vaccine safety data with an eye to withdrawing some from the market, eliminating “entire departments” at the FDA, and immediately dismissing 600 NIH employees. His controversial positions include claims repeatedly rejected by scientists: that vaccines cause autism in children, that AIDS is not caused by HIV, that antidepressants are responsible for mass school shootings, and that atrazine, a widely used herbicide, triggers gender dysphoria and has led to increases in young people identifying as transgender. Kennedy’s unconventional streak isn’t limited to medicine. In the run-up to November’s election, Kennedy said doctors found a worm had eaten part of his brain, video footage revealed him to be the key to a decade-old New York City mystery of a dead bear in Central Park – he dumped it there on his way to the airport – and came under investigation for decapitating a whale. Lawrence Gostin, a global health expert at Georgetown University, called the Kennedy pick “the darkest day for public health and science in my lifetime.” “Trump’s pick of RFK Jr as HHS Secretary is disastrous for public health,” Gostin said. “Having a person sceptical of science and evidence at HHS will make America unhealthy.” Public health victories at risk Public health victories like vaccines and drinking water fluoridation have led to dramatic increases in life expectancy. The World Health Organization estimates vaccines save five million lives annually, with global immunization efforts having saved at least 154 million lives over the past 50 years. Yet Kennedy has repeatedly challenged these achievements by questioning vaccine safety and stating that fluoride is linked to “neurodevelopmental disorders.” The real-world impact of vaccine scepticism is already visible in the US, with the CDC reporting vaccination rates for children dropping for all available vaccines last year and vaccine exemptions for religious reasons rising across the past decade. “Religion doesn’t change that fast,” said Dr Michael Mendoza, a former county Public Health Commissioner in New York State. “This is about ideology and misinformation – and we’re seeing a direct impact in the number of kids unvaccinated.” “We’re at risk of widespread distrust in evidence-based treatments and vaccines,” Mendoza added, noting how health misinformation has directly influenced the increase in risky medical decisions. “Our elected and appointed officials have an obligation to promote experts and guidelines that are grounded in established scientific evidence.” Within the federal workforce, many remain optimistic that little will change. Agencies like the Biomedical Advanced Research and Development Authority (BARDA), which funded the development of COVID-19 vaccines, traditionally receive bipartisan support, resulting in little change across administrations. An HHS employee, speaking to Health Policy Watch on the condition of anonymity to safeguard their job security, noted that the negative perception of the new administration has yet to filter into many agencies. Room for agreement Less controversial is Kennedy’s opposition to the well-documented “revolving door” between the industry and government, where officials frequently switch between regulating companies and working for them – a system he argues has led to the “corporate capture” of US health agencies. In a country that spends more on healthcare than any other developed nation, has one of the world’s highest obesity rates, and whose largest public health crisis – the opioid epidemic – was engineered by pharmaceutical giant Purdue Pharma, his critiques of the system have found resonance. The concern about industry influence has merit: since 2000, every FDA commissioner has taken industry positions after leaving office. Nine out of the last ten, representing 40 years of leadership, have done the same. The pattern continued with Trump’s previous HHS secretary, Scott Gottlieb, who departed to a board seat at Pfizer in 2020. Kennedy’s stance against pharmaceutical interests sets up a likely clash with fellow Republicans, many of whom receive significant industry funding. Several GOP lawmakers have already pledged to dismantle President Joe Biden’s signature Medicare drug price negotiation law, which allows the government to negotiate fairer prices on behalf of its senior citizens, claiming it stifles innovation. Yet Kennedy has promised a direct confrontation with the industry, causing shares of major vaccine makers to plunge after Trump’s announcement of Kennedy’s selection. “Together we will clean up corruption, stop the revolving door between industry and government,” Kennedy said. Kennedy’s promised crusade against chronic diseases and processed foods has also found broad support among public health officials – setting up yet another clash with a major industry traditionally aligned with Republican politics. His pledge to strip ultra-processed foods from school lunches and crack down on food dyes has drawn bipartisan backing, though industry groups warn such moves could increase grocery prices Trump has vowed to reduce. “Senators may say, well, RFK Jr has good ideas like tackling chronic disease and regulating Big Food, but RFK Jr is not to be trusted after a career of peddling falsehoods,” Gostin said. “What we need is nutritional warnings on unhealthy foods, bans on targeting kids, and reduced salt and sugar.” Even some nutrition advocates who oppose Kennedy’s broader agenda acknowledge the need for stricter oversight of the food industry. The FDA has identified concerns about ultra-processed foods’ health impacts, though the agency says more research is needed. The challenge, experts say, will be implementing evidence-based reforms while avoiding Kennedy’s tendency toward unproven theories about food safety. Environmental hero to anti-vaccine empire Headline published in the Defender, the news arm of Kennedy’s anti-vaccine outfit on November 7. Kennedy began his career as a celebrated environmental lawyer, fighting corporate polluters and championing indigenous communities whose lands had been poisoned by industry. His aggressive prosecution of polluters helped restore the Hudson River to health, earning him Time magazine’s “Hero for the Planet” designation. He maintains some of this environmental ethos, promising in his presidential campaign before bowing out to back Trump to tackle unsafe PFAS levels and microplastic contamination. But his path took a sharp turn in 2015 when he took over the struggling World Mercury Project, rebranding it as Children’s Health Defense (CHD) in 2018. Under Kennedy’s leadership, CHD became a global anti-vaccine juggernaut. The organization’s revenue skyrocketed from $1.1 million in 2018 to $23.5 million in 2022, with Kennedy himself earning more than $510,000 in 2022, the last year where filings are available. In mainstream interviews and congressional appearances, Kennedy has worked to promote his least controversial views. He has attempted to moderate his image, telling NBC News: “I’m not going to take away anybody’s vaccines, I’ve never been anti-vaccine.” Yet the organization he led until his presidential campaign – and where he remains a lawyer – continues to fund and promote numerous anti-scientific positions. Public tax filings show Kennedy made $550,000 in executive compensation from Children’s Health Defense in 2022, the last year where records are available. During the pandemic, CHD’s vaccine-related posts were shared more frequently on Twitter than content from CNN, Fox News, NPR and the CDC combined – occasionally eclipsing the readership of the New York Times and Washington Post. The Center for Countering Digital Hate named Kennedy one of the “Disinformation Dozen,” identifying him and CHD as among the top spreaders of vaccine misinformation online. CHD also played a role in coordinating international protests for anti-vaccine movements around the world – with deadly consequences. In 2019, Kennedy’s organization flooded American Samoa with vaccine misinformation and lobbied the government against the use of the MMR vaccine, resulting in a devastating measles outbreak. This week, CHD’s news arm, The Defender, published claims that COVID-19 vaccines pose a “112,000% greater risk of brain clots and strokes than flu shots” – research based on misuse of VAERS, a federal database that records unverified reports of adverse events. The study’s authors include supplement company affiliates and anti-vaccine activists who openly coordinate with Kennedy’s organization. One author chairs a Texas-based organization that tagged Kennedy in a Twitter post on Tuesday calling for the “immediate withdrawal of all COVID-19 vaccines from the market” and the “repeal of the 1986” national childhood vaccination act. In his 2021 book, which sold over a million copies and sat on the New York TImes bestseller list for 17 weeks, Kennedy expands on the ethos behind CDH, calling Anthony Fauci, who led the US response to the COVID-19 pandemic, “the powerful technocrat who helped orchestrate and execute 2020’s historic coup d’état against Western democracy,” claiming his “remedies” – including Covid vaccines – were “often more lethal than the diseases they pretend to treat.” The book also champions Alan Duesberg, praising as “elegant” and “compelling” the discredited scientist’s claims that AIDS is not caused by HIV. Such theories had deadly consequences: 330,000 people died prematurely after being denied life-saving HIV treatment when South Africa’s government embraced view championed by Duesberg in the early 2000s, according to Harvard researchers. Path to Senate confirmation .@RobertKennedyJr has championed issues like healthy foods and the need for greater transparency in our public health infrastructure. I look forward to learning more about his other policy positions and how they will support a conservative, pro-American agenda. — U.S. Senator Bill Cassidy, M.D. (@SenBillCassidy) November 14, 2024 Kennedy’s path to confirmation runs through a Republican-led Senate, where he needs a simple majority of 51 votes. While some Republicans have expressed cautious support, experts point to Trump’s other nominees as the President-elect’s “tests” for Senate loyalty, suggesting the incoming president may bypass the traditional confirmation process entirely. “Any Republican Senator seeking the coveted LEADERSHIP position in the United States Senate must agree to Recess Appointments (in the Senate!), without which we will not be able to get people confirmed in a timely manner,” Trump posted on Sunday. “We need positions filled IMMEDIATELY!” If the Republican-majority Senate agrees to recess appointments – where the President appoints officials when Congress is not in session – Trump’s cabinet picks could stay until the end of 2026. Kennedy joins other iconoclastic nominees. Trump tapped former Democratic Representative Tulsi Gabbard for Director of National Security, noted for her opposition to US support for Ukraine and promoting debunked Russian claims about US-funded biolabs there. He also named Florida Representative Matt Gaetz, who had been facing a congressional ethics investigation over allegations of sex trafficking a minor, as Attorney General. Image Credits: Gage Skidmore, European Union/Martin Matev. Breakthrough Research Promises Shorter Treatment for Multi-Drug-Resistant TB 15/11/2024 Disha Shetty Young Indonesians appeal for an end to TB at the Union’s World Lung Health conference in Bali. In a breakthrough for patients with multi-drug-resistant (MDR) tuberculosis (TB), researchers shared positive trial results for a shorter, tailored alternative at the World Conference on Lung Health in Bali, Indonesia. The insights came from the endTB-Q trial aimed at finding a simpler, less toxic, shorter regimen for fluoroquinolone-resistant MDR-TB. Fluoroquinolone is a common class of medicine used to treat MDR TB, and if patients become resistant, they are considered to be bordering on extensively drug-resistant (XDR) TB, which is extremely hard to treat and can take 18 months. The endTB-Q clinical trial enrolled 323 patients from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam to try to find alternatives to the current longer treatment regimen recommended by the World Health Organization (WHO). Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project “Our trial innovated in several important ways. Since we know that treatment for TB is not ‘one size fits all’, we tested a strategy that tailored treatment duration to disease severity and treatment response based on simple criteria,” said Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project and co-principal investigator of the trial. Researchers tried a combination of four TB drugs used to treat drug-resistant forms of TB – bedaquiline, clofazimine, delamanid and linezolid (BCDL). These drugs were given for six months and extended to nine months in case of delayed treatment response. Around 87% of patients were cured after the treatment in comparison to 89% of patients in the control arm of the trial that received the current WHO regime. But those 87% who did get better had less severe TB, according to the researchers. But for people with severe TB disease, BCDL for nine months was insufficient as they were at risk of TB returning and the longer regimen is still the best option. “Our conclusions are that this regimen, BCDL, given for six to nine months, is an excellent approach for those who don’t have severe disease at baseline. In this group, the success rate is almost 95% and it has a big advantage compared to the historical conventional treatment because it’s much shorter and less toxic,” said Guglielmetti. Researchers shared several breakthrough insights on tuberculosis care at the World Conference on Lung Health. Bedaquiline use in children found safe Researchers also shared updates from a separate trial that looked into whether children can take bedaquiline, which is used to treat drug-resistant TB. The trial found the drug to have a high degree of safety and tolerance for use in children. New data from a different trial funded by the US-research agency National Institute of Health (NIH) called IMPAACT that included experts from Stellenbosch University in South Africa found bedaquiline safe for use in the treatment of infants, children and adolescents with drug-resistant TB. This is a crucial finding as it will allow further optimising the use of bedaquiline in children with drug-resistant TB – an under-served population. “The P1108 trial [bedaquiline] has paved the way for access, finally, to effective, shorter and safer treatment for children with drug-resistant TB. For too long children with TB have been left behind,” said researcher Simon Schaaf. He said that children form nearly 12% of all TB cases or 1.3 million cases every year globally but despite bedaquiline being authorized for use since 2012, there wasn’t any trial for its use in children. Nearly 3,900 stakeholders including industry representatives, patient groups, and doctors from around 150 countries attended the conference. The week-long conference also saw the release of results from other TB trials in countries across Southeast Asia. In Indonesia, researchers found that using mobile chest X-ray screening proved to be a useful tool to find active TB cases in the community. This is especially helpful in cases where people do not show classic symptoms of TB like coughing. Day 2 at #UnionConf24 is underway! 👉 @FIT_eV present their research into active case finding among communities in Vietnam🇻🇳 “Community chest X-ray screening for TB among ethnic minority communities is more than just a health intervention—it’s a vital step toward equity”#EndTB pic.twitter.com/Hn0iAzpr1V — The Union (@TheUnion_TBLH) November 13, 2024 In Vietnam, researchers stressed the importance of active case finding in ethnic minorities and remote communities to ensure access to treatment. They also used mobile X-ray machines. In the Philippines, person-centred active case finding for TB was found to break down barriers to healthcare access for vulnerable populations. The screening was done as a part of a poverty alleviation programme which empowered community members to participate and take a leading role. Trust in community leaders aided the screening of TB. Researchers also shared results from a study that highlighted the need to optimize tests to check whether a patient was susceptible to a particular drug or not, and to expand access to new TB compounds for people with life-threatening TB. “Antimicrobial resistance is among the greatest global health threats we face today. For people at-risk of TB, this threat is multiplied,” said Dr Cassandra Kelly-Cirino, Executive Director of The International Union Against Tuberculosis and Lung Disease (The Union), which convened the conference. “The new research presented at the Union Conference this week represents an invaluable step in managing this challenge and in offering hope to patients of all ages living with extensively drug-resistant TB.” Image Credits: The Union, The Union. Make Clean Air Part of Climate Plans, Experts Say 15/11/2024 Chetan Bhattacharji Smog engulfs Lahore, Pakistan, on Thursday as air pollution levels hit record highs. Some pollutants reached nearly 100 times the World Health Organization’s recommended level, according to IQAir. BAKU, Azerbaijan — Global and Indian experts at COP29 produced new evidence Thursday calling for clean air standards to become part of nations’ climate commitments, as cities across South Asia’s heavily polluted air corridor battled record-breaking smog. In Delhi, authorities closed schools up to grade 5 and halted construction as pollution levels soared to almost twenty times the WHO’s safe daily limit. The crisis came just days after Lahore, Pakistan’s second-largest city just 25 kilometres from the Indian border, saw its highest-ever levels of air pollution. Under the clear skies of Azerbaijan’s capital, experts from the World Bank, WHO, and Indian health ministry were unanimous that air quality improvement should be included in the new Nationally Determined Contributions (NDCs), the self-determined climate targets nations set under the Paris Agreement. “Air quality targets and standards can be a perfect indicator of success if we are successful in targeting the causes of climate change,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “If we could select an indicator of how successful we are in achieving negotiations on climate change mitigation, I think we should use the levels of air quality that people around the world are breathing.” Health experts hope their evidence linking air pollution and climate change will strengthen calls for action at COP29. Supporting this call for action is a new report released by the Clean Air Fund that shows how tropospheric ozone – a little-discussed ‘super pollutant’ – is linked to 500,000 premature deaths and an estimated $500 billion in economic costs annually. Air pollution from all sources contributes to more than eight million premature deaths each year, with economic costs exceeding $8 trillion, the report found. The findings aim to support the push for including air quality standards in the third generation of NDCs – binding climate commitments due before COP30 next year under the Paris Agreement. Only a small fraction of countries currently include air pollution safety in their climate plans despite the health threat to millions worldwide. Clean Air Fund’s founder and CEO, Jane Burston, said tackling super pollutants provides “huge opportunities” for improving climate, health, economic development, and equity. “We know that developing countries are some of the few that have included things like black carbon in their nationally determined contributions, and that’s because a lot of these deaths and this exposure is happening in countries least able to afford action on it,” she added. Super-bad for children Protest by ‘Warrior Moms’, a group for clean air, in Delhi outside India’s health ministry, as air pollution turned ‘severe’ on 14th November, which is celebrated as Children’s Day in the country. Tropospheric ozone and its super-pollutant siblings – including methane, black carbon, nitrous oxide and fluorinated gases – are collectively responsible for nearly half of global warming to date. Unlike other pollutants, tropospheric ozone isn’t directly emitted but forms when sunlight interacts with pollutants from aviation, shipping, agriculture and other sectors. Its health impacts can be severe, from reduced lung function to complications in type 2 diabetes and cardiovascular disease. For children, this pollution poses an especially severe threat. “Young children have smaller lungs,” Dr Soumya Swaminathan, an advisor to the Indian health ministry and former chief scientist at the WHO, explained. “They breathe much faster than adults, and they are shorter, so they’re closer to the ground, where there are more pollutants, and get more respiratory infections.” Dr Valerie Hickey, who leads the World Bank’s environment department, also placed children at the centre of her argument. “Your kid got up coughing so bad they couldn’t go to school does not lead on CNN,” she said. “Though if there are huge floods in Valencia, it does. Both are terrible, but [air pollution] is a public health emergency.” Like climate change itself, air pollution’s threat isn’t only visible in extreme events such as Delhi’s current crisis, where PM2.5 levels have reached almost 300 micrograms per cubic metre. “Every unit you go above five, you actually have a health impact,” explained Swaminathan, who co-chairs Our Common Air. “Even at 20, 30, 40 you start getting effects on the heart, respiratory system, and brain. So we need to take action to keep it as low as possible.” “We have to be pragmatic and set interim targets and do a stepwise plan to reduce it,” she added. “That’s what the NDCs are all about.” ‘Smog diplomacy’ Delhi and Lahore, just 400 kilometres apart, face the world’s highest air pollution levels. Half of the ten most polluted places in the world today are in four countries of South Asia – Pakistan, India, Nepal and Bangladesh. Health experts often say that air pollution knows no borders, an adage now forcing cooperation between long-standing rivals in what’s come to be known as “smog diplomacy.” India and Pakistan, nations that have fought multiple wars since independence, are finding themselves pushed toward dialogue over their shared air crisis. This week, as their major cities Delhi and Lahore traded places as the world’s most polluted, officials in Punjab, Pakistan’s most populous province, drafted a letter to India seeking talks on air pollution. “This is an area of the world where there isn’t always great experience with international diplomacy,” Hickey said. “Countries don’t always like each other, but they’re actually seeing that smog diplomacy is something that can bring them to the table.” The outreach comes as hundreds of millions in both countries face severe health risks borne from common problems plaguing both nations: farmers burning agricultural waste, coal-fired power plants, heavy traffic, construction and windless days trapping emissions. The World Bank has launched a “multi-hundred billion dollar” to address this cross-border crisis, targeting the vast northern plains of South Asia, known as the Indo-Gangetic Plains, Hickey told Health Policy Watch. The Bank has already committed to several regional projects in India, including a $350 million clean air management initiative plus $5 million grant for Uttar Pradesh, reportedly approved by the state cabinet and a pending $300 million loan plus $5 million grant for Haryana. Similar programs are planned for Nepal, Pakistan and Bangladesh to address pollution that readily crosses borders due to the region’s geography and wind patterns. “We need climate diplomacy, as a regional and global issue,” Raja Jahangir Anwar, Punjab’s Secretary for Environment and Climate Change, told CNN. “We are suffering in Lahore due to the eastern wind corridor coming from India. We are not blaming anyone, it’s a natural phenomenon.” Image Credits: https://x.com/ThePeerAli/status/1856985454072963085/photo/1. As World’s Health Ministers Meet in Jeddah: Calls for Strong AMR Science Panel With Authority to ‘Challenge’ Sponsors 14/11/2024 Elaine Ruth Fletcher Thail lab technicians train in surveillance of antimicrobial resistance (AMR) in food-producing animals in Southeast Asia – an driver of AMR that was neglected in the recent UN High Level Meeting declaration. With plans underway for a new “Independent Panel” on Antimicrobial Resistance, endorsed at September’s UN High-Level AMR Meeting, the new body must become a strong scientific authority. It should have the power to “challenge” the agencies that create it and address both human and animal health factors driving drug-resistant pathogens. That was a key message from AMR experts in the lead up to the Fourth Ministerial Meeting on Antimicrobial Resistance, which begins Friday in Jeddah, Saudi Arabia. The Independent Panel “needs to be an inclusive process… listening to scientists… civil society, to industry and other actors. But you also need to make sure that that panel, even though hosted by a Quadripartite, can actually challenge the Quadripartite,” declared John Arne Røttingen, CEO of the UK-based Wellcome Trust, of the panel’s central importance to providing evidence on future AMR policies. The ‘Quadripartite’ includes the World Health Organization, as well as the global environment, food and animal health agencies, which are now formally collaborating to confront the AMR threat. John-Arne Røttingen, CEO of Wellcome Trust. Røttingen was among the more than two dozen experts convened for two high-level AMR sessions at Berlin’s World Health Summit in mid-October to discuss next steps for the battle against drug resistant pathogens in the lead-up to the Jeddah meeting. “Declarations are long. It’s hard to identify the real material commitments that have been made,” Røttingen said at a panel discussion on Milestones and Challenges in Tackling AMR, hosted by the German Ministry of Health. “So it’s great that we come to Jeddah for the ministerial meeting,” he said. “That should be a start of both countries’ [and development agencies] coming together as well as the multi stakeholder partnership platform coming together across sectors to make sure that we are keeping our commitments.” On the research front, meanwhile, new “pull incentives” recently developed in the United Kingdom, Italy and Canada to foster a sustainable market for next generation antibiotics are welcome, but they are not enough, industry experts asserted. Many more nations need to adopt supply-side incentives to ensure that badly-needed new drug candidates actually come to market. Jeddah should be the start of making good on the UN’s AMR Declaration FAO, UNEP, WHO and WOAH heads at September’s UN High Level Meeting that approved a set of new commitments for action on drug resistant pathogens. The health ministers’ confab in Saudi Arabia (15-16 November) is supposed to lay out next steps for delivering on promises made in the Declaration on Antimicrobial Resistance approved at the UN High Level Meeting, 26 September in New York City. September’s declaration was a major milestone in the battle to bring a long-ignored AMR epidemic to the forefront of global health policy. AMR is associated, directly or indirectly, a “silent, slow-motion pandemic” that could kill some 39 million people by 2050. The mandate to create an “independent panel for evidence for action against antimicrobial resistance in 2025” is embedded in a 15-page text, with 106 clauses. But it is widely perceived as a key next move to maintain strategic momentum on AMR threats. The science panel should “facilitate the generation and use of multisectoral, scientific evidence to support Member States in efforts to tackle antimicrobial resistance, making use of existing resources and avoiding duplication of on-going efforts, after an open and transparent consultation with all Member States on its composition, mandate, scope, and deliverables,” the AMR declaration stated. Final HLM declaration omitted target for reducing animal antibiotic consumption Asian meat-packing house. The science panel is supposed to be created and administered by the Quadripartite of agencies whose role in managing the AMR crisis was also formalized by the declaration. Along with WHO, the four-member body includes the UN Food and Agriculture Organization (FAO), the UN Environment Programme (UNEP), and the World Animal Health Organization (WOAH), a non-UN member state body. And that makes the panel’s mandate and composition a sensitive point, in light of the political pressures from big food and other interests that want to play down their role in fostering AMR risks, which some researchers say is the leading driver. Identified AMR hotspots often align with high volumes of antibiotics sales and use in livestock. Pressures from agri-businesses and meat producing nations already led to the deletion of a target for reducing animal antibiotic use by 30% by 2030 from the final HLM declaration. Now, the question is whether scientists can come together to articulate the evidence and agree on science-based policy recommendations. “Even though the declaration was positive, it also didn’t achieve agreement on things that I, from my professional background, …would say should have been agreed,” Røttingen observed. “And that speaks to the interests and the trade offs between different sectors… it speaks to agri-food businesses versus human health, and that’s why we believe a science panel is important.” He said, “We have the target of inverting AMR-related mortality [by 10% by 2030], but we need even more targets and more ambitious targets, so we have a lot to do,” he said. “In the climate sector, we have the IPCC (Intergovernmental Panel on Climate Change),” Røttingen continued. “We know how … contested the climate space is, but still, we have a collective international evidence base… We need authoritative evidence with scientists working in the human sector and the animal sector that can come together to actually give us that evidence base and give guidance. “ For animal health, as well, the ultimate aim is to curb abuse not essential use Arshnee Moodley, CGIAR-Kenya Worldwide, the overuse of such antibiotics in livestock production is widely regarded among experts as a leading, if not the leading, driver of pathogen resistance. But ultimately, the aim of new measures should be win-wins that ensure better access to vaccines and other measures to pre-empt antibiotic use and ensure animal health, panelists at the sessions also underlined. “You need to be able to communicate with the people who can change that [AMR trends],” said Dr. Arshnee Moodley, a Kenya-based lead of CGIAR, which works with farmers on animal health. “And for me, it’s the smallholder famer outside of Nairobi. I need to be able to tell him or her why they shouldn’t use antibiotics,” she said. “And that’s really critical because livestock is also part of the solution; it’s vital food for vulnerable groups,” she continued. “I worked every summer in my grandfather’s farm with three milk houses, from the age of 13. So I know about animal health and the need for small farmers, even in high income countries, to keep their herds healthy,” Røttingen countered. “When I’m concerned about the agricultural sector, it’s not really about the misuse of antibiotics among small scale farmers … it is about big food on several continents and making sure that they are … transparent and they are willing to engage in proper animal welfare, because that’s the starting point for ensuring animal health. Too often, measures related to vaccines and hygiene are bypassed, “by using antibiotics to treat herds that aren’t necessarily requisite,” he explained. Worst of all, is the use of antimicrobials or antibiotics “as growth promotion that has nothing to do with animal health. It’s not healthy for those who eat those animals, and it’s not healthy for the animals. “So … animal health is an important part, but I think the hardest question lies with the big food companies.” For human health – more prevention and better regulation are essential too Malawi’s Minister of Health Khumbize Kandodo Chiponda with Tamas Koncz, Pfizer Germany Much as with animals, infection prevention, appropriate access to drugs and better regulation need to be the operative goals for humans as well, panelists at a second high-level session on AMR agreed. That includes clean water, sanitation and hygiene that many communities and health facilities still lack, as well as stronger laboratory networks, and quality control of antimicrobials in settings were fake and substandard formulas often circulate. “Unfortunately for countries like us, we face challenges, because in terms of manufacturing… we have to get them [products] from outside. So in terms of the quality…. you cannot be 100% sure that what you’re getting really is the very, very good quality,” said Khumbize Kandodo Chiponda Minister of Health, Malawi, speaking at the panel hosted by the global non-profit antibiotic accelerator CARB-X and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Changing community behaviours and patterns can be a major lift, in light of the ease with which people can get antibiotics through more informal channels as well as the expense people might face in seeing a healthcare professional – who will in turn face challenges determining if antibiotics are needed or not – without adequate diagnostics equipment. Access to antibiotics is improving – but Africa is also becoming an AMR hotspot Buying antibiotics in India. Prescriptions are required but the rule is not always enforced. “Access to antibiotics [in LMICs] is improving and that is a good thing,” said Tamas Koncz, a vice-president of Pfizer’s operations in Germany. He pointed to data citing a 114% increase in antibiotic use in low- and middle-income countries between 2000-2015. Pfizer’s 2022 Accord for a Healthier World, which committed to providing all of its patented medicines and vaccines to 45 lower-income countries on a not-for-profit basis, has been one enabler of better access to common antimicrobials, he said. At the same time, weak enforcement of prescription drug rules, as well as a lack of health provider knowledge about which drugs to prescribe, are drivers of drug resistance. “If physicians are not using [the drugs] appropriately, then it’s going to lead to problems. So we need to fix the challenge of access. But I think what is even more important is the overall approach.” Africa, where sales of antibiotics by unlicensed vendors is often widespread, is also becoming a major AMR hotspot, he pointed out – highlighting the challenges of balancing access with judicious use. All-age rate of deaths attributable to/associated with antibiotic resistance, 2019. (Lancet, 2022) The landmark 2022 Lancet study that found 1.27 million deaths globally in 2019 were directly attributable to drug-resistant bacterial infections, including 860,000 in Africa. That same year, Africa saw 640,000 deaths from HIV. “We know from the recent communication from the African CDC and others, that it’s becoming probably the one of the biggest, if not the biggest, healthcare burden, superseding now HIV AIDs, maybe even malaria and tuberculosis,” said Koncz. ‘Pull’ incentives Florence Séjourné, Aurobac and Kevin Outterson, CARB-X. On the supply side of the equation, meanwhile, “more pull incentives” that can incentivize pharma developers of newer, pathogen-resistant antibiotics is a long-neglected topic now finally rising to the top of health ministers’ agendas. The challenge lies in the fact that new antibiotics capable of beating drug-resistant infections also need to used sparingly – to ensure that they, too, don’t fail prey to AMR. But that means companies that develop the drugs can’t count on revenues from blockbuster sales to pay back years of investment in clinical trials. “AMR innovation is in a broken business model right now, needing incentives.” said Florence Séjourné. She is the CEO of the Aurobac Therapeutics, a joint AMR R&D venture created by two leading European pharma firms as well as the founder of the BEAM Alliance association of AMR-focused biotechs. Products risk death in the pipeline While there are now 20 “highly innovative” antibiotics in the early stages of development globally, the number will have dwindled by 75% within eight years if the business model doesn’t change, warned Dr Kevin Outterson, head of CARB-X. “Within four years, we’ll have less than 10 in clinical development globally. And four more years after that, we’ll have less than five.” The of human capital” he added as large companies shut down programmes, and research is concentrated in underfinanced biotech startups. “There is absolutely no interest in private investors in the antibacterial field, which is complex,” added Séjourné. Of the startups, 60% of the BEAM Alliance members have less than a year of cash to fund their activities; 40% are firms of less than 9 employees. “The world is relying on micro companies, companies with less than 10 employees…That’s a very fragile base,” for developing urgently needed new drugs, Outterson added. On the cusp of a solution? Bacterial culture prepared for testing new antibiotic candidates. But, there are also some glimmers of hope on the horizon. The first was the launch of the United Kingdom’s new “subscription model” in May for antimicrobial drugs that need to be held in ‘reserve’ for drug resistant pathogens. This aims to guarantee innovators a return on new drugs, regardless of the quantities used, that can guarantee a market incentive for new drugs, even if they are carefully rationed. Séjourné praised the UK decision as “something to highlight has a good example for others to follow” – although she warned that until a larger number of countries get on board with such changes, “the broken business model will remain.” More recently, at the 10 October meeting of G7 health and finance ministers in Ancona, Italy’s Minister of Health, Orazio Schillaci announced a series of new “pull incentives” aimed at stimulating R&D and ensuring biotech firms a payback on their investment. Canada is also piloting an incentive programme, while other European Union members, as well as Japan, are considering similar moves. In light of those new developments, CARB-X’s Outterson sounds a note of cautious optimism. “At the G7 meeting, I made the economic case for a small, reasonable investment and push and mostly pull incentives, together, yields an amazing return on investment, both on the health side as well as the economic side,” Outterson said. “It was a rare opportunity to be able to speak not just to the health people, but also the finance people,” he said, noting that the issues raised at the meeting appeared to resonate with both sectors. “And so we have a problem, and we know that it’s desperate, and companies are filled with innovation, but not enough capital to move things forward. But we really are on the cusp of the solution as well.” IFPMA Director David Reddy “The UN meeting finished only a few weeks ago,” said IFPMA director David Reddy. “We’re moving towards the meeting in Saudi Arabia, which is the fourth AMR high level event. “I think one thing that is really important is that we are getting a common understanding of where we need to go, and what the challenges are,” he added. “We do need to make progress on the business model. The UK, Japan have already made good moves towards pull incentives, and a pilot has been put in place by Canada. There are a lot of remaining challenges, but I think the key message coming out of this is there is a real thirst to maintain momentum as we head into the meeting in Saudi Arabia.” But “it’s not just about financing,” he added, “it’s also about people and competencies.” “Access but having a really firm understanding of community needs on the ground is essential, because without that, we won’t make progress in the fight against AMR and in bringing antibiotics to those who need them.” Image Credits: USAID Asia/Flickr, USAID Asia , Health Policy Watch , Van Boeckel, Pires et al, 2019, WHO, The Lancet, 2022, AMR Industry Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. 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Health Secures Permanent Spot on COP Agenda – But Little Else 19/11/2024 Stefan Anderson After decades of advocacy, health secures a permanent spot on the UN climate summit agenda. The World Health Organization’s marquee event at COP29 in Baku produced a document that captures the growing frustration felt by delegates, civil society, and people across the globe with UN climate negotiations: a “letter of intent” to form a coalition to continue discussions about taking action. In stark contrast to the glitzy, Bill Gates-adorned fanfare of the inaugural COP Health Day in Dubai a year ago, the WHO-led high-level ministerial on Monday took place in a cramped, windowless meeting room – though, to be fair, the ground floor of Baku’s football stadium, the venue for COP29, has no windows. Seasoned UN observers sensed the event, billed as a “round table” emphasising “sharing best practices” and “reinforcing sustained action,” was unlikely to make headlines. While Dubai’s celebration drew VIPs and global attention, this year’s event peaked at just 18 guest attendees on a Microsoft Teams call attended by Health Policy Watch. The meeting resulted in the “Baku COP Presidencies Continuity Coalition for Climate and Health,” an acronym sure to catch on at the UN climate talks: BCPCCCH. Thank you @COP29_AZ Presidency for establishing the Baku COP Presidencies Continuity Coalition on Climate and Health. This initiative unites the visionary leadership of five COP presidencies that span this critical time for action, underscoring a commitment to elevate health… pic.twitter.com/QhDl91aeFN — Tedros Adhanom Ghebreyesus (@DrTedros) November 13, 2024 The new coalition, coordinated by Azerbaijan in partnership with previous COP hosts Egypt, the United Arab Emirates, the United Kingdom, and the next host, Brazil, commits COP presidencies to ensure health is a central agenda item at future UN climate summits. “By signing the Letter of Intent, we commit to a shared vision of a world where climate and health policies are not isolated but integrated into all aspects of governance and development,” Azerbaijan’s Minister of Health, Teymur Musayev, said in a press conference following the signing. Musayev said the coalition was “not created for dialogue alone,” though provided few specifics on objectives beyond strengthening health initiatives agreed upon at past COPs. ‘Significant milestone’ WHO hailed the letter of intent as a “significant milestone,” while its director-general, Tedros Adhanom Ghebreyesus, said it “unites the visionary leadership” of COP host countries and shows “a collective will to prioritize climate and health now and for the future.” Adding to the chorus of UN buzzwords, COP29 President Mukhtar Babayev called the coalition “another step towards synergistic action on climate and health.” The agreement falls short of making health a formal topic in UN climate negotiations – long considered the holy grail for the health community – despite evidence climate change-related developments, from air pollution to extreme weather, cost nearly ten million lives annually. While both the Azerbaijani presidency and WHO have issued press releases, the letter of intent itself has not been made public at the time of publication. “With the Continuity Coalition, there is now a mechanism to foster presidency-led, high-level attention to health as the norm,” Dr Jeni Miller, executive director of the Global Climate and Health Alliance, told Health Policy Watch. “What we will be looking for is how it makes that a reality.” Missing the mark Delegates celebrate the creation of the Baku coalition following the WHO-led Baku Coalition signing ceremony. For communities on the frontlines of the climate crisis, the pledge to have future discussions about potential actions to protect health – and the celebratory tone adopted by ministers like Babayev and Musayev – miss the mark. The loss of life from climate change and disease that could be prevented by nations living up to Paris Agreement Targets – an ambition so far absent at the midway mark in Baku – would save two million lives annually, WHO said in a report ahead of COP29. Civil society stakeholders from frontline countries are demanding $5 trillion in annual funding as the bare minimum outcome of the summit to cope with the damage already incurred and to adapt and mitigate future climate change. Nations are less ambitious than civil society in their demands, with most targets from developing countries, including the Arab and the African Groups, hovering around the $1-2 trillion range. As the summit enters its second week and UN climate negotiations near the three-decade mark, words on a page, absent any legally binding or financial backing, are ringing increasingly hollow. “I see a disconnect between the global conversation and discourse with the reality that countries are facing,” Nigeria’s Minister of Health, Mohammed Ali Pate, said following the signing ceremony including the countries that inaugurated the coalition. “Nigeria and other countries are pulling within their limited resources,” Pate said. “We need to reconcile this divergence between global rhetoric and real action backed by resources for those who are bearing the brunt of climate change.” What’s the point? WHO COP29 high-level ministerial in progress in Baku. For frontline communities, the Baku coalition’s non-binding ‘promises’ are pyrrhic victories. But for the WHO and health advocates, they represent hard-fought institutional progress. The fight for health to be recognised as a central concern in UN climate summit agendas has been an uphill battle, mirroring the decades-long struggle to force nations to acknowledge the role of fossil fuels in the climate crisis. Just as it took nearly three decades of UN climate negotiations for the global community to finally commit to “transitioning away” from fossil fuels in Dubai last year – making headlines across the globe – the inclusion of health in the climate agenda is a victory that was won over decades. The health breakthrough is also reminiscent of another recent milestone in global environmental negotiations. Just a month ago in Cali, Colombia, Indigenous communities were granted an official expert body seat in UN biodiversity negotiations after years of tireless advocacy, prompting emotional scenes from people and communities who fought relentlessly for recognition. “The place that we have gained over the years for health at the COPs is now secured,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “We don’t need to fight every year to obtain this space.” Indigenous delegates at COP16 in Cali, Colombia, celebrate victory as decades of advocacy and activism lead to official representation in international negotiations. The coalition’s key achievement, while bureaucratic, is significant: after decades of fighting, health advocates and WHO officials will no longer have to relitigate the importance of health as a central concern in climate talks. “Each victory has been a step forward in getting health into the climate conversation,” Miller said. “Negotiators and heads of state [now] recognise that when they are making decisions about climate action, they are making decisions about people’s lives.” WHO can also claim the establishment of the Baku Coalition meets its basic goal for the talks – ensuring delegates recognize they’re negotiating the health of eight billion people – though the 18 attendees on Teams suggest the message may not have reached many member states. That such a modest procedural win emerges as COP29’s headline health achievement however challenges WHO’s message, pushed through two decades of pre-COP media blitzes, that health – as the lived experience of climate change – would be “the argument” driving meaningful climate action. So far, the evidence from Baku suggests that national delegations still aren’t listening. Time saved? It remains to be seen whether the time saved on bureaucratic wrangling with COP presidencies can translate into more careful tracking of achievements or barriers to fulfilling health-related commitments made at previous COP summits. At Glasgow’s COP26, the Alliance for Transformative Action on Climate and Health (ATACH) was launched with a promise to transform health systems to be more climate resilient. The coalition now includes 91 nations – half of UN climate summit participants – after Azerbaijan joined on Monday. While WHO monitors commitments made by ATACH members to low-carbon and net-zero health systems, there is no oversight of whether these have translated into action. Limited international funding available for health has gone largely unnoticed, even by the only country receiving support from the world’s leading climate fund, the Green Climate Fund (GCF). Malawi is the sole recipient of a GCF grant targeting the health sector’s climate needs. Yet Malawi’s own climate minister, interviewed by Health Policy Watch this week, was unaware of the GCF-funded project in their country. GCF has not responded to a request for comment. Baby steps, urgent crisis Delegates convened for the first-ever Health Day at a UN climate summit in Dubai. Last year seemed to mark another step forward in health action, with 150 nations signing a Health and Climate declaration during the first dedicated Health Day in three decades of climate talks. The Dubai COP also featured a two-week series of climate side events at an expanded WHO Health Pavilion, highlighting the impacts of climate change on food systems, air pollution, household air pollution, energy, and biodiversity. But beyond the political rhetoric, it remains unclear the level of progress being made in getting health into formal adaptation and mitigation processes. Health-specific climate action remains severely underfunded, still capturing only 2% of adaptation funding and 0.5% of multilateral climate funding – unchanged since Glasgow five years ago. At COP29, health financing announcements have amounted to a single $10 million grant from the Islamic Development Bank to the WHO. WHO influence in jeopardy WHO kicked off a funding drive to fill its multi-billion budget shortfall in Berlin last month. The WHO’s influence in the funding arena is further complicated by its own financial instability. Already grappling with a multi-billion dollar budget shortfall, the organization faces additional uncertainty with the possibility of the US, its biggest single donor, cutting funds when President-Elect Donald Trump returns to office in 2025. Trump withdrew from WHO in his previous term, and many in his orbit expect the incoming president to do the same this time around. Top WHO officials told Health Policy Watch last month another Trump withdrawal of funding reinstated by Biden would result in a “dramatically bad crisis” for the UN health agency. Brazil offers a glimmer of hope The Amazon Rainforest, Brazil. The buzz in the health world ahead of talks in Baku was to not expect significant health outcomes from COP29. Finance was always going to dominate the agenda, and Azerbaijan – whose delegation has by some accounts never spoken at COPs before hosting this one – was unlikely to lead on the issue. Looking ahead, Brazil’s hosting of COP30 offers a glimmer of hope to many in the health world. Brazil’s president, Luiz Inácio Lula da Silva, has pledged to act on climate and protect the Amazon, reversing four years of the legacy left by his predecessor, Jair Bolsonaro, who denies climate change and allowed deforestation and exploitation of the tropical rainforest to expand at an unprecedented rate. Brazilian officials have also committed to prioritizing health initiatives on next year’s agenda, already participating in high-profile WHO events in Geneva and Berlin ahead of the summit. In Baku, Brazil’s health minister announced that equality will be a key focus of its upcoming COP presidency. And with universal health coverage deeply embedded in Brazil’s national identity, there’s cautious optimism that meaningful health and climate action might finally move from rhetoric to reality in Rio. Image Credits: COP16, WHO , CIFOR-ICRAF. Jeddah Conference Announces More Measures to Combat AMR – But Implementation Plans Are Still Vague 18/11/2024 Kerry Cullinan Saudi Health Minister Fahad Abdulrahman Aljalajil addresses the Ministerial Conference on Antimicrobial Resistance (AMR) in Jeddah. Government leaders from the health, environment and agriculture sectors in 57 countries adopted a 14-point plan to tackle antimicrobial resistance (AMR) at a meeting in Saudi Arabia that ended over the weekend. One of the undertakings of the Jeddah Commitment is support for the establishment of an independent panel to collect evidence about AMR. The United Nations (UN) High-Level Meeting on AMR had already committed to such a panel in September and gave the Quadripartite (Quad) organisations – the World Health Organization (WHO), Food and Agricultural Organization (FAO), UN Evironment Programme (UNEP) and World Organization for Animal Health (WOAH) – the authority to set up the panel. The ministerial conference resolved to support the Quad in a “timely, open and transparent process” to set up “an Independent Panel for Evidence on Action Against AMR”. However further details, including which UN agency should host the panel and its terms of reference, have not yet been resolved. The UK is believed to favour UNEP hosting the panel while other countries believe that the WHO is better equipped to do so as the global health body houses the Quad. The declaration also call for the creation of a new “biotech bridge” to boost research, development and innovation to find solutions to AMR. AMR happens when bacteria, viruses, fungi, and parasites develop resistance to medicines designed to kill them. This makes infections harder and more costly to treat. Drug-resistant pathogens can also spread between people, animals, and the environment. It is driven in large part by the misuse and overuse of antimicrobials, particularly in agriculture. AMR already causes an estimated 1.27 million deaths per year. From agricultural runoff to wastewater, #AntimicrobialResistance spreads through our land & water, threatening ecosystems & health. Effective handling of fertilizers, wastewater & proper hygiene practices can help reduce #AMR in the environment. More🔗https://t.co/7mtNh4ejnI pic.twitter.com/9416GlR4eX — FAO Knowledge (@FAOKnowledge) November 18, 2024 Saudi Arabia launches regional hubs Meanwhile, Saudi Arabia will launch a regional antibiotic access and logistics hub and an AMR One Health learning hub, the country’s health minister, Fahd bin Abdulrahman Al-Jalajel, told conference delegates. The access and logistics hub will initially operate as a pilot in the WHO’s Eastern Mediterranean Region (EMRO). Its purpose is to foster the sustainable procurement of antibiotics and diagnostics and improve end-to-end access to these. A conference participant told Health Policy Watch that the hub would stockpile antibiotics and establish distribution networks to ensure that they reach areas in need, particularly conflict zones. EMRO members include Palestine, Lebanon and Sudan. The One Health AMR Learning Hub will focus on sharing best practices and developing capabilities on how to implement national AMR action plans on AMR with specific national targets. ‘Misunderstanding’ of animal welfare Wendla-Antonia Beyer, policy officer at the farm animal welfare and public health organisation, Four Paws, said that while the Jeddah Commitment “shows there is momentum behind tackling AMR” it also shows that there is “insufficient understanding of how animal welfare impacts antibiotics use in farming”. Beyer said that “73% of our antibiotics are used in agriculture, often for growth-promotion or for diseases that could be prevented if farms had good animal welfare. “Farms where piglets spend more time with their mothers use less antibiotics. Farms with slower-growing chicken breeds use less antibiotics. The solutions are there, proven and viable — they only need to make it into policy and practice. With the Political Declaration and the Jeddah Commitment behind us, governments and global governance structures now need to make animal welfare an integral part of the One Health response to AMR.” Katherine Urbáez, who heads the Health Diplomacy Alliance (HDA), said her organisation would “continue to advocate to ensure the continued political and financial commitment and to tackle AMR”. “This includes the setting up of the panel with the scope and governance that allows the identification of the data and to advance the commitments in the HLM Policital Declaration”. HDA is based in Geneva and works with multi-stakeholders to advance health with diplomacy. This week is World AMR Awareness Week, which has its theme as “Educate. Advocate. Act now.” Image Credits: Health Ministry of Saudi Arabia. Pandemic Agreement Makes Progress But Still Plenty of Sticky Details to Address 15/11/2024 Kerry Cullinan INB co-chair Anne-Claire Amprou and the WHO’s Mike Ryan at the close of INB12. The latest draft of the World Health Organization’s (WHO) pandemic agreement is awash with green highlights – an indication that countries have reached consensus on much of the text. But the Intergovernmental Negotiating Body (INB) announced on Monday that it would not be possible to reach an agreement by December – and countries would push for the adoption of an agreement by the World Health Assembly (WHA) next May. During the past two weeks of the 12th meeting of the INB, progress has been made on research and development(Article 9), local production(Article 10) and regulatory systems strengthening (Article 14). Sticking points But Article 4 on prevention, which details countries’ pandemic prevention and surveillance obligations, is mostly highlighted in yellow. This means that countries have broad agreement on the text but much of the detail is not agreed. Many of the proposals are common sense – such as building the capacity to detect pathogens at the community level, routine immunisation, and prevention of zoonotic spillover. But these measures are a tall order for some low-income countries, which is partly where the resistance is coming from. Under-resourced countries are unsure of how much prevention will cost them and whether they will get help to implement the provisions. Wealthier countries want assurances that their poorer neighbours can contain outbreaks. The rapid spread of mpox in central Africa is an example. Several affected countries have been unable to confirm cases as they lack basic diagnostic laboratories and trained staff. Negotiators are considering a separate annex on prevention, much as the details of a Pathogen Access and Benefit Sharing (PABS) system may be accommodated in a separate annex. Sticking points also remain on technology transfer (Article 11), the PABS system (Article 12), the global supply chain and logistic (GSCL) system (Article 13) and sustainable financing (Article 20). However, the most tangible offering of the agreement is back on the table although not yet agreed: that 20% of vaccines, therapeutics and diagnostics produced to combat that pathogen during a pandemic will be allocated to the WHO for distribution with 10% given free and the remaining amount on yet-to-be determined terms. Earlier, there were reports that some members of the European Union wanted this requirement to be cut down to 10% and 5% respectively. ‘Crucial and delicate’ Tanzanian Ambassador Dr Abdallah Saleh Possi. Tanzanian Ambassador Dr Abdallah Saleh Possi, speaking for the 47 African member states and Egypt, expressed Africa’s disappointment that there was not sufficient consensus to call a special World Health Assembly next month. “Although we had such slow progress in this 12th session that did not realize the convening of a special session in December as anticipated, we all agree that the remaining issues are not many, but crucial and delicate, requiring decision-making and flexibility,” said Possi at the close of the two-week negotiations on Friday. “Significantly, the meeting has generated the commitment to finalize them. We thank all the delegations that organize informal meetings on some sticky areas. We support having informal sessions during inter-sessional period with a view to achieving consensus on key areas. The Africa group plus Egypt is happy to be amongst the groups seeking to find consensus on the remaining issues.” The Philippines on behalf of the Equity Group, expressed appreciation for both the “substantive progress” particularly on articles, 9,10 and 14, and “the cordiality displayed by delegations that helped bring about this progress”. However, warned the Philippines’ delegate, “much work needs to be done to achieve consensus on key articles that operationalize equity such as articles, 11,12, 13, 13 (bis) and 20.” Unlike the Africa Group, which wanted a December resolution, the Equity Group has always advocated for more time to deliberate on the agreement. The negotiators reconvene for a short INB session from 2-6 December, where they will decide on the programme of negotiations for 2025. RFK Jr Nominated as Top US Health Official 15/11/2024 Stefan Anderson & Sophia Samantaroy Robert F. Kennedy Jr, scion of America’s most prominent political family, is set to become the nation’s top health official under Trump. Donald Trump has named Robert F Kennedy Jr as his choice for US health secretary, putting the controversial anti-vaccine activist and environmental lawyer in line to control some of the world’s most influential health agencies. Kennedy shot to political prominence during the COVID-19 pandemic when his organisation, Children’s Health Defense, became a leading global voice questioning vaccine safety and efficacy. His appointment, which requires Senate confirmation, comes after Kennedy dropped his independent presidential bid to back Trump. “He’s going to help make America healthy again,” Trump said in a speech at Mar-a-Lago following his election victory. “He wants to do some things, and we’re going to let him get to it.” Trump described the role atop HHS as “the most important role of any administration”, adding that Kennedy “will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country”. I am thrilled to announce Robert F. Kennedy Jr. as The United States Secretary of Health and Human Services (HHS). For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it… — Donald J. Trump (@realDonaldTrump) November 14, 2024 If confirmed, Kennedy would oversee a sprawling $1.8 trillion department with 10 health agencies and three human services agencies. His leadership of HHS would include the administration of Medicare, Medicaid and the Affordable Care Act while setting priorities for America’s three most powerful health agencies: the Centers for Disease Control and Prevention (CDC), which tracks disease outbreaks and sets public health guidance; the Food and Drug Administration (FDA), which approves medicines and medical devices; and the National Institutes of Health (NIH), the world’s largest public funder of medical research. Kennedy, an environmental lawyer with no health experience, called his appointment “a generational opportunity” to realign US health policy and “put an end to the chronic disease epidemic” in a post accepting the nomination on X. He said Trump has instructed him to “reorganize” the U.S. constellation of federal health agencies. “I look forward to working with the more than 80,000 employees at HHS to free the agencies from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth,” Kennedy said. Global health fallout Beyond domestic agencies, the Trump administration is also expected to reshape America’s role in global health. In his last term, Trump withdrew funding from the World Health Organization over its COVID-19 response and slashed funding to UN agencies, leaving a multi-billion dollar gap in the UN health agency’s budget. With Kennedy – who has questioned global health orthodoxies – by his side, experts expect this isolationist stance to deepen. This could affect millions who rely on HIV/AIDS funding through PEPFAR, a $7 billion US program providing HIV treatment in over 50 countries, the CDC’s network of 65 international offices, and State Department health diplomacy efforts. WHO officials told Health Policy Watch last month they face “a huge fear factor” over potential US funding withdrawal, warning the agency would enter “a dramatically bad crisis” without American support. The Biden administration’s global health security team referred Health Policy Watch to the Trump transition team when asked for comment. Robert Kennedy Junior’s banner photo on X, formerly Twitter, where he boasts over 4.5 million followers. Beyond the mainstream Kennedy’s stated priorities for America’s health system veer from broadly supported reforms to debunked anti-scientific claims that have alarmed health experts. In recent weeks, he has called for removing fluoride from US drinking water – which he claims causes brain disease – reviewing vaccine safety data with an eye to withdrawing some from the market, eliminating “entire departments” at the FDA, and immediately dismissing 600 NIH employees. His controversial positions include claims repeatedly rejected by scientists: that vaccines cause autism in children, that AIDS is not caused by HIV, that antidepressants are responsible for mass school shootings, and that atrazine, a widely used herbicide, triggers gender dysphoria and has led to increases in young people identifying as transgender. Kennedy’s unconventional streak isn’t limited to medicine. In the run-up to November’s election, Kennedy said doctors found a worm had eaten part of his brain, video footage revealed him to be the key to a decade-old New York City mystery of a dead bear in Central Park – he dumped it there on his way to the airport – and came under investigation for decapitating a whale. Lawrence Gostin, a global health expert at Georgetown University, called the Kennedy pick “the darkest day for public health and science in my lifetime.” “Trump’s pick of RFK Jr as HHS Secretary is disastrous for public health,” Gostin said. “Having a person sceptical of science and evidence at HHS will make America unhealthy.” Public health victories at risk Public health victories like vaccines and drinking water fluoridation have led to dramatic increases in life expectancy. The World Health Organization estimates vaccines save five million lives annually, with global immunization efforts having saved at least 154 million lives over the past 50 years. Yet Kennedy has repeatedly challenged these achievements by questioning vaccine safety and stating that fluoride is linked to “neurodevelopmental disorders.” The real-world impact of vaccine scepticism is already visible in the US, with the CDC reporting vaccination rates for children dropping for all available vaccines last year and vaccine exemptions for religious reasons rising across the past decade. “Religion doesn’t change that fast,” said Dr Michael Mendoza, a former county Public Health Commissioner in New York State. “This is about ideology and misinformation – and we’re seeing a direct impact in the number of kids unvaccinated.” “We’re at risk of widespread distrust in evidence-based treatments and vaccines,” Mendoza added, noting how health misinformation has directly influenced the increase in risky medical decisions. “Our elected and appointed officials have an obligation to promote experts and guidelines that are grounded in established scientific evidence.” Within the federal workforce, many remain optimistic that little will change. Agencies like the Biomedical Advanced Research and Development Authority (BARDA), which funded the development of COVID-19 vaccines, traditionally receive bipartisan support, resulting in little change across administrations. An HHS employee, speaking to Health Policy Watch on the condition of anonymity to safeguard their job security, noted that the negative perception of the new administration has yet to filter into many agencies. Room for agreement Less controversial is Kennedy’s opposition to the well-documented “revolving door” between the industry and government, where officials frequently switch between regulating companies and working for them – a system he argues has led to the “corporate capture” of US health agencies. In a country that spends more on healthcare than any other developed nation, has one of the world’s highest obesity rates, and whose largest public health crisis – the opioid epidemic – was engineered by pharmaceutical giant Purdue Pharma, his critiques of the system have found resonance. The concern about industry influence has merit: since 2000, every FDA commissioner has taken industry positions after leaving office. Nine out of the last ten, representing 40 years of leadership, have done the same. The pattern continued with Trump’s previous HHS secretary, Scott Gottlieb, who departed to a board seat at Pfizer in 2020. Kennedy’s stance against pharmaceutical interests sets up a likely clash with fellow Republicans, many of whom receive significant industry funding. Several GOP lawmakers have already pledged to dismantle President Joe Biden’s signature Medicare drug price negotiation law, which allows the government to negotiate fairer prices on behalf of its senior citizens, claiming it stifles innovation. Yet Kennedy has promised a direct confrontation with the industry, causing shares of major vaccine makers to plunge after Trump’s announcement of Kennedy’s selection. “Together we will clean up corruption, stop the revolving door between industry and government,” Kennedy said. Kennedy’s promised crusade against chronic diseases and processed foods has also found broad support among public health officials – setting up yet another clash with a major industry traditionally aligned with Republican politics. His pledge to strip ultra-processed foods from school lunches and crack down on food dyes has drawn bipartisan backing, though industry groups warn such moves could increase grocery prices Trump has vowed to reduce. “Senators may say, well, RFK Jr has good ideas like tackling chronic disease and regulating Big Food, but RFK Jr is not to be trusted after a career of peddling falsehoods,” Gostin said. “What we need is nutritional warnings on unhealthy foods, bans on targeting kids, and reduced salt and sugar.” Even some nutrition advocates who oppose Kennedy’s broader agenda acknowledge the need for stricter oversight of the food industry. The FDA has identified concerns about ultra-processed foods’ health impacts, though the agency says more research is needed. The challenge, experts say, will be implementing evidence-based reforms while avoiding Kennedy’s tendency toward unproven theories about food safety. Environmental hero to anti-vaccine empire Headline published in the Defender, the news arm of Kennedy’s anti-vaccine outfit on November 7. Kennedy began his career as a celebrated environmental lawyer, fighting corporate polluters and championing indigenous communities whose lands had been poisoned by industry. His aggressive prosecution of polluters helped restore the Hudson River to health, earning him Time magazine’s “Hero for the Planet” designation. He maintains some of this environmental ethos, promising in his presidential campaign before bowing out to back Trump to tackle unsafe PFAS levels and microplastic contamination. But his path took a sharp turn in 2015 when he took over the struggling World Mercury Project, rebranding it as Children’s Health Defense (CHD) in 2018. Under Kennedy’s leadership, CHD became a global anti-vaccine juggernaut. The organization’s revenue skyrocketed from $1.1 million in 2018 to $23.5 million in 2022, with Kennedy himself earning more than $510,000 in 2022, the last year where filings are available. In mainstream interviews and congressional appearances, Kennedy has worked to promote his least controversial views. He has attempted to moderate his image, telling NBC News: “I’m not going to take away anybody’s vaccines, I’ve never been anti-vaccine.” Yet the organization he led until his presidential campaign – and where he remains a lawyer – continues to fund and promote numerous anti-scientific positions. Public tax filings show Kennedy made $550,000 in executive compensation from Children’s Health Defense in 2022, the last year where records are available. During the pandemic, CHD’s vaccine-related posts were shared more frequently on Twitter than content from CNN, Fox News, NPR and the CDC combined – occasionally eclipsing the readership of the New York Times and Washington Post. The Center for Countering Digital Hate named Kennedy one of the “Disinformation Dozen,” identifying him and CHD as among the top spreaders of vaccine misinformation online. CHD also played a role in coordinating international protests for anti-vaccine movements around the world – with deadly consequences. In 2019, Kennedy’s organization flooded American Samoa with vaccine misinformation and lobbied the government against the use of the MMR vaccine, resulting in a devastating measles outbreak. This week, CHD’s news arm, The Defender, published claims that COVID-19 vaccines pose a “112,000% greater risk of brain clots and strokes than flu shots” – research based on misuse of VAERS, a federal database that records unverified reports of adverse events. The study’s authors include supplement company affiliates and anti-vaccine activists who openly coordinate with Kennedy’s organization. One author chairs a Texas-based organization that tagged Kennedy in a Twitter post on Tuesday calling for the “immediate withdrawal of all COVID-19 vaccines from the market” and the “repeal of the 1986” national childhood vaccination act. In his 2021 book, which sold over a million copies and sat on the New York TImes bestseller list for 17 weeks, Kennedy expands on the ethos behind CDH, calling Anthony Fauci, who led the US response to the COVID-19 pandemic, “the powerful technocrat who helped orchestrate and execute 2020’s historic coup d’état against Western democracy,” claiming his “remedies” – including Covid vaccines – were “often more lethal than the diseases they pretend to treat.” The book also champions Alan Duesberg, praising as “elegant” and “compelling” the discredited scientist’s claims that AIDS is not caused by HIV. Such theories had deadly consequences: 330,000 people died prematurely after being denied life-saving HIV treatment when South Africa’s government embraced view championed by Duesberg in the early 2000s, according to Harvard researchers. Path to Senate confirmation .@RobertKennedyJr has championed issues like healthy foods and the need for greater transparency in our public health infrastructure. I look forward to learning more about his other policy positions and how they will support a conservative, pro-American agenda. — U.S. Senator Bill Cassidy, M.D. (@SenBillCassidy) November 14, 2024 Kennedy’s path to confirmation runs through a Republican-led Senate, where he needs a simple majority of 51 votes. While some Republicans have expressed cautious support, experts point to Trump’s other nominees as the President-elect’s “tests” for Senate loyalty, suggesting the incoming president may bypass the traditional confirmation process entirely. “Any Republican Senator seeking the coveted LEADERSHIP position in the United States Senate must agree to Recess Appointments (in the Senate!), without which we will not be able to get people confirmed in a timely manner,” Trump posted on Sunday. “We need positions filled IMMEDIATELY!” If the Republican-majority Senate agrees to recess appointments – where the President appoints officials when Congress is not in session – Trump’s cabinet picks could stay until the end of 2026. Kennedy joins other iconoclastic nominees. Trump tapped former Democratic Representative Tulsi Gabbard for Director of National Security, noted for her opposition to US support for Ukraine and promoting debunked Russian claims about US-funded biolabs there. He also named Florida Representative Matt Gaetz, who had been facing a congressional ethics investigation over allegations of sex trafficking a minor, as Attorney General. Image Credits: Gage Skidmore, European Union/Martin Matev. Breakthrough Research Promises Shorter Treatment for Multi-Drug-Resistant TB 15/11/2024 Disha Shetty Young Indonesians appeal for an end to TB at the Union’s World Lung Health conference in Bali. In a breakthrough for patients with multi-drug-resistant (MDR) tuberculosis (TB), researchers shared positive trial results for a shorter, tailored alternative at the World Conference on Lung Health in Bali, Indonesia. The insights came from the endTB-Q trial aimed at finding a simpler, less toxic, shorter regimen for fluoroquinolone-resistant MDR-TB. Fluoroquinolone is a common class of medicine used to treat MDR TB, and if patients become resistant, they are considered to be bordering on extensively drug-resistant (XDR) TB, which is extremely hard to treat and can take 18 months. The endTB-Q clinical trial enrolled 323 patients from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam to try to find alternatives to the current longer treatment regimen recommended by the World Health Organization (WHO). Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project “Our trial innovated in several important ways. Since we know that treatment for TB is not ‘one size fits all’, we tested a strategy that tailored treatment duration to disease severity and treatment response based on simple criteria,” said Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project and co-principal investigator of the trial. Researchers tried a combination of four TB drugs used to treat drug-resistant forms of TB – bedaquiline, clofazimine, delamanid and linezolid (BCDL). These drugs were given for six months and extended to nine months in case of delayed treatment response. Around 87% of patients were cured after the treatment in comparison to 89% of patients in the control arm of the trial that received the current WHO regime. But those 87% who did get better had less severe TB, according to the researchers. But for people with severe TB disease, BCDL for nine months was insufficient as they were at risk of TB returning and the longer regimen is still the best option. “Our conclusions are that this regimen, BCDL, given for six to nine months, is an excellent approach for those who don’t have severe disease at baseline. In this group, the success rate is almost 95% and it has a big advantage compared to the historical conventional treatment because it’s much shorter and less toxic,” said Guglielmetti. Researchers shared several breakthrough insights on tuberculosis care at the World Conference on Lung Health. Bedaquiline use in children found safe Researchers also shared updates from a separate trial that looked into whether children can take bedaquiline, which is used to treat drug-resistant TB. The trial found the drug to have a high degree of safety and tolerance for use in children. New data from a different trial funded by the US-research agency National Institute of Health (NIH) called IMPAACT that included experts from Stellenbosch University in South Africa found bedaquiline safe for use in the treatment of infants, children and adolescents with drug-resistant TB. This is a crucial finding as it will allow further optimising the use of bedaquiline in children with drug-resistant TB – an under-served population. “The P1108 trial [bedaquiline] has paved the way for access, finally, to effective, shorter and safer treatment for children with drug-resistant TB. For too long children with TB have been left behind,” said researcher Simon Schaaf. He said that children form nearly 12% of all TB cases or 1.3 million cases every year globally but despite bedaquiline being authorized for use since 2012, there wasn’t any trial for its use in children. Nearly 3,900 stakeholders including industry representatives, patient groups, and doctors from around 150 countries attended the conference. The week-long conference also saw the release of results from other TB trials in countries across Southeast Asia. In Indonesia, researchers found that using mobile chest X-ray screening proved to be a useful tool to find active TB cases in the community. This is especially helpful in cases where people do not show classic symptoms of TB like coughing. Day 2 at #UnionConf24 is underway! 👉 @FIT_eV present their research into active case finding among communities in Vietnam🇻🇳 “Community chest X-ray screening for TB among ethnic minority communities is more than just a health intervention—it’s a vital step toward equity”#EndTB pic.twitter.com/Hn0iAzpr1V — The Union (@TheUnion_TBLH) November 13, 2024 In Vietnam, researchers stressed the importance of active case finding in ethnic minorities and remote communities to ensure access to treatment. They also used mobile X-ray machines. In the Philippines, person-centred active case finding for TB was found to break down barriers to healthcare access for vulnerable populations. The screening was done as a part of a poverty alleviation programme which empowered community members to participate and take a leading role. Trust in community leaders aided the screening of TB. Researchers also shared results from a study that highlighted the need to optimize tests to check whether a patient was susceptible to a particular drug or not, and to expand access to new TB compounds for people with life-threatening TB. “Antimicrobial resistance is among the greatest global health threats we face today. For people at-risk of TB, this threat is multiplied,” said Dr Cassandra Kelly-Cirino, Executive Director of The International Union Against Tuberculosis and Lung Disease (The Union), which convened the conference. “The new research presented at the Union Conference this week represents an invaluable step in managing this challenge and in offering hope to patients of all ages living with extensively drug-resistant TB.” Image Credits: The Union, The Union. Make Clean Air Part of Climate Plans, Experts Say 15/11/2024 Chetan Bhattacharji Smog engulfs Lahore, Pakistan, on Thursday as air pollution levels hit record highs. Some pollutants reached nearly 100 times the World Health Organization’s recommended level, according to IQAir. BAKU, Azerbaijan — Global and Indian experts at COP29 produced new evidence Thursday calling for clean air standards to become part of nations’ climate commitments, as cities across South Asia’s heavily polluted air corridor battled record-breaking smog. In Delhi, authorities closed schools up to grade 5 and halted construction as pollution levels soared to almost twenty times the WHO’s safe daily limit. The crisis came just days after Lahore, Pakistan’s second-largest city just 25 kilometres from the Indian border, saw its highest-ever levels of air pollution. Under the clear skies of Azerbaijan’s capital, experts from the World Bank, WHO, and Indian health ministry were unanimous that air quality improvement should be included in the new Nationally Determined Contributions (NDCs), the self-determined climate targets nations set under the Paris Agreement. “Air quality targets and standards can be a perfect indicator of success if we are successful in targeting the causes of climate change,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “If we could select an indicator of how successful we are in achieving negotiations on climate change mitigation, I think we should use the levels of air quality that people around the world are breathing.” Health experts hope their evidence linking air pollution and climate change will strengthen calls for action at COP29. Supporting this call for action is a new report released by the Clean Air Fund that shows how tropospheric ozone – a little-discussed ‘super pollutant’ – is linked to 500,000 premature deaths and an estimated $500 billion in economic costs annually. Air pollution from all sources contributes to more than eight million premature deaths each year, with economic costs exceeding $8 trillion, the report found. The findings aim to support the push for including air quality standards in the third generation of NDCs – binding climate commitments due before COP30 next year under the Paris Agreement. Only a small fraction of countries currently include air pollution safety in their climate plans despite the health threat to millions worldwide. Clean Air Fund’s founder and CEO, Jane Burston, said tackling super pollutants provides “huge opportunities” for improving climate, health, economic development, and equity. “We know that developing countries are some of the few that have included things like black carbon in their nationally determined contributions, and that’s because a lot of these deaths and this exposure is happening in countries least able to afford action on it,” she added. Super-bad for children Protest by ‘Warrior Moms’, a group for clean air, in Delhi outside India’s health ministry, as air pollution turned ‘severe’ on 14th November, which is celebrated as Children’s Day in the country. Tropospheric ozone and its super-pollutant siblings – including methane, black carbon, nitrous oxide and fluorinated gases – are collectively responsible for nearly half of global warming to date. Unlike other pollutants, tropospheric ozone isn’t directly emitted but forms when sunlight interacts with pollutants from aviation, shipping, agriculture and other sectors. Its health impacts can be severe, from reduced lung function to complications in type 2 diabetes and cardiovascular disease. For children, this pollution poses an especially severe threat. “Young children have smaller lungs,” Dr Soumya Swaminathan, an advisor to the Indian health ministry and former chief scientist at the WHO, explained. “They breathe much faster than adults, and they are shorter, so they’re closer to the ground, where there are more pollutants, and get more respiratory infections.” Dr Valerie Hickey, who leads the World Bank’s environment department, also placed children at the centre of her argument. “Your kid got up coughing so bad they couldn’t go to school does not lead on CNN,” she said. “Though if there are huge floods in Valencia, it does. Both are terrible, but [air pollution] is a public health emergency.” Like climate change itself, air pollution’s threat isn’t only visible in extreme events such as Delhi’s current crisis, where PM2.5 levels have reached almost 300 micrograms per cubic metre. “Every unit you go above five, you actually have a health impact,” explained Swaminathan, who co-chairs Our Common Air. “Even at 20, 30, 40 you start getting effects on the heart, respiratory system, and brain. So we need to take action to keep it as low as possible.” “We have to be pragmatic and set interim targets and do a stepwise plan to reduce it,” she added. “That’s what the NDCs are all about.” ‘Smog diplomacy’ Delhi and Lahore, just 400 kilometres apart, face the world’s highest air pollution levels. Half of the ten most polluted places in the world today are in four countries of South Asia – Pakistan, India, Nepal and Bangladesh. Health experts often say that air pollution knows no borders, an adage now forcing cooperation between long-standing rivals in what’s come to be known as “smog diplomacy.” India and Pakistan, nations that have fought multiple wars since independence, are finding themselves pushed toward dialogue over their shared air crisis. This week, as their major cities Delhi and Lahore traded places as the world’s most polluted, officials in Punjab, Pakistan’s most populous province, drafted a letter to India seeking talks on air pollution. “This is an area of the world where there isn’t always great experience with international diplomacy,” Hickey said. “Countries don’t always like each other, but they’re actually seeing that smog diplomacy is something that can bring them to the table.” The outreach comes as hundreds of millions in both countries face severe health risks borne from common problems plaguing both nations: farmers burning agricultural waste, coal-fired power plants, heavy traffic, construction and windless days trapping emissions. The World Bank has launched a “multi-hundred billion dollar” to address this cross-border crisis, targeting the vast northern plains of South Asia, known as the Indo-Gangetic Plains, Hickey told Health Policy Watch. The Bank has already committed to several regional projects in India, including a $350 million clean air management initiative plus $5 million grant for Uttar Pradesh, reportedly approved by the state cabinet and a pending $300 million loan plus $5 million grant for Haryana. Similar programs are planned for Nepal, Pakistan and Bangladesh to address pollution that readily crosses borders due to the region’s geography and wind patterns. “We need climate diplomacy, as a regional and global issue,” Raja Jahangir Anwar, Punjab’s Secretary for Environment and Climate Change, told CNN. “We are suffering in Lahore due to the eastern wind corridor coming from India. We are not blaming anyone, it’s a natural phenomenon.” Image Credits: https://x.com/ThePeerAli/status/1856985454072963085/photo/1. As World’s Health Ministers Meet in Jeddah: Calls for Strong AMR Science Panel With Authority to ‘Challenge’ Sponsors 14/11/2024 Elaine Ruth Fletcher Thail lab technicians train in surveillance of antimicrobial resistance (AMR) in food-producing animals in Southeast Asia – an driver of AMR that was neglected in the recent UN High Level Meeting declaration. With plans underway for a new “Independent Panel” on Antimicrobial Resistance, endorsed at September’s UN High-Level AMR Meeting, the new body must become a strong scientific authority. It should have the power to “challenge” the agencies that create it and address both human and animal health factors driving drug-resistant pathogens. That was a key message from AMR experts in the lead up to the Fourth Ministerial Meeting on Antimicrobial Resistance, which begins Friday in Jeddah, Saudi Arabia. The Independent Panel “needs to be an inclusive process… listening to scientists… civil society, to industry and other actors. But you also need to make sure that that panel, even though hosted by a Quadripartite, can actually challenge the Quadripartite,” declared John Arne Røttingen, CEO of the UK-based Wellcome Trust, of the panel’s central importance to providing evidence on future AMR policies. The ‘Quadripartite’ includes the World Health Organization, as well as the global environment, food and animal health agencies, which are now formally collaborating to confront the AMR threat. John-Arne Røttingen, CEO of Wellcome Trust. Røttingen was among the more than two dozen experts convened for two high-level AMR sessions at Berlin’s World Health Summit in mid-October to discuss next steps for the battle against drug resistant pathogens in the lead-up to the Jeddah meeting. “Declarations are long. It’s hard to identify the real material commitments that have been made,” Røttingen said at a panel discussion on Milestones and Challenges in Tackling AMR, hosted by the German Ministry of Health. “So it’s great that we come to Jeddah for the ministerial meeting,” he said. “That should be a start of both countries’ [and development agencies] coming together as well as the multi stakeholder partnership platform coming together across sectors to make sure that we are keeping our commitments.” On the research front, meanwhile, new “pull incentives” recently developed in the United Kingdom, Italy and Canada to foster a sustainable market for next generation antibiotics are welcome, but they are not enough, industry experts asserted. Many more nations need to adopt supply-side incentives to ensure that badly-needed new drug candidates actually come to market. Jeddah should be the start of making good on the UN’s AMR Declaration FAO, UNEP, WHO and WOAH heads at September’s UN High Level Meeting that approved a set of new commitments for action on drug resistant pathogens. The health ministers’ confab in Saudi Arabia (15-16 November) is supposed to lay out next steps for delivering on promises made in the Declaration on Antimicrobial Resistance approved at the UN High Level Meeting, 26 September in New York City. September’s declaration was a major milestone in the battle to bring a long-ignored AMR epidemic to the forefront of global health policy. AMR is associated, directly or indirectly, a “silent, slow-motion pandemic” that could kill some 39 million people by 2050. The mandate to create an “independent panel for evidence for action against antimicrobial resistance in 2025” is embedded in a 15-page text, with 106 clauses. But it is widely perceived as a key next move to maintain strategic momentum on AMR threats. The science panel should “facilitate the generation and use of multisectoral, scientific evidence to support Member States in efforts to tackle antimicrobial resistance, making use of existing resources and avoiding duplication of on-going efforts, after an open and transparent consultation with all Member States on its composition, mandate, scope, and deliverables,” the AMR declaration stated. Final HLM declaration omitted target for reducing animal antibiotic consumption Asian meat-packing house. The science panel is supposed to be created and administered by the Quadripartite of agencies whose role in managing the AMR crisis was also formalized by the declaration. Along with WHO, the four-member body includes the UN Food and Agriculture Organization (FAO), the UN Environment Programme (UNEP), and the World Animal Health Organization (WOAH), a non-UN member state body. And that makes the panel’s mandate and composition a sensitive point, in light of the political pressures from big food and other interests that want to play down their role in fostering AMR risks, which some researchers say is the leading driver. Identified AMR hotspots often align with high volumes of antibiotics sales and use in livestock. Pressures from agri-businesses and meat producing nations already led to the deletion of a target for reducing animal antibiotic use by 30% by 2030 from the final HLM declaration. Now, the question is whether scientists can come together to articulate the evidence and agree on science-based policy recommendations. “Even though the declaration was positive, it also didn’t achieve agreement on things that I, from my professional background, …would say should have been agreed,” Røttingen observed. “And that speaks to the interests and the trade offs between different sectors… it speaks to agri-food businesses versus human health, and that’s why we believe a science panel is important.” He said, “We have the target of inverting AMR-related mortality [by 10% by 2030], but we need even more targets and more ambitious targets, so we have a lot to do,” he said. “In the climate sector, we have the IPCC (Intergovernmental Panel on Climate Change),” Røttingen continued. “We know how … contested the climate space is, but still, we have a collective international evidence base… We need authoritative evidence with scientists working in the human sector and the animal sector that can come together to actually give us that evidence base and give guidance. “ For animal health, as well, the ultimate aim is to curb abuse not essential use Arshnee Moodley, CGIAR-Kenya Worldwide, the overuse of such antibiotics in livestock production is widely regarded among experts as a leading, if not the leading, driver of pathogen resistance. But ultimately, the aim of new measures should be win-wins that ensure better access to vaccines and other measures to pre-empt antibiotic use and ensure animal health, panelists at the sessions also underlined. “You need to be able to communicate with the people who can change that [AMR trends],” said Dr. Arshnee Moodley, a Kenya-based lead of CGIAR, which works with farmers on animal health. “And for me, it’s the smallholder famer outside of Nairobi. I need to be able to tell him or her why they shouldn’t use antibiotics,” she said. “And that’s really critical because livestock is also part of the solution; it’s vital food for vulnerable groups,” she continued. “I worked every summer in my grandfather’s farm with three milk houses, from the age of 13. So I know about animal health and the need for small farmers, even in high income countries, to keep their herds healthy,” Røttingen countered. “When I’m concerned about the agricultural sector, it’s not really about the misuse of antibiotics among small scale farmers … it is about big food on several continents and making sure that they are … transparent and they are willing to engage in proper animal welfare, because that’s the starting point for ensuring animal health. Too often, measures related to vaccines and hygiene are bypassed, “by using antibiotics to treat herds that aren’t necessarily requisite,” he explained. Worst of all, is the use of antimicrobials or antibiotics “as growth promotion that has nothing to do with animal health. It’s not healthy for those who eat those animals, and it’s not healthy for the animals. “So … animal health is an important part, but I think the hardest question lies with the big food companies.” For human health – more prevention and better regulation are essential too Malawi’s Minister of Health Khumbize Kandodo Chiponda with Tamas Koncz, Pfizer Germany Much as with animals, infection prevention, appropriate access to drugs and better regulation need to be the operative goals for humans as well, panelists at a second high-level session on AMR agreed. That includes clean water, sanitation and hygiene that many communities and health facilities still lack, as well as stronger laboratory networks, and quality control of antimicrobials in settings were fake and substandard formulas often circulate. “Unfortunately for countries like us, we face challenges, because in terms of manufacturing… we have to get them [products] from outside. So in terms of the quality…. you cannot be 100% sure that what you’re getting really is the very, very good quality,” said Khumbize Kandodo Chiponda Minister of Health, Malawi, speaking at the panel hosted by the global non-profit antibiotic accelerator CARB-X and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Changing community behaviours and patterns can be a major lift, in light of the ease with which people can get antibiotics through more informal channels as well as the expense people might face in seeing a healthcare professional – who will in turn face challenges determining if antibiotics are needed or not – without adequate diagnostics equipment. Access to antibiotics is improving – but Africa is also becoming an AMR hotspot Buying antibiotics in India. Prescriptions are required but the rule is not always enforced. “Access to antibiotics [in LMICs] is improving and that is a good thing,” said Tamas Koncz, a vice-president of Pfizer’s operations in Germany. He pointed to data citing a 114% increase in antibiotic use in low- and middle-income countries between 2000-2015. Pfizer’s 2022 Accord for a Healthier World, which committed to providing all of its patented medicines and vaccines to 45 lower-income countries on a not-for-profit basis, has been one enabler of better access to common antimicrobials, he said. At the same time, weak enforcement of prescription drug rules, as well as a lack of health provider knowledge about which drugs to prescribe, are drivers of drug resistance. “If physicians are not using [the drugs] appropriately, then it’s going to lead to problems. So we need to fix the challenge of access. But I think what is even more important is the overall approach.” Africa, where sales of antibiotics by unlicensed vendors is often widespread, is also becoming a major AMR hotspot, he pointed out – highlighting the challenges of balancing access with judicious use. All-age rate of deaths attributable to/associated with antibiotic resistance, 2019. (Lancet, 2022) The landmark 2022 Lancet study that found 1.27 million deaths globally in 2019 were directly attributable to drug-resistant bacterial infections, including 860,000 in Africa. That same year, Africa saw 640,000 deaths from HIV. “We know from the recent communication from the African CDC and others, that it’s becoming probably the one of the biggest, if not the biggest, healthcare burden, superseding now HIV AIDs, maybe even malaria and tuberculosis,” said Koncz. ‘Pull’ incentives Florence Séjourné, Aurobac and Kevin Outterson, CARB-X. On the supply side of the equation, meanwhile, “more pull incentives” that can incentivize pharma developers of newer, pathogen-resistant antibiotics is a long-neglected topic now finally rising to the top of health ministers’ agendas. The challenge lies in the fact that new antibiotics capable of beating drug-resistant infections also need to used sparingly – to ensure that they, too, don’t fail prey to AMR. But that means companies that develop the drugs can’t count on revenues from blockbuster sales to pay back years of investment in clinical trials. “AMR innovation is in a broken business model right now, needing incentives.” said Florence Séjourné. She is the CEO of the Aurobac Therapeutics, a joint AMR R&D venture created by two leading European pharma firms as well as the founder of the BEAM Alliance association of AMR-focused biotechs. Products risk death in the pipeline While there are now 20 “highly innovative” antibiotics in the early stages of development globally, the number will have dwindled by 75% within eight years if the business model doesn’t change, warned Dr Kevin Outterson, head of CARB-X. “Within four years, we’ll have less than 10 in clinical development globally. And four more years after that, we’ll have less than five.” The of human capital” he added as large companies shut down programmes, and research is concentrated in underfinanced biotech startups. “There is absolutely no interest in private investors in the antibacterial field, which is complex,” added Séjourné. Of the startups, 60% of the BEAM Alliance members have less than a year of cash to fund their activities; 40% are firms of less than 9 employees. “The world is relying on micro companies, companies with less than 10 employees…That’s a very fragile base,” for developing urgently needed new drugs, Outterson added. On the cusp of a solution? Bacterial culture prepared for testing new antibiotic candidates. But, there are also some glimmers of hope on the horizon. The first was the launch of the United Kingdom’s new “subscription model” in May for antimicrobial drugs that need to be held in ‘reserve’ for drug resistant pathogens. This aims to guarantee innovators a return on new drugs, regardless of the quantities used, that can guarantee a market incentive for new drugs, even if they are carefully rationed. Séjourné praised the UK decision as “something to highlight has a good example for others to follow” – although she warned that until a larger number of countries get on board with such changes, “the broken business model will remain.” More recently, at the 10 October meeting of G7 health and finance ministers in Ancona, Italy’s Minister of Health, Orazio Schillaci announced a series of new “pull incentives” aimed at stimulating R&D and ensuring biotech firms a payback on their investment. Canada is also piloting an incentive programme, while other European Union members, as well as Japan, are considering similar moves. In light of those new developments, CARB-X’s Outterson sounds a note of cautious optimism. “At the G7 meeting, I made the economic case for a small, reasonable investment and push and mostly pull incentives, together, yields an amazing return on investment, both on the health side as well as the economic side,” Outterson said. “It was a rare opportunity to be able to speak not just to the health people, but also the finance people,” he said, noting that the issues raised at the meeting appeared to resonate with both sectors. “And so we have a problem, and we know that it’s desperate, and companies are filled with innovation, but not enough capital to move things forward. But we really are on the cusp of the solution as well.” IFPMA Director David Reddy “The UN meeting finished only a few weeks ago,” said IFPMA director David Reddy. “We’re moving towards the meeting in Saudi Arabia, which is the fourth AMR high level event. “I think one thing that is really important is that we are getting a common understanding of where we need to go, and what the challenges are,” he added. “We do need to make progress on the business model. The UK, Japan have already made good moves towards pull incentives, and a pilot has been put in place by Canada. There are a lot of remaining challenges, but I think the key message coming out of this is there is a real thirst to maintain momentum as we head into the meeting in Saudi Arabia.” But “it’s not just about financing,” he added, “it’s also about people and competencies.” “Access but having a really firm understanding of community needs on the ground is essential, because without that, we won’t make progress in the fight against AMR and in bringing antibiotics to those who need them.” Image Credits: USAID Asia/Flickr, USAID Asia , Health Policy Watch , Van Boeckel, Pires et al, 2019, WHO, The Lancet, 2022, AMR Industry Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. 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Jeddah Conference Announces More Measures to Combat AMR – But Implementation Plans Are Still Vague 18/11/2024 Kerry Cullinan Saudi Health Minister Fahad Abdulrahman Aljalajil addresses the Ministerial Conference on Antimicrobial Resistance (AMR) in Jeddah. Government leaders from the health, environment and agriculture sectors in 57 countries adopted a 14-point plan to tackle antimicrobial resistance (AMR) at a meeting in Saudi Arabia that ended over the weekend. One of the undertakings of the Jeddah Commitment is support for the establishment of an independent panel to collect evidence about AMR. The United Nations (UN) High-Level Meeting on AMR had already committed to such a panel in September and gave the Quadripartite (Quad) organisations – the World Health Organization (WHO), Food and Agricultural Organization (FAO), UN Evironment Programme (UNEP) and World Organization for Animal Health (WOAH) – the authority to set up the panel. The ministerial conference resolved to support the Quad in a “timely, open and transparent process” to set up “an Independent Panel for Evidence on Action Against AMR”. However further details, including which UN agency should host the panel and its terms of reference, have not yet been resolved. The UK is believed to favour UNEP hosting the panel while other countries believe that the WHO is better equipped to do so as the global health body houses the Quad. The declaration also call for the creation of a new “biotech bridge” to boost research, development and innovation to find solutions to AMR. AMR happens when bacteria, viruses, fungi, and parasites develop resistance to medicines designed to kill them. This makes infections harder and more costly to treat. Drug-resistant pathogens can also spread between people, animals, and the environment. It is driven in large part by the misuse and overuse of antimicrobials, particularly in agriculture. AMR already causes an estimated 1.27 million deaths per year. From agricultural runoff to wastewater, #AntimicrobialResistance spreads through our land & water, threatening ecosystems & health. Effective handling of fertilizers, wastewater & proper hygiene practices can help reduce #AMR in the environment. More🔗https://t.co/7mtNh4ejnI pic.twitter.com/9416GlR4eX — FAO Knowledge (@FAOKnowledge) November 18, 2024 Saudi Arabia launches regional hubs Meanwhile, Saudi Arabia will launch a regional antibiotic access and logistics hub and an AMR One Health learning hub, the country’s health minister, Fahd bin Abdulrahman Al-Jalajel, told conference delegates. The access and logistics hub will initially operate as a pilot in the WHO’s Eastern Mediterranean Region (EMRO). Its purpose is to foster the sustainable procurement of antibiotics and diagnostics and improve end-to-end access to these. A conference participant told Health Policy Watch that the hub would stockpile antibiotics and establish distribution networks to ensure that they reach areas in need, particularly conflict zones. EMRO members include Palestine, Lebanon and Sudan. The One Health AMR Learning Hub will focus on sharing best practices and developing capabilities on how to implement national AMR action plans on AMR with specific national targets. ‘Misunderstanding’ of animal welfare Wendla-Antonia Beyer, policy officer at the farm animal welfare and public health organisation, Four Paws, said that while the Jeddah Commitment “shows there is momentum behind tackling AMR” it also shows that there is “insufficient understanding of how animal welfare impacts antibiotics use in farming”. Beyer said that “73% of our antibiotics are used in agriculture, often for growth-promotion or for diseases that could be prevented if farms had good animal welfare. “Farms where piglets spend more time with their mothers use less antibiotics. Farms with slower-growing chicken breeds use less antibiotics. The solutions are there, proven and viable — they only need to make it into policy and practice. With the Political Declaration and the Jeddah Commitment behind us, governments and global governance structures now need to make animal welfare an integral part of the One Health response to AMR.” Katherine Urbáez, who heads the Health Diplomacy Alliance (HDA), said her organisation would “continue to advocate to ensure the continued political and financial commitment and to tackle AMR”. “This includes the setting up of the panel with the scope and governance that allows the identification of the data and to advance the commitments in the HLM Policital Declaration”. HDA is based in Geneva and works with multi-stakeholders to advance health with diplomacy. This week is World AMR Awareness Week, which has its theme as “Educate. Advocate. Act now.” Image Credits: Health Ministry of Saudi Arabia. Pandemic Agreement Makes Progress But Still Plenty of Sticky Details to Address 15/11/2024 Kerry Cullinan INB co-chair Anne-Claire Amprou and the WHO’s Mike Ryan at the close of INB12. The latest draft of the World Health Organization’s (WHO) pandemic agreement is awash with green highlights – an indication that countries have reached consensus on much of the text. But the Intergovernmental Negotiating Body (INB) announced on Monday that it would not be possible to reach an agreement by December – and countries would push for the adoption of an agreement by the World Health Assembly (WHA) next May. During the past two weeks of the 12th meeting of the INB, progress has been made on research and development(Article 9), local production(Article 10) and regulatory systems strengthening (Article 14). Sticking points But Article 4 on prevention, which details countries’ pandemic prevention and surveillance obligations, is mostly highlighted in yellow. This means that countries have broad agreement on the text but much of the detail is not agreed. Many of the proposals are common sense – such as building the capacity to detect pathogens at the community level, routine immunisation, and prevention of zoonotic spillover. But these measures are a tall order for some low-income countries, which is partly where the resistance is coming from. Under-resourced countries are unsure of how much prevention will cost them and whether they will get help to implement the provisions. Wealthier countries want assurances that their poorer neighbours can contain outbreaks. The rapid spread of mpox in central Africa is an example. Several affected countries have been unable to confirm cases as they lack basic diagnostic laboratories and trained staff. Negotiators are considering a separate annex on prevention, much as the details of a Pathogen Access and Benefit Sharing (PABS) system may be accommodated in a separate annex. Sticking points also remain on technology transfer (Article 11), the PABS system (Article 12), the global supply chain and logistic (GSCL) system (Article 13) and sustainable financing (Article 20). However, the most tangible offering of the agreement is back on the table although not yet agreed: that 20% of vaccines, therapeutics and diagnostics produced to combat that pathogen during a pandemic will be allocated to the WHO for distribution with 10% given free and the remaining amount on yet-to-be determined terms. Earlier, there were reports that some members of the European Union wanted this requirement to be cut down to 10% and 5% respectively. ‘Crucial and delicate’ Tanzanian Ambassador Dr Abdallah Saleh Possi. Tanzanian Ambassador Dr Abdallah Saleh Possi, speaking for the 47 African member states and Egypt, expressed Africa’s disappointment that there was not sufficient consensus to call a special World Health Assembly next month. “Although we had such slow progress in this 12th session that did not realize the convening of a special session in December as anticipated, we all agree that the remaining issues are not many, but crucial and delicate, requiring decision-making and flexibility,” said Possi at the close of the two-week negotiations on Friday. “Significantly, the meeting has generated the commitment to finalize them. We thank all the delegations that organize informal meetings on some sticky areas. We support having informal sessions during inter-sessional period with a view to achieving consensus on key areas. The Africa group plus Egypt is happy to be amongst the groups seeking to find consensus on the remaining issues.” The Philippines on behalf of the Equity Group, expressed appreciation for both the “substantive progress” particularly on articles, 9,10 and 14, and “the cordiality displayed by delegations that helped bring about this progress”. However, warned the Philippines’ delegate, “much work needs to be done to achieve consensus on key articles that operationalize equity such as articles, 11,12, 13, 13 (bis) and 20.” Unlike the Africa Group, which wanted a December resolution, the Equity Group has always advocated for more time to deliberate on the agreement. The negotiators reconvene for a short INB session from 2-6 December, where they will decide on the programme of negotiations for 2025. RFK Jr Nominated as Top US Health Official 15/11/2024 Stefan Anderson & Sophia Samantaroy Robert F. Kennedy Jr, scion of America’s most prominent political family, is set to become the nation’s top health official under Trump. Donald Trump has named Robert F Kennedy Jr as his choice for US health secretary, putting the controversial anti-vaccine activist and environmental lawyer in line to control some of the world’s most influential health agencies. Kennedy shot to political prominence during the COVID-19 pandemic when his organisation, Children’s Health Defense, became a leading global voice questioning vaccine safety and efficacy. His appointment, which requires Senate confirmation, comes after Kennedy dropped his independent presidential bid to back Trump. “He’s going to help make America healthy again,” Trump said in a speech at Mar-a-Lago following his election victory. “He wants to do some things, and we’re going to let him get to it.” Trump described the role atop HHS as “the most important role of any administration”, adding that Kennedy “will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country”. I am thrilled to announce Robert F. Kennedy Jr. as The United States Secretary of Health and Human Services (HHS). For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it… — Donald J. Trump (@realDonaldTrump) November 14, 2024 If confirmed, Kennedy would oversee a sprawling $1.8 trillion department with 10 health agencies and three human services agencies. His leadership of HHS would include the administration of Medicare, Medicaid and the Affordable Care Act while setting priorities for America’s three most powerful health agencies: the Centers for Disease Control and Prevention (CDC), which tracks disease outbreaks and sets public health guidance; the Food and Drug Administration (FDA), which approves medicines and medical devices; and the National Institutes of Health (NIH), the world’s largest public funder of medical research. Kennedy, an environmental lawyer with no health experience, called his appointment “a generational opportunity” to realign US health policy and “put an end to the chronic disease epidemic” in a post accepting the nomination on X. He said Trump has instructed him to “reorganize” the U.S. constellation of federal health agencies. “I look forward to working with the more than 80,000 employees at HHS to free the agencies from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth,” Kennedy said. Global health fallout Beyond domestic agencies, the Trump administration is also expected to reshape America’s role in global health. In his last term, Trump withdrew funding from the World Health Organization over its COVID-19 response and slashed funding to UN agencies, leaving a multi-billion dollar gap in the UN health agency’s budget. With Kennedy – who has questioned global health orthodoxies – by his side, experts expect this isolationist stance to deepen. This could affect millions who rely on HIV/AIDS funding through PEPFAR, a $7 billion US program providing HIV treatment in over 50 countries, the CDC’s network of 65 international offices, and State Department health diplomacy efforts. WHO officials told Health Policy Watch last month they face “a huge fear factor” over potential US funding withdrawal, warning the agency would enter “a dramatically bad crisis” without American support. The Biden administration’s global health security team referred Health Policy Watch to the Trump transition team when asked for comment. Robert Kennedy Junior’s banner photo on X, formerly Twitter, where he boasts over 4.5 million followers. Beyond the mainstream Kennedy’s stated priorities for America’s health system veer from broadly supported reforms to debunked anti-scientific claims that have alarmed health experts. In recent weeks, he has called for removing fluoride from US drinking water – which he claims causes brain disease – reviewing vaccine safety data with an eye to withdrawing some from the market, eliminating “entire departments” at the FDA, and immediately dismissing 600 NIH employees. His controversial positions include claims repeatedly rejected by scientists: that vaccines cause autism in children, that AIDS is not caused by HIV, that antidepressants are responsible for mass school shootings, and that atrazine, a widely used herbicide, triggers gender dysphoria and has led to increases in young people identifying as transgender. Kennedy’s unconventional streak isn’t limited to medicine. In the run-up to November’s election, Kennedy said doctors found a worm had eaten part of his brain, video footage revealed him to be the key to a decade-old New York City mystery of a dead bear in Central Park – he dumped it there on his way to the airport – and came under investigation for decapitating a whale. Lawrence Gostin, a global health expert at Georgetown University, called the Kennedy pick “the darkest day for public health and science in my lifetime.” “Trump’s pick of RFK Jr as HHS Secretary is disastrous for public health,” Gostin said. “Having a person sceptical of science and evidence at HHS will make America unhealthy.” Public health victories at risk Public health victories like vaccines and drinking water fluoridation have led to dramatic increases in life expectancy. The World Health Organization estimates vaccines save five million lives annually, with global immunization efforts having saved at least 154 million lives over the past 50 years. Yet Kennedy has repeatedly challenged these achievements by questioning vaccine safety and stating that fluoride is linked to “neurodevelopmental disorders.” The real-world impact of vaccine scepticism is already visible in the US, with the CDC reporting vaccination rates for children dropping for all available vaccines last year and vaccine exemptions for religious reasons rising across the past decade. “Religion doesn’t change that fast,” said Dr Michael Mendoza, a former county Public Health Commissioner in New York State. “This is about ideology and misinformation – and we’re seeing a direct impact in the number of kids unvaccinated.” “We’re at risk of widespread distrust in evidence-based treatments and vaccines,” Mendoza added, noting how health misinformation has directly influenced the increase in risky medical decisions. “Our elected and appointed officials have an obligation to promote experts and guidelines that are grounded in established scientific evidence.” Within the federal workforce, many remain optimistic that little will change. Agencies like the Biomedical Advanced Research and Development Authority (BARDA), which funded the development of COVID-19 vaccines, traditionally receive bipartisan support, resulting in little change across administrations. An HHS employee, speaking to Health Policy Watch on the condition of anonymity to safeguard their job security, noted that the negative perception of the new administration has yet to filter into many agencies. Room for agreement Less controversial is Kennedy’s opposition to the well-documented “revolving door” between the industry and government, where officials frequently switch between regulating companies and working for them – a system he argues has led to the “corporate capture” of US health agencies. In a country that spends more on healthcare than any other developed nation, has one of the world’s highest obesity rates, and whose largest public health crisis – the opioid epidemic – was engineered by pharmaceutical giant Purdue Pharma, his critiques of the system have found resonance. The concern about industry influence has merit: since 2000, every FDA commissioner has taken industry positions after leaving office. Nine out of the last ten, representing 40 years of leadership, have done the same. The pattern continued with Trump’s previous HHS secretary, Scott Gottlieb, who departed to a board seat at Pfizer in 2020. Kennedy’s stance against pharmaceutical interests sets up a likely clash with fellow Republicans, many of whom receive significant industry funding. Several GOP lawmakers have already pledged to dismantle President Joe Biden’s signature Medicare drug price negotiation law, which allows the government to negotiate fairer prices on behalf of its senior citizens, claiming it stifles innovation. Yet Kennedy has promised a direct confrontation with the industry, causing shares of major vaccine makers to plunge after Trump’s announcement of Kennedy’s selection. “Together we will clean up corruption, stop the revolving door between industry and government,” Kennedy said. Kennedy’s promised crusade against chronic diseases and processed foods has also found broad support among public health officials – setting up yet another clash with a major industry traditionally aligned with Republican politics. His pledge to strip ultra-processed foods from school lunches and crack down on food dyes has drawn bipartisan backing, though industry groups warn such moves could increase grocery prices Trump has vowed to reduce. “Senators may say, well, RFK Jr has good ideas like tackling chronic disease and regulating Big Food, but RFK Jr is not to be trusted after a career of peddling falsehoods,” Gostin said. “What we need is nutritional warnings on unhealthy foods, bans on targeting kids, and reduced salt and sugar.” Even some nutrition advocates who oppose Kennedy’s broader agenda acknowledge the need for stricter oversight of the food industry. The FDA has identified concerns about ultra-processed foods’ health impacts, though the agency says more research is needed. The challenge, experts say, will be implementing evidence-based reforms while avoiding Kennedy’s tendency toward unproven theories about food safety. Environmental hero to anti-vaccine empire Headline published in the Defender, the news arm of Kennedy’s anti-vaccine outfit on November 7. Kennedy began his career as a celebrated environmental lawyer, fighting corporate polluters and championing indigenous communities whose lands had been poisoned by industry. His aggressive prosecution of polluters helped restore the Hudson River to health, earning him Time magazine’s “Hero for the Planet” designation. He maintains some of this environmental ethos, promising in his presidential campaign before bowing out to back Trump to tackle unsafe PFAS levels and microplastic contamination. But his path took a sharp turn in 2015 when he took over the struggling World Mercury Project, rebranding it as Children’s Health Defense (CHD) in 2018. Under Kennedy’s leadership, CHD became a global anti-vaccine juggernaut. The organization’s revenue skyrocketed from $1.1 million in 2018 to $23.5 million in 2022, with Kennedy himself earning more than $510,000 in 2022, the last year where filings are available. In mainstream interviews and congressional appearances, Kennedy has worked to promote his least controversial views. He has attempted to moderate his image, telling NBC News: “I’m not going to take away anybody’s vaccines, I’ve never been anti-vaccine.” Yet the organization he led until his presidential campaign – and where he remains a lawyer – continues to fund and promote numerous anti-scientific positions. Public tax filings show Kennedy made $550,000 in executive compensation from Children’s Health Defense in 2022, the last year where records are available. During the pandemic, CHD’s vaccine-related posts were shared more frequently on Twitter than content from CNN, Fox News, NPR and the CDC combined – occasionally eclipsing the readership of the New York Times and Washington Post. The Center for Countering Digital Hate named Kennedy one of the “Disinformation Dozen,” identifying him and CHD as among the top spreaders of vaccine misinformation online. CHD also played a role in coordinating international protests for anti-vaccine movements around the world – with deadly consequences. In 2019, Kennedy’s organization flooded American Samoa with vaccine misinformation and lobbied the government against the use of the MMR vaccine, resulting in a devastating measles outbreak. This week, CHD’s news arm, The Defender, published claims that COVID-19 vaccines pose a “112,000% greater risk of brain clots and strokes than flu shots” – research based on misuse of VAERS, a federal database that records unverified reports of adverse events. The study’s authors include supplement company affiliates and anti-vaccine activists who openly coordinate with Kennedy’s organization. One author chairs a Texas-based organization that tagged Kennedy in a Twitter post on Tuesday calling for the “immediate withdrawal of all COVID-19 vaccines from the market” and the “repeal of the 1986” national childhood vaccination act. In his 2021 book, which sold over a million copies and sat on the New York TImes bestseller list for 17 weeks, Kennedy expands on the ethos behind CDH, calling Anthony Fauci, who led the US response to the COVID-19 pandemic, “the powerful technocrat who helped orchestrate and execute 2020’s historic coup d’état against Western democracy,” claiming his “remedies” – including Covid vaccines – were “often more lethal than the diseases they pretend to treat.” The book also champions Alan Duesberg, praising as “elegant” and “compelling” the discredited scientist’s claims that AIDS is not caused by HIV. Such theories had deadly consequences: 330,000 people died prematurely after being denied life-saving HIV treatment when South Africa’s government embraced view championed by Duesberg in the early 2000s, according to Harvard researchers. Path to Senate confirmation .@RobertKennedyJr has championed issues like healthy foods and the need for greater transparency in our public health infrastructure. I look forward to learning more about his other policy positions and how they will support a conservative, pro-American agenda. — U.S. Senator Bill Cassidy, M.D. (@SenBillCassidy) November 14, 2024 Kennedy’s path to confirmation runs through a Republican-led Senate, where he needs a simple majority of 51 votes. While some Republicans have expressed cautious support, experts point to Trump’s other nominees as the President-elect’s “tests” for Senate loyalty, suggesting the incoming president may bypass the traditional confirmation process entirely. “Any Republican Senator seeking the coveted LEADERSHIP position in the United States Senate must agree to Recess Appointments (in the Senate!), without which we will not be able to get people confirmed in a timely manner,” Trump posted on Sunday. “We need positions filled IMMEDIATELY!” If the Republican-majority Senate agrees to recess appointments – where the President appoints officials when Congress is not in session – Trump’s cabinet picks could stay until the end of 2026. Kennedy joins other iconoclastic nominees. Trump tapped former Democratic Representative Tulsi Gabbard for Director of National Security, noted for her opposition to US support for Ukraine and promoting debunked Russian claims about US-funded biolabs there. He also named Florida Representative Matt Gaetz, who had been facing a congressional ethics investigation over allegations of sex trafficking a minor, as Attorney General. Image Credits: Gage Skidmore, European Union/Martin Matev. Breakthrough Research Promises Shorter Treatment for Multi-Drug-Resistant TB 15/11/2024 Disha Shetty Young Indonesians appeal for an end to TB at the Union’s World Lung Health conference in Bali. In a breakthrough for patients with multi-drug-resistant (MDR) tuberculosis (TB), researchers shared positive trial results for a shorter, tailored alternative at the World Conference on Lung Health in Bali, Indonesia. The insights came from the endTB-Q trial aimed at finding a simpler, less toxic, shorter regimen for fluoroquinolone-resistant MDR-TB. Fluoroquinolone is a common class of medicine used to treat MDR TB, and if patients become resistant, they are considered to be bordering on extensively drug-resistant (XDR) TB, which is extremely hard to treat and can take 18 months. The endTB-Q clinical trial enrolled 323 patients from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam to try to find alternatives to the current longer treatment regimen recommended by the World Health Organization (WHO). Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project “Our trial innovated in several important ways. Since we know that treatment for TB is not ‘one size fits all’, we tested a strategy that tailored treatment duration to disease severity and treatment response based on simple criteria,” said Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project and co-principal investigator of the trial. Researchers tried a combination of four TB drugs used to treat drug-resistant forms of TB – bedaquiline, clofazimine, delamanid and linezolid (BCDL). These drugs were given for six months and extended to nine months in case of delayed treatment response. Around 87% of patients were cured after the treatment in comparison to 89% of patients in the control arm of the trial that received the current WHO regime. But those 87% who did get better had less severe TB, according to the researchers. But for people with severe TB disease, BCDL for nine months was insufficient as they were at risk of TB returning and the longer regimen is still the best option. “Our conclusions are that this regimen, BCDL, given for six to nine months, is an excellent approach for those who don’t have severe disease at baseline. In this group, the success rate is almost 95% and it has a big advantage compared to the historical conventional treatment because it’s much shorter and less toxic,” said Guglielmetti. Researchers shared several breakthrough insights on tuberculosis care at the World Conference on Lung Health. Bedaquiline use in children found safe Researchers also shared updates from a separate trial that looked into whether children can take bedaquiline, which is used to treat drug-resistant TB. The trial found the drug to have a high degree of safety and tolerance for use in children. New data from a different trial funded by the US-research agency National Institute of Health (NIH) called IMPAACT that included experts from Stellenbosch University in South Africa found bedaquiline safe for use in the treatment of infants, children and adolescents with drug-resistant TB. This is a crucial finding as it will allow further optimising the use of bedaquiline in children with drug-resistant TB – an under-served population. “The P1108 trial [bedaquiline] has paved the way for access, finally, to effective, shorter and safer treatment for children with drug-resistant TB. For too long children with TB have been left behind,” said researcher Simon Schaaf. He said that children form nearly 12% of all TB cases or 1.3 million cases every year globally but despite bedaquiline being authorized for use since 2012, there wasn’t any trial for its use in children. Nearly 3,900 stakeholders including industry representatives, patient groups, and doctors from around 150 countries attended the conference. The week-long conference also saw the release of results from other TB trials in countries across Southeast Asia. In Indonesia, researchers found that using mobile chest X-ray screening proved to be a useful tool to find active TB cases in the community. This is especially helpful in cases where people do not show classic symptoms of TB like coughing. Day 2 at #UnionConf24 is underway! 👉 @FIT_eV present their research into active case finding among communities in Vietnam🇻🇳 “Community chest X-ray screening for TB among ethnic minority communities is more than just a health intervention—it’s a vital step toward equity”#EndTB pic.twitter.com/Hn0iAzpr1V — The Union (@TheUnion_TBLH) November 13, 2024 In Vietnam, researchers stressed the importance of active case finding in ethnic minorities and remote communities to ensure access to treatment. They also used mobile X-ray machines. In the Philippines, person-centred active case finding for TB was found to break down barriers to healthcare access for vulnerable populations. The screening was done as a part of a poverty alleviation programme which empowered community members to participate and take a leading role. Trust in community leaders aided the screening of TB. Researchers also shared results from a study that highlighted the need to optimize tests to check whether a patient was susceptible to a particular drug or not, and to expand access to new TB compounds for people with life-threatening TB. “Antimicrobial resistance is among the greatest global health threats we face today. For people at-risk of TB, this threat is multiplied,” said Dr Cassandra Kelly-Cirino, Executive Director of The International Union Against Tuberculosis and Lung Disease (The Union), which convened the conference. “The new research presented at the Union Conference this week represents an invaluable step in managing this challenge and in offering hope to patients of all ages living with extensively drug-resistant TB.” Image Credits: The Union, The Union. Make Clean Air Part of Climate Plans, Experts Say 15/11/2024 Chetan Bhattacharji Smog engulfs Lahore, Pakistan, on Thursday as air pollution levels hit record highs. Some pollutants reached nearly 100 times the World Health Organization’s recommended level, according to IQAir. BAKU, Azerbaijan — Global and Indian experts at COP29 produced new evidence Thursday calling for clean air standards to become part of nations’ climate commitments, as cities across South Asia’s heavily polluted air corridor battled record-breaking smog. In Delhi, authorities closed schools up to grade 5 and halted construction as pollution levels soared to almost twenty times the WHO’s safe daily limit. The crisis came just days after Lahore, Pakistan’s second-largest city just 25 kilometres from the Indian border, saw its highest-ever levels of air pollution. Under the clear skies of Azerbaijan’s capital, experts from the World Bank, WHO, and Indian health ministry were unanimous that air quality improvement should be included in the new Nationally Determined Contributions (NDCs), the self-determined climate targets nations set under the Paris Agreement. “Air quality targets and standards can be a perfect indicator of success if we are successful in targeting the causes of climate change,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “If we could select an indicator of how successful we are in achieving negotiations on climate change mitigation, I think we should use the levels of air quality that people around the world are breathing.” Health experts hope their evidence linking air pollution and climate change will strengthen calls for action at COP29. Supporting this call for action is a new report released by the Clean Air Fund that shows how tropospheric ozone – a little-discussed ‘super pollutant’ – is linked to 500,000 premature deaths and an estimated $500 billion in economic costs annually. Air pollution from all sources contributes to more than eight million premature deaths each year, with economic costs exceeding $8 trillion, the report found. The findings aim to support the push for including air quality standards in the third generation of NDCs – binding climate commitments due before COP30 next year under the Paris Agreement. Only a small fraction of countries currently include air pollution safety in their climate plans despite the health threat to millions worldwide. Clean Air Fund’s founder and CEO, Jane Burston, said tackling super pollutants provides “huge opportunities” for improving climate, health, economic development, and equity. “We know that developing countries are some of the few that have included things like black carbon in their nationally determined contributions, and that’s because a lot of these deaths and this exposure is happening in countries least able to afford action on it,” she added. Super-bad for children Protest by ‘Warrior Moms’, a group for clean air, in Delhi outside India’s health ministry, as air pollution turned ‘severe’ on 14th November, which is celebrated as Children’s Day in the country. Tropospheric ozone and its super-pollutant siblings – including methane, black carbon, nitrous oxide and fluorinated gases – are collectively responsible for nearly half of global warming to date. Unlike other pollutants, tropospheric ozone isn’t directly emitted but forms when sunlight interacts with pollutants from aviation, shipping, agriculture and other sectors. Its health impacts can be severe, from reduced lung function to complications in type 2 diabetes and cardiovascular disease. For children, this pollution poses an especially severe threat. “Young children have smaller lungs,” Dr Soumya Swaminathan, an advisor to the Indian health ministry and former chief scientist at the WHO, explained. “They breathe much faster than adults, and they are shorter, so they’re closer to the ground, where there are more pollutants, and get more respiratory infections.” Dr Valerie Hickey, who leads the World Bank’s environment department, also placed children at the centre of her argument. “Your kid got up coughing so bad they couldn’t go to school does not lead on CNN,” she said. “Though if there are huge floods in Valencia, it does. Both are terrible, but [air pollution] is a public health emergency.” Like climate change itself, air pollution’s threat isn’t only visible in extreme events such as Delhi’s current crisis, where PM2.5 levels have reached almost 300 micrograms per cubic metre. “Every unit you go above five, you actually have a health impact,” explained Swaminathan, who co-chairs Our Common Air. “Even at 20, 30, 40 you start getting effects on the heart, respiratory system, and brain. So we need to take action to keep it as low as possible.” “We have to be pragmatic and set interim targets and do a stepwise plan to reduce it,” she added. “That’s what the NDCs are all about.” ‘Smog diplomacy’ Delhi and Lahore, just 400 kilometres apart, face the world’s highest air pollution levels. Half of the ten most polluted places in the world today are in four countries of South Asia – Pakistan, India, Nepal and Bangladesh. Health experts often say that air pollution knows no borders, an adage now forcing cooperation between long-standing rivals in what’s come to be known as “smog diplomacy.” India and Pakistan, nations that have fought multiple wars since independence, are finding themselves pushed toward dialogue over their shared air crisis. This week, as their major cities Delhi and Lahore traded places as the world’s most polluted, officials in Punjab, Pakistan’s most populous province, drafted a letter to India seeking talks on air pollution. “This is an area of the world where there isn’t always great experience with international diplomacy,” Hickey said. “Countries don’t always like each other, but they’re actually seeing that smog diplomacy is something that can bring them to the table.” The outreach comes as hundreds of millions in both countries face severe health risks borne from common problems plaguing both nations: farmers burning agricultural waste, coal-fired power plants, heavy traffic, construction and windless days trapping emissions. The World Bank has launched a “multi-hundred billion dollar” to address this cross-border crisis, targeting the vast northern plains of South Asia, known as the Indo-Gangetic Plains, Hickey told Health Policy Watch. The Bank has already committed to several regional projects in India, including a $350 million clean air management initiative plus $5 million grant for Uttar Pradesh, reportedly approved by the state cabinet and a pending $300 million loan plus $5 million grant for Haryana. Similar programs are planned for Nepal, Pakistan and Bangladesh to address pollution that readily crosses borders due to the region’s geography and wind patterns. “We need climate diplomacy, as a regional and global issue,” Raja Jahangir Anwar, Punjab’s Secretary for Environment and Climate Change, told CNN. “We are suffering in Lahore due to the eastern wind corridor coming from India. We are not blaming anyone, it’s a natural phenomenon.” Image Credits: https://x.com/ThePeerAli/status/1856985454072963085/photo/1. As World’s Health Ministers Meet in Jeddah: Calls for Strong AMR Science Panel With Authority to ‘Challenge’ Sponsors 14/11/2024 Elaine Ruth Fletcher Thail lab technicians train in surveillance of antimicrobial resistance (AMR) in food-producing animals in Southeast Asia – an driver of AMR that was neglected in the recent UN High Level Meeting declaration. With plans underway for a new “Independent Panel” on Antimicrobial Resistance, endorsed at September’s UN High-Level AMR Meeting, the new body must become a strong scientific authority. It should have the power to “challenge” the agencies that create it and address both human and animal health factors driving drug-resistant pathogens. That was a key message from AMR experts in the lead up to the Fourth Ministerial Meeting on Antimicrobial Resistance, which begins Friday in Jeddah, Saudi Arabia. The Independent Panel “needs to be an inclusive process… listening to scientists… civil society, to industry and other actors. But you also need to make sure that that panel, even though hosted by a Quadripartite, can actually challenge the Quadripartite,” declared John Arne Røttingen, CEO of the UK-based Wellcome Trust, of the panel’s central importance to providing evidence on future AMR policies. The ‘Quadripartite’ includes the World Health Organization, as well as the global environment, food and animal health agencies, which are now formally collaborating to confront the AMR threat. John-Arne Røttingen, CEO of Wellcome Trust. Røttingen was among the more than two dozen experts convened for two high-level AMR sessions at Berlin’s World Health Summit in mid-October to discuss next steps for the battle against drug resistant pathogens in the lead-up to the Jeddah meeting. “Declarations are long. It’s hard to identify the real material commitments that have been made,” Røttingen said at a panel discussion on Milestones and Challenges in Tackling AMR, hosted by the German Ministry of Health. “So it’s great that we come to Jeddah for the ministerial meeting,” he said. “That should be a start of both countries’ [and development agencies] coming together as well as the multi stakeholder partnership platform coming together across sectors to make sure that we are keeping our commitments.” On the research front, meanwhile, new “pull incentives” recently developed in the United Kingdom, Italy and Canada to foster a sustainable market for next generation antibiotics are welcome, but they are not enough, industry experts asserted. Many more nations need to adopt supply-side incentives to ensure that badly-needed new drug candidates actually come to market. Jeddah should be the start of making good on the UN’s AMR Declaration FAO, UNEP, WHO and WOAH heads at September’s UN High Level Meeting that approved a set of new commitments for action on drug resistant pathogens. The health ministers’ confab in Saudi Arabia (15-16 November) is supposed to lay out next steps for delivering on promises made in the Declaration on Antimicrobial Resistance approved at the UN High Level Meeting, 26 September in New York City. September’s declaration was a major milestone in the battle to bring a long-ignored AMR epidemic to the forefront of global health policy. AMR is associated, directly or indirectly, a “silent, slow-motion pandemic” that could kill some 39 million people by 2050. The mandate to create an “independent panel for evidence for action against antimicrobial resistance in 2025” is embedded in a 15-page text, with 106 clauses. But it is widely perceived as a key next move to maintain strategic momentum on AMR threats. The science panel should “facilitate the generation and use of multisectoral, scientific evidence to support Member States in efforts to tackle antimicrobial resistance, making use of existing resources and avoiding duplication of on-going efforts, after an open and transparent consultation with all Member States on its composition, mandate, scope, and deliverables,” the AMR declaration stated. Final HLM declaration omitted target for reducing animal antibiotic consumption Asian meat-packing house. The science panel is supposed to be created and administered by the Quadripartite of agencies whose role in managing the AMR crisis was also formalized by the declaration. Along with WHO, the four-member body includes the UN Food and Agriculture Organization (FAO), the UN Environment Programme (UNEP), and the World Animal Health Organization (WOAH), a non-UN member state body. And that makes the panel’s mandate and composition a sensitive point, in light of the political pressures from big food and other interests that want to play down their role in fostering AMR risks, which some researchers say is the leading driver. Identified AMR hotspots often align with high volumes of antibiotics sales and use in livestock. Pressures from agri-businesses and meat producing nations already led to the deletion of a target for reducing animal antibiotic use by 30% by 2030 from the final HLM declaration. Now, the question is whether scientists can come together to articulate the evidence and agree on science-based policy recommendations. “Even though the declaration was positive, it also didn’t achieve agreement on things that I, from my professional background, …would say should have been agreed,” Røttingen observed. “And that speaks to the interests and the trade offs between different sectors… it speaks to agri-food businesses versus human health, and that’s why we believe a science panel is important.” He said, “We have the target of inverting AMR-related mortality [by 10% by 2030], but we need even more targets and more ambitious targets, so we have a lot to do,” he said. “In the climate sector, we have the IPCC (Intergovernmental Panel on Climate Change),” Røttingen continued. “We know how … contested the climate space is, but still, we have a collective international evidence base… We need authoritative evidence with scientists working in the human sector and the animal sector that can come together to actually give us that evidence base and give guidance. “ For animal health, as well, the ultimate aim is to curb abuse not essential use Arshnee Moodley, CGIAR-Kenya Worldwide, the overuse of such antibiotics in livestock production is widely regarded among experts as a leading, if not the leading, driver of pathogen resistance. But ultimately, the aim of new measures should be win-wins that ensure better access to vaccines and other measures to pre-empt antibiotic use and ensure animal health, panelists at the sessions also underlined. “You need to be able to communicate with the people who can change that [AMR trends],” said Dr. Arshnee Moodley, a Kenya-based lead of CGIAR, which works with farmers on animal health. “And for me, it’s the smallholder famer outside of Nairobi. I need to be able to tell him or her why they shouldn’t use antibiotics,” she said. “And that’s really critical because livestock is also part of the solution; it’s vital food for vulnerable groups,” she continued. “I worked every summer in my grandfather’s farm with three milk houses, from the age of 13. So I know about animal health and the need for small farmers, even in high income countries, to keep their herds healthy,” Røttingen countered. “When I’m concerned about the agricultural sector, it’s not really about the misuse of antibiotics among small scale farmers … it is about big food on several continents and making sure that they are … transparent and they are willing to engage in proper animal welfare, because that’s the starting point for ensuring animal health. Too often, measures related to vaccines and hygiene are bypassed, “by using antibiotics to treat herds that aren’t necessarily requisite,” he explained. Worst of all, is the use of antimicrobials or antibiotics “as growth promotion that has nothing to do with animal health. It’s not healthy for those who eat those animals, and it’s not healthy for the animals. “So … animal health is an important part, but I think the hardest question lies with the big food companies.” For human health – more prevention and better regulation are essential too Malawi’s Minister of Health Khumbize Kandodo Chiponda with Tamas Koncz, Pfizer Germany Much as with animals, infection prevention, appropriate access to drugs and better regulation need to be the operative goals for humans as well, panelists at a second high-level session on AMR agreed. That includes clean water, sanitation and hygiene that many communities and health facilities still lack, as well as stronger laboratory networks, and quality control of antimicrobials in settings were fake and substandard formulas often circulate. “Unfortunately for countries like us, we face challenges, because in terms of manufacturing… we have to get them [products] from outside. So in terms of the quality…. you cannot be 100% sure that what you’re getting really is the very, very good quality,” said Khumbize Kandodo Chiponda Minister of Health, Malawi, speaking at the panel hosted by the global non-profit antibiotic accelerator CARB-X and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Changing community behaviours and patterns can be a major lift, in light of the ease with which people can get antibiotics through more informal channels as well as the expense people might face in seeing a healthcare professional – who will in turn face challenges determining if antibiotics are needed or not – without adequate diagnostics equipment. Access to antibiotics is improving – but Africa is also becoming an AMR hotspot Buying antibiotics in India. Prescriptions are required but the rule is not always enforced. “Access to antibiotics [in LMICs] is improving and that is a good thing,” said Tamas Koncz, a vice-president of Pfizer’s operations in Germany. He pointed to data citing a 114% increase in antibiotic use in low- and middle-income countries between 2000-2015. Pfizer’s 2022 Accord for a Healthier World, which committed to providing all of its patented medicines and vaccines to 45 lower-income countries on a not-for-profit basis, has been one enabler of better access to common antimicrobials, he said. At the same time, weak enforcement of prescription drug rules, as well as a lack of health provider knowledge about which drugs to prescribe, are drivers of drug resistance. “If physicians are not using [the drugs] appropriately, then it’s going to lead to problems. So we need to fix the challenge of access. But I think what is even more important is the overall approach.” Africa, where sales of antibiotics by unlicensed vendors is often widespread, is also becoming a major AMR hotspot, he pointed out – highlighting the challenges of balancing access with judicious use. All-age rate of deaths attributable to/associated with antibiotic resistance, 2019. (Lancet, 2022) The landmark 2022 Lancet study that found 1.27 million deaths globally in 2019 were directly attributable to drug-resistant bacterial infections, including 860,000 in Africa. That same year, Africa saw 640,000 deaths from HIV. “We know from the recent communication from the African CDC and others, that it’s becoming probably the one of the biggest, if not the biggest, healthcare burden, superseding now HIV AIDs, maybe even malaria and tuberculosis,” said Koncz. ‘Pull’ incentives Florence Séjourné, Aurobac and Kevin Outterson, CARB-X. On the supply side of the equation, meanwhile, “more pull incentives” that can incentivize pharma developers of newer, pathogen-resistant antibiotics is a long-neglected topic now finally rising to the top of health ministers’ agendas. The challenge lies in the fact that new antibiotics capable of beating drug-resistant infections also need to used sparingly – to ensure that they, too, don’t fail prey to AMR. But that means companies that develop the drugs can’t count on revenues from blockbuster sales to pay back years of investment in clinical trials. “AMR innovation is in a broken business model right now, needing incentives.” said Florence Séjourné. She is the CEO of the Aurobac Therapeutics, a joint AMR R&D venture created by two leading European pharma firms as well as the founder of the BEAM Alliance association of AMR-focused biotechs. Products risk death in the pipeline While there are now 20 “highly innovative” antibiotics in the early stages of development globally, the number will have dwindled by 75% within eight years if the business model doesn’t change, warned Dr Kevin Outterson, head of CARB-X. “Within four years, we’ll have less than 10 in clinical development globally. And four more years after that, we’ll have less than five.” The of human capital” he added as large companies shut down programmes, and research is concentrated in underfinanced biotech startups. “There is absolutely no interest in private investors in the antibacterial field, which is complex,” added Séjourné. Of the startups, 60% of the BEAM Alliance members have less than a year of cash to fund their activities; 40% are firms of less than 9 employees. “The world is relying on micro companies, companies with less than 10 employees…That’s a very fragile base,” for developing urgently needed new drugs, Outterson added. On the cusp of a solution? Bacterial culture prepared for testing new antibiotic candidates. But, there are also some glimmers of hope on the horizon. The first was the launch of the United Kingdom’s new “subscription model” in May for antimicrobial drugs that need to be held in ‘reserve’ for drug resistant pathogens. This aims to guarantee innovators a return on new drugs, regardless of the quantities used, that can guarantee a market incentive for new drugs, even if they are carefully rationed. Séjourné praised the UK decision as “something to highlight has a good example for others to follow” – although she warned that until a larger number of countries get on board with such changes, “the broken business model will remain.” More recently, at the 10 October meeting of G7 health and finance ministers in Ancona, Italy’s Minister of Health, Orazio Schillaci announced a series of new “pull incentives” aimed at stimulating R&D and ensuring biotech firms a payback on their investment. Canada is also piloting an incentive programme, while other European Union members, as well as Japan, are considering similar moves. In light of those new developments, CARB-X’s Outterson sounds a note of cautious optimism. “At the G7 meeting, I made the economic case for a small, reasonable investment and push and mostly pull incentives, together, yields an amazing return on investment, both on the health side as well as the economic side,” Outterson said. “It was a rare opportunity to be able to speak not just to the health people, but also the finance people,” he said, noting that the issues raised at the meeting appeared to resonate with both sectors. “And so we have a problem, and we know that it’s desperate, and companies are filled with innovation, but not enough capital to move things forward. But we really are on the cusp of the solution as well.” IFPMA Director David Reddy “The UN meeting finished only a few weeks ago,” said IFPMA director David Reddy. “We’re moving towards the meeting in Saudi Arabia, which is the fourth AMR high level event. “I think one thing that is really important is that we are getting a common understanding of where we need to go, and what the challenges are,” he added. “We do need to make progress on the business model. The UK, Japan have already made good moves towards pull incentives, and a pilot has been put in place by Canada. There are a lot of remaining challenges, but I think the key message coming out of this is there is a real thirst to maintain momentum as we head into the meeting in Saudi Arabia.” But “it’s not just about financing,” he added, “it’s also about people and competencies.” “Access but having a really firm understanding of community needs on the ground is essential, because without that, we won’t make progress in the fight against AMR and in bringing antibiotics to those who need them.” Image Credits: USAID Asia/Flickr, USAID Asia , Health Policy Watch , Van Boeckel, Pires et al, 2019, WHO, The Lancet, 2022, AMR Industry Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. 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Pandemic Agreement Makes Progress But Still Plenty of Sticky Details to Address 15/11/2024 Kerry Cullinan INB co-chair Anne-Claire Amprou and the WHO’s Mike Ryan at the close of INB12. The latest draft of the World Health Organization’s (WHO) pandemic agreement is awash with green highlights – an indication that countries have reached consensus on much of the text. But the Intergovernmental Negotiating Body (INB) announced on Monday that it would not be possible to reach an agreement by December – and countries would push for the adoption of an agreement by the World Health Assembly (WHA) next May. During the past two weeks of the 12th meeting of the INB, progress has been made on research and development(Article 9), local production(Article 10) and regulatory systems strengthening (Article 14). Sticking points But Article 4 on prevention, which details countries’ pandemic prevention and surveillance obligations, is mostly highlighted in yellow. This means that countries have broad agreement on the text but much of the detail is not agreed. Many of the proposals are common sense – such as building the capacity to detect pathogens at the community level, routine immunisation, and prevention of zoonotic spillover. But these measures are a tall order for some low-income countries, which is partly where the resistance is coming from. Under-resourced countries are unsure of how much prevention will cost them and whether they will get help to implement the provisions. Wealthier countries want assurances that their poorer neighbours can contain outbreaks. The rapid spread of mpox in central Africa is an example. Several affected countries have been unable to confirm cases as they lack basic diagnostic laboratories and trained staff. Negotiators are considering a separate annex on prevention, much as the details of a Pathogen Access and Benefit Sharing (PABS) system may be accommodated in a separate annex. Sticking points also remain on technology transfer (Article 11), the PABS system (Article 12), the global supply chain and logistic (GSCL) system (Article 13) and sustainable financing (Article 20). However, the most tangible offering of the agreement is back on the table although not yet agreed: that 20% of vaccines, therapeutics and diagnostics produced to combat that pathogen during a pandemic will be allocated to the WHO for distribution with 10% given free and the remaining amount on yet-to-be determined terms. Earlier, there were reports that some members of the European Union wanted this requirement to be cut down to 10% and 5% respectively. ‘Crucial and delicate’ Tanzanian Ambassador Dr Abdallah Saleh Possi. Tanzanian Ambassador Dr Abdallah Saleh Possi, speaking for the 47 African member states and Egypt, expressed Africa’s disappointment that there was not sufficient consensus to call a special World Health Assembly next month. “Although we had such slow progress in this 12th session that did not realize the convening of a special session in December as anticipated, we all agree that the remaining issues are not many, but crucial and delicate, requiring decision-making and flexibility,” said Possi at the close of the two-week negotiations on Friday. “Significantly, the meeting has generated the commitment to finalize them. We thank all the delegations that organize informal meetings on some sticky areas. We support having informal sessions during inter-sessional period with a view to achieving consensus on key areas. The Africa group plus Egypt is happy to be amongst the groups seeking to find consensus on the remaining issues.” The Philippines on behalf of the Equity Group, expressed appreciation for both the “substantive progress” particularly on articles, 9,10 and 14, and “the cordiality displayed by delegations that helped bring about this progress”. However, warned the Philippines’ delegate, “much work needs to be done to achieve consensus on key articles that operationalize equity such as articles, 11,12, 13, 13 (bis) and 20.” Unlike the Africa Group, which wanted a December resolution, the Equity Group has always advocated for more time to deliberate on the agreement. The negotiators reconvene for a short INB session from 2-6 December, where they will decide on the programme of negotiations for 2025. RFK Jr Nominated as Top US Health Official 15/11/2024 Stefan Anderson & Sophia Samantaroy Robert F. Kennedy Jr, scion of America’s most prominent political family, is set to become the nation’s top health official under Trump. Donald Trump has named Robert F Kennedy Jr as his choice for US health secretary, putting the controversial anti-vaccine activist and environmental lawyer in line to control some of the world’s most influential health agencies. Kennedy shot to political prominence during the COVID-19 pandemic when his organisation, Children’s Health Defense, became a leading global voice questioning vaccine safety and efficacy. His appointment, which requires Senate confirmation, comes after Kennedy dropped his independent presidential bid to back Trump. “He’s going to help make America healthy again,” Trump said in a speech at Mar-a-Lago following his election victory. “He wants to do some things, and we’re going to let him get to it.” Trump described the role atop HHS as “the most important role of any administration”, adding that Kennedy “will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country”. I am thrilled to announce Robert F. Kennedy Jr. as The United States Secretary of Health and Human Services (HHS). For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it… — Donald J. Trump (@realDonaldTrump) November 14, 2024 If confirmed, Kennedy would oversee a sprawling $1.8 trillion department with 10 health agencies and three human services agencies. His leadership of HHS would include the administration of Medicare, Medicaid and the Affordable Care Act while setting priorities for America’s three most powerful health agencies: the Centers for Disease Control and Prevention (CDC), which tracks disease outbreaks and sets public health guidance; the Food and Drug Administration (FDA), which approves medicines and medical devices; and the National Institutes of Health (NIH), the world’s largest public funder of medical research. Kennedy, an environmental lawyer with no health experience, called his appointment “a generational opportunity” to realign US health policy and “put an end to the chronic disease epidemic” in a post accepting the nomination on X. He said Trump has instructed him to “reorganize” the U.S. constellation of federal health agencies. “I look forward to working with the more than 80,000 employees at HHS to free the agencies from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth,” Kennedy said. Global health fallout Beyond domestic agencies, the Trump administration is also expected to reshape America’s role in global health. In his last term, Trump withdrew funding from the World Health Organization over its COVID-19 response and slashed funding to UN agencies, leaving a multi-billion dollar gap in the UN health agency’s budget. With Kennedy – who has questioned global health orthodoxies – by his side, experts expect this isolationist stance to deepen. This could affect millions who rely on HIV/AIDS funding through PEPFAR, a $7 billion US program providing HIV treatment in over 50 countries, the CDC’s network of 65 international offices, and State Department health diplomacy efforts. WHO officials told Health Policy Watch last month they face “a huge fear factor” over potential US funding withdrawal, warning the agency would enter “a dramatically bad crisis” without American support. The Biden administration’s global health security team referred Health Policy Watch to the Trump transition team when asked for comment. Robert Kennedy Junior’s banner photo on X, formerly Twitter, where he boasts over 4.5 million followers. Beyond the mainstream Kennedy’s stated priorities for America’s health system veer from broadly supported reforms to debunked anti-scientific claims that have alarmed health experts. In recent weeks, he has called for removing fluoride from US drinking water – which he claims causes brain disease – reviewing vaccine safety data with an eye to withdrawing some from the market, eliminating “entire departments” at the FDA, and immediately dismissing 600 NIH employees. His controversial positions include claims repeatedly rejected by scientists: that vaccines cause autism in children, that AIDS is not caused by HIV, that antidepressants are responsible for mass school shootings, and that atrazine, a widely used herbicide, triggers gender dysphoria and has led to increases in young people identifying as transgender. Kennedy’s unconventional streak isn’t limited to medicine. In the run-up to November’s election, Kennedy said doctors found a worm had eaten part of his brain, video footage revealed him to be the key to a decade-old New York City mystery of a dead bear in Central Park – he dumped it there on his way to the airport – and came under investigation for decapitating a whale. Lawrence Gostin, a global health expert at Georgetown University, called the Kennedy pick “the darkest day for public health and science in my lifetime.” “Trump’s pick of RFK Jr as HHS Secretary is disastrous for public health,” Gostin said. “Having a person sceptical of science and evidence at HHS will make America unhealthy.” Public health victories at risk Public health victories like vaccines and drinking water fluoridation have led to dramatic increases in life expectancy. The World Health Organization estimates vaccines save five million lives annually, with global immunization efforts having saved at least 154 million lives over the past 50 years. Yet Kennedy has repeatedly challenged these achievements by questioning vaccine safety and stating that fluoride is linked to “neurodevelopmental disorders.” The real-world impact of vaccine scepticism is already visible in the US, with the CDC reporting vaccination rates for children dropping for all available vaccines last year and vaccine exemptions for religious reasons rising across the past decade. “Religion doesn’t change that fast,” said Dr Michael Mendoza, a former county Public Health Commissioner in New York State. “This is about ideology and misinformation – and we’re seeing a direct impact in the number of kids unvaccinated.” “We’re at risk of widespread distrust in evidence-based treatments and vaccines,” Mendoza added, noting how health misinformation has directly influenced the increase in risky medical decisions. “Our elected and appointed officials have an obligation to promote experts and guidelines that are grounded in established scientific evidence.” Within the federal workforce, many remain optimistic that little will change. Agencies like the Biomedical Advanced Research and Development Authority (BARDA), which funded the development of COVID-19 vaccines, traditionally receive bipartisan support, resulting in little change across administrations. An HHS employee, speaking to Health Policy Watch on the condition of anonymity to safeguard their job security, noted that the negative perception of the new administration has yet to filter into many agencies. Room for agreement Less controversial is Kennedy’s opposition to the well-documented “revolving door” between the industry and government, where officials frequently switch between regulating companies and working for them – a system he argues has led to the “corporate capture” of US health agencies. In a country that spends more on healthcare than any other developed nation, has one of the world’s highest obesity rates, and whose largest public health crisis – the opioid epidemic – was engineered by pharmaceutical giant Purdue Pharma, his critiques of the system have found resonance. The concern about industry influence has merit: since 2000, every FDA commissioner has taken industry positions after leaving office. Nine out of the last ten, representing 40 years of leadership, have done the same. The pattern continued with Trump’s previous HHS secretary, Scott Gottlieb, who departed to a board seat at Pfizer in 2020. Kennedy’s stance against pharmaceutical interests sets up a likely clash with fellow Republicans, many of whom receive significant industry funding. Several GOP lawmakers have already pledged to dismantle President Joe Biden’s signature Medicare drug price negotiation law, which allows the government to negotiate fairer prices on behalf of its senior citizens, claiming it stifles innovation. Yet Kennedy has promised a direct confrontation with the industry, causing shares of major vaccine makers to plunge after Trump’s announcement of Kennedy’s selection. “Together we will clean up corruption, stop the revolving door between industry and government,” Kennedy said. Kennedy’s promised crusade against chronic diseases and processed foods has also found broad support among public health officials – setting up yet another clash with a major industry traditionally aligned with Republican politics. His pledge to strip ultra-processed foods from school lunches and crack down on food dyes has drawn bipartisan backing, though industry groups warn such moves could increase grocery prices Trump has vowed to reduce. “Senators may say, well, RFK Jr has good ideas like tackling chronic disease and regulating Big Food, but RFK Jr is not to be trusted after a career of peddling falsehoods,” Gostin said. “What we need is nutritional warnings on unhealthy foods, bans on targeting kids, and reduced salt and sugar.” Even some nutrition advocates who oppose Kennedy’s broader agenda acknowledge the need for stricter oversight of the food industry. The FDA has identified concerns about ultra-processed foods’ health impacts, though the agency says more research is needed. The challenge, experts say, will be implementing evidence-based reforms while avoiding Kennedy’s tendency toward unproven theories about food safety. Environmental hero to anti-vaccine empire Headline published in the Defender, the news arm of Kennedy’s anti-vaccine outfit on November 7. Kennedy began his career as a celebrated environmental lawyer, fighting corporate polluters and championing indigenous communities whose lands had been poisoned by industry. His aggressive prosecution of polluters helped restore the Hudson River to health, earning him Time magazine’s “Hero for the Planet” designation. He maintains some of this environmental ethos, promising in his presidential campaign before bowing out to back Trump to tackle unsafe PFAS levels and microplastic contamination. But his path took a sharp turn in 2015 when he took over the struggling World Mercury Project, rebranding it as Children’s Health Defense (CHD) in 2018. Under Kennedy’s leadership, CHD became a global anti-vaccine juggernaut. The organization’s revenue skyrocketed from $1.1 million in 2018 to $23.5 million in 2022, with Kennedy himself earning more than $510,000 in 2022, the last year where filings are available. In mainstream interviews and congressional appearances, Kennedy has worked to promote his least controversial views. He has attempted to moderate his image, telling NBC News: “I’m not going to take away anybody’s vaccines, I’ve never been anti-vaccine.” Yet the organization he led until his presidential campaign – and where he remains a lawyer – continues to fund and promote numerous anti-scientific positions. Public tax filings show Kennedy made $550,000 in executive compensation from Children’s Health Defense in 2022, the last year where records are available. During the pandemic, CHD’s vaccine-related posts were shared more frequently on Twitter than content from CNN, Fox News, NPR and the CDC combined – occasionally eclipsing the readership of the New York Times and Washington Post. The Center for Countering Digital Hate named Kennedy one of the “Disinformation Dozen,” identifying him and CHD as among the top spreaders of vaccine misinformation online. CHD also played a role in coordinating international protests for anti-vaccine movements around the world – with deadly consequences. In 2019, Kennedy’s organization flooded American Samoa with vaccine misinformation and lobbied the government against the use of the MMR vaccine, resulting in a devastating measles outbreak. This week, CHD’s news arm, The Defender, published claims that COVID-19 vaccines pose a “112,000% greater risk of brain clots and strokes than flu shots” – research based on misuse of VAERS, a federal database that records unverified reports of adverse events. The study’s authors include supplement company affiliates and anti-vaccine activists who openly coordinate with Kennedy’s organization. One author chairs a Texas-based organization that tagged Kennedy in a Twitter post on Tuesday calling for the “immediate withdrawal of all COVID-19 vaccines from the market” and the “repeal of the 1986” national childhood vaccination act. In his 2021 book, which sold over a million copies and sat on the New York TImes bestseller list for 17 weeks, Kennedy expands on the ethos behind CDH, calling Anthony Fauci, who led the US response to the COVID-19 pandemic, “the powerful technocrat who helped orchestrate and execute 2020’s historic coup d’état against Western democracy,” claiming his “remedies” – including Covid vaccines – were “often more lethal than the diseases they pretend to treat.” The book also champions Alan Duesberg, praising as “elegant” and “compelling” the discredited scientist’s claims that AIDS is not caused by HIV. Such theories had deadly consequences: 330,000 people died prematurely after being denied life-saving HIV treatment when South Africa’s government embraced view championed by Duesberg in the early 2000s, according to Harvard researchers. Path to Senate confirmation .@RobertKennedyJr has championed issues like healthy foods and the need for greater transparency in our public health infrastructure. I look forward to learning more about his other policy positions and how they will support a conservative, pro-American agenda. — U.S. Senator Bill Cassidy, M.D. (@SenBillCassidy) November 14, 2024 Kennedy’s path to confirmation runs through a Republican-led Senate, where he needs a simple majority of 51 votes. While some Republicans have expressed cautious support, experts point to Trump’s other nominees as the President-elect’s “tests” for Senate loyalty, suggesting the incoming president may bypass the traditional confirmation process entirely. “Any Republican Senator seeking the coveted LEADERSHIP position in the United States Senate must agree to Recess Appointments (in the Senate!), without which we will not be able to get people confirmed in a timely manner,” Trump posted on Sunday. “We need positions filled IMMEDIATELY!” If the Republican-majority Senate agrees to recess appointments – where the President appoints officials when Congress is not in session – Trump’s cabinet picks could stay until the end of 2026. Kennedy joins other iconoclastic nominees. Trump tapped former Democratic Representative Tulsi Gabbard for Director of National Security, noted for her opposition to US support for Ukraine and promoting debunked Russian claims about US-funded biolabs there. He also named Florida Representative Matt Gaetz, who had been facing a congressional ethics investigation over allegations of sex trafficking a minor, as Attorney General. Image Credits: Gage Skidmore, European Union/Martin Matev. Breakthrough Research Promises Shorter Treatment for Multi-Drug-Resistant TB 15/11/2024 Disha Shetty Young Indonesians appeal for an end to TB at the Union’s World Lung Health conference in Bali. In a breakthrough for patients with multi-drug-resistant (MDR) tuberculosis (TB), researchers shared positive trial results for a shorter, tailored alternative at the World Conference on Lung Health in Bali, Indonesia. The insights came from the endTB-Q trial aimed at finding a simpler, less toxic, shorter regimen for fluoroquinolone-resistant MDR-TB. Fluoroquinolone is a common class of medicine used to treat MDR TB, and if patients become resistant, they are considered to be bordering on extensively drug-resistant (XDR) TB, which is extremely hard to treat and can take 18 months. The endTB-Q clinical trial enrolled 323 patients from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam to try to find alternatives to the current longer treatment regimen recommended by the World Health Organization (WHO). Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project “Our trial innovated in several important ways. Since we know that treatment for TB is not ‘one size fits all’, we tested a strategy that tailored treatment duration to disease severity and treatment response based on simple criteria,” said Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project and co-principal investigator of the trial. Researchers tried a combination of four TB drugs used to treat drug-resistant forms of TB – bedaquiline, clofazimine, delamanid and linezolid (BCDL). These drugs were given for six months and extended to nine months in case of delayed treatment response. Around 87% of patients were cured after the treatment in comparison to 89% of patients in the control arm of the trial that received the current WHO regime. But those 87% who did get better had less severe TB, according to the researchers. But for people with severe TB disease, BCDL for nine months was insufficient as they were at risk of TB returning and the longer regimen is still the best option. “Our conclusions are that this regimen, BCDL, given for six to nine months, is an excellent approach for those who don’t have severe disease at baseline. In this group, the success rate is almost 95% and it has a big advantage compared to the historical conventional treatment because it’s much shorter and less toxic,” said Guglielmetti. Researchers shared several breakthrough insights on tuberculosis care at the World Conference on Lung Health. Bedaquiline use in children found safe Researchers also shared updates from a separate trial that looked into whether children can take bedaquiline, which is used to treat drug-resistant TB. The trial found the drug to have a high degree of safety and tolerance for use in children. New data from a different trial funded by the US-research agency National Institute of Health (NIH) called IMPAACT that included experts from Stellenbosch University in South Africa found bedaquiline safe for use in the treatment of infants, children and adolescents with drug-resistant TB. This is a crucial finding as it will allow further optimising the use of bedaquiline in children with drug-resistant TB – an under-served population. “The P1108 trial [bedaquiline] has paved the way for access, finally, to effective, shorter and safer treatment for children with drug-resistant TB. For too long children with TB have been left behind,” said researcher Simon Schaaf. He said that children form nearly 12% of all TB cases or 1.3 million cases every year globally but despite bedaquiline being authorized for use since 2012, there wasn’t any trial for its use in children. Nearly 3,900 stakeholders including industry representatives, patient groups, and doctors from around 150 countries attended the conference. The week-long conference also saw the release of results from other TB trials in countries across Southeast Asia. In Indonesia, researchers found that using mobile chest X-ray screening proved to be a useful tool to find active TB cases in the community. This is especially helpful in cases where people do not show classic symptoms of TB like coughing. Day 2 at #UnionConf24 is underway! 👉 @FIT_eV present their research into active case finding among communities in Vietnam🇻🇳 “Community chest X-ray screening for TB among ethnic minority communities is more than just a health intervention—it’s a vital step toward equity”#EndTB pic.twitter.com/Hn0iAzpr1V — The Union (@TheUnion_TBLH) November 13, 2024 In Vietnam, researchers stressed the importance of active case finding in ethnic minorities and remote communities to ensure access to treatment. They also used mobile X-ray machines. In the Philippines, person-centred active case finding for TB was found to break down barriers to healthcare access for vulnerable populations. The screening was done as a part of a poverty alleviation programme which empowered community members to participate and take a leading role. Trust in community leaders aided the screening of TB. Researchers also shared results from a study that highlighted the need to optimize tests to check whether a patient was susceptible to a particular drug or not, and to expand access to new TB compounds for people with life-threatening TB. “Antimicrobial resistance is among the greatest global health threats we face today. For people at-risk of TB, this threat is multiplied,” said Dr Cassandra Kelly-Cirino, Executive Director of The International Union Against Tuberculosis and Lung Disease (The Union), which convened the conference. “The new research presented at the Union Conference this week represents an invaluable step in managing this challenge and in offering hope to patients of all ages living with extensively drug-resistant TB.” Image Credits: The Union, The Union. Make Clean Air Part of Climate Plans, Experts Say 15/11/2024 Chetan Bhattacharji Smog engulfs Lahore, Pakistan, on Thursday as air pollution levels hit record highs. Some pollutants reached nearly 100 times the World Health Organization’s recommended level, according to IQAir. BAKU, Azerbaijan — Global and Indian experts at COP29 produced new evidence Thursday calling for clean air standards to become part of nations’ climate commitments, as cities across South Asia’s heavily polluted air corridor battled record-breaking smog. In Delhi, authorities closed schools up to grade 5 and halted construction as pollution levels soared to almost twenty times the WHO’s safe daily limit. The crisis came just days after Lahore, Pakistan’s second-largest city just 25 kilometres from the Indian border, saw its highest-ever levels of air pollution. Under the clear skies of Azerbaijan’s capital, experts from the World Bank, WHO, and Indian health ministry were unanimous that air quality improvement should be included in the new Nationally Determined Contributions (NDCs), the self-determined climate targets nations set under the Paris Agreement. “Air quality targets and standards can be a perfect indicator of success if we are successful in targeting the causes of climate change,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “If we could select an indicator of how successful we are in achieving negotiations on climate change mitigation, I think we should use the levels of air quality that people around the world are breathing.” Health experts hope their evidence linking air pollution and climate change will strengthen calls for action at COP29. Supporting this call for action is a new report released by the Clean Air Fund that shows how tropospheric ozone – a little-discussed ‘super pollutant’ – is linked to 500,000 premature deaths and an estimated $500 billion in economic costs annually. Air pollution from all sources contributes to more than eight million premature deaths each year, with economic costs exceeding $8 trillion, the report found. The findings aim to support the push for including air quality standards in the third generation of NDCs – binding climate commitments due before COP30 next year under the Paris Agreement. Only a small fraction of countries currently include air pollution safety in their climate plans despite the health threat to millions worldwide. Clean Air Fund’s founder and CEO, Jane Burston, said tackling super pollutants provides “huge opportunities” for improving climate, health, economic development, and equity. “We know that developing countries are some of the few that have included things like black carbon in their nationally determined contributions, and that’s because a lot of these deaths and this exposure is happening in countries least able to afford action on it,” she added. Super-bad for children Protest by ‘Warrior Moms’, a group for clean air, in Delhi outside India’s health ministry, as air pollution turned ‘severe’ on 14th November, which is celebrated as Children’s Day in the country. Tropospheric ozone and its super-pollutant siblings – including methane, black carbon, nitrous oxide and fluorinated gases – are collectively responsible for nearly half of global warming to date. Unlike other pollutants, tropospheric ozone isn’t directly emitted but forms when sunlight interacts with pollutants from aviation, shipping, agriculture and other sectors. Its health impacts can be severe, from reduced lung function to complications in type 2 diabetes and cardiovascular disease. For children, this pollution poses an especially severe threat. “Young children have smaller lungs,” Dr Soumya Swaminathan, an advisor to the Indian health ministry and former chief scientist at the WHO, explained. “They breathe much faster than adults, and they are shorter, so they’re closer to the ground, where there are more pollutants, and get more respiratory infections.” Dr Valerie Hickey, who leads the World Bank’s environment department, also placed children at the centre of her argument. “Your kid got up coughing so bad they couldn’t go to school does not lead on CNN,” she said. “Though if there are huge floods in Valencia, it does. Both are terrible, but [air pollution] is a public health emergency.” Like climate change itself, air pollution’s threat isn’t only visible in extreme events such as Delhi’s current crisis, where PM2.5 levels have reached almost 300 micrograms per cubic metre. “Every unit you go above five, you actually have a health impact,” explained Swaminathan, who co-chairs Our Common Air. “Even at 20, 30, 40 you start getting effects on the heart, respiratory system, and brain. So we need to take action to keep it as low as possible.” “We have to be pragmatic and set interim targets and do a stepwise plan to reduce it,” she added. “That’s what the NDCs are all about.” ‘Smog diplomacy’ Delhi and Lahore, just 400 kilometres apart, face the world’s highest air pollution levels. Half of the ten most polluted places in the world today are in four countries of South Asia – Pakistan, India, Nepal and Bangladesh. Health experts often say that air pollution knows no borders, an adage now forcing cooperation between long-standing rivals in what’s come to be known as “smog diplomacy.” India and Pakistan, nations that have fought multiple wars since independence, are finding themselves pushed toward dialogue over their shared air crisis. This week, as their major cities Delhi and Lahore traded places as the world’s most polluted, officials in Punjab, Pakistan’s most populous province, drafted a letter to India seeking talks on air pollution. “This is an area of the world where there isn’t always great experience with international diplomacy,” Hickey said. “Countries don’t always like each other, but they’re actually seeing that smog diplomacy is something that can bring them to the table.” The outreach comes as hundreds of millions in both countries face severe health risks borne from common problems plaguing both nations: farmers burning agricultural waste, coal-fired power plants, heavy traffic, construction and windless days trapping emissions. The World Bank has launched a “multi-hundred billion dollar” to address this cross-border crisis, targeting the vast northern plains of South Asia, known as the Indo-Gangetic Plains, Hickey told Health Policy Watch. The Bank has already committed to several regional projects in India, including a $350 million clean air management initiative plus $5 million grant for Uttar Pradesh, reportedly approved by the state cabinet and a pending $300 million loan plus $5 million grant for Haryana. Similar programs are planned for Nepal, Pakistan and Bangladesh to address pollution that readily crosses borders due to the region’s geography and wind patterns. “We need climate diplomacy, as a regional and global issue,” Raja Jahangir Anwar, Punjab’s Secretary for Environment and Climate Change, told CNN. “We are suffering in Lahore due to the eastern wind corridor coming from India. We are not blaming anyone, it’s a natural phenomenon.” Image Credits: https://x.com/ThePeerAli/status/1856985454072963085/photo/1. As World’s Health Ministers Meet in Jeddah: Calls for Strong AMR Science Panel With Authority to ‘Challenge’ Sponsors 14/11/2024 Elaine Ruth Fletcher Thail lab technicians train in surveillance of antimicrobial resistance (AMR) in food-producing animals in Southeast Asia – an driver of AMR that was neglected in the recent UN High Level Meeting declaration. With plans underway for a new “Independent Panel” on Antimicrobial Resistance, endorsed at September’s UN High-Level AMR Meeting, the new body must become a strong scientific authority. It should have the power to “challenge” the agencies that create it and address both human and animal health factors driving drug-resistant pathogens. That was a key message from AMR experts in the lead up to the Fourth Ministerial Meeting on Antimicrobial Resistance, which begins Friday in Jeddah, Saudi Arabia. The Independent Panel “needs to be an inclusive process… listening to scientists… civil society, to industry and other actors. But you also need to make sure that that panel, even though hosted by a Quadripartite, can actually challenge the Quadripartite,” declared John Arne Røttingen, CEO of the UK-based Wellcome Trust, of the panel’s central importance to providing evidence on future AMR policies. The ‘Quadripartite’ includes the World Health Organization, as well as the global environment, food and animal health agencies, which are now formally collaborating to confront the AMR threat. John-Arne Røttingen, CEO of Wellcome Trust. Røttingen was among the more than two dozen experts convened for two high-level AMR sessions at Berlin’s World Health Summit in mid-October to discuss next steps for the battle against drug resistant pathogens in the lead-up to the Jeddah meeting. “Declarations are long. It’s hard to identify the real material commitments that have been made,” Røttingen said at a panel discussion on Milestones and Challenges in Tackling AMR, hosted by the German Ministry of Health. “So it’s great that we come to Jeddah for the ministerial meeting,” he said. “That should be a start of both countries’ [and development agencies] coming together as well as the multi stakeholder partnership platform coming together across sectors to make sure that we are keeping our commitments.” On the research front, meanwhile, new “pull incentives” recently developed in the United Kingdom, Italy and Canada to foster a sustainable market for next generation antibiotics are welcome, but they are not enough, industry experts asserted. Many more nations need to adopt supply-side incentives to ensure that badly-needed new drug candidates actually come to market. Jeddah should be the start of making good on the UN’s AMR Declaration FAO, UNEP, WHO and WOAH heads at September’s UN High Level Meeting that approved a set of new commitments for action on drug resistant pathogens. The health ministers’ confab in Saudi Arabia (15-16 November) is supposed to lay out next steps for delivering on promises made in the Declaration on Antimicrobial Resistance approved at the UN High Level Meeting, 26 September in New York City. September’s declaration was a major milestone in the battle to bring a long-ignored AMR epidemic to the forefront of global health policy. AMR is associated, directly or indirectly, a “silent, slow-motion pandemic” that could kill some 39 million people by 2050. The mandate to create an “independent panel for evidence for action against antimicrobial resistance in 2025” is embedded in a 15-page text, with 106 clauses. But it is widely perceived as a key next move to maintain strategic momentum on AMR threats. The science panel should “facilitate the generation and use of multisectoral, scientific evidence to support Member States in efforts to tackle antimicrobial resistance, making use of existing resources and avoiding duplication of on-going efforts, after an open and transparent consultation with all Member States on its composition, mandate, scope, and deliverables,” the AMR declaration stated. Final HLM declaration omitted target for reducing animal antibiotic consumption Asian meat-packing house. The science panel is supposed to be created and administered by the Quadripartite of agencies whose role in managing the AMR crisis was also formalized by the declaration. Along with WHO, the four-member body includes the UN Food and Agriculture Organization (FAO), the UN Environment Programme (UNEP), and the World Animal Health Organization (WOAH), a non-UN member state body. And that makes the panel’s mandate and composition a sensitive point, in light of the political pressures from big food and other interests that want to play down their role in fostering AMR risks, which some researchers say is the leading driver. Identified AMR hotspots often align with high volumes of antibiotics sales and use in livestock. Pressures from agri-businesses and meat producing nations already led to the deletion of a target for reducing animal antibiotic use by 30% by 2030 from the final HLM declaration. Now, the question is whether scientists can come together to articulate the evidence and agree on science-based policy recommendations. “Even though the declaration was positive, it also didn’t achieve agreement on things that I, from my professional background, …would say should have been agreed,” Røttingen observed. “And that speaks to the interests and the trade offs between different sectors… it speaks to agri-food businesses versus human health, and that’s why we believe a science panel is important.” He said, “We have the target of inverting AMR-related mortality [by 10% by 2030], but we need even more targets and more ambitious targets, so we have a lot to do,” he said. “In the climate sector, we have the IPCC (Intergovernmental Panel on Climate Change),” Røttingen continued. “We know how … contested the climate space is, but still, we have a collective international evidence base… We need authoritative evidence with scientists working in the human sector and the animal sector that can come together to actually give us that evidence base and give guidance. “ For animal health, as well, the ultimate aim is to curb abuse not essential use Arshnee Moodley, CGIAR-Kenya Worldwide, the overuse of such antibiotics in livestock production is widely regarded among experts as a leading, if not the leading, driver of pathogen resistance. But ultimately, the aim of new measures should be win-wins that ensure better access to vaccines and other measures to pre-empt antibiotic use and ensure animal health, panelists at the sessions also underlined. “You need to be able to communicate with the people who can change that [AMR trends],” said Dr. Arshnee Moodley, a Kenya-based lead of CGIAR, which works with farmers on animal health. “And for me, it’s the smallholder famer outside of Nairobi. I need to be able to tell him or her why they shouldn’t use antibiotics,” she said. “And that’s really critical because livestock is also part of the solution; it’s vital food for vulnerable groups,” she continued. “I worked every summer in my grandfather’s farm with three milk houses, from the age of 13. So I know about animal health and the need for small farmers, even in high income countries, to keep their herds healthy,” Røttingen countered. “When I’m concerned about the agricultural sector, it’s not really about the misuse of antibiotics among small scale farmers … it is about big food on several continents and making sure that they are … transparent and they are willing to engage in proper animal welfare, because that’s the starting point for ensuring animal health. Too often, measures related to vaccines and hygiene are bypassed, “by using antibiotics to treat herds that aren’t necessarily requisite,” he explained. Worst of all, is the use of antimicrobials or antibiotics “as growth promotion that has nothing to do with animal health. It’s not healthy for those who eat those animals, and it’s not healthy for the animals. “So … animal health is an important part, but I think the hardest question lies with the big food companies.” For human health – more prevention and better regulation are essential too Malawi’s Minister of Health Khumbize Kandodo Chiponda with Tamas Koncz, Pfizer Germany Much as with animals, infection prevention, appropriate access to drugs and better regulation need to be the operative goals for humans as well, panelists at a second high-level session on AMR agreed. That includes clean water, sanitation and hygiene that many communities and health facilities still lack, as well as stronger laboratory networks, and quality control of antimicrobials in settings were fake and substandard formulas often circulate. “Unfortunately for countries like us, we face challenges, because in terms of manufacturing… we have to get them [products] from outside. So in terms of the quality…. you cannot be 100% sure that what you’re getting really is the very, very good quality,” said Khumbize Kandodo Chiponda Minister of Health, Malawi, speaking at the panel hosted by the global non-profit antibiotic accelerator CARB-X and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Changing community behaviours and patterns can be a major lift, in light of the ease with which people can get antibiotics through more informal channels as well as the expense people might face in seeing a healthcare professional – who will in turn face challenges determining if antibiotics are needed or not – without adequate diagnostics equipment. Access to antibiotics is improving – but Africa is also becoming an AMR hotspot Buying antibiotics in India. Prescriptions are required but the rule is not always enforced. “Access to antibiotics [in LMICs] is improving and that is a good thing,” said Tamas Koncz, a vice-president of Pfizer’s operations in Germany. He pointed to data citing a 114% increase in antibiotic use in low- and middle-income countries between 2000-2015. Pfizer’s 2022 Accord for a Healthier World, which committed to providing all of its patented medicines and vaccines to 45 lower-income countries on a not-for-profit basis, has been one enabler of better access to common antimicrobials, he said. At the same time, weak enforcement of prescription drug rules, as well as a lack of health provider knowledge about which drugs to prescribe, are drivers of drug resistance. “If physicians are not using [the drugs] appropriately, then it’s going to lead to problems. So we need to fix the challenge of access. But I think what is even more important is the overall approach.” Africa, where sales of antibiotics by unlicensed vendors is often widespread, is also becoming a major AMR hotspot, he pointed out – highlighting the challenges of balancing access with judicious use. All-age rate of deaths attributable to/associated with antibiotic resistance, 2019. (Lancet, 2022) The landmark 2022 Lancet study that found 1.27 million deaths globally in 2019 were directly attributable to drug-resistant bacterial infections, including 860,000 in Africa. That same year, Africa saw 640,000 deaths from HIV. “We know from the recent communication from the African CDC and others, that it’s becoming probably the one of the biggest, if not the biggest, healthcare burden, superseding now HIV AIDs, maybe even malaria and tuberculosis,” said Koncz. ‘Pull’ incentives Florence Séjourné, Aurobac and Kevin Outterson, CARB-X. On the supply side of the equation, meanwhile, “more pull incentives” that can incentivize pharma developers of newer, pathogen-resistant antibiotics is a long-neglected topic now finally rising to the top of health ministers’ agendas. The challenge lies in the fact that new antibiotics capable of beating drug-resistant infections also need to used sparingly – to ensure that they, too, don’t fail prey to AMR. But that means companies that develop the drugs can’t count on revenues from blockbuster sales to pay back years of investment in clinical trials. “AMR innovation is in a broken business model right now, needing incentives.” said Florence Séjourné. She is the CEO of the Aurobac Therapeutics, a joint AMR R&D venture created by two leading European pharma firms as well as the founder of the BEAM Alliance association of AMR-focused biotechs. Products risk death in the pipeline While there are now 20 “highly innovative” antibiotics in the early stages of development globally, the number will have dwindled by 75% within eight years if the business model doesn’t change, warned Dr Kevin Outterson, head of CARB-X. “Within four years, we’ll have less than 10 in clinical development globally. And four more years after that, we’ll have less than five.” The of human capital” he added as large companies shut down programmes, and research is concentrated in underfinanced biotech startups. “There is absolutely no interest in private investors in the antibacterial field, which is complex,” added Séjourné. Of the startups, 60% of the BEAM Alliance members have less than a year of cash to fund their activities; 40% are firms of less than 9 employees. “The world is relying on micro companies, companies with less than 10 employees…That’s a very fragile base,” for developing urgently needed new drugs, Outterson added. On the cusp of a solution? Bacterial culture prepared for testing new antibiotic candidates. But, there are also some glimmers of hope on the horizon. The first was the launch of the United Kingdom’s new “subscription model” in May for antimicrobial drugs that need to be held in ‘reserve’ for drug resistant pathogens. This aims to guarantee innovators a return on new drugs, regardless of the quantities used, that can guarantee a market incentive for new drugs, even if they are carefully rationed. Séjourné praised the UK decision as “something to highlight has a good example for others to follow” – although she warned that until a larger number of countries get on board with such changes, “the broken business model will remain.” More recently, at the 10 October meeting of G7 health and finance ministers in Ancona, Italy’s Minister of Health, Orazio Schillaci announced a series of new “pull incentives” aimed at stimulating R&D and ensuring biotech firms a payback on their investment. Canada is also piloting an incentive programme, while other European Union members, as well as Japan, are considering similar moves. In light of those new developments, CARB-X’s Outterson sounds a note of cautious optimism. “At the G7 meeting, I made the economic case for a small, reasonable investment and push and mostly pull incentives, together, yields an amazing return on investment, both on the health side as well as the economic side,” Outterson said. “It was a rare opportunity to be able to speak not just to the health people, but also the finance people,” he said, noting that the issues raised at the meeting appeared to resonate with both sectors. “And so we have a problem, and we know that it’s desperate, and companies are filled with innovation, but not enough capital to move things forward. But we really are on the cusp of the solution as well.” IFPMA Director David Reddy “The UN meeting finished only a few weeks ago,” said IFPMA director David Reddy. “We’re moving towards the meeting in Saudi Arabia, which is the fourth AMR high level event. “I think one thing that is really important is that we are getting a common understanding of where we need to go, and what the challenges are,” he added. “We do need to make progress on the business model. The UK, Japan have already made good moves towards pull incentives, and a pilot has been put in place by Canada. There are a lot of remaining challenges, but I think the key message coming out of this is there is a real thirst to maintain momentum as we head into the meeting in Saudi Arabia.” But “it’s not just about financing,” he added, “it’s also about people and competencies.” “Access but having a really firm understanding of community needs on the ground is essential, because without that, we won’t make progress in the fight against AMR and in bringing antibiotics to those who need them.” Image Credits: USAID Asia/Flickr, USAID Asia , Health Policy Watch , Van Boeckel, Pires et al, 2019, WHO, The Lancet, 2022, AMR Industry Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. 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RFK Jr Nominated as Top US Health Official 15/11/2024 Stefan Anderson & Sophia Samantaroy Robert F. Kennedy Jr, scion of America’s most prominent political family, is set to become the nation’s top health official under Trump. Donald Trump has named Robert F Kennedy Jr as his choice for US health secretary, putting the controversial anti-vaccine activist and environmental lawyer in line to control some of the world’s most influential health agencies. Kennedy shot to political prominence during the COVID-19 pandemic when his organisation, Children’s Health Defense, became a leading global voice questioning vaccine safety and efficacy. His appointment, which requires Senate confirmation, comes after Kennedy dropped his independent presidential bid to back Trump. “He’s going to help make America healthy again,” Trump said in a speech at Mar-a-Lago following his election victory. “He wants to do some things, and we’re going to let him get to it.” Trump described the role atop HHS as “the most important role of any administration”, adding that Kennedy “will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country”. I am thrilled to announce Robert F. Kennedy Jr. as The United States Secretary of Health and Human Services (HHS). For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it… — Donald J. Trump (@realDonaldTrump) November 14, 2024 If confirmed, Kennedy would oversee a sprawling $1.8 trillion department with 10 health agencies and three human services agencies. His leadership of HHS would include the administration of Medicare, Medicaid and the Affordable Care Act while setting priorities for America’s three most powerful health agencies: the Centers for Disease Control and Prevention (CDC), which tracks disease outbreaks and sets public health guidance; the Food and Drug Administration (FDA), which approves medicines and medical devices; and the National Institutes of Health (NIH), the world’s largest public funder of medical research. Kennedy, an environmental lawyer with no health experience, called his appointment “a generational opportunity” to realign US health policy and “put an end to the chronic disease epidemic” in a post accepting the nomination on X. He said Trump has instructed him to “reorganize” the U.S. constellation of federal health agencies. “I look forward to working with the more than 80,000 employees at HHS to free the agencies from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth,” Kennedy said. Global health fallout Beyond domestic agencies, the Trump administration is also expected to reshape America’s role in global health. In his last term, Trump withdrew funding from the World Health Organization over its COVID-19 response and slashed funding to UN agencies, leaving a multi-billion dollar gap in the UN health agency’s budget. With Kennedy – who has questioned global health orthodoxies – by his side, experts expect this isolationist stance to deepen. This could affect millions who rely on HIV/AIDS funding through PEPFAR, a $7 billion US program providing HIV treatment in over 50 countries, the CDC’s network of 65 international offices, and State Department health diplomacy efforts. WHO officials told Health Policy Watch last month they face “a huge fear factor” over potential US funding withdrawal, warning the agency would enter “a dramatically bad crisis” without American support. The Biden administration’s global health security team referred Health Policy Watch to the Trump transition team when asked for comment. Robert Kennedy Junior’s banner photo on X, formerly Twitter, where he boasts over 4.5 million followers. Beyond the mainstream Kennedy’s stated priorities for America’s health system veer from broadly supported reforms to debunked anti-scientific claims that have alarmed health experts. In recent weeks, he has called for removing fluoride from US drinking water – which he claims causes brain disease – reviewing vaccine safety data with an eye to withdrawing some from the market, eliminating “entire departments” at the FDA, and immediately dismissing 600 NIH employees. His controversial positions include claims repeatedly rejected by scientists: that vaccines cause autism in children, that AIDS is not caused by HIV, that antidepressants are responsible for mass school shootings, and that atrazine, a widely used herbicide, triggers gender dysphoria and has led to increases in young people identifying as transgender. Kennedy’s unconventional streak isn’t limited to medicine. In the run-up to November’s election, Kennedy said doctors found a worm had eaten part of his brain, video footage revealed him to be the key to a decade-old New York City mystery of a dead bear in Central Park – he dumped it there on his way to the airport – and came under investigation for decapitating a whale. Lawrence Gostin, a global health expert at Georgetown University, called the Kennedy pick “the darkest day for public health and science in my lifetime.” “Trump’s pick of RFK Jr as HHS Secretary is disastrous for public health,” Gostin said. “Having a person sceptical of science and evidence at HHS will make America unhealthy.” Public health victories at risk Public health victories like vaccines and drinking water fluoridation have led to dramatic increases in life expectancy. The World Health Organization estimates vaccines save five million lives annually, with global immunization efforts having saved at least 154 million lives over the past 50 years. Yet Kennedy has repeatedly challenged these achievements by questioning vaccine safety and stating that fluoride is linked to “neurodevelopmental disorders.” The real-world impact of vaccine scepticism is already visible in the US, with the CDC reporting vaccination rates for children dropping for all available vaccines last year and vaccine exemptions for religious reasons rising across the past decade. “Religion doesn’t change that fast,” said Dr Michael Mendoza, a former county Public Health Commissioner in New York State. “This is about ideology and misinformation – and we’re seeing a direct impact in the number of kids unvaccinated.” “We’re at risk of widespread distrust in evidence-based treatments and vaccines,” Mendoza added, noting how health misinformation has directly influenced the increase in risky medical decisions. “Our elected and appointed officials have an obligation to promote experts and guidelines that are grounded in established scientific evidence.” Within the federal workforce, many remain optimistic that little will change. Agencies like the Biomedical Advanced Research and Development Authority (BARDA), which funded the development of COVID-19 vaccines, traditionally receive bipartisan support, resulting in little change across administrations. An HHS employee, speaking to Health Policy Watch on the condition of anonymity to safeguard their job security, noted that the negative perception of the new administration has yet to filter into many agencies. Room for agreement Less controversial is Kennedy’s opposition to the well-documented “revolving door” between the industry and government, where officials frequently switch between regulating companies and working for them – a system he argues has led to the “corporate capture” of US health agencies. In a country that spends more on healthcare than any other developed nation, has one of the world’s highest obesity rates, and whose largest public health crisis – the opioid epidemic – was engineered by pharmaceutical giant Purdue Pharma, his critiques of the system have found resonance. The concern about industry influence has merit: since 2000, every FDA commissioner has taken industry positions after leaving office. Nine out of the last ten, representing 40 years of leadership, have done the same. The pattern continued with Trump’s previous HHS secretary, Scott Gottlieb, who departed to a board seat at Pfizer in 2020. Kennedy’s stance against pharmaceutical interests sets up a likely clash with fellow Republicans, many of whom receive significant industry funding. Several GOP lawmakers have already pledged to dismantle President Joe Biden’s signature Medicare drug price negotiation law, which allows the government to negotiate fairer prices on behalf of its senior citizens, claiming it stifles innovation. Yet Kennedy has promised a direct confrontation with the industry, causing shares of major vaccine makers to plunge after Trump’s announcement of Kennedy’s selection. “Together we will clean up corruption, stop the revolving door between industry and government,” Kennedy said. Kennedy’s promised crusade against chronic diseases and processed foods has also found broad support among public health officials – setting up yet another clash with a major industry traditionally aligned with Republican politics. His pledge to strip ultra-processed foods from school lunches and crack down on food dyes has drawn bipartisan backing, though industry groups warn such moves could increase grocery prices Trump has vowed to reduce. “Senators may say, well, RFK Jr has good ideas like tackling chronic disease and regulating Big Food, but RFK Jr is not to be trusted after a career of peddling falsehoods,” Gostin said. “What we need is nutritional warnings on unhealthy foods, bans on targeting kids, and reduced salt and sugar.” Even some nutrition advocates who oppose Kennedy’s broader agenda acknowledge the need for stricter oversight of the food industry. The FDA has identified concerns about ultra-processed foods’ health impacts, though the agency says more research is needed. The challenge, experts say, will be implementing evidence-based reforms while avoiding Kennedy’s tendency toward unproven theories about food safety. Environmental hero to anti-vaccine empire Headline published in the Defender, the news arm of Kennedy’s anti-vaccine outfit on November 7. Kennedy began his career as a celebrated environmental lawyer, fighting corporate polluters and championing indigenous communities whose lands had been poisoned by industry. His aggressive prosecution of polluters helped restore the Hudson River to health, earning him Time magazine’s “Hero for the Planet” designation. He maintains some of this environmental ethos, promising in his presidential campaign before bowing out to back Trump to tackle unsafe PFAS levels and microplastic contamination. But his path took a sharp turn in 2015 when he took over the struggling World Mercury Project, rebranding it as Children’s Health Defense (CHD) in 2018. Under Kennedy’s leadership, CHD became a global anti-vaccine juggernaut. The organization’s revenue skyrocketed from $1.1 million in 2018 to $23.5 million in 2022, with Kennedy himself earning more than $510,000 in 2022, the last year where filings are available. In mainstream interviews and congressional appearances, Kennedy has worked to promote his least controversial views. He has attempted to moderate his image, telling NBC News: “I’m not going to take away anybody’s vaccines, I’ve never been anti-vaccine.” Yet the organization he led until his presidential campaign – and where he remains a lawyer – continues to fund and promote numerous anti-scientific positions. Public tax filings show Kennedy made $550,000 in executive compensation from Children’s Health Defense in 2022, the last year where records are available. During the pandemic, CHD’s vaccine-related posts were shared more frequently on Twitter than content from CNN, Fox News, NPR and the CDC combined – occasionally eclipsing the readership of the New York Times and Washington Post. The Center for Countering Digital Hate named Kennedy one of the “Disinformation Dozen,” identifying him and CHD as among the top spreaders of vaccine misinformation online. CHD also played a role in coordinating international protests for anti-vaccine movements around the world – with deadly consequences. In 2019, Kennedy’s organization flooded American Samoa with vaccine misinformation and lobbied the government against the use of the MMR vaccine, resulting in a devastating measles outbreak. This week, CHD’s news arm, The Defender, published claims that COVID-19 vaccines pose a “112,000% greater risk of brain clots and strokes than flu shots” – research based on misuse of VAERS, a federal database that records unverified reports of adverse events. The study’s authors include supplement company affiliates and anti-vaccine activists who openly coordinate with Kennedy’s organization. One author chairs a Texas-based organization that tagged Kennedy in a Twitter post on Tuesday calling for the “immediate withdrawal of all COVID-19 vaccines from the market” and the “repeal of the 1986” national childhood vaccination act. In his 2021 book, which sold over a million copies and sat on the New York TImes bestseller list for 17 weeks, Kennedy expands on the ethos behind CDH, calling Anthony Fauci, who led the US response to the COVID-19 pandemic, “the powerful technocrat who helped orchestrate and execute 2020’s historic coup d’état against Western democracy,” claiming his “remedies” – including Covid vaccines – were “often more lethal than the diseases they pretend to treat.” The book also champions Alan Duesberg, praising as “elegant” and “compelling” the discredited scientist’s claims that AIDS is not caused by HIV. Such theories had deadly consequences: 330,000 people died prematurely after being denied life-saving HIV treatment when South Africa’s government embraced view championed by Duesberg in the early 2000s, according to Harvard researchers. Path to Senate confirmation .@RobertKennedyJr has championed issues like healthy foods and the need for greater transparency in our public health infrastructure. I look forward to learning more about his other policy positions and how they will support a conservative, pro-American agenda. — U.S. Senator Bill Cassidy, M.D. (@SenBillCassidy) November 14, 2024 Kennedy’s path to confirmation runs through a Republican-led Senate, where he needs a simple majority of 51 votes. While some Republicans have expressed cautious support, experts point to Trump’s other nominees as the President-elect’s “tests” for Senate loyalty, suggesting the incoming president may bypass the traditional confirmation process entirely. “Any Republican Senator seeking the coveted LEADERSHIP position in the United States Senate must agree to Recess Appointments (in the Senate!), without which we will not be able to get people confirmed in a timely manner,” Trump posted on Sunday. “We need positions filled IMMEDIATELY!” If the Republican-majority Senate agrees to recess appointments – where the President appoints officials when Congress is not in session – Trump’s cabinet picks could stay until the end of 2026. Kennedy joins other iconoclastic nominees. Trump tapped former Democratic Representative Tulsi Gabbard for Director of National Security, noted for her opposition to US support for Ukraine and promoting debunked Russian claims about US-funded biolabs there. He also named Florida Representative Matt Gaetz, who had been facing a congressional ethics investigation over allegations of sex trafficking a minor, as Attorney General. Image Credits: Gage Skidmore, European Union/Martin Matev. Breakthrough Research Promises Shorter Treatment for Multi-Drug-Resistant TB 15/11/2024 Disha Shetty Young Indonesians appeal for an end to TB at the Union’s World Lung Health conference in Bali. In a breakthrough for patients with multi-drug-resistant (MDR) tuberculosis (TB), researchers shared positive trial results for a shorter, tailored alternative at the World Conference on Lung Health in Bali, Indonesia. The insights came from the endTB-Q trial aimed at finding a simpler, less toxic, shorter regimen for fluoroquinolone-resistant MDR-TB. Fluoroquinolone is a common class of medicine used to treat MDR TB, and if patients become resistant, they are considered to be bordering on extensively drug-resistant (XDR) TB, which is extremely hard to treat and can take 18 months. The endTB-Q clinical trial enrolled 323 patients from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam to try to find alternatives to the current longer treatment regimen recommended by the World Health Organization (WHO). Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project “Our trial innovated in several important ways. Since we know that treatment for TB is not ‘one size fits all’, we tested a strategy that tailored treatment duration to disease severity and treatment response based on simple criteria,” said Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project and co-principal investigator of the trial. Researchers tried a combination of four TB drugs used to treat drug-resistant forms of TB – bedaquiline, clofazimine, delamanid and linezolid (BCDL). These drugs were given for six months and extended to nine months in case of delayed treatment response. Around 87% of patients were cured after the treatment in comparison to 89% of patients in the control arm of the trial that received the current WHO regime. But those 87% who did get better had less severe TB, according to the researchers. But for people with severe TB disease, BCDL for nine months was insufficient as they were at risk of TB returning and the longer regimen is still the best option. “Our conclusions are that this regimen, BCDL, given for six to nine months, is an excellent approach for those who don’t have severe disease at baseline. In this group, the success rate is almost 95% and it has a big advantage compared to the historical conventional treatment because it’s much shorter and less toxic,” said Guglielmetti. Researchers shared several breakthrough insights on tuberculosis care at the World Conference on Lung Health. Bedaquiline use in children found safe Researchers also shared updates from a separate trial that looked into whether children can take bedaquiline, which is used to treat drug-resistant TB. The trial found the drug to have a high degree of safety and tolerance for use in children. New data from a different trial funded by the US-research agency National Institute of Health (NIH) called IMPAACT that included experts from Stellenbosch University in South Africa found bedaquiline safe for use in the treatment of infants, children and adolescents with drug-resistant TB. This is a crucial finding as it will allow further optimising the use of bedaquiline in children with drug-resistant TB – an under-served population. “The P1108 trial [bedaquiline] has paved the way for access, finally, to effective, shorter and safer treatment for children with drug-resistant TB. For too long children with TB have been left behind,” said researcher Simon Schaaf. He said that children form nearly 12% of all TB cases or 1.3 million cases every year globally but despite bedaquiline being authorized for use since 2012, there wasn’t any trial for its use in children. Nearly 3,900 stakeholders including industry representatives, patient groups, and doctors from around 150 countries attended the conference. The week-long conference also saw the release of results from other TB trials in countries across Southeast Asia. In Indonesia, researchers found that using mobile chest X-ray screening proved to be a useful tool to find active TB cases in the community. This is especially helpful in cases where people do not show classic symptoms of TB like coughing. Day 2 at #UnionConf24 is underway! 👉 @FIT_eV present their research into active case finding among communities in Vietnam🇻🇳 “Community chest X-ray screening for TB among ethnic minority communities is more than just a health intervention—it’s a vital step toward equity”#EndTB pic.twitter.com/Hn0iAzpr1V — The Union (@TheUnion_TBLH) November 13, 2024 In Vietnam, researchers stressed the importance of active case finding in ethnic minorities and remote communities to ensure access to treatment. They also used mobile X-ray machines. In the Philippines, person-centred active case finding for TB was found to break down barriers to healthcare access for vulnerable populations. The screening was done as a part of a poverty alleviation programme which empowered community members to participate and take a leading role. Trust in community leaders aided the screening of TB. Researchers also shared results from a study that highlighted the need to optimize tests to check whether a patient was susceptible to a particular drug or not, and to expand access to new TB compounds for people with life-threatening TB. “Antimicrobial resistance is among the greatest global health threats we face today. For people at-risk of TB, this threat is multiplied,” said Dr Cassandra Kelly-Cirino, Executive Director of The International Union Against Tuberculosis and Lung Disease (The Union), which convened the conference. “The new research presented at the Union Conference this week represents an invaluable step in managing this challenge and in offering hope to patients of all ages living with extensively drug-resistant TB.” Image Credits: The Union, The Union. Make Clean Air Part of Climate Plans, Experts Say 15/11/2024 Chetan Bhattacharji Smog engulfs Lahore, Pakistan, on Thursday as air pollution levels hit record highs. Some pollutants reached nearly 100 times the World Health Organization’s recommended level, according to IQAir. BAKU, Azerbaijan — Global and Indian experts at COP29 produced new evidence Thursday calling for clean air standards to become part of nations’ climate commitments, as cities across South Asia’s heavily polluted air corridor battled record-breaking smog. In Delhi, authorities closed schools up to grade 5 and halted construction as pollution levels soared to almost twenty times the WHO’s safe daily limit. The crisis came just days after Lahore, Pakistan’s second-largest city just 25 kilometres from the Indian border, saw its highest-ever levels of air pollution. Under the clear skies of Azerbaijan’s capital, experts from the World Bank, WHO, and Indian health ministry were unanimous that air quality improvement should be included in the new Nationally Determined Contributions (NDCs), the self-determined climate targets nations set under the Paris Agreement. “Air quality targets and standards can be a perfect indicator of success if we are successful in targeting the causes of climate change,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “If we could select an indicator of how successful we are in achieving negotiations on climate change mitigation, I think we should use the levels of air quality that people around the world are breathing.” Health experts hope their evidence linking air pollution and climate change will strengthen calls for action at COP29. Supporting this call for action is a new report released by the Clean Air Fund that shows how tropospheric ozone – a little-discussed ‘super pollutant’ – is linked to 500,000 premature deaths and an estimated $500 billion in economic costs annually. Air pollution from all sources contributes to more than eight million premature deaths each year, with economic costs exceeding $8 trillion, the report found. The findings aim to support the push for including air quality standards in the third generation of NDCs – binding climate commitments due before COP30 next year under the Paris Agreement. Only a small fraction of countries currently include air pollution safety in their climate plans despite the health threat to millions worldwide. Clean Air Fund’s founder and CEO, Jane Burston, said tackling super pollutants provides “huge opportunities” for improving climate, health, economic development, and equity. “We know that developing countries are some of the few that have included things like black carbon in their nationally determined contributions, and that’s because a lot of these deaths and this exposure is happening in countries least able to afford action on it,” she added. Super-bad for children Protest by ‘Warrior Moms’, a group for clean air, in Delhi outside India’s health ministry, as air pollution turned ‘severe’ on 14th November, which is celebrated as Children’s Day in the country. Tropospheric ozone and its super-pollutant siblings – including methane, black carbon, nitrous oxide and fluorinated gases – are collectively responsible for nearly half of global warming to date. Unlike other pollutants, tropospheric ozone isn’t directly emitted but forms when sunlight interacts with pollutants from aviation, shipping, agriculture and other sectors. Its health impacts can be severe, from reduced lung function to complications in type 2 diabetes and cardiovascular disease. For children, this pollution poses an especially severe threat. “Young children have smaller lungs,” Dr Soumya Swaminathan, an advisor to the Indian health ministry and former chief scientist at the WHO, explained. “They breathe much faster than adults, and they are shorter, so they’re closer to the ground, where there are more pollutants, and get more respiratory infections.” Dr Valerie Hickey, who leads the World Bank’s environment department, also placed children at the centre of her argument. “Your kid got up coughing so bad they couldn’t go to school does not lead on CNN,” she said. “Though if there are huge floods in Valencia, it does. Both are terrible, but [air pollution] is a public health emergency.” Like climate change itself, air pollution’s threat isn’t only visible in extreme events such as Delhi’s current crisis, where PM2.5 levels have reached almost 300 micrograms per cubic metre. “Every unit you go above five, you actually have a health impact,” explained Swaminathan, who co-chairs Our Common Air. “Even at 20, 30, 40 you start getting effects on the heart, respiratory system, and brain. So we need to take action to keep it as low as possible.” “We have to be pragmatic and set interim targets and do a stepwise plan to reduce it,” she added. “That’s what the NDCs are all about.” ‘Smog diplomacy’ Delhi and Lahore, just 400 kilometres apart, face the world’s highest air pollution levels. Half of the ten most polluted places in the world today are in four countries of South Asia – Pakistan, India, Nepal and Bangladesh. Health experts often say that air pollution knows no borders, an adage now forcing cooperation between long-standing rivals in what’s come to be known as “smog diplomacy.” India and Pakistan, nations that have fought multiple wars since independence, are finding themselves pushed toward dialogue over their shared air crisis. This week, as their major cities Delhi and Lahore traded places as the world’s most polluted, officials in Punjab, Pakistan’s most populous province, drafted a letter to India seeking talks on air pollution. “This is an area of the world where there isn’t always great experience with international diplomacy,” Hickey said. “Countries don’t always like each other, but they’re actually seeing that smog diplomacy is something that can bring them to the table.” The outreach comes as hundreds of millions in both countries face severe health risks borne from common problems plaguing both nations: farmers burning agricultural waste, coal-fired power plants, heavy traffic, construction and windless days trapping emissions. The World Bank has launched a “multi-hundred billion dollar” to address this cross-border crisis, targeting the vast northern plains of South Asia, known as the Indo-Gangetic Plains, Hickey told Health Policy Watch. The Bank has already committed to several regional projects in India, including a $350 million clean air management initiative plus $5 million grant for Uttar Pradesh, reportedly approved by the state cabinet and a pending $300 million loan plus $5 million grant for Haryana. Similar programs are planned for Nepal, Pakistan and Bangladesh to address pollution that readily crosses borders due to the region’s geography and wind patterns. “We need climate diplomacy, as a regional and global issue,” Raja Jahangir Anwar, Punjab’s Secretary for Environment and Climate Change, told CNN. “We are suffering in Lahore due to the eastern wind corridor coming from India. We are not blaming anyone, it’s a natural phenomenon.” Image Credits: https://x.com/ThePeerAli/status/1856985454072963085/photo/1. As World’s Health Ministers Meet in Jeddah: Calls for Strong AMR Science Panel With Authority to ‘Challenge’ Sponsors 14/11/2024 Elaine Ruth Fletcher Thail lab technicians train in surveillance of antimicrobial resistance (AMR) in food-producing animals in Southeast Asia – an driver of AMR that was neglected in the recent UN High Level Meeting declaration. With plans underway for a new “Independent Panel” on Antimicrobial Resistance, endorsed at September’s UN High-Level AMR Meeting, the new body must become a strong scientific authority. It should have the power to “challenge” the agencies that create it and address both human and animal health factors driving drug-resistant pathogens. That was a key message from AMR experts in the lead up to the Fourth Ministerial Meeting on Antimicrobial Resistance, which begins Friday in Jeddah, Saudi Arabia. The Independent Panel “needs to be an inclusive process… listening to scientists… civil society, to industry and other actors. But you also need to make sure that that panel, even though hosted by a Quadripartite, can actually challenge the Quadripartite,” declared John Arne Røttingen, CEO of the UK-based Wellcome Trust, of the panel’s central importance to providing evidence on future AMR policies. The ‘Quadripartite’ includes the World Health Organization, as well as the global environment, food and animal health agencies, which are now formally collaborating to confront the AMR threat. John-Arne Røttingen, CEO of Wellcome Trust. Røttingen was among the more than two dozen experts convened for two high-level AMR sessions at Berlin’s World Health Summit in mid-October to discuss next steps for the battle against drug resistant pathogens in the lead-up to the Jeddah meeting. “Declarations are long. It’s hard to identify the real material commitments that have been made,” Røttingen said at a panel discussion on Milestones and Challenges in Tackling AMR, hosted by the German Ministry of Health. “So it’s great that we come to Jeddah for the ministerial meeting,” he said. “That should be a start of both countries’ [and development agencies] coming together as well as the multi stakeholder partnership platform coming together across sectors to make sure that we are keeping our commitments.” On the research front, meanwhile, new “pull incentives” recently developed in the United Kingdom, Italy and Canada to foster a sustainable market for next generation antibiotics are welcome, but they are not enough, industry experts asserted. Many more nations need to adopt supply-side incentives to ensure that badly-needed new drug candidates actually come to market. Jeddah should be the start of making good on the UN’s AMR Declaration FAO, UNEP, WHO and WOAH heads at September’s UN High Level Meeting that approved a set of new commitments for action on drug resistant pathogens. The health ministers’ confab in Saudi Arabia (15-16 November) is supposed to lay out next steps for delivering on promises made in the Declaration on Antimicrobial Resistance approved at the UN High Level Meeting, 26 September in New York City. September’s declaration was a major milestone in the battle to bring a long-ignored AMR epidemic to the forefront of global health policy. AMR is associated, directly or indirectly, a “silent, slow-motion pandemic” that could kill some 39 million people by 2050. The mandate to create an “independent panel for evidence for action against antimicrobial resistance in 2025” is embedded in a 15-page text, with 106 clauses. But it is widely perceived as a key next move to maintain strategic momentum on AMR threats. The science panel should “facilitate the generation and use of multisectoral, scientific evidence to support Member States in efforts to tackle antimicrobial resistance, making use of existing resources and avoiding duplication of on-going efforts, after an open and transparent consultation with all Member States on its composition, mandate, scope, and deliverables,” the AMR declaration stated. Final HLM declaration omitted target for reducing animal antibiotic consumption Asian meat-packing house. The science panel is supposed to be created and administered by the Quadripartite of agencies whose role in managing the AMR crisis was also formalized by the declaration. Along with WHO, the four-member body includes the UN Food and Agriculture Organization (FAO), the UN Environment Programme (UNEP), and the World Animal Health Organization (WOAH), a non-UN member state body. And that makes the panel’s mandate and composition a sensitive point, in light of the political pressures from big food and other interests that want to play down their role in fostering AMR risks, which some researchers say is the leading driver. Identified AMR hotspots often align with high volumes of antibiotics sales and use in livestock. Pressures from agri-businesses and meat producing nations already led to the deletion of a target for reducing animal antibiotic use by 30% by 2030 from the final HLM declaration. Now, the question is whether scientists can come together to articulate the evidence and agree on science-based policy recommendations. “Even though the declaration was positive, it also didn’t achieve agreement on things that I, from my professional background, …would say should have been agreed,” Røttingen observed. “And that speaks to the interests and the trade offs between different sectors… it speaks to agri-food businesses versus human health, and that’s why we believe a science panel is important.” He said, “We have the target of inverting AMR-related mortality [by 10% by 2030], but we need even more targets and more ambitious targets, so we have a lot to do,” he said. “In the climate sector, we have the IPCC (Intergovernmental Panel on Climate Change),” Røttingen continued. “We know how … contested the climate space is, but still, we have a collective international evidence base… We need authoritative evidence with scientists working in the human sector and the animal sector that can come together to actually give us that evidence base and give guidance. “ For animal health, as well, the ultimate aim is to curb abuse not essential use Arshnee Moodley, CGIAR-Kenya Worldwide, the overuse of such antibiotics in livestock production is widely regarded among experts as a leading, if not the leading, driver of pathogen resistance. But ultimately, the aim of new measures should be win-wins that ensure better access to vaccines and other measures to pre-empt antibiotic use and ensure animal health, panelists at the sessions also underlined. “You need to be able to communicate with the people who can change that [AMR trends],” said Dr. Arshnee Moodley, a Kenya-based lead of CGIAR, which works with farmers on animal health. “And for me, it’s the smallholder famer outside of Nairobi. I need to be able to tell him or her why they shouldn’t use antibiotics,” she said. “And that’s really critical because livestock is also part of the solution; it’s vital food for vulnerable groups,” she continued. “I worked every summer in my grandfather’s farm with three milk houses, from the age of 13. So I know about animal health and the need for small farmers, even in high income countries, to keep their herds healthy,” Røttingen countered. “When I’m concerned about the agricultural sector, it’s not really about the misuse of antibiotics among small scale farmers … it is about big food on several continents and making sure that they are … transparent and they are willing to engage in proper animal welfare, because that’s the starting point for ensuring animal health. Too often, measures related to vaccines and hygiene are bypassed, “by using antibiotics to treat herds that aren’t necessarily requisite,” he explained. Worst of all, is the use of antimicrobials or antibiotics “as growth promotion that has nothing to do with animal health. It’s not healthy for those who eat those animals, and it’s not healthy for the animals. “So … animal health is an important part, but I think the hardest question lies with the big food companies.” For human health – more prevention and better regulation are essential too Malawi’s Minister of Health Khumbize Kandodo Chiponda with Tamas Koncz, Pfizer Germany Much as with animals, infection prevention, appropriate access to drugs and better regulation need to be the operative goals for humans as well, panelists at a second high-level session on AMR agreed. That includes clean water, sanitation and hygiene that many communities and health facilities still lack, as well as stronger laboratory networks, and quality control of antimicrobials in settings were fake and substandard formulas often circulate. “Unfortunately for countries like us, we face challenges, because in terms of manufacturing… we have to get them [products] from outside. So in terms of the quality…. you cannot be 100% sure that what you’re getting really is the very, very good quality,” said Khumbize Kandodo Chiponda Minister of Health, Malawi, speaking at the panel hosted by the global non-profit antibiotic accelerator CARB-X and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Changing community behaviours and patterns can be a major lift, in light of the ease with which people can get antibiotics through more informal channels as well as the expense people might face in seeing a healthcare professional – who will in turn face challenges determining if antibiotics are needed or not – without adequate diagnostics equipment. Access to antibiotics is improving – but Africa is also becoming an AMR hotspot Buying antibiotics in India. Prescriptions are required but the rule is not always enforced. “Access to antibiotics [in LMICs] is improving and that is a good thing,” said Tamas Koncz, a vice-president of Pfizer’s operations in Germany. He pointed to data citing a 114% increase in antibiotic use in low- and middle-income countries between 2000-2015. Pfizer’s 2022 Accord for a Healthier World, which committed to providing all of its patented medicines and vaccines to 45 lower-income countries on a not-for-profit basis, has been one enabler of better access to common antimicrobials, he said. At the same time, weak enforcement of prescription drug rules, as well as a lack of health provider knowledge about which drugs to prescribe, are drivers of drug resistance. “If physicians are not using [the drugs] appropriately, then it’s going to lead to problems. So we need to fix the challenge of access. But I think what is even more important is the overall approach.” Africa, where sales of antibiotics by unlicensed vendors is often widespread, is also becoming a major AMR hotspot, he pointed out – highlighting the challenges of balancing access with judicious use. All-age rate of deaths attributable to/associated with antibiotic resistance, 2019. (Lancet, 2022) The landmark 2022 Lancet study that found 1.27 million deaths globally in 2019 were directly attributable to drug-resistant bacterial infections, including 860,000 in Africa. That same year, Africa saw 640,000 deaths from HIV. “We know from the recent communication from the African CDC and others, that it’s becoming probably the one of the biggest, if not the biggest, healthcare burden, superseding now HIV AIDs, maybe even malaria and tuberculosis,” said Koncz. ‘Pull’ incentives Florence Séjourné, Aurobac and Kevin Outterson, CARB-X. On the supply side of the equation, meanwhile, “more pull incentives” that can incentivize pharma developers of newer, pathogen-resistant antibiotics is a long-neglected topic now finally rising to the top of health ministers’ agendas. The challenge lies in the fact that new antibiotics capable of beating drug-resistant infections also need to used sparingly – to ensure that they, too, don’t fail prey to AMR. But that means companies that develop the drugs can’t count on revenues from blockbuster sales to pay back years of investment in clinical trials. “AMR innovation is in a broken business model right now, needing incentives.” said Florence Séjourné. She is the CEO of the Aurobac Therapeutics, a joint AMR R&D venture created by two leading European pharma firms as well as the founder of the BEAM Alliance association of AMR-focused biotechs. Products risk death in the pipeline While there are now 20 “highly innovative” antibiotics in the early stages of development globally, the number will have dwindled by 75% within eight years if the business model doesn’t change, warned Dr Kevin Outterson, head of CARB-X. “Within four years, we’ll have less than 10 in clinical development globally. And four more years after that, we’ll have less than five.” The of human capital” he added as large companies shut down programmes, and research is concentrated in underfinanced biotech startups. “There is absolutely no interest in private investors in the antibacterial field, which is complex,” added Séjourné. Of the startups, 60% of the BEAM Alliance members have less than a year of cash to fund their activities; 40% are firms of less than 9 employees. “The world is relying on micro companies, companies with less than 10 employees…That’s a very fragile base,” for developing urgently needed new drugs, Outterson added. On the cusp of a solution? Bacterial culture prepared for testing new antibiotic candidates. But, there are also some glimmers of hope on the horizon. The first was the launch of the United Kingdom’s new “subscription model” in May for antimicrobial drugs that need to be held in ‘reserve’ for drug resistant pathogens. This aims to guarantee innovators a return on new drugs, regardless of the quantities used, that can guarantee a market incentive for new drugs, even if they are carefully rationed. Séjourné praised the UK decision as “something to highlight has a good example for others to follow” – although she warned that until a larger number of countries get on board with such changes, “the broken business model will remain.” More recently, at the 10 October meeting of G7 health and finance ministers in Ancona, Italy’s Minister of Health, Orazio Schillaci announced a series of new “pull incentives” aimed at stimulating R&D and ensuring biotech firms a payback on their investment. Canada is also piloting an incentive programme, while other European Union members, as well as Japan, are considering similar moves. In light of those new developments, CARB-X’s Outterson sounds a note of cautious optimism. “At the G7 meeting, I made the economic case for a small, reasonable investment and push and mostly pull incentives, together, yields an amazing return on investment, both on the health side as well as the economic side,” Outterson said. “It was a rare opportunity to be able to speak not just to the health people, but also the finance people,” he said, noting that the issues raised at the meeting appeared to resonate with both sectors. “And so we have a problem, and we know that it’s desperate, and companies are filled with innovation, but not enough capital to move things forward. But we really are on the cusp of the solution as well.” IFPMA Director David Reddy “The UN meeting finished only a few weeks ago,” said IFPMA director David Reddy. “We’re moving towards the meeting in Saudi Arabia, which is the fourth AMR high level event. “I think one thing that is really important is that we are getting a common understanding of where we need to go, and what the challenges are,” he added. “We do need to make progress on the business model. The UK, Japan have already made good moves towards pull incentives, and a pilot has been put in place by Canada. There are a lot of remaining challenges, but I think the key message coming out of this is there is a real thirst to maintain momentum as we head into the meeting in Saudi Arabia.” But “it’s not just about financing,” he added, “it’s also about people and competencies.” “Access but having a really firm understanding of community needs on the ground is essential, because without that, we won’t make progress in the fight against AMR and in bringing antibiotics to those who need them.” Image Credits: USAID Asia/Flickr, USAID Asia , Health Policy Watch , Van Boeckel, Pires et al, 2019, WHO, The Lancet, 2022, AMR Industry Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. 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Breakthrough Research Promises Shorter Treatment for Multi-Drug-Resistant TB 15/11/2024 Disha Shetty Young Indonesians appeal for an end to TB at the Union’s World Lung Health conference in Bali. In a breakthrough for patients with multi-drug-resistant (MDR) tuberculosis (TB), researchers shared positive trial results for a shorter, tailored alternative at the World Conference on Lung Health in Bali, Indonesia. The insights came from the endTB-Q trial aimed at finding a simpler, less toxic, shorter regimen for fluoroquinolone-resistant MDR-TB. Fluoroquinolone is a common class of medicine used to treat MDR TB, and if patients become resistant, they are considered to be bordering on extensively drug-resistant (XDR) TB, which is extremely hard to treat and can take 18 months. The endTB-Q clinical trial enrolled 323 patients from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam to try to find alternatives to the current longer treatment regimen recommended by the World Health Organization (WHO). Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project “Our trial innovated in several important ways. Since we know that treatment for TB is not ‘one size fits all’, we tested a strategy that tailored treatment duration to disease severity and treatment response based on simple criteria,” said Lorenzo Guglielmetti, Médecins Sans Frontières (MSF) Director for the endTB project and co-principal investigator of the trial. Researchers tried a combination of four TB drugs used to treat drug-resistant forms of TB – bedaquiline, clofazimine, delamanid and linezolid (BCDL). These drugs were given for six months and extended to nine months in case of delayed treatment response. Around 87% of patients were cured after the treatment in comparison to 89% of patients in the control arm of the trial that received the current WHO regime. But those 87% who did get better had less severe TB, according to the researchers. But for people with severe TB disease, BCDL for nine months was insufficient as they were at risk of TB returning and the longer regimen is still the best option. “Our conclusions are that this regimen, BCDL, given for six to nine months, is an excellent approach for those who don’t have severe disease at baseline. In this group, the success rate is almost 95% and it has a big advantage compared to the historical conventional treatment because it’s much shorter and less toxic,” said Guglielmetti. Researchers shared several breakthrough insights on tuberculosis care at the World Conference on Lung Health. Bedaquiline use in children found safe Researchers also shared updates from a separate trial that looked into whether children can take bedaquiline, which is used to treat drug-resistant TB. The trial found the drug to have a high degree of safety and tolerance for use in children. New data from a different trial funded by the US-research agency National Institute of Health (NIH) called IMPAACT that included experts from Stellenbosch University in South Africa found bedaquiline safe for use in the treatment of infants, children and adolescents with drug-resistant TB. This is a crucial finding as it will allow further optimising the use of bedaquiline in children with drug-resistant TB – an under-served population. “The P1108 trial [bedaquiline] has paved the way for access, finally, to effective, shorter and safer treatment for children with drug-resistant TB. For too long children with TB have been left behind,” said researcher Simon Schaaf. He said that children form nearly 12% of all TB cases or 1.3 million cases every year globally but despite bedaquiline being authorized for use since 2012, there wasn’t any trial for its use in children. Nearly 3,900 stakeholders including industry representatives, patient groups, and doctors from around 150 countries attended the conference. The week-long conference also saw the release of results from other TB trials in countries across Southeast Asia. In Indonesia, researchers found that using mobile chest X-ray screening proved to be a useful tool to find active TB cases in the community. This is especially helpful in cases where people do not show classic symptoms of TB like coughing. Day 2 at #UnionConf24 is underway! 👉 @FIT_eV present their research into active case finding among communities in Vietnam🇻🇳 “Community chest X-ray screening for TB among ethnic minority communities is more than just a health intervention—it’s a vital step toward equity”#EndTB pic.twitter.com/Hn0iAzpr1V — The Union (@TheUnion_TBLH) November 13, 2024 In Vietnam, researchers stressed the importance of active case finding in ethnic minorities and remote communities to ensure access to treatment. They also used mobile X-ray machines. In the Philippines, person-centred active case finding for TB was found to break down barriers to healthcare access for vulnerable populations. The screening was done as a part of a poverty alleviation programme which empowered community members to participate and take a leading role. Trust in community leaders aided the screening of TB. Researchers also shared results from a study that highlighted the need to optimize tests to check whether a patient was susceptible to a particular drug or not, and to expand access to new TB compounds for people with life-threatening TB. “Antimicrobial resistance is among the greatest global health threats we face today. For people at-risk of TB, this threat is multiplied,” said Dr Cassandra Kelly-Cirino, Executive Director of The International Union Against Tuberculosis and Lung Disease (The Union), which convened the conference. “The new research presented at the Union Conference this week represents an invaluable step in managing this challenge and in offering hope to patients of all ages living with extensively drug-resistant TB.” Image Credits: The Union, The Union. Make Clean Air Part of Climate Plans, Experts Say 15/11/2024 Chetan Bhattacharji Smog engulfs Lahore, Pakistan, on Thursday as air pollution levels hit record highs. Some pollutants reached nearly 100 times the World Health Organization’s recommended level, according to IQAir. BAKU, Azerbaijan — Global and Indian experts at COP29 produced new evidence Thursday calling for clean air standards to become part of nations’ climate commitments, as cities across South Asia’s heavily polluted air corridor battled record-breaking smog. In Delhi, authorities closed schools up to grade 5 and halted construction as pollution levels soared to almost twenty times the WHO’s safe daily limit. The crisis came just days after Lahore, Pakistan’s second-largest city just 25 kilometres from the Indian border, saw its highest-ever levels of air pollution. Under the clear skies of Azerbaijan’s capital, experts from the World Bank, WHO, and Indian health ministry were unanimous that air quality improvement should be included in the new Nationally Determined Contributions (NDCs), the self-determined climate targets nations set under the Paris Agreement. “Air quality targets and standards can be a perfect indicator of success if we are successful in targeting the causes of climate change,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “If we could select an indicator of how successful we are in achieving negotiations on climate change mitigation, I think we should use the levels of air quality that people around the world are breathing.” Health experts hope their evidence linking air pollution and climate change will strengthen calls for action at COP29. Supporting this call for action is a new report released by the Clean Air Fund that shows how tropospheric ozone – a little-discussed ‘super pollutant’ – is linked to 500,000 premature deaths and an estimated $500 billion in economic costs annually. Air pollution from all sources contributes to more than eight million premature deaths each year, with economic costs exceeding $8 trillion, the report found. The findings aim to support the push for including air quality standards in the third generation of NDCs – binding climate commitments due before COP30 next year under the Paris Agreement. Only a small fraction of countries currently include air pollution safety in their climate plans despite the health threat to millions worldwide. Clean Air Fund’s founder and CEO, Jane Burston, said tackling super pollutants provides “huge opportunities” for improving climate, health, economic development, and equity. “We know that developing countries are some of the few that have included things like black carbon in their nationally determined contributions, and that’s because a lot of these deaths and this exposure is happening in countries least able to afford action on it,” she added. Super-bad for children Protest by ‘Warrior Moms’, a group for clean air, in Delhi outside India’s health ministry, as air pollution turned ‘severe’ on 14th November, which is celebrated as Children’s Day in the country. Tropospheric ozone and its super-pollutant siblings – including methane, black carbon, nitrous oxide and fluorinated gases – are collectively responsible for nearly half of global warming to date. Unlike other pollutants, tropospheric ozone isn’t directly emitted but forms when sunlight interacts with pollutants from aviation, shipping, agriculture and other sectors. Its health impacts can be severe, from reduced lung function to complications in type 2 diabetes and cardiovascular disease. For children, this pollution poses an especially severe threat. “Young children have smaller lungs,” Dr Soumya Swaminathan, an advisor to the Indian health ministry and former chief scientist at the WHO, explained. “They breathe much faster than adults, and they are shorter, so they’re closer to the ground, where there are more pollutants, and get more respiratory infections.” Dr Valerie Hickey, who leads the World Bank’s environment department, also placed children at the centre of her argument. “Your kid got up coughing so bad they couldn’t go to school does not lead on CNN,” she said. “Though if there are huge floods in Valencia, it does. Both are terrible, but [air pollution] is a public health emergency.” Like climate change itself, air pollution’s threat isn’t only visible in extreme events such as Delhi’s current crisis, where PM2.5 levels have reached almost 300 micrograms per cubic metre. “Every unit you go above five, you actually have a health impact,” explained Swaminathan, who co-chairs Our Common Air. “Even at 20, 30, 40 you start getting effects on the heart, respiratory system, and brain. So we need to take action to keep it as low as possible.” “We have to be pragmatic and set interim targets and do a stepwise plan to reduce it,” she added. “That’s what the NDCs are all about.” ‘Smog diplomacy’ Delhi and Lahore, just 400 kilometres apart, face the world’s highest air pollution levels. Half of the ten most polluted places in the world today are in four countries of South Asia – Pakistan, India, Nepal and Bangladesh. Health experts often say that air pollution knows no borders, an adage now forcing cooperation between long-standing rivals in what’s come to be known as “smog diplomacy.” India and Pakistan, nations that have fought multiple wars since independence, are finding themselves pushed toward dialogue over their shared air crisis. This week, as their major cities Delhi and Lahore traded places as the world’s most polluted, officials in Punjab, Pakistan’s most populous province, drafted a letter to India seeking talks on air pollution. “This is an area of the world where there isn’t always great experience with international diplomacy,” Hickey said. “Countries don’t always like each other, but they’re actually seeing that smog diplomacy is something that can bring them to the table.” The outreach comes as hundreds of millions in both countries face severe health risks borne from common problems plaguing both nations: farmers burning agricultural waste, coal-fired power plants, heavy traffic, construction and windless days trapping emissions. The World Bank has launched a “multi-hundred billion dollar” to address this cross-border crisis, targeting the vast northern plains of South Asia, known as the Indo-Gangetic Plains, Hickey told Health Policy Watch. The Bank has already committed to several regional projects in India, including a $350 million clean air management initiative plus $5 million grant for Uttar Pradesh, reportedly approved by the state cabinet and a pending $300 million loan plus $5 million grant for Haryana. Similar programs are planned for Nepal, Pakistan and Bangladesh to address pollution that readily crosses borders due to the region’s geography and wind patterns. “We need climate diplomacy, as a regional and global issue,” Raja Jahangir Anwar, Punjab’s Secretary for Environment and Climate Change, told CNN. “We are suffering in Lahore due to the eastern wind corridor coming from India. We are not blaming anyone, it’s a natural phenomenon.” Image Credits: https://x.com/ThePeerAli/status/1856985454072963085/photo/1. As World’s Health Ministers Meet in Jeddah: Calls for Strong AMR Science Panel With Authority to ‘Challenge’ Sponsors 14/11/2024 Elaine Ruth Fletcher Thail lab technicians train in surveillance of antimicrobial resistance (AMR) in food-producing animals in Southeast Asia – an driver of AMR that was neglected in the recent UN High Level Meeting declaration. With plans underway for a new “Independent Panel” on Antimicrobial Resistance, endorsed at September’s UN High-Level AMR Meeting, the new body must become a strong scientific authority. It should have the power to “challenge” the agencies that create it and address both human and animal health factors driving drug-resistant pathogens. That was a key message from AMR experts in the lead up to the Fourth Ministerial Meeting on Antimicrobial Resistance, which begins Friday in Jeddah, Saudi Arabia. The Independent Panel “needs to be an inclusive process… listening to scientists… civil society, to industry and other actors. But you also need to make sure that that panel, even though hosted by a Quadripartite, can actually challenge the Quadripartite,” declared John Arne Røttingen, CEO of the UK-based Wellcome Trust, of the panel’s central importance to providing evidence on future AMR policies. The ‘Quadripartite’ includes the World Health Organization, as well as the global environment, food and animal health agencies, which are now formally collaborating to confront the AMR threat. John-Arne Røttingen, CEO of Wellcome Trust. Røttingen was among the more than two dozen experts convened for two high-level AMR sessions at Berlin’s World Health Summit in mid-October to discuss next steps for the battle against drug resistant pathogens in the lead-up to the Jeddah meeting. “Declarations are long. It’s hard to identify the real material commitments that have been made,” Røttingen said at a panel discussion on Milestones and Challenges in Tackling AMR, hosted by the German Ministry of Health. “So it’s great that we come to Jeddah for the ministerial meeting,” he said. “That should be a start of both countries’ [and development agencies] coming together as well as the multi stakeholder partnership platform coming together across sectors to make sure that we are keeping our commitments.” On the research front, meanwhile, new “pull incentives” recently developed in the United Kingdom, Italy and Canada to foster a sustainable market for next generation antibiotics are welcome, but they are not enough, industry experts asserted. Many more nations need to adopt supply-side incentives to ensure that badly-needed new drug candidates actually come to market. Jeddah should be the start of making good on the UN’s AMR Declaration FAO, UNEP, WHO and WOAH heads at September’s UN High Level Meeting that approved a set of new commitments for action on drug resistant pathogens. The health ministers’ confab in Saudi Arabia (15-16 November) is supposed to lay out next steps for delivering on promises made in the Declaration on Antimicrobial Resistance approved at the UN High Level Meeting, 26 September in New York City. September’s declaration was a major milestone in the battle to bring a long-ignored AMR epidemic to the forefront of global health policy. AMR is associated, directly or indirectly, a “silent, slow-motion pandemic” that could kill some 39 million people by 2050. The mandate to create an “independent panel for evidence for action against antimicrobial resistance in 2025” is embedded in a 15-page text, with 106 clauses. But it is widely perceived as a key next move to maintain strategic momentum on AMR threats. The science panel should “facilitate the generation and use of multisectoral, scientific evidence to support Member States in efforts to tackle antimicrobial resistance, making use of existing resources and avoiding duplication of on-going efforts, after an open and transparent consultation with all Member States on its composition, mandate, scope, and deliverables,” the AMR declaration stated. Final HLM declaration omitted target for reducing animal antibiotic consumption Asian meat-packing house. The science panel is supposed to be created and administered by the Quadripartite of agencies whose role in managing the AMR crisis was also formalized by the declaration. Along with WHO, the four-member body includes the UN Food and Agriculture Organization (FAO), the UN Environment Programme (UNEP), and the World Animal Health Organization (WOAH), a non-UN member state body. And that makes the panel’s mandate and composition a sensitive point, in light of the political pressures from big food and other interests that want to play down their role in fostering AMR risks, which some researchers say is the leading driver. Identified AMR hotspots often align with high volumes of antibiotics sales and use in livestock. Pressures from agri-businesses and meat producing nations already led to the deletion of a target for reducing animal antibiotic use by 30% by 2030 from the final HLM declaration. Now, the question is whether scientists can come together to articulate the evidence and agree on science-based policy recommendations. “Even though the declaration was positive, it also didn’t achieve agreement on things that I, from my professional background, …would say should have been agreed,” Røttingen observed. “And that speaks to the interests and the trade offs between different sectors… it speaks to agri-food businesses versus human health, and that’s why we believe a science panel is important.” He said, “We have the target of inverting AMR-related mortality [by 10% by 2030], but we need even more targets and more ambitious targets, so we have a lot to do,” he said. “In the climate sector, we have the IPCC (Intergovernmental Panel on Climate Change),” Røttingen continued. “We know how … contested the climate space is, but still, we have a collective international evidence base… We need authoritative evidence with scientists working in the human sector and the animal sector that can come together to actually give us that evidence base and give guidance. “ For animal health, as well, the ultimate aim is to curb abuse not essential use Arshnee Moodley, CGIAR-Kenya Worldwide, the overuse of such antibiotics in livestock production is widely regarded among experts as a leading, if not the leading, driver of pathogen resistance. But ultimately, the aim of new measures should be win-wins that ensure better access to vaccines and other measures to pre-empt antibiotic use and ensure animal health, panelists at the sessions also underlined. “You need to be able to communicate with the people who can change that [AMR trends],” said Dr. Arshnee Moodley, a Kenya-based lead of CGIAR, which works with farmers on animal health. “And for me, it’s the smallholder famer outside of Nairobi. I need to be able to tell him or her why they shouldn’t use antibiotics,” she said. “And that’s really critical because livestock is also part of the solution; it’s vital food for vulnerable groups,” she continued. “I worked every summer in my grandfather’s farm with three milk houses, from the age of 13. So I know about animal health and the need for small farmers, even in high income countries, to keep their herds healthy,” Røttingen countered. “When I’m concerned about the agricultural sector, it’s not really about the misuse of antibiotics among small scale farmers … it is about big food on several continents and making sure that they are … transparent and they are willing to engage in proper animal welfare, because that’s the starting point for ensuring animal health. Too often, measures related to vaccines and hygiene are bypassed, “by using antibiotics to treat herds that aren’t necessarily requisite,” he explained. Worst of all, is the use of antimicrobials or antibiotics “as growth promotion that has nothing to do with animal health. It’s not healthy for those who eat those animals, and it’s not healthy for the animals. “So … animal health is an important part, but I think the hardest question lies with the big food companies.” For human health – more prevention and better regulation are essential too Malawi’s Minister of Health Khumbize Kandodo Chiponda with Tamas Koncz, Pfizer Germany Much as with animals, infection prevention, appropriate access to drugs and better regulation need to be the operative goals for humans as well, panelists at a second high-level session on AMR agreed. That includes clean water, sanitation and hygiene that many communities and health facilities still lack, as well as stronger laboratory networks, and quality control of antimicrobials in settings were fake and substandard formulas often circulate. “Unfortunately for countries like us, we face challenges, because in terms of manufacturing… we have to get them [products] from outside. So in terms of the quality…. you cannot be 100% sure that what you’re getting really is the very, very good quality,” said Khumbize Kandodo Chiponda Minister of Health, Malawi, speaking at the panel hosted by the global non-profit antibiotic accelerator CARB-X and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Changing community behaviours and patterns can be a major lift, in light of the ease with which people can get antibiotics through more informal channels as well as the expense people might face in seeing a healthcare professional – who will in turn face challenges determining if antibiotics are needed or not – without adequate diagnostics equipment. Access to antibiotics is improving – but Africa is also becoming an AMR hotspot Buying antibiotics in India. Prescriptions are required but the rule is not always enforced. “Access to antibiotics [in LMICs] is improving and that is a good thing,” said Tamas Koncz, a vice-president of Pfizer’s operations in Germany. He pointed to data citing a 114% increase in antibiotic use in low- and middle-income countries between 2000-2015. Pfizer’s 2022 Accord for a Healthier World, which committed to providing all of its patented medicines and vaccines to 45 lower-income countries on a not-for-profit basis, has been one enabler of better access to common antimicrobials, he said. At the same time, weak enforcement of prescription drug rules, as well as a lack of health provider knowledge about which drugs to prescribe, are drivers of drug resistance. “If physicians are not using [the drugs] appropriately, then it’s going to lead to problems. So we need to fix the challenge of access. But I think what is even more important is the overall approach.” Africa, where sales of antibiotics by unlicensed vendors is often widespread, is also becoming a major AMR hotspot, he pointed out – highlighting the challenges of balancing access with judicious use. All-age rate of deaths attributable to/associated with antibiotic resistance, 2019. (Lancet, 2022) The landmark 2022 Lancet study that found 1.27 million deaths globally in 2019 were directly attributable to drug-resistant bacterial infections, including 860,000 in Africa. That same year, Africa saw 640,000 deaths from HIV. “We know from the recent communication from the African CDC and others, that it’s becoming probably the one of the biggest, if not the biggest, healthcare burden, superseding now HIV AIDs, maybe even malaria and tuberculosis,” said Koncz. ‘Pull’ incentives Florence Séjourné, Aurobac and Kevin Outterson, CARB-X. On the supply side of the equation, meanwhile, “more pull incentives” that can incentivize pharma developers of newer, pathogen-resistant antibiotics is a long-neglected topic now finally rising to the top of health ministers’ agendas. The challenge lies in the fact that new antibiotics capable of beating drug-resistant infections also need to used sparingly – to ensure that they, too, don’t fail prey to AMR. But that means companies that develop the drugs can’t count on revenues from blockbuster sales to pay back years of investment in clinical trials. “AMR innovation is in a broken business model right now, needing incentives.” said Florence Séjourné. She is the CEO of the Aurobac Therapeutics, a joint AMR R&D venture created by two leading European pharma firms as well as the founder of the BEAM Alliance association of AMR-focused biotechs. Products risk death in the pipeline While there are now 20 “highly innovative” antibiotics in the early stages of development globally, the number will have dwindled by 75% within eight years if the business model doesn’t change, warned Dr Kevin Outterson, head of CARB-X. “Within four years, we’ll have less than 10 in clinical development globally. And four more years after that, we’ll have less than five.” The of human capital” he added as large companies shut down programmes, and research is concentrated in underfinanced biotech startups. “There is absolutely no interest in private investors in the antibacterial field, which is complex,” added Séjourné. Of the startups, 60% of the BEAM Alliance members have less than a year of cash to fund their activities; 40% are firms of less than 9 employees. “The world is relying on micro companies, companies with less than 10 employees…That’s a very fragile base,” for developing urgently needed new drugs, Outterson added. On the cusp of a solution? Bacterial culture prepared for testing new antibiotic candidates. But, there are also some glimmers of hope on the horizon. The first was the launch of the United Kingdom’s new “subscription model” in May for antimicrobial drugs that need to be held in ‘reserve’ for drug resistant pathogens. This aims to guarantee innovators a return on new drugs, regardless of the quantities used, that can guarantee a market incentive for new drugs, even if they are carefully rationed. Séjourné praised the UK decision as “something to highlight has a good example for others to follow” – although she warned that until a larger number of countries get on board with such changes, “the broken business model will remain.” More recently, at the 10 October meeting of G7 health and finance ministers in Ancona, Italy’s Minister of Health, Orazio Schillaci announced a series of new “pull incentives” aimed at stimulating R&D and ensuring biotech firms a payback on their investment. Canada is also piloting an incentive programme, while other European Union members, as well as Japan, are considering similar moves. In light of those new developments, CARB-X’s Outterson sounds a note of cautious optimism. “At the G7 meeting, I made the economic case for a small, reasonable investment and push and mostly pull incentives, together, yields an amazing return on investment, both on the health side as well as the economic side,” Outterson said. “It was a rare opportunity to be able to speak not just to the health people, but also the finance people,” he said, noting that the issues raised at the meeting appeared to resonate with both sectors. “And so we have a problem, and we know that it’s desperate, and companies are filled with innovation, but not enough capital to move things forward. But we really are on the cusp of the solution as well.” IFPMA Director David Reddy “The UN meeting finished only a few weeks ago,” said IFPMA director David Reddy. “We’re moving towards the meeting in Saudi Arabia, which is the fourth AMR high level event. “I think one thing that is really important is that we are getting a common understanding of where we need to go, and what the challenges are,” he added. “We do need to make progress on the business model. The UK, Japan have already made good moves towards pull incentives, and a pilot has been put in place by Canada. There are a lot of remaining challenges, but I think the key message coming out of this is there is a real thirst to maintain momentum as we head into the meeting in Saudi Arabia.” But “it’s not just about financing,” he added, “it’s also about people and competencies.” “Access but having a really firm understanding of community needs on the ground is essential, because without that, we won’t make progress in the fight against AMR and in bringing antibiotics to those who need them.” Image Credits: USAID Asia/Flickr, USAID Asia , Health Policy Watch , Van Boeckel, Pires et al, 2019, WHO, The Lancet, 2022, AMR Industry Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. 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Make Clean Air Part of Climate Plans, Experts Say 15/11/2024 Chetan Bhattacharji Smog engulfs Lahore, Pakistan, on Thursday as air pollution levels hit record highs. Some pollutants reached nearly 100 times the World Health Organization’s recommended level, according to IQAir. BAKU, Azerbaijan — Global and Indian experts at COP29 produced new evidence Thursday calling for clean air standards to become part of nations’ climate commitments, as cities across South Asia’s heavily polluted air corridor battled record-breaking smog. In Delhi, authorities closed schools up to grade 5 and halted construction as pollution levels soared to almost twenty times the WHO’s safe daily limit. The crisis came just days after Lahore, Pakistan’s second-largest city just 25 kilometres from the Indian border, saw its highest-ever levels of air pollution. Under the clear skies of Azerbaijan’s capital, experts from the World Bank, WHO, and Indian health ministry were unanimous that air quality improvement should be included in the new Nationally Determined Contributions (NDCs), the self-determined climate targets nations set under the Paris Agreement. “Air quality targets and standards can be a perfect indicator of success if we are successful in targeting the causes of climate change,” Dr Maria Neira, WHO’s health and climate lead, told Health Policy Watch. “If we could select an indicator of how successful we are in achieving negotiations on climate change mitigation, I think we should use the levels of air quality that people around the world are breathing.” Health experts hope their evidence linking air pollution and climate change will strengthen calls for action at COP29. Supporting this call for action is a new report released by the Clean Air Fund that shows how tropospheric ozone – a little-discussed ‘super pollutant’ – is linked to 500,000 premature deaths and an estimated $500 billion in economic costs annually. Air pollution from all sources contributes to more than eight million premature deaths each year, with economic costs exceeding $8 trillion, the report found. The findings aim to support the push for including air quality standards in the third generation of NDCs – binding climate commitments due before COP30 next year under the Paris Agreement. Only a small fraction of countries currently include air pollution safety in their climate plans despite the health threat to millions worldwide. Clean Air Fund’s founder and CEO, Jane Burston, said tackling super pollutants provides “huge opportunities” for improving climate, health, economic development, and equity. “We know that developing countries are some of the few that have included things like black carbon in their nationally determined contributions, and that’s because a lot of these deaths and this exposure is happening in countries least able to afford action on it,” she added. Super-bad for children Protest by ‘Warrior Moms’, a group for clean air, in Delhi outside India’s health ministry, as air pollution turned ‘severe’ on 14th November, which is celebrated as Children’s Day in the country. Tropospheric ozone and its super-pollutant siblings – including methane, black carbon, nitrous oxide and fluorinated gases – are collectively responsible for nearly half of global warming to date. Unlike other pollutants, tropospheric ozone isn’t directly emitted but forms when sunlight interacts with pollutants from aviation, shipping, agriculture and other sectors. Its health impacts can be severe, from reduced lung function to complications in type 2 diabetes and cardiovascular disease. For children, this pollution poses an especially severe threat. “Young children have smaller lungs,” Dr Soumya Swaminathan, an advisor to the Indian health ministry and former chief scientist at the WHO, explained. “They breathe much faster than adults, and they are shorter, so they’re closer to the ground, where there are more pollutants, and get more respiratory infections.” Dr Valerie Hickey, who leads the World Bank’s environment department, also placed children at the centre of her argument. “Your kid got up coughing so bad they couldn’t go to school does not lead on CNN,” she said. “Though if there are huge floods in Valencia, it does. Both are terrible, but [air pollution] is a public health emergency.” Like climate change itself, air pollution’s threat isn’t only visible in extreme events such as Delhi’s current crisis, where PM2.5 levels have reached almost 300 micrograms per cubic metre. “Every unit you go above five, you actually have a health impact,” explained Swaminathan, who co-chairs Our Common Air. “Even at 20, 30, 40 you start getting effects on the heart, respiratory system, and brain. So we need to take action to keep it as low as possible.” “We have to be pragmatic and set interim targets and do a stepwise plan to reduce it,” she added. “That’s what the NDCs are all about.” ‘Smog diplomacy’ Delhi and Lahore, just 400 kilometres apart, face the world’s highest air pollution levels. Half of the ten most polluted places in the world today are in four countries of South Asia – Pakistan, India, Nepal and Bangladesh. Health experts often say that air pollution knows no borders, an adage now forcing cooperation between long-standing rivals in what’s come to be known as “smog diplomacy.” India and Pakistan, nations that have fought multiple wars since independence, are finding themselves pushed toward dialogue over their shared air crisis. This week, as their major cities Delhi and Lahore traded places as the world’s most polluted, officials in Punjab, Pakistan’s most populous province, drafted a letter to India seeking talks on air pollution. “This is an area of the world where there isn’t always great experience with international diplomacy,” Hickey said. “Countries don’t always like each other, but they’re actually seeing that smog diplomacy is something that can bring them to the table.” The outreach comes as hundreds of millions in both countries face severe health risks borne from common problems plaguing both nations: farmers burning agricultural waste, coal-fired power plants, heavy traffic, construction and windless days trapping emissions. The World Bank has launched a “multi-hundred billion dollar” to address this cross-border crisis, targeting the vast northern plains of South Asia, known as the Indo-Gangetic Plains, Hickey told Health Policy Watch. The Bank has already committed to several regional projects in India, including a $350 million clean air management initiative plus $5 million grant for Uttar Pradesh, reportedly approved by the state cabinet and a pending $300 million loan plus $5 million grant for Haryana. Similar programs are planned for Nepal, Pakistan and Bangladesh to address pollution that readily crosses borders due to the region’s geography and wind patterns. “We need climate diplomacy, as a regional and global issue,” Raja Jahangir Anwar, Punjab’s Secretary for Environment and Climate Change, told CNN. “We are suffering in Lahore due to the eastern wind corridor coming from India. We are not blaming anyone, it’s a natural phenomenon.” Image Credits: https://x.com/ThePeerAli/status/1856985454072963085/photo/1. As World’s Health Ministers Meet in Jeddah: Calls for Strong AMR Science Panel With Authority to ‘Challenge’ Sponsors 14/11/2024 Elaine Ruth Fletcher Thail lab technicians train in surveillance of antimicrobial resistance (AMR) in food-producing animals in Southeast Asia – an driver of AMR that was neglected in the recent UN High Level Meeting declaration. With plans underway for a new “Independent Panel” on Antimicrobial Resistance, endorsed at September’s UN High-Level AMR Meeting, the new body must become a strong scientific authority. It should have the power to “challenge” the agencies that create it and address both human and animal health factors driving drug-resistant pathogens. That was a key message from AMR experts in the lead up to the Fourth Ministerial Meeting on Antimicrobial Resistance, which begins Friday in Jeddah, Saudi Arabia. The Independent Panel “needs to be an inclusive process… listening to scientists… civil society, to industry and other actors. But you also need to make sure that that panel, even though hosted by a Quadripartite, can actually challenge the Quadripartite,” declared John Arne Røttingen, CEO of the UK-based Wellcome Trust, of the panel’s central importance to providing evidence on future AMR policies. The ‘Quadripartite’ includes the World Health Organization, as well as the global environment, food and animal health agencies, which are now formally collaborating to confront the AMR threat. John-Arne Røttingen, CEO of Wellcome Trust. Røttingen was among the more than two dozen experts convened for two high-level AMR sessions at Berlin’s World Health Summit in mid-October to discuss next steps for the battle against drug resistant pathogens in the lead-up to the Jeddah meeting. “Declarations are long. It’s hard to identify the real material commitments that have been made,” Røttingen said at a panel discussion on Milestones and Challenges in Tackling AMR, hosted by the German Ministry of Health. “So it’s great that we come to Jeddah for the ministerial meeting,” he said. “That should be a start of both countries’ [and development agencies] coming together as well as the multi stakeholder partnership platform coming together across sectors to make sure that we are keeping our commitments.” On the research front, meanwhile, new “pull incentives” recently developed in the United Kingdom, Italy and Canada to foster a sustainable market for next generation antibiotics are welcome, but they are not enough, industry experts asserted. Many more nations need to adopt supply-side incentives to ensure that badly-needed new drug candidates actually come to market. Jeddah should be the start of making good on the UN’s AMR Declaration FAO, UNEP, WHO and WOAH heads at September’s UN High Level Meeting that approved a set of new commitments for action on drug resistant pathogens. The health ministers’ confab in Saudi Arabia (15-16 November) is supposed to lay out next steps for delivering on promises made in the Declaration on Antimicrobial Resistance approved at the UN High Level Meeting, 26 September in New York City. September’s declaration was a major milestone in the battle to bring a long-ignored AMR epidemic to the forefront of global health policy. AMR is associated, directly or indirectly, a “silent, slow-motion pandemic” that could kill some 39 million people by 2050. The mandate to create an “independent panel for evidence for action against antimicrobial resistance in 2025” is embedded in a 15-page text, with 106 clauses. But it is widely perceived as a key next move to maintain strategic momentum on AMR threats. The science panel should “facilitate the generation and use of multisectoral, scientific evidence to support Member States in efforts to tackle antimicrobial resistance, making use of existing resources and avoiding duplication of on-going efforts, after an open and transparent consultation with all Member States on its composition, mandate, scope, and deliverables,” the AMR declaration stated. Final HLM declaration omitted target for reducing animal antibiotic consumption Asian meat-packing house. The science panel is supposed to be created and administered by the Quadripartite of agencies whose role in managing the AMR crisis was also formalized by the declaration. Along with WHO, the four-member body includes the UN Food and Agriculture Organization (FAO), the UN Environment Programme (UNEP), and the World Animal Health Organization (WOAH), a non-UN member state body. And that makes the panel’s mandate and composition a sensitive point, in light of the political pressures from big food and other interests that want to play down their role in fostering AMR risks, which some researchers say is the leading driver. Identified AMR hotspots often align with high volumes of antibiotics sales and use in livestock. Pressures from agri-businesses and meat producing nations already led to the deletion of a target for reducing animal antibiotic use by 30% by 2030 from the final HLM declaration. Now, the question is whether scientists can come together to articulate the evidence and agree on science-based policy recommendations. “Even though the declaration was positive, it also didn’t achieve agreement on things that I, from my professional background, …would say should have been agreed,” Røttingen observed. “And that speaks to the interests and the trade offs between different sectors… it speaks to agri-food businesses versus human health, and that’s why we believe a science panel is important.” He said, “We have the target of inverting AMR-related mortality [by 10% by 2030], but we need even more targets and more ambitious targets, so we have a lot to do,” he said. “In the climate sector, we have the IPCC (Intergovernmental Panel on Climate Change),” Røttingen continued. “We know how … contested the climate space is, but still, we have a collective international evidence base… We need authoritative evidence with scientists working in the human sector and the animal sector that can come together to actually give us that evidence base and give guidance. “ For animal health, as well, the ultimate aim is to curb abuse not essential use Arshnee Moodley, CGIAR-Kenya Worldwide, the overuse of such antibiotics in livestock production is widely regarded among experts as a leading, if not the leading, driver of pathogen resistance. But ultimately, the aim of new measures should be win-wins that ensure better access to vaccines and other measures to pre-empt antibiotic use and ensure animal health, panelists at the sessions also underlined. “You need to be able to communicate with the people who can change that [AMR trends],” said Dr. Arshnee Moodley, a Kenya-based lead of CGIAR, which works with farmers on animal health. “And for me, it’s the smallholder famer outside of Nairobi. I need to be able to tell him or her why they shouldn’t use antibiotics,” she said. “And that’s really critical because livestock is also part of the solution; it’s vital food for vulnerable groups,” she continued. “I worked every summer in my grandfather’s farm with three milk houses, from the age of 13. So I know about animal health and the need for small farmers, even in high income countries, to keep their herds healthy,” Røttingen countered. “When I’m concerned about the agricultural sector, it’s not really about the misuse of antibiotics among small scale farmers … it is about big food on several continents and making sure that they are … transparent and they are willing to engage in proper animal welfare, because that’s the starting point for ensuring animal health. Too often, measures related to vaccines and hygiene are bypassed, “by using antibiotics to treat herds that aren’t necessarily requisite,” he explained. Worst of all, is the use of antimicrobials or antibiotics “as growth promotion that has nothing to do with animal health. It’s not healthy for those who eat those animals, and it’s not healthy for the animals. “So … animal health is an important part, but I think the hardest question lies with the big food companies.” For human health – more prevention and better regulation are essential too Malawi’s Minister of Health Khumbize Kandodo Chiponda with Tamas Koncz, Pfizer Germany Much as with animals, infection prevention, appropriate access to drugs and better regulation need to be the operative goals for humans as well, panelists at a second high-level session on AMR agreed. That includes clean water, sanitation and hygiene that many communities and health facilities still lack, as well as stronger laboratory networks, and quality control of antimicrobials in settings were fake and substandard formulas often circulate. “Unfortunately for countries like us, we face challenges, because in terms of manufacturing… we have to get them [products] from outside. So in terms of the quality…. you cannot be 100% sure that what you’re getting really is the very, very good quality,” said Khumbize Kandodo Chiponda Minister of Health, Malawi, speaking at the panel hosted by the global non-profit antibiotic accelerator CARB-X and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Changing community behaviours and patterns can be a major lift, in light of the ease with which people can get antibiotics through more informal channels as well as the expense people might face in seeing a healthcare professional – who will in turn face challenges determining if antibiotics are needed or not – without adequate diagnostics equipment. Access to antibiotics is improving – but Africa is also becoming an AMR hotspot Buying antibiotics in India. Prescriptions are required but the rule is not always enforced. “Access to antibiotics [in LMICs] is improving and that is a good thing,” said Tamas Koncz, a vice-president of Pfizer’s operations in Germany. He pointed to data citing a 114% increase in antibiotic use in low- and middle-income countries between 2000-2015. Pfizer’s 2022 Accord for a Healthier World, which committed to providing all of its patented medicines and vaccines to 45 lower-income countries on a not-for-profit basis, has been one enabler of better access to common antimicrobials, he said. At the same time, weak enforcement of prescription drug rules, as well as a lack of health provider knowledge about which drugs to prescribe, are drivers of drug resistance. “If physicians are not using [the drugs] appropriately, then it’s going to lead to problems. So we need to fix the challenge of access. But I think what is even more important is the overall approach.” Africa, where sales of antibiotics by unlicensed vendors is often widespread, is also becoming a major AMR hotspot, he pointed out – highlighting the challenges of balancing access with judicious use. All-age rate of deaths attributable to/associated with antibiotic resistance, 2019. (Lancet, 2022) The landmark 2022 Lancet study that found 1.27 million deaths globally in 2019 were directly attributable to drug-resistant bacterial infections, including 860,000 in Africa. That same year, Africa saw 640,000 deaths from HIV. “We know from the recent communication from the African CDC and others, that it’s becoming probably the one of the biggest, if not the biggest, healthcare burden, superseding now HIV AIDs, maybe even malaria and tuberculosis,” said Koncz. ‘Pull’ incentives Florence Séjourné, Aurobac and Kevin Outterson, CARB-X. On the supply side of the equation, meanwhile, “more pull incentives” that can incentivize pharma developers of newer, pathogen-resistant antibiotics is a long-neglected topic now finally rising to the top of health ministers’ agendas. The challenge lies in the fact that new antibiotics capable of beating drug-resistant infections also need to used sparingly – to ensure that they, too, don’t fail prey to AMR. But that means companies that develop the drugs can’t count on revenues from blockbuster sales to pay back years of investment in clinical trials. “AMR innovation is in a broken business model right now, needing incentives.” said Florence Séjourné. She is the CEO of the Aurobac Therapeutics, a joint AMR R&D venture created by two leading European pharma firms as well as the founder of the BEAM Alliance association of AMR-focused biotechs. Products risk death in the pipeline While there are now 20 “highly innovative” antibiotics in the early stages of development globally, the number will have dwindled by 75% within eight years if the business model doesn’t change, warned Dr Kevin Outterson, head of CARB-X. “Within four years, we’ll have less than 10 in clinical development globally. And four more years after that, we’ll have less than five.” The of human capital” he added as large companies shut down programmes, and research is concentrated in underfinanced biotech startups. “There is absolutely no interest in private investors in the antibacterial field, which is complex,” added Séjourné. Of the startups, 60% of the BEAM Alliance members have less than a year of cash to fund their activities; 40% are firms of less than 9 employees. “The world is relying on micro companies, companies with less than 10 employees…That’s a very fragile base,” for developing urgently needed new drugs, Outterson added. On the cusp of a solution? Bacterial culture prepared for testing new antibiotic candidates. But, there are also some glimmers of hope on the horizon. The first was the launch of the United Kingdom’s new “subscription model” in May for antimicrobial drugs that need to be held in ‘reserve’ for drug resistant pathogens. This aims to guarantee innovators a return on new drugs, regardless of the quantities used, that can guarantee a market incentive for new drugs, even if they are carefully rationed. Séjourné praised the UK decision as “something to highlight has a good example for others to follow” – although she warned that until a larger number of countries get on board with such changes, “the broken business model will remain.” More recently, at the 10 October meeting of G7 health and finance ministers in Ancona, Italy’s Minister of Health, Orazio Schillaci announced a series of new “pull incentives” aimed at stimulating R&D and ensuring biotech firms a payback on their investment. Canada is also piloting an incentive programme, while other European Union members, as well as Japan, are considering similar moves. In light of those new developments, CARB-X’s Outterson sounds a note of cautious optimism. “At the G7 meeting, I made the economic case for a small, reasonable investment and push and mostly pull incentives, together, yields an amazing return on investment, both on the health side as well as the economic side,” Outterson said. “It was a rare opportunity to be able to speak not just to the health people, but also the finance people,” he said, noting that the issues raised at the meeting appeared to resonate with both sectors. “And so we have a problem, and we know that it’s desperate, and companies are filled with innovation, but not enough capital to move things forward. But we really are on the cusp of the solution as well.” IFPMA Director David Reddy “The UN meeting finished only a few weeks ago,” said IFPMA director David Reddy. “We’re moving towards the meeting in Saudi Arabia, which is the fourth AMR high level event. “I think one thing that is really important is that we are getting a common understanding of where we need to go, and what the challenges are,” he added. “We do need to make progress on the business model. The UK, Japan have already made good moves towards pull incentives, and a pilot has been put in place by Canada. There are a lot of remaining challenges, but I think the key message coming out of this is there is a real thirst to maintain momentum as we head into the meeting in Saudi Arabia.” But “it’s not just about financing,” he added, “it’s also about people and competencies.” “Access but having a really firm understanding of community needs on the ground is essential, because without that, we won’t make progress in the fight against AMR and in bringing antibiotics to those who need them.” Image Credits: USAID Asia/Flickr, USAID Asia , Health Policy Watch , Van Boeckel, Pires et al, 2019, WHO, The Lancet, 2022, AMR Industry Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. 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As World’s Health Ministers Meet in Jeddah: Calls for Strong AMR Science Panel With Authority to ‘Challenge’ Sponsors 14/11/2024 Elaine Ruth Fletcher Thail lab technicians train in surveillance of antimicrobial resistance (AMR) in food-producing animals in Southeast Asia – an driver of AMR that was neglected in the recent UN High Level Meeting declaration. With plans underway for a new “Independent Panel” on Antimicrobial Resistance, endorsed at September’s UN High-Level AMR Meeting, the new body must become a strong scientific authority. It should have the power to “challenge” the agencies that create it and address both human and animal health factors driving drug-resistant pathogens. That was a key message from AMR experts in the lead up to the Fourth Ministerial Meeting on Antimicrobial Resistance, which begins Friday in Jeddah, Saudi Arabia. The Independent Panel “needs to be an inclusive process… listening to scientists… civil society, to industry and other actors. But you also need to make sure that that panel, even though hosted by a Quadripartite, can actually challenge the Quadripartite,” declared John Arne Røttingen, CEO of the UK-based Wellcome Trust, of the panel’s central importance to providing evidence on future AMR policies. The ‘Quadripartite’ includes the World Health Organization, as well as the global environment, food and animal health agencies, which are now formally collaborating to confront the AMR threat. John-Arne Røttingen, CEO of Wellcome Trust. Røttingen was among the more than two dozen experts convened for two high-level AMR sessions at Berlin’s World Health Summit in mid-October to discuss next steps for the battle against drug resistant pathogens in the lead-up to the Jeddah meeting. “Declarations are long. It’s hard to identify the real material commitments that have been made,” Røttingen said at a panel discussion on Milestones and Challenges in Tackling AMR, hosted by the German Ministry of Health. “So it’s great that we come to Jeddah for the ministerial meeting,” he said. “That should be a start of both countries’ [and development agencies] coming together as well as the multi stakeholder partnership platform coming together across sectors to make sure that we are keeping our commitments.” On the research front, meanwhile, new “pull incentives” recently developed in the United Kingdom, Italy and Canada to foster a sustainable market for next generation antibiotics are welcome, but they are not enough, industry experts asserted. Many more nations need to adopt supply-side incentives to ensure that badly-needed new drug candidates actually come to market. Jeddah should be the start of making good on the UN’s AMR Declaration FAO, UNEP, WHO and WOAH heads at September’s UN High Level Meeting that approved a set of new commitments for action on drug resistant pathogens. The health ministers’ confab in Saudi Arabia (15-16 November) is supposed to lay out next steps for delivering on promises made in the Declaration on Antimicrobial Resistance approved at the UN High Level Meeting, 26 September in New York City. September’s declaration was a major milestone in the battle to bring a long-ignored AMR epidemic to the forefront of global health policy. AMR is associated, directly or indirectly, a “silent, slow-motion pandemic” that could kill some 39 million people by 2050. The mandate to create an “independent panel for evidence for action against antimicrobial resistance in 2025” is embedded in a 15-page text, with 106 clauses. But it is widely perceived as a key next move to maintain strategic momentum on AMR threats. The science panel should “facilitate the generation and use of multisectoral, scientific evidence to support Member States in efforts to tackle antimicrobial resistance, making use of existing resources and avoiding duplication of on-going efforts, after an open and transparent consultation with all Member States on its composition, mandate, scope, and deliverables,” the AMR declaration stated. Final HLM declaration omitted target for reducing animal antibiotic consumption Asian meat-packing house. The science panel is supposed to be created and administered by the Quadripartite of agencies whose role in managing the AMR crisis was also formalized by the declaration. Along with WHO, the four-member body includes the UN Food and Agriculture Organization (FAO), the UN Environment Programme (UNEP), and the World Animal Health Organization (WOAH), a non-UN member state body. And that makes the panel’s mandate and composition a sensitive point, in light of the political pressures from big food and other interests that want to play down their role in fostering AMR risks, which some researchers say is the leading driver. Identified AMR hotspots often align with high volumes of antibiotics sales and use in livestock. Pressures from agri-businesses and meat producing nations already led to the deletion of a target for reducing animal antibiotic use by 30% by 2030 from the final HLM declaration. Now, the question is whether scientists can come together to articulate the evidence and agree on science-based policy recommendations. “Even though the declaration was positive, it also didn’t achieve agreement on things that I, from my professional background, …would say should have been agreed,” Røttingen observed. “And that speaks to the interests and the trade offs between different sectors… it speaks to agri-food businesses versus human health, and that’s why we believe a science panel is important.” He said, “We have the target of inverting AMR-related mortality [by 10% by 2030], but we need even more targets and more ambitious targets, so we have a lot to do,” he said. “In the climate sector, we have the IPCC (Intergovernmental Panel on Climate Change),” Røttingen continued. “We know how … contested the climate space is, but still, we have a collective international evidence base… We need authoritative evidence with scientists working in the human sector and the animal sector that can come together to actually give us that evidence base and give guidance. “ For animal health, as well, the ultimate aim is to curb abuse not essential use Arshnee Moodley, CGIAR-Kenya Worldwide, the overuse of such antibiotics in livestock production is widely regarded among experts as a leading, if not the leading, driver of pathogen resistance. But ultimately, the aim of new measures should be win-wins that ensure better access to vaccines and other measures to pre-empt antibiotic use and ensure animal health, panelists at the sessions also underlined. “You need to be able to communicate with the people who can change that [AMR trends],” said Dr. Arshnee Moodley, a Kenya-based lead of CGIAR, which works with farmers on animal health. “And for me, it’s the smallholder famer outside of Nairobi. I need to be able to tell him or her why they shouldn’t use antibiotics,” she said. “And that’s really critical because livestock is also part of the solution; it’s vital food for vulnerable groups,” she continued. “I worked every summer in my grandfather’s farm with three milk houses, from the age of 13. So I know about animal health and the need for small farmers, even in high income countries, to keep their herds healthy,” Røttingen countered. “When I’m concerned about the agricultural sector, it’s not really about the misuse of antibiotics among small scale farmers … it is about big food on several continents and making sure that they are … transparent and they are willing to engage in proper animal welfare, because that’s the starting point for ensuring animal health. Too often, measures related to vaccines and hygiene are bypassed, “by using antibiotics to treat herds that aren’t necessarily requisite,” he explained. Worst of all, is the use of antimicrobials or antibiotics “as growth promotion that has nothing to do with animal health. It’s not healthy for those who eat those animals, and it’s not healthy for the animals. “So … animal health is an important part, but I think the hardest question lies with the big food companies.” For human health – more prevention and better regulation are essential too Malawi’s Minister of Health Khumbize Kandodo Chiponda with Tamas Koncz, Pfizer Germany Much as with animals, infection prevention, appropriate access to drugs and better regulation need to be the operative goals for humans as well, panelists at a second high-level session on AMR agreed. That includes clean water, sanitation and hygiene that many communities and health facilities still lack, as well as stronger laboratory networks, and quality control of antimicrobials in settings were fake and substandard formulas often circulate. “Unfortunately for countries like us, we face challenges, because in terms of manufacturing… we have to get them [products] from outside. So in terms of the quality…. you cannot be 100% sure that what you’re getting really is the very, very good quality,” said Khumbize Kandodo Chiponda Minister of Health, Malawi, speaking at the panel hosted by the global non-profit antibiotic accelerator CARB-X and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Changing community behaviours and patterns can be a major lift, in light of the ease with which people can get antibiotics through more informal channels as well as the expense people might face in seeing a healthcare professional – who will in turn face challenges determining if antibiotics are needed or not – without adequate diagnostics equipment. Access to antibiotics is improving – but Africa is also becoming an AMR hotspot Buying antibiotics in India. Prescriptions are required but the rule is not always enforced. “Access to antibiotics [in LMICs] is improving and that is a good thing,” said Tamas Koncz, a vice-president of Pfizer’s operations in Germany. He pointed to data citing a 114% increase in antibiotic use in low- and middle-income countries between 2000-2015. Pfizer’s 2022 Accord for a Healthier World, which committed to providing all of its patented medicines and vaccines to 45 lower-income countries on a not-for-profit basis, has been one enabler of better access to common antimicrobials, he said. At the same time, weak enforcement of prescription drug rules, as well as a lack of health provider knowledge about which drugs to prescribe, are drivers of drug resistance. “If physicians are not using [the drugs] appropriately, then it’s going to lead to problems. So we need to fix the challenge of access. But I think what is even more important is the overall approach.” Africa, where sales of antibiotics by unlicensed vendors is often widespread, is also becoming a major AMR hotspot, he pointed out – highlighting the challenges of balancing access with judicious use. All-age rate of deaths attributable to/associated with antibiotic resistance, 2019. (Lancet, 2022) The landmark 2022 Lancet study that found 1.27 million deaths globally in 2019 were directly attributable to drug-resistant bacterial infections, including 860,000 in Africa. That same year, Africa saw 640,000 deaths from HIV. “We know from the recent communication from the African CDC and others, that it’s becoming probably the one of the biggest, if not the biggest, healthcare burden, superseding now HIV AIDs, maybe even malaria and tuberculosis,” said Koncz. ‘Pull’ incentives Florence Séjourné, Aurobac and Kevin Outterson, CARB-X. On the supply side of the equation, meanwhile, “more pull incentives” that can incentivize pharma developers of newer, pathogen-resistant antibiotics is a long-neglected topic now finally rising to the top of health ministers’ agendas. The challenge lies in the fact that new antibiotics capable of beating drug-resistant infections also need to used sparingly – to ensure that they, too, don’t fail prey to AMR. But that means companies that develop the drugs can’t count on revenues from blockbuster sales to pay back years of investment in clinical trials. “AMR innovation is in a broken business model right now, needing incentives.” said Florence Séjourné. She is the CEO of the Aurobac Therapeutics, a joint AMR R&D venture created by two leading European pharma firms as well as the founder of the BEAM Alliance association of AMR-focused biotechs. Products risk death in the pipeline While there are now 20 “highly innovative” antibiotics in the early stages of development globally, the number will have dwindled by 75% within eight years if the business model doesn’t change, warned Dr Kevin Outterson, head of CARB-X. “Within four years, we’ll have less than 10 in clinical development globally. And four more years after that, we’ll have less than five.” The of human capital” he added as large companies shut down programmes, and research is concentrated in underfinanced biotech startups. “There is absolutely no interest in private investors in the antibacterial field, which is complex,” added Séjourné. Of the startups, 60% of the BEAM Alliance members have less than a year of cash to fund their activities; 40% are firms of less than 9 employees. “The world is relying on micro companies, companies with less than 10 employees…That’s a very fragile base,” for developing urgently needed new drugs, Outterson added. On the cusp of a solution? Bacterial culture prepared for testing new antibiotic candidates. But, there are also some glimmers of hope on the horizon. The first was the launch of the United Kingdom’s new “subscription model” in May for antimicrobial drugs that need to be held in ‘reserve’ for drug resistant pathogens. This aims to guarantee innovators a return on new drugs, regardless of the quantities used, that can guarantee a market incentive for new drugs, even if they are carefully rationed. Séjourné praised the UK decision as “something to highlight has a good example for others to follow” – although she warned that until a larger number of countries get on board with such changes, “the broken business model will remain.” More recently, at the 10 October meeting of G7 health and finance ministers in Ancona, Italy’s Minister of Health, Orazio Schillaci announced a series of new “pull incentives” aimed at stimulating R&D and ensuring biotech firms a payback on their investment. Canada is also piloting an incentive programme, while other European Union members, as well as Japan, are considering similar moves. In light of those new developments, CARB-X’s Outterson sounds a note of cautious optimism. “At the G7 meeting, I made the economic case for a small, reasonable investment and push and mostly pull incentives, together, yields an amazing return on investment, both on the health side as well as the economic side,” Outterson said. “It was a rare opportunity to be able to speak not just to the health people, but also the finance people,” he said, noting that the issues raised at the meeting appeared to resonate with both sectors. “And so we have a problem, and we know that it’s desperate, and companies are filled with innovation, but not enough capital to move things forward. But we really are on the cusp of the solution as well.” IFPMA Director David Reddy “The UN meeting finished only a few weeks ago,” said IFPMA director David Reddy. “We’re moving towards the meeting in Saudi Arabia, which is the fourth AMR high level event. “I think one thing that is really important is that we are getting a common understanding of where we need to go, and what the challenges are,” he added. “We do need to make progress on the business model. The UK, Japan have already made good moves towards pull incentives, and a pilot has been put in place by Canada. There are a lot of remaining challenges, but I think the key message coming out of this is there is a real thirst to maintain momentum as we head into the meeting in Saudi Arabia.” But “it’s not just about financing,” he added, “it’s also about people and competencies.” “Access but having a really firm understanding of community needs on the ground is essential, because without that, we won’t make progress in the fight against AMR and in bringing antibiotics to those who need them.” Image Credits: USAID Asia/Flickr, USAID Asia , Health Policy Watch , Van Boeckel, Pires et al, 2019, WHO, The Lancet, 2022, AMR Industry Alliance. Posts navigation Older postsNewer posts