Some 822 million people worldwide suffer from hunger, and climate change is driving rising food insecurity in countries struck by worsening patterns of drought, flooding and other extreme weather that reduces  crop yields and livestock production among for the rural poor, as well as causing food price spikes for urban populations, according to the 2018 Global Hunger Index (GHI), released on Tuesday.

According to the report, there were some 37 million more hungry people in the world in 2018 as compared to 2015, when the number of those going hungry was 785 million. Some 43 out of 117 countries have serious levels of hunger, and 4 countries (Chad, Madagascar, Yemen, and Zambia) suffer from alarming hunger levels. And the Central African Republic has patterns of extremely alarming hunger, according to the report, produced annually by the NGO, Concern Worldwide, along with Welthungerhilfe, a German aid organization.

Hunger is increasingly linked to climate-induced changes in patterns of rainfall in regions a dispersed as Honduras and Africa’s Sahel and Lake Chad Basin, where the livelihoods of herdsmen and herdswomen “are evaporating with the lake itself,” said Mary Robinson, former UN High Commissioner for Human Rights and also former president of Ireland, in a preface to this year’s report, which focuses on the climate theme.

“That is the greatest injustice of climate change—that those who bear the least responsibility for climate change are the ones who will suffer the most,” she said, “We can no longer afford to regard the 2030 [Sustainable Development] Agenda and the Paris Climate Agreement as voluntary and a matter for each member state to decide on its own. Instead, the full implementation of both has become imperative in order to secure a livable world for our children and grandchildren. This requires a change of mind-set at the global political level.”

High-income countries are not included in the GHI but other indicators reflect food insecurity experienced by the poor in rich countries. The Food Insecurity Experience Scale—a measure of hunger used in developed countries although not directly comparable to the GHI—shows that in the European Union, 18 percent of households with children under age 15 experience moderate or severe food insecurity.  This year’s GHI report also notes that:

Composition of the Global Hunger Index: Source: Wiesmann et al. (2015). Note: The values of each of the four component indicators are standardized. See Appendix A for the complete GHI formula and Appendix B for the sources of data.
  • Climate change, driven by an average global temperature rise that is already at 1°C above pre-industrial levels, is threatening the ability of food systems to sustainably feed the world’s population.
  • Climate change is increasing the threats to those who currently already suffer from hunger and undernutrition.
  • There is a strong correlation between GHI scores and levels of vulnerability/readiness to climate change. Countries with high GHI scores are often also highly vulnerable to climate change but have the least capacity to adapt; several countries with low GHI scores are the least vulnerable and most ready.
  • Climate change also affects the quality and safety of food. It can lead to production of toxins on crops and worsen the nutritional value of cultivated food.  For example, it can reduce the concentrations of protein, zinc, and iron in crops.  As a result, an estimated additional additional 122 million people could experience protein deficiencies and another 175 million more people could be deficient in zinc and by 2050.

The Global Hunger Index (GHI) is a peer-reviewed tool designed to comprehensively measure and track hunger at global, regional, and national levels. GHI scores are calculated each year to assess progress and setbacks in combating hunger. See this link for more details about assessment tools used.

Image Credits: Global Hunger Index , Global Hunger Index.

The World Health Organization aims to expand mental health coverage to 100 million more people in 12 priority countries by 2023 as part of a new Special Initiative for Mental Health launched Monday at start of the 11th World Mental Health Forum.

Over 20 health ministers from around the world gathered in Geneva along with NGO representatives and WHO officials for the two-day forum, whose theme this year is “Enhancing Country Action on Mental Health.” The Special Initiative is just the latest global action WHO has taken to integrate mental health into its non-communicable disease platform. Just last year, the WHO Director-General called for the agency to accelerate implementation of mental health initiatives in its work.

Since then, the “political interest” in mental health has been “converted” into “large-scale political action,” noted Ren Minghui, assistant deputy-general of Universal Health Coverage, Communicable Disease, and Non-Communicable Disease at the World Health Organization. He citing the first ever technical briefing on mental health at the World Health Assembly in May, new advocacy campaigns around suicide prevention such as the #SpeakYourMind campaign, and recent international conferences to discuss mental health in crisis situations as examples of global efforts in mental health.

“I strongly believe the World Health Organization’s Special Initiative on Mental Health will serve as a further catalyst to the development of this important era for public health,” said Ren.

The goal is to ensure “quality and affordable mental health care,” said Devora Kestel, director of the WHO Department of Mental Health and Substance Abuse.

Two key strategic aims will guide the Special Initiative. They include:

  1. Advancing mental health policies, advocacy, and human rights:
    • Globally, position mental health high on the development and humanitarian agendas;
    • Engage local champions, people who use mental health services, and their organizations and empower them to participate in the development and implementation of mental health policies, strategies, laws and services;
    • Ensure mental health policies, strategies and laws are developed and operationalized based on international human rights standards;
    • Raise Media and community awareness about the importance of mental health across the life course;
    • Align human and financial resources for mental health with the needs.
  2. Scaling up interventions and services across community-based, general health and specialist settings:
    • Scale up quality, affordable mental health care across health and social services;
    • Integrate quality, affordable mental health care into relevant programmes (e.g. for HIV, gender-based violence, disabilities);
    • Include mental health and psychosocial support in preparedness, response and recovery in emergencies;
    • Develop and implement priority interventions for groups in positions of vulnerability (e.g. women, children, youth, older people, staff);
    • Document, monitor and evaluate implementation to improve services;

The 12 countries chosen to pilot the initiative will be finalized during the forum, with preference to countries that have made mental health a priority in their national agendas, the WHO officials said.

US$ 60 million of “catalytic funding” will be needed in kick start the plan, but as the programmes would be embedded in existing health systems only US $1 million per country per year would then be needed to sustain programming in the 4 years afterwards. WHO is still fundraising for the plan.

The WHO is making sustainability of the initiative a priority, Kestel said. This is in contrast to implementing well-designed “single interventions” that are very successful in the short term, but then risk cancellation when special funding runs out because there is “no system designed around them.”

According to WHO, mental health disorders account for 1 out of every 5 years lived with disability globally and cause over US$ 1 trillion per year in economic losses. Someone dies by suicide every 40 seconds, and suicide mortality disproportionately affects young people and elderly women in low- and middle-income countries. People with mental health conditions are also more likely to face other physical health problems (e.g. HIV, TB, and noncommunicable diseases), reducing their life expectancy by as much as 10-20 years.

Taking a human rights perspective, Kestel pointed to the political declaration on Universal Health Coverage issued last month in New York City at a High Level Meeting of the United Nations General Assembly, and quoted the declaration’s reaffirmation of “the right for every human being, without distinction of any kind, to the enjoyment of the highest attainable standard of physical and mental health.”

“We intend to contribute [to realizing the right to health] through our Special Initiative,” said Kestel.

 

Image Credits: WHO/S. Volkov, WHO.

Measles is undergoing a worrisome worldwide resurgence, and it has killed more people in the Democratic Republic of Congo than the current Ebola outbreak – which is finally showing signs of decline, said a panel of vaccine experts in a WHO press briefing on Thursday.

A child gets vaccinated against measles during the outbreak in the DRC.

Meanwhile, a worldwide shortage of human papillomavirus (HPV) vaccine, which protects girls and women from cervical cancer, is confounding efforts to expand coverage, warranting a temporary change in vaccine strategy to focus more exclusively on pre-adolescent girls, said the experts who spoke just after the close of a biannual meeting of the Strategic Advisory Group of Experts on Immunization (SAGE), the principal expert advisory group to WHO for vaccines and immunization.

And Pakistan and Afghanistan are seeing a worrisome resurgence of the wild polio virus, serotype 1. Vaccine-derived polio cases seen in some countries also continue to thwart global eradication efforts – although experts are hopeful that a novel oral polio vaccine (nOPV2) under expedited development and production will demonstrate far greater efficacy in preventing vaccine-derived cases. The new polio vaccine could be ready for deployment as early as June 2020.

Coming the day after donors finalized commitments of US$ 14 billion to the Global Fund to Fight AIDS, Tuberculosis and Malaria, the SAGE briefing was a sober reminder that vaccine-preventable diseases including measles/rubella, polio and HPV remain major challenges for health systems in both affluent countries as well as some of the most underserved regions of the world.

On a more positive note, the Commission of the Global Polio Eradication Initiative will meet next week in Geneva to determine if the world can be certified as free of the wild polio virus serotype 3 – which has not been detected anywhere in the world since 2012.  Africa might be eligible for certification as free of all wild polio viruses by 2020, the group said.

“There is bad and good news on polio,” declared Michel Zaffran, director of WHO’s Polio Eradication Initiative. “The good news is that Serotype 3 of wild polio virus, has not been detected anywhere in the world since 2012. The Global Certification Commission will be reviewing the data  next week, and might be in a position to certify that Serotype 3 of the wild polio virus has been eradicated from the world.

“The [other] good news is that the wild polio virus has not been detected on the African continent for over 3 three years, that is why the region of Africa might be eligible for certification next year,” Zaffran added, noting that Serotype 2 of the wild virus was already eradicated some years ago.

A girl receives an oral polio vaccine in India.

On the downside, serotype 1 of the wild polio virus remains a challenge in Afghanistan and Pakistan, where vaccine coverage is spotty in some regions, and Pakistan has seen a significant upsurge this year with over 70 cases.

In terms of tackling persistent cases of vaccine-derived polio, Zaffran said that the Initiative is working with an Indonesian manufacturer to produce over 100 million doses of the new oral formulation (nOPV2) even while clinical trials are ongoing in parallel.

He said that if the clinical trial results, due to be released in February, show it to be efficacious, “at best case scenario we will have over 100 million doses available for use in June of next year”.

Below is a wrap-up of details on other vaccine issues covered at the SAGE meeting. A new draft global immunization strategy for the coming decade is also currently being finalized and should be released soon for review followed by final approval at the May 2020 World Health Assembly, the experts said.

“Strategy 2020 aims to address the challenges of reaching everyone, with a focus on those who remain left out. It is a people, country and data-focused strategy, with an emphasis on strengthening primary health care,” said Kate O’Brien, WHO Director, Department of Immunization, Vaccines and Biologicals, of the new ten-year strategic plan.

HPV Supply Shortage Warrants Change in Vaccine Strategy  

To address the HPV vaccine shortage, Alejandro Cravioto, SAGE Chairman, said that the expert group would recommend that immunization of teenage boys be temporarily suspended in order to redirect available supplies and efforts on girls, who are directly vulnerable to cervical cancer.

A young girl gets vaccinated against HPV in Sao Paulo, Brazil.

He said that the strategic change would allow countries to “focus use of the vaccine on the groups that would profit more from the vaccination,” adding that current evidence shows that “postponing vaccination of boys is not a public health problem” although the evidence supports vaccinating boys at a later stage, when there is more vaccine available – insofar as boys/men can also transmit the virus to unvaccinated girls/women through sexual contact.

He also noted that many countries with a high level of cervical cancer are not getting the vaccine at all.

“Constraints in the supply of the vaccine have made us think about how can we improve the access to this vaccine, start protecting women in countries that have a high level of cervical cancer,” he said. “We need to use the vaccine that is available in the most efficient way, and to start vaccinating as many girls as possible, whether by age 9 or 11, we need to immunize them before the age of 14, which is before the age of sexual activity.”

But he also stressed that the SAGE recommendations are made to the WHO Director General, “and it is up to the countries to decide if they take on the recommendations made.”

He said that the SAGE panel was also recommending that WHO support the creation of a Global Access Forum specifically for vaccines, where global health officials could interact with the producers, and with other stakeholders on improving access to vaccines whose availability is constrained. “How do we provide a system of access that protects everyone in need and allows us to use vaccines in a more effective way? This Forum is something to be created that would allow us to move not only in the HPV field, but other vaccines.”

Measles, a Worldwide Epidemic

“The world is facing an alarming upsurge in measles cases and deaths in all regions,” said O’Brien. She noted that the epidemic is driven by incomplete coverage of children with the two-dose vaccine, particularly in areas where healthy systems are weak and in conflict zones. But in affluent countries there are pockets of vaccine resistance where fears about vaccine safety or religious beliefs are driving epidemics.

A young girl receives a measles vaccination in Ukraine, which has consistently suffered from vaccine shortages.

“Some 80 countries have achieved and are maintaining the elimination, it is technically feasible to do, with the tools we have, but it requires day and day out vigilance so that coverage remains high,” she emphasized.  “If you don’t keep your eye on the ball, it can slip back.

So far only one WHO region, the Americas, had achieved measles elimination, meaning that there is no transmission and circulation of the virus within or between countries.

“Unfortunately the Americas region lost its elimination status as a result of the ongoing transmission in Brazil and Venezuela,” she noted. In Europe, the UK and the Czech Republic have also lost elimination status.

“The reasons vary from country to country and situation to situation, but the the majority reason is lack of access to the vaccine; the vaccine not available, services insufficient. In high income countries there are sub pockets of the population where immunization is very low. In the US, where coverage is extremely high, there are communities that have very low coverage, and when the virus is introduced in the community, that virus is going to move from child to child.”

A large measles outbreak in the DRC has already “claimed more lives than Ebola, disrupting families, livelihoods and economies,” she added. Along with the deployment of Ebola vaccines, however, campaigns to vaccinate measles have been accelerated “children and adults been vaccinated evermore against a range of diseases.”

Joachim Hombach, SAGE executive secretary, stressed that given the current resurgence of measles, the final “eradication” of the disease remains a distant goal, and countries should focus on ramping up efforts to “eliminate” transmission within and across their borders.

“To have a defined goal for eradication in the measles situation is really not obtainable but what we are proposing is that everyone should go back to the elimination goals and look at the prospect of how we can ramp up the elimination and control of the outbreak and then decide in the long run of how we are going to tackle other [eradication],” he said.

Second Ebola Vaccine is Valuable Tool in Arsenal Even as Outbreak Finally Declines

O’Brien also said that a much-discussed second Ebola vaccine, a two-stage vaccine produced by Johnson & Johnson is soon to be deployed in areas of DRC where there is no direct Ebola transmission.  This decision was taken insofar as the first Ebola vaccine to be deployed, produced by Merck, offers more immediate coverage and has already demonstrated high efficacy in the active transmission zones where some 230,000 people have been immunized.

Response worker prepares an Ebola vaccine in the DRC.

However, even as the current DRC Ebola outbreak seems to be finally in a pattern of decline – with just 14 cases reported in the past week, the Johnson & Johnson vaccine could be useful in offering additional protection to recipients against  future Ebola outbreak risks.

Notably, the Johnson & Johnson formula is intended to offer protection against different Ebola strains that commonly circulate in the region, while the Merck vaccine only offers protection against the  strain of the virus that prompted the current outbreak, ongoing since August 2018.

“Is it worth continuing with this investigating product? The answer is absolutely yes,” said Hombach, ”because we cannot assure at some point that there will not be a surge, as you know this product has different characteristics, there might be value for this type of product, and it is important to have choice of product available as well as a broader supply base.

“We need to look forward to preventive vaccination approaches in the future, this is something where we think this vaccine could play a significant role.

“It [Johnson&Johnson vaccine] is also a vaccine that is composed of non-replicating viruses, in contrast to the Merck vaccines, so may come with less concerns for contraindications. This would need to be evaluated over time, whether the vaccine is effective against the different strains, but if so, it could provide significant additional interest in this product.”

Image Credits: WHO DRC Office Twitter, CDC Global, WHO PAHO, UN Ukraine, WHO Twitter.

The tobacco industry strongly influences policy-making in Japan, Jordan, Egypt and Bangladesh. Conversely, the United Kingdom, Uganda, and Iran emerge as countries with the least industry meddling, according to a first-ever report to systematically assess levels of industry influence in countries, by the watchdog group STOP (Stopping Tobacco Organizations and Products).

A man takes a smoke break in Tokyo, Japan. Japan was ranked as having the highest tobacco industry influence by STOP.

“This report shows that the tobacco industry is as underhanded as ever. It may claim that it is changing in public, but behind the scenes it is fighting tooth and nail to sabotage effective regulation. Governments must stand firm and fulfill their mandate to protect public health,” said Mary Assunta, lead author of the report, head of Global Research and Advocacy at GGTC and a partner in STOP, which is funded by Bloomberg Philanthropies.

Over 8 million deaths annually are caused by tobacco use, including direct and second-hand smoke exposure. About 80% of world’s 1.1 billion smokers live in low and middle-income countries, where the burden of tobacco-related illness and death is heaviest, according to the World Health Organization. Tobacco industry influence has been cited by governments as a major barrier to passing strong tobacco control measures.

The Global Tobacco Industry Interference Index, the first-ever such report, attempts to quantify the level of tobacco-industry interference in the policy-making process. It ranks countries on a scale of 0 to 100, with higher scores showing more industry meddling. Surprisingly, middle income countries such as Uganda, Iran, Kenya, Brazil, and Uruguay emerged as countries with less tobacco industry interference compared to high-income countries such as South Korea, the USA, and Japan. Overall, the UK was found to have the most robust protections against tobacco industry influence, and Japan was found to have the highest industry interference.

The report highlighted a number of alarming trends in overall interference and interference in policy-making. Key findings include:

  • Tobacco companies aggressively targeted departments of Finance, Commerce and Trade, wooing senior officials to achieve policy influence. They used donations and awards to obtain endorsement from senior officials.
  • There is growing evidence of the industry using harm reduction claims about e-cigarettes to justify interactions with government officials and open the door to new products. In 2018, tobacco companies lobbied to make it easier for them to sell or promote e-cigarettes in the United States, Philippines, Mexico, Lebanon and Turkey.
  • Tax breaks benefitted industry in many countries. Incentives, exemptions and duty-free tobacco boost production and sales in markets that may have other regulations in place. Only Sri Lanka bans duty-free sales of cigarettes.

On an optimistic note, the report finds that any country can independently shape tobacco policies if sufficient political will exists. The top three countries that have been the most successful in resisting industry influence – the UK, Uganda, and Iran – are economically, politically and culturally diverse.

In terms of other lessons learned, the report finds that countries fared significantly better when politicians and policymakers were more open about government  dealings with the industry, including recorded interactions and political donations. Political contributions and gifts from the tobacco industry are banned in Brazil, Canada, France, Iran, Myanmar, Turkey, U.K., Uganda and Uruguay. Among the countries surveyed, transparency on political contributions from the tobacco industry is required only in Kenya and the U.S.

The Report provides eight key recommendations to short-circuit industry interference in tobacco-control policies:

  1. Create awareness on tobacco industry interference across all government departments
  2. Limit interaction with the industry to only when strictly necessary
  3. Adopt a code of conduct to firewall government officials, making sure public health policy is developed free of interference
  4. Ensure greater transparency concerning meetings with the tobacco industry
  5. De-normalize so called “socially responsible” activities by the tobacco industry
  6. Remove incentives to the tobacco industry
  7. Require information on production, marketing, and revenue from the tobacco industry
  8. Require disclosure of tobacco industry lobbyists and lobbying expenditures.

Still, even the countries that have implemented measures to exclude the tobacco industry from policy-making processes must remain watchful, especially as the industry shifts it’s focus from health to non-health departments of government, such as development, agriculture or finance.

Sandra Mullin, senior vice president at Vital Strategies and board member of STOP, says, “Our report suggests that even these countries need to be vigilant against new industry tactics.

“You simply cannot create healthier, smoke-free environments with tobacco companies involved in the policy process.”

 

Image Credits: Benicio Murray/Flickr, STOP.

Lyon, France – The global health community needs to scale-up collaborations with product development partnerships (PDPs) that could bring life-saving innovations for prevention, diagnosis, and treatment of HIV/AIDS, Malaria and Tuberculosis to market faster, said health experts at a side event ahead of the Global Fund’s Sixth Replenishment Conference.

A local healthcare worker tests a young girl for malaria in Cambodia.

There are some 55 “potentially transformative” products for HIV/AIDs, tuberculosis and malaria in the drug development pipeline, but the challenge is “how do we take them to the next level” so that they actually reach patients as soon as possible, said David Reddy, chief executive officer of Medicines for Malaria Venture (MMV).

“Products don’t become prevention tools or medicines until they reach the patients that need them, so we need to think end- to-end; we also need the Global Fund. Ending the three diseases won’t be possible without a fully funded Global Fund, and domestic funding and commitment.”

“This is about innovation with urgency, so let’s do it,” he said, noting that planning, better coordination, demand forecasting and demand creation, and innovation in delivery are all necessary to bring promising innovations to market faster, and then ensure that they reach patients.

Reddy spoke at the side event co-sponsored by MMV and six other PDPs, to explore how their unique public-private structure and innovation expertise could be harnessed more effectively for improving public health outcomes for vulnerable groups and Global Fund’s impact. Other co-sponsors included Drugs for Neglected Diseases Initiative (DNDi), Foundation for Innovative New Diagnostics (FIND), Innovative Vector Control Consortium (IVCC), International Partnership for Microbicides (IPM), PATH, TB Alliance.

Michèle Boccoz

The World Health Organization’s top official for health diplomacy, Michèle Boccoz, said that innovation could also help reduce the medicines costs, increasing access.

“The cost of medicines and treatment is too high, innovation, I’m sure, will bring more solutions,” said Michèle Boccoz, director-general envoy for multilateral affairs at the WHO. “We need to ensure we are everywhere,” she said, adding that WHO will support efforts to overcome bottlenecks in bringing new health innovations to those who need them the most.

Marijke Wijnroks, chief of staff at the Global Fund, lauded the large number of innovative new diagnostics and drugs in development. However, she said that prioritizing the most promising tools in the pipeline is a difficult exercise.

Marijke Wijnroks

“Collectively we can do better to leverage all of the great things that are happening in these organizations,” Wijnroks said, referring to a July meeting hosted by WHO, that looked at ways to improve collaboration between the Global Fund and product developers on ways to speed up drug innovation and remove access barriers.

In that vein, panelists at the event highlighted the importance of strong market incentives and collaboration with countries in stimulating innovation and bringing the most essential new products to the populations that need them.

Opportunities for more impact is “not only upstream” with the product developers, but also “downstream” in bringing innovations to the countries and communities that need them, said Renuka Gadde, Vice President for global health with BD, a global diagnostics company.

“Companies care, and we are all in this together. We want to play our part in solving complex global health problems,” she stressed.

Market Incentives for Innovation

Health product innovation can be especially difficult to stimulate in “broken markets,” said Sanne Fournier-Wendes, chief of staff at UNITAID.

Sanne Fournier-Wendes

She noted that in these markets, demand is so dispersed across countries that manufacturers find it overwhelming to develop products. Poor children represent one such market, and pediatric product development across the three big diseases of HIV/AIDs, TB and malaria faces “major bottlenecks.”

But solutions can be found. “Partnership along the whole value chain is important,” she stressed.

“And not just looking at individual projects, but realizing you might need a lot of different pieces of the puzzle to succeed in getting impact.”

Bernard Pécoul, executive director at DNDi, noted that today, after years of effort, new antiretroviral formulations exist for children. To make sure these new medicines are rapidly available, all stakeholders need to work together.

Tom McLean, market access director at IVCC, argued strong demand for new products was crucial.

“Industrial partners need to have confidence that the marketplace will be sustainable and affordable. ”

McLean said pilot studies on a new generation of bednets, conducted with partners such as the Global Fund and UNITAID, looked at how volume guarantees can stimulate bednet production and ensure they get to market.

“One of the things that is very clear to us is that [volume guarantees] have energized many of our other partners who now say ‘we have confidence that the world will actually support these products coming through’.”

Addressing Policy and Regulatory Barriers

Catharina Boehme, chief executive officer of FIND, called for the global health community to work together to tackle bottlenecks in bringing innovative new products to the people who need them most.

In the last two decades, the innovator community of PDPs has delivered about 35 innovations, many of which have played a critical role in the progress achieved by countries and the work of the Global Fund, Boehme told participants.

The emphasis should be to develop innovative systems that are open and “less closed, cheaper, and use more generics,” said Professor François Dabis, President of France Recherche Nord & Sud, Sida-hiv Hépatites (ANRS).

Others noted strategic moves PDPs could make while waiting for guidelines on the use of new products to be developed.

Willo Brock

Willo Brock, senior vice-president for external affairs at the TB Alliance, a PDP that recently developed the 3rd new drug to be approved for TB in half a century, said that even after products receive approval at the country level, it can take WHO up to a year to issue guidance on a new product.

“Waiting loses a lot of time,” he said. “With TB that means tens-of-thousands of lives in one year.”

Brock outlined the importance of using that time to coordinate with countries interested in new products, saying that the TB Alliance, along with Unitaid, are leveraging the waiting period to “understand the process of planning for countries and expose ministers of health to products in the pipeline.”

“Feedback works two-ways…country mechanisms will be very valuable,” he said.

Countries and Communities as Demand Generators

Estelle Tiphonnet Diawara, director of partnerships and capitalization, Coalition PLUS, provided a perspective from affected communities; she emphasized the importance of “taking into account the need of patients and people who are not going into health systems.”

“We need advocates in these countries to work with underprivileged communities …to buy good quality medicines and train people in good procurement policies,” she said.

“Major roadblocks” to downstream introduction of new health tools include low awareness among health professionals and users, low implementation, not enough research and development, and funding, said Sherwin Charles, chief executive officer of Goodbye Malaria, an organization active in public-private partnerships addressing malaria in southern Africa.

On how Goodbye Malaria has been trying to improve awareness of new products, Charles said, “We encourage staff to go and get embedded in health programmes and encourage them to do more.”

Chitalu Chilufya

Chitalu Chilufya, Zambia’s minister of health, provided a country perspective and stressed the importance of political will, noting that Zambia’s President ” has shown unprecedented political will on health.”

With regards to health promotion and innovation, he said, engagement with communities and religious and traditional leaders “is key ” and the trickle-down effects have a high impact. He mentioned examples in HIV/AIDS, TB and Malaria.

“On malaria we saw, for instance, the introduction of rectal artesunate as a pre-referral treatment in children in the rural community reduced mortality by 96%. Now this has been a pilot phase. So it is important that we find resources to roll it out in Zambia”

Dr Chilufya said “innovation is critical,” but overall efforts to re-engineer the country’s health systems are also crucial, especially efforts in improving health promotion and universal health coverage.

As next steps, work streams bringing together implementers and innovators are being created to map out a path for future progress against these key barriers.

“We need a steady pipeline of innovation tools needed to address resistance, facilitate elimination and also to address the underserved and vulnerable populations…. The great news is that we  are working together,” concluded David Reddy.

 

Image Credits: The Global Fund/John Rae, John Zarocostas.

In a suspense-filled finale that carried trappings of an elegant auction cum-political celebrity show, The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria brushed tantalizingly close to its $US 14 billion funding target – rallying some US$13.92 billion in commitments at its Sixth Replenishment Conference,in Lyon, France.

Speculation about whether the goal for the next 3-year funding cycle would in fact be met continued right up until the end of the pledging session, after a late afternoon tally showed that the collective pledges of the  government, private sector and civil society actors gathered for the event totaled $13.8 billion.

(left-right) Peter Sands, Amanda Dushime, Emmanuel Macron, Bono, Bill Gates.

With the prize in sight, French President and conference host Emmanuel Macron touched the finish line and declared victory. Macron added another €60 million of French funds into the pot in the closing minutes of the conference – followed by an additional €60 million contribution from the Bill and Melinda Gates Foundation (BMGF). The French president  declared that he would raise the final $US 80-100 million within the next weeks.

“So, we are at $US 13.92 billion. I can say that we will reasonably reach the $US 14 billion in the coming weeks, so we will be there,” said the French president, standing alongside philanthropist Bill Gates and Global Fund Executive Director Peter Sands at the closing session.

“It’s a fantastic result that everyone in the world should feel extraordinarily proud of, and tomorrow we will look at how to make the best use of these resources in a way that will end these epidemics and transform the world,” said Sands. A former banker, Sands was widely acknowledged for his behind-the-scenes work recruiting contributions from governments and the private sector, but he spared only a few words on the stage during the conference’s day-long high-level meeting.

The two-day conference capped months of lobbying, of donors large and small, rich and less so. In fact, a large number of African countries made first-ever pledges to the Global Fund’s activities – the world’s largest channel of aid to health systems to tackle the world’s three biggest infectious diseases.

A lineup of developed country donors increased their pledges for 2020-2022 by 15% over the previous three-year cycle – in response to repeated calls from Macron and the Global Fund leadership.

A Meeting with History

Macron set the tone in his opening presentation Thursday morning, in which he appeared on stage with Amanda Dushime, an adolescent HIV/AIDs survivor from Burundi, to tell his fellow heads of state and ministers that had gathered for the event that they had a “meeting with history.”

“The actions of the Global Fund have achieved what was thought to be impossible,” Macron said, recalling how the way in which the HIV/AIDS epidemic was rampaging through Africa and malaria claiming the lives of millions of children annually at the time the Fund was created in 2002.

Amanda Dushime, from Burundi, and President Emmanuel Macron

Today, deaths from malaria have plummeted by 60% over the past 20 years.  New HIV infections have declined by one half since 2005, and some 30 million lives have been saved, he said, citing data from a recent Global Fund review of its activities.

“The end of HIV/AIDS, TB and malaria is possible in our generation,” Macron declared.  “Twenty years ago, these number were thought of as being impossible.  It happened because the Global Fund worked with the governments, with the NGOs, with the stakeholders, to show by example what the international community can do when we have the will.”

However, he warned that the gains that have been made could also be erased if the push against the three killer diseases does not continue. “The next three years will determine if we win or not,” asserted Macron.

“I talked about 30 million lives saved. But there are regions and zones where the battle is not over; new HIV infections are resurging in 50 countries, including in Africa and the Americas.  Resistance to malaria medications and insecticides is gaining territory. So today, the situation is critical. If we don’t win the battle, we can lose everything that we have gained.  If we uphold our commitments there are 16 million lives that can be saved in the next 3 years. … We have a meeting with history and with our responsibilities.”

In the pledging conference dubbed “#StepUpTheFight”, Macron unabashedly challenged countries ranging from Japan to Australia and Norway to increase their pledges by 15% or more over the previous three-year cycle. And he invited oil-rich Gulf countries such as the Emirates, Qatar and Saudi Arabia to “join the club of donors” with new or bigger contributions than before.

“Multilateralism is still standing tall,” Macron told the crowd. “In the 3 hours that come, we have to get to the 14 million. Have you understood, the pressure is going to be maximal.”

Leadership and Multilateralism

Ultimately, most countries responded – inspired, led or dragged by France. As the Global Fund’s second largest donor, the French pledge ultimately topped US $2.1 billion, for a 20% increase over the past funding cycle.

US Global Ambassador for HIV/AIDs, Deborah Birx also announced an imposing $US 4.68 billion commitment, a 15% increase over the past three years. She said that it reflected the “compassion of the American people that transcended political parties,’’ for a mission that had earned the “unwavering support of three US administrations.” The US has historically been the Fund’s largest donor, contributing some $104 billion in total since its creation in 2002.

It was Macron, however, not US President Donald Trump, who won the biggest rounds of political acclaim on the funding stage as the champion of compassion – and of multilateralism.

“Every time I listen to him, my energy and idealism has been renewed, he has been a perfect host, and everyone has stepped up,” said Gates, heaping praise on the French Prime Minister while announcing a BMFG commitment of US $700 million midway through the day.  “Although we don’t know the exact total yet, it is clear we have been able to do far more than we were able to do three years ago. This is particularly significant when we see countries turning inwards. But here we see that to solve the toughest problems, whether it is diseases, climate change or terrorism, we really have to work together.”

Bono and Peter Sands

Rock star Bono [Paul David Hewson] was even more blunt in his remarks:  “If you want to know what leadership is, it looks like Emmanuel Macron. He’s fighting for our humanity,” said the U2 lead singer who also heads (RED) a foundation that recruits private sector support to the Global Fund through product sales.

As the ultimate count of total donations got underway behind the scenes in the waning afternoon hours, Bono reflected on the wider meaning of the replenishment event.

“Although we only need to count to 14, remember these are not just numbers, these are people.  This is saying, where you live cannot decide whether you live. We are putting down a marker for the populists, the cynics and the nativists who breed dispute and division. You demonize the other, we enlarge the concept of neighbourhood,” Bono said.

“We have made great advances but there are still 14 million HIV carriers who cannot get access to ARVs.  For 14 million people who can’t get the medication it’s still San Francisco in 1985, it’s Johannesburg in 2000.  14 million lives are in our hearts.  [US$] 14 billion is what we have in our minds.”

Bono also applauded the roster of “new donors” that had joined the Global Fund club, including not only Monaco (EUR € 400,000), Malta (EUR € 300,000), and Ukraine (US $80,000), but also Central Asian, Middle Eastern and African countries such as Azerbaijan (US$ 50,000), Mali (EUR € 500,000 EUR), Burkina Faso (US$ 1 million), Eswatini (US$ 6 million), Madagascar (US$ 1 million), and the United Arab Emirates (EUR € 50 million).

A number of leading foundations also joined the Global Fund drive for the first time, including – the Rockefeller Foundation (US$ 15 million) and the Children’s Investment Fund Foundation (US$ 25 million).

And donors that increased their pledges beyond their previous commitments at the very last minute during the day also came in for special mention, including – Switzerland (EUR € 6.4 million added increase), France (EUR € 60 added increase), the BMGF (EUR € 60 million added increase to match France), Luxembourg (EUR € 1.2 million added increase), and Kuwait (US$ 1 million added increase).

Also receiving praise from the stage Thursday were the countries in Europe and elsewhere in the developed that announced increases of 15% or more over the previous funding cycle – including Canada, Italy, The United Kingdom, The United States, Germany, Portugal, the European Union, Ireland, and New Zealand.

Japan increased its pledge by 5%, making it the only G7 country that did not increase its commitment by at least 15%.

Some donors also upped their commitments in the morning round of announcements; Norway doubled their planned increase, from 2.02 billion NOK to 2.04 billion “after the president [Macron’s great speech],” according to the Norwegian envoy, Axel Jacobsen, of the Minister of Foreign Affairs.

Jacobsen noted that moving forward “it will be important to continue to foster synergies” between the Global Fund and some eleven other global health organizations, referring to a new Global Action Plan that is supposed to improve coordination, which was initiated by Ghana, Germany and Norway and recently launched on the margins of the 74th United Nations General Assembly.

“If we are to reach our goal of Universal Health Coverage, the Global Fund is essential and the Global Fund remains a pillar in Norwegian development efforts. We are the largest per capita contributor,” he said.

Strengthening Health Systems

Indeed, the next three years will test the organization’s commitment to use funds more efficiently and to support the development not only of better disease control programmes but of more sustainable health systems in low- and- middle income countries, leading speakers asserted.

“It is time to go beyond speeches,” said Donald Kaberuka, Global Fund Chairman of the Board. “We have to do things differently and we have to do things with countries in the leadership role.. it is time to change the gears. We have promised value for money.  Our board leadership is aligned on this. We are trying to get countries to do a bit more. Our countries have to commit to better policies, inclusion and more money for health systems.

“Money alone doesn’t solve the problem. It is money plus policies,” he said.

WHO Director General Tedros Adhanom Ghebreyesus, himself a former chairman of the Global Fund Board, also called on the Global Fund leadership to use its newfound resources to support stronger health systems development and greater collaboration between agencies.

Dr. Tedros

“I have seen the life changing power of the Global Fund from three perspectives, as health minister, as chairman of the Global Fund from 2009-2011, and now as director of the WHO,” he said, speaking on behalf of all of the UN Agencies (UNITAID, UNAIDS, and the World Bank) that sit on the Global Fund board.

“In each of the three experiences that I have had, I have seen the impact…The essence of the Global Fund is partnership. We succeed or fail together …we still have a lot of work to do,” said Dr Tedros.

“We have to continue to strive for universal health coverage. We have pledged to work more collectively with countries at the centre,” he added.

“This is why the replenishment of the Global Fund is so important. It is an investment in our shared vision of a healthier, safer and fairer world. We have come far, but  we have not achieved our goal; every death is one too many. Now is not the time to lose focus. Now is the time to achieve our ends together.”

 

 

Image Credits: The Global Fund.

The Global Fund to Fight HIV/AIDs, Tuberculosis, and Malaria’s Sixth Replenishment Conference opens Wednesday in Lyon, France with the aim to secure some US$14 billion in funding for the next three years to tackle the world’s most deadly infectious diseases.

But while French President Emmanuel Macron prepared to host a carefully-orchestrated high-level event Thursday, strongly publicized by star-studded celebrity support, concrete pledges from donors so far were only about 41% towards the US$14 billion goal, said a Global Fund Advocates network of civil society organizations tracking the pledges.

Approximately US$5.8 billion has been pledged so far, leaving a shortfall of US$8.2 billion. Credit: Global Fund Advocates Network

And the needle didn’t change much more on Monday, even after Denmark committed some DKK350 million (US$51 million) to the Replenishment drive, for an increase of 16% over its last pledge cycle. The Danish announcement followed a Swedish commitment last Thursday for about SEK 2.85 billion, or around US$290 million to the Global Fund.

On Tuesday, a series of pre-conference events are set to focus on themes ranging from scaling up synergies on innovation, to gender equity and universal health coverage, reflecting on the Global Fund’s expanding role both within and beyond initiatives on the “big 3” diseases – HIV/AIDs, tuberculosis, and malaria.

Although the Global Fund was founded in the Millennium Development Goal era to target the major communicable diseases of HIV/AIDs, tuberculosis, and malaria, the agency has been trying to re-brand itself as an institution that takes a more holistic approach to health in the period of Sustainable Development Goals, highlighting the roles it’s programs have in supporting non-disease specific health systems strengthening.

Other health policy leaders have supported this trend. The Global Fund has helped support “robust, primary-healthcare systems” through its network of grants and support, wrote Dr. Tedros Adhanom Ghebreyesus, director-general of the World Health Organization and former Chair of the Global Fund Board, in an Op-ed for Asharq Al-awsat (translated from Arabic). “It is our duty. It is everyone’s duty. We cannot achieve the Sustainable Development Goals without replenishing the Global Fund,” Tedros said.

At the same time, Global Fund leaders and its key supporters continue to stress the importance of tackling the “big three” diseases, which still count among the most significant health threats to low- and lower-middle income countries.

“HIV, tuberculosis and malaria are the most deadly diseases globally, and while we see progress in many areas, some people are still being left behind – not least women and girls,” said Denmark’s Minister for Development Cooperation Rasmus Prehn, in a press release.

Global Fund Executive Director Peter Sands commended Denmark’s “human rights-based approach in international development,” calling it “fundamental” to ending the epidemics of the “big 3” – HIV/AIDs, tuberculosis, and malaria – and achieving universal health coverage, or “health for all.”

Calls To Step Up The Pledges

With the finale Replenishment event just days away, global health leaders, celebrities, civil society and countries alike continued to urge major donors to step up their Global Fund pledges.

“Giving through bilateral programs is not enough. Only by acting together can we step up and win this fight!” Elton John, singer and HIV activist, tweeted his support for the Global Fund replenishment. John appeared at a “Make Music Day” event with Macron appealing to donor governments to increase their pledges earlier this year.

John is one of eight celebrities that launched a highly publicized petition calling on the international community to “step up the fight” to help the Global Fund reach its replenishment goal. The petition has over 70,000 signatures to date, with French football player Amandine Henry, South African-American comedian Trevor Noah, Actress Charlize Theron, and British artist Ed Sheeran as only a few of the celebrity signatories.

Portugal was the first country to increase its pledge to a total of US $750,000, almost triple that of its last commitment. Since then, more than 11 major donors have followed in those footsteps, all increasing their pledges by between 5% and 230% over the next three years.

Still, some countries, such as Malta and Argentina, have yet to give to the Global Fund, and significant donors have held out from publicly upping their commitments. The United States, which has contributed about a third of the Fund’s total commitments since its inception and is the top donor to the Global Fund, has not yet announced its commitment. Concerns about the Trump administration slashing Global Fund funding will likely be allayed at the pledging conference, said Friends of the Global Fund, where it is expected that the US government will increase their pledge by 15%, matching incremental increases from major donors like Canada, the European Union, and Scandinavian countries like Norway and Sweden.

Critics of the United States’ foreign aid policies have pointed to French President Emmanuel Macron’s commitment to multilateral aid as “a rare exception” to stagnating or declining global health spending. Yet France, the second largest public donor to the Fund and the host of the Sixth Replenishment Conference, has not increased its pledge to the Global Fund since 2010.

France must show that “multilateralism is not just a good intention,” said civil society group Friends of the Global Fund Europe, calling for France to increase its pledge by 25%.

The final replenishment pledges will be announced Thursday morning, following addresses from Pete Aguilar of the US House of Representatives, African Heads of State, Macron, and a message from Secretary-General of the United Nations António Guterres.

A person who lives with HIV demonstrates condoms use to fellow HIV support group members in front of her home in Zambia.

The Global Fund and Universal Health Coverage

The Global Fund released a report last month claiming that it had saved 32 million lives since 2000. However, by reaching the full pledge of $14 billion over the next three years, the Global Fund claims it can accelerate efforts to save an additional 16 million, slash the mortality rate from HIV/AIDs, TB and malaria in half, and strengthen health systems by 2023.

But it is clear that the agency is also trying to rebrand itself as a player not only in vertical disease control programmes, but also as an agency that promotes health systems strengthening and universal health coverage expansion .

As the WHO Director-General pointed out, the Global Fund is also playing a key role in strengthening health systems with grants used not only to support disease-specific activities but also general healthcare training, such as training for over 40,000 community healthcare workers in Ethiopia, and “expanding access to preventive and curative services for HIV, tuberculosis and malaria, as well as child and maternal health services, and basic detection of noncommunicable diseases.”

The side events scheduled for the pre-conference session Tuesday, as well as events on the first official conference day Wednesday, will discuss the Fund’s collaborations with a range of other UN and civil society organizations, and its role in expanding Universal Health Coverage (UHC), in line with the new policy emphasis on a more integrated approach to health and health systems.

Tuesday and Wednesday’s pre-conference events include forums on topics such as:  “Scaling up Synergies between the Global Fund and Innovators to break down barriers to health innovation” co-sponsored by Medicines for Malaria Venture and six other product development partnerships, “Situating HIV/AIDS, tuberculosis and malaria and Global Fund advocacy within the UHC narrative,” “For a feminist approach to the fight against HIV/AIDS,” and “Universal Health Coverage & HIV – The Potential Impact of Collaborative Innovations with Viral Hepatitis Elimination”.

 

 

Image Credits: The Global Fund/John Rae, Global Fund Advocates Network, The Global Fund/.

Bad Hofgastein, Austria – A call to action to make stronger individual and collective commitments for climate change and health marked the end of the European Health Forum (Gastein).

The closing plenary session, titled “the global climate crisis: a public health emergency,” ended the varied program with discussions on two issues high on the political agenda – climate change and universal health coverage – recalling the commitments made by national governments at the Climate Action Summit and High-Level Meeting on Universal Health Coverage in New York early last week.

A recent report found that the healthcare sector is responsible for approximately 4.4% of global emissions. At the same time, it has been established that climate change fuels health issues such as increases in vector-borne disease, air pollution-related illnesses, and natural disasters. This relationship was highlighted by many of the panelists, who discussed the roles of individuals, governments, the health sector, and civil society in taking climate actions to improve health, and vice versa.

Closing plenary at the European Health Forum Gastein is “disrupted” by delegates with biodegradeable boomwhackers

The discussions around the climate-health nexus ended a three-day forum, organized around the theme “a healthy dose of disruption,” where over 600 policy makers, academics, clinicians, public health professionals, and young practitioners gathered to discuss topics ranging from cannabis regulation to electronic health records.

Key Remarks from “The Global Climate Crisis: A Public Health Emergency”

 

Clemens Martin Auer, president, European Health Forum Gastein – Step outside your narrow interest or silo and be part of this community of healthy disruptors because if we don’t do it, others will and their disruption will be destructive. Do it as a trailblazer, protector, a hospital worker, and illuminator, do it in your agency, in an NGO, as a health professional… There is no classical ‘treatment’ for climate change – it is a true multidisciplinary, intersectoral issue which affects everyone in this room.

 

Stella Auer, Extinction Rebellion, Austria – Truly ask yourself, with all that I currently know about the climate and ecological crises, am I doing enough? Am I acting accordingly?… Every other form of protest has not worked so far, and [climate change] has never been as dangerous as this situation we are in… All of you in the health sector have an important role to play, but before we can have such changes we need some form of disruption in the system. Civil disobedience has been very effective if you get 3.5% of the population involved, so I would ask you just as people to come join some form of rebellion.

 

Brigitte Zarfl, minister of Labor, Social Affairs, Health and Consumer Protection, Austria –  The situation around health and climate change is well known, there has been some efforts around that but we all know it is not enough…We have prepared systems to deal with the existing outcomes, regarding heat, air pollution and so on, but now we see that we have to use them. We have installed a heat telephone in Austria and had to activate it in the last two summers to protect vulnerable groups by informing them how to cope with the hot temperatures especially in the bigger cities…But we are also acting as producers of carbon dioxide… Health systems contribute to nearly 7% of the carbon dioxide production in Austria. This 7% of carbon dioxide emissions is caused by the use of pharmaceutical products, their production and their distribution and by the health sector, ambulance, and by the ways patients and professionals go to providers and to work places. We are working towards a better organization [to control healthcare sector emissions].

 

Andrew Haines, professor, Environmental Change and Public Health, London School of Hygiene and Tropical Medicine (LSHTM) – We can see the direct health effects [of climate change] from rising death rates from increased temperatures, increased frequency of floods and other natural disasters, and reduced labour productivity. We can see Indirect effects from changes in distribution of vector borne diseases and water borne diseases, and malnutrition from declining and lower nutritional-quality crop yields. Social and economic effects of climate change will push 100 million people back into poverty and increase the risk of conflict… The WHO estimates of a quarter of million extra deaths [due to climate change] per year are underestimates because they only reflect a limited number of health outcomes… We’re moving towards catastrophic health effects towards the middle of the century if we exceed the 1.5 degrees Celsius threshold, and we have a high probability of breaching the 2 degrees threshold. We are becoming increasingly aware that the health care sector is a major emitter… if it was a country, it would be the fifth biggest emitter of the world… In Europe we have a number of partial success stories. England’s National Health Service was able to reduce its emissions by about 18%. In Scandanavia and the Netherlands, we see a number of health care facilities moving towards zero emissions facilities.

 

Stefi Barna, co-director, Center for Sustainable Healthcare, UK – Even if we decarbonize our energy [in the healthcare sector], that only addresses 20-30 percent of health care. We have to work with each health specialty to see how we can reduce the carbon footprint. We found that implementing decarbonizing measures improves staff morale and reduces waste … Public health has the skills to bring this institutional change about… We can help them to ask the questions and take the lead in decarbonizing the way that medicine is practiced through designing leaner pathways and keeping people out of hospitals.

 

Veronika Manfredi, director, Quality of Life, European Commission Directorate-General for Environment (DG ENV) – The EU is one area of the world where we have managed to decouple growth from economic interests… We have the tools, we have the technologies. For example, in the area of water filtering techniques… EU companies have 41% of the international patents… What we need is stronger political will for climate action. In the first 100 days of their term, the EU president has promised to come up with a new climate law to achieve climate neutrality by 2050 that will really push Europe forward… However, we are facing a public health emergency when it comes to air quality. We’re very clear about zero tolerance for infringements of current standards, but we also want to make sure that European standards are fully aligned with WHO’s latest recommendations. The EU is not even aligned to the 2006 recommendation of the WHO [for fine particulates pm2.5 and 10] so we are not as protected as we should be.

Key Remarks from the Fireside Chat with Ilona Kickbusch

 

Vytenis Andriukaitus, outgoing commissioner for Health and Food Safety, European Commission – I follow the old definition of health which is a complete state of social and mental health being… and not merely the absence of disease. We need to keep as healthy as possible as long as possible… is it the goal of the health care system? Of course not. I practiced 27 years, I know what to do in surgery and what I can do with patients, but I don’t know what to do with people. We need to speak about the synergies of different pandemics; infectious pandemics, behavior pandemics, commercial pandemics… Young people need to create ten commandments to be healthier – including stop smoking. One cigarette butt can contaminate 150 meters of water, not only with toxic chemicals but also microplastics… We have commercial pandemics because multi-national companies are practicing an ethic of ‘produce, consume, and discard,’ when they should be practicing an ethic of ‘produce, consume, recycle.’ We need to raise health high on the agenda… how can climate disrupters understand that health is their business?

 

Piroska Östlin, acting regional director, WHO Europe Regional Office – WHO is very serious about environment and health, including climate change.. In Europe we are very active; we have a center in Bonn and are working on national action plans to help countries adapt to climate change and take mitigation measures… Just last year, we released the first ever WHO report on climate change and health, which helped inform the negotiations of all the parties to the United Nations Framework Convention on Climate Change (UNFCCC) Conference of the Parties (COP) in December 2018. We’re also active through the European Healthy Cities movement… somehow it is easier to work with several sectors all at once in cities, but we need to scale that model up for use at the national level.

 

Ilona Kickbusch, professor and chair of the Global Health Centre, Graduate Institute of International and Development Studies, Geneva – This movement needs a direction, and the direction is health in combination with climate change as a major determinant of health. It needs passion to bring about change, it needs better collaboration. There needs to be a much more forceful debate [among multilateral organizations]… that needs to reflect that passion and commitment. The WHO is definitely becoming more political and will become more political as it moves forward, but also needs a different types of disruption… This movement needs a lot of work behind the scenes that is not that visible… We must also respect those people who we often don’t see and whose names we don’t know.

 

Grace Ren contributed reporting to this story.

 

Image Credits: European Health Forum Gastein, Naomi Fein/Think Visual, European Health Forum Gastein.

San Diego, US (4 October 2019) – A trial involving a safe, novel ingestible sensor connected to a paired mobile device that lets medical staff remotely monitor patients’ intake of tuberculosis (TB) medicine, has shown better results than directly observed therapy (DOT), where a healthcare worker watches the patient swallow medication, leading researchers to suggest that the technology could be a game changer in high prevalence countries where treatment adherence remains a stumbling block to eliminating TB.

The randomised controlled trial conducted in California, was published today in PLOS Medicine ahead of the 50th Union World Conference on Lung Health be held in Hyderabad, India, October 30-November 2,2019.

Today TB is the world’s largest infectious disease killer, despite it being preventable, treatable and curable. In 2017, 10 million people globally fell ill with TB and 1.6 million died from the disease. India has the highest TB burden in the world with 1 in 4 people affected by the disease residing in the country.

Health workers provide directly observed therapy to a patient at home in Lima, Peru.

The trial demonstrates that Wirelessly Observed Therapy (WOT) was reported as highly accurate in recording medication ingestion (99.3 per cent) and persons with active TB using WOT were confirmed as taking 93 per cent of their daily prescribed doses as opposed to 63 per cent using DOT. All the patients using WOT completed treatment, were cured, and preferred it to DOT. The system allowed patients to manage their own medication taking, preserving patient privacy and autonomy, but also enabled highly targeted treatment support from practitioners with permission.

Poor adherence to TB treatment has long been associated with continued transmission, increased unfavorable treatment outcomes including relapse, and the emergence of drug-resistant TB.

“We are not doing people affected by TB justice when we have robust genomic diagnostic tests and the emergence of new antibiotic drugs that can cure TB but cannot guarantee consistent, convenient and private treatment support for them,” said Sara Browne, Professor of Clinical Medicine in the Division of Infectious Diseases & Global Public Health at the University of California San Diego, who led the trial.

“If we are serious about eliminating TB then we have to get some fundamental things right such as increased support for patient care that efficiently helps patients complete all of their treatment,” concluded Browne, who is also the founder of Specialists in Global Health (SIGH), a non-profit that provided funding for Bi-national participants in this trial.

The trial evaluated a novel technology termed Wirelessly Observed Therapy (WOT) consisting of a tiny ingestible sensor, a patch worn on the torso and a paired a mobile device.

The sensor is the size of a grain of sand and coated with tiny amounts of dietary minerals; one side with copper and the other with magnesium. When a pill is swallowed, the liquid in the stomach connects the two sides, generating an electrical signal that can be picked up by the torso patch.

WOT is FDA approved and can be accessed by patients with a physician’s prescription and downloadable app. It determined the accuracy of ingestion detection in clinical and home settings using WOT and subsequently compared, in a randomized control trial (RCT), confirmed daily adherence to medication in persons using WOT or directly observed therapy (DOT) during TB treatment.

The trial evaluated WOT in 77 participants with drug-susceptible TB in the continuation phase of treatment recruited from San Diego (SD) and Orange County (OC) Divisions of TB Control and Refugee Health, using ingestion sensor-enabled combination isoniazid 150 mg/rifampin 300 mg (IS-Rifamate) prescribed daily. In terms of accuracy, WOT was equivalent to DOT. WOT was superior to DOT in supporting confirmed daily adherence to TB medications during the continuation phase of TB treatment and was overwhelmingly preferred by participants.

“We are now moving into an era of all-oral regimens for the treatment of drug resistant TB, without the need for daily injections. And we now have an opportunity to explore the potential of medication adherence support using WOT in the use of TB treatment regimes worldwide,” said Dr. Constance Benson, Professor of Medicine in the Division of Infectious Disease & Global Public Health at the University of California San Diego and co-lead on the trial.

”We have a limited number of drugs available for the drug-resistant strains of TB and better treatment support will be essential to help ensure that the integrity of those drugs is preserved in the long term,” concluded Benson.

Dr. Mark Cotton, Distinguished Professor of Pediatrics and Child Health at Stellenbosch University and Tygerberg Children’s Hospital in  Cape Town South Africa, is an advocate of evaluating WOT in TB treatment.

“We must urgently evaluate the applicability of WOT in high prevalence countries such as India and South Africa where treatment adherence rates are often poor due to geographical barriers, stigma and poverty,” said Cotton. “WOT could potentially be a lifesaver for millions.”

Image Credits: WHO PAHO.

Bad Hofgastein, Austria – A stronger research agenda for cannabis is urgently required to guide European health policymakers through a bewildering maze of medical and recreational cannabis and cannabinoid products that are fast emerging on the European market, said researchers and policymakers at a panel session of the 2019 European Health Forum (Gastein), which concluded Friday.

Currently, awareness is low and policies are inconsistent regarding the regulation of both medical and recreational cannabis in Europe– a plant whose components includes hundreds of different molecules of very different active ingredients.

Adding to the complexity is the fact that the best known cannabis components, which are THC and cannabidiol (CBD), now appear to have diametrically opposed effects on the brain, and that is stimulating new opportunities for medical applications, but also new questions. CBD’s potential anti-anxiety and anti-psychotic properties are being explored by researchers in the United Kingdom and elsewhere – while a trademarked version of CBD, Epidiolex®, was recently approved by the US Food and Drug Administration as well as by the European Medicines Agency for treatment of a rare form of childhood epilepsy.

(Left-right) Lisbeth Vandem, EMCDDA; Ian Hamilton, Unviersity of York; Paola Kruger, patient advocate; Philip McGuire, Kings College London.

The contrasting impacts of CBD and THC on mental health were underlined by King’s College London Professor Philip McGuire who discussed the results of a recent trial that he led on the use of pure CBD in chronically schizophrenic patients. Those patients’ symptoms were reduced after a period of CBD use as an adjunctive therapy to their regular medication, as compared to patients administered a placebo.

“This is one of the first pieces of evidence that CBD might have anti-psychotic properties,” he told the panel, adding that in MRI scans conducted by researchers, CBD also had very different impacts on brain function than THC, and in some cases “completely opposite effects.”

“We found that the addition of CBD seemed to reduce psychotic symptoms. Its pathways of action on the brain seems to be very different.” While this research is only just emerging, it’s potential is huge because there have not been significantly new anti-psychotic drugs developed for several decades, McGuire told the panel. Based on findings from the recent trial and an as-yet unpublished trial on young adults with prodromal phase psychotic symptoms, he said the research team plans to embark on larger multi-country trials of CBD involving young adults at risk of psychosis in Europe and the United States.

Philip McGuire, King’s College London

“We know THC can cause anxiety and paranoia, and if CBD has the opposite effect then potentially it can be used to treat anxiety and paranoia,” said McGuire in a follow-up interview with Health Policy Watch.  “We have been studying the effects of cannabis on mental health for 20-30 years, initially that was  all about the adverse effects of THC… and then we learned more about CBD and that it seemed to have opposite effects to THC, and that led to thinking about using it as a medicine,” he said.  He added that he hoped that larger trials might lead to eventual regulatory approval for CBD in patients with certain mental health disorders, although he emphasized that the research is still in its early days.

“It’s very new, we have not known about CBD until relatively recently,” he said. “You have to be confident that it is safe and effective… if you have the trials, then the regulation follows because you can show x=z. Otherwise it is just based on opinion.”

Paradoxically, in the medical cannabis applications involving THC-rich products, which are already being used very widely in some countries of Europe, there have been relatively few strictly controlled clinical trials, the panel members noted. Some research, however, has reported positive outcomes for relief of conditions such as irritable bowel syndrome; chronic pain; as well as the symptoms or side effects associated with other chronic diseases or disease treatments, such as cancer.

Diversity of Products and Regulatory Approaches in Europe

Within the WHO European region, there is a growing diversity in the types of cannabis and cannabinoid compounds available, said Liesbeth Vandam, of the European Monitoring Centre for Drugs and Drugs Addiction (EMCDDA), citing a recent agency report.

But regulators, policymakers, health practitioners and the public, all are struggling to keep up with the flood of new products coming onto the market,  Within Europe there are very diverse approaches to regulation of cannabis and cannabinoid products for both medical and recreational use, said Vandam.

These range from cannabis products that are both legal and illegal, as well as natural and synthetic, to over-the counter CBD sold as food supplements, and which are likely to contain only very small amounts of actual CBD.

Some national regulatory agencies have legalized the medical use of cannabis-rich in THC for the treatment of pain and other chronic conditions, but with little recognition of the potential for medical applications of CBD. Other countries may allow CBD-rich products to be sold over-the counter, while cannabis products with higher levels of THC may be harder to obtain, including by prescription.

“Cannabis products have become increasingly diverse in Europe,” says the recent EMCDDA report, cited by Vandam. It notes that more detailed information needs to be collected on the precise components of various products being made available, at national and European levels, in order to better monitor health effects.”

Rising levels of THC in recreational cannabis. Credit: Ian Hamilton, University of York.

Other concerns expressed by the panelists included the steadily increasing THC potency of recreational cannabis products on the market today, as well as a cross-over influences from the medical cannabis market, which some fear could stimulate increased recreational use and abuse, particularly in adolescents and young adults whose developing brains are more vulnerable to THC.

The ratio of psychoactive THC to CBD in street cannabis in the UK has increased eight-fold between 1995 and 2014, noted Ian Hamilton, a senior  lecturer on addiction and mental health at the UK’s University of York,. In the United Kingdom, recreational cannabis is still illegal, and medical cannabis was approved for use only last year, but use has been very constrained by its high price and doctor’s reluctance to prescribe, he said.

Increased THC potency in street cannabis products has also been observed elsewhere across Europe, according to the recent EMCDDA study, said Vandam.

Needed: Coherent Research Agenda

Overall, she says, “there is a strong need for additional research and clinical studies including larger and better-designed trials; studies looking at dosage and interactions between medicines; and studies with longer-term follow-up of participants.”

Ian Hamilton, University of York, United Kingdom

Among the research and policy issues, adds Hamilton, are lack of agreed-upon definitions for the products tested and used, as well as for the recreational users, in terms of what levels of use might actually constitute dependency or addiction, with significantly greater health impacts.

“The UK government has struggled to come up with a policy for cannabis-based products, and they have struggled to be clear in their definitions,” he said. But key questions still remain open, such as whether policies also cover raw cannabis products, or cannabis-derived oils?

“In [addiction] research, the other problem is that different researchers define a regular [cannabis user] in different ways.  There needs to be more standardization in the terminology. There needs to be some agreement; otherwise we have all of these interesting bits of research, but we cannot compare them.”

Malta is another European country that has recently moved forward with the legalization of medical cannabis, including granting licenses for cannabis cultivation, noted Natasha Azzopardi-Muscat, a health professional with the National Directorate for Health Information & Research and President of the European Public Health Association.

“It’’s very clear, many countries are facing a new frontier, and we all have to learn together,” said Azzopardi-Muscat, who moderated the cannabis session.

She said that she was concerned, in particular, with the “blurring of the use between cannabis as a medicinal product and cannabis as a recreational product, and that is where we need to do further homework.

“Nobody quarrels to cannabis being elevated to the status of medicinal product if it can satisfy the traditional scientific thresholds for quality, safety, efficacy that are normally ascribed to medicines,” she added.

“But there is a wide difference between the wide varieties of the plant and its constituents – the different types of cannabinoids.  That is where the science starts to become really complicated, and the policy and regulatory issues become increasingly difficult.

“The key take-home lesson is that this is an issue which is scientifically very complex, which policymakers are going to find very difficult to regulate. And there isn’t a clear pool of expertise – it is fragmented between different research areas and activities.”

She said that she hoped the new flagship European Union research initiative, Horizon Europe, can provide a “window of opportunity to promote a clear research agenda that would be able to support policy agendas.

“My key message is to push the research agenda, involving both clinicians and public health specialists in a carefully structured debate. There is a window of opportunity to address this issue in Horizon Europe,” she said.  “I do see this as something that may be discussed on the European health policy agenda, but by then we may be too late, and we may be struggling to regulate a horse that has bolted.”

Natasha Azzopardi-Muscat, President, European Public Health Association

 

Image Credits: EHF-Gastein , EHF-Gastein, Ian Hamilton, University of York.