Dr Tedros Adhanom Ghebreyesus speaking at the media briefing in Geneva on Wednesday.

With the sixth meeting of the Intergovernmental Negotiating Body (INB) meeting to develop a  pandemic accord currently underway in Geneva, the World Health Organization (WHO) chief minced no words when he slammed “groups with vested interests” for trying to sabotage the negotiations.

“Twenty years ago, the tobacco industry tried to undermine negotiations on the WHO Framework Convention on Tobacco Control. The same thing is happening now,” Dr Tedros Adhanom Ghebreyesus told a media briefing at the WHO headquarters in Geneva on Wednesday.  

“Groups with vested interests are claiming falsely that the accord is a power grab by WHO, and that it will stymie innovation and research. Both claims are completely false,” said Tedros.

The sixth INB meeting, which ends on Friday, when it will meet with the Working Group on the amendments to the International Health Regulations (WGIHR). The WGIHR, which is looking into how to tighten compulsory international regulations that govern public health outbreaks and pandemics, holds its fourth meeting from 24 to 28 July. 

Both groups are expected to present final drafts of their negotiations at the World Health Assembly in 2024. 

Doubling down on his displeasure with the unnamed “vested groups”, Tedros said that those who spread “lies” about the pandemic instrument are “endangering the health and safety of future generations”. 

“This accord aims to address the lack of solidarity and equity that hampered the global response to COVID-19. It’s a historic opportunity for the world to learn the painful lessons COVID-19 told us and make the world safer for generations to come.”

On Monday, as the INB negotiations resumed, co-chair Roland Driece, urged member states to complete discussions on the contentious Chapter Two of the compilation draft before a first draft could be formulated for text-based negotiations. 

“I would rather have a first draft that has substance, which we all feel is strong enough to have real line-to-line discussions on, than having something in between which is not good enough yet,” said Driece.

Tedros’ words come in light of the continued efforts to dispel mis- and disinformation about the pandemic instrument on social media. Twitter in particular has been awash with conspiracy theories about COVID-19 and the subsequent pandemic accord negotiations.

Earlier this year, Twitter CEO Elon Musk tweeted that “Countries must not cede authority to the WHO”. His tweet was in response to a speech by the Australian Senator Malcolm Roberts criticising the global health agency. 

Tedros responded that the countries would not be ceding sovereignty to the WHO as the pandemic accord will not change the sovereign status of any country. 

Tedros said on Wednesday that the pandemic accord is like a business contract signed by two companies, likening countries to companies. 

“If two companies sign a business contract and use lawyers to help them develop it, that doesn’t give the lawyers control over the contract, nor make them a party to it. It’s the same here,” he said. 

“The pandemic accord is an agreement between countries and the WHO is helping them to develop that agreement. But WHO will not be a party to the agreement…This is an agreement between countries and countries alone.”

Image Credits: WHO.

For the second time this year, a new drug showed that the cognitive decline caused by Alzheimer’s disease – the leading cause of dementia worldwide that affects an estimated 55 million people – can be slowed down.

Clinical trial results for donanemab, presented to the Alzheimer’s Association International Conference on Monday, showed the antibody medicine developed by Eli Lilly slowed the cognitive decline of Alzheimer’s patients by 35%. The drug was even more effective in the earliest stages of the disease, reducing cognitive decline in patients by around 60%.

Lecanemab, a similar drug made by Eisai and Biogen, received full marketing approval from the US Food and Drug Administration (FDA) earlier this month, based on clinical trial data that showed the drug slowed cognitive decline in participants by 27%. 

The back-to-back success of trials for antibody treatments targeted at Alzheimer’s are the culmination of decades of research long viewed as a dead-end. A decade ago, leading drugmakers such as GSK, AstraZeneca and Pfizer shelved efforts to develop drugs to treat the disease, citing the high price tag and slim chances of success. 

“We have waited a long time for Alzheimer’s treatments, so it’s really encouraging to see tangible progress continuing to gather pace in the field,” said Giles Hardingham, who leads the UK Dementia Research Institute. “It is terrific to see these results published.” 

The FDA approval of Lecanemab in June was the first time a drug proven to slow the effects of Alzheimer’s was made available to patients, marking a watershed moment in the fight against the disease. Eli Lilly said in a press release it expects the FDA to take regulatory action on donanemab by the end of this year. 

While the clinical effects of recent breakthrough drugs remain modest, experts said their efficacy proves that the once unstoppable disease could one day be managed and treated. 

“This is truly a turning point in the fight against Alzheimer’s,” said Dr Richard Oakley, an associate director of research and innovation at the Alzheimer’s Society. “Science is proving that it is possible to slow down the disease.”

Clinical results highlight the complexity of Alzheimer disease

Both new drugs are based on a theory of Alzheimer’s called the ‘amyloid cascade hypothesis’, which holds that the abnormal buildup of a small proteins in the brains of people with Alzheimer’s is a primary cause of the disease. 

The proteins, known as amyloid peptides, clump together to form plaques that can damage neurons and kill cells. Lecanemab and donanemab work by clearing these toxic proteins from the brains of patients.

Brain scans of patients participating in the clinical trials showed both drugs were extremely effective at eliminating the amyloid proteins they are designed to target. Donanemab was so effective that a significant number of patients were switched to a placebo after the drug cleared enough amyloid plaques. 

The trials show that removing amyloid from the brain is capable of changing the course of Alzheimer’s. But a series of editorials published in the Journal of the American Medical Association (JAMA) alongside the results for Eli Lilly’s drug said the data showed amyloids are just one part of the complex picture of Alzheimer’s. 

“Donanemab was very effective at eliminating its target,” Jennifer Manly, from Columbia University Irving Medical Center, and Kacie Deters, from the University of California, Los Angeles, wrote in one JAMA editorial. “The clinical effect was comparatively weak.”

In another editorial, a team of experts from the University of California, the University of Wisconsin and Upstate Medical University echoed similar concerns about the drug’s limitations, observing that the “results serve to highlight the complexity of Alzheimer disease itself.” 

“The exceptional ability of drugs such as donanemab and lecanemab to remove amyloid, paired with their rather subtle effect on the rate of decline in cognitive and functional measures, suggests that amyloid is likely not the only factor that contributes to Alzheimer’s disease progression,” they said. 

Both drugs also involve risks. Brain swelling was observed in up to a third of patients in the donanemab trial, mostly without incident. Brain bleeding occurred in a small minority of patients, and three participants, including one from the placebo group. died of “treatment-related” complications.

Then there is the price-tag: One year of Lecanemab costs $26,500 in the United States. The competition introduced by Eli Lilly’s new drug is expected to reduce the price, but cutting-edge treatments don’t become inexpensive overnight. 

“The modest benefits would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer,” another JAMA editorial observed. “They are none of these.”

A ‘new era’ in the dementia fight

Eli Lilly said it expects the FDA to take regulatory action by the end of 2023.

Science still has much to learn about Alzheimer’s, but the pace of research is picking up. More trials for Alzheimer’s drugs are ongoing now than ever before, according to research from the University of Nevada.

And there is a lot of ground to catch-up: Nearly 5 million papers about cancer have been published on the public medical research database PubMed – 19 times more than on dementia. Experts hope recent breakthroughs will stimulate funding and allow the field to build towards more effective medicines.

“This is just a start,” said Howard Fillit, chief scientist of the Alzheimer’s Drug Discovery Foundation. “We must continue advancing the drug pipeline to develop the next class of drugs centered around the biology of aging to ultimately stop Alzheimer’s in its tracks.

The new treatments for Alzheimer’s disease are not a cure, but they can still be life-changing. Slowing the onset of common symptoms like memory loss, concentration lapses, and difficulties communicating can allow people with Alzheimer’s to live active, independent lives for longer.

David Colley, an 80-year-old patient who took part in the clinical trial of the drug donanemab, told the BBC that he is “one of the luckiest people you’ll ever meet.”

His son, who observed Colley’s cognitive decline in the years leading up to the trial, said the treatment stabilized his father’s condition, allowing him to continue to participate in the family’s life.

“Thanks to decades of research, the outlook for dementia and its impacts on people and society is finally changing,” said Dr. Susan Kohlhaas, research director at Alzheimer’s Research UK. “We’re entering a new era where Alzheimer’s disease could become treatable.”

Oral polio vaccination – despite a post-COVID rebound, 20.5 million children still missed out on routine vaccinations in 2022.

Routine childhood immuniaztions rebounded in 2022 from the set-backs of the COVID pandemic.  But coverage still fell short of pre-COVID numbers in 2019, with 20.5 million children missing out on one or more routine vaccines last year as compared to 18.4 million in 2019.

The new data is contained in a report published jointly Tuesday morning by the World Health Organization and UNICEF.  The data tracks a wide range of vaccines, but uses immunization against diptheria, tetanus and pertussis (DTP) as a marker for immunization coverage globally.

In 2022, 20.5 million children missed out on one or more DTP vaccines, as compared to 24.4 million children in 2021, according to the new global data set.

Of the 20.5 million children who missed out on one or more doses of their DTP vaccines in 2022, 14.3 million did not receive a single dose, so-called ‘zero-dose’ children. The 2022 figure represents an improvement over the 18.1 million zero-dose children in 2021 but remains higher than the 12.9 million children that missed all DTP doses in 2019.

“These data are encouraging, and a tribute to those who have worked so hard to restore life-saving immunization services after two years of sustained decline in immunization coverage,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “But global and regional averages don’t tell the whole story and mask severe and persistent inequities. When countries and regions lag, children pay the price.”

Indeed, progress was greater in large, and better-resourced countries like India and Indonesia, the WHO/UNICEF report notes. It was much less so in many other low-income countries.

Of the 73 countries that recorded substantial declines in coverage during the pandemic, 15 recovered to pre-pandemic levels and 24 are on route to recovery, the report finds. However, another 34 have seen vaccination rates stagnate at pandemic levels, or even continue to decline.

“These concerning trends echo patterns seen in other health metrics,” said WHO.

Additionally, while DTP is used as a marker, vaccinations against various childhood diseases still vary widely.  For instance, vaccination against measles – one of the most infectious pathogens – has not recovered as well as other vaccines, putting an additional 35.2 million children at risk of measles infection, WHO said in a press release.

First dose measles coverage increased to 83 per cent in 2022 from 81 per cent in 2021 but remained lower than the 86 per cent achieved in 2019. As a result, last year, 21.9 million children missed the routine measles vaccination in their first year of life – 2.7 million more than in 2019 – while an additional 13.3 million did not receive their second dose, placing children in under-vaccinated communities at risk of outbreaks.

Overall, coverage with three DTP doses in 57 low-income countries supported by Gavi, The Vaccine Alliance, increased to 81% in 2022, as compared to only 78% in 2021, however, this remains below the pre-pandemic rates of  86% recorded in 2019, UNICEF said.

“Beneath the positive trend lies a grave warning,” said UNICEF Executive Director Catherine Russell. “Until more countries mend the gaps in routine immunization coverage, children everywhere will remain at risk of contracting and dying from diseases we can prevent. Viruses like measles do not recognize borders.”

Image Credits: UNICEF South Africa/2013/Hearfield, Sanofi Pastuer/Flickr.

The Rwandan national ballet performs at the opening of Women Deliver 2023

Women Deliver, one of the world’s largest gatherings on gender equity and sexual and reproductive health and rights (SRHR), opened in Kigali in Rwanda on Monday amid a global backlash against abortion.

“We’re facing enormous headwinds against gender equality, including the COVID-19 pandemic, the climate crisis, and a growing anti-rights movement worldwide,” said Maliha Khan, President and CEO of Women Deliver, at the opening press conference.

“The only way we can push past them is if we double down on our efforts and work together. The time has come for us to unite against the global rollback of rights – change is inevitable, progress is not. We have to work at it.”

An estimated 6000 delegates are attending the week-long conference, which has attracted global politicians, activists and philanthropists.

“Each delegate and speaker has converged here with a collective purpose: to identify and act upon evidence-based solutions,” said Maliha. “This week centers on creating empowering spaces for the feminist movement, holding leaders accountable, and creating a groundswell of voices for gender equality. This groundswell of collective action is critical to urge political leaders to act.” 

Anti-rights president addresses opening

However, surprisingly Hungary’s rightwing president, Katalina Novak, was invited to address the opening along with Rwandan President Paul Kagame. As Family Minister in the populist government of Viktor Orban, Novak has been party to anti-LGBTQ laws and the tightening of abortion regulations in her country.

Novak has also told women not to expect the same pay as men, while her government has outlawed adoption by unmarried couples, thus excluding LGBTQ couples from adopting children, and refused to ratify the Istanbul Convention, designed to protect women from violence.

Other speakers include Nobel Peace Prize laureate Malala Yousafzai, US politician Stacey Abrahams, Mozambican former first lady Dr Graça Machel, and former Irish President Mary Robinson.

“Women Deliver underscores the vital role of democratic systems in advancing gender equality,” Phumzile Mlambo-Ngcuka, Chair of the Women Deliver Board and former UN Under-Secretary-General, told the media briefing.

“Open democracies foster an enabling environment for women’s political participation, policy and law shaping, as well as the protection of women’s rights and the creation of equal opportunities. They facilitate improved access to education and healthcare for girls and women while establishing effective mechanisms to combat gender-based violence.”

Women Deliver developed out of the Safe Motherhood Initiative, with an exclusive focus on reproductive, maternal, and newborn health, and has evolved into an independent organization focusing on gender equality.

Women Deliver itself has undergone an internal transformation after facing allegations of racism from staff members three years ago.

Meanwhile, on Monday, the World Health Organization launched a new digital resource at the conference, RESPECT, to help end violence against women and girls  

RESPECT outlines a set of action-oriented steps to support policy makers and programme implementers to design, plan, implement, monitor and evaluate programmes using seven strategies to prevent violence against women. Each letter of R-E-S-P-E-C-T represents one of these strategies. The framework, grounded in a gender equality and human rights approach, builds on an increasing body of evidence on what works to prevent violence against women.

The UN has warned that millions of people could face hunger if the deal is not saved.

Russia has withdrawn from a UN-brokered agreement that allowed Ukraine to safely export grains from its ports in the Black Sea. The move is expected to have a significant impact on global food prices, imperilling the food security of millions around the world. 

“I deeply regret Russia’s decision to terminate the implementation of the Black Sea Initiative, which has been a lifeline for global food security in a troubled world,” UN Secretary-General António Guterres said on Monday. “Hundreds of millions facing hunger and consumers confronting a global cost-of-living crisis will pay the price.”

The first months of Russia’s full-scale invasion of Ukraine saw global food prices surge as Russian naval blockades trapped around 20 million tonnes of grain in Ukraine’s Black Sea ports, triggering the worst global food crisis since 2008

The United Nations warned food-insecure countries in the Middle East and Africa were at risk of famine if the blockades continued, while the International Monetary Fund estimated the lives of 345 million people were put in immediate danger by the shock waves sent across global food markets by the war.

The mounting global food crisis and international pressure led to a rare instance of successful diplomacy between invader and invaded. The Black Sea grain initiative, which came into effect a year ago, created a safe corridor for commercial ships to enter and exit the Black Sea, allowing Ukrainian grain exports to resume.

The deal helped ease the upward pressure on global food prices, with around 33 million metric tons of grain and oilseeds exported under the deal.

Prices for grains and oilseeds have already risen in response to Russia’s exit from the deal. Aid agencies are bracing for further increases.

Consequences for the global food crisis

The 10 countries/territories with the highest numbers of people facing life-threatening levels of food insecurity.

As the last ship protected by the agreement set sail from the port of Odesa on Sunday morning, fears grew that the progress made in stabilising the global food crisis could be lost overnight.

The confluence of COVID-19, the war in Ukraine and climate shocks have overlapped to create the “largest and most complex hunger and humanitarian crisis in more than 70 years”, the World Food Programme said in its annual report last month. 

A record 349 million people experienced acute hunger in 2022, while 772,000 balanced on the knife’s edge of famine. Around 2.4 billion people did not have constant access to food. 

According to the UN, 47% of exports from Ukraine under the deal have gone to high-income countries, 26% to upper-middle-income countries, and 27% to low and lower-middle-income countries. 

Russia has criticized Ukraine for not exporting more to low-income countries. The UN, EU, United States and Ukraine argue the grain deal benefits people around the world due to its deflationary effect on food prices, which are at a 10-year high.

Ukraine was WFP’s top provider of grain in 2021, accounting for 20% of the total purchased by the UN agency. That number rose to 80% in the first half of this year.

European Commission President Ursula Von der Leyen condemned Russia’s “cynical move” to exit the agreement. The EU is “working to ensure food security for the world’s most vulnerable”, and will continue to help Ukraine deliver its agri-food products to global markets, she said. 

The UN has warned that millions of people could face hunger if the deal is not saved. Countries facing high levels of food insecurity such as Afghanistan, Yemen, Somalia, South Sudan and Syria will be the hardest hit. 

“Today’s decision by Russia to terminate the implementation of the Black Sea Initiative will strike a blow to people in need everywhere,” said Guterres.

Will Russia return to the deal?

Russia has pulled out of the Black Sea grain deal before. In November, Russia announced it was leaving the agreement, stoking panic in global food markets. Under pressure from Turkey, it rejoined the deal one day later. 

Kremlin spokesperson Dmitry Peskov said on Monday that the Black Sea grain deal has been “terminated”, but that Russia would rejoin the agreement “as soon as the relevant agreements are fulfilled”.

Russian demands include lifting obstacles to its own grain and fertilizer exports, reopening an ammonia pipeline from Odesa to Russia, and reconnecting the Russian Agricultural Bank to the SWIFT international payment system.

Moscow has repeatedly criticized the deal as one-sided, providing a lifeline to Ukrainian farmers without benefiting Russia. 

“Absolutely nothing has been done – I want to stress that. It’s one-way traffic,” Russian President Vladimir Putin said of the grain deal last week. “Not a single point linked to the fact Russia has its own interests has been fulfilled.” 

EU and US sanctions do not directly target Russia’s food and agriculture sectors, but have blocked the export of machinery needed for agriculture and complicated Russian efforts to export food and fertilizer.

EU officials said negotiations are still ongoing, and Turkish President Recep Tayyip Erdoğan said on Monday he believes Putin “wants the Black Sea Grain deal to continue”.

The United Nations and European Union have offered to reconnect a subsidiary of Russia’s Agricultural Bank to the SWIFT international payments system if it operates independently and agrees to regular UN audits. 

Russia was made aware of this proposal by UN Secretary-General Antonio Guterres last week, but pressed on with its exit from the deal.

Despite the stalemate, the deal still stands, a senior EU official told the Wall Street Journal on Monday. 

Image Credits: Breta Valek.

INB co-chairs Roland Driece and Precious Matsoso

Pandemic accord negotiations resumed on Monday with World Health Organization (WHO) member states expressing a hunger for text-based talks to begin on a first draft amid grave concerns about whether enough progress will be made before the northern hemisphere summer break.

Roland Driece, co-chair of the Bureau of the Intergovernmental Negotiating Body (INB), told the body’s sixth formal meeting that while he understood member states’ eagerness for a first draft on which to start text-based negotiations, discussions on Chapter Two of the compilation text (referred to as WHO CA+), focusing on equity, should be completed first.

“I would rather have a first draft that has substance which we all feel is strong enough to have real line-to-line discussions on, than having something in between which is not good enough yet,” said Driece. “So I would rather have a good first draft than a quick first draft, but we will come back with a proposal on how to get there.”

Informal inter-sessional meetings

Since the last INB meeting a month ago, member states have met in informal sessions to discuss three controversial issues in Chapter Two of the compilation draft. These sessions focused on research and development related to pandemic products, particularly vaccines and medicines (Article 9); access to these products and benefit-sharing, including sharing genomic sequencing of whatever pathogen is causing the pandemic(Article 12) and supply chain logistics (Article 13).

This week’s meeting will continue negotiations on Chapter Two, focusing on Articles 15 to 19, then Articles one to three, if there is enough time.

Member states generally regarded the informal sessions as being useful to enable them to understand countries with different positions better, as well as for elucidating how clauses could be practically implemented.

But while some countries felt that the informal sessions could be used to generate new text to enhance the compilation draft of the pandemic accord, others were adamant that the negotiations should not splinter further.

US Ambassador Pamela Hamamoto

“The informals clearly provided a valuable opportunity for member states to clarify their proposals and ask questions, which we believe helped improve our collective understanding of what may or may not be feasible for the accord,” said US Ambassador Pamela Hamamoto. 

“We suggest laying out a process this week for ongoing work by the co-facilitators, further empowering them to convene additional discussions on their respective articles, and if possible, to develop draft text to bring back to our next formal meetings,” she added.

“In this way, we can take strong collective steps under the guidance of the Bureau to move from helpful but still high-level discussions to more specific line-by-line negotiations and begin to build the first draft of the negotiating text together.”

African proposals missing amid concern about onerous meeting schedule

South Africa’s Dr Aquina Thulare

South Africa’s Dr Aquina Thulare, speaking on behalf of 47 African countries, noted that a number of suggestions from the continent had not made their way into the latest compilation text.

Nigeria posited that the informal meetings could “be used as an opportunity to highlight and discuss some of these issues and also see a way to re-import them into the document”.

But Namibia and Botswana were against “having to fight to incorporate our proposals through the informal process”. 

Kenya asked the INB’s Bureau to clarify when and where member states will be able to add text to the Bureau’s compilation. 

“In our view, this should be the preserve of the formal meetings of the INB, and as such, we propose that informal sessions maintain focus on clarity seeking and consensus building as their main mandate,” said Kenya.

Many under-resourced countries are also struggling to keep up with the heavy burden of meetings and fear being excluded if the INB splinters into even more informal sessions.

This was clearly articulated by Fiji, which said that while the informal sessions may assist in speeding up talks, “we run the risk of losing necessary representation and meaningful participation in the process”. 

“Therefore, the inter-sessional meetings should be seen as a useful method to enable better understanding and shifting negotiations forward. but the substantive negotiations must happen within the formal processes of the drafting group, and the INB.”

While sympathetic to this position, New Zealand proposed that the informal sessions could, nonetheless, be “empowered to identify convergence and divergence, restructure articles where it makes sense, and draw on member states’ proposals to help identify compromise text”.

Bureau co-chair Roland Driece reassured the INB that the informal sessions were never intended to replace formal discussions, but rather to “find the room”.

“Decisions are always here in this room and not in the informals,” said Driece, but added that the informal meetings were essential to enhance appreciation of one another’s viewpoints.

“We hear that not some of you struggle a little bit and we have to recognise as a Bureau that it’s not 100% clear on what the mandate of co-facilitators is or what the exact aim of a group is and we are working our way through this,” said Driece.

“But there is no other option than to keep on talking till we reach where we want to go,” he added. “I understand that nobody is willing to put all its cards on the table yet to show complete transparency about where they want to go or what their room to manoeuvre is, but at least everybody needs to show as much of their own cards [as possible]  in order to for the other ones to understand how to move on.”

Robust ‘One Health’ approach essential for prevention

France’s Ambassador Anne-Claire Amprou

Meanwhile, France speaking for the “One Health” group, stressed that pandemic prevention “is at the heart of the mandate” given to countries to negotiate a pandemic accord.

“We must take into consideration the ties between people and animals, both wild and domestic, and the environment in order to understand the fundamental factors and the trends that lead to the emergence and re-emergence of diseases,” stressed France’s Ambassador Anne-Claire Amprou. 

“The One Health approach is fundamental in order to fight risk factors and guarantee multiparty and multidisciplinary collaboration between the environment, human health and animal health experts.

“We have a unique opportunity to reinforce ties between these sectors by focusing on existing systems and capacities to ensure prevention preparedness and rapid response to pandemics. The pandemic accord could not be completed without a One Health approach that is robust and strong.”

New method of work 

European Union’s Director General for Health and Food Safety  (DG Santé) Sandra Gallina,

The European Union’s Director General for Health and Food Safety  (DG Santé)  Sandra Gallina, supported the “new method of work” introduced during the closed drafting session of the June INB meeting.

“The interactive and constructive discussions on key topics that prevailed during the meeting marked a significant shift and they are precisely what we need in order to increase the level of understanding of each other proposals,” said Gallina. 

“In particular, the opportunity given to delegations during the drafting group to present their proposals on access and benefit sharing, and the question and answer sessions that followed, proved to be very useful to increase the level of understanding of the various proposals,” she added.

Gallina stressed that this methodology, along with the informal inter-sessional meetings, should be applied to key topics related to the entire pandemic prevention, preparedness and response (PPR) cycle. 

Commenting that much of the current discussion had focused on response, Gallina urged “interactive and constructive discussion on key topics linked to prevention and preparedness” as “the best way of handling future pandemics is to prevent them from happening in the first place”.

Way forward to the first draft

Concluding the opening plenary, co-chair Driece said that the Bureau was “ a bit squeezed” between the time constraints of delivering an accord by May 2024 and accommodating countries’ concerns about having to attend so many meetings.

Driece added that it was not practical to reinstate the entire compilation text as the basis for negotiations and that the Bureau had done its best to summarise countries’ positions.

“We’ve always said if you feel that we left something out which you have proposed, for example, a third option where we present two or a second option where we present one, this room is the place to tell us that.”

On presenting a first draft for text-based negotiations, Driece said that the Bureau felt this was not possible until discussions on Chapter Two of the compilation text had been completed.

“I would rather have a first draft that has substance which we all feel is strong enough to have real line-to-line discussions on, than having something in between which is not good enough yet. So I would rather have a good first draft than a quick first draft, but we will come back with a proposal on how to get there.”

Médecins Sans Frontières (MSF) supporters protesting in front of the New York Stock Exchange in 2020, demanding that Johnson & Johnson makes bedaquiline available for all people with drug-resistant tuberculosis for no more than a dollar a day.

The licensing agreement reached between Johnson & Johnson (J&J) and the Stop TB Partnership on Thursday to allow the generic production of the tuberculosis drug, bedaquiline, is simply a “stop-gap” measure that applies to a limited number of countries, according to Médecins Sans Frontières (MSF).

At least nine countries in the Eastern Europe and Central Asia region with some of the world’s highest burden of drug-resistant TB are likely to be excluded from this deal, according to MSF.

While the countries included in the deal have not yet been made public, J&J has an exclusive commercial agreement with Russia’s Pharmstandard to supply bedaquiline to a number of countries in Eastern Europe and Central Asia and these are thus unlikely to benefit from the Stop TB deal.

Over the past week, J&J has faced public outrage for seeking to extend its patent on bedaquiline, the primary medication to treat drug-resistant TB. The global patent is due to expire next Tuesday but medicine access activists have accused the company of seeking secondary patents in 66 countries. 

US author John Green’s social media posts about the extension of the bedaquiline patent received significant traction, causing #PatientsnotPatents to trend on Twitter on Thursday.

In the midst of the media row, the Stop TB Partnership announced on Thursday that, “following lengthy negotiations”, J&J had granted licenses to its Global Drug Facility (GDF) to “tender, procure, and supply generic versions of bedaquiline for the majority of low-and middle-income countries, including countries where patents remain in effect”.

The GDF plans to launch a global, competitive tender for bedaquiline by the end of July and has reached out to potential suppliers about the process, according to the Stop TB announcement.

But MSF’s Christophe Perrin described the deal as “just a stop-gap because bedaquiline will only be available to a limited number of countries that will be included in this agreement, procuring through the Global Drug Facility”. 

“We remain concerned that J&J retains the global authority to determine access to lifesaving generic versions of bedaquiline in countries with a high burden of TB, even after the expiration of the main patent next week,” said Perrin.

“By continuing to pursue an extension of their monopoly on the drug in many countries, including 34 high-TB-burden countries where J&J still has a secondary patent on bedaquiline, J&J is maintaining control over countries’ ability to offer more people the treatments they need to stay alive and healthy.  

“We reiterate our call on J&J to publicly announce it will not enforce any secondary patents on bedaquiline in any country with a high burden of TB, and withdraw and abandon all pending secondary patent applications for this lifesaving drug,” added Perrin.

However, J&J has denied claims that its patents have prevented TB patients from access to bedaquiline.

“Unfortunately, the most significant barrier to treatment access for patients today is the fact that millions of patients with TB go undiagnosed every year. This is a challenge that we have invested significant resources to overcome and must all get behind if we are to achieve the global goal of ending TB,” said the company.

Key medicine for drug-resistant TB

Bedaquiline is the cornerstone of the best available regimens to cure drug-resistant TB (DR-TB), which is a tough-to-treat form of TB that nearly half a million people get each year, according to the Treatment Action Group (TAG).

“Many countries with high burdens of TB are unable to fully scale up access to DR-TB treatment due to the high cost, up to 70% of which is driven by the price of bedaquiline,” according to TAG.

“Recent estimates suggest that generic versions could shave up to 80% off the price of the drug, resulting in major savings for already cash-strapped TB programs in low- and middle-income countries. Around three-quarters of people in need of treatment for DR-TB live in countries affected by the secondary patents, including countries experiencing active conflicts or humanitarian crises such as Ukraine, Cameroon, Sierra Leone, and Malawi,” added TAG.

The current price that Pharmstandard currently charges the Russian Federation for bedaquiline is around 17 times higher than that agreed on between J&J and Stop TB.

Image Credits: The Global Fund / Evgeny Maloletka, Médecins Sans Frontières.

Children in Muheza, Tanzania, await testing for lymphatic filariasis and onchocerciasis.

African leaders must take the lead in the fight against Neglected Tropical Diseases, invest in their control and elimination, and foster cross-border collaboration to achieve the goal of eliminating NTDs as public health concerns by 2030.

Neglected Tropical Diseases (NTDs) continue to pose a significant threat to the health and well-being of millions of people across Africa. As we strive towards the ambitious goal of eliminating NTDs as public health problems by 2030, it is imperative that we forge greater collaboration at global and regional levels. The Continental Framework and African Common Position on NTDs alongside the WHO Global Roadmap on NTDs (2021-2030) provide provides us with a clear roadmap for action, offering hope and a renewed commitment to tackling these diseases head-on.

Promising steps towards NTD elimination

Africa has made remarkable progress in the fight against NTDs, achieving significant victories against specific diseases. Blinding trachoma has been eradicated in Benin, Gambia, Ghana, Malawi, Mali, Morocco and Togo, while lymphatic filariasis has been eliminated in Egypt, Malawi and Togo. The eradication of Guinea worm extends to Benin, Burkina Faso, Cameroon, Central African Republic, Cote D’Ivoire, Ghana, Kenya, Mauritania, Niger, Nigeria, Senegal, Togo, and Uganda.

One of the key factors contributing to these successes has been the establishment of successful public-private partnerships. Non-governmental development organizations have played a crucial role by contributing to the donation of medicines for Mass Drug Administration (MDA) and supporting other vital NTD interventions, including research and innovation.

Additionally, mass drug administration targets diseases like lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted helminths, and trachoma, leading to a decline in prevalence.

Countries are also scaling up control efforts, employing case management, vector control, Water, Sanitation and Hygiene (WASH) strategies, and One Health approaches. These collective actions demonstrate Africa’s unwavering commitment to combating NTDs and improving the well-being of its people. 

Collective action and innovative financing are essential 

The NTDs prioritized by the WHO are a diverse group of 20 diseases and disease groups that have one thing in common: their devastating impact on impoverished communities.

Despite these successes,  we cannot afford to overlook the persistent challenges that continue to hinder progress in eliminating NTDs. Africa bears a significant burden, accounting for around 40% of global NTD cases. 

Among the 55 African Union Member States, 37 nations face the co-endemicity of at least five NTDs, disproportionately affecting impoverished and marginalized communities. The consequences of these diseases, such as blindness, disfigurement, social stigma, chronic pain, cognitive impairment, disabilities, and long-term irreversible damage, hinder education, employment, economic growth, and overall development, perpetuating the cycle of poverty.

Furthermore, a majority of NTD programmes across the continent suffer from insufficient funding, hindering sustained progress against these debilitating diseases. In alignment with this, WHO’s Case for Investment in NTDs highlights the gaps in funding for NTDs and emphasizes the necessity to consistently support cost-effective interventions and develop innovative financing strategies that can better facilitate collaborative actions across various sectors.

In terms of policy, interventions often occur in isolation, with limited coordination and integration at national and regional levels, further impeding efforts towards elimination.

Africa is leading the fight in reducing the burden of disease, including NTDs and malaria, through mechanisms such as the Africa Health Strategy and the Catalytic framework to end AIDS, TB, and Malaria. These efforts have shaped our response and set a clear direction for the control, elimination, and eradication of diseases by 2030. The WHO NTD Roadmap complements these initiatives, providing overall guidance.

Additionally, the recently established Continental Framework on the elimination of NTDs in Africa offers a vital roadmap to guide our collective efforts in combatting NTDs. By aligning with these ambitious frameworks, we can chart a course toward a healthier future for our continent. 

Coordinated policy integration is critical to overcome barriers 

President Umaro Sissoco Embaló of the Republic of Guinea Bissau and Chair of the African Leaders Malaria Alliance (ALMA).

Now is the time for African Union member states to unite, strengthen our resolve, and take decisive action against NTDs. To truly make an impact, we must fully embrace our responsibility, take ownership, and demonstrate leadership in reducing the prevalence, elimination, and eradication of NTDs. This entails reinforcing policies that promote effective control and elimination strategies. Moreover, fostering inter-state partnerships, especially through cross-border collaboration, is crucial in our fight against NTDs. 

Furthermore, investment in NTD programmes, research and development, and the advancement of local diagnostic tools are essential for informed intervention strategies. Mobilising domestic resources plays a pivotal role in this endeavour.

My own country, Guinea Bissau, serves as a great point of reference, leading the way in alternative financing for NTDs by establishing an integrated End Malaria and NTDs Council. This high-level multisectoral council will keep malaria high on the advocacy and development agenda and mobilise both public and private sector resources to support the elimination of both NTDs and malaria. I am encouraging all countries in Africa to establish their own Malaria and NTD councils and funds as a means of strengthening local interventions.

Addressing the social determinants of health also is paramount in our battle against NTDs. Poverty, inadequate sanitation, lack of clean water, and limited access to education perpetuate the cycle of NTDs. To break free from this cycle, we must collaborate across multiple sectors to tackle these underlying factors. This includes investing in sanitation infrastructure, promoting hygienic practices, and empowering individuals economically. By addressing the root causes of NTDs, we can create lasting change and enhance the overall well-being of our communities.

Harness data for greater progress

NTD scorecard for Guinea Bissau’s Southeastern neighbour, Guinea, for July to December 2022.

Data is an invaluable tool in the development and implementation of strategic interventions against NTDs. Since 2017, the African Leaders Malaria Alliance (ALMA) has been actively supporting African Union Member States in their efforts to control and eliminate NTDs through the use of NTDs scorecards for accountability and action.

So far, 17 countries have adopted these scorecard tools, resulting in significant outcomes. For instance, NTD scorecards have helped to secure additional domestic and partner resources to address the identified areas of underperformance. The scorecards have also improved the availability of real-time data by encouraging countries to include NTD indicators in their routine Health Management Information Systems. 

By strengthening surveillance and data collection efforts, countries can enhance their diagnostic capabilities and build resilient health systems capable of delivering high-quality and equitable healthcare to all. The fight against NTDs requires a united and coordinated effort from all fronts. By implementing these measures and committing the necessary resources, we can create a healthier and more prosperous Africa, ensuring that no one is left behind in our pursuit of a continent free from the burden of NTDs. 

As we move forward, let us draw inspiration from the progress made by countries within our continent and continually work towards mitigating persistent challenges head on. By collaborating, strengthening our health systems and addressing key gaps, we can eradicate NTDs and establish a healthier and more prosperous Africa that benefits everyone. This commitment requires investment at both national and international levels to ensure sustained progress. We must act now, and in unity.

His Excellency Umaro Sissoco Embaló is the President of the Republic of Guinea Bissau and current chair of the African Leaders Malaria Alliance (ALMA).

 

Image Credits: CDC, ALMA.

In groundbreaking new research, experts at the International Agency for Research on Cancer (IARC) have raised a cautious red flag about the artificial sweetener, aspartame, and its link to liver cancer, but stress that evidence is “limited”.

IARC’s Dr Mary Schubauer-Berigan described the artificial sweetener as “possibly carcinogenic to humans” based on “limited evidence” of links to a liver cancer called hepatocellular carcinoma. She spoke at an embargoed media briefing on Wednesday, just before the release of the new IARC report, early Friday morning.

But in light of the dearth of evidence, the World Health Organization (WHO) will not changed its guideline on aspartame consumption, the agency said in an assessment of exposure risks. The WHO guideline, set in 1981, holds that it is safe for most people to consume up to 40 milligrams of aspartame daily per kilogram of body weight. 

In the WHO risk assessment, issued simultaneously, the WHO and Food and Agriculture Organization’s Joint Expert Committee on Food Additives (JECFA) concluded that there was “no convincing evidence from experimental animal or human data that aspartame has adverse effects after ingestion”, said Dr Francesco Branca, the WHO’s Director of Nutrition and Food Safety. He also spoke at the Wednesday media briefing just ahead of the release of the IARC and WHO reports Friday.  

IARC assesses potentially carcinogenic substances, WHO determines safe levels of exposure

Aspartame’s chemical formula

While IARC assesses carcinogenic hazards, as such, JECFA looks at what levels of actual exposure to the hazard are really dangerous.

“It is very important to note that this was a hazard identification and not a risk assessment,” said Schubauer-Berigan, who heads the monograph programme at IARC, a Lyon, France-based research institution affiliated with the WHO.

“A hazard identification aims to identify the specific properties of the agent and its potential to cause harm,” she added.

IARC has four classifications: 1. causes cancer; 2A. probably causes cancer; 2B. possibly causes cancer and 3. unclassifiable as a cancer risk. It has given aspartame a “2B” classification.  

Advice for consumers

Ethiopia’s Coca-Cola Beverages soft drink bottling plant – Africa’s most popular beverage, by far.

Even so, WHO has already recommended that people should be moving away from sweetened drinks – whether sweetened with sugar or artificial ingredients, Branca said.

“If consumers are faced with the decision of whether to take cola with sweeteners or one with sugar I think there should be a third option, which is to drink water instead,” said Branca.

Franco Branca, WHO’s Director of Nutrition and Food Safety.

He pointed to a recent WHO guideline that showed artificial sweeteners may also be associated with an increased risk of type 2 diabetes and cardiovascular diseases, as well as not protecting against excess weight gain.

Common sodas contain between 200 and 300 mg of aspartame, meaning that an adult would need to consume between nine and 14 cans daily to exceed the WHO recommended threshold of 40mg/kg, “which is quite a large amount”, added Branca. 

“So definitely, WHO is not recommending that producers or authorities withdraw products from the market, but considering that there are some concerns identified by some studies… certainly advising the consumers to limit the consumption of sweeteners,” he added.

Moderation and switching to naturally sweet food such as fruit is important because “the consumption of products containing sweeteners has increased and the use of sweeteners, including aspartame has increased to try and respond to consumers’ demand to reduce free sugars”, said Branca. 

“This is particularly important for young children who will be exposed early enough to a taste adjustment,” said Branca.

Call to scientists to do more research

In discussing IARC’s assessment,  Schubauer-Berigan said that “the findings of limited evidence of carcinogenicity in humans and animals, and of limited mechanistic evidence on how carcinogenicity may occur, underscore the need for more research to refine our understanding on whether consumption of aspartame poses a carcinogenic hazard”. 

“One of the key limitations of the existing studies is that most of them measured artificially sweetened beverage consumption only at a single time point,” she added.

IARC had used studies in the US and Europe

Dr Mary Schubauer-Berigan, acting director of the IARC Monographs programme.

Branca agreed, adding that some of the evidence missing included epidemiological studies looking at human outcomes over a longer period, and better mechanistic studies to understand how aspartame could actually affect insulin balance or the risk of inducing cancer.

“We’ve in a sense, raised a flag here, indicating that we need to clarify much more the situation,” said Branca.

Dr Federica Madia, IARC’s senior toxicologist,  said that while aspartame’s key components were almost completely hydrolysed during digestion, there was consistent evidence of oxidative stress, some evidence that it increased insulin levels, and suggestions of impact on “chronic inflammation and increase angiogenesis”.

“The evidence is still limited, but it is there where we would like to go through and investigate more,” said Madia.

Dr Moez Sanaa, WHO’s Head of Standards and Scientific Advice on Food and Nutrition Unit, said: “We need better studies with longer follow-up and repeated dietary questionnaires in existing cohorts. We need randomized controlled trials, including studies of mechanistic pathways relevant to insulin regulation, metabolic syndrome and diabetes, particularly as related to carcinogenicity.”

Aspartame’s links to other health conditions

Aspartame has been linked to a wide range of other serious health conditions aside from cancer. A July roundup by the US-based public health group, Right to Know, cites peer-reviewed studies around the sweetener’s links to cardiovascular disease, Alzheimer’s seizures, stroke and dementia, along with a range of head, stomach and mood disorders, and even weight gain. 

Branca said that JECFA had only found associations with type 2 diabetes and cerebrovascular disease and that these findings were in observational studies and “difficult to interpret”.

Research published last week looking at aspartame’s possible links to Parkinson’s disease found “multiple studies demonstrated decreased brain dopamine, decreased brain norepinephrine, increased oxidative stress, increased lipid peroxidation, and decreased memory function in rodents after (aspartame) use”. 

However, Branca said this study had been published too late for IARC or JECFA to consider.

“We have not clearly identified a potential mechanism of action. Potentially insulin sensitivity could be a pathway but we need to have more demonstrations about that,” said Branca.

Evaluations by the US Food and Drug Administration (FDA), and the European Food Safety Authority have so far rebuffed claims that there is significant evidence of health risks. The FDA states that aspartame is “safe for the general population under certain conditions of use.

Image Credits: Coca Cola, Regular Toxicology and Pharmacology /Elsevier, James Hall/Twitter .

hunger
A woman shows how her maize ears have dried in the drought stricken garden. Due to droughts exacerbated by climate change, people living in the Mauritanian Sahel were at risk of food insecurity in 2012.

The world is on track to miss the United Nations’ target of eradicating hunger by 2030 by 600 million people, according to a flagship UN report on food security released Wednesday.

The report, jointly published by the Food and Agriculture Organization, the International Fund for Agricultural Development, the United Nations Children’s Fund, the World Health Organization, and the World Food Programme, found that the number of people facing hunger has increased by 122 million since 2019, to 735 million.

The number of people experiencing food insecurity stabilized in 2022 after hitting record numbers in 2021, but the situation remains grim. Hunger continued to rise in Western Asia, the Caribbean, and all African subregions. Africa continues to be the worst affected, with one in five people facing hunger on the continent — more than double the global average.

“Recovery from the global pandemic has been uneven, and the war in Ukraine has affected nutritious food and health diets,” said Qu Dongyu, director-general of the FAO. “This is the ‘new normal’ where climate change, conflict, and economic instability are pushing those on the margins even further away from safety.”

Global hunger remained virtually unchanged from 2021 to 2022 but is still far above pre-pandemic levels.

The report found that the number of people who did not have constant access to food rose to 2.4 billion in 2022, nearly 30% of the global population. Of those, 900 million faced severe food insecurity. Food inflation rose by 7% between 2019 and 2021, resulting in 42% of the global population — over 3.1 billion people — not being able to afford a healthy diet.

“One of the major messages of the report is that if we run the contrafactual – what would have happened if there was no COVID-19 – we would have seen a decline [in hungry people],” FAO Chief Economist Maximo Torero told Devex, adding that the same could be said for the war in Ukraine.

Children under five continue to be especially hard hit by the global food crisis, with millions suffering from malnutrition. Nearly 200 million were undernourished, while 37 million were overweight.

“There are rays of hope, some regions are on track to achieve some 2030 nutrition targets. But overall, we need an intense and immediate global effort to rescue the Sustainable Development Goals,” UN Secretary-General Antonio Guterres said in a statement during the report’s launch at UN headquarters in New York. “We must build resilience against the crises and shocks that drive food insecurity — from conflict to climate.”

Climate models underestimate odds of ‘synchronized’ global crop failures

The onset of the Russian invasion exacerbated the global food crisis. Russian President Vladimir Putin has leveraged the importance of the Black Sea corridor to global food security obtain concessions from the international community.

The Black Sea grain corridor that allows for the safe passage of ships carrying grain out of Ukraine’s ports is set to expire on Monday. If the deal is not renewed by Russian President Vladimir Putin, it could have dire consequences for the global food crisis. Prices could rise even further, and millions more people could go hungry.

UN Secretary-General Antonio Guterres has proposed that Putin extend the deal in return for reconnecting a subsidiary of Russia’s agricultural bank to the SWIFT international payment system, according to Reuters. All Russian banks have been cut off from SWIFT since June 2022.

The release of the UN report on food security came as the world was experiencing its hottest week on record. The unprecedented surface and ocean temperatures coincided with the onset of El Niño, a climate pattern that makes the ocean water in the Pacific Ocean warmer than usual.

El Niño events, which occur naturally but are influenced by human-caused climate change, are expected to become more frequent and intense as the planet warms. The resulting temperature spikes could have a significant impact on weather patterns all over the world.

The record-breaking temperatures “highlight the far-reaching changes taking place in Earth’s system as a result of human-induced climate change,” the World Meteorological Organization said.

“We are in uncharted territory, and we can expect more records to fall as El Nino develops further,” said Christopher Hewitt, Director of Climate Services at the World Metereological Organization. “This is worrying news for the planet.”

Climate change is already having a dire impact on the world’s food supplies, and the situation is only expected to worsen. New research suggests that climate models may underestimate the risk of simultaneous crop failures across the world’s breadbaskets, a finding that could have dire consequences for global food security.

The study, published in the journal Nature Communications last week, found that climate models have been “excellent” at projecting the mean response to continued greenhouse gas emissions, but that the models may underestimate the likelihood of concurrent extreme weather events that could lead to crop failures.

“Concurrent crop failures in major crop-producing regions constitute a systemic risk,” said the team of scientists from University of Columbia. “Evidence for high-risk blind spots such as an underestimation of synchronized harvest failures as identified here, manifests the urgency of rapid emission reductions, lest climate extremes and their complex interactions might increasingly become unmanageable.”

The war in Ukraine has limited the world’s access to one vital breadbasket. Climate change could hit multiple breadbaskets simultaneously, with dire consequences for millions of people around the world.

Image Credits: Pablo Tosco/Oxfam, Breta Valek.