By Laura Klivans, KQED

San Francisco’s Board of Supervisors is slated to vote Tuesday to ban the sale and distribution of e-cigarettes in the city. The city is the corporate home of Juul Labs, the biggest producer of e-cigarettes in the country.

The ordinances would make the sale of e-cigarettes illegal in brick-and-mortar stores and online when shipping to San Francisco addresses.

San Francisco Mayor London Breed has 10 days to sign the legislation, which she has said she will do. The law will be enforced seven months from that date, in early 2020.

San Francisco Supervisor Shamann Walton, who co-authored the legislation, sees it as part of a long-term battle against the effects of smoking.

“We spent a few decades fighting big tobacco in the form of cigarettes,” Walton said. “Now we have to do it again in the form of e-cigarettes.”

Photo: Mike Mozart

Under federal law, the minimum age to buy tobacco products is 18. California and 15 other states, however, have raised that age to 21 or passed measures that will set it to 21 by 2021. Despite this, use of e-cigarettes, or vaping, has skyrocketed among teenagers nationally.

Last year, 1 in 5 high school seniors reported vaping in the past month. That’s almost double the number from the year before. Even eighth graders are vaping in record numbers.

These increases come after years of declines in teenagers smoking traditional cigarettes.

Public health officials are concerned about the rising number of teenagers using e-cigarettes, as nicotine can harm a young person’s developing brain. The Centers for Disease Control and Prevention warns that young people who vape may be more likely to start smoking traditional cigarettes.

Walton said he’s disgusted with the actions of Juul and similar companies, who he said are “putting profits before the health of young people, and people in general.”

Despite the tobacco age limit, Walton noted that vaping devices are commonly confiscated from students in the city’s middle and high schools.

The ordinance is accompanied by another that prevents the manufacture, distribution and sale of e-cigarettes on San Francisco property. The ordinance takes direct aim at Juul Labs, which leases space from the city on San Francisco’s Pier 70. The ordinance is not retroactive, so it would not remove Juul from the company’s current space, but it would prevent other e-cigarette makers from renting city property in the future. In a statement, Juul spokesman Ted Kwong wrote that, regardless, the company does not “manufacture, distribute or sell our product from this space.”

Juul’s vaping device was introduced in 2015. It’s small, sleek and discreet, looking similar to a flash drive. The company now controls 70% of the vaping market.

In a statement, Juul Labs said it shares the city’s goal of keeping e-cigarettes away from young people. The company said it has made it harder for underage buyers to purchase Juul off its website and has shut down Juul accounts on Facebook and Instagram.

But, the company argues that “the prohibition of vapor products for all adults in San Francisco will not effectively address underage use and will leave cigarettes on shelves as the only choice for adult smokers, even though they kill 40,000 Californians every year.”

Walton doesn’t buy that argument, however. He said that’s simply “trading one nicotine addiction for another.” What’s more, he’s concerned that for every adult that might benefit, dozens of young people could become addicted.

San Francisco resident Jay Friedman said the complete e-cigarette ban goes too far. The software engineer smoked a pack of cigarettes a day for 20 years, and smoking e-cigarettes has reduced his regular cigarette habit to two to three a day. He said he feels better physically.

Friedman supported a ban on flavored tobacco that city voters passed last year. “I feel like it was good to get rid of the fruit flavors for kids,” he said, “but this feels like maybe a step too far.”

If e-cigarettes are banned, he said, he would try to quit nicotine altogether. But, “there would be a point in a moment of weakness where I’d just end up buying a pack of smokes again and then it’s just a slippery slope from there.”

Small businesses in San Francisco are concerned the ban will hurt their bottom line.

Miriam Zouzounis and her family own Ted’s Market, a convenience store near downtown San Francisco. She said e-cigarettes are an “anchor” product: They draw people into the store.

“When people come and want to purchase something at the store and we don’t have that exact item that they want, they’re not going to buy the rest of the items that they might on that trip: a drink or a sandwich,” Zouzounis said.

She said sales from e-cigarettes account for at least $200 to $300 a day in sales. As a board member of the Arab American Grocers Association, she said she believes laws like this mostly affect businesses owned by immigrants.

Abbey Chaitin is a 15-year-old lifelong San Francisco resident. She isn’t drawn to using e-cigarettes, she said, because she has seen peers become addicted to them.

“I’ll see them in class fidgeting,” Chaitin said. “They need it to focus, to function.”

And Chaitin predicted that, regardless of a ban, young people will still get their hands on e-cigarettes: “People my age can find a way around that if they really need to,” she said.

Meanwhile, Juul is collecting signatures for a November ballot initiative to override the ban.

This story is part of a partnership that includes KQED, NPR and Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

A sensitive, closed-door selection of the new Executive Director for UNAIDS has kicked up a noisy social media debate among a number of leading global health figures, who questioned whether a separate bureaucracy for one disease, founded at the height of the AIDS epidemic, remains justified today – when bigger global health threats now loom.Continue reading ->

Image Credits: Wikimedia Foundation, John Zarocostas, UNAIDS.

[By Reuters]

NEW YORK (Reuters) – Merck & Co Chief Executive Ken Frazier said on Thursday a rule to base the price the U.S. government pays for some prescription drugs in it[s] Medicare program on lower prices in other countries would face legal challenges if adopted.

U.S. President Donald Trump said last year that one way his administration would seek to lower drug costs to consumers could be through an international pricing index (IPI) that would determine what Medicare pays for certain medicines based on the prices set in a handful of other countries. A proposed version of the rule is expected in August.

Ken Frazier, Chairman and CEO, Merck & Co., speaks during a meeting of the Economic Club of New York in New York City, U.S., October 3, 2018. REUTERS/Brendan McDermid

Other developed nations with single payer systems typically pay far less for drugs than the United States, which Trump called “global freeloading.”

“I think there will be challenges to the rule,” Frazier told reporters following the drugmaker’s investor day in New York. “A lot of people have objections to that rule. It’s not just pharmaceutical companies.”

Frazier, a lawyer by trade, did not say whether Merck would launch its own legal challenge to the proposed rule.

The company was one of three U.S. drugmakers that sued the U.S. Department of Health and Human Services this week over a new government regulation requiring them to disclose the list price of prescription drugs in direct-to-consumer television advertisements.

Of the Trump administration proposals to lower drug costs, the IPI option is the one Frazier said most concerns him, due to the effect importing price controls from other countries might have on innovation and patient access in the United States.

“We tell incomplete stories about those markets,” Frazier said, noting that some countries ration treatments available to patients. He pointed to lower survival rates for lung cancer in Britain, which has an agency that can bar the use of approved new medicines based on their cost.

Earlier on Thursday, Merck executives touted the company’s pipeline of experimental drugs beyond its blockbuster cancer treatment Keytruda.

The investor event was also an opportunity for Merck to showcase executives other than Frazier, who turns 65 in December. Last year, the company scrapped its mandatory retirement age of 65 for its CEO, saying it gave the board flexibility around finding his successor.

“I’m extremely pleased by the breadth of the leadership talent at the company,” Frazier said in response to a question about succession. “I know that the board feels the same way. And they will continue to look at when the right opportunity is … to make a selection.”

(Reporting by Michael Erman; Editing by Bill Berkrot)

Image Credits: REUTERS/Brendan McDermid.

[WHO news release] Three quarters of people living with epilepsy in low-income countries do not get the treatment they need, increasing their risk of dying prematurely and condemning many to a life of stigma.

These findings are part of a first-ever global report on Epilepsy, a public health imperative, released today by WHO and two leading nongovernmental organizations for epilepsy, the International League Against Epilepsy and the International Bureau for Epilepsy.

“The treatment gap for epilepsy is unacceptably high, when we know that 70% of people with the condition can be seizure-free when they have access to medicines that can cost as little as US$5 per year and can be delivered through primary health systems,” said Dr Tarun Dua, from WHO’s Department of Mental Health and Substance Abuse.

Premature death is three times higher in people with epilepsy

Epilepsy, characterized by abnormal electrical activity causing seizures or unusual behaviour, sensations and sometimes loss of awareness, is one of the world’s most common neurological diseases, affecting nearly 50 million people of all ages around the world – with peaks among children and people over the age of 60.

Globally, the risk of premature death in people with epilepsy is up to three times higher than for the general population. In low- and middle-income countries, early death among people with epilepsy is significantly higher than in high-income countries. Reasons for this premature mortality in low- and middle-income countries are likely associated with lack of access to health facilities when seizures are long-lasting or occur close together without recovery in between, and preventable causes such as drowning, head injuries and burns.

Roughly half of adults with epilepsy have at least one other health condition. The most common are depression and anxiety: 23% of adults with epilepsy will experience clinical depression during their lifetime and 20% will have anxiety. Mental health conditions such as these can make seizures worse and reduce quality of life. Development and learning difficulties are experienced by 30-40% of children with epilepsy.

Stigma is widespread

Stigma about the condition is also widespread. “The stigma associated with epilepsy is one of the main factors preventing people from seeking treatment,” said Dr Martin Brodie, President of the International Bureau for Epilepsy. “Many children with epilepsy do not go to school and adults are denied work, the right to drive and even to get married. These human rights violations experienced by people with epilepsy need to come to an end.”

Public information campaigns in schools, workplaces, and the broader community to help reduce stigma and the introduction of legislation to prevent discrimination and violations of human rights are also important elements of the public health response.

25% of epilepsy cases can be prevented – Treatment can be offered at primary care level

Causes of epilepsy include injury around the time of birth, traumatic brain injury, infections of the brain (such as meningitis or encephalitis) and stroke. It is estimated that 25% of cases can be prevented.

Effective interventions for prevention of epilepsy can be delivered as part of broader public health responses in maternal and newborn health care, communicable disease control, injury prevention and cardiovascular health. Screening for pregnancy complications and the presence of trained birth attendants can help prevent injury around the time of birth. Similarly, immunization against pneumonia and meningitis; malaria control programmes in endemic areas; initiatives to reduce road traffic injuries, violence and falls; and health and community interventions to prevent high blood pressure, diabetes, obesity and tobacco use can all help reduce epilepsy rates.

The report highlights that when the political will exists, the diagnosis of and treatment for epilepsy can be successfully integrated into primary health services. Pilot programmes in Ghana, Mozambique, Myanmar and Viet Nam as part of WHO’s “Reducing the epilepsy treatment gap” programme have led to a considerable increase in access, such that 6.5 million more people have access to treatment for epilepsy should they need it.

“We know how to reduce the epilepsy treatment gap. Now action to introduce the measures needed to make a difference needs to be accelerated,” said Dr Samuel Wiebe, President of the International League Against Epilepsy. “Ensuring uninterrupted supply of access to anti-seizure medicines is one of the highest priorities, as is training of non-specialist health providers working in primary health-care centres.”

Image Credits: WHO.

The proportion of the world’s population using safely managed sanitation services increased from 28-45% between 2000 and 2017, according to the latest joint report of the World Health Organization and UNICEF on Progress in Household Drinking Water, Sanitation and Hygiene.

However, huge service gaps still remain, with 4.2 billion people worldwide still lacking access to what WHO defines as hygienic toilets or latrines — where wastes are treated and disposed of safely. And while numbers have declined by one-half since the year 2000, some 673 million people still practiced open defecation in 2017.

In terms of drinking-water, the proportion of people with a “safe” drinking water sources, increased from 61% to 71% between 2000-2017, notes the WHO report, released Tuesday. However, some 2.2 billion people  still lack access to a safe drinking-water source, which WHO defines as water located on the household premises, free from contamination and available when needed. Finally, some 3 billion people also lack  basic-hand washing facilities of soap and water at home; these are critical in preventing transmission of many bacterial and parasitic diseases.

The report, Progress on drinking water, sanitation and hygiene: 2000-2017: Special focus on inequalities finds that large gaps also remain in the quality of services that can be accessed by rich and poor, as well as by urban and rural populations.

Of the 2 billion people that still lack access to even the most basic toilet or latrine, 7 out of 10 live in rural areas and one third live in least  developed countries, the report notes.  Nearly three quarters of people in least developed countries still do not have basic hand washing facilities  at home.

And in countries where service levels were assessed by socio-economic group, coverage of basic services among the richest sectors of the population was far higher than among the poor.

“Mere access is not enough. If the water isn’t clean, isn’t safe to drink or is far away, and if toilet access is unsafe or limited, then we’re not delivering for the world’s children,” said Kelly Ann Naylor, Associate Director of Water, Sanitation and Hygiene, UNICEF, in a WHO press release. “Children and their families in poor and rural communities are most at risk of being left behind. Governments must invest in their communities if we are going to bridge these economic and geographic divides and deliver this essential human right.”

Without stepped-up action, the world will fail to meet the 2030 Sustainable Development Goal 6 for universal access to safe water and sanitation services, WHO officials warned.  That translates into higher rates of transmissible diseases, which are both deadly as well as costly to treat for budget-strapped health systems.

“If countries fail to step up efforts on sanitation, safe water and hygiene, we will continue to live with diseases that should have been long ago consigned to the history books: diseases like diarrhoea, cholera, typhoid, hepatitis A and neglected tropical diseases including trachoma, intestinal worms and schistosomiasis,” said Maria Neira, Director of WHO’s Department of Public Health, Environmental and Social Determinants of Health in the WHO press release.

WHO estimates that some 297 000 children under the age of 5 die every year as a result of diarrhoeal diseases linked to unsafe drinking water, inadequate sanitation or hygiene. Poor sanitation and contaminated water are also linked to transmission of deadly water-borne diseases such as cholera, dysentery, hepatitis A, and typhoid.

Although some 2.1 billion people have gained access to basic sanitation services since 2000, in many parts of the world the wastes produced by toilets and latrines leach untreated into ground and water sources – meaning that they are not really adequate sanitation solutions.

And despite the global decline in open defecation, in 39 countries the practice has actually increased over the past 17 years, the report notes. The majority of these countries are in sub-Saharan Africa, which has experienced strong population growth over the same period.

“Closing inequality gaps in the accessibility, quality and availability of water, sanitation and hygiene should be at the heart of government funding and planning strategies. To relent on investment plans for universal coverage is to undermine decades worth of progress at the expense of coming generations,” said Naylor.

The report is the latest in the series of reports that are issued by the WHO/UNICEF Joint Monitoring Programme (JMP) for Water Supply, Sanitation and Hygiene, which is the official United Nations mechanism for tracking global progress on safe drinking water, sanitation and hygiene, in relation to the Sustainable Development Goals (SDG).

 

Image Credits: UN Water, WHO.

The World Health Organization (WHO) today launched a global AWaRe campaign, which aims to support national health systems to make more judicious use of lifesaving drugs so as to combat a worldwide trend of antimicrobial resistance (AMR) – including increased pathogen resistance to common antibiotics, antivirals and anti-fungal medications.

However, WHO’s own 2018 Report on Surveillance of Antibiotic Consumption shows that some of the biggest countries worldwide, including the US, China and India, have not submitted even the most basic data on total amounts of antibiotics consumed nationally every year by their countries’ health systems.

Ironically, the US Food and Drug Administration (FDA) does report on animal antibiotic use; that data shows the US to be the largest net consumer, by far, of antibiotics in animal agriculture in comparison to most European countries combined.

In light of the growing urgency of the AMR threat – which a major new UN report in April said could lead to as many as 10 million deaths by 2050 – some leading AMR researchers and advocates from the United Kingdom, Thailand, Australia and the US, are saying that a simple global metric is needed to track the quantities of drugs that countries are actually using.

Their work, available at Antibioticfootprint.net, and supported by a grant from the Wellcome Trust, compares aggregate use of antibiotics by country, for human and animal sectors, relying upon publicly available, official data. (See also In Focus).

Papers published out of the project in the Journal of Antimicrobial Chemotherapy as well as by the Center for Disease Dynamics, Economics, and Policy (CDDEP) make the argument that a simplified “antibiotic footprint” is needed to communicate to the wider public the magnitude of antibiotic use in humans, animals and industry.

The antibiotic footprint project builds upon a concept originally developed by a Thai researcher,  Direk Limmathurotsakul at Mahidol University, Bangkok, and then adopted by other leaders in the AMR field, including:  Ramanan Laxminarayan of CDDEP, New Delhi,  Marc Mendelson, of the University of Cape Town, and Philip Howard, President of the British Society for Antimicrobial Chemotherapy (BSAC).

In an interview with Health Policy Watch, Howard called the footprint a “One Health” Approach to antimicrobial resistance.  “At the moment every country you look at through official data sources considers human and animal [antibiotic] consumption separately. We wanted to show everything in a single place,” he said.

He noted that this holistic approach is important because recent evidence indicates that if you can “reduce the amount of antibiotic use in animals, then you can reduce resistance in humans by as much as 24% — with the strongest correlation among people working in food production.”

He said that the footprint’s data, all peer reviewed, is based solely upon official data submitted to WHO, other international agencies or published by national governments, but often buried in the fine print of highly technical sources.

“What the antibiotic footprint tries to do is to pull together freely available information, ideally information that has been submitted to WHO about antibiotic consumption, World Organization for Animal Health, or published by national governments,”  said Howard.

Currently there are very wide regional discrepancies in countries that report on antibiotic consumption to WHO or others, said Howard. “If you look at the countries who are submitting data on human use of antibiotics, you will see Europe is very good –  85% of countries submit data, whereas in the Western Pacific Region it is only 22%; in the Americas it’s only 17% percent of countries, and then Africa has 9%; and there is no data submitted from South East Asia.”

Limmathurotsakul says that in developing the site he was inspired by similar efforts to create carbon footprints for awareness-raising about climate change. The simple formulation of the website allows the public to visually grasp trends, such as the very high use of antibiotics for animals in some countries; very consistent levels of reporting in Europe and Japan; and key gaps in data elsewhere. “If you don’t know the amount you are using, you can never reduce,” he pointed out.

The site also provides a snapshot of available per capita data on antibiotic use by country – to put comparisons on a more equal playing field.  Those countries ranking very high in per capital human consumption, such as Mongolia, tend to be middle or upper middle income nations Limmathurotsakul observed. In such countries people  can afford to purchase drugs, but products may also be poorly controlled by regulatory authorities, leading to overuse.  The footprint data also reflects the fact that in lower middle income countries, little data on animal consumption exists. “I think that many lower middle income countries are doing a good job, but the data from the animal sectors is still lacking from most lower middle income countries; they need to do more,” said Limmathurotsakul.

WHO AWaRe campaign

In contrast to the antibiotic footprint, the WHO AWaRe tool is aimed more squarely at the health sector – and at shifting from the use of drugs that should be held in reserve for the most serious health conditions, to drugs that are effective in combating most common pathogens, but less likely to stimulate trends of antimicrobial resistance.

The WHO tool can also be used to rationally expand access to antibiotics among groups that don’t currently get such drugs at all, said Assistant Director General for Access to Medicines, Mariângela Simão, speaking today at a WHO press briefing.

“It is a tool that countries can use to reduce antimicrobial resistance, but also a tool [for supporting] use of antibiotics where access is low,” said Simão, noting that an estimated 1 million children die every year from treatable bacterial disease linked to the lack of antibiotic treatment.

“On one side we have an imbalance in [human] access to antibiotics,” she said. “In other countries there is an imbalance in antibiotic use, where animals and agriculture have an excess use.

The tool helps hospitals and health systems assess and classify their drug use in terms of categories defined by WHO as Access, Watch and Reserve, said Hanan Balkhy, WHO’s new Assistant Director General of Antimicrobial resistance. The 19 medicines in the  “Access” category can be made widely available without high risks of stimulating antimicrobial resistance.  Amoxycilin is an example of such a drug, used for many common infections, she said. Another 11 drugs in the “Watch” category should be used only as a second resort, and not at all in animal health; another class of antibiotics, Fluoroquinolones belong in that category. Finally, there is a list of 7 “Reserve” drugs should only be used as a last resort, Balkhy explained.

Out of WHO’s 194 member states, some 65 countries worldwide are reporting to WHO on their antibiotic use through use of the AWaRe tool, Balkhy said.  Of those, only 29 countries meet the goal recommended by WHO for 60% overall use of drugs in the lowest-risk “Access” category.

While national monitoring of aggregate drug consumption would still be required to use the WHO tools, pulling together such data globally is difficult, Balkhy asserted, since “there is not one single tool that all countries are using.”

The AWaRe tool will be formally launched Wednesday at the Second Ministerial Conference on Antimicrobial Resistance, which is taking place 19-20 June in Noordwijk, The Netherlands, in collaboration with WHO, the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE).

The conference will look at ways to advance the Global Action Plan on Antimicrobial Resistance, approved by the World Health Assembly 2015.  The Global Action Plan takes a multi-pronged approach to combating AMR, with more rational and optimal use of existing drugs in humans and animals; development of new drug therapies; more effective management of sanitation and hygiene in health facilities, livestock production and communities, where sewage and waste may provide a fertile breeding ground for resistant microbes; as well as improved surveillance, research and awareness-raising.

Balkhy acknowledged that the AWaRe tool addresses just one of the “big pieces of this big mosaic, of antimicrobial resistance that we all need to tackle.  The other pieces are just as critical, and they all have to be put into place to slow down and mitigate AMR. But if we don’t do this, it will probably lead to a halt in modern medicine as we know it today.”

 

 

 

Image Credits: WHO .

The global community needs to reduce climate emissions by 45% by 2030 to avoid the most dire warming scenarios. But drastic action to confront the “climate emergency” would mean better health and more jobs, declared the UN’s top climate official, Patricia Espinosa, at Monday’s opening of the Bonn Climate Change Conference (SB50), the warm-up to September’s UN Climate Summit.

“This is the fight of our lives,” said Espinosa, executive secretary of the UN Framework Convention on Climate Change (UNFCCC), at a press briefing. She noted that the poor level of commitment so far by countries that signed the 2015 Paris Agreement “will take us to a warming of the atmosphere of 3°C ” – something that scientists have warned will lead to widespread disruptions in food production, water resources and other ecosystems – all affecting health.

“People will be getting sicker, it will lead to battles over resources like water, land of course,” remarked Espinosa. “Where are those communities displaced from coastal areas [by sea level rise] going to go?  It is important for all people open their eyes to how urgent things are, there is no time to waste.”

But while “reducing emissions may sound like a very technical concept”, it can actually generate huge benefits for health and well-being, Espinosa asserted. “What does it really mean? It means for instance, less air pollution, which leads to improved health, especially for children.” More than 90% of the world’s children breathe toxic air and some 600,000 children a year die from air pollution-related diseases, according to WHO estimates. That pollution is largely generated by the same dirty fuels and sources that spur climate change.

 

Referring to her home country, Mexico, Espinosa noted that due to high air pollution levels, schools last year were closed for some days, and on other days children were confined indoors. “They needed to stay inside because the air was so polluted…. So this is what reducing emissions means, having the clarity that your child can go out and play, and not having to worry about it. “It means cleaner water. It means that children in big cities doesn’t have to be restricted in the way we are seeing. It also means more new green jobs. And it means the possibility of achieving our 1.5°C degree goal,” she concluded.

The Bonn conference, 17-27 June, plays host to a wide range of events, meetings, and negotiating sessions that aim to “raise ambitions” for the September gathering by heads of state at UN Headquarters in New York City, followed by the December Conference of Parties (COP25) in Santiago, Chile.

UN Secretary General António Guterres has called on national leaders to bring concrete commitments to the UN Summit  for investments that will curb greenhouse gas emissions and accelerate climate resilience. To pave the way, Espinosa said that she hoped the Bonn meeting would advance an agreement for “solid rules for carbon markets to finally take shape.”

There are some “very good” climate finance initiatives happening around the world but “they are all over the place,” Espinosa observed.  “What is bringing them together? It is time to bring them together, and I think the [UN] Secretary General’s Climate Summit will be an enormous, important opportunity to move in that direction.” “We need more ambition on mitigation, more ambition on adaptation, more ambition on finance.”

She said the Bonn session would also focus on getting developed countries to deliver on the promise made in the 2015 Paris Agreement to mobilize US$ 100 billion annually by 2020 to fund climate mitigation and adaptation activities in developing countries. “Not all have lived up to it, so we need to remind them about this commitment that was made,” she quipped.

Other themes to be covered include: the role of local communities, indigenous communities, and youth in climate action. Referring to recent youth demonstrations and strikes over climate change, Espinosa said, “If your child is running into the room and saying there is a fire in the kitchen, everyone would run into the kitchen to do everything to put out the fire before it burns down the house. What the youth are saying now is that the house is burning. They shouldn’t be ignored in our process.

“The only option we have is to go for a low emissions future.  We have to do it very fast. We need to get to the 1.5 °C degree goal,” she said, referring to the 2015 Paris Agreement to keep warming below 2°C. “If we don’t do that immediately, we really don’t know what will be the result for humanity.”

 

 

Nine months after a historic high-level UN meeting where countries pledged to end the global tuberculosis epidemic by 2030, a chronic lack of R&D financing jeopardises that ambitious goal, said expert panelists at a briefing on the TB R&D landscape last week in Geneva, hosted by South Africa’s Permanent Mission to the UN.

While there are now more TB drugs in the development pipeline, massive funding as well as other types of policy and institutional support are needed to support the large and decentralized network of small and medium enterprises, research groups, and public-private partnerships aspiring to bring new tools to market, said panelists at the event on “The Way Forward for TB: Innovation and Research.”

In particular, global donors and policymakers need to harness the momentum of new research initiatives underway in the so-called “BRICS” countries of Brazil, Russia, India, China and South Africa – where TB remains very prevalent, some experts stressed. Speakers included representatives from the Stop TB Partnership, the  International Union Against Tuberculosis and Lung Disease (The Union), Medicines Patent Pool (MPP), Médecins Sans Frontières (MSF), the South Centre, and the Treatment Action Group (TAG).

Tuberculosis remains among the top 10 causes of death worldwide. In 2017, TB caused an estimated 1.6 million deaths, including 300,000 deaths among HIV-positive people, according to WHO’s Global Tuberculosis Report 2018 [pdf]. The situation is aggravated by growing incidence of multi-drug resistant TB (MDR-TB), where strains of Mycobacterium tuberculosis fail to respond to the most common forms of antibiotic treatment.

To meet the longstanding challenge of inadequate drugs and vaccine tools, the September, 2018 political declaration [pdf] of the UN High Level Meeting on the Fight to End Tuberculosis, was a milestone.  Notably, the UN declaration committed to increase global TB research investments to US$ 2 billion annually, closing an estimated $1.3  billion annual research funding gap.  Other assessments have concluded that $2.5 billion annually is in fact needed to make up for inflation and funding shortfalls in previous years.

TB and TB-MDR Detection and Treatment in Lima, Peru

TB Pipeline Improving But Funding Gap Slows R&D for Vaccines & Treatments

Funding is needed to speed up development for some of the most promising solutions, said Ezio Tavora dos Santos Filho, of REDE-TB, a Brazilian based NGO, and a member of WHO’s Civil Society Task Force on TB. As one example, Tavora referred to a new TB vaccine candidate that yielded positive results in a Phase IIb trial and, “urgently needs to be advanced into a Phase III trial.” The existing BCG vaccine for TB, the only one currently available, is often administered to infants in settings with high TB prevalence. But it is only partially effective and does not confer lifelong immunity.

Compared to the past, the TB R&D pipeline is looking better, said Estaban Burrone, head of policy at the Medicines Patent Pool (MPP). However, there remains an acute need for more affordable oral and short-term TB regimens.

Overall, the R&D landscape remains “very weak” in terms of new drugs, treatment regimens and diagnostics, asserted Viviana Munoz-Tellez, of the South Centre. Besides funding, another barrier is the lack of agreed-upon criteria for making choices about compounds and vaccine candidates to advance, she said, when such choices also involves taking calculated risks about what to move forward.

To address chronic under funding of TB strategies, Erica Lessem, deputy executive director, Programs, at TAG suggested that countries worldwide should each divert 0.1 percent of their research spending to tuberculosis. That “very realistic strategy” would close the funding gap, she said. She added that research should be guided by core principles of affordability, efficiency, and equity; end-user prices should also be “delinked” from the costs of R&D and production.

Old Model of R&D Needs Reform for TB Research to Advance

In fact, the TB research incentives landscape needs deeper reform, in particular for later-stage R&D, according to Suerie Moon, director of research at the Global Health Centre of Geneva’s Graduate Institute of International and Development Studies.

She noted that such R&D had  historically been focused in a cluster of large companies based in high-income countries, but TB research is now being carried out in dozens of middle-income countries as well. And critical TB research initiatives are increasingly led by small and medium-sized enterprises, as well as publicly-funded product development partnerships, and academic research institutions. Since TB research cannot often compete with more lucrative drugs, such as cancer treatments, in the portfolios of large pharmaceutical firms, an even greater focus on funding distributed to this broader network of actors, would be more effective, she said.

Encouraging transparency around R&D processes is also important,  Moon added. “In policy debates and in the public imagination,” R&D is a black box, with the assumption that R&D is complicated, extremely expensive, and takes forever, she said. Opening the black box would ensure that people understands how it really works, and see that it is “very feasible to do it in a different way.”

Other speakers, such as the South Centre’s Munoz-Teller, contended that patents are an insufficient driver for industry innovation when it comes to TB research. If and when patents are obtained, they can also limit access and delay competition for TB drugs, she said.

With close to 80 percent of research funding coming from a range of public or philanthropic sources, funders have considerable leverage to impose price and marketing conditions on new health products that reach regulatory approval so that they can be more accessible, MPP’s Burrone agreed. According to the 2018 Tuberculosis Research Funding report, by Stop TB and TAG, some 66 percent of global TB funding in 2017 came from public sources, 19 percent from philanthropies, 11 percent from private industry, and 4 percent from UN and other multilateral organizations.

Way Forward for TB Innovation and Research – Panelists (left to right): Paula Fujiwara, The Union; Erica Lessem, Treatment Action Group; Suerie Moon – Graduate Institute; Pauline Beatlie – EDCTP.

Data Sharing Key for Innovation

Data sharing is another key to unlocking the potential of TB research and innovation said Brigden. Data sharing allows for wider collaboration, helps decision-makers in their choices, and is directly linked to access to products. For example, data from failed trails is very important in guiding successful design of further trials. Data also serves to accelerate registration of new tools, promote good scientific practices in a cost effective and timely manner, and facilitate meta-analyses that further synthesize data useful to the development of global guidelines as well as market access analyses, she explained.

Contrary to some preconceptions, the academic world can be even more protective of its data than industry, said Pauline Beattie, operations manager for the European & Developing Countries Clinical Trials Partnership (EDCTP), which recently forged a partnership between the European Union and sub-Saharan African countries to accelerate clinical research on poverty-related diseases such as TB. Beattie also noted that low- and middle-income countries are sometimes reluctant to share their data, if in the past such data were used by others without their consent.

WHO Global Strategy on TB R&D In Progress

In order to meet the 2030 target to end the TB epidemic, WHO is meanwhile working on the development of a Global Strategy for TB Research and Innovation.  The strategy is currently open for consultation and comments by member states, said Teresa Kasaeva, director of WHO’s Global Tuberculosis Programme.

The strategy aims at creating an enabling environment for TB innovation; increasing financial investments in TB research and innovation; ensuring equitable access to the benefits of research; and promoting and improving approaches to data sharing. The draft global strategy will be presented to the next WHO Executive Board in January 2020.

According to Munoz, the draft strategy offers a useful approach insofar as it covers the whole value chain, and it also considers a wide range of actors in the arena of diagnostics, vaccines, and treatment.

However, she said, the access to treatment safeguards in the draft strategy should be more specific, including: recommendations for clear provisions in drug development contracts ensuring broad access to medicines thus developed, as well as more open innovation, collaboration and data-sharing.

BRICS Countries Are Moving

Another bright spot in the funding landscape is the recent investment of BRICS countries (Brazil, Russia, India, China and South Africa) into TB research that would yield safe and affordable drugs and diagnostics.  This includes the BRICS TB Research Network, said Tavora, an initiative to which Brazil has also made a major funding commitment. Such investments are significant insofar as BRICS countries represent some 40 percent of the global population and bear 50 percent of the TB burden, including 60 percent of multi-drug resistant TB incidence, Tavora noted.

During last month’s World Health Assembly last month, BRICS countries proposed that WHO’s Global TB department host the Network Secretariat, Brigden told Health Policy Watch.

 

 

 

Image Credits: PAHO/WHO, Catherine Saez.