Some 11,258 scientists from 153 countries have issued a sharp warning in the journal BioScience, about the climate emergency faced by the global community.

The scientists calls for “bold and drastic transformations” in six key areas to pull earth from the precipice of potentially catastrophic deterioration in basic life support systems. Their prescription includes: a rapid shift of economies from fossil fuels to renewables; reduced emissions of short-lived climate pollutants like methane and black carbon (soot) that could slow short-term warming trends “while saving millions of lives” from air pollution; restoration of degraded natural ecosystems from coral reefs to savannas; shifting to mostly plant-based foods; reduced over-consumption of materials and minerals; and stabilization of population growth with access to family planning services, progress in gender equity, and universal primary and secondary education including for girls and young women.

The article published on Monday, a month ahead of the 25th Climate Conference (COP 25) in Madrid, carries a particular note of urgency in light of the large number of signatures by scientists, who normally frame their views in cautious, incremental terms.

“Scientists have a moral obligation to clearly warn humanity of any catastrophic threat and to “tell it like it is.” On the basis of this obligation and the graphical indicators presented below, we declare, with more than 11,000 scientist signatories from around the world, clearly and unequivocally that planet Earth is facing a climate emergency,” states the article published on Tuesday.

Earth’s Vital Signs in Red Zone

The scientists note that average global temperature increases are alone insufficient to capture the dimensions of the problems faced. They point to a range of “concurrent trends in the vital signs of climatic impacts” that represent a “suite of graphical vital signs of climate change over the past 40 years”.

These include: continued increases in atmospheric CO2, concentrations; in greenhouse gas emissions (CO2, methane, and nitrous oxide); and a particularly ominous 2019 spike in CO2.

Monthly mean carbon dioxide measured at Mauna Loa Observatory, Hawaii. The carbon dioxide data ([black] curve), measured as the mole fraction in dry air, on Mauna Loa constitute the longest record of direct measurements of CO2 in the atmosphere. […] The [black line represents] the monthly mean values, centered on the middle of each month. The [red line represents] the same, after correction for the average seasonal cycle. The latter is determined as a moving average of SEVEN adjacent seasonal cycles centered on the month to be corrected, except for the first and last THREE and one-half years of the record, where the seasonal cycle has been averaged over the first and last SEVEN years, respectively. Source: https://www.esrl.noaa.gov/gmd/ccgg/trends/
In addition, global ice cover “has been rapidly disappearing, evidenced by declining trends in minimum summer Arctic sea ice, Greenland and Antarctic ice sheets, and glacier thickness worldwide. Ocean heat content, ocean acidity, sea level, area burned in the United States, and extreme weather and associated damage costs have all been trending upward… Climate change is predicted to greatly affect marine, freshwater, and terrestrial life, from plankton and corals to fishes and forests (IPCC 20182019). These issues highlight the urgent need for action,” the scientists state.

“Profoundly troubling signs from human activities include sustained increases in both human and ruminant livestock populations, per capita meat production, world gross domestic product, global tree cover loss, fossil fuel consumption, the number of air passengers carried, carbon dioxide (CO2) emissions, and per capita CO2 emissions since 2000,” they add.  There are also positive trends, such as declines in global fertility rates, increased solar and wind power production, reduced forest loss in the Amazon, and fossil fuel divestment.  But renewable power production still lags far behind that of fossil fuels, and annual fossil fuel subsidies remained greater than US$400 billion in 2018.

“To secure a sustainable future, we must change how we live, in ways that improve the vital signs summarized by our graphs. Economic and population growth are among the most important drivers of increases in CO2 emissions from fossil fuel combustion (Pachauri et al. 2014, Bongaarts and O’Neill 2018); therefore, we need bold and drastic transformations regarding economic and population policies. We suggest six critical and interrelated steps (in no particular order) that governments, businesses, and the rest of humanity can take to lessen the worst effects of climate change. These are important steps but are not the only actions needed or possible,” the scientists add. Those include:

Energy

“The world must quickly implement massive energy efficiency and conservation practices and must replace fossil fuels with low-carbon renewables (figure 1h) and other cleaner sources of energy if safe for people and the environment. We should leave remaining stocks of fossil fuels in the ground (see the timelines in IPCC 2018) and should carefully pursue effective negative emissions using technology such as carbon extraction from the source and capture from the air and especially by enhancing natural systems (see “Nature” section). Wealthier countries need to support poorer nations in transitioning away from fossil fuels. We must swiftly eliminate subsidies for fossil fuels and use effective  and fair policies for steadily escalating carbon prices to restrain their use.”

Short-lived pollutants

“We need to promptly reduce the emissions of short-lived climate pollutants, including methane (figure 2b), black carbon (soot), and hydrofluorocarbons (HFCs). Doing this could slow climate feedback loops and potentially reduce the short-term warming trend by more than 50% over the next few decades while saving millions of lives and increasing crop yields due to reduced air pollution (Shindell et al. 2017). The 2016 Kigali amendment to phase down HFCs is welcomed.”

Nature

“We must protect and restore Earth’s ecosystems. Phytoplankton, coral reefs, forests, savannas, grasslands, wetlands, peatlands, soils, mangroves, and sea grasses contribute greatly to sequestration of atmospheric CO2. Marine and terrestrial plants, animals, and microorganisms play significant roles in carbon and nutrient cycling and storage. We need to quickly curtail habitat and biodiversity loss (figure 1f–1g), protecting the remaining primary and intact forests, especially those with high carbon stores and other forests with the capacity to rapidly sequester carbon (proforestation), while increasing reforestation and afforestation where appropriate at enormous scales. Although available land may be limiting in places, up to a third of emissions reductions needed by 2030 for the Paris agreement (less than 2°C) could be obtained with these natural climate solutions (Griscom et al. 2017).”

Food

“Eating mostly plant-based foods while reducing the global consumption of animal products (figure 1c–d), especially ruminant livestock (Ripple et al. 2014), can improve human health and significantly lower GHG emissions (including methane in the “Short-lived pollutants” step). Moreover, this will free up croplands for growing much-needed human plant food instead of livestock feed, while releasing some grazing land to support natural climate solutions (see “Nature” section). Cropping practices such as minimum tillage that increase soil carbon are vitally important. We need to drastically reduce the enormous amount of food waste around the world.”

Economy

“Excessive extraction of materials and overexploitation of ecosystems, driven by economic growth, must be quickly curtailed to maintain long-term sustainability of the biosphere. We need a carbon-free economy that explicitly addresses human dependence on the biosphere and policies that guide economic decisions accordingly. Our goals need to shift from GDP growth and the pursuit of affluence toward sustaining ecosystems and improving human well-being by prioritizing basic needs and reducing inequality.”

Population

“Still increasing by roughly 80 million people per year, or more than 200,000 per day (figure 1a–b), the world population must be stabilized—and, ideally, gradually reduced—within a framework that ensures social integrity. There are proven and effective policies that strengthen human rights while lowering fertility rates and lessening the impacts of population growth on GHG emissions and biodiversity loss. These policies make family-planning services available to all people, remove barriers to their access and achieve full gender equity, including primary and secondary education as a global norm for all, especially girls and young women (Bongaarts and O’Neill 2018).”

 

Image Credits: blog.oup.com, Bioscience.

Demonstrators poured onto the streets and politicians pointed fingers as Delhi’s air pollution levels soared above the threshold air quality monitoring stations could record on Sunday. The Indian Supreme Court issued a scathing statement calling for politicians to stop “passing the buck” on the air pollution issue and take urgent action in the “public health emergency” declared last Friday.

Levels of dangerous PM10 small particles rose above 999 micrograms/cubic meter Sunday morning throughout the city, breaking previous records. And levels of even more deadly PM2.5 fine particles hit a peak at around 860 in parts of the city at times on the same day – over 20 times higher than the WHO Air Quality 24 hour guideline limits – [50 micrograms/m3 PM10 and 25 micrograms/m3 PM2.5].

Young protesters from the Democratic Youth Federation Of India, Delhi state, take to the streets to demand action against air pollution.

“Delhi is choking every year and we are not able to do anything,” said Justice Arun Mishra in a Supreme Court hearing about the air pollution. The Court summoned top bureaucrats from Delhi as well as neighboring states to attend a hearing on Tuesday over the crisis.

Defunct “state-machinery” has resulted in politicians passing responsibility for the air pollution issue between city and national governments without taking real action to reduce the annual spike in dangerous air pollution, the Court said, in a far reaching order obtained by Health Policy Watch calling on bureaucrats at all levels and in urban and rural regions to halt burning. The sources of air pollution include urban vehicles, urban waste incineration, industrial and household emissions as well as uncontrolled crop burning from the surrounding Punjab and Haryana, the Court documents noted.

But India’s Prime Minister (PM) Narendra Modi maintained his silence over the crisis, while on a trip abroad. According to the prime minister’s official website, PM Modi was spending Monday evening in Thailand at an annual Summit of Asian Heads of State, before returning to Delhi Monday evening.

The Prime Minister’s Office had announced it would be hosting an emergency meeting on the issue soon. Still, citizens were critical of prime minister Modi’s decision to remain away from Delhi during the “public health emergency.”

Delhi politicians such as Akanksha Ola are up in arms, calling the national government led by PM Modi and local government of Arvind Kejriwal “equal partners in crime on strangulating the people of Delhi.”

City residents are furious at the political relay, staging protests and Tweetstorms to flood the streets and social media with news of Delhi’s plight. Members of the Indian Congress party protested in front of Delhi Chief Minister Kejriwal’s residence on Monday, while twitter hashtags such as #DelhiChokes and #DelhiAirEmergency were trending all around the world.

Ineffective Efforts to Reduce Air Pollution

Emergency efforts to reduce air pollution announced on Friday, such as temporarily banning construction in the city and permit private vehicles to circulate only on alternate certain days as per the odd-even digits of license plate numbers, have either failed to be enforced or failed to be effective.

Supreme Court members asked city leaders to justify the “logic” behind the odd-even scheme, asking them to present concrete data showing that it actually reduced the number of polluting vehicles on the roads or had a measurable effect on the air pollution levels.

Air pollution levels at Monday 10pm in Delhi, showing the combined data of three government monitoring networks, CPCB, DPCC and SAFAR.

Speaking to Health Policy Watch, clean air advocate Jyoti Pande Levakare praised the High Court for taking action to call all of the governing parties together, but said that without political movement, as well, the system remains stalled.

“Only the Supreme Court seems to care. Nothing else has really changed. Our prime minister is breathing better air in Thailand while we choke here. Indian lungs are cheap,” she said. “Unless clean air is made a mission of national importance, unless human health is made a priority, we will continue to lurch from crisis to crisis.”

A major focus of controversy continued to be the uncontrolled “stubble burning” of rice fields in Punjab and Haryana – whose smoke has been drifting into the city and contributing to about 40% of Delhi’s air pollution levels, according to informed estimates.

Clean air advocates as well as scientists note that the burning of stubble had become a more serious problem over the past decade – after the government ordered farmers to delay their planting and harvest season by a couple of months.  Since the prevailing winds shift towards Delhi in late fall/early winter, that has left the city more exposed than it was in the past to the burning of harvested rice stalks.

Regional Impacts of Pollution Plume in India

Also, more and more rice is being grown in Punjab, replacing other indigenous food staples that didn’t require burning of fields, post-harvest, critics have said. However, with no clear leadership from prime minister Modi’s office, solutions for the seasonal issue seemed to be hostage to competing political and commercial interests.

Subsidies for machines to clear the rice stubble from fields have been proposed – although those are unlikely to be affordable to smallholder farmers.  Others have suggested replacing rice with GMO cotton or maize for livestock and poultry feed – although critics say that this would convert valuable farm production from plant-based foods for human consumption to foods for livestock feed – in a country that has a high proportion of vegetarians. Water-hungry cotton would remove valuable land from food production altogether — as well as causing even further damage to aquifers. Against the storm of debate, few people seem to be thinking about practical solutions that fit India’s land resources and food production needs, said Lavakare, although those have been laid out over and over.

“Farmers in Punjab and Haryana burn crop stubble to clear their fields as they have no real alternatives. Burning is the fastest way to turnaround their capital—their acreage.” she wrote in an article published in the Delhi-based Financial Express during last year’s crisis, in October 2018.

“These are areas that used to grow low water-use, nutrition-dense coarse grains such as pearl millet (bajra), finger millet (ragi), sorghum (jowar), barley, rye and maize. Perhaps the government can offer better price support to encourage farmers to switch back to crops like these…Incentivizing low water-use crops like millets instead of [rice] paddies, paying for farm-waste – especially involving enterprises that can use the waste as a raw material—make better sense.”

 

Image Credits: DYFI Delhi Twitter, www.aqicn.org.

Delhi declared a public health emergency as air pollution levels soared on Friday, while Chief Minister Arvind Kejriwal said that the mega-city had “turned into a gas chamber”.

According to official government monitoring stations, levels of tiny PM10 air pollution particles had risen as high as 20 times WHO Air Quality Guideline levels in parts of the city over recent days. As of Friday evening, concentrations of the small particles, among the most health hazardous pollutants, were averaging 300-500 micrograms per cubic meter of air – or 6-10 times the WHO 24-hour guideline of 50.

Air pollution levels at 10 p.m. Friday night near Delhi national stadium, showing the combined data of three government monitoring networks, CPCB, DPCC and SAFAR

To cope with the emergency, the Delhi Government launched an unprecedented mass distribution of some 5 million masks to school children, banned construction, cancelled school until Tuesday and placed sharp limits on vehicle travel with an “odd-even” scheme permitting private vehicles to travel only on alternate days, as per the digits of their license plate.

“In the interest of protecting our children, it has been decided to keep all the schools – Government, Government-aided, and Private – in the National Capital Territory of Delhi closed until November 5th 2019,” said the Office of the Deputy Chief Minister in a decree published on Twitter.

Kejriwal blamed the increase in “stubble burning” in neighboring regions of Punjab and Haryana for Delhi’s recent spike in air pollution levels. The practice of burning leftover straw after grains are harvested is a rapid method for farmers to clear their fields, but also sends huge plumes of smoke and biomass pollution into the air, spreading for hundreds of kilometers.

“Delhi has turned into a gas chamber due to smoke from crop burning in neighbouring states,” said the minister on his Twitter feed. “It is very important that we protect ourselves from this toxic air. Through pvt & govt schools, we have started distributing 50 lakh [5 million] masks today I urge all Delhiites to use them whenever needed.”

But scientists and civil society activists maintained that no single source can be blamed for the city’s chronic air pollution problems, which peak in the early winter every year. Rather, a combination of urban and rural sources create a perfect storm of pollution that hovers over the city and the wider region. These also include pollution from domestic wood/biomass stoves; unfiltered smokestack emissions from Delhi area power plants; urban waste incineration; construction dust; the rampant use of polluting two-stroke engines in two-wheeler vehicles; as well as the seasonal “Diwali” festival of lights – where setting off firecrackers is a traditional ritual.

(left-right) Delhi sky on Sept 27, Delhi sky on Nov 1, Kejriwal distributes masks to school children in air pollution emergency

“We know that the air pollution comes from at least 8-10 sources.  We want the government to address all of these and not just cherry pick,” said Jyoti Pande Lavakare an activist journalist who runs the organization CareForAir.org and is completing a book “Breathing Here is Injurious To Your Health” to be published early next year.

She said that her organization had grave misgivings about the mask distribution scheme – whether the masks would in fact have adequate air pollution filters, and whether they would really reach 5 million people. On top of that, unless masks are properly fitted they won’t work at all, even as a stopgap measure – and for many children the masks will just be too large.

“Masks are not a solution,” said Lavakare. “And they may give you a false sense of security.  Masks are more of a visual. I am for masks because they make an invisible problem visible; they are an immediate necessity, but only if they fit well. And people who have asthma will feel suffocated if they wear a mask. The only real thing to do in an emergency is to stay indoors and keep respiration rates low.”

However, she added that Delhi’s chronic air pollution issues, which peak annually in November and December, required more than “short-term band-aid measures”, adding that leadership from the very top of the political spectrum was needed.

“I want the prime minister [Narendra Modi] to actually lead this issue; currently it is actually rudderless and leaderless. You cannot have a prime minister who is talking about clean India without talking about clean air.  And yet he has been strangely silent on this issue.  In no forum has he talked about air pollution,” she observed, noting that each air pollution source has a longstanding history of failure behind it.

For example, a Ministry of Environment, Forestry and Climate Change decision to install modern pollution filters on Delhi area power plants by 2017, potentially reducing average air pollution levels by about 30% in northern India, has been delayed for over two years by the Ministry of Power and could remain stalled until 2020 if the latter Ministry has its way. Three-wheeler vehicles, auto rickshaws, which provide much of the Delhi’s public transport, still run on heavily polluting two-stroke engines. And regional pollution from crop-burning has intensified as local varieties of nutrient-rich food crops were gradually replaced by rice, produced mainly for export and sucking up scarce water resources, says Lavakare.

Lavakare is, however, more hopeful that the debate about air pollution is growing stronger and public opinion more informed about the multiple health risks air pollution creates – which according to WHO range from spikes in hospital admissions and death rates during air pollution emergencies to stunted childhood lung development, reduced long-term life expectancy and higher premature mortality from stroke, heart disease, lung cancer, and respiratory disease as a result of chronic air pollution exposures. Recent evidence has also pointed to serious air pollution impacts on the brain development of infants and young children.

“When we started to build awareness three years ago, we were told by top government officials that it was a rich person’s problem. The point they were missing was that it is a bigger social inequity for the disenfranchised and the homeless people who don’t have the privilege of having masks, air purifiers and four walls to keep the pollution out.

“Now, the government can no longer say this is just a rich person’s problem. It’s clear that it is everyone’s problem.  And the Indian media is finally fully supportive,” said Lavakare. “No one [politician] cares if it it really is creating toxic impacts on health, but people do care if it gets them votes. And at least that is a start. But we need a tipping point – like the film ‘Under the Dome‘ which got China to do something.”

It was clear that after the fifth day without sunlight, average Delhi residents were crying for change.

“No air circulation. Eyes burn. Breathing is difficult. Can’t even go out for a walk. Sick!” commented one commentator on Twitter.

One Indian parliamentary member, former cricketeer Gautam Gambhir critiqued the high-level response and urged Kejriwal to check how many construction sites are complying with the new regulations on the ground.

A high profile, India-Bangladesh cricket match planned for Sunday provided a lightning rod for a lively debate over the air pollution emergency, with critics calling for the match to be postponed because of the irreversible health impacts exposure to such high air pollution levels can have, but sports authorities resisting.

UN Goodwill Ambassador and Indian actress Dia Mirza blasted the Board of Control for Cricket in India (BCCI) decision to continue hosting the India versus Bangladesh match on November 3rd, despite the dismal air quality.

“BCCI please stop hiding your head in the smog,” she tweeted. “This air harms players and the people that come to watch these games.”

One cricket commentator drolly observed that perhaps the BCCI’s decision to not cancel the match was strategic, saying that “Indian cricketers are better used to such bad air than any other cricketing nation.”

Indian players, used to playing in environments with poor air quality, will be able to better tolerate the ghastly air pollution levels and play better than athletes who are used to training in climates with lower levels of air pollution, he reasoned.

India shall, through series openers scheduled in Delhi’s toxic air, introduce pulmonary disintegration to the game,” said Siddharth Monga in a piece for ESPN.

Grace Ren contributed reporting to this story.

Image Credits: www.aqicn.org, Arvind Kejriwal.

Cutting-edge health technologies – such as gene editing therapies for cancer – have the potential to save lives, and the international intellectual property system should be leveraged to drive innovation and bring those therapies to people who need them, said the leaders of global health, trade and intellectual property agencies at a Trilateral Symposium on Thursday.

The symposium, convened under the theme “Cutting-edge Health Technologies: Opportunities and Challenges,” is the eighth such open forum co-hosted by the World Health Organization (WHO), the World Trade Organization (WTO), and the World Intellectual Property Organization (WIPO) to foster collaboration around public health and intellectual property.

(left-right) Dr Tedros, Roberto Azevêdos, and Minelik Alemu Getahun.

“The essential insight is that while improving access to existing technologies remains an important priority, it will not suffice to meet future public health challenges,” said the WTO Director-General, Roberto Azevêdo, in his opening statement. He noted that advancements in new diagnostic tools, therapies, and prophylaxis treatments have greatly expanded the possibilities for treating and preventing certain diseases.

As an example, Azevêdo highlighted CAR-T (chimeric antigen receptor) cell therapy, a cutting-edge cancer treatment still under development. This form of cell therapy leverages advancements in gene editing by genetically altering natural white blood cells to attack cancerous cells. Public sector research institutions currently hold 40% of the patents in this area of medical research, while private firms hold 49%.

“How [the patent holders] choose to license these technologies will be an important factor in how therapies are rolled out in practice,” said Azêvedo.

The Director-General of the WHO, Dr Tedros Adhanom Ghebreyesus agreed, stating that “Advances in science and technology are opening up new horizons in public health that were considered science fiction not so very long ago… And yet we continue to live in a world marked by shocking inequality.”

Dr Tedros posed the question, “How do we harness the power of innovation to narrow inequalities, rather than widen them?”

“We must understand better the benefits, costs and limitations of mechanisms for incentivizing innovation and their impacts on the pricing of health products,” he added, reaffirming WHO’s commitment to Universal Health Coverage, including increasing access to medicines and vaccines.

The IP system also faces challenges as scientific advancements quickly move forward, WIPO Assistant Director-General Minelik Alemu Getahun said, noting that IP regulations must balance “incentivizing and rewarding innovation” while ensuring that knowledge to support “continued innovation” is shared.

“Today’s discussions will explore the landscape of cutting-edge health technologies and consider some of the opportunities and challenges of optimizing their use in a variety of settings. We should endeavour to make our discussions as accessible to the public as possible by elucidating concepts and providing clear, fact-based information related to these exciting and ever-evolving health technologies,” he said.

The three opening speakers set the stage for a broader technical discussion on the challenges and opportunities of cutting-edge health technologies. A morning plenary reviewed highlights of new medical innovations in biotechnology, information technology, and the application of big data to the medical sector. A second panel focused more on issues of access to new medical innovations, affordability and increasing costs for health care systems, along with the ethics of using patient data.

For more information, see the WTO press release.

Image Credits: WTO.

The UN COP Bureau has accepted Spain’s offer to host the COP25 Climate Conference in Madrid from December 2-13, following a tumultuous few days after Chile suddenly withdrew from hosting the conference due to a massive wave of protests in Santiago.

In a short statement released Friday, UN Climate Change Executive Secretary Patricia Espinosa said, “We are pleased to announce the COP Bureau has agreed that COP25 will take place from 2-13 December in Madrid, Spain.”

Spain offered to host the upcoming UN Climate Conference (COP 25) on behalf of Chile on Thursday, which said on Wednesday that it could not stage this year’s meeting in Santiago due to security concerns related to the civil unrest that has been raging for the past two weeks in the capital city.

“Following [Wednesday’s] announcement, the Government of Chile, as incoming Presidency, has informed me that they received a generous offer of support from the Government of Spain to hold the United Nations Climate Change Conference (COP25) in Madrid on the same dates as originally planned. We are hopeful that the COP Bureau can consider this proposed solution as soon as possible,” said Espinosa, in a curt statement on Thursday, released by UN media. “It is encouraging to see countries working together in the spirit of multilateralism to address climate change, the biggest challenge facing this and future generations.”

The Spanish offer shed a glimmer of light over the troubled preparations for the 25th annual meeting of the United Nations Framework on Climate Change (UNFCCC) after plans fell into disarray for the second time in a year. Late last year, Brazil withdrew its request to host the 2019 conference, after the election of the far-right President Jair Bolsonaro. Bolsonaro claimed the move was due to budget restrictions, but the new Brazilian leader has also appointed a climate skeptic as foreign minister, and has also taken steps to increase development in the sensitive Amazon rain forest region.

Madrid

The bold, face-saving measure by Spain to host the 2-13 December conference should help revive some of the momentum around this year’s COP event, which marks the 25th anniversary of the Framework Convention. This year’s COP is also significant as it comes on the heels of the 23 September UN Climate Summit, where countries made a lukewarm showing of commitment to key mitigation measures that climate experts say are desperately needed to keep global warming below 2° C.

Even if formal country commitments to climate action remain weak, the annual conference usually draws tens of thousands of participants – and features a wide array of events and exhibits not only for official delegates but also involving civil society, businesses and the public.

Observers close to the conference preparations had assumed that following Chile’s announcement, the meeting by default would be moved to Bonn, Germany, home of the UNFCCC Secretariat. Now, however, the UNFCCC has accepted the offer by Spain’s acting Prime Minister Pedro Sanchez to use Madrid as the alternative location, which the Chileans have accepted and recommended to the UN.

Under the proposed arrangements, Chile would still assume the presidency of this year’s COP, while Spain hosts the event. A similar arrangement occurred in 2017, when COP23 was held in Bonn, while Fiji held the presidency.

1 November 2019 – This story has been updated to reflect recent announcements from the COP Bureau confirming the new location of COP25.

Image Credits: Cuellar .

Non-communicable diseases (NCDs) such as cancer, heart disease and stroke, as well as road traffic injuries, are among the leading causes of death in cities – killing some 42 million people worldwide every year. A new report released by the World Health Organization shows how urban leaders can tackle these urban maladies through simple environmental design strategies and as well as food, tobacco and alcohol policy measures.

The report, The Power of Cities: Tackling Non-communicable Diseases and Road Traffic Injuries, suggests ten high-impact interventions for cities, based on WHO expertise as well as the experiences of 19 cities where the strategies have been tested in case-studies.

“Over half the world’s people live in cities, and the numbers are rising,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General in a press release about the initiative, released on the UN-designated World Cities Day.

“City leaders take decisions that impact on the health of billions, and for cities to thrive, everyone needs access to services that will improve their health – public transport, safe, clean and attractive outdoor spaces, healthy food, and, of course, affordable health services.”

The case-studies cover low-, middle- and high-income countries, with 15 of the 19 studies focusing on cities in developing countries, where 85% of premature adult NCD deaths and a whopping 93% of road traffic crashes occur. Currently, seven of the ten largest cities in the world are in developing countries, and 90% of future urban population growth will occur in low- and middle-income countries, the report notes.

The report’s stated goal is to share knowledge and best-case practices between city leaders and help them to “identify at least one area which could be changed for the better.”

“By replicating the most effective measures on a global scale, we can save millions of lives,” said WHO’s Global Ambassador for NCDs and injuries, and three-term New York City Mayor, Michael Bloomberg.

“We’re working to raise awareness among city leaders and policy makers about the real gains that can be achieved when effective programs are in place.”

High-Impact Interventions for NCDs and Road Traffic Safety
A man bikes in Fortaleza, a Brazilian city that implemented a bike-sharing scheme in 2014.

From anti-tobacco actions in Beijing and Bogor, Indonesia, to road safety initiatives in Accra, Ghana and Bangkok, a bike sharing scheme in Fortaleza, Brazil and actions to create more walkable streets that have reduced pedestrian deaths among older people in New York City by 16%, the report aims to share knowledge between urban policy planners.

Specifically, the report highlights ten key interventions that could reduce NCDs and road traffic accidents:

  • Monitor NCD risk factors – Conduct a population-based survey of behavioral risk factors for NCDs, such as tobacco use, alcohol consumption, dietary habits and physical activity.
  • Create a smoke-free city – Protect people from second-hand smoke through the introduction, passage and enforcement of legislation that makes all indoor public places 100% smoke-free.
  • Ban tobacco advertising – Ban all forms of direct and indirect tobacco advertising, promotion and sponsorship.
  • Reduce the consumption of sugar-sweetened beverages – Establish and implement policies to reduce sugar-sweetened beverage consumption, such as taxes on the production or sale of sugar-sweetened beverages.
  • Reduce salt consumption – Implement key components of the WHO SHAKE package for salt reduction in city communities, businesses, and institutions.
  • Create walkable, bikeable, and liveable streets – Improve pedestrian and bicycle networks and infrastructure across the city to ensure safe and equitable access to services, and to promote more walking and cycling for recreation and transport.
  • Clean the air – Reduce ambient air pollution through promotion of cleaner transport, municipal solid waste management, and controls on industrial emissions, and promote cleaner indoor air by improving access to cleaner fuels and technologies for cooking, heating and lighting.
  • Reduce drunk-driving – Increase enforcement of drunk driving laws
  • Manage speed – Establish lower speed limits and strengthen existing speed-limit enforcement.
  • Increase seatbelt and helmet use – Increase enforcement of seat-belt and motorcycle helmet use.

Many of the interventions are based on the WHO’s Best Buys for NCD Control that list policies that can not only help countries reduce the health impacts of NCDs, but also their economic costs.  It is estimated that implementing such measures could help low- and middle-income countries save some US$350 billion by 2030.

The report was produced as part of a Bloomberg Philanthropies-funded joint initiative the Partnership for Healthy Cities, involving WHO and the global health NGO Vital Strategies. The partners are now working with city leaders to implement variations of the ten interventions in 54 participating cities around the world.

The initiatives covered some 216 million people in urban areas with at least one intervention to help reduce the risk of NCDs or road traffic accidents in 2017. On a larger scale, the city-level initiatives are contributing to fulfilling countries’ commitments to the Sustainable Development Goals – to reduce premature deaths from NCDs by a third by 2030, and to halving road traffic deaths and injuries by 2020.

“With most of the world living in cities, bold action by urban leaders has greater potential to improve lives than ever before… Increasingly, we see cities rising to societies’ biggest challenges – from climate change and road safety, to obesity and tobacco use. They are engines of change, able to move quickly to implement life-changing policies that affect great numbers of people,” said José Luis Castro, president and chief executive officer at Vital Strategies, in a statement on World Cities Day.

Along with the report, WHO has provided a number of technical resources to city leaders to help guide policy-making for NCDs and road traffic safety – for more information, see the report webpage.

Image Credits: WHO/Vital Strategies, WHO/The Power of Cities: Tackling NCDs and Road Traffic Injuries.

Berlin, Germany – A “public interest R&D” model can bring effective treatments for neglected diseases to patients at comparatively low cost, through a collaborative, access-oriented development process.

The model is outlined in the new report 15 Years of Needs-Driven Innovation for Access, by Drugs for Neglected Disease Initiative (DNDi), released Wednesday.

The model etches an alternative formula to conventional for-profit R&D systems, highlighting both successes and challenges that are faced in developing treatments for over a dozen diseases, such as sleeping sickness and Chagas disease, that affect some of the poorest and hardest to reach populations in the world.

A healthcare provider screens people for African sleeping sickness, a disease for which DNDi developed the first all-oral treatment, fexinidazole.

“After 15 years I think I am proudest of the model. It was originally just an idea but now it is a reality,” Bernard Pécoul, executive director of DNDi, said during a day-long symposium reflecting on DNDi’s research experiences held on the occasion of the organization’s 15-year anniversary. He said that the report takes “30 pages to describe 15 years of a story.”

According to the report, the organization has delivered eight field-adapted and affordable treatments for diseases as varied as paediatric HIV, sleeping sickness, and Chagas disease to date, and expects seven or eight more treatments by 2023. Currently, DNDi has more than forty R&D projects across seven disease areas, as well as more than 20 new compounds – known as “new chemical entities (NCEs) – in early stages of development.

The report attributes DNDi’s success to an innovative funding, partnership and access model, among other factors. By partnering with academia and the private sector, for instance, the organization is able to access existing research databases holding information about millions of compounds, and has screened 4 million to date. It is through such screening that the organization has been able to identify compounds that had potential to treat serious diseases, but had simply been ignored or discarded in the R&D pipeline because their profit potential was low.

At the same time, the organization’s access policies ensure that the collaborations with industry are negotiated up front, in a way that any consequent drugs produced will be made widely available at affordable prices– e.g. through open licensing or generic formulations that are not limited by patent requirements to pay expensive royalties.

In addition, some 60% of DNDi’s funding still comes from public sources such as government grants, and the organization attempts to maintain financial independence by “not having one donor with more than a 25 percent share of contributions,” said Pécoul.

In terms of collaborations, DNDi’s model has stressed working in countries that are affected by the diseases that it is tackling, the report notes.

The organization is working with over 180 partners in more than 40 countries, with at least one third of the collaborating institutions based in lower-middle income countries. These partnerships include five new disease-specific clinical research platforms based in Africa and Latin America. Through these partnerships, the organization runs an average of 20 clinical trials enrolling over 2500 patients total at any given time.

“Public Interest R&D” – How Does This Model Work?

The report summarizes six elements identified as key to the success of DNDi’s alternative, non-profit R&D model. These include positioning the product development partnership as: needs-driven; independent; collaborative, open and transparent; globally networked; access oriented; and “transformative.”

In keeping with its public-interest mission, the organization publishes its financial data on an annual basis to remain “open and transparent,” informing the debate around R&D costs.

Adjusting for attrition, DNDi estimates that it can develop and register new combinations or new formulations of existing treatments for €4-32 million, and an entirely new chemical entity for €60-190 million. Conventional industry estimates are for a US$2.6 billion cost to bring a new drug to market. Although the numbers are not directly comparable because DNDi’s work is focused on a few key infectious diseases and industry estimates also include the “opportunity costs” of capital investments, they provide an order of magnitude comparison of how non-profit R&D can be cost-effective, DNDi experts say.

Public and private contributions pay for the cost of R&D up front, allowing the organization to focus on developing new drugs based on patient needs rather than the need to recoup R&D costs.

R&D is guided by the use of public-interest “target product profiles,” which include concerns around access and affordability from the outset.

For example, until 2009, the standard treatment for African sleeping sickness caused by a parasite transmitted by the tsetse fly, was an arsenic-based intravenous treatment that was so toxic that it used to kill one in twenty patients – but the disease itself was almost invariably fatal without treatment.

Sleeping sickness affects some of the poorest and hardest-to-reach populations in the world, with over 80% of cases occurring in the most remote regions of the Democratic Republic of the Congo. In the traditional treatment, highly trained staff had to deliver as series of infusions over a period of weeks, following diagnosis via a painful lumbar puncture.

The first DNDi breakthrough came in 2009, when it developed a less toxic and more effective oral nifurtimox-intravenous eflornithine combination therapy (NECT).

That replaced the arsenic-based Melarsoprol. However, the treatment still requires 21 days of hospitalization, or massive equipment if deployed in a field clinic, as well as highly trained staff who had to deliver a series of infusions, following diagnosis via a painful lumbar puncture.

In response to the need for a yet more adaptable and field-friendly treatment, DNDi identified fexinidazole out of a Sanofi library of chemicals as having potential efficacy against sleeping sickness.

In November 2018, the drug was approved by the European Medicines Agency as first oral medication for sleeping sickness, and it was registered in DRC just a month later, thanks to an EMA collaboration with African regulatory authorities, also facilitated by DNDi.

The 3C’s:  Collaboration, Coordination & Cooperation

The story of sleeping sickness illustrates how a collaborative, open and transparent process, driven by a global network of partners, has been key to the DNDi treatment breakthroughs.

Fexinidazole ultimately was developed in partnership with more than 15 organizations representing government, private industry, and civil society, while Sanofi remained the main pharmaceutical development partner. Clinical trials for fexinidazole were conducted in the DRC and Central African Republic.

“DNDi owes its successes to collaborations with a large global network of over 180 partners from the pharmaceutical industry, academia, health ministries, other NGOs, treatment providers, and patients and their communities, as well as our donors,” said Pécoul in a press release.

“We are the conductors of a ‘virtual orchestra’, and the eight new treatments we have delivered in the past 15 years would not exist without the commitment and shared vision of our partners and donors.”

One of the latest brainchilds of DNDi is not a product – it’s a new organization dedicated to tackling the growing threat of antimicrobial resistance, the Global Antibiotic Research and Development Partnership (GARDP).

Initially housed within DNDi after its inception in 2016, GARDP launched as an independent organization in July and is now running four R&D programmes for drug-resistance infections, applying the DNDi drug development model to the neglected area of developing new and improved antibiotic treatments.

Image Credits: Xavier Vahed/DNDi, DNDi/15 Years of Needs-Driven Innovation for Access.

Chile pulled out of hosting the COP25 Climate Change Conference on Wednesday, following two weeks of protests in the hosting city of Santiago. The announcement throws preparations for the conference, scheduled for December, into disarray for the second time, after Brazil withdrew its request to host the 2019 conference late last year.

COP25 logo

It casts a shadow over the efforts of UN Secretary-General Antonio Guterrez to ramp up climate action in the wake of the UN Climate Action Summit in New York City in September.

“Earlier today, I was informed of the decision by the Government of Chile not to host COP25 in view of the difficult situation that the country is undergoing. We are currently exploring alternative hosting options,” United National Climate Change Executive Secretary Patricia Espinosa said in a statement.

Following a wave of massive civil unrest with over 1 million people taking to the streets to protest inequality, president Sebastian Pinera announced the decision to withdraw from hosting COP25, along with dropping the Asian-Pacific Economic Cooperation (APEC) Summit, which was planned for next month.

“As a president, I have a duty to put the needs of Chileans first. Therefore, with pain, we have decided to cancel APEC and COP summits to guarantee order and social peace, focus on dialogue, and a new social agenda to provide urgent solutions to major demands,” the president announced on Twitter (translated from Spanish).

 

Image Credits: COP25 Twitter.

Berlin, Germany – The Drugs for Neglected Diseases Initiative (DNDi) is celebrating its 15th anniversary and in a special event Tuesday night, founders and supporters of the product development partnership (PDP) gathered in Berlin to reflect on lessons learned and challenges that still lie ahead. Here below are excerpts of what they had to say.  

Marie-Paule Kieny, Chair of the Board of DNDi

15 years ago the Drugs for Neglected Diseases was created as a response to the frustration of clinicians and the desperation of patients facing the reality that their treatment was either ineffective, highly toxic, or unavailable, when it even existed at all.

Against this background DNDi was established as an experiment. After 15 years, what are lessons to be learned from these experiments?

DNDi is a needs-driven organization, we put patients and not profits as a value. Scientific independence guarantees a needs-based approach. Our research is collaborative, open and transparent; knowledge is worth something when its shared, open science is a key strategy. DNDi is only possible through collaboration – networking is a key part of our innovation. Public leadership is imperative to promote coherent ecosystems to make medicines available to all patients. Without sustainable, affordable accessible and adaptable medicines we will not be able to meet the Sustainable Development Goals.

Veronika von Messling, Director-General of the Life Sciences Division, Federal Ministry of Education and Research, Germany

The overall mission was to improve the health and quality of life of people suffering from neglected diseases, filling a gap that was left by pharmaceutical industries, because neglected diseases were not a priority. It is to DNDi’s credit that game-changing treatments for diseases such as sleeping sickness have been developed.

Research and development, innovation and access are drivers worldwide. The German government is committed to funding global health research because we are convinced this will contribute to global health.

We are aware that despite the remarkable advances made there are still significant gaps, and therefore Germany remains committed to further development of PDPs [product development partnerships] that ensure no one is left behind.

Soumya Swaminathan, Chief scientist, World Health Organization; former head of the Indian Medical Research Council

I can remember as a practitioner in India, when we were still doing spleen punctures for diagnosis of Kala Azar (visceral leishmaniasis). And all we had available were very toxic treatments. Children would come to us who were already skin and bone, their abdomens would be all bloated with enlarged livers and spleens. So it was torture for the patients and it was difficult for us as the treating physicians to subject our patients to so much discomfort, and many of them came too late to be cured.

Now thanks to treatments like those developed by DNDi, Kala-Azar has almost disappeared from the Indian sub-continent. We still have pockets in the most vulnerable groups. And it is because of poor housing that the sand flies breed. You improve housing and leishmaniasis disappears. It’s all tied up to development. More recently, I met Nathalie [Strub-Wourgaft] of DNDi when we were in Sudan at the world’s only Mycetoma Research Center. Mycetoma is not immediately fatal but it is incapacitating. The amazing thing to me was that DNDi was there, doing this collaboration on a clinical trial for a new mycetoma drug. Most people would not have heard of mycetoma. The victims would remain invisible unless organizations like WHO and DNDi spoke about it. Investments in science and research are very important, not only at global level but also at country level – this is where we see the whole end-to-end approach is needed. We need to be talking about neglected populations, neglected pathogens and neglected products – and not only neglected diseases.

You can have the product on the shelf, but how do you ensure access? Our job at WHO is to think through all of these things with our partners, including DNDi. So we have created a forum for the PDPs and their funders to come together and discuss their common challenges, opportunities and plan strategically. To think about issues such as “what does access look like?”

When you have publicly funded R&D, if that product is successful, how is it going to reach populations, how will it be priced, and how are countries going to be able to adopt innovations? Financing is one aspect, but the other aspect is the capacity of countries to absorb these innovations into the health system, and to be able to prioritize based on local needs.”

John Amuasi, Executive Director of the African Research Network for Neglected Tropical Disease

There is indeed a constant tussle between having the high-level endorsements for a new treatment and moving fast enough with the evidence available to put it in place on the ground. I would recommend some effort be put into the assessment of these technologies as actionable on the ground. Health Technology Assessments are very context specific and can relate to things like cultural practices that do influence the final decision on implementation.

Public interest R&D and research that is in the interest of the public is really two different things. I recognize the challenges inherent in getting leaders of low- and middle-income countries to commit more. When people such as ministers have to make these decisions, if they don’t think that people are interested, they will not focus on it, even if it is in the interest of the public. So in looking at public interest R&D one key question is how to draw the public interest in it.

Do people really judge their governments to the degree which their health has improved? If we are able to demonstrate clearly that our R&D activities impact directly on improving primary health care… via health system strengthening, I think we would be even more successful in our efforts in promoting R&D. If we can show how this work directly impacts on improving primary health care and universal health coverage, if this link can be exposed and made more visible it would go a long way to supporting public interest in R&D.

Jeremy Farrar, executive director of the Wellcome Trust

We are at a really critical juncture in global health. There is no doubt that investments we have made are starting to bear fruit, but at that very juncture we see a world that is looking very fragile. We have a world challenged by climate change, persistent and emerging infections and of course non-communicable diseases – and that double whammy is going to be an enormous challenge. None of us should underestimate the challenges of delivering Universal Health Coverage in this context.

If you look at the trends in the pharma industry, I worry that industry, while having been sometimes a difficult partner, could become even less of a partner and that is a worry as they step away from antibiotics, for example. I worry that we have been through a relative honeymoon period. There is a vacuum, and that vacuum has to be filled.

I think we have to think through more as a community how we can fill that vacuum, including in financing. As we go forward, how are we going to fill that gap? In terms of all of these PDPs,  DNDi, Medicines for Malaria Venture, etc., how can we put this on a more sustainable footing, one that isn’t just reliant on charity and philanthropy, through more innovative financing. There is an incredible opportunity because interest rates are almost at 0%. And if we don’t use this moment in time to access capital, I worry that we won’t be able to rely on governments stepping up, or on philanthropy, and we may look back on the 15 years that have passed as the easy period. So should we start to change and adapt to that future when we are at our strongest? I wonder if now isn’t the time to do that, given the prevailing winds?

I also call on Germany to not lose sight of multilateralism, as other countries shift away and become more nationalistic, that Germany and Europe stand up for the values that have made it what it is over the past few decades.

Bernard Pécoul, executive director of DNDi

When Médecins Sans Frontières (MSF) received the Nobel Peace Prize [in 1999], the decision was to dedicate the prize money to the creation of DNDi.  We are not driven by profit but by patient needs, we focus on populations for which there is no solution or very bad solutions. Our close links to MSF have kept us on track. When we started researching drugs for sleeping sickness it was still being treated with arsenic.  First we improved the treatment, now we have registered the first oral treatment.

Our vision has been the best science for the most neglected diseases.  It was easy to formulate and a lot harder to implement. But the fact that we established a relationship from the start with the Institut Pasteur helped us to bring scientific credibility on the table.  They helped us to select the initial projects.  DNDi is strongly rooted in the countries where the majority of our patients live.  We commit to strengthen the research institutions close to patients and communities. DNDi has strived for countries to lead the response rather than being passive beneficiaries. This is part of the vision.

DNDi believes in sharing our lessons learned, to shape [the research environment].  We have from the start supported the WHO role and worked closely with WHO to facilitate implementation and support development of new guidelines for drugs that we develop.”

Representatives from the founding partners of DNDi

Image Credits: E Fletcher/HP-Watch, Lukas Schramm/DNDi.

The Drugs for Neglected Diseases Initiative (DNDi) celebrates its 15th anniversary this week, as a non-profit drug R&D organization that sought to create an alternative model for developing drug treatments for the most neglected diseases and the world’s poorest populations. Since DNDi’s launch in 2003, the organization has developed eight new treatments, including the first-ever oral drug for sleeping sickness, fexinidazole. Executive Director Dr Bernard Pé‏‏‏coul, who has guided the organization since its creation in 2003, looks back on the mission and its progress.

Dr Pécoul holds the malaria treatment artesunate and amodiaquine (ASAQ), DNDi‘s first treatment successfully brought to market.

Health Policy Watch: You are celebrating the 15th anniversary of DNDi.  How did DNDi come about and what gap has it filled in the R&D landscape?

Bernard Pé‏‏‏coul: We were created in 2003 and started operations in 2004 based on an assessment that the R&D for neglected diseases was totally abandoned. At the time I was director of [the Médecins Sans Frontières (MSF) Campaign for Access to Essential Medicines]. We documented this imbalance in a publication, saying that it’s time to create a different model, at the time the gap was big, and they were trying to find other solutions. The three gaps we documented included:

  1. The lack of new drug candidates. So [in DNDi] we created a consortium to not only screen [candidate molecules] but also to lead optimization [of those molecules] until we have clear chemical entities ready to enter into clinical development.  In our portfolio we [now] have 22 chemical entities in this process, some led by us and some by other partners as leads.
  2. Barriers to clinical development. Typically, the private sector was not ready to enter these complicated clinical settings. This is really the phase in which DNDi is very active.  Typically, we are in charge of the clinical development, and we develop most of the phase 2 and phase 3 studies. We are not alone because we always work in partnership with institutions at the country level, with global health, institutions. At the same time, we try to secure a partnership with Pharma, or with several pharma companies, as this is also a phase where we need to consolidate industry partners for the next phase – which is registration of the product and distribution. So, while we collaborate with pharma to identify the molecules, we “de-risk” pharma because we oversee the clinical studies.
  3. The gap between product and treatment. There is a still a gap at the end of the pipeline, or a lack of incentives to complete the development of new formulations in ways that are more adapted to the field. This means combining creating formulations for children or combining drugs into fixed-dose formulations, which is what we did for malaria. That’s why we talk about treatments and not products.  Our objective is to respond to patient needs, and treatments respond better than products.

HP-Watch: Can you summarize the 3-4 biggest breakthroughs you have experienced in drug development – up to the recent approval of the new drug fexinidazole for sleeping sickness?

Pécoul: Fexinidazole was the first time we developed a product from beginning to the end. The previous successes have been improving new drugs from new formulations.  Altogether there have been another 7 initial treatments that we developed.

The first breakthrough was a malaria treatment combining [the two most effective malaria drugs]. We completed development of that in 2007, with registration and prequalification, and in the last 10-12 years more than 500 million people have received this this treatment in Africa. Our partner in this was Sanofi; they accepted non-exclusivity in the contract, so that there are also generic companies producing the combinations.

Then there was a new formulation for children for Chagas disease [a chronic and disabling disease transmitted by the triatomine bug in Latin America]. Many children are affected, but when we entered this portfolio, the only formulation available was an adult formulation. We were not able to deliver a proper dose for children affected with Chagas. [People would have to split the pill into pieces]. We partnered with pharma companies in Brazil and in Argentina to devise two sources of a paediatric formulation.

A child with HIV takes a paediatric dose of antiretroviral medication, a formulation which DNDi developed.

Then, we achieved something similar in developing paediatric formulations [of antiretroviral drug combinations] for HIV. The existing formulations could be very difficult to take, or they would need special handling, such as refrigeration. So, we are developing a new formulation adapted to kids that was just submitted to the US Food and Drug Administration (FDA) in October this year.  That is a four-in-one combination of the first-line drugs recommended by WHO, but for which today there is no formulation adapted to the kids. We have done this in partnership with the Indian-based generic company CIPLA.  This required a lot of research work, going back to pre-clinical studies.

HP-Watch: What are the key lessons you think have been learned from DNDi’s model, in terms of:  sustainable financing, ensuring more returns on public investments, an end to end approach?

Pécoul: We are releasing today a “model paper”, [a report] on lessons we have learned over our 15 years.  These include lessons about how to facilitate the regulatory process; on how important it is to be very strongly linked with governments and to have public leadership on R&D reflecting commitment from the affected country; and the importance of target [drug candidate] profiles. I think having access [and therefore affordability] in mind from the beginning is very important, this influences your choice of partners but also the candidates you will develop.

Because we are a not-for-profit, and we position access as a key element of our investment, we are trying to develop public goods (i.e. generics) as much as possible. This means that the fruit of the innovation will go back to the public at an affordable price.  The return on investment is more about benefits for the population.  At the same time, because we are not making any profit from what we invest, we have very few mechanisms to secure sustainable funding.

When we are investing on treatments for very neglected populations, so the opportunities to establish sustainable funding to finance our investments are very few:  the populations we serve, by definition, have no purchasing power.

you had stable insulin that you could use in tropical conditions, this would be an interesting innovation.

HP-Watch: So, are you looking at some aspects of NCDs as another future gap or opportunity?

Sample preparation at bio-repository CEADES-DNDi, a partner for DNDi’s clinical studies on Chagas in Bolivia

Pécoul: Not for the time being, but we are not closing the door.  A few years ago, we revisited our mission statement, and we talk about neglected populations [a broader concept than neglected diseases]. But at DNDi we have so far not had the capacity to respond to the big issue of access. We have tried to demonstrate that a different R&D model could work. But we are not the only solution to the problem of innovation and access.

HP-Watch: At the same time, with regards to R&D costs, DNDi’s assessment of its own R&D experiences indicates that costs are not necessarily as high as some of the industry estimates that are out there.  Can you describe and explain why the gap is so high?

Pécoul: We have estimated the cost of improving the treatment of existing drugs to be on the order of US$ 10-30 million. When we talk about developing wholly new chemical entities from scratch, and including attrition, then we are more talking about US$ 60-200 million. True, we are still far away from the US$ 2 billion [quoted by pharmaceutical industry sources].

But we need to be careful about comparing things that are not comparable. We are developing treatments in a field that is very abandoned; we [only] must demonstrate superiority against treatments that are very bad.

Much of the new research is industry documenting that their drug is slightly better than the previous one, and that is very costly. Most of the big companies have abandoned the field of communicable diseases. Secondly industry includes their opportunity costs or costs of capital for investing for years in a product. What we calculate is the real cost of developing. So, the way that we calculate is not the same.

The DNDi model is more cost-effective because it is tailored to achieving the goal that we are trying to pursue. But I don’t think that we could expect that a large pharma company would do the job [in the same way]. What we have achieved is to get a lot of support and commitment from [big] Pharma to pursue our goal.

HP-Watch: What challenges lie ahead?  Do you see DNDi continuing to address infectious diseases only, or could NCDs also be a target, insofar as they are an increasingly large proportion of the burden in LMICs but receive very little investment for treatments geared to low-income populations.

Pécoul: We still have a big challenge with leishmaniasis, it is very prevalent in many parts of the world, and we still use old products that are very difficult to use. We have identified a series of new chemical entities and we want to complete the development of an oral treatment for leishmaniasis. [As of now, there are no all-oral treatments.].

HP-Watch: Are there diseases that might be ripe for elimination?

A doctor dispenses fexinidazole, the first-ever oral treatment for sleeping sickness, which was developed by DNDi.

Pécoul: The best example is sleeping sickness. Fexinidazole, the new oral treatment developed for DNDi in 2018 is taken for 10 days, and is already a massive improvement on early options. But we have one project in the portfolio [pipeline] that would be a single dose treatment for sleeping sickness. If we are successful in developing a single dose, we could be successful in eliminating the Gambiense form of the disease, which is the most common one, and where the reservoir is primarily other human beings, although tsetse flies are vectors.

HP-Watch: What about malaria? Can you explain your involvement with that disease?

Pécoul: We were involved initially in malaria, where we developed two combination dose formulations, as mentioned.  But we completed the job and then transferred to Medicines for Malaria Venture.  They are a close partner of MMV, and they continuing to monitor these projects.

HP-Watch: And other disease frontiers where you see DNDi playing a role?

Pécoul: We will remain focused on NTDs, but not exclusively. For instance, in the last few years we have worked on paediatric formulations for HIV, and we also worked on adult medications for hepatitis C. We could at some point include some NCDs or other issues. For instance, there is the issue of snakebites. It is a neglected disease area.

But in all choices, we would have to assess the needs and the science to see if the scientific background is there to create the basis for success. We are not going back to basic research and we also must look if others are better positioned to do the job.

Concerning antimicrobial resistance, together with WHO we helped incubate GARDP, in which we are trying to use the model of DNDi to develop a new generation of treatments for AMR.

HP-Watch: Recently, DNDi worked with the European Medicines Agency [EMA] to make use of a special section of its regulatory code, known as “Article 58” to help fast-track regulatory approval of the new drug for sleeping sickness, fexinidazole, bringing African regulatory authorities into the process. Can you describe why that process represents a precedent that can help get new treatments to patients more rapidly?

Pécoul. Article 58 is an agreement between WHO and EMA, and in this agreement EMA reviews a dossier for a product that will be used outside of Europe, and they agree to include regulatory authorities from the countries involved.  So, in this case, representatives of the Democratic Republic of Congo (DRC), [which is one of the primary areas affected by sleeping sickness], were involved. That, in turn, helped expedite the national regulatory process, since DRC representatives sat on the EMA body that approved the drug. It’s a good example of collaboration on regulatory issues.

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Dr Bernard Pécoul has led the Drugs for Neglected Diseases initiative (DNDi) since its founding in 2003. Under his guidance, DNDi – a not-for-profit research and development organization – with hundreds of public and private partners, has delivered eight new treatments for the most neglected diseases (leishmaniasis, sleeping sickness, and Chagas disease) and for malaria. It has developed a robust portfolio of projects spanning from discovery to implementation for these diseases as well as filaria, paediatric HIV, mycetoma, and hepatitis C. As part of DNDi’s dynamic portfolio approach, Dr Pécoul also led the creation with WHO of GARDP, a new product development partnership to address R&D for new antibiotic treatments.

DNDi aims to deliver a total of 16 to 18 new treatments for neglected patients by 2023. The initiative, through its R&D work, also builds capacity in disease endemic countries through research platforms and technology transfers and advocates for greater public leadership to sustainably address the health needs of neglected patients.

Prior to DNDi, Dr Pécoul was Director of the Médecins Sans Frontières (MSF) Campaign for Access to Essential Medicines from 1998 to 2003, a position he took on after that of Executive Director of MSF-France. While working with MSF, Dr Pécoul carried out field missions in Africa, Latin America, and Asia. In 1988, he co-founded Epicentre, an MSF-affiliated NGO specialized in epidemiology.

Image Credits: Paul Kamau/ DNDi, FBBVA, Ana Ferreira/DNDi, Xavier Vahed/DNDi.