Efforts to eliminate river blindness, a debilitating parasitic disease that causes vision loss in 1.15 million people, may be threatened by another infection known as African eye worm, according to a modelling study published in Clinical Infectious Diseases. While the World Health Organization has set a target to eliminate river blindness in most African countries in the next five years, the study predicts that 4 million people living in areas with African eye worm will still be at risk of the blinding disease in 2025, threatening almost four decades of elimination efforts.

The study, co-authored by researchers from Erasmus MC, University Medical Center Rotterdam in the Netherlands, and the Drugs for Neglected Diseases Initiative, also predicts that 90% of these people will live in areas currently not covered by treatment programmes for river blindness.

A villager’s eyes are being examined for African eye worm by Dr Philippe Urwotho, a medical doctor and Provincial Coordinator of the DRC’s Neglected Tropical Disease National Programme.

Elimination of river blindness, also known as onchocerciasis, is mainly reliant on a strategy of “mass drug administration,” whereby entire communities living in endemic areas are given a safe and effective drug called ivermectin regularly in order to prevent the parasitic disease from progressing or spreading. Ivermectin only targets the juvenile worms that can cause blindness or severe chronic skin itching, so mass drug administration needs to be repeated for the full life span of the adult parasite – 10 to 12 years – to fully eliminate the parasite from a community.

The problem arises when communities live in areas with both the river blindness parasite and the African eye worm, or Loa loa – people who have a high number of Loa loa larvae in their blood are at risk of life-threatening complications if they receive ivermectin. As a result, ivermectin cannot be safely used in mass drug administration campaigns in areas co-endemic for both diseases, and river blindness treatment programmes in these areas have not started.

“The current approach to preventing river blindness based on mass drug administration of ivermectin has been extraordinarily successful,’ says Sabine Specht, Head of Filarial Clinical Programme at DNDi, in a press release. “But alternative treatment strategies will be needed if we want to eliminate the disease, including the development of entirely new tools that offer a rapid and safe cure for river blindness.”

The authors predict that in 2025, there will still be at least 31,000 individuals infected with onchocerciasis and unable to use ivermectin, due to the high load of  Loa loa worms in their bloodstream – as the current treatment regimens for co-infected people are not well adapted for use in the field. According to the study, there are also currently no safe medications that can be used to kill adult forms of the worms that cause river blindness. The authors highlight that the lack of existing field-friendly treatments and diagnostics for both diseases merit further R&D for both diseases.

River blindness is transmitted by the bite of infected blackflies, which live near fast-moving rivers. The disease can progress to severe itching, skin lesions, and eventual blindness. Before large-scale control campaigns began in the mid-1970s, whole villages would eventually go blind from the disease. In 2017, it was estimated that 14.6 million people infected with onchocerciasis had severe chronic itching and skin disease, and 1.15 million had vision loss.

African eye worm, or Loa loa, gets its name from its most infamous tell-tale sign: the visible passing of the Loa loa worm through the eye. While previously thought to be rather mild, recent studies show that Loa loa infection can cause severe illness such as cardiac fibrosis, encephalopathy, and neurological or psychiatric disorders.

Image Credits: DNDi.

The World Health Organization and African Union have signed a sweeping Memorandum of Understanding to collaborate on improving access to medicines, strengthening epidemic preparedness, and expanding universal health coverage across the African continent.

These are the three main pillars of the MOU signed Monday by the WHO Director-General Dr Tedros Adhanom Ghebreyesus and African Union Chair Moussa Faki Mahamat at a two AU meeting in Geneva.

Moussa Faki Mahamat (left) and Dr Tedros Adhanom Ghebreyesus (right) hold the signed MOU

The MOU commits WHO to providing technical expertise to the newfound African Medicines Agency (AMA), in order to support regulatory approvals and local production of essential medicines, hopefully increasing access to quality-assured drugs. The African Union voted just last year to endorse a treaty to establish the AMA, and officially adopted the treaty in February 2019.

It is hoped that the AMA’s creation will foster more uniform drug rules and regulations across the continent, also fostering faster approval for new medications and cheaper prices. Up until now, most African countries wait until a new drug is approved by a developed country regulatory authority, such as the US Food and Drug Administration or the European Medicines Agency, and then a number of regional African entities, or each country individually, considers if to approve the drug for use.

“The three pillars of our new MOU pose three challenges that we must address together if we are to realize our shared vision for a healthier, safer, fairer Africa,” said Dr Tedros in a statement to the AU Commission Chair and AU ambassadors on Sunday.

“First, we must invest in access to medical products that are high-quality, safe and effective. Second, we must invest in preparedness, not panic. And third, we must invest in primary health care.”

Once it is up and running, the AMA will be responsible for assessing the safety and efficacy of new health products proposed for use in Africa, issuing guidance to African Union countries regarding regulatory approval and use. It will be modeled after the European Medicines Agency, which provides regulatory guidance for new health products introduced on the European continent.

The next steps are to define more precisely the scope of activities for the new regulatory body. In particular, Tedros says, the AMA should also focus on “creating an enabling environment to foster local production,” noting that “too many of our brothers and sisters don’t have access to the medicines they need, or use medicines that are substandard or falsified.”

About 1 in 10 medical products in low- and middle-income countries is either manufactured or packaged in substandard ways or falsified, according to a 2017 WHO report. The WHO African Region contributed 42% of the substandard or falsified product reports to this analysis.

The AMA will also provide a continental approach towards harmonizing existing regional initiatives to regulate new health products,  including those by the Economic Community of West African States (ECOWAS), the South African Development Community (SADC), and the East African Community Medicines Regulatory Harmonisation (EAC MHR).

Civil Society Pushes ARIPO to Use More TRIPS Flexibilities

The MOU announcement between WHO and the AU coincided with an open letter published by over 90 civil society organizations demanding reform of the African Regional Intellectual Property Organization (ARIPO), which handles patent applications for pharmaceutical products for 18 countries contracted to the Harare Protocol.

The civil society organizations signed an open letter to Ministers of ARIPO asking them to take bolder actions in leveraging TRIPS flexibilities to promote access to generic medicines at the ARIPO Ministerial Meeting from November 18 – 20 in Liberia.

ARIPO’s patent practices are largely dictated by the Harare Protocol, and the patents issued apply to the ARIPO region, which includes countries such as Kenya and Zimbabwe. The letter urges Ministers to update the Harare protocol to incorporate more TRIPS flexibilities at the regional level to allow generic versions of new drugs to enter the market earlier.

TRIPS flexibilities, which allow countries to remedy anti-competitive practices in situations of public health need, are currently not being implemented in the ARIPO patent process, the letter says. Specifically, key TRIPS flexibilities such as the Least Developed Country (LDC) patent exemption, which gives the LDCs maximum flexibility in patenting pharmaceutical products until 2033, have not been implemented through the Harare Protocol. Some 13 of the 18 ARIPO member states are classified as LDCs according to UN.

Experts say that establishing the AMA and reforming ARIPO patent practices together could improve access to cheaper, quality assured generic medications.

“IP reform has to go hand in hand with regulatory reform and coordination to remove two of the main barriers to robust generic competition in quality assured medicines,” says Brook K. Baker, professor at Northeastern University School of Law and senior policy advisor at Health GAP (Global Access Project), an HIV advocacy organization that works in several ARIPO countries.

Setting high standards for issuing patents could allow generics to be produced for more medicines, and having the regulatory mechanisms that can assess the safety and efficacy of these products will provide the regulatory approval needed to to speed their entry to market, he says.

Epidemic Preparedness and Universal Health Coverage on MOU  Agenda

The other two pillars of the WHO-AU MOU also focus on building capacity in the African continent, to respond more strongly to epidemic threats and to expand primary health care.

Tedros called the ongoing Ebola outbreak in the DRC as “a stark reminder than many AU countries are vulnerable to the impact of epidemics.”

Dr Tedros delivering a statement at the Sunday meeting with the AUC Chair and AU ambassadors

For too long, he said, the world has “invested in panic, rather than in epidemic preparedness,” noting that the global health community has largely responded to outbreaks reactively, instead of preemptively investing in health systems to prevent epidemics.

Working with the African Center for Disease Control, the WHO will support efforts to strengthen the health workforce in AU countries and establish a Volunteer Health Corps for Africa, and support the development of national action plans for emergency preparedness.

Lastly, the MOU commits the WHO to support the implementation of the Addis Ababa Call to Action on universal health coverage, endorsed by the African Union Summit in February. The WHO will help facilitate dialogue between Health and Finance Ministers to help countries increase domestic financing for primary health care by at least 1% GDP.

Image Credits: Twitter: @WHO, Twitter: @DrTedros.

Millions of sanitation workers in the developing world are forced to work in toxic conditions, coming into direct contact with human waste and toxic chemicals, with little to no pay or legal protections. Sanitation workers provide essential public services, yet are often the most marginalized, poor, and discriminated against members of society.

These are the main findings of a new report, Health, Safety, and Dignity of Sanitation Workers, released Thursday by the World Health Organization, International Labour Organisation, WaterAid, and the World Bank. The report examines case studies of sanitation workers’ conditions in nine countries – Bangladesh, Bolivia, Bukina Faso, Haiti, India, Kenya, Senegal, South Africa, and Uganda – and is the most extensive study of sanitation workers’ occupational conditions and livelihoods to date.

Manual pit emptying in India

“A fundamental principle of health is “first do no harm.” Sanitation workers make a key contribution to public health around the world – but in so doing, put their own health at risk. This is unacceptable,” said Dr Maria Neira, director of WHO’s Department of Public Health and Environment in a press release. “We must improve working conditions for these people and strengthen the sanitation workforce, so we can meet global water and sanitation targets.”

Meanwhile, a report published by OECD on the same day found that antibiotics and other pharmaceutical residues are being discharged into freshwater systems through untreated household wastewater and runoff from municipal wastewater treatment plants – throwing ecosystems out of balance and potentially exacerbating the problem of growing drug resistance in deadly bacterial, fungal, and viral diseases.

Sanitation workers provide key public health services such as cleaning public toilets, emptying pits and septic tanks, cleaning sewers and manholes, and transporting fecal sludge. Workers are often exposed to a number of hazardous chemicals or diseases such as cholera in untreated waste or water, the WHO report finds.

Many sanitation workers work informally for little pay, and have few legal or social protections. The work is often stigmatized and done at night with little lighting or protective equipment, increasing the occupational risks to the job. While there are few statistics on how many sanitation workers there are around the world, the report estimates that one sanitation worker dies every five days in the sewers of India.

Still, report ends on a positive note, highlighting examples of countries such as South Africa where sanitation work is more formalized and protected under national labor standards and explaining next steps that can be taken to improve the health, dignity, and autonomy of sanitation workers.

Despite the horrid working conditions, sanitation work is an essential public health service, and the workers themselves know it. The report quotes workers like Senzi Dumakude, a sewage blockage crew member in South Africa, who says, “I enjoy serving the community, making sure that our city is clean… We are making sure it is safe.”

Risks Faced by Sanitation Workers and Potential Solutions

While some sanitation workers are public or private employees that have benefits and clear legal protections, a number of people work informally, for little to no pay in ghastly conditions exposing workers to a number of health hazards. The WHO report found four key challenges and risks to sanitation workers:

  • Sanitation workers are exposed to multiple occupational and environmental hazards.
  • Sanitation workers have weak legal protection resulting from working informally, a lack of occupational and health standards, and weak agency to demand their rights.
  • Financial insecurity is a great concern because typically, informal and temporary sanitation workers are poorly paid, and income can be unpredictable. Some sanitation workers report being only paid in food.
  • Social stigma and discrimination exist, and in some cases, are experienced as total and intergenerational exclusion.

The report highlights so-called “manual emptiers” as a particularly vulnerable class of workers. These laborers are responsible for emptying pits, cleaning toilets or sewers with little to no protective clothing, and often use buckets, ropes, and shovels for their work. Some workers can only use their hands and feet. Efforts to ban manual emptying have driven the practice underground, where workers have even fewer protections in the informal sector.

Sanitation workers who are not protected by adequate health and safety measures are at high risk of health problems. Dizziness, fever, cholera, hepatitis, and polio, along with physical trauma such as puncture wounds and cuts, back pain, and death by asphyxiation from noxious gases have all been directly associated with unprotected sanitation work, the report notes.

Countries such as Bangladesh and South Africa have formalized the sanitation sector, which represents a huge step in protection sanitation workers. To protect the health and safety of sanitation workers, the report recommends five good practices:

  • Providing acknowledgment and formalization to sanitation workforce (including legal protections)
  • Mitigating occupational health risks for sanitation workers, such as protective clothing or mechanical equipment for sanitation work.
  • Delivering health services to sanitation workers
  • Establishing standard operating procedures and guidelines
  • Promoting workers’ empowerment through unions and associations
Antibiotic Residues In The Environment Could Contribute To AMR
Credit: aus der Beek T. et al., 2016

Antibiotics and other pharmaceutical residues are being found in water systems around the world, with untreated wastewater as a primary source of these runoffs. An OECD report, Pharmaceutical Residues in Freshwater: Hazards and Policy Responses, released Thursday pointed to a growing prevalence of pharmaceutical residues in the environment, citing studies that show residues from up to 200 different compounds have been found in parts of the world. The report cited a forthcoming study that found antibiotics in 65% of 711 river sites in 72 countries.

In 111 of the sites, the concentrations of antibiotics exceeded safe levels, with the worst cases more than 300 times over the safe limit set by the AMR Industry Alliance. The over-use and mis-use of antibiotics is greatly associated with growing antimicrobial resistance, as continued exposure to antibiotics may enable bacteria to evolve new genes resistant to the drugs.

Drug-resistant infections are currently estimated to cause 700,000 deaths annually, and an AMR review commissioned by the UK Prime Minister estimates that AMR-related deaths could increase to 10 million per year by 2050.

Image Credits: CS Sharada Prasad/Water AId/Safai Karmachari Kavalu Samiti, Health, Safety, and Dignity of Sanitation Workers: An Initial Assessment.

Pakistan became the first country in the world to introduce the typhoid conjugate vaccine (TCV) into its routine immunization program on Friday. The government of Pakistan is launching the national vaccine with a campaign in Sindh Province, which has already been deploying the vaccine on an emergency basis since April 2019 to tackle an ongoing extensively drug-resistant (XDR) typhoid outbreak that began in November 2016.

“Children are disproportionately affected by typhoid and its associated complications, and we strongly believe that TCV would protect our children against potentially fatal disease of typhoid,” said Dr Zafar Mirza, Special Assistant to the Prime Minister on Health said in a press release issued by Gavi, The Vaccine Alliance. “Starting with Sindh Province, where the need is most urgent, the government of Pakistan has planned a phased national introduction strategy with strong, coordinated support from global and local partners.”

A child is prepared for a vaccine in Pakistan.

Pakistan’s current extensively drug resistant (XDR) outbreak of typhoid, which has infected more than 10,000 people, mostly in Sindh province, is the first-ever reported outbreak of typhoid resistant to all but one oral antibiotic for typhoid. Use of the World Health Organization-recommended TCV has helped protect some individuals against the deadly strain.

Typhoid, a serious illness caused by Salmonella Typhi, is spread through contaminated food and water and disproportionally impacts children and low-resource communities in Asia and sub-Saharan Africa. The Global Burden of Disease study estimates that, in 2017, there were nearly 11 million typhoid cases and more than 116,000 typhoid deaths worldwide.

In 2017, 63% of typhoid cases and 70% of typhoid deaths in Pakistan were among children younger than 15 years of age. TCV is the first typhoid vaccine that can be given to children as young as 6 months of age and confers longer term protection against typhoid.

With funding support from Gavi, the vaccine introduction will begin with a two-week vaccination campaign targeting 10 million children 9 months to 15 years old in urban areas of Sindh Province. It will be followed by a transition to routine immunization of 9-month-old infants in all parts of the province once the campaign ends. The vaccine will be introduced in neighboring Punjab Province and Islamabad next year and then nationally in 2021.

“Typhoid is a highly contagious disease that spreads more quickly and easily when people live in crowded neighborhoods with weak water and sanitation infrastructure. Beginning the vaccination in urban areas is critical in preventing the disease among the communities most at risk,” said Dr. Azra Fazal Pechuho, Provincial Minister of Sindh for Health, and Population Welfare. While she claims vaccination is the best protection against typhoid, the government will also be promoting water, sanitation, and hygiene solutions.

WHO issued its formal recommendation in support of typhoid conjugate vaccine introduction in March 2018 following positive results from clinical trials conducted in Bangladesh. In anticipation of the availability of typhoid conjugate vaccines, Gavi earmarked US$85 million to support eligible countries with the introduction of typhoid conjugate vaccines into their routine immunization programs.

“Before the discovery of antibiotics, typhoid would kill as many as one in five people who contracted it,” said Dr Seth Berkley, CEO of Gavi. “The rise of extreme drug resistant typhoid risks bringing us back to levels of mortality not seen since the 19th century, posing a risk to all of us.”

Liberia and Zimbabwe are also preparing to introduce the typhoid conjugate vaccine next year with Gavi support, and several other countries are considering use of the vaccine as they review data on the incidence of typhoid in their countries.

For more information see the press release.

Image Credits: CDC.

The debate around drug price transparency was a highlight of the 4th Forum on Access to Medicines in Europe, hosted by the European Public Health Alliance (EPHA) Thursday. The forum focused its discussions around cancer therapies, medicines shortages, and transparency around R&D costs.

“It is high time to challenge the status quo on medicines policy – it can no longer be dismissed as business as usual,” said Fiona Godfrey, secretary-general of the EPHA, in an opening statement at the day-long event.

The high costs of cancer treatment was singled out as a topic of particular interest, guiding discussions in the first plenary session. Speakers noted that new cancer treatments often show low evidence of substantial clinical benefit as compared to drugs already on the market, but are still priced at exorbitant prices.

“Cancer drugs should be the cheapest. I don’t understand how we pay so much when we don’t know what we are buying. We need a dialogue to find a better balance between commercial and non-commercial research,” said Denis Lacombe, director-general of the European Organisation for Research and Treatment of Cancer.

The session also shed light on the inequity in cancer treatment between Eastern and Western Europe, challenges in scaling up innovative products, and the opacity around cancer R&D, observers noted.

Bjørn-Inge Larsen speaking at the 4th EPHA Forum on Access to Medicines in Europe.

Along with other figures that have been driving the transparency agenda in global health policy-making, Bjørn-Inge Larsen, secretary-general of Norway’s Ministry of Health and Care Services, challenged policy-makers to tackle the transparency issue and growing concerns about rising drug prices.

“We need to find balance between new technology and costs…It’s good that so many new medicines are available, but we need to make sure patients can benefit from them” said Bjørn-Inge Larsen in a keynote speech.

Inge Larsen highlighted the importance of drug price transparency and the challenges associated, noting that “we need to show how we are spending [taxpayers’] money, and currently politicians cannot explain prices and availability to patients.” He added that Norway was in discussions with Denmark and Iceland to jointly negotiate access to innovative, but expensive new therapies.

Image Credits: Twitter: @EPHA_EU.

WHO’s agenda for the next Executive Board (EB) meeting, scheduled for 3-8 February 2020, will see discussions grouped for the first time ever around the three key pillars of the WHO Global Plan of Work for 2019-2023, including expanding health and wellbeing, protection from health emergencies, and universal health coverage to one billion more people.

This is an innovation in the way governing board sessions are organized – but may also help to bring greater focus to debate, organized around key themes.

The 144th Meeting of the EB

Proposed EB discussions on access to gene and cell therapies for cancer and medicines for rare diseases, requested by South Africa and Peru respectively, will be merged and postponed until 2021, according to the list of topics to be tackled at the next EB session included in a note on the EB agenda released Thursday.

The decision received a mixed response from access groups wishing to keep these two issues alive following last year’s approval of the milestone WHA Resolution on transparency in medicines markets.

“The challenges of providing equal access to the new technologies are significant, and the WHO needs to engage now. That said, the deferral to the 2021 Executive Board [meeting] gives everyone more time to prepare and reflect on the measures needed to address the shocking inequalities of access,” said James Love, director of Knowledge Ecology International.

KEI also welcomed the fact that there will be a discussion of public health, innovation and intellectual property issues as proposed by Brazil in the February 2020 meeting.

It is likely that the tight schedule for this year’s governing body meetings also has created pressure to keep the agendas more limited, observers noted.

Exceptionally, the next meeting of the Executive Board, which includes some 34 country representatives elected by the World Health Assembly for 3-year terms, has been scheduled for February. Usually meetings are in the first month of the year but the schedule has been shifted due to the Lunar New Year on January 25.

Next year’s WHA meeting in May 2020 will also take place over only 4 ½ days due to the concurrence of the Muslim festival of Eid al-Fitr, making the scheduling for that meeting particularly tight.

One change welcomed by civil society has been the publication of more detailed notes under Director-General Dr Tedros Adhanom Ghebreyesus’s tenure, such as this one, which give an indication of upcoming priorities and discussion items in the WHO governing boards.

Other key items on the EB agenda will include a discussion of the WHO’s NCD Action Plan, including an item on the elimination of cervical cancer as a public health problem, the Roadmap on Neglected Tropical Diseases (NTDs), healthy ageing, nutrition, WHO’s work in health emergencies, and a global digital health strategy.

For more details see the Preliminary Draft Agenda of the 146th EB Meeting and the Note for the Record on the October 5 EB Meeting.

 

Image Credits: WHO.

The world is experiencing a record-breaking surge in wildfires, downward trends in crop production, unprecedented heat waves, and a rise in infectious diseases as a result of the unabated pace of climate change – affecting the health and safety of hundreds of millions of people worldwide. However, dramatic action now could still keep the global average temperature rise to below 2 degrees Celsius if bold new, approaches are taken.

These are among the main findings of the annual Lancet Countdown on Health and Climate Change, one of the most comprehensive scientific reviews of the ongoing effects on health of climate change. The report collates data on some 41 key climate and health indicators culled from studies by 35 academic and research institutions and 120 experts worldwide, to lay out the lifelong health consequences of rising temperatures should the world follow a “business-as-usual” pattern.

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

This year, the accelerating impacts of climate change have become clearer than ever”, said Professor Hugh Montgomery, co-chair of The Lancet Countdown and director of the Institute for Human Health and Performance at University College London in a press release. “The highest recorded temperatures in Western Europe and wildfires in Siberia, Queensland, and California triggered asthma, respiratory infections and heat stroke.”

But while the world is already seeing the very immediate health impacts from climate change in terms of greater exposures to heatwaves, wildfires, and extreme weather, as well as greater food insecurity, the lion’s share of the health burden will fall on the younger and future generations, the report warns. Children born today could be threatened by even more widespread food insecurity, even greater increased risks of infectious diseases, and lasting health effects from environmental pollution related to climate change.

“Children are particularly vulnerable to the health risks of a changing climate. Their bodies and immune systems are still developing, leaving them more susceptible to disease and environmental pollutants,” says Dr Nick Watts, executive director of The Countdown.

If global action against climate change isn’t accelerated, average global temperatures could rise between 4-7 degrees Celsius by the end of the century, according to the report. However, a 7.4% year-on-year reduction in fossil fuel-related CO2 emissions starting between 2019 to 2050 could still limit global warming to under 1.5 degrees Celsius by 2050, the report concludes. Limiting global warming to 1.5 Celsius is one of the goals outlined in the 2015 Paris Agreement.

Sobering Trends and a Glimmer of Hope

Among the most sobering trends, the Countdown notes the following:

  • Globally, 77% of countries experienced an increase in daily population exposure to wildfires from 2001–2004 to 2015–18. India and China sustained the largest increases, with an increase of over 21 million exposures in India and 17 million exposures in China over this time period.
  • In 2018, vulnerable populations experienced 220 million additional heatwave exposures globally, breaking the previous record of 209 million set in 2015. Already faced with the challenge of an ageing population, Japan had 32 million heatwave exposures affecting people aged 65 years and older in 2018, the equivalent of almost every person in this age group experiencing a heatwave.
  • In 2018, 45 billion potential work hours were lost globally; southern areas of the USA lost 15–20% of potential daylight work hours during the hottest month of 2018.
  • In low-income countries, almost all economic losses from extreme weather events are uninsured, placing a particularly high burden on individuals and households.
  • Downward trends in global yield potential for all major crops tracked since 1960 threaten global food production and food security. Crop growth season duration has been reduced by 2.9% for maize, 3.8% for winter wheat and 3.1% for soybean crops from 1988 to 2017. Air pollution as well as more extreme heat, rainfall and drought can reduce crop productivity.

Despite this gloomy outlook, the Countdown report finds positive trends as well, which could be the basis for slowing warming, if these picked up momentum.

For instance, despite a small increase in total coal use in 2018, in key countries such as China coal’s share in electricity generation has declined.

Renewables accounted for 45% of global growth in power generation capacity in 2016, and low-carbon electricity reached a high of 32% of global electricity in 2016.

Global per capita use of electric vehicles increased by 20.6% between 2015 and 2016, and now represents 1.8% of China’s total transportation fuel use.

Improvements in air pollution seen in Europe from 2015 to 2016 could lead to significant reductions in air pollution-related illness and disability if trends are maintained over the course of the average lifetime, potentially saving economies up to €5.2 billion annually.

And cities and health systems are becoming more resilient to the effects of climate change; about 50% of countries and 69% of cities surveyed reported efforts to conduct national health adaptation plans or climate change risk assessments.

Authors Urge For Action For Future Generations

However the positive trends are nowhere strong enough at present to blunt the continued increase in climate emissions. Bold new actions are required to keep global warming below 2 degrees Celsius, the report says. The health impacts of climate change can be mitigated by four key actions:

  • Delivering rapid, urgent, and complete phase-out of coal-fired power worldwide.
  • Ensuring high-income countries meet international climate finance commitments of US$100 billion a year by 2020 to help low-income countries shift to low-carbon technologies and adapt to climate change.
  • Increasing accessible, affordable, efficient public and active transport systems, particularly walking and cycling, such as the creation of cycle lanes and cycle hire or purchase schemes.
  • Making major investments in health system adaptation to ensure that the health impacts from climate change don’t overwhelm the capacity of emergency and health services.

Authors of the report point to the upcoming COP25 Climate Change Conference in Madrid (2-13 December) and a growing global movement against climate change, led by young people as catalysts for more assertive action.

Co-Author Dr. Stella Hartinger was quoted in The Countdown’s press release saying, “We must listen to the millions of young people who have led the wave of school strikes for urgent action. It will take the work of the 7.5 billion people currently alive to ensure that the health of a child born today isn’t defined by a changing climate.”

For more information about the 2019 Report, its findings and policy implications, see the Lancet Countdown’s Resources Page.

Image Credits: Pablo Tosco/Oxfam, The Lancet Countdown on Health and Climate Change, The Lancet Countdown.

The World Health Organization announced Wednesday that it would implement a pilot programme to include human insulin products in its Prequalification of Medicines programme, in an effort to expand access to treatment for diabetes in low- and middle-income countries. The move is the first in a series of steps WHO is taking to address the growing burden of diabetes, which is now one of the top ten leading causes of death around the world.

“Diabetes is on the rise globally, and rising faster in low-income countries,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General in a press release. “Too many people who need insulin encounter financial hardship in accessing it, or go without it and risk their lives. WHO’s prequalification initiative for insulin is a vital step towards ensuring everyone who needs this life-saving product can access it.”

Human insulin has been on the WHO Essential Medicines List since 1977, which guides many national government decisions about products to support in public health services. However, only about half of the 65 million people with Type 2 Diabetes who need insulin can actually access it, WHO estimates, due to the high prices of insulin products and unavailability in public health facilities.

Currently just three pharmaceutical companies – Novo Nordisk, Eli Lilly, and Sanofi – control most of the global market for insulin products, and prevailing prices remain prohibitive for many people and low-income countries, and even in some high-income groups as well.

Including insulin in WHO’s Prequalification of Medicines programme, would make it more attractive for new competitors to enter the market – by submitting proposals to WHO review for production of quality-assured insulin products at lower prices. WHO prequalified products also are used as the basis for many donor-supported initiatives to make bulk purchases of products at preferred prices for low- and middle-income countries.

The ultimate result, WHO officials believe, would be an increase in the number of quality-assured human insulin products on the international market, and a wider range of choices for patients at lower prices.

“Prequalifying products from additional companies will hopefully help to level the playing field and ensure a steadier supply of quality insulin in all countries,” said Dr Mariângela Simão, assistant director general for Medicines and Health Products at WHO.

A WHO spokesperson told Health Policy Watch that already, at least three new market entrants have informally expressed their interest in applying for WHO Prequalification as part of the pilot.

“Clearly we hope more come forward now that the pilot is official, because clearly the more companies that meet international quality standards, the larger the chance that insulin will become affordable,” said the spokesperson.

The target WHO assessment time is 270 days, meaning if companies submit their applications within the next few months, new WHO-prequalified products could be on the market as early as this time next year.

Prequalification is a process in which WHO evaluates the quality, safety, and efficacy of medical products and issues guidance on their use. Many low- or middle-income countries also see WHO prequalification of a product as a stamp of approval to begin registering the health product for use in their own countries.

Access To Insulin A Global Challenge

From 2016-2019, human insulin was available only in 61% of all health facilities and analogue insulins (altered forms of human insulin) were only available in 13%, according to WHO data from 24 countries. The data showed that a month’s supply of insulin would cost the average worker in Accra, Ghana almost a quarter of their monthly income.

Even in high-income countries, the high price of insulin results in many people rationing its use, which can be deadly for people who do not receive the appropriate daily dose.

Globally, some 422 million people live with diabetes. Diabetes is the seventh leading cause of death globally and a major cause of costly and debilitating complications such as heart attacks, stroke, kidney failure, blindness and lower limb amputations.

People with Type 1 diabetes need insulin for their very survival and to maintain their blood glucose at levels to reduce the risk of common complications such as blindness and kidney failure. People with Type 2 diabetes need insulin for controlling blood glucose levels, and to avoid further complications when oral medicines become less effective as the illness progresses.

Decision Follows Debate Over Inclusion of Analogue Insulin in WHO Essential Medicines List 

WHO’s decision to pilot human insulin prequalification also follows a contentious debate earlier this year over the proposed inclusion of still more pricey insulin analogues (altered forms of human insulin) in WHO’s Essential Medicines List (EML). The list is used by many countries as a basis for national decisions on the basket of medicines to be procured, offered or supported.

Civil society, scientific experts, and patient access groups opposed the petition to include analogues in the EML, arguing that including these products without addressing the lack of competition in the insulin space could send the wrong message to governments, making analogue insulin the new norm. And that could actually drive up prices that low- and middle- income countries were paying for insulin products.

The Pre-Qualification initiative appears aimed at addressing some of those existing needs and gaps. Health Action International (HAI), one of the same civil society groups that opposed the petition to include analogues in the EML, commended the WHO’s decision to include human insulin in the prequalification program.

Dr. David Beran, University of Geneva professor and co-lead investigator of a HAI study group focusing on insulin access (ACCISS) expressed his hope that WHO’s decision will impact the limited competition in the insulin market in a statement released by the group. “This initiative should ultimately lead to greater competition and hopefully lower prices, thus improving affordability for people and health systems.”

This story was updated November 14.

Image Credits: WHO.

With rates of self-harm, suicide and anxiety among children and young people growing around the world, UNICEF and the World Health Organization hosted the first ever “Leading Minds” Conference to tackle adolescent mental health on November 7-9. The forum highlighted the growing recognition of mental health as a global health problem, and follows moves made earlier this year by WHO to scale up social media campaigns for suicide prevention and implement a new Special Initiative for Mental Health.

“Around the world, 1 in 5 children and adolescents live with a mental health condition, such as depression or anxiety. Children living in poverty, or exposed to war, violence at home, or other difficult life situations, are particularly vulnerable. Very few of these young people have access to the [mental health] services they need,” said Dr Tedros Adhonym Ghebreyesus, director-general of the WHO.

“We need to break the silence and eliminate stigma. We need to find better ways to reach young people, through their families, peers, schools and online channels, and help them thrive.”

The first ever such forum co-hosted by UNICEF’s research center Innocenti and WHO in Florence, Italy brought together a variety of stakeholders from different sectors to develop recommended actions to tackle mental health in young people. The by-invitation only forum featured experts such as the Minister of Health of Kazakhstan, who discussed how their country mainstreamed adolescent mental health care into the education and health systems.

Experts at the conference noted the importance of shedding light on adolescent mental health as a particularly neglected area in the mental health space.

“Total development spending and government spending in mental health care make up less than 1% of overall health spending. And less than 1% of that amount is spent on children and young people,” Dr. Vikram Patel, a professor and adolescent health researcher at Harvard Medical School, pointed out in a video from UNICEF Innocenti.

He noted that adolescent mental health is still an area where researchers know very little. This is mostly because most research in mental health has been conducted on adult mental disorders, and mental health problems in young people “don’t fit neatly into these sorts of biomedical activities.”

Despite the lack of knowledge, investing in young people’s mental health is both a “moral and practical, economic” imperative, said Henrietta Fore, executive director of UNICEF, in her opening statement. Since half of all lifetime mental health disorders manifest before the age of 14, early detection, prevention, treatment and rehabilitation is key to “avoid further social and health care costs down the road,” she argued.

Dr. Tedros agreed, calling on all countries to invest in adolescent mental health as part of their efforts to expand Universal Health Coverage.

“After all,” he said, “There is no health without mental health.”

Image Credits: Twitter: @WHO.

MMV CEO David Reddy talks about the steps MMV is taking to support a new generation of malaria research leadership, promote more gender-sensitive malaria treatment and fast-track innovation on new malaria combination therapies. This follows a string of MMV successes over the past two decades in fostering new paediatric malaria treatments, new combination therapies to fight drug resistance and a breakthrough single-dose treatment, tafenoquine, for the relapsing form of malaria.

Health Policy Watch: You are celebrating the 20th anniversary of MMV’s creation. It was also one of the first non-profit “product development partnerships (PDP)” to be created, involving both industry and public sector actors in malaria R&D. How did MMV come about, and what gap has it filled in the R&D landscape?

David Reddy: MMV was formed in 1999, out of a WHA discussion with African leaders who were worried that there was more parasite resistance developing [to existing malaria drugs] and not enough R&D being done on new treatments, effectively there was a market failure.

It came out of the forward-thinking people in Industry and WHO, and incubated at the TDR, the Special Programme for Research and Training in Tropical Diseases.

Today we have a broad partner network, including some 26 pharma partners, both innovators and generic producers, as well as research and academic institutions, governments, international organizations, NGOs and non-profits, and clinical trial centres in endemic countries.

For the past two decades, MMV has been leading the development of new antimalarial treatments, supporting expansion of R&D capacity in malaria-endemic countries, and working to ensure access to antimalarial treatment by the world’s most neglected populations.

HP-Watch: We have heard you recently speak about how MMV had its roots in industry, while Drugs for Neglected Disease Initiative DNDi), had its roots in civil society activism – but you both have gotten to a similar place in your development. Can you talk a little more about that?

Reddy: Well, I compare it to the blue whale and the whale shark.  On the evolutionary tree, DNDI and MMV started from different places, but we are addressing the same underlying issues in the drug development ecosystem – market failure. In addition, we at MMV, we focus solely on malaria whereas DNDi’s remit is wider in terms of neglected tropical diseases.

Because of where we came from, we started from a strong R&D base; there were a lot of people from industry who became part of MMV.  So, I think we were positioned very well in terms of being able to get industry to contribute to the model.  Additionally, I have led teams [while at Roche] that had developed drugs with regulators, so I also know that mindset. And in fact, the regulators are quite agnostic about whether the innovation comes from industry or a non-profit group – the same rules apply.

HP-Watch: There has been a lot of discussion recently about the importance of insuring for wide access to treatments up front. When MMV engages with the private sector or others. What’s MMV’s approach on that, and how is it similar or different to others?

Reddy: In every agreement we have with our partners, we build in access and affordability clauses.  Those include two elements: a commitment to make the drug available and affordable in malaria-endemic countries.  We generally define what that means and in the context of affordability we have enforcement clauses, as well. If a partner doesn’t live up to those obligations, we can take action, such as moving manufacturing capacity across to another partner.

HP-Watch: Is there a motive for pharma to participate if the costs are kept low?

Reddy: Because of the sheer volume of the malaria drugs that need to be provided, [there is still an incentive]. It is a real challenge for other disease areas, where the populations are smaller. For some of our partners, the motive is corporate social responsibility. Others take a no-profit, no loss approach. Incentives such as the US FDA Priority Review Voucher programme can be important.  A partner can use a voucher (awarded upon approval of a new neglected disease treatment to get a rapid approval of another drug in a profitable disease area, where a six-month time to market advantage is worth a considerable amount of money.  And once the vouchers have been issued, they can also be transferred and sold. These kinds of benefits do help tip the balance of the pharma companies participating in this area.

HP-Watch:  Can you briefly summarize the 3-4 biggest breakthroughs you have experienced in drug development – up to the recent approval of the new drug tafenoquine – and their meaning for public health?

A health worker dispenses a child-friendly formulation of Coartem®, MMV’s first paediatric malaria treatment.

The first breakthrough was the product we co-developed with Novartis, that was a child-friendly version of their antimalarial drug, Coartem®, [the first artemisinin-combination therapy]. In less than ten years since launch, some 385 million courses of that treatment have been delivered.  This is a key success since most people who die from malaria are children under 5 years of age. And yet children are among the last to get [paediatric formulations of] medicines [due to the sensitivity of clinical trials involving children]. So, this was really important.”

Pyramax® (pyronaridine-artesunate), is another ACT – based on the drug pyrimidine, that has shown some nice activity in areas where resistance has been seen.

Testing for malaria (P. vivax) parasites in Brazil, the first malaria-endemic country to approve the first GSK and MMV co-developed treatment for relapsing malaria.

This is a particularly important development programme because we are working with a generic company, Shin Poong in South Korea, and they formed a joint team with us.  We were able to bring our knowledge of drug development and the malaria space to them and help bridge the gap between generic companies and innovators. So, it was a capacity development journey for them and for us it was useful in getting the product on the market.

Then, just last year, tafenoquine, which was developed in partnership with GSK and is a single dose cure for the relapsing form of malaria (caused by the Plasmodium vivax parasite), which in some patients can replace 14 days of treatment with the currently used drug. Tafenoquine was approved by the US FDA and Australian TGA. It has also just been approved by the Brazilian regulatory authorities.

 

A child receives injectable artesunate for severe malaria, a formulation that MMV is helping generic manufacturers produce.

In addition, we are supporting generic manufacturers to produce quality-assured variations of rectal artesunate and injectable artesunate, [for immediate treatment of severe malaria episodes]. This was massively important in terms of getting these products onto the WHO Pre-Qualification list, [which undertakes a stringent review and can be a pathway for approval by national regulatory agencies]. For the injectables alone, some 144 million vials have been shipped since 2011, and we estimate that has saved 950,000 more lives in comparison to the alternative treatment, injectable quinine – if people were even to receive that at all. For the suppositories, some 3.2 million have been shipped since 2017, and we estimate about 300,000 lives have been saved.

HP-Watch: What about malaria resistance… how serious a threat is that, where and what is MMV doing about it?

Reddy: There is resistance being seen with some of the ACTs – current first-line treatment for uncomplicated malaria. o\On that basis, we are developing, with Novartis, a new combination of novel compound ganaplacide with a new formulation lumefantrine. This is a non-artemisinin-based combination, which is what we need to be looking for, with a new mechanism of action against resistant parasite forms. It is in Phase 2b studies, and we are hoping it could be a one- or two-day therapy. That would provide a big benefit, in terms of its utility because one of the big challenges that we have seen with the ACTs [which have a 3-dose regimen] is that while people will take the first and second dose, there is a tendency for people to hold back on that last day of dosing, if they are feeling better, thinking that they can save the pill until the next child gets sick. And that fosters resistance.

Resistance is something that needs to be taken really, really seriously, we have seen it in each of the malaria drugs that have been developed, which is why using them in combination is so important.

So, we are trying to pursue an approach where multiple approaches for first-line therapy are available in every country, keeps the pressure on the parasite. Secondly, we are trying to develop new combinations with new mechanisms of action, like the Novartis project I just mentioned. Towards this end, there were 5 biological targets – ways we could hit the parasite – 20 years ago. Today there are 25 targets, and this can give rise to entirely new drugs; a number of them are already in clinical development.

Malaria parasite (blue-left) attaches to a human red blood cell (red-right)

We see the parasites being resistant to the drugs, we see the mosquitoes becoming resistant to the insecticides. We even see the parasites developing a form of resistance to the rapid tests that we use to identify them. In some of the tests, they had worked out a way to escape the test, by deleting a part of their genome that gave rise to a protein used by the rapid test to detect them. This multi-layered counter-offensive is something as a biologist that I have never seen.

The threat of resistance is compounded by other regional or global changes.  For instance, with climate change you get flooding, destruction of infrastructure that reverses the development progress that has been made. The other challenge is political instability, you can see that in the resurgence of malaria in Venezuela.

HP-Watch: The theme of malaria “eradication” has been much in the news, with some agencies saying it’s feasible and WHO saying that the elimination agenda first must get back on track. What’s your view?

Reddy: There were two reports on this topic that were launched a few months ago, one was by the Lancet Commission and one was by the WHO Strategic Advisory Group on Malaria Eradication (SAGEme).  Both effectively came to the same conclusion, which was that eradication should be our objective.  The WHO report [also] said that there is no biological impediment for why it cannot be achieved. But we will need new interventions.

I believe in the feasibility of eradication. What it requires is systematic elimination from countries and regions, as we have done it in Europe and North America. [It also requires a change in mindset], because many people have this inherent belief that the countries in Africa are locked into malaria.

Hans Rosling, in his book Factfulness said that countries in Africa have developed beyond most people’s understanding, at a strong pace. African countries are showing strong ownership of the concept of eradication and they are putting resources behind it. We have seen enormous progress in pushing back malaria, and a number of countries are on the cusp of elimination of malaria [as a public health risk]. But in other countries, we need to do more, including getting more real time data on what is working and what is not.  Groups such as USAID Presidents Malaria Initiative, the Global Fund and the Gates Foundation are really putting processes in in place to get better real time access to data that is needed. And part of it is up to us, to bring a new generation of medicines forward for prevention and treatment. We have made enormous progress; we have entirely new ways of attacking the parasite. Now it’s a matter of getting innovations through development and into the hands of clinics and patients.

HP-Watch: Some critics have accused the health sector of abandoning vector control, including environmentally-friendly measures such as better management of water resources and housing (e.g. screening) as modes of “treatment”, which can also reduce reliance on chemicals, and therefor vector resistance to chemical tools.

Reddy: I think vector control is being addressed from a different angle, the developmental angle.  We do see significant developmental progress and there will be a positive collateral effect on malaria. The Zero Malaria Starts with Me [a continent-wide campaign to eliminate malaria], begun by Senegal, is about communities; it is ensuring that trash is cleaned up, etc. I think the zero malaria starts with me is a good starting point.  But I agree that if we want to address malaria and really beat it, it is a belt and braces approach, we shouldn’t be throwing out any interventions without a thorough assessment.

HP-Watch: What about R&D costs, a subject in the news recently.  Do you have any assessment of the costs to bring a new or adapted drug to market?

MMV and partners have implemented a series of platforms to gather data to feed into a tool to allow unbiased prioritization of optimal drug combinations for further research.

Reddy: The overall costs for development of a malaria drug is about $US 100 million.  The fully loaded costs are probably in the region of $US 200 million. If we pay a dollar, the pharma pays a dollar plus in-kind contribution such as their facilities.  This is not including drug attrition. But since we have a strong system of pre-clinical assays, we can kill drugs pretty early.

Today, we have a strong network of SCID (severe combined immune deficiency) mice assays that allow you to test drug or drug combinations very quickly. [at a later stage] We can also run tests on healthy human volunteers infected with very small amounts of malaria parasites before it becomes clinical, you can treat them [with the experimental drug], and then you can treat them with the standard drugs, so that in a very, very controlled setting you can explore your drugs, are they going to work, and the likely dose you can use with patients. This keeps costs down and speeds things up.

HP-Watch: What challenges lie ahead, and do you see MMV continuing to address malaria only, or could there be other targets for your work?

Reddy: I think there is a real acknowledgement that it is not the current generation of leadership that will finish this job, and that includes me.  We need to be looking for that next generation of leadership and scientists. Much of that leadership is going to be coming from the malaria endemic countries.  So, our work on empowering needs to be rooted in the Malaria endemic countries.

MMV will be focusing on developing better treatments for pregnant women in the coming years

We will be looking more closely at groups such as pregnant women, who are disproportionately affected by malaria.  Yet in drug development programmes, pregnant women are classed as a vulnerable population, and therefore [in the traditional R&D mindset] you protect them from new drugs. [But that leads to us not having adequate drugs for women in pregnancy]. We are all realizing that we have been thinking about this in completely the wrong way, and so we need to see how we can get them included in studies so that they can benefit from new drugs earlier. We need to create a stronger programmatic stream [around malaria in women/pregnancy] if we are going to change things and move towards more equitable access.

Finally, new malaria combination drugs are going to become more and more important in order to avoid resistance.  So, we are launching a “malaria drug development catalyst” [initiative].  This is a unique way of bringing partners together at an earlier stage of development, to look at what drugs can be combined.

With out partners, we have already developed the technical tools, such as mouse assays and human volunteer studies, that allow us to perform tests in a consistent way. All partners can access the molecules, and the molecules can be put through the same assays, so that you can do an apples to apples comparison and see which molecules work best.

As with the assays, we want to create a common way of doing assessments and common agreements with the different companies and partners, so that it is easier for them to work with us and together. This is becoming very important now because we have a number of new drugs coming up through the pipeline. So, it is one of those perfect moments in time when everything comes together, and this is a way of formalizing and accelerating things.

 

This story is part of a series supported by MMV on malaria innovation.___________________________________

About David Reddy: Prior to joining MMV, in 2010, Reddy was a Vice President at Roche Pharmaceuticals, in Basel, Switzerland. With 20 years of management experience in the healthcare industry includes: successful leadership of drug development teams; licensing and alliance management; market analytics and business planning; product and disease area management; and interfacing with Governments, NGOs and patient advocacy groups in priority disease areas including HIV/AIDS and pandemic influenza. He has a doctorate in Cellular and Molecular Biology from the University of Auckland, New Zealand and completed a Post-Doctoral fellowship in molecular neurobiology at the Friedrich-Miescher Institute in Basel Switzerland.

 

Image Credits: Anna Wang/MMV, Novartis, Ben Moldenhauer/MMV, NIAID, NIH, MMV, Elizabeth Poll/MMV.