With the death toll from the world’s worst measles outbreak in the Democratic Republic of the Congo (DRC) now exceeding 6000, the World Health Organization (WHO) appealed to donors on Tuesday for $US 40 million more in funding to stop the advance of the disease – which has killed nearly three times as many people as the Ebola outbreak raging for more than a year.

Measles Immunization in DRC’s Kivu region

Meanwhile, Ebola, which had almost been squashed in late November, continued its resurgence, with some 29 cases reported over the last two weeks of December, according to the latest WHO disease news outbreak report. The surge in cases, which had dropped to less than ten a week, occurred in the wake of widespread civil unrest as well as targeted attacks on health workers by militias in the eastern DRC in late November and early December.

The violence interrupted community-based work to contain the epidemic in a few remaining hotspots, restricting the access of health workers to affected communities for the referral of Ebola patients to treatment centres, vaccination of contacts, and safe burials for Ebola victims.

As for measles, lack of funding remains a key barrier to curbing the outbreak, WHO said, calling on donors to step up to the bat with more contributions to measles vaccine efforts in the DRC.

Despite ramped up immunization campaigns in 2019, routine measles vaccination coverage remains low in some areas of the countries, due to weak health systems as well as the ongoing civil unrest. As evidence of that, some 25% of the reported measles cases are occurring in children over the age of five, who are the most vulnerable, said WHO.

Officials said that while $US27.6 million has been mobilized, another US$ 40 million is required for a six-month plan to extend the vaccination to children in the vulnerable age categories of six to 14 years. The plan would also reinforce elements of the outbreak response beyond vaccination, including improving treatment, health education, community engagement, health system strengthening, epidemiological surveillance and response coordination.

“We are doing our utmost to bring this epidemic under control. Yet to be truly successful we must ensure that no child faces the unnecessary risk of death from a disease that is easily preventable by a vaccine. We urge our donor partners to urgently step up their assistance,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.

In 2019, around 310 000 suspected measles cases were reported. In the same year, the DRC Ministry of Health together with WHO, Gavi, the Vaccine Alliance, The European Union’s Humanitarian Aid department and other aid agencies vaccinated more than 18 million children under 5 years of age across the country.  But that has not been enough.

“We recognize the Government’s engagement in the efforts to end the outbreak and we are grateful for the generosity of our donors. But we still need to do more,” said Dr Amédée Prosper Djiguimdé, Officer in charge of WHO’s DRC office. “Thousands of Congolese families need our help to lift the burden of this prolonged epidemic from their backs. We cannot achieve this without adequate finances.”

The measles outbreak in DRC is part of a broader worldwide epidemic – which has hit poor countries where weak health systems are unable to reach vulnerable populations with immunizations, as well as more affluent countries where pockets of “vaccine resistance” exist in some communities. For a country to be safe from measles, 95% of the population must be immune, WHO says. Yet global vaccination rates have remained stagnant for the last ten years – hovering at around 10% below the recommended threshold for the first dose and 25% below the recommended level for the second dose.

Measles case distribution by month and WHO Region (2015-November 2019).

As for Ebola, the 29 latest confirmed cases were reported from eight health areas in four health zones: Mabalako (62%, n=18), Butembo (14%, n=4), Kalunguta (17%, n=5), and Katwa (7%, n=2). As of the end of 2019, a total of 3380 Ebola cases had been reported, WHO said.  This included some 3262 confirmed and 118 probable cases. Among these, 2232 people had died for an overall case fatality rate of 66%.

 

Image Credits: WHO/African Region, WHO/John Kisimir, WHO .

Chinese authorities have ruled out seasonal influenza, avian flu, adenovirus, SARS and MERS as the cause of a mysterious strain of pneumonia that has now stricken 59 people in the Chinese city of Wuhan, according to the latest data from WHO.

The unidentified virus, which has left seven people critically ill, may have emerged from the city’s large fish market, which also includes trade in exotic animals, the agency suggested.

Wuhan, China

“There is limited information to determine the overall risk of this reported cluster of pneumonia of unknown etiology. The reported link to a wholesale fish and live animal market could indicate an exposure link to animals,” stated the WHO report.

Some of the pneumonia victims were operating dealers or vendors in the Wuhan South China Seafood City, according to another report published by Chinese authorities on Friday.  The market has now been provisionally closed for hygiene and sanitation inspections.

Direct contact with animals is a common trigger for the emergence of new viruses in humans. As the infection is propagated, the virus can mutate and become transmissible from human to human, greatly increasing spread.

So far human-to-human transmission of the unidentified virus affecting Wuhan’s population has not been observed, said WHO: “Based on the preliminary information from the Chinese investigation team, no evidence of significant human-to-human transmission and no health care worker infections have been reported.”

The number of reported infections has more than doubled, however, in the week since the appearance of the pneumonia “of unknown cause” in 24 people in Wuhan was first reported to WHO by the Chinese authorities on 31 December.

There were clear concerns that the pneumonia may represent a new form of a coronavirus, which can be particularly deadly if it begins to spread from person to person, but experts said that more time was needed to identify the virus.

“I think we need to give them a couple of days but I want to hear something from a credible source on the investigations that are ongoing,” Marion Koopmans, director of the department of virology at Erasmus Medical Center in Rotterdam, the Netherlands, was quoted by STAT News as saying.

In 2002, a deadly coronavirus, severe acute respiratory syndrome coronavirus (SARS-CoV), was detected in China, after emerging from animal reservoirs such as bats to infect civet cats, which some Chinese consume, and then spreading more widely through human-to-human contact. SARS infected over 8000 people in more than two dozen countries over a period of 18 months before the epidemic was squashed. However, since that time, China’s outbreak detection and response capacity has improved considerably.

Middle East Respiratory syndrome (MERS-CoV), another deadly coronavirus strain, was first identified in Saudia Arabia in 2012 and killed some 851 of the nearly 2500 people infected with a case fatality rate of about 34%, according to WHO.

Coronaviruses consist of single-stranded of RNA genetic material; they belong to a family of viruses that infect both humans and animals.

Wuhan health authorities said that the patients’ symptoms mainly included fever, although some people had developed difficulties breahing and lesions on their lungs.  Some 120 close contacts of the pneumonia victims have been identified and placed under medical observation.  Pathogen identification and the tracing of the causes are underway, along with assessment of environmental sanitation and hygiene in the animal markets where the pneumonia is suspected to have emerged.

WHO said that it had requested more information from the Chinese authorities on laboratory tests that have so far been performed, however officials maintained an upbeat note: “Good to receive update information from #China on #pneumonia of unknown cause in Wuhan city,” declared World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, in a tweet on Monday.

WHO said that it was not recommending any travel restrictions as a result of the mysterious outbreak, noting, “WHO advises against the application of any travel or trade restrictions on China based on the current information available on this event.”

Singapore and Hong Kong, however, both said that they had both set up measures to check travellers from China for signs of illness, following reports that some arrivals had displayed pneumonia-like symptoms. However, none of the suspected cases so far had been confirmed to be infected with the unidentified pneumonia strain, authorities in both cities said.

Wuhan, a city of 19 million people, is the capital of Hubei province.

 

Image Credits: Wikipedia .

[UN News] Kenya, Mozambique and Niger curbed different outbreaks of vaccine-derived poliovirus over the past 24 months which affected 14 children, said a senior WHO official on Monday.

Although wild poliovirus virus has not been detected in Africa since 2016, roughly 12 countries are currently facing outbreaks of vaccine-derived poliovirus.

© UNICEF/Claudio Fauvrelle
Mothers take their babies to receive vaccinations at a mobile unit in Molumbo district, Mozambique.

“Ending outbreaks in the three countries is proof that response activities along with high quality immunization campaigns and vigilant disease surveillance can stop the remaining outbreaks in the region”, said Dr. Modjirom Ndoutabe, coordinator of WHO-led polio outbreaks Rapid Response Team for the African Region.

“We are strongly encouraged by this achievement and determined in our efforts to see all types of polio eradicated from the continent. It is a demonstration of the commitment by governments, WHO and our partners to ensure that future generations live free of this debilitating virus”.

Polio is a highly infectious viral disease that can lead to paralysis.  It mainly affects children under five.

While there is no cure, the disease can be prevented through a simple vaccine.

Polio is transmitted from person-to-person and is spread through contact with infected faeces or, less frequently, through contaminated water or food.  The virus enters the body via the mouth and multiplies through the intestines.

“When children are immunized with the oral polio vaccine, the attenuated vaccine virus replicates in their intestines for a short time to build up the needed immunity and is then excreted in faeces into the environment where it can mutate”, Ndoutabe explained.

Vaccine-derived polioviruses are rare, according to WHO. They only emerge in areas where overall immunization rates are low and sanitation is inadequate, leading to transmission of the mutated polio virus via sources such as contaminated sewage.

Another 12 African countries continue to experience vaccine-derived polio outbreaks, including: Angola, Benin, Cameroon, Central African Republic, Chad, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Ghana, Nigeria, Togo and Zambia.

Weak routine vaccination coverage, vaccine refusal and difficulty in accessing some locations, are some of the risk factors behind these outbreaks, according to WHO.

 

Image Credits: © UNICEF/Claudio Fauvrelle.

The number of cholera cases decreased by 60% in 2018 compared to 2017. Cholera-endemic countries such as Haiti, Somalia, and the Democratic Republic of the Congo saw some of the highest reductions.

Cholera vaccination in Nigeria

“The decrease we are seeing in several major cholera-endemic countries demonstrates the increased engagement of countries in global efforts to slow and prevent cholera outbreaks and shows the vital role of mass cholera vaccination campaigns,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release. “The long-term solution for ending cholera lies in increasing access to clean drinking water and providing adequate sanitation and hygiene.”

There were 499,447 reported cases and 2990 deaths in 2018, significantly lower than the 1.2 million cases and 5654 deaths reported in 2017. The country most affected by the ongoing cholera pandemic continues to be Yemen, which reported 128,121 cases and 2485 deaths in 2018, according to data collected by WHO.

However, several cholera-endemic countries saw dramatic decreases in the number of cases – including Haiti, Somalia, DRC, Zambia, South Sudan, United Republic of Tanzania, Somalia, Bangladesh, and Nigeria – thanks to the implementation of new national action plans for cholera control.

“The global decrease in case numbers we are observing appears to be linked to large-scale vaccination campaigns and countries beginning to adopt the Global Roadmap to 2030 strategy in their national cholera action plans,” said Dr Dominique Legros, head of WHO’s cholera programme in Geneva.

“We must continue to strengthen our efforts to engage all cholera-endemic countries in this global strategy to eliminate cholera.”

Nearly 18 million doses of Oral Cholera Vaccine (OCV) were shipped to 11 countries in 2018, financed in part by Gavi, the Vaccine Alliance. However, experts at WHO say that vaccination must be supplemented with efforts to improve access to clean water and sanitation. Vibro cholerae, the bacterium that causes the acute diarrhoeal infection, breeds in contaminated food and water.

Mass vaccination and water and sanitation interventions are recommended as part of the Global Roadmap strategy, which provides a three-pillar framework for national action plans focusing on:

  • Early detection and rapid response to contain outbreaks
  • A multisectoral approach integrating strengthened surveillance, vaccination, community mobilization, and water, sanitation and hygiene to prevent cholera in hotspots in endemic countries
  • An effective mechanism of coordination for technical support, resource mobilization and partnership at the local and global levels.

Image Credits: WHO.

For the first time in two decades, tobacco use is projected to decline among men in 2020, according to a new World Health Organization report on trends in global tobacco use. However, the new report does not consider trends in e-cigarette use, where use may in fact be increasing.

“For many years now we had witnessed a steady rise in the number of males using deadly tobacco products. But now, for the first time, we are seeing a decline in male use, driven by governments being tougher on the tobacco industry,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release about the new report.

Based on data collected from 149 countries, global tobacco use has been steadily declining for the past 18 years, from 1.397 billion people in 2000 to 1.337 billion in 2018. But that downward trend had been primarily driven by declining use in women.  About 100 million fewer women used tobacco in 2018 as compared to 2000, and women’s use of tobacco is projected to decline further over the coming five years.

However, over the same 2000-2018 period, the number of men using tobacco actually increased by 40 million people, and males currently represent some 82% of tobacco users.

Yet over just the past year, prevalence of tobacco use in males has plateaued, and it is now projected to begin declining in 2020, the latest data shows. WHO estimates that there will be 2 million fewer male users in 2020 as compared to 2018, and 5 million fewer by 2025.

“Showing that tobacco use can be reversed gives the public health community confidence we can get back on track and meet the global targets of a 30% reduction [in smoking rates] by 2025 as compared to 2010,” Ruediger Krech, director of WHO’s Department of Health Promotion said at a press briefing.

Projections of a decline in male tobacco use for 2020 are not the same across all regions either, the WHO officials cautioned. While fewer men are expected to be seen smoking in the Americas, Europe, and Western Pacific regions, WHO’s South-East Asian region, which currently has the highest proportion of male smokers at 62.5%, is projected to see a slight increase in absolute numbers over the next five years. Numbers of male smokers are also predicted to increase in the WHO Eastern Mediterranean and African regions.

And around the world, 43.8 million children between 13-15 used tobacco in 2018. That number excludes the use of e-cigarettes and other such nicotine delivery devices, which some country specific surveys have found is on the rise in youth in countries such as the United States.

Krech credited the inroads made against tobacco use over the past two decades to increasingly strong policy measures such as: banning smoking in public places, tobacco taxation, and marketing restrictions like plain packaging of tobacco products, as well as bans on marketing aimed at teens and children.  But he said that such measures must be amplified in order to reach the global targets.

“The downwards trend in tobacco use offers a challenge to governments. We cannot be satisfied with a slow decline when over 1 billion people are still using tobacco,” said Krech. “We must dramatically accelerate tobacco control measures to protect current and future generations from tobacco.”

The Unknown Contribution of E-Cigarette Use

Another unknown involves the use of smokeless tobacco devices. Use of e-cigarettes, as welll as other electronic nicotine delivery and heated tobacco devices were all excluded from the analysis, raising questions about whether potential smokers might also be shifting away from traditional tobacco products over to such methods.

Originally marketed as smoking cessation devices, electronic nicotine delivery systems (ENDS) have gained increasing notoriety for allegedly hooking young people onto nicotine at earlier ages. According to the US National Youth Tobacco survey, one of the most comprehensive national surveys that collects data on nicotine consumption annually, the proportion of high-school students who have used an ENDS device at least once shot up to 27.5% in 2019, as compared to only 12% in 2017. Manufacturers have been accused of targeting their marketing directly towards young people, particularly by producing the nicotine liquid pods in a variety of flavors popular among teenagers.

“If there are flavors like chewing gum or strawberry, who is the target audience? Me or my grandchildren,” Krech remarked.

As for whether an increase in e-cigarette use has perhaps led to a decrease in use of other tobacco products, Krech said that WHO could not at this time “say whether that has an impact or not.”  However, he acknowledged that many tobacco smokers are so-called “dual-users” – using both combustible cigarettes and e-cigarettes.

Krech added that WHO is currently collecting data on e-cigarette use and tobacco vaping, and is planning to release a more comprehensive report on the subject in February 2020. Countries have only begun collecting nationally representative data on the use of ENDS in 2013, and currently data from 42 countries is available, with more reports coming in every day.

“There is no “safety” associated with e-cigarettes,” said Krech. “There are a lot of risks associated with e-cigarettes, and we’re going to be a bit more concrete about those risks [in the February report].”

Accelerate Actions to Decrease Tobacco Use

In terms of policy measures, the report finds a clear trend towards more stringent government policies and regulations aimed at reducing tobacco use and second-hand smoke exposures. As of 2018, 137 countries have put into place at least one of the six methods recommended by the WHO in line with guidelines of the Framework Convention on Tobacco Control (FCTC).

Some 116 of these 137 countries have seen their tobacco use rates decline since implementing the measures, which include stronger measures for monitoring tobacco use; protection against second-hand smoke exposures; quit smoking programmes; awareness raising about tobacco’s dangers; restrictions and bans on tobacco advertising, promotion, and sponsorship of activities; and increased taxes on tobacco products.

The report found that strong declines in average tobacco use prevalence were mostly seen in regions that implemented the policies. This was true for the WHO South-East Asia region, which saw reductions in tobacco use – mostly in smokeless tobacco – after all 11 countries of the region had implemented at least one policy.

“Continuing to reduce tobacco use will help save lives, nurture families, and strengthen communities,” said Krech. “We must dramatically accelerate tobacco control measures to protect current and future generations from tobacco.”

Civil society organizations agreed. Gan Quan, director of Tobacco Control at the International Union Against Tuberculosis and Lung Disease and a partner in tobacco industry watchdog STOP (Stopping Tobacco Organizations and Products), said in a statement, “The problem is that the tobacco industry continues to undermine such measures all over the world and to market their products aggressively.”

Quan added, “The data is clear: tobacco use falls when governments implement policies that are proven to encourage quitting and deter youth from starting to use tobacco.”

Image Credits: WHO, WHO global report on trends in the prevalence of tobacco use, MomentiMedia/Flickr.

The World Health Organization (WHO) has given its quality seal of approval to a biologically similar formulation of the breast cancer drug  – trastuzumab – in a move the agency says could help make the costly, life-saving treatment more affordable and available to women globally.

Breast cancer is the most common form of cancer in women. Some 2.1 million women contracted breast cancer in 2018. 630,000 of them died from the disease, many because of late diagnosis and lack of access to affordable treatment, WHO said in a press release announcing the move.

Trastuzumab – a monoclonal antibody – was included in the WHO Essential Medicines List in 2015 as an essential treatment for the estimated 20% of breast cancer tumors that test positive for the protein human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. In such tumors, the drug has shown high efficacy in curing early stage breast cancer and in some cases more advanced forms of the disease, WHO says.

Trastuzumab, which was originally produced under the brand name Herceptin® by Roche Pharmaceuticals, is among a number of biotherapeutics, or pharmaceutical products, derived from biological and living sources, which have become increasingly important in cancer treatment. “Biosimilar” formulations of biological health products are the equivalent of generic formulations of synthetic drugs.

Cancer patient received a drug infusion

The newly pre-qualified product is produced by the Dutch-based firm Samsung Bioepis; it was the first is the first trastuzumab product to be assessed by WHO and found comparable to the originator product in terms of efficacy, safety and quality, the global health agency said.

The WHO Prequalification process is a seal of good quality that makes a drug company’s product eligible for bulk procurement by United Nations agencies. But in the case of drugs for cancer and other non-communicable diseases, there are almost no UN-based donor programmes for procurement and supply to low-income countries.

Even so, the WHO label will signal to national governments that the product is quality-approved by WHO. Such a signal can eventually help pave the way for more bulk purchases of  cheaper, but quality-approved biosimilar cancer drugs by national health systems, thereby reducing prices, said a WHO scientist in an interview with Health Policy Watch.

“Historically, the WHO Prequalifiation process was used to pave the way for procurement of products for HIV, TB and malaria [by donors and UN agencies]. Then, it was expanded to some reproductive health drugs and to diagnostic devices, and then to drugs for other neglected diseases.  Now, cancer has become part of the process.  Although we don’t have a big procurement of cancer drugs from a UN agency, this signals that cancer treatment is an integral part of Universal Health Coverage, and should be part of a national benefits package,” the scientist said.

Integration of such drugs into the WHO Prequalification process could help drive down costs of treatment by about 60-70% of the prevailing prices: “but lets see how the market reacts,” the scientist said. Currently, annual treatment costs for the brand name product range from about US$ 10,000 in South Africa to about US$ 19,000 in Australia and US $29,000 in the USA, according to an informal WHO survey of published consumer list prices in the marketplace.  Biosimilars sold in India and Italy cost around US$ 4,000.

“WHO prequalification of biosimilar trastuzumab is good news for women everywhere,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General in the press release. “Women in many cultures suffer from gender disparity when it comes to accessing health services. In poor countries, there is the added burden of a lack of access to treatment for many, and the high cost of medicines. Effective, affordable breast cancer treatment should be a right for all women, not the privilege of a few.”

Biotherapeutic medicines, which are produced from biological sources such as cells rather than synthesized chemicals, are important treatments for some cancers and other non-communicable diseases. Like generic medicines, biosimilars can be much less expensive versions of innovator biotherapeutics while keeping the same effectiveness. They are usually manufactured by other companies once the patent on the original product has expired.

WHO’s International Agency for Research on Cancer estimates that by 2040 the number of diagnosed breast cancers will reach 3.1 million, with the greatest increase in low- and middle-income countries.

A recent study of breast cancer in sub-Saharan Africa found that of 1325 women surveyed in three countries, cancer treatment had not been initiated within one year of diagnosis for 227 (17%) women and for 185 (14%) women with stage I-III disease. Self-reported treatment barriers confirmed treatment costs as a major contributor to not receiving treatment.

“We need to act now and try to avoid more preventable deaths,” said Mariângela Simão, WHO Assistant Director General for Medicines and Health Products. “The availability of biosimilars has decreased prices, making even innovative treatments more affordable and hopefully available to more people.”

James Love of Knowledge Ecology International, which has advocated for reducing cancer drug prices as an important element of increasing drug access, welcomed the WHO move but said that more needed to be done to fund the WHO Prequalification process more fully so that it could conduct more such reviews, and more rapidly.

“The PreQual process has always been very important to patients, particularly those living in countries with limited capacity to provide safety and efficacy regulation,” Love said in a statement to Health Policy Watch. “The limitations on this process have largely been financial, finding donors or other ways to pay for the necessary reviews. It’s a stain on the WHO and its members that the agency has never been able to marshal the resources that are needed to expand the program into the many areas where it is needed, and certainly drugs for cancer and biologic drugs are among those areas where PQ is really needed.  The Samsung trastuzmab decision is a welcome step, and one hopes that someday the WHO will have the resources to do what is needed.”

However reducing the price of cancer drugs such as trastuzumab will not, alone, ensure that women get cancer treatment in low or even middle income countries, WHO officials also stress. Use of the drug firstly requires a well functioning health system that can provide early diagnosis of cancer tumors, followed by appropriate surgery, chemotherapy and/or radiation treatment, as preconditions for optimal use of biological drug therapies.

“It’s not a test and treat pill,” underlined the WHO scientist in the Health Policy Watch interview. “Its part of a combined regimen, and fairly complex. These are not easy drugs to delvier, and the largest gains are generally for women with early diagnosed breast cancer of HER2+.   Still, this signals how WHO is trying to project cancer drugs as something for which we should increase the uptake.

Gene-based therapies such as CAR-T are among the other new biologic “specialty treatments” that have been developed to treat other rare forms of cancer, and currently they come with even higher price tags attached.  Examples of other biotherapeutics products, include therapeutic vaccines, blood, blood components, cells, gene therapies, tissues and other materials. They are used to treat chronic diseases such as diabetes, Crohn’s disease and other autoimmune conditions, including lupus, and various forms of rheumatoid arthritis.

WHO Prequalification is a service provided by the agency to assess the quality, safety and efficacy of products that address global public health priorities. Products that receive WHO’s seal, are then listed on the Prequalification web site as eligible for procurement, giving purchasing agencies a range of quality-assured diagnostics, medicines and vaccines from which to choose. Every year, billions of dollars’ worth of medicines and other health products are purchased by international procurement agencies for distribution in low-income countries, based on WHO recommendations. Many low-income countries also use WHO’s lists of prequalified products to guide their selection of medicines, vaccines and technologies for national procurement.

In July 2018, WHO launched a pilot project expanding the scope of prequalification to two biotherapeutic medicines, including rituximab used to treat certain leukemias and lymphomas, along with trastuzumab, as a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries. About six other companies have begun producting trastuzumab over the past five years, driving down prices of the original product, but the Dutch product is the first to be prequalified as part of the pilot.

Image Credits: Linda Bartlett/National Cancer Institute.

After collecting a windfall of nearly US$14 billion in donor commitments in October, the Global Fund to Fight AIDS, TB and Malaria, on Wednesday published its blueprint to distribute most of the money to over 100 low- and middle-income countries worldwide, saying that allocations will increase by 23% over the next three years.

Nigeria, Mozambique and the Democratic Republic of Congo are set to receive the largest awards with over $US 890 million, $US 751 million and $US 644 mllion respectively. according to the  allocation plan published on the Global Fund website. Tanzania, Uganda, South Africa, Malawi, India and Zimbabwe would receive allocations of $US 500-US $600 million each,  followed by grants ranging from tens of million to several hundred million dollars each to other qualifying African, Asian and Latin American countries, as well as Russia and former Soviet Union states. The allocation amounts represent threshholds against which countries then apply for final funding in one or all of the disease categories.

The country allocations total some US$12.71 billion, the agency said in a press release, adding, “The funds will help save 16 million lives, cut the mortality rate for the three diseases in half and get the world back on track to end the epidemics of AIDS, tuberculosis and malaria by 2030.”  In addition, countries can also apply to a separate fund of US$890 million for so-called “catalytic investments” that aim to scale up specific aspects of HIV and TB prevention or treatment, as well as strengthening health services overall.

French President Emmanuel Macron (center), and Microsoft’s Bill Gates, (far right), stand triumphantly with other Global Fund partners and supporters at the end of the successful Replenishment Drive in October that collected nearly US$14 billion in commitments.

Most eligible countries will receive funding increases, the Global Fund said. Countries in Africa are receiving around US$2 billion more than in the previous period, and countries in West & Central Africa have the biggest increase – US$780 million. Worldwide, there are 32 countries with an increase of 40% or higher.

Allocations to individual countries are calculated using a formula that is predominantly based on each country’s disease burden and economy, and then further adjusted to account for “important contextual factors”, the press release stated.

The aim is to drive funding to: “higher burden, lower income countries, specifically accounting for HIV epidemics among key and vulnerable populations, the threat of multidrug-resistant TB, and for the risk of malaria resurgence.” On the other end of the spectrum, the Global Fund aims to provide “sustainable and paced reductions where funding is decreasing” in middle and upper middle income countries that have made significant inroads in reducing disease but still require support.

“World leaders came together at our Replenishment and made commitments to step up the fight to end these epidemics by 2030,” said Peter Sands, Executive Director of the Global Fund, in the press release. “Now the real work begins. Our allocations will allow partners to expand programs that work, and to find innovative solutions for new challenges. In addition to more money, we need better collaboration and more effective programs.”

The Global Fund’s 2020-2022 allocation methodology is geared toward increasing the overall impact of programs to prevent, treat and care for people affected by HIV, TB and malaria, and to build stronger health systems, the press release stated. “The allocations provide significantly more resources for the highest burden and lowest income countries, while maintaining current funding levels or moderating the pace of reductions in other contexts.”

The allocations include increased investments in Eastern and Southern Africa for HIV prevention among adolescent girls and young women; more funding for the countries with the highest burden of TB in Africa and Asia; continued investments in Eastern Europe to cover the costs of treatment for multidrug-resistant TB; more funding for African countries with a high burden of malaria, and increased focus in the Sahel region to boost vector control and seasonal prevention campaigns.

The full list of allocations is available on the Global Fund website, along with a detailed explanation of the allocation process. In the next step of the funding process, countries convene coordinating committees to prepare and submit funding requests to the Global Fund for review and approval of the grant allocations, which may be disbursed to government as well as non-governmental funding recipients and partners.

 

Image Credits: The Global Fund.

Novartis has relinquished a patent granted by the European Patent Office for Kymriah, a promising new gene therapy for certain forms of leukemia, claiming the patent was no longer essential to the development and marketing of the treatment. The decision followed the moves by the Swiss-based NGO, Public Eye and the French-based Doctors of the World/Médecins du Monde to contest the patent in the European Patent Office. Their opposition, filed in in July, claimed that the price of the innovative therapy was “exorbitant” – with one infusion of the therapy costing CHF 370,000 in Switzerland.

Frozen T-cells of cancer patients are genetically modified to attack cancer cells in novel CAR-T therapies.

Kymriah, one of the first CAR-T [Chimeric antigen receptors T cell] therapies to receive marketing approval in Europe, is specifically designed for treating relapsing or treatment-resistant forms of acute lymphoblastic leukemia (ALL). It was developed by the University of Pennsylvania and later licensed exclusively by Novartis. CAR-T cell therapies rely on an innovative process in which a patient’s own T cells, which are critical to the body’s immune system, are collected and genetically modified to target cancer cells more effectively, and then reinfused back into the patient to attack the cancer.

The Kymriah treatment is so far being used in a limited number of patients, for instance about 100 people a year in Switzerland.  However, the underlying technology of CAR-T therapy holds much promise for treating other kinds of cancer as well. This could mean a rapid increase in the demand for similar therapies in the near future. Thus, the decision on the “patentability of such procedures” is “crucial” for setting a precedent, Public Eye said in a July statement about the patent opposition.

In a letter to the European Patent Office dated 29 November, representatives for Novartis and the University of Pennsylvania, requested the revocation of the patent on the grounds that “the proprietor no longer approves the text on the basis of which the patent was granted, and will not be submitting an amended text.”

The unexpected move was welcomed by Public Eye and Médicines du Monde, who had prepared for a long fight after they officially filed an opposition with the European Patent Office in July on the grounds that the “subject-matter lacks novelty.” The NGOs said the patent would pave the way for the Swiss pharma company to claim broad, exclusive rights not only over Kymriah, as such, but over other CAR-T cell technologies on the European market. Surprisingly, the patent holders submitted a request to withdraw the patent before the opposition procedure had in fact begun.

In response to the recent patent revocation request, Public Eye said in a statement, “This volte-face confirms that the patent should never have been granted in the first place, given that the underlying technology is not novel. It also questions the validity of other patents on Kymriah and weakens the monopoly position of the Swiss giant in future price reviews.”

The NGO added that the revocation should benefit an initiative by a number of leading Swiss university hospitals, among others, “to develop similar but considerably cheaper cancer therapies.”

In the patent revocation letter, Novartis and the University of Pennsylvania’s representatives claimed that the opposition’s arguments were “without merit.”

“[We] strongly believe in the importance of intellectual property rights as an incentive for ground-breaking innovation such as Kymriah. However, the opposed patent is not critical to the continued developement and marketing of Kymriah and the decision has therefore been taken to withdraw the opposed patent,” a Novartis spokesperson was quoted as saying to the Swiss online journal, swissinfo.ch.

Last September, Novartis also dropped a second patent application for another aspect of the treatment. However, Novartis does hold a patent on Kymriah, as such, in Europe and elsewhere. Experts in intellectual property law say that this patent still protects Novartis against the production of identical versions of Kymriah by competitors.  However, withdrawal of the other two patents leaves open a wider door for competitors to lower costs with the advance of further CAR-T innovations.

Image Credits: Novartis, Novartis.

More than one-third of low- and middle-income countries worldwide are facing significant rates of obesity alongside continued pockets of undernutrition, according to a major new study published on Monday in The Lancet.

The four-part series The Double Burden of Malnutrition, led by the World Health Organization in collaboration with a number of universities and researchers worldwide, examined historical nutrition survey data to estimate the prevalence of obesity alongside undernutrition across some 126 countries.

Some 48 of the 126 low- and middle- income countries surveyed had a “double burden” of obesity and undernutrition, the study found. According to the study criteria, this meant that at least 20% of the overall population was overweight or obese, while at the same time a high proportion of children were either stunted (30% having low height for their age) or wasted (15% having low weight for their height) or more than 20% of adult women were particularly thin.

Chubby infants are often seen as a sign of good health in many cultures, although new research indicates that significantly overweight babies may be at greater risks of obesity later in life.

The series heralds “a new nutrition reality in the world,” said Francesco Branca, lead author of a Lancet Comment that is part of the series, and director of the Department of Nutrition for Health and Development at the World Health Organization in a press conference.

“We are living at a time when multiple forms of malnutrition co-exist… They exist simultaneously in the same country, the same community, and often in the same individual – either simultaneously or at different stages of the life-course. And this type of burden of malnutrition is growing.”

Obesity, once a trend mostly seen in higher-income countries has now expanded to middle- and low-income countries – often existing right alongside undernutrition as well, the series emphasizes.

Globally, estimates from the WHO suggest that almost 2.3 billion children and adults are overweight, while more than 150 million children are stunted.  The double burden among children and adults is growing most rapidly in South-east Asia and sub-Saharan Africa.

Children are both experiencing undernutrition in early life and then becoming overweight later – due to the increasing preponderance of processed foods, fast foods and carbohydrate dense and/or fat-heavy foods in local diets, and decreased access to fresh, healthy food options, the authors conclude.  This, in turn, increases the risk of non-communicable diseases such as type 2 diabetes, stroke, and heart disease.

“The poorest countries in the world are carrying an enormous burden of undernutrition and now a growing burden of overweight and obesity,” said Abigail Perry, senior nutrition advisor at the UK Department for International Development (DFID) and the chair of the stakeholder group of the Global Nutrition Report at the launch of the series at a webcast event in London on Monday.

Changing food systems are largely to blame for the dual trends, the report finds.

Since 2004, worldwide availability of unhealthy processed foods, snacks and beverages high in energy, sugar, fat, and salt has soared. These foods are often marketed aggressively and more easily accessible and cheaper than healthy alternatives. Sales of breastmilk substitutes are also growing, despite strong evidence that breastfeeding is a healthier alternative which reduces risks of both undernutrition as well as providing a healthier nutritional balance to infants.

In addition, urban environments and lifestyles are raising barriers to safe, healthy physical activity, that could help reduce some of the obesity risks.

The prevalence of the double burden of malnutrition in the 1990s (top) and the 2010s (bottom). Darker red indicates a higher prevalence of obesity and undernutrition.

“The poorest low- and middle-income countries are seeing a rapid transformation in the way people eat, drink, and move at work, home, in transport and in leisure,” explained author of the first paper in the series, Barry Popkin, professor at University of North Carolina, USA, in a press release.

Ultra-processed foods, he said, are linked to increased weight gain and negatively affect infant and pre-schooler diets. Access to fresh, healthy foods is becoming more constrained in low-and middle-income countries due to disappearing fresh food markets as well as growing “control of the food chain by supermarkets, and global food, catering and agriculture companies in many countries,” he added.

So far, the research informing health sector policies that address malnutrition have focused largely on nutrients and nutrient supplementation, noted Branca, in a press briefing prior to the report’s release.

The report reflects the need to take more of a systems approach, he said, looking at dietary balance, and how health systems and food systems should support dietary choices for a healthy, balanced diet, including including fresh fruits, legumes, seeds, fruits and whole grains, along with modest amounts of meat or fish, as appropriate.

“Without a profound food system transformation, the economic, social, and environmental costs of inaction will hinder the growth and development of individuals and societies for decades to come,” said Branca.

Countries need to adopt a set of “double-duty” nutrition measures to address the double burden – including measures that health systems can take to promote healthy eating during pregnancy and early childhood, adjustment to food supplementation programmes; and also stronger agricultural and food policies to prioritize healthy diets, the report’s authors conclude.

“Double Burden” Evident Within Households & Among Adults and Children

The Lancet report found that the “double burden” manifests at the national level, household level, and even in individuals at different stages of life.

The combination of overweight mothers with children with stunted growth is the most common form of the double burden seen at the household level, although there is also a trend of children being stunted in their early years, followed by being overweight or obese later in childhood or adulthood.

Diets of children, women and girls is particularly important, notes Popkin, as women’s nutrition in pregnancy has a profound effect on the likelihood of an infant and young childre to suffer from the effects of undernutrition, as well as obesity, later in life.

A child is more likely to face stunting if their mother was undernourished during pregnancy, and likewise, a child is more likely to be overweight or obese if their mother was obese during pregnancy, for example. Meanwhile, overweight or obese adults who were undernourished in childhood may be at even higher risk of non-communicable diseases than those who were consistently overweight from childhood, the study notes.

Children who experience stunting in their first few years of life are also more at risk of becoming overweight or obese – rather than growing taller and lean – if they are subsequently provided with high-energy diets. As a result, classic health sector nutrition programmes that made inroads on stunting and wasting by through supplementation with foods high in fats and carbohydrates – may have inadvertently increased children’s health risks, because the diets were too low in protein, fibres, and micronutrients.

“There are strong biological and environmental linkages, and indeed intergenerational linkages that mean we must take a more coordinated and connected approach towards addressing malnutrition in all its forms,” said Alessandro Demaio at the press briefing, professor in the School of Global Health, University of Copenhagen and senior author on the second paper on the report, which explores the causative factors of individual-level DBM.

“By focusing on undernutrition and food insecurity for so long, nutrition programmes have absolutely allowed, or they have prevented, [the dialogue about] foods high in fats, sugars, and salts from moving center stage. So this means that obesity has grown under the watch of programs designed to target undernutrition,” added Corinna Hawkes in the briefing. Hawkes, a professor at City University in London, is lead author of the third paper in the report, which addresses the actions needed to mitigate both undernutrition and obesity.

However, Hawkes says that the answer is not to disregard undernutrition, which still represents a huge burden of malnutrition around the world, but to “redesign” programmes to reduce undernutrition while also reducing the risk of obesity and diet-related non-communicable diseases.

“The good news is, despite the heavy burden of malnutrition, there are some efficient and effective solutions that actually require some fairly modest redesigning of existing actions which can really be used to tackle this problem effectively,” said Hawkes.

But this will also require stronger policies against market actors who press junk food products on children and vulnerable groups by saying that they are “fortified” with some kind of nutrition, noted Perry at Monday’s launch event, saying, “People are still coming in with solutions that involve fortifying donuts.. that hasn’t gone away.”

Restructuring Food and Health Systems for “Double-Duty” Actions Against the Double Burden – Promoting Healthy Diets and Reducing Consumption of Processed Foods

The authors propose a series of “double-duty” approaches by the health sector, the agricultural sector as well as school systems and the social welfare sector to simultaneously decrease undernutrition and obesity.

Some of the proposals are actions that the health sector can lead, while others would involve a broader restructuring of agricultural development and food system priorities – to increase incentives for production and promotion of healthier foods, more fresh foods, and more diverse diets.

Currently, economic incentives in low and middle income countries are pushing systems in almost the opposite direction – towards cheaper foods, less diverse foods, and more packaged and processed foods, the studies authors acknowledged.

“It’s an epidemic of systems,” said Perry.  “The reality is that health is not really in the core objectives of the food system.”

“Without a profound food system transformation, the economic, social, and environmental costs of inaction will hinder the growth and development of individuals and societies for decades to come,” said Branca.

Still, the report notes that there are some immediate policy measures that health, education and social welfare sectors could advocate around to initiate changes, including: better labeling of healthy and unhealthy foods, using domestic fiscal policies to support healthy foods production; healthier food procurement for schools; and more systematic restrictions of marketing around junk food.

For its part, Branca said that WHO was working on new guidelines to indicate the optimal proportion of plant-based foods in a healthy diet, and another set of guidelines related to processing of food products – which should help to contribute to more of a whole diet and whole systems approach to nutrition.

For civil society actors, the report’s strong call for fixing food systems is a welcome one.

Katie Dain, chief executive officer of the NCD Alliance, said, “We’ve long known that NCDs are a global health emergency and this report’s stark warning of the consequences of inaction on the double burden of malnutrition may well be the jolting wake-up call that political leaders need.”

“The globalisation of processed junk food has brought us all to this precipice, and getting off it will require swift, coordinated and creative action from a range of decision makers across society who recognise the value in ensuring healthy diets for all in all countries. The costs of ignoring NCD prevention as we tackle all forms of malnutrition will be borne by us all.”

Richard Horton, editor-in-chief of the Lancet and moderator of the launch event, said the study would propel the nutrition research community to embrace a more holistic approach, breaking down the silos between obesity and undernutrition research

“We’ve rather badly separated off obesity from undernutrition, and we will never do that again,” said Horton.

Image Credits: Flickr/Jen Wen Luoh, Lancet Series on the Double Burden of Malnutrition, Twitter: @TheLancet, Lancet Series on the Double Burden of Malnutrition.