Breakthroughs Blog: WHO

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email.Last Wednesday, GlaxoSmithKline (GSK) announced its two-drug HIV regimen, Dovato, was successful in suppressing the virus in patients over a 48-week period at the same level of a previous three-drug treatment in a late-stage trial. The study evaluated the effectiveness of Dovato in adults with HIV-1 virus, the most widespread strain, who switched to the regimen from at least a triple combination containing Gilead’s Vemlidy. GSK’s HIV drugs division, ViiV, noted that adults who used Dovato did not develop any resistance to the treatment. Dovato, a combination of dolutegravir and lamivudine, was approved in the United States in April for newly diagnosed patients. GSK already has a two-drug regimen, Juluca, on the market but only for HIV patients that have received prior treatment.Two experimental Ebola drugs, an antiviral called remdesivir and an antibody treatment called ZMapp, have been found to be effective in laboratory studies in treating the strain of the virus responsible for the deaths of more than 1,600 people in the current outbreak affecting the Democratic Republic of Congo (DRC). According to this new research performed by the Centers for Disease Control and Prevention, in laboratory studies both drugs inhibited the growth of the virus strain in human cells. These two treatments were developed based on strains from previous outbreaks, and this study was the first to test them on the strain causing the current outbreak, which researchers are calling the Ituri strain. According to the latest figures from the World Health Organization (WHO), the Ebola outbreak in DRC has killed 1,630 people with 2,418 total cases—making it the second biggest outbreak of the disease in history.On July 9, WHO published updates to two lists critical for global health: the twenty-first WHO Model List of Essential Medicines and the second WHO Model List of Essential Diagnostics (EDL). These lists help countries prioritize critical health products that should be available, accessible, and affordable in a health system. While the first EDL, developed in 2018, covered a limited number of priority diseases, the second list has expanded to include more noncommunicable and communicable diseases, consisting of 122 test categories. In this editorial piece, Dr. Madhukar Pai, Canada Research Chair of Epidemiology & Global Health at McGill University, explains what’s included in the EDL, what follow up is required by low-and middle-income countries (LMIC) to make the list work, and the LMIC investment required to develop the diagnostic tests and laboratories necessary to deliver on universal health coverage and to better detect outbreaks, antimicrobial resistance, and pandemics.

On Saturday, heads of state and government from the world’s leading economies concluded this year’s G20 Summit in Osaka, Japan by issuing a declaration committing to advance global health.Noting that “health is a prerequisite for sustainable and inclusive economic growth,” G20 leaders made a myriad of noteworthy commitments in the G20 Osaka Leaders’ Declaration from advancing universal health coverage (UHC), to controlling noncommunicable and communicable diseases, to tackling health emergencies and antimicrobial resistance (AMR). Recognition of the role of research and new technologies in confronting these challenges was present, but inconsistent.In welcome news, the declaration generally recognized the “importance of science, technology and innovation (STI)” for achieving the Sustainable Development Goals and committed to strengthening health systems to achieve UHC by “promoting public and private sector innovation, such as cost-effective and appropriate digital and other innovative technologies.” GHTC was pleased to see this call out for “affordable” and “appropriate” technologies, which are critical elements for addressing health needs in the world’s poorest places, and that leaders recognized that both the public and private sector have a role to play in accelerating new innovations, such as treatments, vaccines, and diagnostics. But as the declaration delved into particular health challenges, recognition of the importance of research and development (R&D) was somewhat inconsistent.On the positive side, leaders committed to promoting R&D to tackle AMR, noting the ongoing work by the Global AMR R&D Hub, first established under the German G20 presidency to foster international agenda setting and collaboration on research for new antibiotics and treatments. They also called on members and the hub to “analyze push and pull mechanisms to identify best models for AMR R&D.” It is constructive that the G20 committed to moving this agenda forward, as growing drug resistance is complicating the fight against leading global killers, such as malaria, tuberculosis, and HIV and AIDS, which heads of state reaffirmed their commitment to end. A lack of market incentive remains a barrier to spurring new antimicrobial and drug development.AMR is just one emerging threat in our increasingly interconnected world, so we were pleased to see the G20 once again put a spotlight on the importance of improving public health preparedness and the need for sustainable financing mechanisms to prevent and respond to health crises like the current Ebola outbreak in the Democratic Republic of Congo. We were, however, disappointed to see no recognition of the role of R&D and health technologies in enhancing preparedness. Just two years ago, the G20 health ministers, under the German presidency, pledged strong support for collaborative efforts for R&D preparedness, including the Coalition for Epidemic Preparedness Innovations [CEPI] and ongoing work under the World Health Organization’s R&D Blueprint.Despite this criticism, last week’s G20 Summit remains a significant political win for global health advocates—and that’s important to recognize. It was just two years ago that global health, and R&D for global health, featured for the first time ever as part of the G20 leaders’ declaration. With so many pressing global challenges from migration, to climate change, to the impact of disruptive technological innovation, it is promising to see G20 leaders continue to position global health as a priority area for international action and as a critical driver of economic development.In a twist on previous G20 presidencies, last week’s Leaders’ Summit marked a mid-way point in this year’s G20 ministerial process, rather than its usual annual conclusion. With the G20 Health Ministerial Meeting set to take place in October, it is now vital that health ministers build on the positive foundation set at the Leaders’ Summit to put in place more concrete action plans and financial resources to realize the G20’s global health commitments—that rightfully place R&D as a central driver in achieving these goals.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. The National Institutes of Health has launched a large clinical trial to assess treatments for preventing people at high risk from developing multidrug-resistant tuberculosis (MDR-TB). The study is comparing the safety and efficacy of a newer TB drug delamanid—one of the first drugs available specifically to treat MDR-TB and the first to exist in a child-friendly formulation—with isoniazid, a decades-old drug for TB prevention, in preventing development of active MDR-TB among high-risk individuals exposed to household members with MDR-TB. Study participants are considered at high risk if if they have latent TB infection, suppressed immune systems from HIV or other factors, or are younger than five years old. Study investigators hypothesize that delamanid will be a better prophylactic treatment than isoniazid in reducing the likelihood that at-risk household members of individuals living with MDR-TB will develop active TB. Existing treatments for MDR-TB are often toxic, poorly tolerated, expensive, and aren’t always available. The World Health Organization (WHO) estimated 460,000 people worldwide developed MDR-TB in 2017. According the Access to Medicine Index issued last month, which ranks the world’s 20 largest pharmaceutical companies on their efforts to improve access to medications for the world’s poorest, the industry has made remarkable progress in increasing access to lifesaving medicines, through efforts like drug donation and licensing patents to generic producers. However, according to the report, most of the progress made by the industry is limited to a few companies with their efforts too reliant on donor dollars. GSK has ranked first every year since the rankings began, with its score steadily rising each year. Dr. Jayasree K. Iyer, executive director of the Access to Medicine Foundation which releases the index, stated that two billion people still lack access to the products they need, implying progress on access has just begun. A new, rapid diagnostic test that can detect yaws—a debilitating bacterial disease spread through skin-to-skin contact causing skin lesions and ulcers—may reinvigorate efforts to eradicate the disease which affects thousands of the world’s poorest children. The molecular diagnostic test costs just US$2 and can detect yaws within 30 minutes at point-of-care, eliminating the time-consuming need to transfer disease samples to expensive high-tech labs. Though WHO reported more than 80,000 suspected cases of yaws in 2018, the real number of infections is likely to be much higher. The rapid diagnostic test is one of 30 finalists of the WHO Innovation Challenge and was showcased at the Africa Health Forum earlier this year. The diagnostic has shown “impressive results” in small trials, according to its creator, who is looking to do larger scale testing.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. A large new study confirms previous research suggesting that a vaccine against rotavirus—a highly contagious virus that can cause severe illness and death in infants and young children— may have an added benefit: lowering the risk for Type 1 diabetes, an autoimmune disease that usually develops in childhood. The study showed a 33 percent reduction in the incidence of Type 1 diabetes among children who completed the three-dose RotaTeq series compared with unvaccinated children. RotaTeq, which protects against five different strains of rotavirus, is one of two orally administered rotavirus vaccines. Among those children in the study who took only one or two of the required three RotaTeq doses, there was no reduction in incidence compared with unvaccinated children. The reductions in risk in those who took the other version of the rotavirus vaccine, Rotarix, were not statistically significant. Approximately one million treatment courses of new child-friendly, easy-to-administer tuberculosis (TB) medicines have been ordered by 93 countries since they were first introduced in 2016, according to developer TB Alliance. Prior to the development of these treatments, caregivers would approximate children’s dosing by crushing or splitting bitter-flavored adult pills, which created adherence challenges. The new treatments meet World Health Organization (WHO) guidelines for childhood TB treatment and are dissolvable in water and flavored for palatability, making it easier for caregivers to administer. The 93 countries in which these treatments have been introduced account for 75 percent of the estimated global childhood TB burden. According to WHO, one million children are diagnosed with TB every year. US President Donald Trump recently issued an executive order calling for all US federal agencies to cut at least one-third of their advisory committees by September—a move many previous agency heads and critics say would weaken science-based regulation processes and the use of evidence-based policymaking. When excluding agencies that are mandated by law, a total of 462 boards and advisory committees that advise on government regulations and provide scientific oversight on other agency decisions are potentially on the chopping block as a result of the executive order. Critics of the executive order said that the one-third number put forth by the Trump administration seemed completely arbitrary and also pushed back on the notion that cutting the committees would save taxpayer dollars.