Marissa Chmiola

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. According to a recent study out of Oxford University, rapid evolution of the HIV virus is slowing the virus’s ability to cause AIDS. In this study of 2,000 women in South Africa and Botswana, researchers found that the HIV virus had evolved to adapt to a specific gene known as HLA-B*57, which provides some protective effect against HIV, slowing the progress to AIDS. As the virus has adapted to reduce this protective effect in individuals, the virus has also reduced its ability to replicate, making it less virulent over all. Last Thursday, the UN Secretary-General launched his synthesis report for the sustainable development goals. In this report, Secretary General Ban Ki-moon reaffirmed his support for the 17 goals and 160 targets proposed by the United Nations Open Working Group, despite concerns from some member states that the current list is too long. Of the 17 proposed goals, two contain targets related to the research and development of new technologies. Researchers are developing a powdered form of the measles vaccine which could make it easier and safer to deliver the vaccine to people in developing nations. The current FDA-approved measles vaccine is a live virus that has been freeze-dried into a powder, which requires reconstitution with water before being administered via syringe. The new vaccine under development is a powder that can be inhaled. This new formulation would eliminate the need for sterile water and needles, as well as cold-chain storage. A modified regimen of the HIV vaccine candidate RV144 was shown to be safe and capable of inducing a robust immune response in safety trials in South Africa. RV144—which was developed by the US and Thai military—showed early promise in clinical trials, but it was found to lose efficacy over time. This new regime is the same earlier RV144 vaccine regime with an added booster shot one year later. Further clinical trials of this new regime are set to begin in South Africa in early 2015.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In the spirit of the Thanksgiving holiday, GHTC’s communications officer Marissa Chmiola put together a list of ten global health advancements she’s thankful for this holiday season. The list includes advancements toward polio eradication, new Ebola treatments, vaccine candidates against hookworm, dengue fever, malaria, and much more. The Bill & Melinda Gates Foundation announced a new policy that will require all research it funds to be published in a manner that is free for the public to access. Vox gives the lowdown on how this new policy could impact researchers. Since this Gates Foundation policy is in conflict with the practice of top scientific journals who charge access fees for their articles, Gates-funded scientists could have to stop publishing their articles in these top journals. On the other hand, it’s also possible that since the Gates Foundation funds so much research—spending US$900 million each year—these journals may have to change their policies or lose out on publishing potentially important research. The New Yorker takes an in-depth look at how the growing global vaccine market is spurring companies to pursue development of an Ebola vaccine. According to the author, companies have realized that while vaccines can be more difficult to develop than prescription drugs, that difficulty can also be an asset because it is then harder for generic companies to produce copycat versions. While an Ebola vaccine likely won’t become a big money maker for pharmaceutical companies, with government and aid agencies offsetting some of the development costs, companies could break even on their investments and gain some positive publicity in the process. This past week saw lots of great articles for World AIDS Day discussing progress on fighting HIV and AIDS. The International Partnership for Microbicides’ Chief Executive Officer Dr. Zeda Rosenberg discusses the need for new products such as microbicides which will help women protect themselves from HIV. AVAC’s Executive Director Mitchell Warren argues that more precision is needed in setting the prevention targets to meet UNAIDS five-year goal of reducing HIV infections by 500,000, including research into new prevention and treatment options.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last week we learned just how much pharmaceutical companies think a fast track review by the Food and Drug Administration (FDA) could be worth. Gilead Sciences paid US$125 million via auction to purchase a priority review voucher from Knight Therapeutics. This voucher will allow Gilead to shave four months off of the FDA review time for a drug of its choice. The priority review voucher system was created in 2007 to incentivize development of drugs for neglected diseases. Bloomberg reports on a recent study out of the Tufts Center for the Study of Drug Development which found it costs pharmaceutical companies on average $2.56 billion to bring a new drug to market. This is more than twice the cost it took 11 years ago. According to the study’s author, this higher cost results from larger and more complex clinical trials, as well as the number of drugs that fail in development. The Bill & Melinda Gates Foundation last week pledged $5.7 million to test potential treatments for Ebola. The research being funded will examine the effectiveness of using blood plasma taken from Ebola survivors to treat those infected, as well the effectiveness of an experimental antiviral drug called brincidofovir. While it has been common practice for decades for doctors to use blood donations from Ebola survivors as a form of treatment, there has not yet been rigorous studies conducted to examine the effectiveness of this practice until now. The US Department of Health and Human Services last Wednesday unveiled new proposed reporting requirements or clinical researchers registering and submitting results to ClinicalTrials.gov. The most significant proposed change is that companies will be required to submit summary results from trials even if the product has not been approved or licensed for use in the United States.

We have many reasons to be thankful. Photo: Satya Murthy As global health advocates, our work often requires us to focus on unmet needs—such as the number of people worldwide who still die from preventable diseases each year, or the lack of adequate resources and investment to tackle these diseases. Yet with Thanksgiving just around the corner, there is much for which we, as global health advocates, can be grateful in terms of advancements achieved in the development and deployment of lifesaving global health technologies. In the spirit of the holiday, here is my list of ten global health advancements I’m thankful for this Thanksgiving: After years of slow progress in the development of drugs, vaccines, and diagnostic tools to fight Ebola, efforts are now moving at hyper speed. Several experimental treatments and vaccines are now being tested in clinical trials in Ebola-endemic countries. Thanks to the development and widespread implementation of effective vaccines, this year the world moved one step closer to the eradication of polio. Scientists from the US Centers for Disease Control and Prevention believe that the second of three forms of poliovirus has successfully been eradicated. The first vaccine against hookworm has been shown to be safe in early-stage clinical trials. An effective vaccine could protect the more than 600 million people infected with this dangerous parasite worldwide. Widespread access to and use of antiretroviral therapy (ART) is fueling incredible progress in the fight against HIV and AIDS. According to the UNAIDS 2014 report, 2013 saw the lowest level of new HIV infections this century and the lowest number of AIDS-related deaths since 2005. As of this summer, nearly 14 million people are accessing ART. The world could soon have an important new tool in the first against dengue fever. Results from the second Phase III trial of the first vaccine candidate against dengue fever showed the vaccine to decrease incidences of dengue fever by nearly 60 percent. Within a few years, women could have new, user-friendly options to protect themselves against HIV. Several new antimicrobial vaginal gels and antiretroviral-releasing contraceptive vaginal rings are currently undergoing clinical trials. Significant progress has been achieved this year towards the development of new tools to fight malaria. After receiving expedited regulatory approval from the US Food and Drug Administration last year, new malaria drug treatment candidate tafenoquine entered Phase III trials this year. Additionally, the malaria vaccine candidate RTS,S is now under regulatory review by the European Medicines Agency. New pediatric drug formulations to treat tuberculosis (TB) could be available as early as late next year, according to developers. This advancement is critical as there is currently no appropriately dosed, child-friendly TB treatment available. New vaccines, drugs, diagnostics, and other health innovations have led to 4.2 million fewer child deaths globally last year compared to 1990. There are 365 global health products in the research pipeline that have the potential to fuel incredible gains in health for people around the world. With so much accomplished in 2014 and so many promising tools on the cusp of development and delivery, we have much to be thankful for this Thanksgiving. This Thursday, enjoy your Turkey and fixings with family and friends and give thanks for the incredible progress we’ve achieved this year. And then next week, when our turkey hangovers pass, we’ll get back to work.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last week, East Asia Summit members signed a regional commitment to eradicate malaria from the Asia-Pacific region by 2030. This communique, which came out of the 9th East Asia Summit, includes support for the research and development of new drugs and diagnostic tools to fight malaria. As the international community races to develop a vaccine against the Ebola virus, a World Health Organization official said the World Bank may establish a mechanism to help indemnify Ebola vaccine makers in case liabilities arise once a vaccine is widely administered. In some cases, rare adverse reactions to a drug are not always identified through the clinical trial process, so a mechanism that protects manufacturers from liability could reduce the financial risk of bringing an Ebola vaccine to market. The New York Times Magazine took an in-depth look at why there are so few blockbuster drugs invented today. Scientists expected that once the human genome was sequenced, it would usher in a golden era of drug development and profits for the pharmaceutical industry. While there have been breakthroughs, it’s since been discovered that most diseases affecting large numbers of individuals are caused by a handful of interacting mutations, which makes them tougher to treat and prevent. The article looks at this and other factors impacting drug development. A team of Chinese scientists claim to have eradicated malaria in Comoros—a small island nation off the east coast of Africa—by administering a new Chinese-made drug to all 700,000 people on the island as part of a massive medical experiment supported by the Comoran government. The scientists say that by administering repeated doses of medicine to everyone in the country for three months, they removed the malaria parasite from the bloodstream of the entire population, thereby halting the life cycle

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC’s Senior Policy and Advocacy Associate Jenny Howell assesses how tomorrow’s congressional election results could impact global health research and development (R&D). With Republicans expected to gain seats in the House and take control of the Senate, shifts in the makeup and leadership of key committees with oversight over global health R&D are expected. Senators Tom Harkin (D-IA) and Lamar Alexander (R-TN) announced their intention to introduce a new bill to accelerate the development of treatments and vaccines for Ebola. The bill would add Ebola to the list of qualifying tropical diseases for the Food and Drug Administration’s priority review voucher program—which is designed to incentivize the development of drugs, vaccines, and other health tools for neglected tropical diseases. Emily Donaldson, program coordinator at AVAC, and Tom Harmon, senior policy analyst at the International AIDS Vaccine Initiative (IAVI), discussed the state of HIV prevention research funding while the first-ever conference devoted solely to HIV prevention R&D took place last week in Cape Town, South Africa. During his speech at the annual meeting of the American Society of Tropical Medicine and Hygiene, Bill Gates said he believes it is possible to eradicate malaria within a generation. To reach that goal, Gates pledged that the Bill & Melinda Gates Foundation would increase its malaria program budget by 30 percent—to more than $200 million per year. A group of European universities and medical groups plan to give experimental drugs to Ebola patients in West Africa without assigning any trial participants to a placebo group. These groups say it would be unethical to withhold potentially lifesaving treatment, but US officials argue that without a control group, it is impossible to assess whether the drugs are effective. The Wall Street Journal takes a deeper look at this debate.