Research Roundup: Drug development costs, the price of priority review, new clinical trial requirements, and more

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.

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.