Research Roundup: Malaria eradication, indemnity for Ebola vaccine manufacturers, drug development impediments, and more

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.

At the 45th Union World Lung Health Conference, TB activists called for more funding for TB R&D. Photo: Steve Forrest/The UnionIn this guest post, Mike Watson Frick—TB/HIV program officer at Treatment Action Group (TAG)—writes about the state of tuberculosis (TB) research funding and civil society actions that took place at the recent Union World Conference on Lung Health in Barcelona, Spain. At the end of last month, the global community of TB scientists, activists, and healthcare workers gathered in Barcelona, Spain for the 45th Union World Conference on Lung Health. For the first time, the conference opened with a rousing call by civil society organizations to triple annual spending on TB research to US$2 billion per year. At the conference's opening ceremony, activists from Treatment Action Campaign (TAC), TAG, the Global TB Community Advisory Board, AIDS Free World, International Treatment Preparedness Coalition, and HIV i-Base called on governments, donors, and industry to #CoughUpTheTBMoney to fully fund TB research and the development of new TB treatments.The activists who took the stage in Barcelona were reacting to the dismal news contained in a report released by TAG the previous week showing that funding for TB research in 2013 fell $1.3 billion short of the $2 billion the Stop TB Partnership estimates the world must spend each year in order to eliminate TB as a public health threat.2014 Report on Tuberculosis Research Funding Trends. Photo: Treatment Action GroupTAG's annual Report on Tuberculosis Research Funding Trends shows that funding for TB research has flat lined since 2009. After declining in 2012, funding for TB research & development (R&D) increased slightly in 2013, due largely to an increase in spending by the Bill & Melinda Gates Foundation. Worldwide, governments, charities, industry groups, and multilateral organizations spent just $676.6 million on TB R&D in 2013. Funding shortfalls persist in every category of TB research tracked by TAG—basic science, diagnostics, drugs, vaccines, and operational research—making 2013 the ninth straight year of missed funding targets. The gap is largest, in absolute terms, in TB drug research where funders spent just $255 million of the $740 million funding target.The human consequences of such anemic funding for TB drug research were voiced by many of the TB patients and survivors attending the conference in Barcelona. At the opening ceremony, two women personally affected by TB read statements about their experiences, illustrating the pressing need to support research. Portia Serote of TAC described the lengthy duration, side effects, and difficulties of receiving drug-sensitive TB treatment, while Stephanie A.—a woman from Los Angeles whose brother has extensively drug-resistant (XDR)TB—described how side effects from XDR TB drugs are causing her brother to lose his hearing, as well as feeling in his hands and feet. For both drug-sensitive and drug-resistant TB, shorter, less-toxic regimens would improve the arduous journey patients must endure to cure their TB.Yet desperately needed progress in TB research rests on a shaky financial foundation rocked by two forces. First, the pharmaceutical industry is abandoning TB research as reflected in the 33 percent drop in industry spending from $144.97 million in 2011 to $99.6 million in 2013. With expenditures under $100 million, the private sector now spends less on TB R&D than it did in 2009 at the peak of the economic crisis. Even more alarming, 60 percent of industry spending on TB research in 2013 came from one just one company: Otsuka. Not considering Otsuka's investment of $58.7 million, other private sector companies mustered just $40 million on research to develop new TB drugs, diagnostics, and vaccines. Three pharmaceutical companies have left TB research in as many years, a rate of attrition driven by an industry-wide shift away from anti-infectives research as pharmaceutical companies either concentrate on more lucrative endeavors—such as developing new vaccines and drugs for chronic diseases or pursuing mergers and acquisitions to focus on core business. The abandonment of anti-infectives work has become severe enough to prompt a Presidential executive order that includes a recommendation to give incentives of $800 million per year for pharmaceutical companies to develop new drugs.Conference participants signed posters with the rallying cry #CoughUptheTBMoney. Photo: Mike Frick/TAGPharmaceutical disinvestment is increasing pressure on public funders to shoulder a greater percentage of TB R&D funding at a time when many government agencies are fighting off the shortsighted cutbacks of fiscal austerity measures—the second force undermining TB research. Federally mandated, across-the-board budget cuts under sequestration in 2013 led to lower TB R&D spending at the US National Institute of Allergy and Infectious Diseases and the US Centers for Disease Control and Prevention—the first and ninth largest funders respectively of TB R&D globally. Sixty-two percent of public money for TB research comes from one country—the United States—revealing the TB research endeavor’s depth of dependency on just a handful of public agencies, whose budgets are either being actively scaled back or, at best, failing to keep pace with inflation and the rising costs of biomedical research.Reducing TB deaths by 95 percent and cutting the number of new TB cases by 90 percent by 2035—the two goals of the post-2015 TB strategy approved by the World Health Assembly (WHA) in May 2013—will require research to develop and introduce new tools. The WHA notes that new tools must be introduced no later than 2025—and preferably sooner. Yet chronic underfunding of TB research jeopardizes this vision of achieving a world free of TB. Reversing this stagnation will require building a movement for TB research that can bring money, muscle, and political commitment to bear on research funders—new and old—from all sectors. The message to #CoughUpTheTBMoney, repeated throughout the meeting in Barcelona and endorsed by hundreds of signatures from conference delegates, represents a small but significant first step toward building a stronger TB research movement.