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In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. At the annual Grand Challenges meeting in Brazil this month, the Bill & Melinda Gates Foundation announced a new partnership with pharmaceutical companies to accelerate vaccine research and development (R&D). For the first project, the Gates Foundation will partner with GlaxoSmithKline on early-stage research for vaccine thermostability. According to studies published in Nature, a potential new HIV treatment has a "profound and unprecedented" impact on the virus. The trials were performed by Harvard Medical School and the National Institute of Allergy and Infectious Diseases. GHTC member Treatment Action Group released a new report on tuberculosis (TB) research funding. The report finds that after seven years of slow and unsteady increases in funding, TB R&D investors reported a drop in spending in 2012 that threatens to undermine the tenuous gains made since 2005. The Centers of Disease Control and Prevention released a report stating that the number of malaria cases in the United States is at the highest level in forty years. Nearly all the cases were Americans or foreign travelers bringing it into the country. About two-thirds were infected in Africa, where malaria is common. A new analysis published in The Lancet Global Health found that only 37—or four percent—of the 850 drugs and vaccines registered from 2000 to 2011 were for neglected diseases. The study also found that just 1 percent of existing clinical trials are for the development of tools for neglected diseases.

In this guest post, Mike Frick—project officer at the Treatment Action Group (TAG)—writes about the organization’s new report on funding for tuberculosis (TB) product development. Each year since 2006, TAG has tracked spending on research and development (R&D) for new diagnostics, drugs, and vaccines to improve TB treatment and prevention. The 2013 Report on Tuberculosis Research Funding Trends: 2005–2012 presents eight years of funding data. It also compares current spending in six research areas to the corresponding R&D funding targets outlined in the Stop TB Partnership’s Global Plan to Stop TB, 2011–2015. For the first time, TAG also analyzed investments in pediatric TB R&D. The report finds that after seven years of slow and unsteady increases in funding, TB R&D investors reported a drop in spending in 2012 that threatens to undermine the tenuous gains made since 2005. How much did funding decline? Funding for TB R&D fell by $30.4 million from 2011 to 2012. The $627.4 million spent on TB R&D in 2012 represents just 31.4 percent of the $2 billion annual investment called for by the 2011-2015 Global Plan and leaves a shortfall of $1.39 billion. At $10.3 million, investments in pediatric TB R&D comprised less than 2 percent of total 2012 spending and declined by 12 percent compared with 2011 levels. Where did funding fall the most? Compared to 2011, spending on TB R&D fell in four research categories: Funding for diagnostics fell by 23.4 percent from $55.4 million in 2011 to $42.4 million in 2012, leaving 87.5 percent of the $340 million annual target unfunded. Drug research spending dropped by 6.7 percent from $254.8 million in 2011 to $237.8 million in 2012. This leaves 67.9 percent of the $740 million annual target unfunded. Investments in vaccines declined by 9.3 percent from $95.4 million in 2011 to $86.6 million in 2012, leaving 77.2 percent of the $380 million annual target unfunded. After exceeding the annualtarget in 2011, funding for operational research dropped back below this target amount, declining by 9.8 percent from $85.5 in 2011 to $77.1 million in 2012. Funding for TB R&D fell by $30.4 million from 2011 to 2012. The $627.4 million spent on TB R&D in 2012 represents just 31.4 percent of the $2 billion annual investment called for by the 2011-2015 Global Plan and leaves a shortfall of $1.39 billion. Source: TAG/Hollander Snow Studio Who supports TB R&D? Public sector donors gave 61 percent of the global total, followed by the philanthropic sectorwith 20 percent and the private sector with 18 percent. Multilateral institutions contributed just 1 percent of total spending. The top ten donors disbursed 78 percent of total TB R&D investments in 2012. Two organizations – the National Institute for Allergy and Infectious Diseases (NIAID) and the Bill & Melinda Gates Foundation – each spent over $100 million and together comprise 45 percent of the global total. Public and philanthropic institutions in the United States and United Kingdom continue to underwrite the bulk of TB R&D. The BRICS countries (Brazil, Russia, India, China, and South Africa) remain conspicuously absent from the top 10 list. Top 10 TB R&D Funders in 2012 Including 2012 amount and increase (↑)/decrease (↓) /flat-funding (→) compared with 2011 level 1. NIAID ($169.1 million) ↑ 2. The Bill & Melinda Gates Foundation ($111.6 million) → 3. Otsuka Pharmaceuticals ($60 million) ↓ 4. Other National Institutes of Health (NIH) Institutes and Centers ($36.6 million) ↓ 5. The European Commission ($27.3 million) ↓ 6. Anonymous pharmaceutical company ($22.8 million) ↓ 7. The US Centers for Disease Control and Prevention (CDC) ($18.8 million) ↑ 8. The UK Department for International Development ($16.9 million) ↓ 9. The UK Medical Research Council ($14.8 million) ↓ 10. The Wellcome Trust ($13.4 million) ↑ Will funding continue to fall? The $30.4 million decline may intensify in coming years. This drop does not reflect the impact of sequestration-related funding cuts in the US, which forced the NIH to cut 5 percent ($1.55 billion) of its fiscal year 2013 budget. Sequestration led the CDC to cut support for the Tuberculosis Trials Consortium (TBTC), one of the world’s leading TB drug research networks, by 13 percent. In response, the TBTC closed three clinical trials sites. In a field that has struggled to attract scientific attention and talent for decades, sequestration-related cuts could eliminate critical opportunities for young investigators to build their scientific careers in TB R&D. Will the private sector close this gap? Private sector companies could play a much larger role in TB R&D. Yet, for the first time since 2005, private sector spending declined, dropping by 22.1 percent in 2012 compared with 2011. Pfizer, which contributed $6.3 million to TB drug research in 2011, recently announced the closure of its anti-infectives research division. Other drug companies decreased their investments, including Otsuka, whose TB drug delamanid will soon complete a Phase III trial. Wavering commitments to TB R&D from the private sector will place greater pressure on public institutions just as they begin to face unprecedented budgetary drawbacks. Philanthropic support also remained relatively flat, increasing by just 3.1 percent over 2011. What is the impact of this decline? Decreased funding today will delay the development, approval, and implementation of faster diagnostic tests, better drug regimens, and more broadly protective vaccines that are urgently needed to fight TB, which causes 8.7 million people to fall sick and kills 1.4 million people each year. Donors from all sectors in high-, middle-, and low-income countries must recommit to meeting the funding levels required to accelerate TB R&D and end the global TB epidemic.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The GHTC this week released a new fact sheet on the US Agency for International Development and its longstanding support for global health product development. Despite the recent federal budget deal that re-opened the government, the “worst may not be over for US researchers,” Nature reports. Researchers “face the possibility of another government shutdown in mid-January, when the deeply divided US Congress must agree on a new plan to fund government operations.” For the first time, an oral cholera vaccine has shown sustained protection for five years against the disease. GHTC member Aeras has released its 2012 annual report, which highlights progress made toward developing safe and effective vaccines against tuberculosis. A new study in The Lancet Global Health provides an in-depth assessment of the drug and vaccine landscape for neglected diseases between 2000 and 2011. Health ministers of countries represented in the Organization of the Islamic Conference (OIC) have agreed to appoint Indonesia as the “center of excellence” in developing vaccines that would be supplied to OIC member states. A new Q&A with Renate Baehr—executive director of the German organization Deutsche Stiftung Weltbevoelkerung—highlights the importance of public-private partnerships for global health.

  “You’re in a position to make such a difference and to be innovative with your thinking,” Margaret McCluskey, senior technical advisor at the US Agency for International Development (USAID), said to an audience of Congressional staffers at a briefing yesterday on Capitol Hill. The briefing, co-hosted by GHTC and PATH, focused on the critical role USAID plays in supporting lifesaving global health research and development (R&D) for new health tools. Panelists also stressed the need for policymakers in Congress and across the US government to support the development of new and innovative health products. All of the panelists at yesterday’s briefing called on the US government to continue its strong investment in global health research. Rep. Albio Sires (D-NJ)—lead co-sponsor of the 21st Century Global Health Technology Act, a bill that would strengthen health R&D and product development at USAID—spoke at the briefing and reiterated this important message. “New vaccines, drugs, and tests are desperately needed, but progress cannot be sustained without R&D,” he said, adding that the United States has a legacy of supporting global health R&D and that health R&D is a smart economic investment. Rep. Sires: “New vaccines, drugs, and tests are desperately needed, but progress cannot be sustained without R&D." Photo credit: Aeras/Liz Roll Much progress in global health R&D has been made over the years, and USAID has unquestionably supported many of today’s success stories—including new tools for malaria, HIV and AIDS, child health, family planning, and reproductive health. Several panelists stressed that product development for global health tools doesn’t happen overnight, and that USAID’s sustained commitment to research has been a crucial element of these health R&D success stories. Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides, stressed that R&D can take many years, and thanked USAID for its support for mircobicide research—as well as for providing dedicated resources and long-term investments in global health product development.   Panelists also emphasized that despite this progress, there is still a need for sustained investment in R&D today to ensure that there are appropriate tools for diseases of poverty tomorrow. Rosenberg warned that complacency with today’s current tools is the wrong mindset, saying, “As soon as you think you’ve got [a health issue] under control, you’ve lost.” Kari Stoever, vice president of external affairs at Aeras, noted that investing now in tuberculosis (TB) vaccine research will save billions of dollars in future spending for TB treatment programs in low- and middle-income countries, which currently costs $8-10 billion per year. She added, “Without an effective vaccine, many lives are at risk.” USAID does not currently fund TB vaccine R&D. Additionally, USAID’s partnerships with the private and nongovernmental sectors have been key to its success in developing effective public health tools. One particularly effective partnership is USAID’s support for nonprofit product developers (NPPDs). These organizations combine the resources of governments, the experience of the private sector, and the know-how of nonprofit groups. PATH is one such NPPD that, with USAID support, partnered with Becton, Dickenson and Company (BD) to develop the SoloShot™ syringe and Uniject™ system. Both devices are designed specifically for use in low- and middle-income countries. “Though BD is a for-profit company, we share a common goal of providing access to important devices where they are needed most,” said Renuka Gadde, vice president of Global Health at BD. She added at none of these successes would have happened without government agencies like USAID looking at complex global health problems and spurring various sectors to become involved through programs like the Saving Lives at Birth Grand Challenge. Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides, stressed that R&D can take many years, and thanked USAID for its continuous support. Photo credit: Aeras/Liz Roll While USAID is a key player in global health R&D, coordination between the other US agencies involved in this work—such as the Centers for Disease Control and Prevention, the Department of Defense, the US Food and Drug Administration, and the National Institutes of Health (NIH)—is crucial. The 21st Century Global Health Technology Act requests that USAID work to align its health-related research strategy with similar strategies at other agencies, with the goal of creating a whole-of government approach to global health R&D. Greater coordination among US agencies can held lead to more efficient health R&D—for example, Rosenberg noted at the briefing that both USAID and NIH are supporting the organization’s microbicide clinical trials. We are at a critical juncture in much of the global health R&D currently underway, and USAID will be instrumental in ensuring these technologies come to fruition. As McCluskey said at the end of the briefing, “Don’t be business as usual with infectious diseases.” Dr. Joanne Carter—executive director of RESULTS/RESULTS Educational Fund and moderator of the briefing—summed it up nicely: “Investments in R&D are what’s needed to take us to the next level in global health.”