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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. The TB Alliance recently launched an online resource that allows users to follow the progress of the organization’s efforts to develop new drugs for tuberculosis (TB). The US Food and Drug Administration has announced a five-year, $7.5 million contract with the World Health Organization (WHO) to support regulatory science and enhance global regulatory capacity. The funding will support WHO’s efforts to provide substantial regulatory support to many of its 193 Member States. A new report from the Institute of Medicine finds that a National Institutes of Health program to spur the translation of science to clinical therapies is largely successful but could be more collaborative. WHO, the World Trade Organization, and the World Intellectual Property Organization are planning a discussion on the current model for researching and developing new medical and pharmaceutical products—as well as new incentives and collaborative innovation models. The University of Washington has received funding from the Department of Defense to continue a project aimed at developing a small, paper-based device that could test for infectious in areas where diagnostic capabilities are limited.

Congress is heading for its July 4 recess next week, having made a few incremental steps toward a fiscal year (FY) 2014 budget for the federal government—including releasing spending levels for several agencies and programs that support global health and research efforts. The Senate released its FY14 302(b) allocations last week (the House released its own allocations a few weeks back). 302(b) allocations set limits on congressional appropriations for key accounts. As expected, the Senate’s allocations are overall higher than their House counterparts. For example, the State and Foreign Operations budget, which includes global health research and development (R&D) programs under the State Department and US Agency for International Development, is funded at $50.6 billion—essentially flat compared with the FY 2013 enacted level. It is also somewhat lower than President Obama’s FY 2014 request for that account. In contrast, the House budget level for this account is $10 billion lower than the Senate version and would require significant cuts from current spending. The Senate’s budget for the Labor, Health and Human Services (HHS) account—another controversial account—is a whopping $42 billion higher than the House level of $121.8 billion. This account include key programs at the Centers for Disease Control and Prevention, as well as the National Institutes of Health. Congress recently released spending levels for several agencies and programs that support global health and research efforts. Credit: Richard Franco. This pattern should sound familiar, as recent appropriations cycles have seen similar cavernous differences between the House and Senate. And as we know very well, the threat of budget sequestration has not been enough to bridge the gap. These huge disparities will make it extremely difficult for policymakers to agree on a final budget level for the government, meaning that we are almost certainly headed for another continuing resolution to keep the government open past September. There are some positive signs on the policy side of the appropriations saga. Both the House and Senate included report language in recently passed appropriations bills that would improve the US Food and Drug Administration’s (FDA) engagement in global health by boosting its global partnerships and ensuring its ability to review and license new global health technologies for all neglected diseases. Language was also included in the House’s version of US Department of Defense legislation promoting the development of a malaria vaccine, although the full House has not passed this bill yet. Aside from the Defense and FDA bills, neither the House nor Senate has progressed on appropriations legislation that directly affects global health R&D. Neither chamber has taken up bills for State and Foreign Operations or Labor-HHS. If past years are any indication, it’s very unclear whether this will happen at all. On a more positive note, the House Foreign Affairs Committee Subcommittee on Africa and Global Health is holding a hearing today to examine the need for new treatments for neglected diseases. As Subcommittee Chair Rep. Chris Smith (R-NJ) stated, “A number of so-called ‘neglected diseases’ receive little attention from researchers in such critical areas as detection, strategies, vaccines, or drug therapies.” Although research into new tools to combat neglected diseases does rely on researcher interest, even more essential to this effort is a strong combination of US government and private-sector funding and support for programs and partnerships that conduct global health research. Still, this hearing is a welcome contrast to potential threats to global health research faced in ongoing budget sequestration and the stalled appropriations process. Whether through FY 2014 budget negotiations or other legislative mechanisms, Congress should help move this cause forward by protecting US research and product development funding and promoting a comprehensive, thoughtful, and coordinated strategy for global health R&D.

In this guest post, Dr. John Boslego, director of PATH’s Vaccine Development Global Program, writes about an innovative partnership between the United States and India to develop an oral vaccine against rotavirus diarrhea. I recently had the pleasure of attending an international symposium on rotavirus vaccines where the government of India’s Department of Biotechnology (DBT) and the Indian vaccine manufacturer Bharat Biotech announced positive results from a Phase III clinical trial of an oral rotavirus vaccine that was developed and manufactured in India. Data from the trial showed the vaccine, ROTAVAC®, to be safe and effective in protecting infants against severe rotavirus diarrhea, the most lethal cause of childhood diarrhea. ROTAVAC® represents an important scientific breakthrough against severe rotavirus diarrhea, responsible for approximately 100,000 deaths of small children in India each year. Credit: PATH. However, what’s most extraordinary about this announcement actually may not be the results themselves, but the long and unique road that ROTAVAC® traveled to reach this point. This vaccine is the product of an innovative partnership between the United States and India, involving renowned experts from a range of agencies and sectors across the two countries. The vaccine originated from an attenuated (weakened) strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in the mid-1980s. Since then, partners in the vaccine’s development have included DBT, Bharat Biotech, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and PATH. Each group has provided its own contribution to the project, ranging from technical assistance on vaccine development and manufacturing the vaccine batches used in clinical trials, to guidance on designing and implementing clinical trials that meet international standards. With the development costs shared by several partners, Bharat Biotech was able to commit to a price of US$1.00 per dose for ROTAVAC®. As such, Bharat Biotech plans to register the vaccine for use in India first. If licensed by the Indian regulatory authority, the vaccine will be a more affordable alternative to the rotavirus vaccines already on the market. This represents an important scientific breakthrough against severe rotavirus diarrhea, responsible for approximately 100,000 deaths of small children in India each year. If licensed, this vaccine could save the lives of thousands of children each year in the country. Bharat Biotech also plans to submit ROTAVAC® for prequalification by the World Health Organization, so it may be procured for subsidized use in the developing world, giving it the potential to have an enormous impact on global public health by reducing rotavirus-related illness and deaths worldwide. I’m proud of the role that PATH has played in reaching this incredible milestone, and I am particularly impressed with how this truly innovative approach to a vaccine development partnership has resulted in the production of a safe and efficacious new rotavirus vaccine, ROTAVAC®.

  “A small, modest investment from the US government could truly transform the lives of people around the world and make a serious public health impact,” Rachel Cohen from the Drugs for Neglected Diseases initiative said yesterday at a congressional briefing focused on neglected tropical diseases (NTDs). NTDs are a group of 17 diseases that infect more than one billion people around the world, most of whom live on less than $1.25 per day. The briefing focused on how the US government has played a significant role in combatting NTDs globally through programs like those at the US Agency for International Development (USAID), which has helped deliver more than half a billion treatments in six years to more than 250 million people. At the same time, Cohen and other panelists stressed that significant changes are needed to make US NTD programs even more successful. For instance, several speakers argued that while USAID’s NTD program has been remarkable in its efforts to provide NTD patients with access to existing therapies, the agency must expand the program to include funding for research into new NTD drugs, vaccines, and diagnostics. The fact that USAID does not currently support NTD product development “is a serious gap in USAID’s efforts against NTDs, as most NTDs do not have adequate prevention, diagnostic, or treatment options,” moderator Kaitlin Christenson, GHTC’s coalition director, pointed out. She added that “many existing NTD drugs are toxic, expensive, and difficult to administer in resource-poor settings.” Christenson and other panelists added that congressional support is critical for USAID to expand its mandate into NTD research and product development. Panelists at a Congressional briefing on Monday discuss the US response to neglected tropical diseases. From left: Kaitlin Christenson, Brian D'Cruz, Rachel Cohen, and Larry Buxbaum. Credit: Research!America Panelists also highlighted that USAID’s program—which currently addresses only seven NTDs—should expand to include research and control efforts for all 17 diseases. Dr. Brian D’Cruz, an emergency physician who has served with Médecins Sans Frontières (MSF), discussed his experience providing treatment for sleeping sickness in the Central African Republic and Democratic Republic of the Congo to illustrate the need for expanded US support. D’Cruz told the story of Natasha, a 12-year-old girl in the Congo who died of sleeping sickness before his MSF team could provide adequate diagnosis and treatment. He added that MSF physicians are hindered in their efforts to treat patients like Natasha by cumbersome diagnostics and outdated, lengthy treatment regimens. Dr. Larry Buxbaum with the Philadelphia Research and Educational Foundation also highlighted that many NTDs, such as Chagas, are increasingly affecting populations in the United States. “Climate change is moving many tropical diseases north,” he said, adding “So while research is needed to help people with NTDs in Africa and South America, this research will be useful right here in the US as well.” D’Cruz also said that he has treated patients with Chagas disease in his capacity as a physician in Northern Virginia: “These NTDs exist just a few metro stops away.” Finally, all the panelists urged US policymakers to become increasingly involved in an ongoing global discussion about how to redefine NTD research and product development efforts. All three of these changes—investing in NTD product development, expanded support for all 17 NTDs, and engaging in global discussions about NTD research—will help ensure that the US makes the greatest impact possible against NTDs worldwide. “We need breakthrough, completely modern therapies and diagnostics for these diseases,” Cohen said, adding, “They are literally in the pipeline. US support could help us get closer and closer to elimination.”