Report Calls for US Funding to Speed Global Health Research and Innovation

A coalition of 30 nonprofit health organizations promoting the development of drugs, vaccines, and other health-related products designed for use in the developing world is calling on US policy makers and regulators to accelerate scientific innovation and streamline the approval process for safe and affordable new medical products that can be used worldwide.

At a time when a sluggish economy is prompting the US Congress and the Obama administration to consider ways to reduce government spending, a report issued by the Global Health Technologies Coalition, funded by the Bill & Melinda Gates Foundation, makes a case in a policy report why US policy makers should sustain US investment in global health research and development (http://bit.ly/lsbDkG).

“In times like this, when budgets are tight, policy makers are forced to make decisions about our national investments to spur economic growth,” said Kaitlin Christenson, director of the coalition, in explaining the rationale behind issuing the report. “But data show funding health innovations stimulates job creation here as well as addresses the United States' moral imperative to help those around the world.”

The report noted that in California, for example, global health activities in 2007 generated an estimated $50 billion in business, supporting 350 000 high-quality jobs and $19.7 billion in wages and salaries.

Federal funding is so critical for these nonprofit health organizations that substantial cutbacks could deal a serious blow to their programs. For example, coalition member FHI (formally Family Health International), which provides family planning and reproductive health services in more than 50 countries and also administers some of the largest HIV/AIDS programs worldwide, currently receives 85% of its funding from the US government.

“The realities of the US deficit and problems with the global economy slow our ability to develop our programs, which in the long run save the world money,” said FHI president Ward Cates Jr, MD, MPH. “What we have shown, in many cases, is that investment by the United States has benefitted not only the lower-resource countries, but it works in lowering our security risks.”

Another coalition member, the Global Alliance for TB Drug Development (TB Alliance), is moving forward with efforts to create new and less costly treatment regimens to help prevent the nearly 2 million deaths from tuberculosis (TB) that occur annually. In November, the TB Alliance launched a phase 2 clinical trial it hopes will show efficacy of a new treatment regimen using novel compounds. But because of the lack of congressional appropriations, the $40 million authorized by the US Agency for International Development (USAID) intended for the alliance has resulted in only $9 million being disbursed so far, hampering the group’s ability to do its work.

As part of the report, the coalition points out that the Obama administration had laid out its support in 2009 in its Global Health Initiative and in 2010 through a presidential policy directive for investing in research to provide innovative biomedical interventions and technologies to address global health needs. The report cited the release in 2009 of the White House's Global Health Initiative, which emphasized the benefits of research to spur innovation for the discovery and development of new biomedical interventions and technologies. Last year, the administration also unveiled the first-ever Presidential Policy Directive on global development in which scientific collaboration with other countries and investing in science and technology is intended to improve health and development.

In 2010 alone, the group noted, several developments underscored that federal support in such efforts did bear fruit. For example, a USAID-supported study provided proof-of-concept that a microbicide gel could provide women with protection against HIV and herpes. The National Institutes of Health launched 5 pilot projects to spur drug development for diseases such as schistosomiasis and hookworm, which have a substantial impact in developing countries. It also partially funded development of a novel, rapid, easy-to-use diagnostic test for TB (including drug-resistant infections) that was endorsed in October 2010 by the World Health Organization as a tool that “could revolutionize TB care and control” (http://bit.ly/idXOrJ). Additionally, the Department of Defense launched the first clinical trials of a vaccine against the species of malaria parasite that causes the vast majority of all malaria infections.

Regarding policy issues, the coalition wants the United States to sustain and protect its investment in global health research and product development, develop concrete plans to incorporate research and development as a key priority within US global health programs, and ensure that US investments in global health research are coordinated, efficient, and streamlined.

The report also focuses on the US Food and Drug Administration (FDA) and its ability to regulate health products to prevent, diagnose, and treat widespread infectious diseases. Specifically, the report suggests that the FDA make public the recommendations of its neglected disease review group (which advises the FDA commissioner about potential options to support and facilitate the development and evaluation of medical products to prevent, diagnose, and treat neglected diseases of the developing world) and allow for public comment. The coalition is urging the FDA to establish stronger partnerships with other regulatory stakeholders, such as the World Health Organization and the European Medicines Agency, and to enhance its capacity in handling neglected diseases and better engage with groups developing global health tools.

“The current system for global health products is complex, and the FDA has an opportunity to partner with the World Health Organization and nonprofits developing and distributing those products,” Christenson said.