In 2008, Congress passed the Tom Lantos and Henry J. Hyde United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act with strong bipartisan support. In addition to reauthorizing The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the bill provided a legislative framework for a bold new effort to fight tuberculosis (TB), a curable disease that claims 1.45 million lives each year and is the leading killer of people living with HIV/AIDS.
The law states that as a matter of U.S. policy, “it is a major objective of the foreign assistance program of the United States to control tuberculosis.” Despite a clear legislative mandate, the U.S. Global Health Initiative (GHI) has consistently failed to live up to the goals of this landmark legislation.
Lowering the Bar on TB Treatment
The Lantos-Hyde Act called for a plan to treat 4.5 million new TB patients and 90,000 patients with drug-resistant TB. Just 18 months after the bill became law, the GHI drastically curtailed these goals. Current GHI TB treatment goals are less than 60 percent of what was mandated in the Lantos-Hyde Act. At current funding levels it’s unlikely the U.S. will achieve even the attenuated goals of the GHI, let alone the targets originally specified in the law.
Missed Opportunities on New Tools to Fight TB
The failure to implement the Lantos-Hyde Act has impeded the race to develop new tools to fight TB, including the first new treatments for TB patients in nearly 50 years. Shortly after the bill was signed into law, the Global Alliance for TB Drug Development, a public-private partnership, signed a cooperative agreement with the U.S. Agency for International Development (USAID) with a funding envelope of $40 million. Four years into the five-year agreement, funding is decreasing. At the current trajectory, the TB Alliance will face a funding shortfall of more than $25 million over the life of the grant.
While important progress on new drugs continues, this shortfall comes at a heavy cost. These cutbacks contributed to the TB Alliance:
- reducing the patient enrollment target for a Phase III clinical trial from 2,400 to 1,900 patients, making it more difficult to prove statistical significance, which could ultimately impact the ability to register this new TB regimen;
- not utilizing clinical sites in countries where it was more expensive to conduct clinical development, undermining the most effective evaluation of new drugs in the clinical pipeline (This may ultimately impact the speed with which drugs are registered in countries which have not participated in the clinical development); and
- not pursuing work to improve the availability of present first line TB drugs in formulations appropriate for children.
In recognition of the urgent need for an effective TB vaccine, Congress included language in the Lantos-Hyde Act authorizing contributions to TB vaccine development programs, including the Aeras Global TB Vaccine Foundation. As full funding for TB has failed to materialize, Aeras has not received any support from USAID for its vaccine development efforts.
Funding to Stop a Global Killer
The Lantos-Hyde Act authorized $4 billion to support the Global Plan to Stop TB. The GHI is on pace to spend just 28.5 percent of the Lantos-Hyde Act authorization for TB. While the Obama administration’s proposed $18 million cut to TB funding for fiscal year 2013 comes at a particularly difficult budget moment, even the initial expanding GHI budgets did not seek funding for TB consistent with the legislation or commensurate with the impact of the disease. Expanding U.S. support for the Global Fund to Fight AIDS, Tuberculosis and Malaria (which provides over 80 percent of donor financing for TB) is critical, but complementary bilateral investments in USAID’s TB program have lagged far behind.
Opportunity in Need of Leadership
This World TB Day, the TB community is buzzing with the enormous potential that lies ahead: a new rapid diagnostic test that can drastically improve detection; novel drug combinations to treat drug-susceptible and drug-resistant TB; a new blueprint for TB vaccine development; increased attention to TB in women and children; progress in the integration of TB and HIV services; and new support in Congress for the fight against TB at home and abroad.
There is ample opportunity to make tuberculosis a signature accomplishment of the GHI. As the final authorized fiscal year of the Lantos-Hyde Act is debated, there’s still time to embrace its mandate: a bold effort to confront the world’s leading curable infectious killer.