The following commentary was submitted, by the CEOs of the TB Alliance and Aeras Global TB Vaccine Foundation, to the US Department of State in response to the most recent draft of Presiden Barack Obama's Global Health Initative:
We applaud the Obama Administration’s leadership on global health and commitment to increasing funding in spite of the current budget situation. The most recently released draft strategy of the President’s Global Health Initiative (GHI) rightly expands the US government’s global health policy to address several key areas. However, we are concerned by the GHI’s stance on tuberculosis, including a significant disparity in funding compared to diseases of similar magnitude and a disappointingly meager requested increase in funding for FY2011. It would appear that tuberculosis is a relatively low priority for the Administration, which is puzzling since TB is the world’s second-leading infectious killer and is the leading cause of death among people living with HIV/AIDS. One third of the world’s people are infected with latent tuberculosis; over 9.2 million new infections occur each year; and 1.8 million people die each year from tuberculosis. There is more tuberculosis now than in any previous year in human history. Better prevention and treatment are urgently needed, yet will remain far out of reach if the current GHI proposal is not changed.
The alarming rise in multiple-drug-resistant and extensively drug-resistant (MDR and XDR) TB is also a growing global health concern that recognizes no borders and threatens the United States. Failure to invest in drugs and vaccines to better control TB will have severe ramifications for our public health system and for US taxpayers. For example, an outbreak of MDR-TB in New York from 1989 – 1991 cost this country more than $1 billion to contain. The expense of treating extensively resistant strains is even greater – in February 2009, the US Centers for Disease Control and Prevention estimated that treating a single case of XDR-TB in the US costs almost $600,000, a burden borne largely by the public health system. Better TB prevention and treatment will benefit people at home and abroad.
TB is a disease of poverty, affecting the most vulnerable and marginalized. It is closely linked to substandard housing, poor nutrition, and other social determinants of health. Despite its devastating impact worldwide, TB rarely captures headlines or garners celebrity attention, and TB continues to be overlooked by the public and, unfortunately, some donors. US government (USG) funding for diseases that claim similar numbers of lives is significantly higher. We agree with the need to fund those diseases, but question the rationale for the comparative neglect of TB. This disparity is certainly not evidence-based, since TB claims a staggering number of lives. The proposed GHI treatment targets and funding levels represent a step backwards from the commitment established by Congress in the 2008 Lantos-Hyde PEPFAR reauthorization to increase funding and prioritize TB research and control. This stance threatens to mitigate the impact of the GHI in other priority areas. The Lantos-Hyde Act sought to halve the deaths of the 2 million patients that die each year from TB and by 2050, eliminate it as a public concern. Over five years, it aimed to treat 4.5 million drug-sensitive patients and 90,000 drug-resistant patients and authorized $4 billion for TB control. It also set out a long-term strategy of investing in research and development to create new and improved tools, including vaccines and drugs, to prevent and treat the growing TB problem. By contrast, the GHI proposes to treat 2.6 million patients afflicted with drug-sensitive TB and 52,700 patients suffering from drug-resistant tuberculosis around the world – 40% fewer than called for in Lantos-Hyde.
Although we welcome the Administration’s emphasis on innovation, GHI also does not explicitly address research and development, focusing only on operational research and implementation rather than including the vitally important work undertaken by several USG agencies to accelerate the development of new global health products. In particular, this draft strategy omits the significant role played by USAID in funding the development of new technologies to combat tuberculosis – efforts that urgently require greater investment.
Current TB treatments were developed over forty years ago and require patients to undergo a lengthy and complex regimen – which is even longer and more difficult to comply with in the case of drug-resistant tuberculosis – and which cannot be administered with certain HIV medications. The existing vaccine – which has limited effectiveness and is not recommended for HIV-positive infants – was invented almost 90 years ago. The most commonly available diagnostic method in developing countries, sputum smear microscopy, was developed over 120 years ago. The GHI should highlight the fact that TB will not be controlled or ultimately eliminated without the development of new tools, such as new drug regimens, new TB vaccines, and improved diagnostics.
A modeling study based in Southeast Asia and published in 2009 in the Proceedings of the National Academies of Science found that even a 60% effective new TB vaccine could reduce morbidity and mortality by nearly 80% by 2050 if administered to everyone in the population and a new shorter drug regimen effective against drug-resistant strains of TB could reduce incidence by as much as 27%. Yet the U.S. government has not yet joined the other governments and foundations funding late-stage clinical trials for better TB vaccines and has provided only minimal funding for TB drug trials.
The GHI identifies six priority areas for intervention: HIV/AIDS; malaria; tuberculosis; reproductive, maternal, newborn, and child health; health systems and health workforce; and neglected tropical diseases. However, by failing to invest adequately in TB, the GHI undermines its ability to make progress in all priority areas or leverage the cross-cutting global health impact of a comprehensive TB elimination strategy. Please consider the following:
- HIV/AIDS – TB is the leading killer of people living with HIV in developing countries. In 2008, the United Nations identified the integration of TB and HIV control programs as a global health priority. Failing to address TB undermines existing USG investments in AIDS treatment; each year, thousands of people whose lives have been preserved by antiretroviral treatment die from undiagnosed and/or untreated TB.
- Reproductive, maternal, newborn, and child health – TB is a leading cause of death in women of childbearing age and claims the lives of more than 100,000 children every year. In India alone, 300,000 children are orphaned each year because their mothers have died of TB.
- Health systems and health workforce – The global TB burden (over 9 million cases yearly) combined with the length and complexity of TB treatment (including drugresistant TB) places substantial burdens on healthcare systems.
We respectfully request that the Administration reconsider its apparent lack of concern for the TB epidemic. Commitments to funding levels and treatment targets in the GHI must be, at a minimum, restored to the levels contained in the Lantos-Hyde Act, and the development of new tools to address the epidemic must be an expressly defined part of the strategy.
Sincerely,
Jerald C. Sadoff, MD
President & Chief Executive Officer
Aeras Global TB Vaccine Foundation
Mel Spigelman, MD
President & Chief Executive Officer
Global Alliance for TB Drug Development