The race to stay ahead of HIV disease is falling victim to the lack of a federal budget for fiscal year (FY) 2007. Losses in funding for HIV/AIDS research will set back efforts to fight drug-resistant strains and to find less toxic medications, according to the HIV Medicine Association (HIVMA). HIVMA is calling on the new Congress to reverse these losses as it reconsiders health and education spending for the rest of the fiscal year.
Last year's Congress failed to pass a budget for FY 2007 before adjourning. It left the federal government running on a continuing resolution at FY 2006 levels, which, after inflation, amounts to about a 3.5 percent cut. Furthermore, National Institutes of Health (NIH) policy is to disburse only 80 percent of a research grant's funding until a final budget is approved.
As a result, the National Institute of Allergy and Infectious Diseases (NIAID) is awarding fewer research grants and reducing funding for its clinical trial networks. It is also closing several sites in the AIDS Clinical Trials Group (ACTG), which tests new therapies for HIV/AIDS and opportunistic infections. In addition to the losses to inflation, the remaining centers face uncertainty about when or if they will see the other 20 percent of their NIH funding, making it almost impossible for these centers to plan studies or recruit patients. They also must struggle to keep enough staff to assure patient safety and comply with the complex regulations governing clinical research.
"The reason AIDS is no longer a death sentence is largely because of therapeutics developed through basic research and clinical trials funded by NIAID," said HIVMA chair Daniel R. Kuritzkes. "Highly active antiretroviral therapy has reduced AIDS-related deaths by 80 percent, and we are beginning to see similar inroads in resource-limited settings."
"But it would be a serious mistake to consider the fight against HIV/AIDS a done deal," he added. HIV has a remarkable ability to mutate and develop resistance to antiretroviral medications. An estimated one-third of patients in the United States are infected with multidrug-resistant virus. Today's antiretrovirals are less toxic than their predecessors, but there are still concerns about long-term cardiovascular, liver, and other toxic effects. And studies are needed to evaluate the safety for pregnant women and children of new antiretrovirals and to develop formulations appropriate for them.
"We need to keep up the pace to develop new drugs that are less toxic and more effective against this ever-changing virus," he added. "HIV won't wait for us."
HIVMA vice chair Arlene Bardeguez, MD, MPH, added, "With fewer centers in the clinical trials networks it will be harder to enroll women and minorities, who have historically been underrepresented in these studies. This is a problem not only because these are the groups increasingly affected by the HIV/AIDS epidemic. It is also a concern because the same drug may affect people of different races, genders, and ages differently. In addition, there are the factors of behavior to consider, and what other drugs patients may be taking. Without a large enough sample of the patients affected by HIV today we may get a misleading picture of how effective a drug is, or we may miss a dangerous side-effect."
The continuing resolution funding most of the government at last year's levels expires Feb. 15, 2007. The new Congress has expressed a desire to bolster a limited number of high-priority health and education programs at that point. HIVMA is hoping that NIH research is one of the critical items on the list for funding increases.
"The United States is a world leader in HIV research," Bardeguez said. "Discoveries made here benefit the rest of the world as well. What's more, AIDS research has also paid off in other areas of medicine including cancer, organ transplantation, and treating other viral infections such as hepatitis C."
Kuritzkes concluded, "Congress needs to fund the vital research that is saving the lives of people with HIV/AIDS around the world. NIAID grant-driven research has produced some very promising new classes of drugs that attack HIV in whole new ways. If they work, they could be a tremendous boon to patients. We need the research capacity to continue to engage investigators and to do safe and rigorous multi-center trials. Slowing or stalling the scientific engine that has brought a new lease on life to so many while millions continue to suffer the ravages of HIV infection would be a tragic mistake."