March 30, 2007 – Updated 7:32 p.m.
Countries that get funds from the United States to fight AIDS should have more power to determine the proportions of prevention, treatment and abstinence money that work best within their particular borders, the Institute of Medicine said Friday.
The current U.S. formula that fixes the percentage of funds allocated among those areas should be dropped, said Jaime Sepulveda, chairman of the Institute panel that prepared the report.
Much larger quantities of lower-cost anti-retroviral drugs to counter the disease would reach AIDS patients abroad if the United States moved away from requiring Food and Drug Administration review of those products, the report added.
Required under the legislation that established the five-year, $15 billion U.S. plan to counter global AIDS, the Institute report also urged greater emphasis on programs to prevent the spread of AIDS and a shift to establishing enduring health care systems to counter the disease.
Overall, the evaluation of the plan, known as the President’s Emergency Plan for AIDS Relief (PEPFAR), said it has made a “good start” toward countering the pandemic. “But because the fight against AIDS will be a protracted one, it is also important to build toward a sustainable program,” said Sepulveda, who is a visiting professor at the University of California in San Francisco and has served as the National Institutes of Health of Mexico.
Mark R. Dybul, who heads the PEPFAR program as U.S. Global AIDS Coordinator, said in a telephone interview that “we very much welcome the report. No one’s got all the right answers.” Its emphasis on increasing prevention, building up the supply of health care workers, and creating more enduring systems echoes the Bush administration’s own thinking on PEPFAR’s future, he said. But he defended the allocation percentages and the FDA approval process.
The report also addressed a range of other issues, including the role of violence against women in spreading AIDS.
The funding proportions were a key issue in the legislative battle to pass PEPFAR, with proponents of abstinence education insisting that 33 percent of prevention funds be devoted to attempts to delay sex until marriage.
Overall, Congress mandated that 55 percent of funds go for treatment, 20 percent for prevention, 15 percent for “palliative care” to relieve pain including at the end of life, and 10 percent to assist orphans and other children affected by the pandemic.
The 2003 law (PL 108-25) that established PEPFAR sets the goal of preventing 7 million HIV infections, treating two million people with AIDS or the HIV virus with anti-retroviral drugs, and providing care for 10 million people infected with and affected by HIV or AIDS, including orphans —all within five years.
With greater latitude to determine how money is spent, the 15 countries that are the main recipients of PEPFAR money could more easily reach those performance goals, the report said. For example, Sepulveda said, it doesn’t make sense to focus on abstinence education in Vietnam where the AIDS virus is often spread by shared drug needles.
“Having the same budget allocations for 15 countries with different epidemics is not useful,” he said in a press briefing Friday morning.
Under the plan, FDA also is required to approve the drugs on which PEPFAR funds can be spent. But the report recommends shifting to studying the World Health Organization’s system for pre-clearing drugs used in global relief efforts and “transitioning to it as rapidly as feasible.”
Another member of the Institute’s PEPFAR evaluation committee, Brown University medical professor Charles Carpenter, said countries report being able to obtain two or three times the quantities of drugs they want at the prices they want by relying on the WHO system.
Reshaping PEPFAR when it is reauthorized —the program runs through fiscal 2008 —to drop the budget allocations and the FDA requirement may be politically difficult, though Democratic control of Congress may mean less opposition to the recommended changes.
Another recommendation of the report is that women and girls be empowered to counter “gender violence” that is causing girls and women to make up a growing percentage of the AIDS population. But Sepulveda said suggesting how that could be accomplished was beyond the scope of the report.
Dybul said of dropping the budget allocation percentages, "I think eventually that might be something to do," and cited as an example that 55 percent might not be the right percentage for drug treatment dollars. But Dybul added that the requirement has dramatically increased the number of people getting pharmaceutical treatment. Several years ago, global AIDS relief money went entirely to prevention, he said, and "right now, it's too early to drop the directive."
Dybul added that FDA has approved more drugs as suitable for PEPFAR relief dollars since the IoM completed the evaluation on which the report is based. Access has widened to the point that supplies of low-cost drugs are essentially no more restricted using the FDA approval list than the WHO list -- in fact, the FDA approval process is adding products to the WHO list, he said.
First posted March 30, 2007 4:36 p.m.


