by Bob Roehr
WASHINGTON, D.C. –
The US international AIDS effort known as PEPFAR – the President's Emergency Plan for AIDS Relief – "represents a notable achievement not only in its conceptualization but also in its implementation," the Institute of Medicine (IOM) said in a 420-page report released March 30.
The independent study was mandated by Congress in the 2003 legislation that created the program. It primarily focuses on the first two years of full funding for PEPFAR, which ended in September 2006.
It said the most notable contribution of PEPFAR "has been to demonstrate that HIV/AIDS services, particularly treatment, can be rapidly scaled up in resources-constrained and otherwise severely challenged environments – something that many had doubted could be done."
The report criticizes requirements that 55 percent of funds be spent for therapeutic medical care and 20 percent for prevention, with a third of that on abstinence only programs. It said, "Congress should remove the budget allocations and replace them with more appropriate mechanisms that ensure accountability."
"Having the same budget allocation formula for 15 countries with very different kinds of epidemics is not useful," said Jaime Sepulveda, MD, the chair of the committee that conducted the evaluation and the former director of the National Institutes of Health of Mexico. "Having a one-size-fits-all kind of approach is not helping the countries to handle the resources for their local epidemic."
Ambassador Mark Dybul, MD, the openly gay administrator of PEPFAR, supported that approach in theory, but he said in an exclusive telephone interview that he has not found those restrictions to be overly burdensome. And in some instances they have been useful in overcoming bureaucratic inertia.
"Without some congressional directive saying you must move rapidly toward increasing treatment, I'm not sure we would have moved as quickly." Dybul pointed out that spending formulas apply to the overall program and not to individual countries, which retain flexibility to respond to their local epidemic.
The IOM report also faulted the requirement that PEPFAR may only purchase drugs that are approved by the FDA, which initially meant only brand name drugs and not less expensive generic alternatives.
Committee member Charles Carpenter, MD, head of the AIDS Center at Brown University in Providence, said that only 10 percent of the pharmaceuticals purchased by PEPFAR were generic in fiscal year 2005, though that did increase to 27 percent in the fiscal year that ended last September.
The report recommends that PEPFAR study accepting certification by the World Health Organization, a criteria used by most of the host countries, rather than FDA approval as the standard for eligibility for purchase.
Dybul agreed that the issue of FDA approval of generics initially was a problem, but he believes it largely has been resolved. "All individual HIV drugs and combinations are now available" for PEPFAR to purchase. That list includes 41 products, some of which were approved by the FDA within the last six months, after the IOM completed gathering information for the report.
"We probably have the best price in the world for Cipla's 3-in-1 product, I think we are at $92 a year," Dybul said. He was referring to a generic version of Atripla that the Indian pharmaceutical company produces under license. The US price for the same drug is about $14,000 a year.
