FDA Vioxx fiasco raises questions about AIDS drug approvals for developing world

AIDS Healthcare Foundation (AHF), today noted that the current "FDA fiasco" involving the agency's initial approval and subsequent recall of Merck's troubled arthritis drug, Vioxx, raises serious questions about the FDA's ongoing parallel role in the approval of generic AIDS drugs for widespread use in Africa and the developing world.

At present, the President's Emergency Plan for AIDS Relief (PEPFAR) which pays for, or provides AIDS drug treatments for patients in developing world countries stipulates that if cheaper generic drugs are to be used, they must be approved for 'bio-equivalency' to their branded drug counterpart by the FDA.

"This latest FDA fiasco underscores the need for a better method for drug approval to ensure the health and welfare of all patients-be they in Alabama or Africa, India or Indiana," said Michael Weinstein, AIDS Healthcare Foundation president. "Drug industry spin usually slants heavily toward the notion that 'branded equals safe,' yet this Vioxx recall and the removal of Rezulin from the market in 1997, remind us that any drug could have problems. Just as there are some dangerous branded drugs, there are also some excellent generics drugs. The issue is really one of developing a competent and respected testing and approval process that the public can truly trust."

The drug safety issue rose in Washington yesterday in testimony before a United States Senate Committee by Dr. David Graham, the FDA official who first blew the whistle on the approval and subsequent recall of Merck's Vioxx. The arthritis drug has been implicated in as many as 160,000 heart attacks and strokes in patients and has been removed from the marketplace. According to the Guardian newspaper, "Dr. Graham (also) identified GlaxoSmithKline's asthma drug, Serevent, AstraZeneca's cholesterol fighter Crestor, Pfizer's arthritis treatment Bextra, Roche's acne treatment Accutane and Abbott Laboratories weight-loss drug Meridia, as carrying possible risks."

In a similar arena, the World Health Organization last week de-listed several generic AIDS drugs manufactured by the Indian drug company, Ranbaxy from its list of WHO-approved 'essential medicines' over concerns for the drugs' bio-equivalency tests. At present, no problems have been found with the use of any of these cheaper generic medications; however, many drug industry lobbyists and officials who oppose the use of such cheaper generic HIV/AIDS drugs quickly capitalized on the WHO de-listing. Ranbaxy is expected to resubmit the required bio-equivalency testing data to WHO by January.

"After Vioxx and the flu vaccine debacle, why should we trust the FDA?" continued AHF's Weinstein. "Tens of thousands have died because of FDA malpractice, whereas not one single person has been shown to be harmed by AIDS generics. The assumption that expensive branded drugs are safer is a myth that is supported if not outright cultivated by the pharmaceutical industry and its cronies. Millions of people in developing areas are dying while U.S. regulators and politicians fuss over the fine points of the safety and efficacy of generic drugs, when Vioxx clearly shows the problem is more about the approval process itself. AHF currently has 13 treatment centers operating in poor countries worldwide; all told, these clinics provide life-saving generic HIV treatment to thousands and we have had no serious safety or efficacy problems to date. It's high time we fix the drug approval process for all drugs, both branded and generic, for use here and in the developing world."