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No Black and White Answers
James K. Glassman, Tech Central Station, 1-10-05

In the struggle against AIDS in Africa, there is a growing dispute over whether or not generic copies of AIDS medicines are as safe and effective as the original brand name drugs on which they are based. On the one hand, there is the World Health Organization (WHO), the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and groups like Doctors Without Borders, which claim that the WHO approved generics are as safe and effective as any branded drugs used in wealthy countries.

On the other hand, there is a growing chorus of skepticism from groups like the Hudson Institute, the American Enterprise Institute, and others who note that, as James Glassman does here, “the WHO list [of approved drugs, including generic AIDS drugs] is maintained by a tiny staff with no facilities for testing, and the WHO does not warrant safety or effectiveness. Drugs that do not meet even these standards are now floating all over Africa, with no means of recall.”

The U.S has established a process at the FDA for fast tracking approval of combination generic AIDS drugs (in as little as six weeks) but to date “none of the copy drugs has been approved, and the FDA will not say if any have been submitted.” At the same time, “since June, 18 Indian-made ARVs that were once listed by WHO as pre-qualified for use in relief programs were removed by the United Nations agency or voluntarily by the manufacturers—Ranbaxy, Cipla and Hetero.”

This is not just an ivory tower dispute between academics over whose authorization counts: “a flood of untested generics…could lead to widespread misuse and eventually to drug resistance [in strains of the AIDS virus], eradicating years of progress.”

There is some additional reason for concern as well, since the UN is under tremendous pressure to fulfill its commitment to treat 3 million AIDS patients by 2005 – a goal that it will almost certainly miss. UN officials are also desperately eager to salvage its reputation after the massive oil-for-food scandal.

The underlying question is whether the UN is approving untested, and possibly dangerous generic drugs to salvage its own reputation. Perhaps it isn’t and these drugs will turn out to be every bit as safe and effective as claimed.

But it is disturbing that no one is asking hard questions and demanding clear answers.

After all, we can be sure that if an American company and the FDA had approved these drugs for use in Africa, and then suddenly withdrew them, there would be an international hue and cry.

Project FDA.
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