June 4, 2005
by Carol Adelman
Volume 365, Number 9475, June 4, 2005
Ensuring the safety of HIV/AIDS generics
I fully agree with Kevin Frost's concern that “much of the generics market-place operates outside rigorous governmental or agency review” and that “people with HIV, whether they live in developed or developing countries, have a fundamental right to know that the drugs they are taking are safe and effective” (Apr 9, p 1290). Frost cites my article “Deadly medicine” from the Wall Street Journal Europe as contesting the value of generics in treating AIDS patients. I have always approved of generic drugs. The problem with many of the drugs Frost discusses is that they are not generics. They are copy drugs that have not been tested against reference products and, in some cases, there is no reference product against which to test them.
I am completely in favour of the generic drug just approved by the US Food and Drug Administration (FDA). But Frost, like many, continues to misunderstand the issue. The FDA-approved AIDS drug is not the same drug that he cites. The FDA-approved drug is not by regulatory definition a “triple antiretroviral regimen” or a “triple combination therapy”. The drug is a co-packaged product, with a combined tablet containing zidovudine plus lamivudine and a separate single tablet of nevirapine. The co-packaging allows physicians to administer nevirapine when clinically indicated, or remove it when not. This FDA-approved drug is a true generic since it is based on a reference product, Combivir.
The main drug recommended by WHO in its 3 by 5 plan is a triple combination drug from India, combining in one tablet lamivudine, stavudine, and nevirapine—a combination that has never been adequately tested for safety and efficacy. Since many countries do not require drug regulatory authority approval for drugs they export, we have no way of knowing, other than by testing them on poor patients, whether they work and whether they are safe.
It is important that we understand the nomenclature of the antiretroviral drugs under discussion. If we fail to differentiate regimens clearly, then it is difficult to see how we can help those less familiar with regulatory issues. We should all be grateful to President Bush's Emergency Plan For AIDS Relief (PEPFAR). The directors of this US$15 billion AIDS effort are upholding the highest standards in AIDS treatment. They are by no means wasting money. Many of the proven safe and efficacious AIDS drugs they purchase are cheaper than the unproven copy drugs. PEPFAR has been steadfast to the principle of informed consent for all patients as well. It has sustained this policy despite the pressure by WHO and other activist groups to purchase the untested triple dose combination drug containing nevirapine—a drug known to have toxic side-effects.
Carol Adelman is a Senior Fellow at Hudson Institute and director of Hudson's Center for Global Prosperity. She served as a career foreign service officer for ten years and as an assistant administrator from 1988-1993 at the Agency for International Development (USAID).
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