Haste makes waste

"Haste makes waste" Continued...

Issue: "UN's abuse of power," July 24, 2004

U.S. stubbornness over quality received some vindication in late May, when the WHO yanked from its list two AIDS drugs it had previously recommended. WHO officials admitted that the drugs, often used in poor countries, were not chemically identical to their branded counterparts. "This admirable public acknowledgment cannot but raise questions on the acceptability of this process as a whole," said Bernard Van de Wal, an associate professor of medicine at Stellenbosch University in South Africa.

Besides initial quality, administration officials also worry about the long-term potential for increased bodily resistance to combination drugs. In U.S. treatment programs, for instance, about half the patients are already showing resistance to one or more of the drugs in their cocktail, and 10 percent are resistant to all three classes of drugs available. If those sorts of figures took hold in Africa, where some 28 million have the AIDS virus, that would render current treatments ineffective within 10 years.

The generic drug of choice among AIDS activists boosts the potential for such resistance levels, according to critics. Manufactured in India under the names Triomune and Triviro, the drug is a combination of three AIDS medications that are patented separately, but not in combination, by different Western drug makers. Triomune performed well in a study conducted by Doctors Without Borders, and comes with an attractive price tag: Its Indian manufacturer reportedly promised the Clinton Foundation they could provide a year's worth for just $140 -- half the cost of other combination drugs.

But research has shown that taken separately, the body absorbs and expels the three drugs in Triomune/Triviro at different rates. One of the three, Nevirapine, stops working after one to seven days, while the other two wear off after a few hours. Without the ability to dose separately, a patient would end up on Nevirapine only instead of all three drugs necessary. And with only one drug to fight the disease in those gap hours before the next dose, the AIDS virus can more easily mutate and become resistant to Nevirapine.

That would be a disaster in developing countries, where patients can ill afford even the cheapest generics, much less the far more expensive "second-line" drugs given to patients who've developed resistance to their initial prescription.

With the U.S. government taking a go-slow approach, the WHO is determined to press ahead on its own with medications for 3 million patients by next year -- a noble but risky goal, some experts say.

"Unfortunately, the truth today is that no single way of using anti-retroviral treatment in Africa has been validated to be the best approach in all the different parts of Africa, in different subpopulations, clinical settings and against different viral strains," says Dr. Robert Redfield, co-founder of the Institute of Human Virology in Baltimore. "This is why rather than try to treat 3 million people by 2005 by a single approach, I would rather encourage us to treat 10,000 people, 300 different ways and learn what works best."

Slowly but surely, some governments seem to be learning that caving in to public pressure is certainly not what works best. On July 13, South African officials announced the public-health service would no longer distribute Nevirapine as a stand-alone drug. (It will still be used as part of a drug cocktail.) The reason: A new study shows pregnant women who take Nevirapine develop increased resistance to the drug in subsequent pregnancies.

The country's most powerful AIDS organization immediately criticized the ban. "We think that it would be wrong of the government to simply withdraw Nevirapine," said Mark Heywood, a spokesman for the Treatment Action Campaign. "What the government needs to do is to introduce, as soon as possible, access to double drug regimens or triple drug regimens for pregnant women."

But the government is unlikely to be moved by TAC's cries. It was activist groups like TAC, after all, that went to court in 2002 to force the immediate distribution of Nevirapine despite the reservations of medical experts. Two years later the experts are vindicated and the activists discredited.

No word whether the protesters in Bangkok got that memo, either.


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