AIDS TREATMENT NEWS Issue #391, May 30, 2003
John S. James

Researchers are having continuing difficulties getting the drugs for trials of antiretrovirals in developing countries. Writer Jon Cohen outlined the problem in an article in the current SCIENCE magazine (May 26, 2003).

The U.S. National Institutes of Health conducts some drug trials in developing countries -- but will not pay for the drugs, which are normally donated by the manufacturer for U.S. trials leading to drug approval. But generally the drugs used in these developing-country trials have already been approved in the U.S., and companies have little incentive to donate them for these trials, which usually focus on operations research on how to best deliver treatment in developing countries. And for ethical reasons the U.S. insists that patients be offered continued treatment after the trial -- a disincentive for the manufacturers or anyone else to provide drugs. For various reasons the researchers often cannot or do not want to use lower-cost generic versions of the drugs.

Cohen quotes well-known AIDS researcher Bruce Walker, whose study in South Africa has been delayed for a year:

"Right now, there are plenty of groups like ours that are ready to treat people, and we can't get drugs... The absurdity of the situation is that 95% of HIV infections exist in countries where you have minimal experience giving the drugs...

"We're letting a lot of people die because we're saying [you must treat] forever. We have plenty of people who were dying who are now alive because they're on therapy. People would rather be alive and faced with having to figure out what they're going to do in three years than be dead."

Comment

These problems would never be tolerated if it were killing people in the U.S. and Europe instead of mostly in Africa.

In recent years a few activists have successfully demanded that the ethical standards that evolved in developed countries be applied without flexibility to research everywhere -- a policy some Africans called ethical imperialism. Now the consequences - - sometimes no research at all -- are here.

The consensus that researchers must offer continued treatment after a trial evolved in the context of testing experimental drugs -- on volunteers who took the risk of unknown side effects or of a drug that did not work, and had no control over whether they received the experimental drug or were randomly assigned to something else. The company hoping to benefit commercially from the research was expected to offer continued treatment to these volunteers either until the drug was approved (so patients could buy it if it helped them), or dropped from development (usually because the drug did not work or was unsafe). To morph this ethical standard onto operations research in developing countries -- with drugs already known to work and approved for routine use, with no pharmaceutical company standing to benefit, with no time limit on how long the researchers must plan to finance the drugs after the trial, and with much lower cost generics becoming available for continued treatment but not to the researchers -- is an absurdity never imagined when the consensus for continuing access to treatment developed.

The world must not stand by and let critically important research be halted because companies and governments evade responsibility, or because of the unthinking misuse of well- intentioned ideas.

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