Aids victims in drugs lottery

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The Independent Online

Medical Correspondent

Thousands of American Aids patients are joining a lottery to decide who will get access to free experimental drugs before they are proven safe and effective in clinical trials.

The United States Food and Drug Administration (FDA) has approved a scheme which gives the drugs to some patients in the final stages of Aids for whom all other therapies have failed. British Aids activists have condemned the lottery as "inhuman" and say it will not be allowed here.

Under the scheme, more than 1,000 eligible Aids patients will be selected at random by an independent auditor, and the remainder placed on a waiting list for the drugs, known as protease inhibitors, an FDA spokesman said yesterday.

In the absence of any viable vaccine against HIV, the protease inhibitors which work by blocking a vital enzyme the virus needs to replicate, are viewed as the "last great hope", according to a spokesman for ACT-UP, an Aids activist group in New York.

The decision by manufacturers, Merck & Co. and Hoffman-La Roche, has been dismissed as a cynical marketing ploy designed to create publicity and demand for the drugs.

Negotiations are underway with Hoffman-La Roche to introduce a similar "expanded access" programme for its drug, Invirase, in Europe. Merck is also seeking 750 patients from outside the US to take its drug, Crixivan.

Robin Gorna of the Terence Higgins Trust which is involved in negotiations, said yesterday. "[Expanded access] is a good option for people in dire need who are not responding to AZT and whose CD4 [white blood cells] are falling. But it really is inhuman to give out the drugs in what is a lottery. British patients who get the drugs will have to meet strict criteria."