Thousands of New Yorkers will have to go without an AIDS drug because underground supplies of the experimental drug ddC were found to be tainted or improperly prepared, AIDS activists said yesterday.
The federal Food and Drug Administration this week warned AIDS "buyers clubs" - which procure and distribute unapproved treatments to people infected with the AIDS virus - that they should stop selling the drug.
Some 6,000 people are now receiving the drug free, and legally, through a special research protocol run by the manufacturer, Hoffmann-LaRoche Inc. of Nutley, N.J.
But another estimated 10,000 people in the United States take ddC through underground buyers clubs, said Derek Hodel of the New York Buyers Group, which will no longer sell the drug. Thousands of New Yorkers will no longer be able to get the drug, he said.
"It's just a disaster," declared Hodel. The FDA tested underground supplies from New York City, San Francisco and Florida. Some samples, agency officials said, contained no ddC at all. Others were full of impurities or had dangerously excessive doses. The underground ddC is not made by Hoffmann-LaRoche; it is not known where the pills were manufactured.
Hodel blamed Hoffmann-LaRoche for the situation, saying there wouldn't be a ddC underground if the company would expand access to the experimental drug.
Company spokesman Paul Oestreicher said Hoffman-LaRoche has done everything possible to give people access to the drug. But he said that the guidelines for testing ddC, jointly designed by the company and the federal government, limit its use to patients who are not also taking AZT, a federally approved drug.
The real issue, Ostreicher said, is getting FDA approval to openly market the drug, taking it out of the experimental category and allowing broad legal use. The company applied for such approval last October. The FDA has given no indication of when it will rule on the request.
Most of the people who take ddC on the underground use it with AZT. Recent studies show the benefits of AZT are enhanced when taken with ddC.
Although the AIDS buyers clubs buy and distribute unapproved drugs, the FDA long ago decided it was better to work with them rather than to try to ban the clubs.
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