Avoid Risky Products, AIDS Drugs ‘Buyers’ Clubs’ Told : Health: FDA also warns groups to accept physician supervision and stay clear of fraud. Activists say they are concerned and want to operate under guidelines.

The Food and Drug Administration Tuesday directed so-called AIDS drugs “buyers’ clubs” to conduct their activities under physician supervision and warned them against distributing potentially dangerous products.

Also, the FDA warned the clubs not to engage in excessive promotion or commercialization of their products that could constitute health fraud.

The guidelines, which have been under discussion between the FDA and the clubs for many months, were outlined in a letter sent to the nation’s 12 recognized AIDS “buyers’ clubs” from Dr. Randolph F. Wykoff, director of the FDA’s office of AIDS coordination.

The clubs have sprung up in recent years as AIDS activists became increasingly frustrated by the slow pace of federal drug approval. They have served as a source of both experimental drugs and approved drugs, which they sell at substantially lower-than-market prices to persons with AIDS and HIV infection.

Initially, the clubs were organized to import drugs from overseas that had not yet been approved here.

The clubs are illegal, but the FDA has thus far exercised a “hands-off” approach to their activities, choosing to monitor them, but not to shut them down.

Last summer, for example, the FDA determined that some clubs were distributing capsules of the antiviral drug DDC that varied in strength from the recommended dosage and alerted the clubs to the problem. They asked the clubs to halt sales until the situation was resolved and the clubs responded immediately.

“We’re concerned with many of the exact same things as the FDA,” said Sally Cooper, executive director of the Persons With AIDS Health Group, a New York-based buyers club. “We do extensive testing of all products that we get that aren’t from major pharmaceutical companies, and the vast majority of our patients are referred by physicians. We abide by most of these regulations, and most of the clubs are not for profit, unlike any drug company in this country.”

In its letter, the FDA stressed that the clubs must be able to document physician involvement in the dispensing of any AIDS drugs, approved or unapproved.

“We feel that the well-being of any patient is not served by not having a physician involved in that care,” Wykoff said.

The agency also warned against the potential of health fraud, which usually means an “unacceptable level of personal profit associated with the distribution of a product,” particularly an unproven treatment that could lure patients away from conventional therapy, Wykoff said.

While none of the AIDS clubs has been associated with such fraud, FDA’s concern is that other less scrupulous groups could call themselves “buyers’ clubs” and attempt to take advantage of the FDA’s current approach.

Finally, the letter stressed that clubs should not distribute products manufactured by unknown sources or under unknown manufacturing conditions.

“The clubs began by importing drugs available in other countries, and it was hard (for the FDA) to make the case that someone who was dying shouldn’t have access to these drugs,” Wykoff said. “What we are concerned about is seeing products made by bathtub chemists--that poses substantial risks, particularly for people with immune system problems.”

Derek Hodel, treatment issues director for the Washington-based AIDS Action Council and former executive director of the PWA Health Group, praised the FDA’s emphasis on protecting AIDS patients from fraud.

“We’re concerned about people with AIDS being taken advantage of in any way,” he said. “In so far as the FDA is able to prevent that, we would be very supportive.”

Martin Delaney, founding director of Project Inform, a San Francisco-based treatment information and advocacy group, said he would prefer that FDA officials “didn’t stick their noses” into the activities of the clubs. But he acknowledged that other groups could “take advantage of this special regulatory off-limits space afforded buyers’ clubs” by the FDA.

“The challenge is to continue to provide special treatment for people with life-threatening illness, without opening the flood-gates of fraud,” he said.