Fed up with years of FDA foot dragging, relatives of Alzheimer's patients are launching a "buyers' club" to distribute unapproved drugs for the disease. Taking their cue from several dozen buyers' clubs that import large quantities of experimental drugs for sale to AIDS patients, the new club's organizers plan to sell THA, the promising Alzheimer's drug that the FDA has refused to approve. (See "Unequal Treatments," April.)
Although FDA regulations allow patients to import only small amounts of unapproved drugs for personal use, the agency has turned a blind eye to the AIDS buyers' clubs. But the Alzheimer's buyers' club is likely to attract more attention, partly because of the enormous potential market for unapproved Alzheimer's drugs: Between 4 million and 5 million Americans have Alzheimer's. Some 200,000 new cases are diagnosed every year—more than the total number of AIDS cases in the country.
Unlike the AIDS buyers' clubs, which resemble shops, the Alzheimer's buyers' club will be a moving target. Customers will mail their orders to an address outside the United States. Saul Kent, president of the Florida-based Life Extension Foundation, which is helping to promote the club, won't say whether that address will be the point of distribution for the drugs.
"Just let the FDA try to figure that out," he says. "They're going to have a very hard time tracking these people down."
A newsletter, The Caregiver, will advertise the club and provide its foreign mailing address. Like the drug shipments, the newsletter will seem to come out of nowhere, unnumbered and with no return address. Until now, relatives have had to smuggle THA in from abroad at great personal expense and risk.
"These are just ordinary, older, conservative Americans," says Kent. "When you cause people like that to become radical, they become more radical than the young people."
This article originally appeared in print under the headline "Traveling Pharmacy".