In an action aimed at pressuring the U.S. Food and Drug Administration to release promising drugs for life-threatening illnesses, a group of AIDS patients and their doctors in New York announced Monday that they have set up a nationwide network to import prescription drugs not yet approved for use in this country.
The new program was unveiled at a press conference by the People With AIDS Health Group, a “buyer’s club” that has helped obtain non-prescription, over-the-counter medications for thousands of clients since its formation two years ago.
A network of overseas doctors and suppliers will take part in the program, which was designed in consultation with lawyers familiar with FDA guidelines permitting individuals to import prescription as well as non-prescription drugs for personal use.
“Unless and until the over-protective stance of the FDA is relaxed, and until the U.S. government views AIDS as a health emergency requiring rapid drug development and approval, we doctors will feel compelled to direct our patients to foreign sources of drugs we feel have been proven safe and effective,” said Dr. Peter Seitzman, a private physician with a large AIDS practice.
The FDA appeared to be taking a wait-and-see attitude Monday.
“Our personal-use policy is for individuals, not organizations,” said Brad Stone, an agency spokesman. “I imagine that if we are not contacted by (the group) in the next few days, we will make some efforts to contact them” to obtain details of the program.
‘Act as Middlemen’
Stone said whether the drugs are prescription or non-prescription was not of great importance. “Our primary concern is to avoid having drugs come in by the truckload,” he added.
Under the new program, patients who want to receive the drugs will be required to present prescriptions or letters from their personal physicians confirming that they are being supervised. “We’ll simply act as middlemen,” relaying orders to foreign sources, said Michael Callen, a founder of the group.
The new treatment program was endorsed by a wide range of gay and AIDS organizations, including Gay Men’s Health Crisis, New York Physicians for Human Rights, ACT UP, Lambda Legal Defense and Education Fund, National Gay and Lesbian Task Force and the Community Research Initiative.
Martin Delaney, co-founder of Project Inform, a clearinghouse for AIDS treatment information, endorsed the group’s goals but questioned the wisdom of calling a press conference to publicize the new program. “My preference would have been to keep this on an underground level,” he said. “It doesn’t help matters to wave a red flag.”
One of the primary drugs the group will help patients obtain is fluconazole, an anti-fungal drug made by Pfizer that is now available by prescription in England, France, Denmark and Ireland, and is believed to be close to approval by the FDA. The drug has shown promise in treating cryptococcal meningitis, an often fatal opportunistic infection that attacks between 10% and 15% of AIDS patients and is believed to be far less toxic than the treatment for this condition available now.
AIDS patient advocates acknowledged importation of such drugs would only benefit the wealthiest patients. Fluconazole, administered as a maintenance treatment, costs about $800 a month.
“Reimbursement from insurance companies for unapproved drugs is out of the question,” Seitzman said. “We hope our program will serve to embarrass the FDA,” which oversees the lengthiest drug approval process in the world.
Other drugs that will be made available through the program are ribavirin and isoprinisine, which are already available to AIDS patients through the mail from Mexican pharmacies.