FDA Panel OKs New AIDS Drug Access Activists Demands Met at Tense D.C. Meetings
BETHESDA, MD [September 4, 1989] — A new AIDS drug distribution program, long touted by AIDS activists, was given a shot in the arm recently when a Food and Drug Administration advisory panel agreed to support the plan, and to form a committee to implement it.
Meeting at a Bethesda, MD hotel Aug. 18 [1989], the Anti-Infective Drugs Advisory Committee of the FDA Center for Drug Evaluation and Research heard testimony and debated the merits and potential dangers of the program, known as parallel track, during a lengthy, often tense meeting.
Initially devised by AIDS activists, the parallel track would give people with AIDS who do not qualify for standard clinical drug trials access to experimental AIDS drugs. The treatments would be available on a broad scale after the drug's toxicity levels are established, but before its effectiveness is actually proven.
The testimony and discussion were marked alternately by cheers and hisses from the nearly 50 members of ACT UP/NY present. Eight hours later, the panel quietly approved the concept of the parallel track, without specifically defining it. The committee also recommended that the Department of Health and Human Services appoint a panel of Public Health Service representatives, AIDS patients and AIDS activists to implement the program.
Most, if not all of the items agreed upon by the panel were directly lifted from a consensus statement crafted by ACT UP and signed by 17 lesbian/gay activist and AIDS service groups.
Still, a myriad of questions remain about who would qualify for the parallel track; what kind of data would be collected from people taking the drugs; what legal precautions would need to be taken; and how the program would be financed.
The panel's motion for consensus on parallel track came almost immediately after Aldyn McKean of ACT UP stood up and vocally expressed the frustration of the audience. [...]
Jim Eigo of ACT UP/NY and Martin Delaney of San Francisco's Project Inform, two of several invited guests at the front table, took exception with the hypothesis put forth by drug companies that the program would deplete the pool of potential participants for standard drug trials[.]
"Trials are [only] under-enrolled when they're not designed with people in mind," stated Eigo.
[...]
The first drug being looked at for the parallel track is ddI, an experimental anti-HIV drug which will enter standard Phase II effectiveness trials in September. Drug manufacturer Bristol Myers has already announced that it will distribute the drug outside of clinical trials, although only to 5,000 people nationwide.
In Eigo's testimony, however, he claimed that the drug company has already received 40,000 requests for the drug.
Also at the meeting, a selfdescribed representative from the investment industry was heckled loudly when, after the heartfelt testimony of several people living with AIDS, he took the stand to tell the panel that his company is now telling their clients that good financial investments may be made in companies that manufacture HIV antibody tests.
"What about companies that manufacture tombstones?" shouted one ACT UP member.
Another highly charged moment in the meeting came when, closing the public testimony, [activist Larry] Kramer took the podium and loudly tongue-lashed the panel, opening With, "I am going to threaten you, and I'm not making jokes. What does it take to get this fucking country to take its thumb out of its ass?" Kramer shouted at the panel.
After listing a series of demands of the panel to an unusually and uncomfortably silent room, Kramer threatened the advisory panel that if they did not "approve these drugs now," AIDS patients would rise up, sabotage standard drug trials and copy promising therapies in underground laboratories.
"Revolutions don't occur when there is no hope," bellowed Kramer, "Revolutions occur when there is hope .... I beg of you, make fucking history."
— Cliff O'Neill, OutWeek Magazine No. 11, September 4, 1989, p. 14.
