Newsday - April 22, 1992
Laurie Garret
Faced with weak, often contradictory data, an advisory panel of the Food and Drug Administration voted yesterday to reject the sole use of the drug ddC to fight AIDS, but approved its use in combination with AZT.
The decision split the AIDS activist community, left doctors confused about the treatment options, pleased the FDA and left the drug's manufacturer, Hoffmann-LaRoche of Nutley, N.J., stunned. FDA Commissioner Dr. David Kessler is expected to follow the recommendation of the AIDS Advisory Panel, possibly licensing the drug within three months.
Kessler said he was pleased by the action of the panel, which made ddC the first drug backed under the agency's new accelerated approval program. Rules for the program went into the Federal Register six days ago, having been formulated by Kessler's office and Vice President Dan Quayle's Council on Competitiveness as a move to streamline drug approval and reduce pharmaceutical company research and development costs.
"The agency certainly is committed to accelerating the approval of drugs when warranted," Kessler said in an interview. "If there ever were a case to be made for accelerated approval," Kessler continued, "this is the one."
But Kessler's enthusiasm was not universally echoed. Attorney David Barr, of Gay Men's Health Crisis in Manhattan, said he takes ddC in combination with AZT, having obtained the drug through AIDS buyers' clubs. He sat through both days of hearings and found Hoffmann-LaRoche's ddC studies so poor that he is considering dropping ddC.
"I think it's clearly a big deal to the Bush administration," Barr said. "Now, in an election year, Bush will be able to say two AIDS drugs were approved within six months of each other on his watch. Kessler basically said to the panel, `We don't care what the data says, approve the drug,' " Barr charged.
The problem facing the AIDS advisory panel, made up of 11 non-FDA scientists, doctors and consumer representatives, was staggering. On the one hand, AIDS patients and their physicians were clamoring for a third AIDS drug - something people could take when the side effects of the two FDA-approved anti-viral drugs, ddI (dideoxyinosine) and AZT, become intolerable or the drugs are rendered useless by viral resistance.
On the other hand, the data presented in support of ddC (dideoxycytidine) were extremely limited, having been based on small numbers of patients who generally only took the drug for short periods. The panel was presented with the results of four studies in which ddC was used by itself, and patients were compared with those who used AZT alone.
No study showed clear clinical benefit from ddC use, in terms of symptoms, secondary infections or survival. All studies showed the drug was toxic, causing nerve damage of the limbs, known as peripheral neuropathy, of various degrees of severity in upwards of a third of the ddC patients, FDA analyst Dr. Steven Gitterman said.
The panel voted 8-2 with one abstention against approving ddC as an AIDS drug to be taken by itself.
In contrast, the majority of panel members said some other studies indicated the possibility the drug worked with AZT. So in an 8-3 vote, they backed the combination.
Hoffmann-LaRoche representative Paul Oestreicher said the split decision was "unexpected" and said the company felt strongly that "the totality of evidence supports ddC use as a single therapy."
AIDS activists split, with some backing the company's position and others condemning the company's research. Some panel members said they felt pressure to approve ddC for something. Once a drug is approved for any use, doctors can legally prescribe it for a multitude of purposes, including the monotherapy that was rejected by the panel.
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