DOI: 10.1097/01.COT.0000285921.04692.77
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Issn Print: 0276-2234
Publication Date: 2002/05/01
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Excerpt
“The responsibilities of the chairman as well as those of general committee members carry pretty high stakes, but I think we did some good things,” he said in an interview. “I saw my primary job as patient advocate—to get good stuff [new therapeutic agents] for people suffering from cancer—and we did that.”
Stacy I. Nerenstone, MD, is the current ODAC Chair (until the end of next month).
“I've been impressed by how seriously the committee members take their jobs. There's a lot of work beforehand—hours of reading—but everyone always comes to the meeting prepared, said Dr. Nerenstone, Associate Clinical Professor at Oncology Associates of the Helen and Harry Gray Cancer Center in Hartford, CT.
When asked about the processes ODAC uses to come to a decision about recommending new agents, Dr. Schiffer responded, “What you see is pretty much what it is.” He was referring to the two full days that the 15 or so ODAC members and guest experts (including two consumer representatives) sit at a big table in a less-than-elegant hotel in Bethesda, MD, with FDA reviewers and administrators—in front of members of the media and the public, recorded by three or four video cameras—and hash out the implications of recommending for approval the various drugs presented to them by commercial sponsors: pharmaceutical companies.
“Things are pretty straightforward,” said Janice P. Dutcher, MD, Professor of Medicine at New York Medical College and Associate Director for Clinical Affairs at Our Lady of Mercy Cancer Center in Bronx, NY, who was ODAC Chairman from 1996 to 1999.
“What we were there to discuss was whether the drug had a definite clinical benefit—which didn't necessarily have to be survival,” she said. “That was our job and that's what we did. I felt, and I think a lot of the other members agreed, that if there was any kind of benefit at all, we should recommend approval, as long as the toxicity wasn't prohibitive. We thought that it was a good thing to get the drugs out there and let the marketing people worry about whether anyone would actually use them. Oncologists, like everyone else, vote with their feet.”
Dr. Schiffer noted that the tendency to recommend approval has increased since he was chairman. “Things have gotten kind of loose,” he said.
