Word: seiden
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Dates: during 1990-1999
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...also be effective in preventing heart disease and breast cancer in older women. Clinical trials of the drug's ability to stave off heart attacks begins in May, with testing of the impact on breast cancer to start later this year. The implications could be huge for Lilly. Carl Seiden, an analyst who follows the drug industry for J.P. Morgan Securities, says sales of Evista as an osteoporosis remedy alone could approach $2 billion...
...What Seiden and others claim is that the FDA glossed over evidence that both Redux and the older drug fenfluramine cause significant brain damage in laboratory animals, from mice to baboons. The problem, they say, is that after the drugs are withdrawn, serotonin levels plummet and stay low for weeks at least. The effect is similar to one caused by the recreational drug Ecstasy, a distant chemical cousin of the fenfluramine family, and the cause is evidently the same: neurotoxicity, or more plainly, the killing of brain cells. An overdose of Redux makes the neurons that produce serotonin swell, then...
Then Interneuron went after and got FDA approval--a ruling that critics charge was made with unseemly--and perhaps even unprofessional--haste. Says Lewis Seiden, a University of Chicago pharmacologist who testified before the FDA advisory committee: "The procedures were loose, to be mild about...
Hence the November meeting. Bilstad acknowledges that the schedule conflicted with the San Diego neurosciences conference. But since Seiden and other Redux opponents had thoroughly aired their views in September and had no new findings, Bilstad decided to go ahead. Says he: "We weighed the idea of putting off the decision for several months, until those experts could be there. Since the committee had heard their presentations before and were given transcripts, we decided that we had the benefit of their comments on the issues. It was a judgment call...
...advisory committee's recommendation wasn't legally binding on FDA Commissioner David Kessler. Last December 22 neuroscientists, including Seiden and Dr. George Ricaurte of Johns Hopkins, asked the FDA to "forgo a final decision on dexfenfluramine until more information is available on its serotonin-neurotoxic potential in humans." Nevertheless, Kessler gave the go-ahead for Redux last spring...