Word: redux
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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 The problem, they say, is that after the drugs are withdrawn, serotonin levels plummet and stay low for weeks at least.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...
This potential danger, when combined with the generally acknowledged risk of pph, was enough to persuade the FDA advisory committee to reject Redux by a 5-to-3 vote on the question of safety when it first came up for consideration a year ago. But a few hours later, FDA official Dr. James Bilstad reopened the discussion after some committee members had left the meeting. Since there was no longer a quorum, a new meeting was called for two months later, in November...
When that time came, however, the anti-Redux forces were missing. The meeting had been scheduled--all too conveniently, they suggest--to coincide with an international neurosciences conference in San Diego. And at the second meeting, Redux won approval by a one-vote margin. That, along with the fact that Interneuron sent a high-profile member of its board of directors, Alexander Haig, to the November meeting in what was perceived as a high-pressure lobbying effort, led to charges that Redux was moved through improperly...
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...
...fact, there is more than one way to interpret the neurotoxicity research. For one thing, observes Wurtman, animals don't necessarily respond to drugs the way humans do. The toxic dose of Redux in a monkey is only twice the therapeutic dose, but the therapeutic dose in a monkey is much higher to start with--as much as 10 times that of a human. It's therefore highly unlikely, he says, that a human user would...