Before Prozac: The Troubled History of Mood Disorders in Psychiatry by Edward Shorter

Author:Edward Shorter
Language: eng
Format: mobi, pdf
Published: 2010-04-26T02:30:00+00:00

Epilogue

How did the first drug set do in terms of the NAS/NRC evaluation and the FDA's subsequent implementation? Not very well. We've already touched on the outcome of some of them, but let's review the results more closely.

Mephenesin, Frank Berger's baby, was toast. Launched in 1954, it was considered in 1968 by various panels to be "obsolete," of too brief duration, and "clinically ineffective." In a perfect world, there would have been curiosity about the mechanism of action of this drug that could give peace if only briefly to spastic twitching and tics. It was withdrawn in 1970.89

As for meprobamate, psychiatry's first blockbuster drug, the FDA had tried to sink it on the grounds of potential addictiveness in the 1966 hearings (Chapter 4), but the drug staggered on in appeals until, losing those, it was listed in 1970 as a controlled and dangerous substance subject to abuse. It made it through the DESI process with its wings further clipped. The evidence of its effectiveness in anxiety-tension was overwhelming. But all other indications (e.g., mood disorders) were removed from the label, which was also toned down.9° Meprobamate was rapidly losing ground to Librium and Valium anyway.

Methylphenidate (Ritalin), launched in 1955 as an antidepressant and then later the drug of choice for attention deficit hyperactivity disorder (ADHD), was scratched as an antidepressant, though evidence in favor of that indication was impressive. It remained on the market for narcolepsy and hyperactivity in children.91

Iproniazid (Marsilid), launched in 1957 as the first of the inhibitors of monoamine oxidase, had already been withdrawn by the time of DESI, in what was probably an unbalanced weighing of its risk of liver toxicity versus its benefit. It was a highly effective antidepressant in some ill-defined subpopulation. Among the later MAOIs, the psychiatry panel found nialamide (Pfizer's Niamid), launched in 1959, "possibly effective" for depression and everything else; it was withdrawn in 1974.9k Phenelzine (Warner-Chilcott's Nardil), also approved in 1959, made it through the DESI process more or less intact, though it got a prominent warning about hypertensive crises (the "cheese effect") that would have scared many prescribers away.93 It's still on the market today.

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