THE PLAINTIFF WAS UNHAPPY
July 18, 2008
Prozac, the antidepressant first introduced in 1987, has become a cautionary tale for the drug industry --of pharmaceutical success inspiring suspicion, controversy and backlash, says Mark Herrmann, a Chicago lawyer whose firm has defended drug manufacturers in product liability cases.
In a new book, "Side Effects," Alison Bass recasts the history of debate and analysis over the "hidden" effects of antidepressants as one of corporate greed.
Bass treats the Food and Drug Administration (FDA) as a shill for the "Big Pharma" industry -- despite its having thoroughly reviewed the suicide matter and required warnings on product labels where it saw fit:
- She makes the usual complaint that the FDA has reduced its time frame for approving new drugs, but she says not a word about how society suffers when the FDA approves new drugs too slowly, depriving patients of life-improving and life-saving medicines.
- Nor does she mention the studies showing that more rapid drug approval timelines in the European Union have not led to more drug-safety withdrawals.
There are two sides to this story, and Bass tells only one, says Herrmann. What Bass neglects to mention is a comprehensive analysis of more than two dozen studies, published in April 2007 by the Journal of the American Medical. The analysis found:
- For children and adolescents on antidepressants, the risk of suicidal thinking or behavior is smaller than previously thought.
- Antidepressants were more effective than placebos in treating children and teens for major depression and other disorders.
- A pooled analysis of nearly 100,000 patients conducted by the FDA in 2006 showed no increased suicidality for adults ages 25 to 64 taking antidepressants.
"Side Effects" is lively and well-written, but readers should be warned that only half the story has been told, says Herrmann.
Source: Mark Herrmann, "The Plaintiff Was Unhappy," Wall Street Journal, July 16, 2008; and Alison Bass, "Side Effects," Algonquin Books, June 2008.
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