Wednesday, July 16, 2008
Book review in the Wall Street Journal -- The Plaintiff Was Unhappy, by Mark Herrmann (of Jones Day and the Drug & Device Blog; picture left). Herrman is critical of the new book, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, by Alison Bass (picture right). Here's an excerpt of Herrmann's review:
For Ms. Bass the judgment of researchers, together with their data and claims, are untrustworthy if they have received money from drug companies to finance clinical trials. She is particularly hard on a professor of psychiatry from Brown University who has defended Paxil. But if the drug companies didn't pay for such trials, who would? And why shouldn't companies seek advice from the best scientific minds and pay them for their efforts?
Most odd of all, Ms. Bass treats the FDA as a shill for 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: "That sprint came with a price tag. A flood of questionable drugs was unleashed on the market, many of which," like Vioxx, "would later have to be recalled."
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; Ms. Bass tells only one.