July 16th 2008
Being mentioned in any capacity is flattering and as such I don’t wish to take issue with Mark Herrmann’s implication in his review of Alison Bass’s Side Effects that my interests are conflicted, particularly as I’m serially on record as saying that my contacts with drug companies and others have unquestionably biased me. I don’t mind Mr Herrmann noting that my testimony was thrown out in one case, or failing to note the judge in the same case noted that Pfizer’s sciences was “extreme and incredible. Pfizer’s view of the applicable ‘science’ is heavily slanted towards its self-interest”, or failing to mention that in all other cases the courts have taken a completely different view of my testimony.
But Mr Herrmann’s review is misleading on the facts. Two years before the “anecdotes” about suicidality on Prozac surfaced in 1990, all adult clinical trials combined pointed to a doubling of suicidal acts on novel antidepressants compared to placebo. This has remained the case for every year since then. Furthermore in their submissions of adult data to FDA in the late 1980s and early 1990s, the major companies miscoded the clinical trial data for suicides and suicidal acts in a manner that minimised the problem. It took the regulator over a decade to catch up, after which the companies resorted to other ruses to hide the problems. And to this day, although they have asked companies for all their trials, FDA still have neither all the adult trials, nor all the data, and possibly not much of a clue as to how they’ve been outmaneuvered. He also fails to mention that such data as FDA does have shows an increased risk of completed suicides and suicidal acts in adults.
It is possible that Mr Herrmann as a trial lawyer who has acted on behalf of pharmaceutical companies could have written a compelling piece on the many ways companies fool both regulators and academics like me, that Alison Bass’ book doesn’t touch upon. He might have acknowledged the key point in the book, namely that while the key data is hidden, in clear breach of the norms of science, conflicting interests become an issue. But I don’t understand why he only mentions men in his review, when the book is all about women who took on the system.
David Healy MD