On December 13, 2006, the FDA’s Psychopharmacologic Drugs Advisory Committee will hold a public hearing to review the suicidality data from the adult selective serotonin reuptake inhibitor (SSRI) studies.
And, for what seems like the umpteenth time, SSRI experts from all over the US, and as far away as the UK, will travel to Washington to once again testify at yet another hearing on the suicide risks associated with these drugs.
The committee is expected to vote on whether the risk of SSRI-induced suicidality in adults should be included in a Black Box warning on all SSRI labels, including Paxil, Prozac, Zoloft, Lexapro, and Celexa.
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I read through Pringle’s article and I’ll start with the things I liked…
The information from Healy, in my view, is as good as it gets. Yes, the FDA released their findings on suicide and SSRI’s yesterday, but I’d trust Healy’s numbers over the FDA’s any day of the week. Healy, unlike many other data analysts, excluded suicide attempts made during placebo washout periods (i.e., everyone was receiving placebo at the time), because during these occasions, there was nobody taking the antidepressant drug to which the placebo was being compared. Perhaps the FDA did so in their most recent analysis as well; I don’t know.
Pringle discussed that Healy points out that much of the psychiatric litter-ature, er, literature, has been ghostwritten. Thus, he argues that such work should be labeled as drug advertising and regulated by the FDA. I think there is much merit to his argument. Drug company X hires medical communication company Y, which then cranks out a friendly review article for drug company X’s product. Then, academic author A, who receives a good chunk of change from drug company X, sticks his or her name in the author line, and POOF, the article appears to be written by an independent academic author. Just ask Siegfried Kasper. Healy is absolutely correct that this is not science; it’s stealth marketing.
One comment by Allen Jones, who helped blow the whistle on the Pennsylvania government’s unsavory relationship with drug companies, really summed it all up nicely: “Academic researchers with industry ties put favorable spin on dubious clinical trial results and then the embellished results are presented to FDA Advisory Boards peopled with Pharma consultants, grantees, and advisors.”
Here’s what I do not like about Pringle’s writing. Her own conflict of interest seems rather blatant. It reads like an advertisement for the Baum Hedlund law firm, specifically for attorney Karen Barth-Menzies. I’m not saying that some individuals do not have legitimate legal concerns, but it seems to me that Pringle has some sort of relationship with this law firm and that the firm gets good play in her stories as a result. I’ve written about this concern previously on my site.
In addition, while true that a JAMA study in 2005 found no change in suicidal ideation, gestures, and attempts as treatment with SSRIs increased, the most important variable is completed suicides. So I think citing this in her article was a bit of a red herring. The epidemiological evidence on the topic is a mess, with data supporting all sorts of conclusions depending on how the data are examined and which data are included. However, the clinical trials data discussed by Healy is actually quite clear -- SSRIs relate to more suicides than placebo by a large margin.
If my long blathering in this comment failed to satisfy your appetite on this issue, feel free to visit my site (pardon the self-promotion) for further discussion on many of these matters. David Healy's site is also a treasure trove on the topic.
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