Monday, April 07, 2008

The Lingering Stain of Paxil Study 329

Neal Ryan has an editorial in this month's American Journal of Psychiatry. Dr. Ryan is a noted academic child psychiatrist who played a role in the infamous Paxil Study 329, which obfuscated its own findings that Paxil possessed little if any efficacy relative to a placebo and carried more risk than placebo in terms of suicidal thoughts/attempts, and aggressive behavior.

A summary of the excellent Panorama expose on the study included the following snippet:

Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329.

In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK.

He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.

In amongst the archive of emails in Malibu, Shelley was surprised to find that her own emails to Dr Ryan from 2002 asking questions about the safety of Seroxat had been forwarded to GSK asking for advice on how to respond to her.

She also found an email from a public relations executive working for GSK which said: "Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results.

"Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise."

But now Ryan has changed his tune. He writes in the latest American Journal of Psychiatry about a trial of fluoxetine (Prozac) in the treatment of children and adolescents with depression. In the piece, he begins with some background information:
Other, newer antidepressants have at most a single controlled trial showing efficacy in the treatment of major depression in youths, and thus far studies of several antidepressants have not shown statistical superiority to placebo in well-designed trials in this population
He cites one source (Bridge et al., 2007) in support of this statement. I checked his source and it is clear from the table (eTable 1 to be precise) in the source that the single trial showing superiority of drug over placebo is not the Paxil study he coauthored.

Ryan in 2001: Paroxetine is generally well-tolerated and effective for major depression in adolescents (p. 762). Yet he is now saying that antidepressants such as Paxil are not effective in treating depression.

Note that Dr. Ryan does not specifically retract his earlier claims about the efficacy of Paxil, but that his current statement does certainly contradict his prior writing about the wonders of Paxil. Well, to be fair, his statement from 2001 about the efficacy of paroxetine could very well have been ghostwritten, as we now know that the good majority of the paper was written by ghostwriters under the employ of GlaxoSmithKline.

And in the end of his current editorial, it is stated that:
Dr. Ryan has received research support from NIMH. He reports no other competing interests.
Did Dr. Ryan participate in Paxil Study 329 for free? I would guess that he indeed received funding from GSK for his efforts on the study, but perhaps I'm wrong. But that is actually a peripheral point.

The main point is that Ryan never disavowed the overstatement of efficacy or the minimization of risk that occurred in the published study report of Paxil 329 findings, yet now he pens an editorial in which he states that no antidepressants except Prozac possess any efficacy in treating child/adolescent depression. Either Paxil works or it does not work, and Dr. Ryan cannot have it both ways.

Still waiting for the first key opinion leader to admit frankly that the efficacy claims made in Paxil 329 were inaccurate...

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