1 Boring Old Man

Journal Refuses To Retract Controversial Paxil Study
Pharmalot
By Ed Silverman
January 9th, 2013

^{Last summer, GlaxoSmithKline agreed to plead guilty and pay $3 billion to resolve criminal and civil charges in connection with off-label promotion of several drugs, failing to report safety data and reporting false prices. One infraction, in particular, concerned a controversial study that was conducted for the Paxil antidepressant. Specifically, the feds noted the drugmaker participated in preparing, publishing and distributing what was called a “misleading medical journal article” because the results misreported that a Paxil clinical trial demonstrated efficacy in treating depression in patients under age 18, when the study failed to demonstrate efficacy. The trial, known as Study 329, missed its endpoints [here is the study]…}

^{Just the same, the Journal of the American Academy of Child and Adolescent Psychiatry had repeatedly refused to issue a retraction. After the settlement with Glaxo, however, several detractors hoped this presented a fresh opportunity to convince the journal to issue a retraction. As it turns out, the journal has again declined to do so, according to an e-mail exchange with an academic who has previously pushed for retraction.}

^{In a Dec. 21, 2012, e-mail, AACAP editor-in-chief and Yale University psychiatry professor Andres Martin wrote that the “journal’s editorial team undertook a thorough evaluation of the article, the legal settlement and related materials. The authors of the article were contacted and asked to respond to the questions and concerns raised by the settlement. “After a comprehensive and extensive review, the journal editors found no basis for retraction or other editorial action,” he wrote about what he called a “lengthy” review. His e-mail was addressed to Jon Jureidini, a psychiatry professor at the University of Adelaide in Australia…}

^{In this case, the interpretation of the data seems unreasonable, but the data itself appears to be correctly listed for anyone who cares to examine it for themselves. As such, I’m not completely convinced this rises to the level of a retraction, which is usually reserved for papers in which data has been fabricated…}

^{No misrepresentation of data, just a lot of unseemly spin. In my experience that’s pretty normal in science publications ranging from physics to medicine. What is lacking to meet the usual criteria for retraction is fabricated data…}

^{… just a lot of unseemly spin.}

^{… that’s pretty normal in science publications ranging from physics to medicine.}

I obviously think of the article in question, Paxil Study 329, as residing well outside the domain of spin and solidly placed in the land of crime – worthy of retraction a long time ago. It’s still in need of retraction both as a symbol and because it makes the recommendation that is as dangerous today as it was the day it was published. But people like me don’t get to decide such things for obvious reasons. I’m biased by personal experience. I’ve prescribed SSRIs to adolescents and have seen little in the way of efficacy, and several cases of the potentially lethal side effect that Paxil Study 329 denies. But I don’t have a double blind placebo controlled clinical trial of my own to back up what I say – just my own eyes. So in a voir dire, I’d be struck from the jury.

But in the case of this article, there’s something else, a time honored compass to use in this murky swamp of spin. This article has been to court, over and over. Eliot Spitzer took it to court in 2004 in New York and won his case. More to the point, this article was a major exhibit in the case the DOJ brought against GSK recently, and GSK settled, admitting to all charges – paying "$3 billion to resolve criminal and civil charges in connection with off-label promotion of several drugs." So by the only non-negotiable standard we have, our court system, Paxil Study 329 was party to a crime. We’ve all watched enough episodes of Law and Order and The Closer to know that the driver of the get-away car in a bank robbery where the teller was killed is guilty of murder. So in the case of Paxil Study 329, it has been duly declared to be a crime.

We haven’t heard from JAACAP Editor, Dr. Andres Martin, about how he decided not to retract this article. We can make some guesses about what he might say, but he’s as biased as I am. He doesn’t want his journal or the previous editor embarrassed. He’s under pressure from the authors who occupy key positions in the American Academy of Child and Adolescent Psychiatry, the mother organization of his Journal. But what he says doesn’t really matter any more. Paxil Study 329 was not only deceitful, that deceit was part of a crime – guilty of criminal intent. In the parlance of science, the null hypothesis was rejected with a p value of "beyond reasonable doubt" – actually even more than that, because guilt was admitted by the perpetrator.