as it should be…

Posted on Sunday 16 June 2013

Last summer, the raw data for Paxil Study 329 appeared on the GSK web site. I had a go at analyzing it armed with Excel and 30+ year old memories of rudimentary statistics, but I got far enough to feel confident that what we’ve thought all along was, in fact, true. This study did not show Paxil to be efficacious in adolescent depression, and the adverse effects were way under-reported in the original article. I forwarded my findings [below] to the AACAP ethics committee, the incoming president, and the editor of the JAACAP as did others, but no action was taken. The fact that it was ghost-written, did not meet its primary outcomes, was deceitfully presented, reached erroneous conclusions, and has been universally villified were apparently insufficient reasons for retracting the article. Here’s my earlier series about Paxil Study 329:

The RIAT [Restoring Invisible and Abandoned Trials] proposal published last week in the British Journal of Psychiatry [“a bold remedy”…, the talk of the town…] suggests that studies like this one that have been discredited but not retracted should be republished from the raw data analyzed by neutral investigators. They call it "restorative publication." In the article by Doshi et al [Restoring invisible and abandoned trials: a call for people to publish the findings], there is a table of the clinical trials where their group already has the data available to reanalyze, and Paxil Study 329 is on that list.

The time for listing the reasons this Paxil Study needs to be retracted from our literature has long passed, as has speculation about why it hasn’t been. It simply stands as an anachronistic monument to a reckless and embarrassing time. In my last post [wordplay…] about the meanings of the words academic and scholarly, I said:
I was watching a youtube video of a BBC Panorama program about Paxil Study 329. They interviewed Dr. Mina Dulcan, the editor of the Journal of the American Academy of Child and Adolescent Psychiatry who had accepted the study over the objections of the peer reviewers. She first talked about the Journal’s classy ranking [@13:57]. Then, when asked if she had any regrets about publishing it [@14:58], she said, "Oh I don’t have any regrets about publishing at all. It generated all sorts of useful discussion, which is the purpose of a scholarly journal."
I should have included what Dr. Dulcan said about the Journal itself…
"We rank – and this is a world-wide ranking – we rank number one in child mental health and number two in pediatrics."
…as if that were relevant. Dr. Dulcan’s playing the prestige card is exemplary of the whole problem with these industry-manipulated studies that pepper our literature. The perpetrators, industry and authors, have used the time honored prestige of the sponsoring academic institutions to certify deceitful science – Joseph Biederman at Harvard, Martin Keller at Brown, Alan Schatzberg at Stanford, Charlie Nemeroff at Emory, Mina Dulcan at the Journal of the American Academy of Child and Adolescent Psychiatry. The list is shamefully long.

No journal editor or sponsoring organization, no matter how prestigious, should have the power to decide to leave something like this article reporting Paxil Study 329 that has been so thoroughly discredited in the scientific literature unchallenged, in perpetuity. No academic scholars who understood the responsibility of their respected positions would. But that’s exactly what has happened. So unless someone in the American Academy of Child and Adolescent Psychiatry comes to their senses and finally retracts the 2001 article [Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial], I would predict that Paxil Study 329 will be the very first candidate for the proposed "restorative publication."

That is as it should be…
    June 16, 2013 | 7:33 AM

    Agree absolutely. I reckon Study 329 should, by far and away, top of the list. It’s a notorious and profound example of corruption in the “academic” literature and, despite the extensive revelation of its fraud, the Journal’s refusal to retract makes it a great target to demonstrate our seriousness and intention to comprehensively correct the literature.

    June 16, 2013 | 10:11 AM

    Corruption in research is only part of the problem.
    Prescribing is the other.

    Assuming the corruption behind all of these studies became so mainstream that every psychiatrist knew the data was worthless, we would still have a problem.

    We would still have tens of thousands of psychiatrists whose living depends on prescribing worthless, dangerous drugs, including those who work with children.

    The studies are interesting.
    They serve as examples of how not to conduct business for MBA ethic classes.
    But the buck stops with the prescriber.


    June 16, 2013 | 10:16 AM

    Joanna Moncrieff, M.D. – The Myth of the Chemical Cure: The Politics of Psychiatric Drug Treatment –


    June 16, 2013 | 10:31 AM

    This approach may finally force the issue. A day of reckoning may finally be at hand.

    June 16, 2013 | 10:35 AM

    Thank you 1bom for all your good work. Take care.

    June 16, 2013 | 11:53 AM


    Child In Mind

    Wednesday, June 12, 2013

    Too many psychiatric diagnoses for children: an epidemic of labels

    “Allen Frances, professor of child psychiatry at Duke University and chair of the DSM IV(Diagnostic and Statistical Manual of Mental Disorders) task force hit the nail on the head in a recent commentary “Why So Many Epidemics of Childhood Mental Disorders?” in the Journal of Developmental and Behavioral Pediatrics. Because he makes his argument so clearly and persuasively (and the full article is only available to those who subscribe to the journal) I will quote it at length.”

    June 16, 2013 | 12:00 PM

    Was it the Lancet which published that horrendous vaccination/autism paper? Journals editors need to take some responsibility for that, and the medical community needs to acknowledge that some people are made ill by vaccinations.

    Perhaps Journals need to make it clear to their readers and especially the press, that one study doesn’t prove anything no matter how much it may or may not confirm an existing bias. We have to tell ourselves that a lot, I think. So much information, so little time.

    June 16, 2013 | 12:09 PM


    Real Psychiatry

    Sunday, June 9, 2013

    “I finally saw a copy of the DSM-5 today. It was sitting on a table at a course on the DSM put on by the Minnesota Psychiatric Society. The DSM-5 portion of the course was about 3 1/4 hours of lectures (98 information dense PowerPoint slides) by Jon Grant, MD. Dr. Grant explained that he was in a unique position to provide the information because he and Donald Black, MD had been asked by the American Psychiatric Association (APA) to write the DSM-5 Guidebook.”

    June 16, 2013 | 3:11 PM


    “We would still have tens of thousands of psychiatrists whose living depends on prescribing worthless, dangerous drugs, including those who work with children.” — Duane

    No, I don’t think so. It would just set the clock back maybe 45 or more years, in my opinion, before I ever heard the word “Psychopharmacologist”. That is as I remember it.

    The shrinks might once again have to have a dialogue with their patients.


    June 16, 2013 | 4:22 PM


    IMO, psychiatrists could begin to focus on the body – from the neck down – rather than assuming “mental” illness is always in the brain. The vast majority of time (notwithstanding traumatic brain injury, organic brain disorders) it is not.

    The ‘dialogue’ part can be done without medical school or a license to practice medicine. In other words, by counselors, therapists, clergy.


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