Study 329: Transparency in Limbo at the British Medical Journal

David Healy, MD
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Leonie

Two weeks ago the BMJ ran an editorial by Richard Smith (former editor) and Fiona Godlee (current editor) on the retraction of a 1989 article by R K Chandra under the heading of A Major Failure of Scientific Governance.

While making money from the publication of pharmaceutical company trials, and in the face of a complete failure by industry to adhere to basic scientific norms and make data available, BMJ and other journals — although BMJ in particular — have run a series of articles on supposed Academic Fraud. These articles feature instances of fraud sometimes as bizarre as researcher claiming he cannot show the data as it was eaten by termites. A common theme, as with Chandra, is the academic community are held back from tackling the issue by fear the dude will sue. The universal feature is that these are academic studies, and academic fraud is an issue in academia. Talks on this topic are often given by representatives of pharma such as Frank Wells for the Association of the British Pharmaceutical Industry (ABPI).

A day after the editorial appeared, Leonie Fennell submitted a Rapid Response (RR) to the editorial that used several of the words of the editorial itself. This RR was posted. Then the response disappeared. A while later it was re-posted. This time it was there long enough for someone to like it and for the screenshot above to be taken. But establishing its reality by liking it was apparently not enough. It was removed again, and has not reappeared since.

This is a comment in limbo. Until recently many Irish believed that stillborn babies went to limbo and the vague promise their parents held on to was that their children would be saved on the Last Day.

In that spirit, here is Leonie’s comment:

“To err is human, to cover up is unforgivable, and to fail to learn is inexcusable.” I agree with both BMJ editors (past and present) on the latter, yet I still have some concerns. Surely if the BMJ had actually learned from this, it would have been more proactive with Study 329, where scientific fraud has so obviously once again prevailed. Is the BMJ, as David Healy suggests, terrified when publishing anything that might make a pharmaceutical company uncomfortable? It’s interesting that an earlier article regarding Study 329 was reviewed and turned down by the BMJ (reviewers included the former editor in chief, Richard Smith).

The findings of Study 329, that Paroxetine was ‘safe and effective for adolescents’ led to the widespread medicating of children with Selective Serotonin ReUptake Inhibitors, subsequently causing many deaths. Saying that universities, authorities and the world of science have a chance to learn from the Chandra case is all well and good, but what have the BMJ actually done to right this latest, very evident wrong? Brown University, GSK and Keller et al are digging their heels in. The BMJ needs to act now while there is still time to put its own house in order. ‘Good men doing nothing’ is just not good enough. The BMJ’s current reputation as one of the leading medical journals is at stake here.”

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3 COMMENTS

  1. Very interesting information indeed, thanks!

    A few thoughts:

    1. It is unnerving that the study 329 remain unregistered.

    2. 97 out of 136 (71%) of the paroxetine studies registered at ClinicalTrials.gov remain unpublished over five years after their completion date.

    3. ClinicalTrials.gov: paroxetine studies on childrens completed before Oct 2010: 14 studies:

    – Two (n=2) of these studies recruited exclusively children patients (NCT01376128 and NCT00074815)
    – One (n=1) study recruited children and adult patients.
    – The remaining eleven (n=11) studies recruited patients of all ages (childrens, adult, and seniors).
    – PubMed search: “The following terms were not found in PubMed: NCT00031317, NCT00025740, NCT01371435, NCT01371448, NCT01376128, NCT01371474, NCT00519012, NCT00100464, NCT00069225, NCT00009568, NCT00046553.”
    – Only three records (out of fourteen) were found on PubMed: 15 publications (NCT00074815, NCT00594269, NCT00012558)

    This study is also very interesting (no results & unpublished)

    Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)
    https://ClinicalTrials.gov/show/NCT01376128

    Reference

    Ramirez, Jorge H; Casañas, Marc (2014): Paroxetine: analysis of unpublished human studies (observationals and clinical trials). figshare. http://dx.doi.org/10.6084/m9.figshare.1103284

  2. Something that I always found as strange is that at university they drill into students that ghostwriting, plagiarizing, fraud, etc, are bad and may lead to the student being expelled, however in the ‘real world’ these things are standard business practice for Big Pharma, psychiatry, and medical journals.