grown-up stuff…

Posted on Thursday 14 November 2013

This letter from the Juriedini/GSK communications posted in Doshi’s article in the last post [how that should work…] is an example of the central difficulty in believing GSK’s commitment to the AllTrials Project they so publicly embrace. In fact, it is deliberately misleading. The comment, "was subjected to peer review on three occasions prior to publication" is true. The first was when it was submitted to the Journal of the American Medical Association who turned it down after peer review [available October 1999 and here]. There’s nothing in those peer reviews that support the article that I can see. Then they planned to submit it to the American Journal of Psychiatry, but later abruptly changed to the Journal of the American Academy of Child and Adolescent Psychiatry [see the lesson of Study 329: the hurdles…]. There, there were several rounds of peer review August 2000, November 2000, and January 2001 all now available to read from subpoenaed documents, See if you find any favorable comments in the bunch. So the fact that it "was subjected to peer review on three occasions prior to publication" is nothing particularly germane. All articles are peer reviewed. It was accepted in spite of peer review. Any serious reader of this letter already knew that.

Likewise, their comments: "accurately reflects the honestly-held views of the clinical investigator authors" and "the JAACAP editorial board undertook a ‘comprehensive and extensive review’ and ‘found no basis for retraction’ or ‘other editorial action’" indicate no real engagement with Dr. Juriedini’s complaint, nor do they acknowledge the obvious point that SKB/GSK were the prime movers in both writing this article and shepherding it through the process of getting published. This is not good faith negotiating and is typical – responding with carefully crafted, strategically designed, lawyer vetted or written letters and releases that obfuscate rather than address the issues at hand. Last year, after the $3 B settlement, there was one from GSK’s lawyer in the Chronicle of Higher Education retracting everything they had just signed in the settlement [see the only enduring contract…]. It’s a great irony that they can try to retract their own settlement, but not this beyond dubious article. This is an ingenuous statement, "In light of the above, GSK does not believe it appropriate to request retraction of the article."

I think what Ben Goldacre and Iain Clamers have done for Data Transparency is an amazing accomplishment, but I have to agree with David Healy’s concern [GSK’s Transparency and Access Journey] that they are playing with fire to embrace GSK’s support of the AllTrials Project in its current form. The process outlined for Data Transparency being offered by GSK still feels like a Trojan Horse [the wisdom of the Dixie Chicks…, trojan horse or real reform? the jury’s still out…] – something that could ultimately undermine the whole effort. This letter is typical of the kind of wordplay one sees with adolescents who have just come into their ability to use argument and logic or recently graduated defense lawyers mounting their best defense in a courtroom, but the questions at hand are way too important to play with like teenagers or green defense lawyers. This is grown-up stuff, things that really matter.

Peter Doshi’s recent article is entitled  Putting GlaxoSmithKline to the test over paroxetine. That’s not actually the primary goal of the RIAT project – the point is correcting our stained literature. But he’s right, GSK is on trial. They and the pharmaceutical industry in general are being asked to take seriously and incorporate a genuine medical ethic into their own bottom line. If they can’t do that, BMJ editor Fiona Godlee is absolutely correct, they have an irreducible conflict [a sticky wicket…], and have no right to participate in the final evaluation and approval of the drugs that enter the market. "In her testimony before the UK Public Accounts Committee in the earlier post [goldacre and godlee… ], Dr. Fiona Godlee says [@15:55]":

"Unless we can find a solution to the commercial incompetence problem, we have to recognize that the pharmaceutical industry has an irreducible conflict of interest in relation to the way it represents its drugs, in science and in marketing. And unless we can resolve this in a way that is more in the public interest and in patients’ interest, I would argue that drug companies should not be allowed to evaluate their own products."

Update: Very encouraging!

  1.  
    Steve Lucas
    November 14, 2013 | 8:15 AM
     

    At this point people should be well aware, much like the maiden or frog, of what they are dealing with, and like that punch line: you know what pharma is when you read their material.

    Steve Lucas

  2.  
    November 14, 2013 | 1:54 PM
     

    Wait wait…wasn’t Study 329 denounced in the U.S. Justice Department action that resulted in GlaxoSmithKline LLC paying $3 billion in fines in 2012? http://healthland.time.com/2012/07/05/breaking-down-glaxosmithklines-billion-dollar-wrongdoing/

    How soon they forget.

  3.  
    November 14, 2013 | 3:10 PM
     

    What I find striking bout the correspondence is the lack of input from Witty himself. What is he afraid of? Whichever way he paints it [all part of an era] it’s still his dog turd, it still stinks. He’s merely throwing water of it to temporarily get rid of the flies… but flies will always return to shit, right?

    This isn’t the first time Witty has refused to engage about Paxil. – http://fiddaman.blogspot.co.uk/2013/11/wittys-era-still-smells-of-329-rotten.html

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