Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, December 27, 2012

"Remarkable efficacy of Paxil" - Endorsed for Kids by the JAACAP




Okay, the JAACAP [Journal of the American Academy of Child and Adolescent Psychiatry] aren't exactly endorsing Paxil for kids but, in my opinion, they are doing the next best thing.

GlaxoSmithKline's... [Strike that]... Sally Laden's published study, in which eminent psychiatrists pretended they had wrote, Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial, has been the subject of much debate over the years. When it was flagged as being incorrect the pretend authors defended it. When it was proven to be incorrect the pretend authors went all quiet on us.

Now, we have a piece of literature purportedly written by the likes of Martin Keller, Neal Ryan and Karen Wagner to name but a few, that still causes controversy, this time from the publishers of the said piece, the Journal of the American Academy of Child and Adolescent Psychiatry.  I've Previously wrote about one of the more lesser known authors, Stan Kutcher. [Links at foot of post]





In a nutshell, the published study apparently proved that Paxil, taken by kids, showed remarkable efficacy. This has since been disproved and the paper has, through internal Glaxo documents, been shown to be written by none of the published authors/reviewers.

With all of this proof that has become available via litigation one would think that a journal, often used by prescribing physicians, would immediately retract such junk science. Not the Journal of the American Academy of Child and Adolescent Psychiatry though.

They have stood firm and allowed for it to be disseminated far and wide.

Many leading figures have called upon it to be retracted, Jon Juriedini being the most tenacious.

In July of this year, Juriedini wrote to the journal to point out Glaxo's record breaking $3billion settlement with the US Department of Justice. The study, more commonly known as Paxil 329, and the fact that it was mentioned in the lawsuit and shown to be ghostwritten and full of errors was mentioned in Juriedini's correspondence to them. They had previously declined to remove the study on numerous occasions. Maybe, just maybe, the fact that it had been implicated in illegal activities may have just swayed the JAACAP to retract it.

Not so.

The response to Juriedini from the journal editor, Dr. Andres Martin, was short and swift:


Thank you for your Letter to the Editor, submitted July 20, 2012, regarding Keller et al., 2001. Following the June 27, 2012 settlement between GlaxoSmithKline and the U.S. Department of Justice, 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.
Due to the nature of the concerns and serious consideration given to the situation, the evaluation process was quite lengthy, and we appreciate your patience while the editorial team conducted its review. The inquiry is considered complete, and as such, your letter will not be published in the Journal.

Not only is the journal refusing to retract fraud, they are now, it appears, refusing to publish any letters that mention the flaws in 329.

Way to go!

Here we have a moderator, editor, who is choosing to defend a decision and then disallowing any comment of criticism for the masses to make up their own minds.

Sieg Heil! for the journal and Glaxo but not so much of a victory for fully informed consent.

Boring Old Man blogger, Mickey Nardo, has covered the subject of 329 many times on his blog. Many of his posts can be viewed via, the lesson of Study 329: an unfinished symphony…

Meantime, if reading isn't your thing, a short half hour documentary aired by the BBC pretty much covers the whole 329 fraud. Video at foot of this post.

As for the fraudulent activities/studies/authors, the debate still continues and doctor's around the world possibly still use the piece when deciding to ignore the warnings [risk v benefit] and look at the published findings - in this instance, a study written by Glaxo and Sally Laden, a Scientific writer who wasn't even present during the clinical trials, given credibility by authors that are all well known in the field of child and adolescent psychiatry.

It's a study full of holes that not one single person wants to accept responsibility. I, myself, wrote to Glaxo CEO, Andrew Witty, earlier this year that, in essence, urged him to support the backing of the retraction of the study. You can see that letter here - he never replied.

Remarkable is a word that has never been more apt.






Stan Kutcher "Vote Paxil"

Newspaper Issues Apology to Canadian Politician Stan Kutcher

Why 'The Coast' Pulled the Stan Kutcher Article

Stan Kutcher's Followers Doing Him No Favours

Dalhousie University Stand By Their Stan











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