Zantac Lawsuit


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

Saturday, April 30, 2011

Why 'The Coast' Pulled the Stan Kutcher Article



The Internet and social networking websites are awash with the controversial decision of the Canadian newspaper, 'The Coast', to retract and apologise for an article it printed and disseminated online on Thursday April 28.

According to an article posted on Scribed, Kutcher had demanded a retraction of the article that he claimed was "confusing opinion with science."

The article on Scribed writes:

Kutcher demanded a retraction and threatened to launch a defamation suit against the publication as a result of its inflammatory innuendo and the potential to damage his personal,professional and political reputation.

The Coast complied and removed the article.

The original article pointed out that Kutcher was a co-author of Efficacy of Paroxetine in the Treatment of Adolescent Major Depression:A Randomized, Controlled Trial, a trial that concluded that paroxetine [Paxil,Seroxat] provided evidence of the efficacy and safety of the SSRI, paroxetine, in the treatment of adolescent depression. Additional studies are called for to define the optimal length of therapy and dose of SSRIs in this population

In other words, the authors, of which Kutcher was one, agreed that paroxetine was safe for children and adolescents.

Kutcher also co-authored SAFETY OF PAROXETINE AND IMIPRAMINE IN THE TREATMENT OF ADOLESCENT DEPRESSION, the conclusion being :

The results of this study demonstrate the safety of paroxetine in the treatment of adolescent depression. Side effects were modest with paroxetine. Given the high rate of adverse cardiac events with imipramine, clinicians should carefully monitor cardiovascular functioning when treating depressed adolescents with imipramine.

Kutcher is quoted as saying that The Coast is confusing opinion with science. What science? Even the manufacturers of paroxetine, GlaxoSmithKline, have claimed that paroxetine is not recommended for children and adolescents. This from the GSK web page:

Paroxetine is not approved for the treatment of patients younger than 18 years of age. Please refer to the approved prescribing information for additional warnings and information.

This after misrepresenting information concerning the safety and efficacy of paroxetine for treating MDD in children and adolescents.

The following is from SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF NEW YORK

THE PEOPLE OF THE STATE OF NEW YORK, :
by ELIOT SPITZER, Attorney General of the State of New York, :

against

GLAXOSMITHKLINE, pIc.,
d/b/a/ GIaxoSmithKIine,
SMITHKLINE BEECHAM CORPORATION.

[PDF]


An internal GSK document from 1998 concluded that, in light of the mixed efficacy outcomes from study 329 and the entirely negative results of study 377, GSK's "target" was "[t]o effectively manage the dissemination of these data in order to minimise any potential negative commercial impact.


As part of its campaign to "manage the dissemination of these data," the document recommended that GSK prepare and cause the publication of a full artic]e on the on]y study with some favorable conclusions, study 329.

Thereafter, and in accordance with the recommended plan, an article that described and analyzed the results of study 329 was published in a professional journal. The authors of this article included two GSK employees who authored GSK's final clinical report for study 329.

The 329 study has recently been the subject of yet more controversy.

Jon Jureidini and Leemon McHenry have pointed out to the Journal of the American Academy of Child and Adolescent Psychiatry that the published evidence of fabrication, plagiarism and failure to disclose conflicts of interest on the part of its authors should deem that the original publication be retracted.

Unlike The Coast, the Journal of the American Academy of Child and Adolescent Psychiatry refused to retract the study finding that paroxetine was safe and effective in adolescents.

For more on Paxil 329 visit the Healthy Skepticism website and view the internal documents. Another great source is the book 'Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial' by Alison Bass.

Investigative journalist Evelyn Pringle has written 41 articles on Paxil HERE

If reading isn't your thing then sit back and watch the following video HERE







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