Another Psychiatrist Busted !

Texas Psychiatrist Karen Wagner Under Scrutiny

en. Charles Grassley’s focused investigation is clearly aimed at cleansing fraudulent, industry-crafted promotional pieces that have made a mockery of evidence-based clinical practice in psychiatry. Citing Dr. Wagner’s failure to disclose $160,000 she received from GlaxoSmithKline, Sen. Charles Grassley has requested the Inspector General of the Department of Health and Human Services to investigate the controversial University of Texas, psychiatrist, Karen Wagner MD, for failure to comply with federal regulations by failing disclose her income from drug manufacturers while receiving government grants. According to Sen. Grassley, Dr. Wagner disclosed $600.

Dr. Wagner co-authored the notorious, ghostwritten Paxil pediatric study #329, whose lead author, Martin Keller, MD, was replaced last month as chairman of psychiatry at Brown University. The Glaxo-paid authors of study #329 helped the company promote the myth that Paxil was “safe and effective” for use in children as early as 1998: in a poster presentation, Dr. Wagner claimed “The results of this study demonstrate the safety ofparoxetine in the treatment of adolescent depression. Side effects were modest with paroxetine.” [2] But internal Glaxo emails show the data from pediatric Paxil trials were negative.

In 2004 the Canadian Medical Association Journal published an Editorial citing an internal GSK document (1998) clearly acknowledging that GSK officials were aware that study #329 was negative.[3] See, GSK document at: http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg5.html

The published report of Study 329 misrepresented the research data. [1] The published report failed to state that Paxil showed no benefit for adolescents compared to placebo, but the data did show that adolescents taking Paxil had a significant increased risk of suicide:

Of 93 adolescents taking Paxil in the study, six had a suicide event (five attempted suicide), whereas one of the 89 adolescents on placebo had a suicide event (none attempted suicide). The suicide risk ratio for adolescents exposed to Paxil in Study 329 was six times greater than those on placebo.

laxoSmithKline’s failure to disclose the evidence led New York State to sue GlaxoSmithKline for fraud in 2004. Glaxo paid $14 million to settle the suit out of court, but none of the influential child psychiatrists funded by Glaxo who “authored” the published report were not held accountable.

Articles such as [1] and [2] referenced below, are representative of the entire pseudo-scientific pediatric literature governing clinical practice in psychiatry.

en. Charles Grassley’s focused investigation is clearly aimed at cleansing fraudulent, industry-crafted promotional pieces that have made a mockery of evidence-based clinical practice in psychiatry. Psychiatry’s reliance on corporate manipulated data and corporate largess has resulted in mostly harm-producing treatments passed off as “safe and effective.” Those millions of dollars that drug manufacturers dole out to psychiatry’s institutions and leadership are passed on to taxpayers who foot the bill of exorbitant priced psychotropic drugs.

How else can psychiatry explain the abysmal outcomes of patients within the U.S. mental health system whose life-span has been cut short by 25 years since psychiatry’s exclusive reliance on drugs?

These are the questions that the American Psychiatric Association needs to address but will NOT address at its annual meeting next week-end in San Francisco.

Posted by Vera Sharav from the Alliance for Human Research Protection

1.Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial P. Journal of Amer Academy of Child & Adolescent Psychiatry. 40(7):762-772, July 2001.
2. SAFETY OF P AROXETINE AND IMIPRAMINE IN THE TREATMENT OF ADOLESCENT DEPRESSION
Karen Dineen Wagner, M.D., Ph.D. I, Boris Birmaher, M.D.2, Gabrielle Carlson, M.D.3,Greg Clarke, Ph.D.4, Graham Emslie, M.D.5,Barbara Geller, M.D.6,Martin B. Keller, M.D.7, Rachel Klein, Ph.D., Stanley Kutcher, M.D. 9, George Papatheodorou, M.D.IO, Neal Ryan, M.D. II, Michael Strober, Ph.D.12, Elizabeth Weller, M.D.13
See: http://www.healthyskepticism.org/documents/documents/WagnerPoster.pdf
3. Drug company experts advised staff to withhold data about SSRI use in children. Editorial
Wayne Kondro. Canadian Medical Association Journal. 170 (5) March 2, 2004.