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: https://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. http://pn.psychiatryonline.org/cgi/content/full/39/6/2
GlaxoSmithKline’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.
Sen. 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.
References:
1. Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial
KELLER, MARTIN B.; RYAN, NEAL D.; STROBER, MICHAEL; KLEIN, RACHEL G.; KUTCHER, STAN P.; BIRMAHER, BORIS; HAGINO, OWEN R.; KOPLEWICZ, HAROLD; CARLSON, GABRIELLE A.; CLARKE, GREGORY N.; EMSLIE, GRAHAM J.; FEINBERG, DAVID; GELLER, BARBARA; KUSUMAKAR, VIVEK; PAPATHEODOROU, GEORGE; SACK, WILLIAM H.; SWEENEY, MICHAEL; WAGNER, KAREN DINEEN; WELLER, ELIZABETH B.; WINTERS, NANCY C.; OAKES, ROSEMARY; MCCAFFERTY, JAMES 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.
Posted by Vera Sharav
Dallas Morning News
Federal investigator could review UT researcher
Emily Ramshaw
May 08, 2009An influential U.S. senator has reported a University of Texas researcher’s financial relationship with a drug company to the top investigator at the U.S. Department of Health and Human Services.
Iowa Sen. Chuck Grassley, the ranking member of the Senate Finance Committee, sent a letter to the University of Texas System in September raising concerns that child pharmacology researcher Karen Wagner had not properly disclosed her financial connections with drug companies. He reported her in a letter to the Health and Human Services Office of the Inspector General on Tuesday, one addressed to UT System Chancellor Francisco Cigarroa.
The university system has not disciplined Wagner, who could not be reached for comment. But Vice Chancellor and General Counsel Barry Bergdorf said she has been under investigation for the last two weeks. Wagner will remain at work throughout the investigation, he said, and the UT Board of Regents has been notified.
"We’ve taken all reasonable steps and will continue to do so," Bergdorf said. The fact that Grassley made the report to the inspector general "is probably of concern to Dr. Wagner."Grassley’s research into doctor-drug company connections has helped spark a national debate over the influence big pharmaceutical companies wield in medical research. He has filed a federal bill to force drug companies to report gifts, travel and payments to doctors, legislation Texas lawmakers are considering – but appear unlikely to pass — on a state level.
According to Grassley’s research, GlaxoSmithKline paid Wagner, who is the director of child and adolescent psychiatry at the University of Texas Medical Branch in Galveston, more than $160,000 between 2000 and 2005. She only reported $600 to UTMB.
During two of those years, she worked on a major study on the company’s drug Paxil – research that has been widely criticized for over-promoting positive findings while downplaying heightened suicidal thoughts and behavior in adolescents.
UTMB didn’t require researchers to report outside income until 2002. But since 1995, the National Institutes of Health has required researchers who receive federal grants to keep financial disclosures on file with their universities. Wagner has received such grants, Grassley says, and as such, should’ve reported her income.
Grassley’s letter also includes several research proposals filled out by Wagner during those years where she said she had no financial interest in the drug companies she was working with.A woman who answered the phone at Wagner’s office said she was attending a conference and was not available to talk.
"I ask your continued cooperation in examining conflicts of interest," Grassley wrote. "Institutions across the United States must be able to rely on the representations of its faculty."