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Saturday, June 05, 2010

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician


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BACK STORIES

PART I

PART II

Part III of this series shows how GlaxoSmithKline are using the services of an expert statistician in the up and coming UK Seroxat Group Action.

It's a name that took me by surprise and one that has been mentioned throughout blog land on numerous occasions. The name of the witness is synonymous with names such as Joseph Biederman, David Dunner, Graham Emslie, Daniel Geller, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer and Karen Wagner.

Most of the above played a major role in the ghost written articles regarding the safety and efficacy of Paxil [Seroxat] in children.

It would appear that his views on SSRi use for children remains positive, despite much evidence to the contrary.

Step up to the witness box, Dr. Robert Gibbons, Glaxo's expert statistician they will be using in the up and coming UK Seroxat Group Action.

Gibbons pretty much wrote his own destiny when he was the co-author of a study that appeared in the American Journal of Psychiatry in 2007

Gibbons co-authored study claimed there was a correlation between a 22% decrease in SSRI prescriptions and a 14% increase in youth suicide rates between 2003 and 2004, after warnings were issued by the FDA. However, the study was criticised by many.

Respected British Columbia researcher, Jon Jureidini, said the Gibbons study "incorrectly analyzed the relationship between U.S. selective serotonin reuptake inhibitor (SSRI) prescription rates and suicide rates among children."

"As it turns out," Dr Jureidini wrote, "preliminary figures are now available from the Centers for Disease Control (CDC), which show that fewer people under age 25 committed suicide in 2005 (when prescribing did decrease) than in 2004."

"In the year in which suicide rates rose sharply," he said, "there was no significant drop in SSRI prescribing."

Despite his critics, Gibbons said at a 2009 Medscape Continuing Medical Education seminar, sponsored by Lexapro and Celexa maker, Forest Labs, "we have seen in 2004 and 2005, the years for which CDC [Centers for Disease Control] has available data on youth suicide rates, the largest increases in youth suicide rates in history since they initially were monitored."

The disclosure section for the seminar shows Gibbons had served as an expert witness for Zoloft maker, Pfizer, and Wyeth Pharmaceuticals, maker of the antidepressants, Effexor and Pristiq.

Gibbons is a Professor of Biostatistics and Psychiatry and Director of the Center for Health Statistics at the [UIC] University of Illinois at Chicago College of Medicine, according to his bio on the Department of Psychiatry's webpage.

In 2007, the American Foundation for Suicide Prevention, and Seroxat maker, GlaxoSmithKline, donated between $10,000 and $24,000, to UIC College of Medicine, according to the Spring 2008 "UIC Medicine," newsletter.

Gibbons study received further criticism particularly after a Newsweek article entitled "Trouble in a 'Black Box", where Gibbons stated, "I think the FDA has made a very serious mistake. It should lift its black-box warning because all it's doing is killing kids."

After reading the Newsweek article, Dr Barry Duncan, a clinical psychologist, noticed the problematic claims being made.

He wrote a letter to both the author of the article and the Newsweek editors pointing out the problems with the article.

Duncan wrote:

Dear Editor:

Please find below our letter in response to the article, “Trouble in a Black Box.”

Our examination of the study forming the basis for the article revealed a glaring inaccuracy–the study’s results do not match the findings reported in the Newsweek article. Given that very few individuals read or understand research, we believe it important for Newsweek readers to be aware of this discrepancy to evaluate the necessity of the Black Box warning:

Tony Dokoupil’s Trouble in a ‘Black Box’ (July 16) importantly addresses the risks and benefits of prescribing antidepressants to children. However, the referenced study is far from “compelling” evidence for removing the FDA Black Box warning and such an interpretation of its findings is misleading. An inspection of this industry funded study reveals that the precipitous drop in SSRI prescriptions did not occur, as reported, from 2003 to 2005 but rather from February to October of 2005 (over 85% of the drop in the last 6 months of the reported time). The so-called “parallel development” of increased suicides occurred between 2003 and 2004 and therefore had no relationship to the drop in prescription rates reported in this study. Given that the decrease in prescription rates and increase in suicides occurred in different time periods, it begs the question of how such unsubstantiated statements could be made by the experts cited in the article.

Only 3 of 15 clinical trials have shown antidepressants to be superior to a sugar pill on primary measures. Children and parents in those 15 studies reported no advantage of antidepressants over a sugar pill. Data from the FDA and its British counterpart demonstrate that children and adolescents taking antidepressants are twice as likely to experience suicide-related events. Given the meager results and increased risk for suicide-related events (as well as other serious adverse events), antidepressants are not a good first choice for youth struggling with depression a conclusion reached after an extensive risk/benefit analysis conducted by the American Psychological Association’s Work Group on Psychotropic Medication

Barry Duncan, Psy.D., Jacqueline Sparks, Ph.D. & Scott Miller, Ph.D.


It could be argued that that Glaxo's expert statistician isn't that expert after all. His study has come under fire from many, as have his statistics.

Gibbons CV can be read here.

Special thanks to investigative journalist, Evelyn Pringle, for passing on documents regarding Dr. Robert Gibbons, many of which, have been forwarded to the solicitors representing the plaintiffs in the UK Seroxat Group Action.

Coming soon: Part IV - Another Glaxo expert witnessed revealed...along with his ties to Glaxo and it's huge donations.

Related links:

Suicide Syndrome

SSRI Pushers under Fire - By Evelyn Pringle

Paxil Study 329: Paroxetine vs Imipramine vs Placebo in Adolescents - Healthy Skepticism

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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