Zantac Lawsuit

Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Tuesday, December 16, 2008

The Great SmithKline Cover-Up

My postman rang my bell today, he had a package for me. There I was thinking my stalker had decided to send me an early Christmas present... in fact it was better than that, so much better.

I'm about to start reading 'Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial' , a book written by Alison Bass.

From the Inside Flap
As the mental health reporter for the Boston Globe, Alison Bass's front-page reporting on conflicts of interest in medical research stunned readers, and her series on sexual misconduct among psychiatrists earned her a Pulitzer Prize nomination. Now she turns her investigative skills to a landmark case that exposed increased suicide rates among adolescents taking popular antidepressants such as Paxil, Prozac, and Zoloft.

In Side Effects we meet a courageous Ivy League university employee who risked her job to expose suspicious practices at her lab, a feisty assistant attorney general who spearheaded an unprecedented lawsuit against a pharmaceutical giant, plus the medical researchers who were being paid by the drug companies whose products they were testing. And Bass introduces us to the vulnerable children and adults placed at risk because of greed, corruption, and negligence.

Though pediatric prescriptions of Paxil—at the time one of the world's bestselling antidepressants—were soaring, there was no hard proof that the drug performed any better than sugar pills in children and adolescents. Bass reveals how data from drug trials and the suicide risk the drug posed were withheld, allowing GlaxoSmithKline, the maker of Paxil, to mislead physicians and consumers about the safety and efficacy of the drug.

When the New York State attorney general's office brought its lawsuit against GlaxoSmithKline for consumer fraud, it launched a tidal wave of protest. As a result of this case, drug companies agreed to publish negative results from their research studies. A congressional investigation into industry practices finally prompted the FDA to mandate strict warnings for all antidepressants.

In the tradition of A Civil Action, Side Effects goes behind the scenes of the headline-making case that forced the government to start protecting its citizens. It lays bare the unhealthy state of our country's pharmaceutical industry.


Alison has placed some documents on her blog. She writes:

The first document here is from the final GlaxoSmithKline report of study 329 (publicly available on its website), which shows that a 14-year-old boy who was in the Paxil arm of the study lost control, punching pictures, breaking glass and injuring himself in November 1994. He was hospitalized and seen as suicidal by the psychiatrists treating him. Yet this patient , known as #65 in the study, was not labeled as suicidal when the study was published in the July 2001 issue of the Journal of the American Academy of Child and Adolescent Psychiatry. (The following year, Paxil became the most widely prescribed antidepressant in the U.S.).

The second document here is a memo to Brown University's Institutional Review Board from Martin Keller, chief of psychiatry at Brown and principal investigator of study 329. In the memo, Keller reports that a teenager in the Paxil study was hospitalized in September 1995 due to becoming combative and suicidal. Yet in the memo, Keller says he has labeled this patient (#106) as noncompliant instead of suicidal as a result of taking Paxil. Likewise in the published 2001 study, this teenager is labeled noncomplaint and not included in the list of adolescents withdrawn from the study as the result of adverse side effects.

The third and perhaps most mysterious
document is a memo from Keller to the IRBs at Brown and two of its affiliated hospitals, Butler and Bradley. In this January 30, 1995 memo, Keller reports that a teenage girl, patient #70 in study 329, ingested 82 Tylenol pills on January 19 and was hospitalized at St. Ann's Hospital. She was discontinued from the study at the end of January and coded as noncompliant according to another memo from Keller to Brown's IRB here. Yet according to the GlaxoSmithKline's final report, patient #70 in the same study was a 12-year-old boy enrolled in the trial on February, 22, 1995 and withdrawn on March 24 after suffering from chest pains. This patient had been randomized to the imipramine arm of study 329.

So the question remains: how did patient #70 go from being a teenage girl who overdosed on Tylenol to a 12-year-old boy with chest pains?

How indeed?


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal


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