Healthy Skepticism Library item: 428

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Publication type: news

Jason CATO.
Drug maker misled consumers on antidepressant use, suit alleges
The Herald 2004 Jun 3

Full text:

The top attorney for the state of New York filed a lawsuit Wednesday against an international drug maker, accusing the company of concealing important information about the safety and effectiveness of an antidepressant.

Attorney General Eliot Spitzer’s lawsuit against GlaxoSmithKline, the maker of Paxil, comes a day after attorneys for a boy charged with double murder in Chester County began arguing that confidential documents from another drug manufacturer should be made available for his defense.

Lawyers for Christopher Pittman, charged with killing his grandparents in November 2001, are seeking concealed internal memos and documents from Pfizer. They allege these documents will help prove an adverse reaction to the antidepressant Zoloft led to Pittman’s violent behavior.

Their efforts to get those documents made available will continue during pretrial hearings June 10. Pittman’s trial is scheduled to begin June 14.

On Wednesday, Pittman’s attorneys said Spitzer’s action could not have come at a better time.

“I just wish he would have included Pfizer in there as well,” said Andy Vickery, a Houston-based attorney helping with Pittman’s defense. “As far as being evasive … GlaxoSmithKline doesn’t hold a candle to Pfizer.”

Karen Barth Menzies, a Los Angeles-based attorney also part of the Pittman defense team, said in a written statement: “There is no difference between what GSK (GlaxoSmithKline) has done regarding Paxil and what Pfizer has done related to Zoloft. Quite frankly, there has been a huge fraud perpetrated against the public by these companies. …

“We have been trying for years to raise public awareness about these issues because we have seen, through our litigation, the secret internal company documents that no one ever gets to see, not even the FDA. Even now, we are prohibited, due to confidentiality orders, from disclosing these documents.
But, you can only hide the truth for so long. Too many people have been harmed by these drugs, too many lives have been shattered.”

Spitzer’s lawsuit alleges that GSK practiced “repeated and persistent” fraud by withholding negative information and misrepresenting information about the drug’s safety and effectiveness in treating depression in children and adolescents. The company told its sales representatives, according to the lawsuit, that Paxil had “remarkable efficacy and safety in the treatment of adolescent depression” when its own trials showed the drug may increase risks of suicidal thoughts or acts in some juveniles.

The suit seeks for Glaxo to give up profits made in New York from sales of Paxil to treat depression in juvenile patients.

In a press release, Spitzer stated: “Doctors should have access to all scientifically sound information so that they can prescribe appropriate medication for their patients. By concealing critically important scientific studies on Paxil, GSK impaired doctors’ ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety.”

A Glaxo spokesperson could not be reached for comment.

Paxil has been approved to treat depression in adult patients, but, like Zoloft, has not been approved to treat depression in juvenile patients.
Prozac is the only FDA-approved antidepressant for treating depression in young patients. Doctors can prescribe all antidepressants to children through a practice known as “off-label” prescribing.

Previously unpublished studies from antidepressant makers, including Glaxo and Pfizer, has led the FDA to request caution labels on such drugs warning doctors and patients to watch for increased signs of suicide. The British drug review agency has all but banned prescribing antidepressants to children after determining most were either ineffective or too dangerous.
Prozac was the lone exception.

Pittman had been on a five-week regimen of Paxil and Zoloft before authorities say he killed Joe Frank Pittman and Joy Roberts Pittman on Nov.
28, 2001, and burned their house down with their bodies still inside. He was
12 at the time.

Now 15, he will be tried as an adult and could receive up to life in prison if convicted.