Spitzer’s Lawsuit Will Shake Up the Drug Industry – Full Disclosure is the Goal

Spitzer’s Lawsuit Will Shake Up the Drug Industry – Full Disclosure is the Goal

Thu, 3 Jun 2004

New York State Attorney General, Eliot Spitzer’s lawsuit against GlaxoSmithKline challenges the pharmaceutical industry’s fraudulent marketing of drugs.

Karen Barth Menzes, an attorney representing victims of antidepressant drug effects, told The (So. Carolina) Herald online:

“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.”

In recent years, the drug industry has been given carte blanche by FDA officials–even to the point of intervening on industry’s behalf–helping to conceal evidence of hazardous drug effects. In some children and adults, the drugs induce mania, hostility, aggression, uncharacteristic violent outbursts–even suicidal and homicidal behavior–and they produce severe withdrawal symptoms.

Yet, in US advertisements, GlaxoSmithKline made the false claim: “Paxil is non-habit forming.” In August 2002, a federal judge ordered GSK to stop the ads because they were “misleading and created inaccurate expectations about the ease of withdrawal.” GSK argued (with the help of FDA officials) that the First Amendment protected their right to advertise, and they argued that Paxil was not habit forming, claiming that the risk of withdrawal symptoms in patients who stopped taking the drug was only 2 per 1,000 (0.2%).

Robert Temple, MD, FDA’s associate director of medical policy, claimed in a court affidavit that an “in-depth” review concluded “the drug is, in fact, not habit forming.”

However, after the scope and severity of the Paxil/Seroxat withdrawal problem was revealed by two BBC-Panorama news reports, GSK changed the UK label on June 25, 2003, acknowledging that there was a 25% risk of withdrawal symptoms–not 2% as the label indicated until that date.

See: Transcript of The Secrets of Seroxat (October 13, 2002). http://news.bbc.co.uk/1/shared/spl/hi/programmes/panorama/transcripts/seroxat.txt
See: Transcript of From the Edge (May 11, 2003). http://news.bbc.co.uk/nol/shared/spl/hi/programmes/panorama/transcripts/emailsfromtheedge.txt See also: Charles Medawar & Anita Hardon, Medinces Out of Control?, 2004, Askant.

Similarly, in countries such as, the Netherlands, France, Italy, Ireland and Spain, Paxil/Seroxat labels acknowledge the drug causes withdrawal and dependence.

FDA’s failure to enforce the law to protect the public from hazardous drug effects – as is its mission–has shattering lives and emboldened drug manufacturers to make factually unsupportable, even outlandish claims about the safety and effectiveness of antidepressants. Failure to warn physicians about the potential drug hazards has had devastating consequences.

Christopher Pittman is charged with killing his grandparents in November 2001, when he was 12 years old. The Herald reports that Christopher had been “on a five-week regimen of Paxil and Zoloft before” the killings. His lawyers “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.”

Today, June 3, thirty Utah residents who have suffered withdrawal reactions as a result of taking the antidepressant Paxil, filed a mass joinder lawsuit in the US District Court, Northern Division of Utah, against GlaxoSmithkline (“GSK”). The complaint alleges GSK knew that Paxil could cause severe withdrawal reactions, but “for years concealed, suppressed and downplayed the severity and frequency of their existence to patients, the medical community and the consuming public.”

The New York Attorney General’s lawsuit will afford the medical community and the public at large an opportunity to learn about the nature and scope of the concealed data, and about the intricate drug marketing schemes in which a prominent cadre of psychiatrists participated. The media’s failure to identify psychiatrists who are paid consultants to drug manufacturers, lent credibility to their, often false, claims about the drugs. They proclaimed the drugs “safe and effective” in medical journals, at professional meetings, and in the media. They did so in the knowledge that negative data contradicting those claims was kept hidden.

To families whose children suffered the consequences of hidden adverse antidepressant drug effects–some of whom committed suicide, others who have become drug dependent–Eliot Spitzer is a hero.

Contact: Vera Hassner Sharav
Tel: 212-595-8974

http://www.heraldonline.com/local/story/3625753p-3227083c.html.
Drug maker misled consumers on antidepressant use, suit alleges
By Jason Cato
The Herald

(Published June 3, 2004)

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.

Jason Cato . 329-4071

Copyright C 2004 The Herald, South Carolina

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