Paxil Five-Year Litigation History

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The complaint also alleges that Glaxo failed to disclose this information in "Medical Information Letters" that the company sent to physicians.

"By concealing critically important scientific studies on Paxil," Mr Spitzer said in the press release, "GSK impaired doctors' ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety."

Mr Spitzer noted that an internal Glaxo document from 1998 showed that Glaxo intended to "manage the dissemination of data in order to minimize any potential negative commercial impact."

The lawsuit also alleges that Glaxo misrepresented the results of its research to sales representatives who promoted Paxil to doctors and portrayed the drug as having "remarkable efficacy and safety in the treatment of adolescent depression."

According to the lawsuit, Glaxo's studies did not demonstrate efficacy and in fact in one study, the children in the placebo group actually out performed the children in the Paxil group.

This impression was reinforced, the lawsuit said, by the mischaracterization of much of the information that Glaxo did disclose, and its Paxil-related targeting of psychiatrists who treated only pediatric patients.

In a statement responding to the allegations in the lawsuit, Barry Perlman, M.D., President of the New York State Psychiatric Association, said:

"The relationship between a doctor and a patient must be based on a sense of trust. In order to hold true to that principle, physicians must have access to all relevant medical information regarding treatment. Any obstacle placed in the way of full and complete communication with our patients undermines the trust upon which the doctor-patient relationship is based and prevents us from providing the best care we can to our patients."

Other members of the medical profession expressed similar views. Arthur Levin, Executive Director, for the Center for Medical Consumers, stated: "The ability of drug companies to pick and choose the research they provide doctors in support of their product is an outrageous conflict of interest and puts us all in harm's way."

Less than 3 months after the filing of the lawsuit, in an August 26, 2004, press release, Attorney General Spitzer reported that Glaxo would pay $2.5 million in disgorgement and costs to the State of New York as part of the agreement to resolve the charges that Glaxo concealed information about the safety and effectiveness of Paxil.

In addition, the press release said, Glaxo will establish an online "Clinical Trials Register" that will contain summaries of results for all GSK-sponsored clinical studies of drugs conducted after December 27, 2000 and any earlier studies that may be relevant.

"Each clinical study summary posted," Mr Spitzer advised, "will contain over 20 categories of information including information regarding the effectiveness of the drug tested, the type and severity of adverse side effects the study participants experienced, whether the goals or other components of the study were changed mid-stream, and whether the study was terminated early before full completion and why."

"This settlement holds GSK to a new standard of disclosure about studies concerning its drugs," Mr Spitzer said, "a standard that helps to ensure that doctors and patients have access to all scientifically sound information so doctors can prescribe appropriate medication for their patients."

As part of the settlement, Glaxo also agreed to ensure that all Medical Information Letters provided to doctors concerning off-label use of Paxil and other drugs "will fairly and accurately reflect the safety and efficacy data from clinical studies concerning off-label use."

Shortly after the settlement was announced, Mr Spitzer said that he would continue to watch Glaxo despite the settlement, because the company and its CEO, J.P. Garnier, appeared "unrepentant" with regard to changing behavior related to the disclosure of adverse clinical trials.

He referred to the "arrogance" of the Glaxo official as "offensive and problematic" and said, "We are going to be watching them with a hawk's eye to see that they have abided by the terms of the settlement."

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