Glaxo Misled Doctors About Safety of Paxil, NY Charges

June 2, 2004
State Attorney General Eliot Spitzer has filed a lawsuit against one of the world's leading pharmaceutical companies for concealing important information about the safety and efficacy of an anti-depressant drug.

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The lawsuit, filed today in New York State Supreme Court in Manhattan, alleges that GlaxoSmithKline (GSK) engaged in repeated and persistent fraud by concealing and failing to disclose to physicians information about Paxil, a drug used to treat depression. Paxil has been approved by the FDA for the treatment of depression in adults, but not in children.

Prozac is the only antidepressant that has been approved to treat depression in children. Physicians, however, have professional discretion to prescribe Paxil for treatment in children, a so-called "off-label" use.

"Doctors should have access to all scientifically sound information so that they can prescribe appropriate medication for their patients," Spitzer said. "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."

The lawsuit alleges that, starting in 1998, GSK engaged in a concerted effort to withhold negative information concerning Paxil and misrepresented data concerning Paxil's safety and efficacy when prescribed for depression in children and adolescents.

Specifically, GSK conducted at least five studies on the use of Paxil in children and adolescents. However, GSK only published and disseminated one of these studies, which showed mixed results on efficacy. The lawsuit alleges that the company suppressed the negative results of the other studies, which failed to demonstrate that Paxil is effective and which suggested a possible increased risk of suicidal thinking and acts. GSK is also alleged to have failed to disclose this information in "Medical Information Letters" that it sent to physicians.

An internal GSK document from 1998 shows that GSK intended to "manage the dissemination of (the) data in order to minimize any potential negative commercial impact."

The lawsuit also alleges that GSK misrepresented the results of its research on Paxil as a treatment for children and adolescents to its sales representatives who promote Paxil to physicians. The company portrayed the drug as having "remarkable efficacy and safety in the treatment of adolescent depression."

In fact, GSK's studies did not demonstrate that Paxil is effective in treating children and adolescents with major depressive disorder and showed the possibility of increased risk of suicidal thoughts and acts in adolescents. In documents submitted to the FDA and similar agencies in the United Kingdom and Europe, GSK admitted that its studies "all failed to separate [Paxil] from placebo overall and so do not provide strong evidence of efficacy in this indication."

Through these and other acts, GSK deprived physicians of the information they needed to evaluate the risks and benefits of prescribing Paxil for children and adolescents and deprived these youngsters of the benefit of their physicians' professional judgment.

The lawsuit seeks disgorgement of all profits obtained by GSK as a result of the conduct alleged in the suit.

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."

Arthur Levin, Executive Director, Center for Medical Consumers, said: "The fact is that published drug studies are hugely biased towards good news - the drug works and is safe - and that studies reaching the opposite conclusion are likely never to see the light of day. 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."

More than two million prescriptions for Paxil were written for children and adolescents in the United States in 2002. Nearly 900,000 of these prescriptions were for youngsters whose primary diagnosis was a mood disorder, the most common of which is depression. Prescriptions for Paxil to treat mood disorders in children and adolescents translated into US sales for GSK of approximately $55 million in 2002 alone.

In the last year, the use of Paxil for children and adolescents for the treatment of major depressive disorder has come under scrutiny by the FDA and regulatory agencies in the UK, Ireland, Europe and Canada. The FDA has advised caution in prescribing Paxil in children and adolescents for the treatment of major depressive disorder and is currently conducting an analysis of the data related to the use of Paxil and the possibility of increased suicidal thoughts. Regulatory agencies in the UK, Europe, Ireland and Canada have recommended that Paxil not be prescribed for adolescents and children with depression.

GSK is based in the United Kingdom with subsidiaries in the United States and several other nations.

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