NYS Attorney General files suit against GlaxoSmithKline

NYS Attorney General files suit against GlaxoSmithKline for Concealing Drug Information

Wed, 2 Jun 2004

The most positive development in the antidepressant drug saga is the filing of a much needed lawsuit by Eliot Spitzer, New York State Attorney General. The suit charges GlaxoSmithKline with having “engaged in repeated and persistent fraud by concealing and failing to disclose to physicians information about Paxil, a drug used to treat depression.”

The suit states: ” 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” See GSK internal memo: http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

“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.”

Eliot Spitzer has picked up the ball to protect children’s lives, leaving the foot dragging FDA and the psychiatric drug establishment in the dust.

We hope this is the first of such suits against drug companies that deliberately concealed scientific evidence of drug-related harmful effects.

The suit challenges the pre-emption assertion by FDA’s chief counsel, Daniel Troy, who used his authority to shield his former clients, encouraging them not to disclose the suicidal risk of antidepressants. See: http://www.ahrp.org/risks/SSRI0204/AHRP.php

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

http://www.oag.state.ny.us/press/2004/jun/jun2b_04.html

Department of Law
120 Broadway
New York, NY 10271

Department of Law
The State Capitol
Albany, NY 12224

For More Information:
(212) 416-8060
For Immediate Release
June 2, 2004

MAJOR PHARMACEUTICAL FIRM CONCEALED DRUG INFORMATION
GlaxoSmithKline Misled Doctors About the Safety of Drug Used to Treat Depression in Children

State Attorney General Eliot Spitzer today announced 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.

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 1999 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.

The investigation was handled by Assistant Attorneys General Rose Firestein and Shirley Stark, under the supervision of Thomas Conway, Chief of the Consumer Frauds Bureau, and Joseph Baker, Chief of the Health Care Bureau.

Attachment:

Complaint
Statement by the New York State Psychiatric Association, Inc.

FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.