Generic Paxil Suicide Lawsuit

Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Thursday, June 04, 2009

GlaxoSmithKline Exposed Part I



Taken from the excellent Paxil Protest website archives.

Look past GlaxoSmithKline's public relations facade and what you'll find an unethical corporation whose principal reason for existence is to rake in huge profits for its stockholders.

In fact, one could argue — based on an abundance of evidence accessible to anyone with an Internet connection — that GlaxoSmithKline views the public as little more than its own personal "ATM machine," and whose citizens are apparently suitable for use as experimental animals.

We are a high-integrity company.
We know what the rules are
and we follow them
Jean-Pierre Garnier
CEO of GlaxoSmithKline

Integrity? Standards? Surely Mr. Garnier was being facetious. After all, GlaxoSmithKline's way of doing business includes:

Defrauding the public on multiple occasions, and on a massive scale.

Operating in a manner one would commonly associate with an ongoing criminal enterprise.

Engaging in an ongoing pattern of false advertising; here's just one example.

Repeatedly refusing to comply with minimum drug manufacturing quality control standards mandated by the United States Food and Drug Administration that, in 2005, resulted in two GlaxoSmithKline production facilities being shut down and millions of PaxilCR tablets seized by U.S. Federal Marshals.

Trashing the environment in spite of what Dr. Anne Phillips, Vice President, Research & Development and Chief Medical Officer of GlaxoSmithKline has claimed: While GlaxoSmithKline strives to produce medications that safely and effectively treat medical conditions, we're also committed to protecting the environment.

Little wonder GlaxoSmithKline was named one of the ten worst corporations of 2004 by Multinational Monitor. (It's not GlaxoSmithKline's first time on the list either.)

Anatomy of a Paxil Fraud

On June 2nd, 2004 State Attorney General Eliot Spitzer announced a lawsuit against GlaxoSmithKline for concealing important information about the safety and efficacy of Paxil.

The lawsuit alleged that GlaxoSmithKline engaged in repeated and persistent fraud by concealing and failing to disclose to physicians information about Paxil. The lawsuit alleged that, starting in 1998, GlaxoSmithKline 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, GlaxoSmithKline 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 alleged 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 GlaxoSmithKline document from 1998 shows that GlaxoSmithKline intended to "manage the dissemination of (the) data in order to minimize any potential negative commercial impact."

Spitzer's lawsuit also alleged that GlaxoSmithKline 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.

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.


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