Forest Labs under Spitzer scrutiny

Related tags Glaxosmithkline Pharmacology Pharmaceutical industry Food and drug administration

New York Attorney General Elliot Spitzer has continued in his
crusade to investigate pharmaceutical company practice by
requesting information from Forest Laboratories which is accused of
promoting its products for "off-label" usage.

Whilst not a subpoena, Forest has stated they will fully cooperate with the Attorney General's request and believes that it has been in compliance with all applicable New York State laws.

The term "off label" is used to describe a doctor's prescription for a condition different than what the drug has been approved for by the Food and Drug Administration.

The news is the latest to have surfaced during Eliot Spitzer's ongoing investigation of the drug industry, which is also looking into whether drug makers are secretly burying negative clinical studies to promote a positive view to investors.

Just recently the Attorney General filed a lawsuit against GlaxoSmithKline​ alleging the company covered up negative studies about the effect of the antidepressant Paxil (paroxetine) on children.

And Forest itself has been the subject of another investigation by the Food and Drug Administration (FDA) for not publishing data from clinical trials of its antidepressant drug Celexa (citalopram).

Two European studies claimed Celexa had a greater risk for younger patients of serious side effects than was previously thought. In response to these new claims Forest sent out a press release reviewing the results of trials on Celexa.

Forest​ concluded that Celexa did not increase suicide risk, but said it will follow FDA recommendations and add a warning to its label about the possibility of suicide in younger patients.

Celexa has not been given FDA approval as a treatment for depression in those under the age of 18. Doctors who prescribe this drug to underage patients are essentially going off label. But according to estimates, something under 10 per cent of Celexa prescriptions go to underage patients.

Company corruption

Meanwhile, charges of corruption and illegal practices has emerged earlier this week are sending shockwaves through the $400 billion pharmaceutical industry.

The New York Times recently reported on a government crackdown by Boston federal prosecutors on the drug industry's marketing tactics, particularly the financial lures pharmaceutical companies have allegedly used to persuade physicians to favour their drugs.

Drug company Schering-Plough is accused of paying doctors large sums to prescribe its drug for hepatitis C and to take part in company-sponsored clinical trials that the NYT claims were little more than thinly disguised marketing efforts that required little effort on the doctors' part.

Just about every big global drug company including Johnson & Johnson, Wyeth and Bristol-Myers Squibb has received a federal subpoena. Most are juggling subpoenas stemming from several investigations, said the newspaper.

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