Wednesday, February 25, 2009

Hot off the Press: US Investigating Forest Labs for Illicit Promotion of Kids' Antidepressants

As you have no doubt discerned, this blog is not exactly CNN-- you ordinarily do not turn here for the very latest news. However, thanks to alert e-mail correspondents and friends of our blog, I am able to shoot this out to you pretty quickly:

http://www.usdoj.gov/opa/pr/2009/February/09-civ-163.html

The Feds are investigating Forest Laboratories for illicit promotion of their antidepressant drugs Celexa and Lexapro. The basic charge is that the company funded a study in which it was shown that these drugs did not help kids with depression, and actually increased the suicide rate. [CORRECTION ADDED 2/26: Sorry, rushed this too fast yesterday. The actual study results did not show increased completed suicides but rather increased suicide ideation and attempts.] The FDA decided on the basis of this study not to approve the drug for use in children. But, as too often happens, the FDA then apparently did nothing to force release of these data. The company then concealed the data and aggressively marketed the drug for off-label use in pediatrics, using a full court press of the usual monetary bribes (speaker fees, consulting fees, lavish meals, etc.). Eventually the study led the FDA to demand a black box warning on the drugs regarding pediatric risks. The company's behavior came to light as a result of whistleblowers, according to the federal complaint.

1 comment:

Marilyn Mann said...

Here's the NYT article:

http://www.nytimes.com/2009/02/26/business/26drug.html?_r=1&ref=health