A recent column in the Houston Chronicle suggested that it may be time for drug companies “to take their place in public esteem somewhere south of bankers, Wall Street whiz kids and used-car salesmen,” and this next item helps illustrate why.
The U.S. attorney’s office in Boston has filed a civil complaint against drug maker Forest Laboratories, alleging the company defrauded the government out of millions of dollars by illegally marketing Celexa and Lexapro, two versions of the anti-depressant, “citalopram,” for unapproved uses in children and adolescents. While doctors are allowed to prescribe drugs for uses not approved by the FDA, it is illegal for companies to promote such “off label” use—which is exactly what Forest is accused of doing in this case.
Here’s the gist of the reported scam: two studies were done to help facilitate FDA approval of Forest’s anti-depressant for use in the treatment of young people. One of the studies showed the drug was of no help to kids—and might even be harmful to them. The other (which was financed by Forest) showed that the drug worked wonders for them. So which study do you think the company sought to promote?
If you guessed the favorable study, eat a cookie, because you’re exactly right! In the meantime, Forest buried the negative study for three years—even hiding it from its own medical advisers and sales reps—fessing up only after the New York Times published an article about it in 2004.
As for the FDA’s role…Forest revealed both studies to the agency in 2002, and the FDA withheld pediatric approval of the drug as a result. Nevertheless, it did not disclose the negative study’s findings to the public because “Forest had submitted them confidentially.” (How’s that for an effective “government watchdog?”)
Meanwhile, Forest provided things like baseball tickets, gift certificates to expensive restaurants, and paid vacations to doctors who agreed to prescribe its anti-depressant to kids, while federal programs were often tapped to foot the bill—hence the government’s lawsuit.
Kinda’ makes used-car salesman look good, eh?
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