March 22, 2009
A five year probe of Forest Laboratories by the U.S. Justice Department into illegal marketing of Lexapro to children has an ironic twist to it: The FDA just approved the use of Lexapro for depression in children.
“Federal health care programs have paid thousands of false and fraudulent claims for Celexa and Lexapro prescriptions that were not covered for off-label pediatric use and/or were ineligible for payment as a result of illegal kickbacks paid by Forest.”
On February 25, the Justice Department accused Forest of bribing pediatricians to prescribe Celexa and Lexapro with things like spa visits, sports tickets, Broadway shows, and fishing trips. On Friday, the Food and Drug Administration gave the go-ahead to use Lexapro to treat depression in adolescents aged 12 to 17.
Federal prosecutors say Celexa is not any more effective for children or teenagers than taking a placebo, and more patients taking Celexa attempted suicide or reported suicidal thoughts.
The Justice Department prosecutors also claim that both Lexapro and Celexa, another of Forest’s antidepressants, have been improperly used for treating depression in children for a long time. One study showed that Celexa was not effective for use in children, and even Forest admits that the effectiveness was not shown in two different studies, a Lexapro trial with patients aged 7 to 17 and another study of Celexa in adolescents.
Even weirder, Forest Laboratories said that Lexapro’s ability to maintain control of symptoms in adolescents had not been demonstrated, but the FDA concluded that maintenance efficacy can be “extrapolated” from adult data. How’s that for federal intervention – the FDA contradicts the maker of the drug. Makes me wish we had a “WTF?” category for this blog, ’cause “Health” is kinda misleading…
Forest Labs claims that 2 million adolescents in the United States are affected by depression, and Lexapro is only the second approved drug for that age group.
Not surprising, Lexapro is Forest Laboratories’ highest selling product, bringing in over $2 billion a year, and the fifteenth top seller of all prescription drugs in the US.
So who’s getting paid off here?
There’s never any mention made in studies of depression in children about diet or lifestyle, yet many experts have made the connection between the foods we eat and the way we feel. Wouldn’t it be wonderful if our practice of prescribing drugs to children was a last resort and not driven by a heavily marketed, payola-based scheme?
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