Not that we are surprised, but on Wednesday of this week, the Justice Department charged the drug maker Forest Laboratories with “defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers.” Check out the NY Times article for details.
The complaint alleges that during heavy marketing from 2001 to 2004, the former execs of Forest concealed a clinical study that showed that the drugs were not effective in children and caused some children to become suicidal. The drugs in question are Celexa and Lexapro. They are only approved by the FDA for adults, but doctors can prescribe them to all patients so a company just needs to convince the doctors that the drugs are good for children too. But, companies can’t actively promote use of the drugs for non-FDA approved means, which creates a bit of a quandary. If they told doctors about the suicides, it would probably dampen prescribing of the drug somewhat.
On top of this, federal prosecutors are charging that Forest paid kickbacks to doctors who prescribed its drugs. What kind of kickbacks? Those simple things like baseball tickets, restaurant gift certificates, and free vacations. Who knew? Apparently giving gifts like that is considered a kickback by the federal prosecutors. Maybe that’s why we passed a gift ban here in Massachusetts….
Drug makers are required to disclose the results of all of their clinical trials. Yup- now it is required. Apparently, Dr. Erick H. Turner from Oregon Health and Science University “found that most antidepressant makers had in the past failed to report negative findings, or tried to cast a positive light on their findings, to make their drugs appear more effective in adults.” So it seems that these companies started doing the right thing only after they were forced to do so. Makes you wonder.
I guess shedding some light on the issue can be a good thing. At least for the patients.