Lexapro Maker Charged Over Teen Prescriptions
> 3/2/2009 12:24:47 PM

 In what will almost certainly prove to be a controversial case, the United States Justice Department charged drug maker Forest Laboratories with fraud for paying doctors to market major antidepressant medications Lexapro and Celexa to teenagers and children despite the fact that the FDA has not approved these drugs for those under 18. 

Under current law, doctors are free to prescribe the drugs to such individuals as they see fit but drug companies cannot legally promote their products for unapproved uses. These drugs continue to be prescribed to teenagers every day because they often work. And we believe that the FDA could eliminate the conflicts of interest that created this case by approving the drugs for teenagers. The substance of this story illustrates the complex nature of the relationship between drug manufacturers and the doctors who prescribe their products. The roles and responsibilities of these interdependent parties are not always clear.  

The worst of Forest's transgressions, according to the civil complaint filed by the U.S. Attorney's office in Boston, include hiding the results of unfavorable studies and offering various under-the-table goodies to doctors who agreed to prescribe their drugs. In order to increase profits, Forest played pick-and-choose with their research, publishing only complimentary studies that labeled SSRIs effective for teens (drug makers are legally required to publish the results of all related clinical trials). They also provided non-cash kickbacks in the form of gift certificates, paid vacations and tickets to sporting events for doctors who followed their instructions in prescribing a greater number of these drugs to teens. 
The relationship between pharmaceutical manufacturers and doctors legally authorized to prescribe their products is often complex and interdependent. Many see gifts from pharmaceutical companies as a form of supplemental income. And researchers rely on drug companies to provide a large share of the funding for the studies that ultimately produce groundbreaking medications. Of course, pharmaceutical producers should have no sway over the treatments a doctor ultimately chooses for his or her patients. And only full transparency can ensure that this is the case. The accountability line grows blurry when doctors, either by mistake or design, do not disclose all of their dealings with manufacturers. 

Dr. Fredrick Goodwin, a prominent psychiatrist and former head of the National Institute of Mental Health, ran into trouble in 2008 when a congressional investigation determined that he was being paid to give market lectures for major drugmakers and that he never mentioned this fact on his nationally syndicated radio show when discussing the same drugmakers' products. Goodwin was one of the nation's most respected mental health professionals, and his program won both a plethora of editorial awards and a sea of listeners across the country. Goodwin's defense cited legal changes to explain his seeming conflict of interest, noting that previous regulations did not prohibit relationships like the one he had with GlaxoSmithKline. He mentioned many of his consulting jobs in a 2003 study and claimed that, because he consulted with so many different manufacturers, he had no particular bias. But he may have retained his credibility if he had fully disclosed his relationship with the drug maker in question. And the issue would be far less problematic if the manufacturers themselves were legally required to disclose all payments to medical professionals.   

The accusations made against Forest Laboratories are considerable, but the case may never have come to light had the FDA approved the drugs for teens instead of amending their black boxes to warn of a supposedly increased suicide risk. Treatment Online has previously pointed out the ridiculousness of antidepressant suicide warnings and this suit offers an opportunity to restate our opposition to the ruling. The fact that some studies were inconclusive on the benefits of SSRIs for teens does not change the fact that the number of teenagers who've been successfully treated with SSRIs is exponentially higher than those who've suffered from their adverse influence. 

These drugs may prove to be the only source of relief for teenagers with major depression. Even if antidepressants are not miracle cures - and no experienced psychiatrist would argue that they are - treatment including therapy and antidepressants decreases suicide rates. And SSRIs are certainly better than popular self-medication alternatives like street drugs and alcohol. One of the major reasons their success rates remain in doubt is the fact that the vast majority of doctors who prescribe them are not licensed psychiatrists and do not compliment their prescriptions with regular therapy sessions or checkups. A Lexapro prescription alone does not constitute effective treatment.  

The most important end result of this complex web is effective pharmaceutical treatment for patients suffering through depression and related disorders. And we believe that Celexa and Lexapro should be approved for teens so that companies like Forest can legally include them in lists of potential patients. These are effective drugs that, when properly prescribed, have helped millions of people (including adolescents and young adults) overcome the crippling effects of mental illness. But they may be viewed with greater skepticism by the public because of their manufacturers' supposed misdeeds. This distrust could lead hundreds or thousands of patients to go without the drugs they need - and that would be a true tragedy.

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