Most prescriptions are written for conditions for which the medicine was not initially approved.
A jury this week awarded punitive damages of $8 billion against Johnson & Johnson over their marketing of the antipsychotic drug Risperdal.
The plaintiff claimed he was not warned that the drug had a side effect that caused him to grow large breasts. The condition, gynecomastia, is reversible, but the lawsuit stated the man’s breast growth was permanent.
A few things about this lawsuit stink.
The man, who is 26, began taking Risperdal for symptoms of autism when he was 9. That was in 2003.
Risperdal, an antipsychotic developed for schizophrenia and later labeled for bipolar disorder, was approved for use in children with autism in 2006.
The prescription was written for off label use.
Off label use is the use of a drug for something other than what the drug is currently approved for by the FDA. It’s not illegal, although the marketing practices by the pharmaceutical companies to promote off label use are shady.
Johnson & Johnson claims they were not given the opportunity to introduce into evidence marketing materials from 2002 that they say clearly outlined side effects of Risperdal. What’s not clear is how aggressively they were promoting this off label use for Risperdal at that time, and what they were telling doctors verbally during sales calls in addition to printed backup materials about research and side effects.
At first glance it may seem crazy to use a medicine, especially something as powerful as an atypical antipsychotic, for a condition for which the drug has not been approved. To prescribe a drug like this for a child seems doubly unwise.
But 62% of the prescriptions written by pediatricians are for off label use.
Anticonvulsants, often used for treatment in mental illness, are the most off label prescribed drugs on the market. I began taking one for my bipolar disorder when it was still only approved for the prevention of seizures in patients with epilepsy.
It worked for me, but a study found that 73% of off label use of anticonvulsants has little or no scientific support.
So where are doctors getting the ideas for the off label use of drugs? Surely from the detailers, or sales reps, from the pharmaceutical companies who visit them to promote prescription medicines.
Doctors are buying it, and not just pediatricians and psychiatrists. Over 60% of the prescriptions written by oncologists, too, are for off label use.
With so little science to support off label use, it’s curious what is being discussed between those detailers and doctors and what printed material is being presented for reference, if any.
All of this remains legal. In fact, the FDA is currently considering allowing pharmaceutical companies to advertise off label uses directly to consumers.
As for that lawsuit, the $8 billion award is sure to be reduced by the judge. A previous lawsuit resulted in $680,000 in compensatory damages. Appeals by J&J will keep the case tied up for years, and it’s unlikely the more than 10,000 people with similar complaints will ever see very much.
I’m conflicted about the whole thing. The anticonvulsant I was prescribed off label did help me with bipolar depression, whereas antidepressants threw me spinning into manic episodes. Also, the drug was eventually approved as a mood stabilizer.
Risperdal, too, was later approved for use in children with autism.
But if pharmaceutical companies so aggressively pitch drugs for off label use, and doctors so aggressively prescribe them, who is looking carefully at new side effects?
Drugs, once FDA approved for something, are quickly sold for something else. Something not researched or tested as rigorously as what the drug was initially developed for. This helps drug companies extend patents, Admittedly, it also helps many people get well.
Still, damage can be done and money can be wasted. Lawsuits like the one against J&J shouldn’t surprise us. What should surprise us is how lax the regulations about off label uses are, and how willing doctors are to prescribe drugs off label with so little peer reviewed research to back up claims for off label uses.