Johnson and Johnson Agrees to Pay $2.2 Billion to Settle Drug Marketing Investigation

The pharmaceutical giant Johnson and Johnson was forced to agree to the third largest settlement in a drug case ever by the Justice Department, as announced by chief Eric Holder today.   The New York Times online article can be found at: http://www.nytimes.com/2013/11/05/business/johnson-johnson-to-settle-risperdal-improper-marketing-case.html  The investigation involved three drugs, the most famous of which is Risperdal, a powerful antipsychotic drug that J+J promoted for controlling behavior in demented patients and children with behavior disorders– inappropriately, as it turned out.

The other two drugs were obscure, a heart-failure treatment and another antipsychotic, both of which were marketed inappropriately.

In the case of Risperdal, which has coincidentally gone off patent recently, the drug was only approved by the FDA for use in patients with disorders such as schizophrenia.  Doctors were free to use it for other problems on their own, but the drug companies were not supposed to promote the drug except for the approved indications.  To increase Risperdal’s use, drug representatives (who personally buttonhole physicians in their offices and extol the virtues of their drugs) went beyond the approved indications to other, much more common unapproved uses.  Antipsychotic drugs are among the most used ones in cases were a patient’s behavior is a problem due to their restlessness or aggression.

However, there is no research showing effectiveness of these drugs for these purposes and it is likely that they produce benefits primarily through their sedative action.   In addition to making patients drowsy, Risperdal also interferes with their ability to think connectedly and causes unpleasant feelings of confusion.  In addition, Risperdal frequently causes increased appetite and uncontrollable weight gain, usually resulting in Type 2 diabetes.  A large number of serious chronic mental patients have been transformed into grossly obese, drooling, shambling zombies by Risperdal and related drugs.

There are a few patients in whom Risperdal is not only indicated, primarily schizophrenics, but the drug of choice.   Unfortunately for J+J, these patients are few and far between, minimizing their profit potential.

The article states that “As part of the settlement, Johnson & Johnson has agreed to plead guilty to a criminal misdemeanor, acknowledging that it improperly marketed Risperdal to older adults for unapproved uses. It did not admit to wrongdoing for the civil portion of the settlement, which involves claims that the company promoted the drug’s use in children and the developmentally disabled, as well as accusations that it paid kickbacks to doctors and pharmacists in exchange for writing more prescriptions.”  We hope that a 2 billion dollar fine will inhibit further inappropriate promotion of branded drugs for unapproved indications.