The FDA told Johnson & Johnson (JNJ) in 1997 that its request to market the antipsychotic drug Risperdal for children was "without any justification." In the following years, J&J's army of pharmaceutical sales reps made 100,000 sales calls on child and adolescent psychiatrists, justifying this by "qualifying" the docs if they had as few as one adult patient exhibiting signs of schizophrenia, according to a lawsuit.
It was a distinction only a lawyer can love, and now the Massachusetts attorney general is using it against J&J and its Janssen unit, alleging that J&J's promotion of Risperdal for children was misleading.
J&J had initially asked the FDA to approve the drug for use in children, and the FDA eventually allowed limited use in the over-10s in the 2006 and 2007. But in 1997, without clinical evidence to back its request, the FDA frowned on use of the drug for children. In a latter the J&J, the FDA wrote:
To permit the inclusion of the proposed vague references to the safety and effectiveness in pediatric patients and the nonspecific cautionary advice about how to prescribe Risperdal for the unspecified target indications would serve only to promote the use of this drug in pediatric patients without any justification."Promote use of this drug in pediatric patients" is exactly what J&J then did, according to the suit:
From January 1994 through September 2006, Janssen sales representatives directly promoted Risperdal to thousands of child and adolescent psychiatrists and pediatricians even though Risperdal was not approved to treat any pediatric conditions until October 2006.Doctors were paid $1,000 to attend J&J's pediatric "advisory board" meetings held at posh resorts, and eventually Risperdal reached a 50 percent share of pediatric antispychotic category, the suit alleges.
Kids grew breasts, docs went to the Four Seasons
This success came at some price to the children receiving the drug, as Risperdal's side effects include weight gain, diabetes and "galactarhea," the premature production of breast milk in both boys and girls. One of J&J's sales reps made this internal sales call note on that issue:
An August 2, 2001 call note (000000244279 ) reports on a sales call with a Braintree doctor: ". . . . She is using Risperdal with great success in kids ala Biederman. She did mention galactarhea so I told her how Biederman is using Dostinex. She is going to get more info on this dopamine agonist. She is going to attend the 4 Seasons event.""4 Seasons" is likely a reference to the posh Four Seasons hotel in Boston (its indoor pool is pictured). The Biederman name is familiar to anyone following the Risperdal saga, of course. Joseph Biederman was the Harvard medical school doctor who was paid by J&J to churn out reams of studies promoting Risperdal in kids. He became infamous when he suggested in a deposition that he was one pay-scale below God.
J&J's Risperdal sales were up 5.3 percent in 2010 to $1.5 billion.
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