Promoting Risperdal as superior to other antipsychotics even when forbidden by the FDA and being warned for infractions
Continuing to deny Risperdal’s propensity to weight gain and glucose intolerance even when warned by the FDA
Promoting Risperdal off-label in children
The part that I found upsetting were the Call-Notes. These were forms filled out by the Sales Reps after each encounter with a physician. First, there were a lot of calls on Child Psychiatrists to begin with. At the time, Risperdal was only approved for adults with Schizophrenia. And though many Child Psychiatrists do see adult patients, I doubt they see many Schizophrenic patients. Second, the majority of the Call-Notes on these Child Psychiatrists didn’t even have a blank for the Rep’s comments. That’s unusual too. But it was the cases where there were comments that were kind of jarring.
• "Had an entire waiting room of foster kids; Rosemary said she sees at least 10 Risperdal prescriptions go out a day."
• "Continued selling Risperdal for bipolar and mood in mono- and combo-therapy; agreed to using more after hard close; used mtab in a child and encouraged increased use here."
• "One of the best calls with her!! Discussed the core M&M message vs Zyprexa/Seroquel; really pushed Texas PDL vs Zyprexa because the office is having major problems with wait time and gathering info for the PA process ….. Use this to our advantage!! This office is all Medicaid!! She prescribed … Risperdal while I was there, maybe show the combo effect of Concerta/Risperdal and the JAACAP next call as lots of kids are on both stimulants and antipsychotics."
• "Continued with John’s call and spoke of new areas to use Risperdal. Used JAACAP to show augmentation to stimulants with low dose – low dose Risperdal for hostility/aggression. This seemed to spark some interest, so we might need to elaborate here since he sees so many kids."
• "Introduced M-Tab with demo and was well received … she said to speak with Dr. Feruzzi to start using immediately … will be very helpful to the unit and for the kids."
• "Core M&A with m-tab intro .. really need to push utilization in his population of kids and on inpatient."
• "Discussed m-tab for ease of care with children and closed here over Seroquel."
• "CGC breakfast/orientation … full intro to new child fellows and quick plug on Risperdal."
• "Back from vacation in SF … pushed m-tab for kids."
• "Good core for M&A with receptor binding chart/KAPUR. need to be better in identifying Seroquel use; full m-tab and agreement to push on parents for new starts with their kids."
• "Doctor will be seeing kids from St. PJ’s on Friday, so might be an opportunity for more business."
• "Thought of every reason not to use, mainly cost and insurance, but I closed her on specific noncompliant patients and kids with difficulty swallowing. "
• "Discussed using Risperdal oral/M-Tab in adolescent and children patients."
• "Go over why Abilify shouldn’t be used in kids, review why Risperdal is best choice for children and adolescent patients."
• "Reviewed MOA [mechanism of action] of Risperdal M-Tab and why it’s ideal for children and adolescents."
But as I listened to all of this testimony and saw the slides of the Call-Notes flashing by, I found myself wondering about the psychiatrists listening to all this. They knew the rules too. Most of them likely knew that the FDA had not approved Risperdal for use in kids. I wondered how many of them said something about that to the reps themselves or to the authorities. Who would you even report it to? I suppose the FDA, but I don’t know for sure. I didn’t see drug reps myself, so it never occurred to me to know the answer. But it does now.