I know that transcripts from a trial are tedious, and more or less, I’m likely preaching to the choir when it comes to the misbehavior at Janssen with Risperdal. But there’s one part that struck me particularly hard listening to the testimony. It began during the testimony of Arnold Friede, the Plaintiff’s expert witness in FDA Law [volume 5], but continued in the testimony of other witnesses – adverse and sympathetic. He focused on three areas:
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Promoting Risperdal as superior to other antipsychotics even when forbidden by the FDA and being warned for infractions
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Continuing to deny Risperdal’s propensity to weight gain and glucose intolerance even when warned by the FDA
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Promoting Risperdal off-label in children
And he showed that these misbehaviors were present at the Corporate level [business plans], at the level of staff training [slides and promotional materials], and from the field – the direct interface of the Sales Reps with doctors. During the period he was examining, Risperdal was not approved for any use in children – in fact it had been specifically turned down for use in children by the FDA.
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.
These are some examples from the testimony in the transcripts:
• "Big M-Tab push in kids and advantages" – "and advantages special population."
• "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."
• "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."
The rules are clear. Everybody presumably knows them. Doctors may prescribe off-label, but Pharmaceutical Companies and their Sales Reps are forbidden from promoting a drug for any indication that’s not specifically approved by the FDA. And this wasn’t just rogue Reps promoting off-label, it was company policy, a concerted campaign that was competing with other companies promoting similar drugs off-label [something that’s clearly illegal and the subject of multiple other suits in both the past and the future]. The defense in Cross-Examination was that the Sales Reps never said Risperdal specifically had FDA Approval in children. Lame!
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.
That Janssen’s marketing was way out of line would be apparent to anyone listening to the evidence presented in this trial – particularly the Call-Notes – but I found myself wondering about the doctors listening to this sales patter. This pitch obviously worked because the sales of Risperdal soared throughout the period in question. Every single pill that was part of that obscene Janssen profit graph was from a prescription written by a physician. I was sitting in that trial decrying Janssen’s under-the-table financing of the TriUniversity Guidelines and TMAP, paying Steven Shon et al to sell their bogus Algorithms to other States, sending out waves of pretty young women with no science background to sell doctors on Risperdal off-label, defying the FDA’s clear directives about what they could and could not advertise, seeding the literature with ghost-written articles, and so many other things, but on the side of my mind I was wondering about the doctors. We’re a part of this problem too. Much to ponder here…
“… I found myself wondering about the psychiatrists listening to all this. They knew the rules too.”
Not so fast. You and I (and your readers) may know the rules, but I’m not so sure about others.
“We’re a part of this problem too.”
True that.
“but I found myself wondering about the doctors listening to this sales patter. This pitch obviously worked because the sales of Risperdal soared throughout the period in question. Every single pill that was part of that obscene Janssen profit graph was from a prescription written by a physician. I was sitting in that trial decrying Janssen’s under-the-table financing of the TriUniversity Guidelines and TMAP, paying Steven Shon et al to sell their bogus Algorithms to other States, sending out waves of pretty young women with no science background to sell doctors on Risperdal off-label, defying the FDA’s clear directives about what they could and could not advertise, seeding the literature with ghost-written articles, and so many other things, but on the side of my mind I was wondering about the doctors. We’re a part of this problem too. Much to ponder here…â€
Mickey—
Thanks for the above inclusion. A decade (or more) earlier, diabetics were facing the same kind of dilemma. My hubby—who had used natural animal insulin for more than 3 decades (at the time), actually tried the new, “latest-greatest†product—rDNA insulin. Genetically engineered, promoted as “just like the human body makes—who wouldn’t want to use human insulinâ€â€”but found it was problematic. When he reported the results to his physician—a corporate enabler if ever there was one, he was fired—“if you don’t trust me, get another doctor†were the words used, I believe. Neither the manufacturer, the clinician(s), nor the regulator (FDA) would acknowledge the adverse events reported by hubby and some of his peers.
Over the years, I have been so angry at the medical professionals treating diabetics because, as you say, “Every single pill (injection) that was part of that obscene Janssen (Lilly) profit graph was from a prescription written by a physician.†Trying to lessen my anger, I recognize that some doctors could ‘see the writing on the wall’ and were finding a pathway that would allow them to continue caring for their patients. Others, I am sure, were already trapped in the business model that demanded they see ever-increasing numbers of patients to merely pay the help and keep the lights on> They were truly “too busy†to challenge the changing paradigm. Another group, in all likelihood, had no intellectual curiosity to truly investigate the claims by pharma. If that cute little sales rep had the literature to support the company claims, that was good enough. And I’m sure a small group could see the proposed business model that would enhance both their stature and checkbooks. But in those quiet, dark moments when I see where diabetes is now situated, I continually return to the fact that without enabling behavior by doctors, things would be different (if not better) now. If a single KOL or a small coterie of practitioners had merely shouted, “Not so fast, my friendâ€, would direction, research and treatment have been better? Unknowable, isn’t it?
Melody