1 Boring Old Man

Another blogger covering the trial has a pretty good profile of Allen Jones from last week [Lucre and the law: A money narrative of who stands to gain from suing a pharmaceutical company]. It’s ongoing coverage [see Risperdal on Trial].

I want to go back to the beginning of the day and start from scratch. A Call Note is something drug reps for Janssen filled out after every contact with a doctor. The focus in the morning was on the calls on Child and Adolescent Psychiatrists. The comments, when available, were short, abbreviated – sort of like a "tweet" on "twitter." Among the large number of Call Notes they had, many had no comment. Even stranger, a lot of the Call Notes for C&A had no comment blank at all to even fill out. So first up was Tiffany Moake, the drug rep covering San Antonio 2002 through 2004 followed by her District Manager Shane Scott. Tiffany has some kind of relationship with Janssen – paid for her time being deposed, represented by their Lawyers. She was guarded and defensive. She was apparently a top seller. They showed several emails and slides that highlighted her enthusiasm. Up front, she said that she had not detailed Risperdal off label for kids to her docs and denied having "ice cream parties" for her C&A docs. Then, we saw Call Note after Call Note where she had documented detailing her docs to use Risperdal in kids and having held ice cream socials. Moake continued to claim a lower incidence of Diabetes even after the FDA warning letter. Shane Scott? same thing, though he said he was "concerned" hearing Tiffany’s Call Notes. Both denied off-label promotion. But the Call-Notes left no doubt that they were pushing Risperdal use in children, even having a "back to school" campaign. This was all before Risperdal had been approved for any use in children. For example, one Call Note talked about detailing a psychiatrist with a "waiting room full of foster kids"  who produced "ten Risperdal prescriptions a day."

• Children are more vulnerable to Adverse Events than adults.
• The first FDA Approval for Risperdal in kids was Irritability associated with Autism in 2006. It was approved for the Manic phase of Bipolar Disorder and the Psychosis with Schizophrenia about a year later. All three rare conditions.
• He reviewed literature showing that doctor’s prescribing habits are affected by contacts with pharmaceutical reps, by "seeded" literature, and showed spreadsheets with articles being generated by medical writers with authors "TBD" – "to be determined."
• He showed a review of studies of Risperdal in children: 600 articles found, only 161 had data, only 3 were double blind placebo controlled studies.
• He quoted the TEOSS study [double blind placebo controlled with comparators] that showed no advantage for Risperdal over first generation antipsychotics [an 8 week study]. The later 44 week follow-up showed only 4 of the 44 Risperdal patients were still on Risperdal at one year.

The reason I just listed things [I’m sure I missed some] was that all the conferences and objections fragmented the testimony and made it hard to follow. The cross examination was long and consisted of a recapitulation of the Risperdal selling points from their sales campaign. They added in some Call Notes where doctors expressed enthusiasm for Risperdal, others where they wouldn’t use it. Dr Perry had been prohibited from talking about marketing because it was outside his area of expertise, yet the cross examination was all about marketing. I wondered why the plaintiff’s lawyers didn’t object. But on redirect, that meant that Dr. Perry was allowed to discuss marketing practices and unintended biases [since the defendants opened up the topic]. I realize that my summary of this testimony is disjointed. That’s how it felt in person. Obviously, the defendants’ lawyers wanted to defuse this testimony. They didn’t totally succeed, but they sure made things confusing.

I’m flying home tomorrow night, so I’ll be able to stay for tomorrow’s morning session. I wish I could stay the course, but even retired people have responsibilities. In some ways, I also look forward to getting away from the courtroom so I can think about this trial, or at least the part of it I witnessed. As I wrote earlier in the day, when I’m there, I get so caught up in the details of court procedure and the specific testimony that it’s hard to get above the din. This is one thing I do know. Watching the deposition of Dr. Shon last week and several depositions of the Janssen employees along the way – it was worse than I thought. The term "loose cannons" come to mind. Dr. Shon was jetting from place to place on Janssen’s nickle selling TMAP around the country. He had Janssen’s checks sent to him personally. He participated in Janssen’s marketing plans and execution all the while while being the medical director of the TXMHMR. He was supported by Janssen because he held that position. All of that was not just against the rules, it was illegal.

Another thing I know is that the off-label marketing  of Risperidal for kids was Janssen directed, Janssen executed, and blatant. The Call Notes were uncontestable evidence from where I sat in that courtroom. Another thing I knew, but now know better – TMAP really was a scheme to get the State of Texas to use drugs that cost forty or fifty times as much as the alternative, equally effective drugs. And Janssen continued to deny adverse effects like Diabetes even when directed by the FDA to come clean. I know Janssen seeded the literature with articles to support their campaign. I’m not on that jury, so what I’m now sure I know is of no consequence in the outcome of the trial, but it means a lot to me because I heard it with my own ears and saw the documents with my own eyes.

I doubt that I’ll ever forget this week in Austin Texas. Besides being interesting in and of itself, it was another confirmation of the fact that many of the changes in psychiatry that I’ve witnessed over the last twenty-five years have not been some natural evolution of the specialty, some scientific revolution. A major factor has been the active intrusion of the pharmaceutical industry into the field, in this case involving complicity of both academic and administrative psychiatrists.