1 Boring Old Man

J&J CEO Alex Gorsky talks Risperdal, via deposition, with lawyers nearby
Philadelphia Inquirer
by David Sell
September 17, 2012

Johnson & Johnson Chief Executive Office Alex Gorsky was proud enough of helping to boost Risperdal sales to include the numbers on his resume at one point, according to court filings, but he is trying to hard to avoid talking about the antipsychotic drug on the witness stand in front of a jury in a trials scheduled for the next several weeks in Philadelphia… The 60-page transcript of Gorsky’s deposition in the individual suit filed by Aron Banks in Philadelphia was a publicly-available exhibit in the case. Gorsky was ordered to give a deposition in that case, just as he was in the Texas whistle-blower lawsuit brought by former Pennsylvania investigator Allen Jones, which ended after six days of trial with J&J paying $158 million to settle… As for Gorsky, Drinker, Biddle attorneys fought the deposition and then spent 10 hours with him preparing. Pharmaceutical industry veterans might remember – and dismiss as normal practice – episodes from 2000-02 discussed in deposition. But regular people who serve on juries might not find them so acceptable, and plaintiffs attorneys Stephen Sheller and Brian McCormick hope to use much of that.

For example, the jury would hear about Dr. Joseph Biederman, the Harvard Medical School professor and Massachusetts General Hospital pediatric psychiatrist who gained fame – and criticism – for advocating the greater use of pharmaceuticals to treat children with perceived mential illness long before the U.S. Food and Drug Administration approved in still-limited ways, drugs like Risperdal for children. Biederman was exposed in 2008 by Sen. Charles Grassley (R.-Iowa) for not reporting payments from drug companies and the stories got a lot of attention then. And they would be replayed. The jurors would learn that Risperdal was only approved for adults with schizophrenia and bipolar disorder in 2001, but because that has a limited number of patients, J&J has been accused of inappropriate promotion of the drug for uses not approved by the FDA.

In the deposition, McCormick walks Gorsky through Biederman’s one page letter, dated Dec. 7, 2001, requesting $500,000 payment to start what became the Johnson & Johnson Center for the Study of Pediatric Psychopathology. Gorsky says in the deposition that he approved that payment. Any chance J&J was trying to buy its way to an endorsement for greater use of Risperdal from Biederman and by extension, Massachusetts General Hospital and Harvard, or at least wider diagnosis and treatment of child and adolescent mental disorders? "I think our goal was to, yes, have better diagnostic criteria for children who are in need of treatment and to have better therapeutic options for children who are in need of treatment," Gorsky said, according to the transcript of the deposition.

The jury likely would then hear McCormick, as he did in the deposition, discuss with Gorsky a document called "Annual Report 2002: The Johnson & Johnson Center for Pediatric Psychopathology at Massachusetts General Hospital." Biederman was the director of the center and one of the goals of its research, according to the report, was that "it will move forward the commercial goals of J&J." A link to the PDF transcript of Gorsky’s deposition is here.

^{BY MR. McCORMICK:
Q. The next sentence says, "Although the RISPERDAL Base business is rooted in the Schizophrenia marketplace, another fast-growing portion of this market is in children and adolescents. The child/adolescent antipsychotic segment (19 years and under) is growing at a rate of 17% and is currently valued at approximately $340 million. Use of RISPERDAL in this segment has grown 50% in the past two years, and prescriptions in this category account for 20% of overall RISPERDAL use." Did I read that right?
A. Yes, you did.
Q. And because of the growth of the child and adolescent antipsychotic market, did Risperdal begin to — did Johnson & Johnson begin to approach this market in a different way in or around 2001?
MR. MURPHY: Objection to the form of the question, lack of foundation. You may answer.
THE WITNESS: Not that I’m aware, other than we were continuing to pursue the clinical development program of the product in that area.
MR. McCORMICK: Okay.
BY MR. McCORMICK:
Q. Turn to the top of the next page, please, page 261. See where it says "RISPERDAL use in the child/adolescent population is exploding"? Is that correct?
A. That’s what it says, yes.
Q. Then down below it says, "Key Base Business Goals — well, strike that. I’m sorry. "RISPERDAL use in the child/adolescent population is exploding," but in this time frame, 2001/2002, Risperdal is not indicated by the FDA for any pediatric use, is it?
A. Again, we did not have the specific indication, as we discussed earlier, until 2006. I don’t remember exactly what the labeling said regarding use in children, but as I discussed earlier, there was a significant — there appeared to be a significant increase in the recognition of this condition in children and adolescents during this time, which was substantiated by data and its occurrence. And physicians have an opportunity to use a treatment that they perceive to be appropriate and effective in a particular patient population, and that’s clearly what we were seeing happening in this area.
Q. Look down at the heading that says "Key Base Business Goals and Objectives." Do you see that?
A. Yes.
Q. And the fifth of the Key Base Business Goals says "Grow and protect share in child/adolescents." Is that right?
A. Yes, that’s correct.
Q. My question is, how can Johnson & Johnson grow a share in a child and adolescent market when the drug isn’t even indicated for use in the child and adolescent market?}

hat tip to Jamzo