Former FDA chief David Kessler says J&J broke the law in promoting Risperdal
The Philadelphia Inquirer
by David Sell
October 4, 2012
Former U.S. Food and Drug Administration Commissioner David Kessler, a pediatrician by training, said that Johnson & Johnson and its Janssen subsidiary broke the law in marketing its antipsychotic drug Risperdal for use in children and adolescents. "In my opinion," Kessler wrote in a report submitted for a trial set to begin Oct. 9 in in Philadelphia’s Court of Common Pleas, "Janssen promoted Risperdal for non-approved uses in violation of the Federal Food, Drug, and Cosmetic Act."[UPDATE: J&J settled four so-called bellweather cases Thursday morning for undisclosed amounts. Asked if the prospect of Kessler testifying against the company prompted it to offer enough to settle, plaintiffs’ attorney Stephen Sheller said, "Yes."]
In his report, Kessler wrote that there were levels of concern in these matter and actions of J&J and Janssen rose fairly high. "The promotion of non-approved uses by a manufacturer, because it undercuts the system and safeguards of drug regulation, is concerning," Kessler wrote. "The promotion of non-approved uses by a manufacturer of powerful drugs is more concerning." "The promotion of non-approved uses in the most vulnerable children of powerful drugs is most concerning." "Janssen’s promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling."
Kessler served as FDA Commissioner from 2000 through 2007, under Presidents George H.W. Bush and Bill Clinton. It probably won’t shock anyone to know that J&J’s attorneys in the lawsuit didn’t want Kessler saying anything on the witness stand in the suit, in which a Missouri mother sued on behalf of her 16-year old son who grew breasts after being prescribed Risperdal. But the J&J attorneys in their motion to prevent Kessler from testifying focused on the relatively last-minute nature of the plaintiff’s attorneys request to add Kessler to the witness list and the submission of Kessler’s 92-page report, without letting them depose Kessler ahead of time.
"On August 20, 2012, almost four months after fact discovery closed and three months after the deadline to produce generic expert reports passed in this bellwether case, counsel identified David A. Kessler, M.D. as a trial witness in this mass tort for the first time," the motion read in part. "Almost one month later, on September 18, counsel produced Dr. Kessler’s ninety-two-page expert report in another bellwether case. Finally, on September 27, Plaintiffs S.B. and Donna Barney informed Janssen that they intend to call Dr. Kessler as ‘a failure-to-warn expert[.]’ Plaintiffs should be precluded from calling Dr. Kessler at trial, as their untimely disclosure of his identity violates the discovery rules governing this mass tort and causes the unfair prejudice they are designed to prevent." Kessler’s report was posted to the Court of Common Pleas electronic docket system late Wednesday in four pieces, as part of the J&J motion to preclude him from testifying. The pieces are all PDFs and links are here, here, here and here…
Risperdal reproached!
In the case of drug companies greedy exploitation of the *mentally challenged* with the SGA (Second generation Anti psychotics) it is especially contemptible.Most subjects victimized are disadvantaged mental patients,many one step from costly $1,000 day institutions and the state handlers are more than willing to *experiment* with a $15 per pill medication.A mental patient or a child is unlikely to sue for damages.
J and J the ‘baby care people’ are getting no slack for their association with family care products.
-Daniel Haszard FMI http://www.zyprexa-victims.com
I understand that it is good that Kessler is coming forward now but where was he when this was actually going on and he was heading the FDA !
Sandy,
I agree, but I wonder where I was too. Some of it was that we were all in the dark too, though I agree that he was in a position where he was more likely to have “known.”
Mickey
I have enormous respect for you but I was working in the 90’s (in a practice in which neuroleptics were first line) and saw the change in how pharma infiltrated academic practice. I knew they were not supposed to promote off label uses and I was wondering where the FDA was on this. Perhaps they did not have evidence for the most egregious practices (ghost writing, etc.), but I do not understand how they missed so much of this. It was clear to me that the risperidone study above was flawed because the dose of haloperidol was so high. It was also clear to me within a year that olanzapine caused serous weight gain. It was also clear that the much touted claims that the second generation neuroleptics were effective for negative symptoms were exaggerated.
I think that some clinicians were naive to the influence of pharma advertising, thinking they could go to the dinners and not be influenced but I do not understand how the FDA and the academics who were deeply involved could not have been more aware of the distortions in how these drugs were promoted. I have a hard time giving Kessler a pass on this without having some more explanation.
Sandy,
Your point is well made and taken. I think I’m still so mystified at what I didn’t know myself that I’m too permissive on that point. I knew psychiatry had become alien to me and I avoided it in part because I felt exiled and in part because it seemed irrelevant. My colleagues after academia were in the analytic community, the broader psychotherapy community, and the college academics who were in graduate departments [psychoanalytic studies, comparative literature, etc]. I was busy with patients and teaching [and life], and I don’t think I knew that I was living in a bubble. I guess that’s the way it is when you’re in a good bubble.
But unlike you, I didn’t see regular psychiatric practice, or drug reps. Since I rarely wrote prescriptions, I didn’t even know what “off-label” meant. I saw lots of difficult and challenging patients, but they weren’t “Kraepelinian” – rather they were among the personality disordered and traumatized. You’re completely correct in that after I retired and later came back to do some volunteer work, it didn’t take long [a week or two] to become horrified at what patients were taking. I bought some textbooks and started reading articles, and it was worse than I could’ve imagined. I kept saying that I was a ‘stranger in a strange land’ – because I was.
As for Kessler, He’s a pediatrician appointed by Bush Sr. but reappointed by Clinton. He was a do-gooder type – getting AIDS drugs approved and rabidly crusading to shut down the tobacco industry via the FDA. According to Wikipedia, he left the FDA in 1997. He might have missed the main event with the atypicals…
Point well taken. Thanks.