1 Boring Old Man

J&J Marketed Rispersal for Children After FDA Warnings, Texas Jury Told
Bloomberg
By David Voreacos, Margaret Cronin Fisk and Jef Feeley
January 14, 2012

The antipsychotic drug Risperdal was marketed for children and adolescents by Johnson & Johnson’s Janssen unit after warnings by the U.S. Food and Drug Administration not to do so, a witness told jurors. Janssen’s marketing to children began after the drug’s introduction in 1994 and continued until the FDA’s first approval for pediatric uses in 2006, jurors in state court in Austin, Texas, heard yesterday from attorney Arnold Friede, an expert witness for the state. Texas seeks at least $579 million from J&J, claiming it defrauded the state Medicaid program by hyping Risperdal and overbilling. Friede explained company documents and FDA letters as lawyers for Texas seek to show Janssen repeatedly disregarded agency admonitions to not market Risperdal beyond its initial approved use for psychotic disorders including schizophrenia…

In questioning yesterday, Friede reviewed a 1994 business plan for Risperdal that discussed “seeding the literature and, if appropriate, changing current labeling” for uses including sales to children. Friede said company policy stated “seeding” studies or those with “limited scientific value generally designed to promote product utilization are prohibited.” He reviewed an FDA letter that denied a 1996 application by Janssen to allow use in children. The Janssen application never said “for what child or adolescent psychiatric disorders Risperdal would be intended,” the FDA said. “Your rationale for proposing this supplement appears to be simply that, since Risperdal is being used in pediatric patients, this use should be acknowledged in some way in labeling,” according to the FDA letter in September 1997. Typed notes by Janssen sales representatives of their calls on doctors showed they discussed the use of Risperdal with children, Friede told jurors.

Friede also reviewed FDA admonitions to Janssen to avoid saying that Risperdal was superior to an earlier class of antipsychotics. The drug agency sent J&J a warning about its Risperdal marketing practices in 1999. It followed with a stronger warning after the company sent a letter on Nov. 10, 2003, to 700,000 doctors in the U.S. J&J wrote to tell the doctors that the FDA wanted all makers of so-called atypical antipsychotics, including J&J, Pfizer Inc., and Eli Lilly & Co., to warn in product labels of the risk of hyperglycemia and diabetes mellitus. J&J said research “suggests” that Risperdal “is not associated with an increased risk of diabetes” compared with an earlier class of antipsychotics. It also said evidence “suggests” Risperdal is “associated with a lower risk of diabetes than some other studied atypical antipsychotics.”

An FDA warning letter sent in April 2004 said the J&J missive failed to disclose new data on diabetes in the warning label; “minimizes the risk of hyperglycemia-related adverse events” that can lead to coma or death; fails to recommend glucose control monitoring for patients; and “misleadingly claims that Risperdal is safer than other atypical antipsychotics.” J&J then sent a corrective letter to doctors…

In the course of the day, we were shown four documents that relate to my topic. First, we looked at a document from the President Gorsky of Janssen around Risperdal roll-out time. It was about coorporate policy – a lofty document that specifically said there was to be no "seeding" of the literature, that publishing studies of “limited scientific value generally designed to promote product utilization are prohibited.” It also said that promoting  "unsupported" or "off-label" uses of medications were "illegal" and reflect badly on the "reputation of the company." Then, a bit later, we saw a Business Plan about expanding the market [1994] that listed "children" as a targeted market. It said "’seeding the literature and, if appropriate, changing current labeling’ for uses including sales to children." So much for Gorsky’s policy Memo. The third document in my chain was an FDA letter from 1996, responding to Janssen’s request for approval for kids. In essence, they said "No." The request had been unaccompanied by any studies. The FDA knew of no studies that would meet their requirements. And the request essentially was based on the fact that Risperdal was being widely used in children – why not make it official? When I saw that FDA letter, I read it as a "not just NO, but HELL NO!" letter.

Time passed in the courtroom, during which Mr. Jacks, lawyer for the Plaintiff, and Mr. Friede went through the Business Plans, the Training materials, and the drug reps’ Call-Notes showing widespread evidence of misbranding  and off-label promotion. I can only say "slam-dunk" or "nailed" as my own reaction [I don’t even need to put my usual "I’m biased" disclaimer]. Jacks and Friede made the phrase, "and that’s why I get paid the big bucks" come alive. I wondered what the Janssen lawyers were going to do when it came to cross examination. But, they get "paid the big bucks" too, so I knew they’d have something to say.

As they droned on, nit-picking the call-notes ["How do you know when the note says ‘kids’ that they meant…?"], my mind wandered. Then, they produced the fourth document. It was Janssen’s request for approval for children [1996] to the FDA – the one turned down in the third document [above]. Mr. Friede hadn’t seen it. It was as advertised – saying since people were already using Risperdal in kids, why not approve it? I was still not fully attentive, but then I got the gist of where the cross-examiner was going. He was suggesting that Janssen was applying for approval with no supporting data or studies for altruistic reasons. He suggested that since it was already being used in kids and teens, Janssen wanted approval so their drug reps could talk to doctors about the proper doses – to keep doctors from using excessive doses of Risperdal. I was by now fully alert and fighting the impulse to stand up and say, "Are you serious?"

We’d just been shown a business plan  from two years before that laid out a campaign to promote Risperdal by, “seeding the literature and, if appropriate, changing current labeling” [recall that “seeding the literature” means publishing studies of “limited scientific value generally designed to promote product utilization"]. I know the Janssen lawyers needed to try to discredit this very credible expert witness and that one way to do that is instill doubt in his testimony and to make their client look good. But this was too far out in left field for my sensibilities. And by the way, “seeding the literature” isn’t exactly kosher. Their own President had explicitly prohibited it. It essentially means flooding the literature with "experimercials" – industry conducted studies written professionally by ghost-writers and signed onto by KOL "guest-authors" who had nothing to do with the study itself.

I suppose the reason that I found that line of cross examination so offensive is that the Call-Notes from the morning testimony had really brought home just how much effort Jansen was putting into promoting Risperdal off-label to children – detailing child psychiatrists about using Risperdal, leaving reprints of a favorable studies with the doctors, and touting its superiority to Zyprexa in children. I hadn’t really known about that. I thought the use of Risperdal in kids came later, when Biederman’s Bipolar Child craze came on the scene. For them to say that their looking for FDA approval for using Risperdal in kids was altruistic or noble, protecting children from higher doses, was just too cynical.