1 Boring Old Man

J&J to Oppose Texas in $1 Billion Trial Over Risperdal Marketing Practices
Bloomberg
By Margaret Cronin Fisk, David Voreacos and Jef Feeley
Jan 9, 2012<

Johnson & Johnson, which has lost judgments of almost $660 million over the marketing of its antipsychotic drug Risperdal, goes to trial today facing a demand by Texas for damages of more than $1 billion. State Attorney General Greg Abbott says J&J’s Janssen unit paid state officials to get Risperdal on approved drug lists, marketed it for unapproved uses to children and the elderly, and lied about its safety and effectiveness. The case in state court in Austin was filed by a whistle-blower and joined by the state, which is seeking reimbursement of Medicaid payments.

A jury weighing only the claim that the company downplayed the drug’s risks awarded Louisiana $257.7 million in 2010. A judge in South Carolina last year ordered J&J to pay $327 million over Risperdal sold in the state. The Texas suit may result in the largest-ever false-claims verdict, said Patrick Burns of the advocacy organization Taxpayers Against Fraud in Washington.

“It’s going to be massive,” Burns said in an interview. “They’ll lose in Texas, and then they’re going to face litigation from stockholders for failing to settle this.” J&J and its Janssen unit, which sold Risperdal, deny any wrongdoing. “We are committed to ethical business practices, and have policies in place to ensure that our products are only promoted for their FDA-approved indication,” Teresa Mueller, a J&J spokeswoman, said in an e-mail. She said the company will fight the allegation…

One thing about the reports on this case that’s regularly omitted. Psychiatrists and other physicians were also victims in this scheme. The allegations focus on the doctors who were complicit in lending their expert status to J&J’s marketing program – creating biased algorithms, becoming traveling salesmen for J&J, etc. But that was a small number of people. The rest of us were eager for a replacement for the toxic drugs used to treat severe mental illnesses and relied on our usual sources of information about this new drug, Risperdal, that told us it was a genuine advance in both efficacy and safety. We had no way of knowing that one of our biggest sources, our literature, was being flooded with ghost-written articles commissioned by J&J, prepared by Exerptia Medica’s professional writers, and published under the names of recruited psychiatrists who were "guest authors" – lending their names and reputations but having little to no involvement in the articles themselves. Dr. Bernard Carroll coined the term "experimercials" for this genre – but we didn’t know that was what they were back then. And, in retrospect, those articles were everywhere.

Had we been properly informed about Risperdal, I expect it would’ve been used with the same caution as its predecessors, and its use more limited to the real indication – Schizophrenia. At least I think that’s what we would’ve done. So in this scheme, not only were psychiatrists and primary care physicians the misinformed agents of the massive overuse of this drug and some of its followers, the doctors now bear the burden of the motive – "Psychiatrists just want to over-medicate their patients." Maybe we earned some of that on our own, but without the cheerleading KOLs, the efforts of PHARMA, the ghost-written literature, [and the pressure from managed care], the magnitude of this problem would be geometrically reduced. There were plenty of well intentioned psychiatrists and general physicians who were as duped by J&J and their compromised, pseudoscientist experts as the patients they gave these medications to.