J&J and Risperdal: New Claims of Kickbacks and Fraudulent Marketing
The news on Risperdal continues to get worse for Johnson & Johnson and its antipsychotic unit, Janssen Pharmaceuticals. Texas officials filed suit against the company alleging Medicaid fraud, kickbacks and improper marketing of the drug to children and the poor in that state. J&J denies the claims.
BNET readers know this is the latest in a series of allegations that J&J orchestrated a dubious campaign to get Risperdal accepted as a treatment for a variety of indications in a variety of populations -- including kids -- when in fact it's a suitable only for a small population of deeply disturbed patients. The FDA recently stated that it wants to reduce use of Risperdal and other atypical antipsychotics in kids. And here's BNET's summary of the alleged money trail J&J created in its funding of the idea that Risperdal should be more widely used. A summary of the new allegations against J&J can be read in the Dallas Morning News.
But it's worth reading the actual complaint yourself. Here's BNET's summary of the highlights, in case you're too lazy to even do that. The state's suit accuses Janssen of getting Risperdal on Texas' list of preferred Medicaid drugs by distributing marketing tools disguised as scientific research:
Statistically insignificant studies, ghostwritten publications, and "independent" articles that were nothing of the kind.
Janssen used Texas' mental health officials as "pitchmen," the suit alleges:Providing them with trips, perks, travel expenses, honoraria and other payments.
The suit begins by setting the stage regarding J&J's expectations of where Risperdal sales would actually come from:Defendants pre-launch marketing plans anticipated that up to 85% of Risperdal sales would be to public sector payors, like Texas Medicaid.
The fact that only 15% of sales were expected to come from traditional insurers is an eye-opener in itself. J&J began by claiming Risperdal was safer and more effective:This was in direct contravention of the FDA's warning to Janssen in December 1993 that the FDA would consider any advertisement or promotional labelling for Risperdal false, misleading or lacking fair balance if there is a presentation of data that conveys the impression that risperidone was superior to haloperidol or any other marketed antypsyhcoic, drug product.
Defendants used tactics such as initiating, controlling and producing scientifically-insignificant studies ... ghostwritten publications, and/or letters to editors of professional journals, and seemingly independent articles related to non-FDA approved indications, some of which were ghostwritten, for marketing and public relations purposes. Defendants engaged in such tactics to "seed the litrerature" and increase the "noise level" in the public and healthcare communities about Risperdal."
This compromised objectivity led to the publication of biased research in favor of Risperdal, which was disseminated by the Defendants' sales force.
That makes the Wyeth ghostwriting claim look like a mere bagatelle. The next part of the suit seems to argue that CME itself is fraudulent (a position increasingly popular in some circles):Defendants masked their undue influence and frauduluent scheme by using third party vendors and advocacy organziations as a conduit for funneling their funding and control. For example, additional marketing tools employed by Defendants included publications and presentations targeting medical professionals and state mental health decision makers disseminated by third party contractors which gave the impression that the information received was from an independent source.
The complaint alleges that Risperdal was approved for only a very small population of adults with schizophrenia and bipolar disorder. But:Defendants used each of the marketing tools described above to promote Risperdal as a medication that could be safely prescribed for a variety of symptoms and disorders in the child and adolescent and other vulnerable populations.
In September 2003 the FDA warned Janssen that it believed diabetes was a side effect of Risperdal, but:It was not until July 2004 that Defendants finally sent a "Dear Healthcare Provider Letter" That was acceptable to the FDA, containing the new warnings."
Another surprising allegation is that the Robert Wood Johnson Foundation funded the Texas Medical Algorithm Project, and as a result Risperdal became a first-line therapy in TMAP, an important guide for doctors as to when therapy should begin. The foundation is one of the most important parts of J&J's brand equity in terms of its commitment to "giving back" to the community. If it was to emerge that the foundation was merely a tool of the drug company's marketing arm, that would be disastrous inside both the foundation and J&J itself:Once TMAP became infused with funding from Defendants and other manufacturers of atypical antipsychotics, the algorithms transformed to require doctors to first treat their patients with the newest, most expensive drugs, the atypicals.
One primary reason Defendants made a significant investment in the Texas algorithms was so they could develop the algorithm models and then export them across the country.
The suit makes a reference to an older investigation of Risperdal that stemmed from Pennsylvania's version of TMAP. The Texas mess was essentially exported to Pennsylvania, the suit claims. The suit next alleges that Texas officials were improperly influenced by kickbacks:The Pennsylvania investigation ... revealed suspected Medicaid fraud and kick-backs involving Defendants, Texas state officials, TMPA and PennMAP.
Finally, the Dallas Morning News blots its copybook somewhat by using this anti-Risperdal source for comment:"The state had a duty to spend our money wisely, to set responsible standards, to keep Medicaid kids safe," said Lee Spiller, research director for the Texas branch of the Citizens Commission on Human Rights, which was established by the Church of Scientology, known for its disdain for psychiatric drugs in general. "They blew it."
Hat tip to Pharmalot.Image from Flickr user ninja poodles, CC