Researchers Backpedal From Their Own Risperdal Study

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11/20/2013 

In the wake of the $2.2 billion settlement by Johnson & Johnson to resolve criminal and civil charges for illegal marketing of the Risperdal antipsychotic pill (more here), two of the authors of a medical paper that was used to inappropriately market the medicine are back peddling from the publication, according to The Chronicle of Higher Education.

Denis Daneman, a professor and chair of pediatrics at the University of Toronto, asked The Journal of Clinical Psychiatry, which published the article a decade ago, to retract the article or remove his name. But the publisher declined to do so, maintaining that the article was peer-reviewed and there was no evidence of any misrepresentation, the paper writes.

Meanwhile, Robert Findling, a professor of psychiatry and behavioral sciences at the Johns Hopkins University, says the settlement has prompted him to reconsider the article. “In light of recent events,” Findling told the paper, “I am concerned about the questions raised and, if there are errors, am committed to determining what they may be and to correcting them.” But he adds, “at this time, I do not have sufficient scientific evidence that would lead me to ask for a retraction.”

The publisher, John Shelton, did not respond to the Chronicle and, Alan Greenberg, the editor in chief and a professor and chair of psychiatry at the Pennsylvania State University medical school, also did not respond to requests for comment.

Here is the significance: Risperdal was not approved for use in children until 2006, but was known to cause various side effects in youngsters, including gynecomastia, which is the abnormal development of large mammary glands in males. But J&J marketed the pill aggressively to children, according to documents filed by the US Department of Justice (exhibits are here) and lawsuits filed against J&J by numerous families.

And the journal article concluded that levels of prolactin, a hormone that can stimulate breast development and milk production, tended to rise and fall within the first couple of months in boys taking Risperdal, but then steadily declined to a normal range in three to five months (here is the abstract). The article also included an error that cut by half the actual rate at which young boys taking the pill developed breasts, according to the Chron.

The journal article was among 44 scientific papers that were managed by J&J to influence Risperdal prescribing, according to a company document cited in a report compiled by former FDA commish David Kessler, the Chron writes. The report was prepared in connection with his role as an expert witness in the Risperdal litigation.

In his report, Kessler reviewed various efforts to promote Risperdal to physicians allegedly without providing sufficient side effect data, such as preparing articles for publication in medical journals and sponsoring symposiums in which lectures were delivered by academics and physicians dating back more than a decade ago in which off-label use was discussed. His report includes excerpts from internal memos (read hereherehere and here.)

As for the authors of the 2003 article, several have industry ties. Findling, for instance, listed three dozen companies, including J&J, in recent financial disclosures, the Chron writes. Daneman says he rarely participated in clinical trials and relied in the 2003 article on data provided by others, according to the Chron.

He adds that he still believes academic physicians should help drugmakers evaluate medicines, but  “there is sometimes a line crossed, obviously, and that’s happened here, in terms of what the drug company has expected its physicians to sign off on—and that scares the living daylights out of me.” He says he was paid $5,000 for his work on the article and will now donate the money to charity.

“We need doctors like him to set this example of leadership and integrity,” Steve Sheller, an attorney who has filed lawsuits against J&J over the gynocamastia, tells the Chron. As for Findling, he notes that the physician is editor of Child & Adolescent Psychopharmacology News, which published an article this month saying it was known in 2002 that Risperdal increased prolactin levels more than similar drugs.

Link

Researchers Back Peddle From their Own Risperdal Study” Pharmalot, November 20, 2013

 

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