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Drug Company May Have Altered Study on Risperdal Side Effects

RisperdalAs recent litigation regarding pharmaceutical risks and complications has demonstrated, there is ample evidence that major drug companies have influence on both doctors and their published research.  The Star reports that former head of the FDA — Dr. David Kessler — believes that physicians were manipulated by Janssen to understate the side effects of their antipsychotic drug Risperdal in a 2003 article published in the Journal of Clinical Psychiatry. According to the published findings, there was no significant link between Risperdal use in young males and abnormal breast growth – a condition known as gynecomastia.

The allegedly skewed article on Risperdal side effects was cited in recent product liability litigation filed against Janssen as a purported example of their conduct.  In documents submitted to the court, a draft of the study shows results that were deemed “significant” by one Janssen staff member that were never included in the published version. According to Kessler’s investigations and report, Janssen “controlled and influenced” over 40 medical manuscripts, including one by a Toronto doctor who co-authored the Risperdal study.

Kessler argues that Janssen’s deceitful promotion of Risperdal use in young children is “deeply troubling” considering the drug’s inherent risks.

Published study downplays risk of Risperdal side effects

Denis Daneman, the pediatrician-in-chief at Toronto’s Hospital for Sick Children, told the Star about his role in the 2003 article. “My name is on an article in which there is some data that has been left out. That, to me, crosses a line.” Over the course of his career, Daneman has co-authored dozens of other published scientific journals.

Daneman told the Star his contributions to the article were made in good faith and that he had no knowledge of alleged revisions to the data by Janssen employees. However, during a 2012 deposition in the U.S., in which he was questioned by a claimant’s attorney, Daneman conceded that the Risperdal research reflected data errors that ultimately minimized the rate of adverse side effects.

Janssen has gone on record saying they disagree with Kessler’s report, which was prepared for a lawyer representing more than 400 plaintiffs who claim they suffered Risperdal breast growth after taking the drug. All of the claimants contend that they were not properly warned about the risks of gynecomastia and that Janssen purposely misled the public in their quest for financial gain.

Kessler’s report includes a Janssen business plan for Risperdal, in which the company states its goal is to “leverage the data and the business opportunity within the child/adolescent market via medical education.”

New studies suggest risperidone and gynecomastia risk

And while Daneman admits that data calculations may have been off in his co-authored report, he says the results are still consistent with other published research regarding Risperidone side effects. However, more recent findings suggest otherwise. An epidemiologic study on one million U.S. men taking Risperdal found that patients were more at risk for developing gynecomastia compared to those not taking the antipsychotic. This combined with another review by FDA researchers that demonstrates how Risperdone influences prolactin production and breast growth may bolster allegations raised in Risperdal lawsuits filed across the country.

Risperdal lawsuits continue to be filed against Janssen

The bulk of litigation involving Risperdal and gynecomastia has been coordinated in Philadelphia, where earlier this year, a jury handed down a $2.5 million judgement to a male plaintiff who developed size DD breasts after using the drug when he was a child. The defendant has since attempted to have the Risperdal verdict overturned.

In a separate lawsuit, the Philadelphia panel determined that Risperdal did not cause the plaintiff’s breast growth, but it did find that Janssen failed to adequately warn about the heightened risks of gynecomastia.

  1. The Star, Drug company accused of altering study by top SickKids pediatrician

  2. Journal of Clinical Psychiatry Prolactin levels during long-term risperidone treatment in children and adolescents