Evidence J&J Withheld Risperdal Clinical Trial Data

November 13, 2013 — Evidence that Johnson & Johnson’s subsidiary Janssen Pharmaceuticals withheld clinical trial data on Risperdal (risperidone) emerged last week, after the company agreed to a $2.2 billion settlement for illegally marketing Risperdal. The complaint (PDF) filed by the Department of Justice (DOJ) cited several memos from physicians involved in the trial.

The clinical trial in question was called RIS-USA-232. It was the fourth study involving Risperdal in elderly dementia patients. When Janssen received results of the study in March 2003, they showed that Risperdal was not effective at treating dementia and increased the risk of cardiovascular events. The results of the study were not immediately disclosed.

On September 1, 2003, a physician who designed the RIS-USA-232 trial sent an memo (PDF) to a senior Janssen executive to encourage publication of the results. According to the physician:

“Janssen has been sitting on the [RIS-USA-232] trial results for a long time. Yet it has a moral and ethical responsibility to publish results quickly and in a way that they can be understood and makes clinical sense. It has an obligation to publish not just the clinical efficacy data which could very well be informative and supportive of the use of risperidone if considered properly, but also the safety data, including events that have been labeled in the past as “cerebrovascular adverse events” and deaths.”

Through 2004, Janssen told doctors and sales representatives about “pooled data” involving three earlier clinical trials of Risperdal, but they did not include data from the RIS-USA-232 trial. In March 2004, another doctor urged Janssen to include data from the trial in this memo (PDF):

“At this point, so long after RIS 232 has been completed, I think it is wrong to continue to submit abstracts of the three pooled studies. At this point, we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings from RIS 232.”

Janssen executives agreed, and finally presented the study and safety data at medical symposiums in June 2004 and October 2004. The full results of the study were published in March 2006.

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