November 13, 2013 — In the wake of a $2.2 billion settlement with the Department of Justice (DOJ), evidence has emerged that Johnson & Johnson (J&J) and Janssen Pharmaceuticals intentionally withheld data from clinical trials involving Risperdal (risperidone), according to the civil complaint.
Prosecutors cited several memos written by physicians involved in the RIS-USA-232 clinical trial. It was the fourth study of Risperdal in elderly dementia patients. Results of the study were available in March 2003, and they were very concerning — Risperdal was not effective at treating dementia, and it was associated with a higher risk of cardiovascular events. Today, Risperdal carries a “Black Box Warning” that it increases the risk of death for elderly dementia patients.
Janssen did not immediately disclose these results to sales representatives or doctors who were requesting information on Risperdal. On September 1, 2003, the physician who designed the RIS-USA-232 trial encouraged senior executives at Janssen to publish the results. According to the physician’s memo (PDF):
“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.”
Janssen continued to conceal results of the RIS-USA-232 study throughout 2004. They provided “pooled data” from three previous studies, but not RIS-USA-232. In March 2004, another physician wrote a memo (PDF) admonishing Janssen for stalling:
“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.”
Executives at Janssen finally agreed to present data from the RIS-USA-232 trial at medical symposiums in June and October 2004. In March 2006, the full results of the trial were finally published.