Did Johnson & Johnson know about - and try to hide – the side effects of Risperdal, the company’s popular anti-psychotic? The possibility has been raised by newly released internal documents related to a clinical trial known as RIS 232. The documents were released by the Department of Justice and make for some pretty interesting reading.
A substantial proportion of the subjects who were enrolled should not have been enrolled.
Risperdal’s already in the news a lot lately; J&J’s multi-billion dollar settlement over its practice of encouraging off-label uses of the medication made headlines around the world. Now, however, new accusations have come to light – specifically, that Janssen, a J&J subsidiary, never publicized the results of RIS 232 despite one researcher writing in an email that they had a “moral and ethical responsibility” to do so.
The emails released by the Department of Justice include a request by a clinical researcher that Janssen publicize “safety data, including events that have been labeled in the past as ‘cerebrovascular adverse events’ and death.” The name of the researcher has not been released, but the following paragraph shows pretty clearly how strong his or her opinion was:
Respecting fully any confidentiality agreement that I have with Janssen, it is obvious to me and to others who may not be so bound and who have learned about the data that this trial is on its face nearly completely negative… because a substantial proportion of the subjects who were enrolled should not have been enrolled, and would not have been prescribed antipsychotics if they had been ordinary clinic patients.
The study was eventually released in 2006, more than ten years after Risperdal had become commercially available. The newly-released documents are part of a wider agreement between J&J and the Department of Justice that brings an end to the investigation into Risperdal’s marketing. The company has also been accused of bribery and of encouraging Risperdal’s use in elderly dementia patients, as well as children.
If you’ve experienced problems after taking Risperdal, including male breast growth (known as gynecomastia), it’s not too late to seek legal help. Share your experiences in the comments below or fill out the form on the right for more information.