Johnson & Johnson, Risperdal And A Lack Of Clinical Trial Disclosure

In the wake of the $2.2 billion settlement that Johnson & Johnson will pay to resolve both criminal and civil charges leveled by US authorities has focused attention on off-label marketing practices and kickbacks paid to physicians and a nursing home pharmacy (back story with links). But court documents reveal another troubling issue – withholding clinical trial data. The disclosure comes amid a heated debate over the extent to which drugmakers are willing to disclose trial data. The pharmaceutical industry is, by and large, fighting a proposal by the European Medicines Agency (read here and here) as well as a separate online campaign to provide patient-level data, claiming such a move would compromise trade secrets (look here and here). The episode involving J&J’s Janssen unit occurred a decade ago, but serves to underscore the cries for transparency. In this instance, there were safety signals found in the trial, which tested the Risperdal antipsychotic for treating psychosis in Alzheimer’s patients. At the same time, though, the healthcare giant was allegedly marketing the drug for unapproved uses to the elderly, placing them at risk. In an August 2003 memo, a J&J consultant who worked on the design and protocol for a trial called RIS-232, wrote that there were problems with subject enrollment – a “substantial number” should have not been enrolled. As a result, the study failed. The consultant, whose name was redacted along with the name of the reci...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs