A Department of Justice press release (here) announced a 19 count indictment against 9 individuals “with conspiracy to commit mail and wire fraud, mail fraud, wire fraud, aggravated identity theft, conspiracy to defraud the United States, and failure to maintain adequate records.” Basically, the press release goes on to describe fraudulent activities relative to the conduct of clinical studies (get this now) performed on behalf of 8 pharmaceutical companies.
The co-defendants are alleged to have subverted normal clinical study requirements “by enrolling subjects in clinical trials under fictitious names, enrolling past subjects without their knowledge, and enrolling other subjects who did not meet pre-established criteria. In addition, the defendants allegedly fabricated and falsified medical records, informed consent forms, and other documentation for fictitious study subjects.” Having lived through the generic drug scandal of the late 1980s and having seen some egregious behavior by both drug companies and some FDA employees, this does not come as a major shock to me (although it should). When there is a way to profit from illicit behavior, companies must be on high alert when evaluating the use of contact manufacturers and contract research organizations to avoid encountering potential bad actors. While the judicial system process needs to proceed prior to a finding of guilt for these individuals, the 8 companies for whom they conducted clinical studies have obviously been substantially delayed in the conduct of their real clinical studies.
While such behavior is not very common, there have been several high-profile issues associated with problematic work by contract research organizations. Please assure that you perform a detailed due diligence process prior to selecting a clinical research company if you are not very familiar with them. For additional information or assistance for due diligence activities, please contact Linda Evans O’Connor at Lachman Consultants at email@example.com.