BMS & PPD staff cited by FDA for manipulating study data

Documents released by the FDA disclose that the blood-thinning drug Eliquis was examined closely before approval, because a whistle-blower working for PPD implicated BMS and PPD in data manipulation at a study site in China. The drug is now sold by Bristol-Myers Squibb and Pfizer, after the FDA determined that the fraud that took place at a single site in China was not sufficient to compromise the quality of the overall data package.

The document states that “A clinical site monitor employed at one the Clinical Research Organization (CRO) for ARISTOTLE, PPD, alleged that records at the clinical investigator site of Dr. Shiyao Wu in Shanghai, China (site 1200) appeared to have been recently changed apparently in preparation for the upcoming FDA inspection of that site. Specifically, a chart which contained records of outpatient visits had been altered.” The PPD monitor also reported that another PPD employee “told her that he had altered data containing subject records on a USB drive at the direction of the BMS site manager. The records were altered in order to cover-up GCP violations which had occurred at the site.” The data from this site was not used in support of the NDA, as were data from 23 other sites where these staff had worked on the study.

The report concludes that “overall, the study appears to have been conducted and monitored adequately” and that “no regulatory violations were identified during the PPD inspection; and minor regulatory violations found during the Sponsor inspections.