By Peter M. Jaensch –
In what a federal grand jury charges was a several-months-long effort in 2010 to maintain their job security, a clinical trial investigator and clinical trial coordinator in Kansas allegedly falsified clinical drug trial study data in submissions to the Food and Drug Administration (“FDA”).
Following an investigation by FDA, on June 2, 2011, the U.S. Attorney’s Office for the District of Kansas announced the Grand Jury Indictment of Wayne Spencer, MD, and Lisa Sharp. According to the Indictment, in July 2009, Lee Research Institute (“LRI”) was engaged by Schering-Plough (“Schering”) to conduct a clinical study evaluating the safety of Schering’s ragweed sublingual tablet in adults 50 and older with ragweed-induced rhino conjunctivitis. Dr. Spencer, an LRI employee, was the Principal Investigator on the study. Ms. Sharp served as both Director of Clinical Trials for LRI and as the Lead Clinical Research Coordinator on the Schering study. The five-count Indictment charges each defendant with one count of conspiracy (in violation of 18 U.S.C. § 371), three counts of mail fraud (in violation of 18 U.S.C. § 1341), and one count of failure to maintain adequate records (in violation of 21 U.S.C. § 331(e)).
The factual bases for these charges center on the alleged inclusion of ineligible study participants and falsification of related records. According to the Indictment, from about January through May, 2010, Dr. Spencer and Ms. Sharp conspired to falsify data for this study, so as to “remain in the clinical drug trial” and “receive monies from Schering/Plough.” The indictment alleges that Dr. Spencer and Ms. Sharp accomplished this by: (1) enrolling LRI employees who were under 50 years old as study participants under false names; (2) falsely recording physical examinations of these participants that were never performed; (3) fraudulently signing multiple documents on these participants’ behalf without their knowledge; (4) concealing these improper enrollments by scheduling their visits only when LRI’s executive director was not present; and (5) falsely affirming that these participants met the inclusion criteria for the study. The Indictment also alleges that this conduct caused LRI to receive three payments for the study totalling approximately $32,000.
Despite these relatively small financial gains, if convicted, the defendants face significant penalties. According to the U.S. Attorney’s Office press release, each defendant faces up to 5 years imprisonment and a $250,000 fine on the conspiracy charge, up to 20 years imprisonment and a $250,000 fine for each mail fraud count, and up to 3 years imprisonment and a $10,000 fine for the failure to maintain adequate records count.