WICHITA, Kan. (AP) — A Kansas doctor and a researcher have admitted to conspiring to defraud a pharmaceutical company by falsifying data in a clinical trial they were paid to conduct on human subjects.
The guilty pleas were made Wednesday in U.S. District Court in Topeka in the case against Wayne Spencer, a 73-year-old Topeka physician, and Lisa Sharp, 48, a registered nurse from Olathe who was the director of clinical trials for the Lee Research Institute. In addition to the conspiracy count, each also pleaded guilty to a count of failing to maintain records in a clinical trial as required by the Food and Drug Administration.
Judge Richard Rogers could order Spencer and Sharp to serve up to five years in prison for the conspiracy charge and fine them up to $250,000 each at their sentencing, which was scheduled for Jan. 20. However, as part of their plea deals, prosecutors agreed to recommend they serve only probation.
Both defendants also agreed their plea agreements to be jointly and individually liable for restitution of $36,046, the amount they defrauded Schering-Plough, which is a subsidiary of Merck and Co.
Spencer and Sharp worked for Lee Research Institute, which was paid by Schering-Plough to conduct a 28-day clinical trial in 2010 on an allergy pill. Spencer was the principal investigator for the study and Sharp was the lead clinical research coordinator.
The trial was to involve eight human subjects ages 50 and older to demonstrate the safety and effectiveness of a pill for the treatment of allergies, specifically allergies induced by ragweed, so that the FDA could decide whether to approve it for marketing. The defendants admitted they concealed that two of the subjects were not qualified because they were too young and because they worked for the testing company.
To hide this, the Spencer and Sharp used false names and birthdates for the two subjects on several documents and they approved payments to the two employees for participating, according to court documents. Spencer also signed documents stating he had performed physical examinations on those employees, when he hadn’t.
