Physician, Researcher Plead Guilty
To Falsifying Clinical Drug Trial
TOPEKA, KAN. – A physician and a clinical research coordinator have pleaded guilty to falsifying study data in a clinical drug trial they were paid to conduct, U.S. Attorney Barry Grissom said today.
Wayne Spencer, 73, Topeka, Kan., a licensed physician, and Lisa Sharp, 48, Olathe, Kan., a clinical research coordinator and registered nurse, pleaded guilty to one count of conspiracy and one count of failing to maintain records in a clinical trial.
In their pleas, they admitted falsifying the results of a clinical drug trail they were paid to perform while they were employed by Lee Research Institute. Lee Research Institute was hired by Schering/Plough, a pharmaceutical company, to perform clinical drug trials on a tablet developed for treating allergies. Spencer was the principal investigator for the clinical study and Sharp was the director of clinical trials for Lee Research Institute.
Schering/Plough’s plans for the study called for all test subjects to be 50 years of age or older and to suffer from ragweed-induced allergy symptoms. Schering/Plough required that employees of the clinical trial facility be excluded as test subjects.
Sharp and Spencer reported that eight test subjects were qualified, even though they knew two of the subjects were not qualified. The two subjects were employees at Lee Research Institute, who were using false names and dates of birth to participate in the study. Both were under 50.
Spencer signed multiple documents for the enrolled employees, including forms falsely indicating he had performed physical examinations on the two. Sharp signed multiple documents for the two employees, including documents that falsely stated their dates of birth. She also arranged for the two to have office visits when the Executive Director was at lunch in order to conceal from her that the two employees were participating in the study. As a result of the fraud, Schering/Plough issued checks totaling more than $30,000 to Lee Research Institute in payment for the clinical study.
Sentencing is set for Jan. 20. They face a maximum penalty of five years in federal prison and a fine up to $250,000 on the conspiracy charge, and a maximum penalty of three years and a fine up to $10,000 on the charge of failing to maintain records in a clinical trial.
The Food and Drug Administration investigated. Assistant U.S. Attorney Tanya Treadway is prosecuting.