June 2, 2011: Physician, Researcher Charged with Falsifying Clinical Drug Trial
Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
June 2, 2011
United States Attorney
District of Kansas
TOPEKA, KAN. - A physician and a clinical research coordinator have been indicted on charges of 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, are charged with one count of conspiracy, three counts of mail fraud, and one count of falsifying information required by the Food and Drug Administration. The crimes are alleged to have occurred from January 2010 to May 2010 in Johnson County, Kan.
The indictment alleges Sharp and Spencer 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 treatment of 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.
The indictment alleges Sharp and Spencer provided false information on the test subjects. They falsely stated physical examinations had been conducted on the two unqualified subjects. They signed false statements to FDA indicating the clinical study was being conducted in accordance with proper protocol. They also arranged for the unqualified subjects to have office visits while the executive director was at lunch in order to conceal from her the fact the subjects were ineligible. As a result, Schering/Plough issued checks totaling more than $30,000 to Lee Research Institute in payment for the clinical study.
If convicted, they face a maximum penalty of five years in federal prison and a fine up to $250,000 on the conspiracy charge, a maximum penalty of 20 years and a fine up to $250,000 on each of the mail fraud charges and a maximum penalty of three years and a fine up to $10,000 on providing false information to the FDA.
The Food and Drug Administration investigated. Assistant U.S. Attorney Tanya Treadway is prosecuting.