Two former employees of Kansas-based Lee Research Institute have been indicted for falsifying study data in a clinical trial, according to a report in the Kansas City Business Journal.
The U.S. Attorney’s Office for the District of Kansas said Dr. Wayne Spencer, 73, and Lisa Sharp, 48, were charged with conspiracy, mail fraud and falsifying information to the FDA.
In a released statement, institute officials said they terminated Spencer and Sharp after learning of their alleged actions in June 2010. They then conducted an internal investigation and cooperated with the FDA and Schering/Plough on their separate investigations.
“Throughout the investigation by Schering/Plough and the federal authorities, the company has been advised by the investigating officers that no wrongdoing of any sort has been found on the part of the company,” the statement reads. “In fact, the indictment itself alleges that the individuals involved took great pains to hide their actions from the company. The company continues to fully cooperate in ongoing investigations.”
Prosecutors said Schering/Plough, a subsidiary of pharmaceutical giant Merck, contracted with Lee Research last year to do clinical trials on a new allergy drug. Spencer was the principal investigator for the study and Sharp was lead clinical research coordinator for the study and director of clinical trials at Lee Research.
Schering/Plough’s study called for test subjects to be age 50 or older and suffer from ragweed-induced allergy symptoms. It also prohibited employees of Lee Research from participating in the trial, prosecutors said.
The indictment alleges that two of the eight test subjects Sharp and Spencer signed up for the trial were institute employees and that they were given false names and birth dates to hide that they were younger than 50.
It also claims the pair falsely reported that the ineligible subjects had physical examinations, gave false statements to the FDA that the trial was following proper protocols and further tried to hide the subjects’ ineligibility by scheduling their required office visits when the institute’s executive director was out of the office.
Schering/Plough paid the institute $30,000 for the study, the prosecutors said.
Spencer didn’t immediately return a phone call for comment. Sharp was not available for comment.
If convicted, Spencer and Sharp could face a maximum of five years in federal prison and $250,000 in fines for the conspiracy charge; 20 years and $250,000 for each mail fraud charge; and three years and $10,000 for providing false information to the FDA.
