Ex-Lee Research Institute Employees Admit to Falsifying Data

By Paul Koepp, Reporter - Kansas City Business Journal

Two former employees of Lenexa-based Lee Research Institute have pleaded guilty to charges related to falsifying study data in a clinical drug trial.

Dr. Wayne Spencer, 73, of Topeka, and Lisa Sharp, 48, of Olathe, pleaded guilty to conspiracy and failing to maintain records, the U.S. Attorney’s Office for the District of Kansas said Wednesday.

Each faces as much as five years in prison and a fine of $250,000 on the conspiracy charge, and three years in prison and $10,000 on the records charge. They were indicted in June.

Schering/Plough, a subsidiary of Merck & Co., contracted with Lee Research last year to do clinical trials on an allergy drug. Spencer was the principal investigator for the study and Sharp was the lead clinical research coordinator.

The study called for test subjects 50 or older who suffered from ragweed-induced allergy symptoms. It prohibited employees of Lee Research from participating.

Prosecutors said two of the eight test subjects Spencer and Sharp signed up were institute employees who used false names and birth dates to hide the fact that they were younger than 50.

Schering/Plough paid the institute $30,000 for the study, prosecutors said. Spencer and Sharp also were accused of making false statements to the U.S. Food and Drug Administration.

Institute officials said they fired Spencer and Sharp after learning of the allegations in June 2010. They also conducted an internal investigation and cooperated with the FDA and Schering/Plough on their separate investigations.

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