Falsified Data

Two employees of contract research organization the Lee Research Institute admitted to falsifying study data, reports Pharmalot's Ed Silverman. Registered nurse Lisa Sharp and 73-year-old doctor Wayne Spencer pleaded guilty to conspiracy to defraud Schering Plough, which paid the CRO to conduct a clinical trial for a tablet to treat allergies, Silverman says. Sharp and Spencer also pleaded guilty for not maintaining FDA records. "They could face up to five years in prison and fines up to $250,000 each for the conspiracy charge, and up to three years and a $10,000 fine for failing to maintain records in a clinical trial," Silverman says. "The study was to have enrolled patients at least 50 years old who suffer from ragweed-induced allergy symptoms. Employees at the CRO, which is based in Lenexa, Kansas, were not supposed to participate, but two subjects were Lee Research employees and both were younger than 50." Schering Plough, which is now owned by Merck, paid Lee Research more than $30,000 for its work. Sentencing for Sharp and Spencer has been scheduled for January, Silverman adds, and prosecutors have recommended probation.