A Northern Virginia physician hired by pharmaceutical companies to test pain relievers has been indicted by a federal grand jury on charges he falsified data submitted to the Food and Drug Administration for use in evaluating the drugs' safety.
The 19-count indictment, made public yesterday in Alexandria, charged that Dr. James J. Scheiner of Fairfax County furnished false information on tests he ostensibly conducted on 339 outpatients for three major drug manufacturers between 1975 and 1978.
The companies submitted the data to the FDA as evidence of the drugs' reliability and safety, the indictment said.
The drugs were identified as Motrin, a well-known arthritic pain reliever made by the Upjohn Co.; Butazolidin, nicknamed "Bute" and popular with athletes, made by Ciba-Geigy Corp.; and Suprofen, an antiarthritic-pain drug produced by Ortho Pharmaceutical Corp. but later withdrawn from FDA consideration.
FDA officials said yesterday that tests of the drugs' safety had been duplicated by other physicians and that Scheiner's allegedly false data is not crucial to the agency's findings.
Scheiner, 46, an orthopedic surgeon associated with Jefferson Memorial Hospital in Alexandria, was unavailable for comment. If convicted, he could face up to 95 years in prison and $19,000 in fines on charges of mail and wire fraud and making false statements to the FDA.
The indictment said Scheiner was paid a total of about $34,000 by the three drug companies and an independent monitoring firm. While the FDA performs laboratory testing of new drugs, their use on patients is contracted out by manufacturers to thousands of private physicians approved by the government.
Law enforcement officials, who asked not to be identified, said yesterday that questions about Scheiner's work arose following a routine spot check by FDA officials.
In the indictment, the grand jury charged Scheiner allegedly falsified information about patients -- including name, age, sex, race, times and dates when drugs were administered, and medical histories -- in reports he was required to forward to the manufacturers.