INDICTMENT ACCUSES DRUG-TESTING FIRM OF FALSIFYING RESULTS



Posted: 10 March 2008


Washington Post, The (DC)-June 1, 1979
Author: Morton Mintz, Washington Post Staff Writer

In indictment accusing a New Jersey company of falsifying results of medicine tests on animals has been returned by a federal grand jury in Newark. The testing was to determine if the medicines cause cancer.

The indictment, which investigators said was the first to lodge such charges against an independent contract laboratory, names Biometric Testing Inc. of Englewood Cliffs; board chairman Max A. Tesler, 48, a physician, and four former officers.

Irregularities at the nine-year-old lab were first disclosed at hearings held in 1976 by Sen. Edward M. Kennedy (D-Mass.) on the safety of drugs, pesticides and other products.

At the same hearings, the Food and Drug Administration listed serious deficiencies in animal testing done for the FDA and other federal agencies by Industrial Biotest Laboratories of Northbrook, III. A grand jury has subpoenaed its records for an investigation.

The FDA also told Kennedy that it had recommended that a grand jury investigate animal testing done by G. D. Searle & Co., a leading pharmaceutical manufacturer. Over the FDA's objections, the U.S. attorney in Chicago dropped the case last December without presenting it to a grand jury.

The Biometric indictment, announced Wednesday by U.S. attorney Robert J. Del Tufo, accuses the defendants of one count of conspiring to submit false reports on animal research done under contract for two pharmaceutical firms. The firms, in turn, passed the data on to the FDA as evidence that their experimental medicines were safe and effective, and qualified for testing in humans.

In three additional counts, the defendants are accused of submitting two false reports on the cancer causing potential of Catrix-X, an anti-inflammantory drug, and one false report on the long-term toxicity of GK-101, a drug used to remove dental caries. The indictment imputes no wrongdoing to the manufacturers - Lescarden Ltd. of Goshen, N.Y., and National Patent Development Corp. of New York City, respectively. A lawyer for Biometric said it will plead not guilty.

In addition to Tesler, the individual defendants are former president Eugene R. Jolly, 54 of Neenah, Wis., a physician; former vice president-scientific affairs Steven Carson; 54, Brooklyn; former executive vice president Samuel Posner, 45, Pleasantville, N.Y., and former vice president and general manager Edward J. Rogers, 54, North Grosvenordale, Conn.

Edition: Final Edition
Section: First Section
Page: A9
1979 The Washington Post