RESEARCH WORKERS AGREE TO ADMIT FAKING DRUG TESTS.Byline: City News Service The president and two employees of a Whittier research firm agreed to plead guilty to submitting false safety and effective drug tests to the U.S. Food and Drug Administration, a prosecutor said Friday. ``This is, as far as I know, a very rare case,'' said Assistant U.S. Attorney Steven Linick. ``I've never seen such a case before.'' Southern California Research Institute, also known as American Pharmaceutical Research Inc., was hired by drug manufacturers to carry out clinical drug studies on human subjects, Linick said. The company tested numerous drugs, including treatments for hypertension, diabetes, sinusitis sinusitis Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise. , asthma, vaginitis vaginitis Inflammation of the vagina. The chief symptom is a whitish or yellowish vaginal discharge. Treatment depends on the cause: appropriate drugs for sexually transmitted diseases (often from Gardnerella bacteria or trichomonads) or yeast infections; estrogen cream for and menopause, Linick said. Dr. Robert Fiddles, Laverne Charpentier and Delfina Hernandez have signed plea agreements and are expected to plead guilty Monday to conspiracy charges, Linick said. According to the federal sentencing guidelines The Federal Sentencing Guidelines are rules that set out a uniform sentencing policy for convicted defendants in the United States federal court system. The Guidelines are the product of the United States Sentencing Commission and are part of an overall federal sentencing reform , if Fiddles has no prior criminal history, he could face 24 to 30 months in jail and be fined. Prosecutors claim that for about six years, the defendants carried out drug tests in which they enrolled nonqualifying patients. In some tests, they allegedly falsified patients' electrocardiogram electrocardiogram /elec·tro·car·dio·gram/ (-kahr´de-o-gram?) a graphic tracing of the variations in electrical potential caused by the excitation of the heart muscle and detected at the body surface. results, and in other cases substituted patients' blood for blood of SCRI SCRI Scottish Crop Research Institute (formerly Scottish Horticultural Research Institute, United Kingdom) SCRI Supercomputer Computations Research Institute SCRI Steel Can Recycling Institute SCRI Secure Configuration Remediation Initiative employees. Linick said SCRI was paid more than $800,000 by drug companies to conduct those tests. They include Pharmaco-Arganon, SmithKline Beecham, PPD-Zambon, Bayer, CTMS/Glaxo, Pfizer, Rhone-Poulenc Rorer and Roche. Linick said the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. became aware of the scheme after employees in the company told them ``there were irregularities taking place in the trials.'' |
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