Doctor Who Falsified Drug Tests Sentenced
The president of a Whittier Research Company was sentenced to 15 months in federal prison Tuesday for falsifying results of human drug tests submitted to the Food and Drug Administration.
Dr. Robert A. Fiddes, 53, of Palos Verdes, pleaded guilty to a charge of making false statements to the FDA about drugs being considered for approval.
For the record:
12:00 AM, Sep. 24, 1998 For the Record
Los Angeles Times Thursday September 24, 1998 Home Edition Metro Part B Page 3 Metro Desk 2 inches; 62 words Type of Material: Correction
Drug research firm--An article on Sept. 16 reported that the owner of a Whittier drug research company, operating as the Southern California Research Institute, was sentenced to 15 months in federal prison for falsifying test data submitted to the Food and Drug Administration. The Whittier firm is not connected in any way with the Los Angeles-based Southern California Research Institute, a nonprofit scientific research organization.
Two employees at Fiddes’ Southern California Research Institute are scheduled to be sentenced on similar charges today by U.S. District Judge Robert M. Takasugi.
Federal prosecutors said they were uncertain whether any drugs tested by Fiddes were ever approved by the FDA. A letter written by an FDA official in Washington gave no indication that any improperly tested drugs had made their way into the market.
Dr. Hsien Ju, medical officer at the FDA’s Center for Drug Evaluation and Research, said the agency was forced to reevaluate scores of test results prepared by Fiddes and his staff.
Fiddes, the owner and principal researcher at Southern California Research Institute, was involved in 91 studies that were either submitted or in the process of being submitted to the FDA in support of new drug approvals.
Conducted on behalf of pharmaceutical firms, the studies tested human reactions to drugs intended for treatment of numerous conditions, including hypertension, diabetes, asthma and vaginitis.
In a study of a drug designed to combat yeast infections, Fiddes was accused of creating documents indicating that the test had been run on 25 patients. The government said only one subject was used.
Fiddes and employees Laverne Carpentier, 51, of Walnut Creek, and Delfina Hernandez, 35, of Whittier, carried out similar falsifications in studies on a birth control product and an asthma drug.
Prosecutors said it is a standard practice for pharmaceutical companies to hire several research companies to perform the same tests on a drug, minimizing the chance of false results.