3 Agree to Plead Guilty in False Drug Reports
The president and two employees of a Whittier research company have agreed to plead guilty to conspiracy charges stemming from their falsification of test results used to evaluate drugs for the federal Food and Drug Administration, federal prosecutors said Friday.
The Southern California Research Institute, also known as American Pharmaceutical Research Inc., had been hired by some major pharmaceutical manufacturers to test more than 80 drugs on human subjects, according to Assistant U.S. Atty. Steven Linick.
Linick said the drugs tested were intended to combat a number of afflictions, including hypertension, diabetes, sinusitis, asthma, vaginitis and menopause. Another drug tested was intended for use as a birth control product.
He said the research firm falsified electrocardiogram results, switched blood samples, used human subjects who were not suffering from the afflictions specified, lied about the number of subjects tested and submitted false statements about the types of tests that were performed.
Linick said that at least two drugs tested by the research institute were later approved by the FDA and are on the market.
However, he stressed that the Whittier firm was only one of many testing the drugs, and he said it is not known whether the pharmaceutical companies that hired the research firm will be required to determine whether the bogus studies have any bearing on the safety and efficacy of their drugs.
Some drugs could be recalled as a result of further investigations, Linick said.
Assistant U.S. Atty. Lawrence Ng said that Robert A. Fiddes, 52, of Palos Verdes, the owner and president of the firm; Laverne Charpentier, 50, of Walnut; and Delfina Hernandez, 34, of Whittier have signed plea agreements and are expected to plead guilty to charges of conspiring to make false statements to the FDA in connection with the drug-approval process.
Those pleas could be entered Monday, when the three are scheduled for arraignment in Los Angeles federal court.
None of the defendants could be reached for comment Friday.
Under federal guidelines, they could face fines and 21 to 30 months in prison. The U.S. attorney’s office said Fiddes has agreed to pay more than $800,000 in restitution to eight pharmaceutical companies for which the drugs were tested--Bayer, CTMS/Glaxo, Pfizer, Pharmco-Arganon, PPD-Zambon, Roche, Rhone-Poulenc Rorer and SmithKlein Beecham.
Officials said an FBI investigation of the research firm was launched after other employees told the FDA about “irregularities” in testing procedures that extended over a six-year period.
In one case, Ng said, the defendants falsified the results for virtually an entire study of a drug used to treat vaginal yeast infections. Ng said the trio submitted documentation in March 1996 indicating that more than 25 patients participated in the study when, in fact, only one patient participated.
He said the defendants submitted similarly false documentation about patients supposedly treated with drugs used for birth control and to treat asthma.
The plea agreement says that between 1995 and 1996, Charpentier told a researcher that if a patient was not eligible for a test because of a low urine flow rate, water could be run through a flow meter to “qualify” the patient.
The agreement says that during that same period, Charpentier ordered the destruction of X-rays showing that certain patients did not have osteoarthritis, as required by a study protocol.
In 1993, Charpentier and Hernandez “each used their daughters’ names and personal data, including birth date, weight, height and medical history” to create documentation falsely indicating that the daughters were participating in tests, the agreement states. It says that Charpentier later used her husband’s treadmill results to qualify several patients for testing.