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Executive Summary

NSAID INVESTIGATOR ORDERED TO REPAY DRUG FIRMS $ 1.86 MIL. as part of a conviction for clinical data falsification. The restitution to the drug companies is on top of a four-year prison term for Robert Fogari, MD, sentenced on Feb. 2 in the Federal District Court of Newark, New Jersey. Fogari was also fined $ 2 mil. for falsifying study data that he generated for nine pharmaceutical firms. According to FDA, the sentence is the most severe ever imposed in an agency case. The New Jersey clinical investigator was convicted of four felonies involving the 18 fraudulent studies that he conducted with 10 experimental nonsteroidal anti-inflammatory drugs (NSAIDS) during the period from 1977 to 1985. The felonies involve conspiracy, making two false statements, and obstruction of justice. For the conspiracy conviction, Fogari was sentenced to three years in prison, fined $ 2 mil., and instructed to make restitution to the drug firms. FDA says if Fogari makes restitution within six months, the amount will go towards his fine. Fogari falsified and fabricated data in NSAID studies that he conducted for the following companies: Beecham, Berlex Labs, Ciba-Geigy, McNeil Pharmaceutical, Merck, Pfizer, Syntex, Upjohn and Warner-Lambert (for a list of the drugs involved in the studies, see chart below). NSAIDs INVOLVED IN FRAUDULENT STUDIES CONDUCTED BY ROBERT FOGARI, MD Ansaid (flurbiprofen) -- Upjohn Feldene (piroxicam) -- Pfizer Maxicam (isoxicam) -- Warner-Lambert Naprosyn (naproxen) -- Syntex pirazolac -- Berlex Relafen (nabumatone) -- Beecham Tolectin (tolmetin sodium) -- McNeil Voltaren (diclofenac sodium) -- Ciba-Geigy Zomax (zomepirac sodium) -- McNeil undisclosed NSAID -- Merck FDA said that the agency became aware of Fogari's fraudulent activities during a routine audit of his studies in 1983. At the same time, FDA received a report from Ciba-Geigy that it had found inconsistencies in data that Fogari had gathered. In 1984, FDA held an investogator disqualification hearing at which Fogari agreed to enter into a consent agreement, under which he was disqualified from conducting further studies of experimental drugs. In February 1988, he was indicted by a U.S. Grand Jury in Newark and charged with 20 counts of conspiracy, making false statements, and obstruction of justice. Following a seven-day trial in October 1988, Fogari pled guilty to four of the 20 counts. According to FDA, Fogari's indictment charged that he failed to perform examinations of study patients, and instead invented examination data for purposes of completing patient forms. He failed to conduct required tests and fabricated test results, FDA said. Fogari also failed to report adverse reactions to the companies, and in one case, back-dated a patient record to conceal the fact that the patient was hospitalized and later died. That patient's illness and subsequent death was not associated with the study, FDA says. Warner-Lambert filed a civil suit against Fogari in August 1988 in the Federal District Court of Newark. The suit seeks reimbursement of the money that the company paid Fogari for conducting six studies with the NSAID Maxicam. Warner-Lambert is considering withdrawing the suit in light of the restitution requirement.

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