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Biggest drug research fraud case in FDA history - Food and Drug Administration

FDA Consumer, June, 1989 by Judy Folkenberg

Biggest Drug Research Fraud Case In FDA History

After pleading guilty to pocketing nearly $2 million from pharmaceutical firms for experimental drug tests that he never performed, prominent New Jersey physician Robert A. Fogari was sentenced to four years in prison on Feb. 2. He was also fined $2 million and ordered to make financial restitution to the drug companies he defrauded. After serving his prison sentence, Fogari will be placed on probation for five years.

"This is one of the worst cases I've ever seen, and I would not have believed it if I had not seen it," said Judge Garrett Brown of the U.S. District Court for the District of New Jersey, who presided over the trial. "What you did was worse than dealing in drugs and murder," he told Fogari. "You betrayed the public trust. Our system of drug testing relies on honesty."

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The judge said the sentence was as compassionate as possible considering the circumstances.

Fogari's case is believed to be the biggest investigational drug fraud case in the history of FDA, according to Alan B. Lisook, M.D., chief of FDA's clinical investigations.

At the beginning of his trial last Sept. 27, Fogari, an arthritis specialist, had pleaded not guilty to 20 charges of fraud and obstruction of justice. But seven days into what was expected to be a month-long trial he changed his plea and admitted guilt on four counts: conspiring to falsify drug test data, making two false statements to FDA,

Fogari also admitted that he concealed the deaths of two patients "enrolled" in the bogus drug studies because he wanted to "maintain a favorable impression" with the pharmaceutical companies that had hired him, according to assistant U.S. attorney Paul Weissman, who prosecuted the case. However, Fogari said the deaths were not related to the experimental drugs, and FDA had no evidence to contradict him. (Although Fogari never conducted any formal research, he may have used the experimental drugs in a haphazard fashion.)

Between 1977 and 1985, pharmaceutical companies that were seeking FDA approval for anti-inflammatory arthritis drugs paid Fogari to conduct clinical studies. Payment was based on the number of patients enrolled, the number of office visits, and the number of procedures performed during the study. According to Weissman, Fogari submitted thousands of falsified reports to drug companies.

During the week-long trial, former employees, who were given immunity, testified that Fogari instructed them to list the names of persons who were not enrolled in the study, make up patients, and continue to include patients who had dropped out of the study. Fogari also failed to conduct urine, stool, and blood tests necessary for the study. Under questioning from Weissman, Fogari admitted to forging the signatures of radiologists and other specialists to documents attesting that X-rays and other tests or exams had been performed.

The most damaging testimony came from Patricia Cunningham Czorniewy, a former assistant to Fogari who admitted under questioning that the doctor had pressured her to sign an affidavit falsely stating that she had invented study data. It was after her testimony that Fogari changed his plea from innocent to guilty. Questioned by Weissman, Fogari admitted it was he who falsified all data and that he did not conduct any legitimate research during the entire eight-year period.

Fogari participated as an investigator in at least 18 experimental drug studies for nine drug manufacturers, including Ciba-Geigy, Johnson & Johnson, Warner-Lambert, Pfizer, Upjohn, Syntex, and Merck, Sharp & Dohme. The drugs he was supposed to test included Voltaren, Maxicam, Seldene, and Naprosyn. However, Anthony Panzica, director of FDA's compliance branch in the Newark district office, emphasizes that the drug manufacturers deleted Fogari's data from their marketing applications after they were notified of his disqualification. Panzica said that most of the drugs have not yet been approved by FDA, and those that were did not depend on his data for approval.

"His research did not influence decisions to put any drugs on the market," said Panzica.

Fogari was first investigated by FDA in 1983 after officials at Ciba-Geigy became suspicious because his data were "too perfect," said Weissman.

Fogari's sentence angered many patients and former patients. He had a "great following among his patients, and people couldn't believe what had happened," said Diane Kolaitis, a compliance officer in FDA's Newark office. He was known as a kind doctor, and long lines of patients were a familiar sight at his office, according to newspaper accounts.

Fogari can no longer practice medicine since the New Jersey State Board of Medical Examiners revoked Fogari's medical license as of March 17, according to Deputy Attorney General James F. Lafargue.

Another Case of Fraud

As New Jersey physician Robert Fogari faced trial in the biggest case of fraudulent drug research in FDA's history (see preceding article), a board-certified urologist pleaded guilty in the U.S. District Court of Massachusetts on charges of faking research data.

Biggest drug research fraud case in FDA history - Food and Drug Administration

FDA Consumer, June, 1989 by Judy Folkenberg

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