Psychiatrist sentenced for research fraud - University of Minnesota child psychiatrist Barry Garfinkel

A prominent University of Minnesota child psychiatrist was sentenced to six months in a federal correctional facility and six months of home detention with work release for engaging in mail fraud and making false statements in documents about clinical studies of the psychiatric drag Anafranil (clomipramine hydrochloride).

Barry Garfinkel, M.D., former director of the university' s child and adolescent psychiatry department and a leading teen suicide expert, was free at press time pending appeal. His sentencing last Nov. 19 in the U.S. District Court for the District of Minnesota followed conviction on five felony counts.

The court also sentenced Garfinkel to pay $214,000 in fines and perform 400 hours of community service. The jury acquitted him of 18 other charges. Garfinkel also could lose his medical license if his convictions are upheld.

Garfinkel, 46, was chief researcher in a $250,000 study begun in 1986 to determine whether Anafranil, an antidepressant, was safe and effective in treating children and adolescents with obsessive-compulsive disorder (OCD). OCD has several forms, one of which is an obsession with cleanliness that manifests itself with repetitive hand washing or showering.

FDA approved Anafranil for commercial marketing in late 1989, but the agency did not use Garfinkel's data.

The Swiss-based drag company Ciba-Geigy, which sponsored the drug, chose the University of Minnesota in 1986 as one of five U.S. sites for the Anafranil studies. The approved research protocols for the study required that patients undergo weekly psychiatric evaluations and be monitored for benefits and adverse side effects of the medication. Patients were not to take other medications that affect the central nervous system.

Rather than follow these procedures strictly, Garfinkel "established and executed his own research protocols but didn't tell anybody--not the university, Ciba-Geigy, or FDA--about it," says Mark Brown, associate FDA chief counsel who co-prosecuted the case.

Garfinkel's wrongdoings came to light in March 1989, when his study coordinator, Michelle Rennie, complained of research misconduct to university and Ciba-Geigy officials. Both launched inquiries right away. The university's investigation found irregularities but no intentional misdeeds. But in June 1989, Ciba-Geigy notified FDA that it would not include Garfinkel's data in its new drug application for Anafranil approval due to problems it found with the university study.

FDA conducted its own investigation from January 1990 through May 1991. The probe was delayed because the university refused to share its findings with FDA. The government subsequently obtained these findings through a subpoena. Ultimately, FDA collected an investigalive file of more than 10,000 pages. Evidence confirmed widespread misconduct in Garfinkel's study.

In mid-1992, the U.S. attorney's office in Minnesota further investigated the case and led Garfinkel's prosecution.

In court, the government's case centered on the evidence FDA had gathered, such as patient record forms Garfinkel submitted to Ciba-Geigy falsely representing that he had followed research protocols. At trial, the prosecution presented evidence that in as many as 140 instances, required office visits and psychiatric evaluations either did not occur or were conducted by employees with little or no medical training. For example, Rennie testified that Garfinkel told her to make up data for the official forms and to provide therapy to some study participants despite her lack of training. Other evidence showed that Garfinkel sometimes "examined" patients by having Rennie talk to them over the phone and that he administered medication prohibited in the study protocols.

Yet Garfinkel signed documents throughout the study falsely representing that he complied with required protocols.

The Garfinkel case "underscores the importance of the federal drug approval system," says FDA's Brown. "The system is supposed to ensure that any new drug is safe anti effective before being made available. By falsifying data, Garfinkel undermined the integrity of this system."

In addition to Garfinkel's appeal, FDA also is appealing the sentence on the grounds that the court should have applied sentencing guidelines more strictly, resulting in a stiffer sentence. Garfinkel could have received up to 125 years in prison had he been convicted on all 25 counts originally named in his indictment.

John Henkel is a staff writer for FDA Consumer.

COPYRIGHT 1994 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group