Psychiatrist Sentenced for Research Fraud
Henkel, John, FDA Consumer
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. …