Monday, November 26, 2012

For the University of Minnesota’s Department of Psychiatry, it’s déjà vu all over again




The recent research scandals out of the Department of Psychiatry may be alarming, but they are not new.  Back in the 1990s, when the university was working its way towards a crippling probation by the National Institutes of Health, the Department of Psychiatry hosted two spectacular episodes of research wrongdoing, both of which resulted in faculty members being debarred from conducting research by the FDA.

The first was the case of Dr. Barry Garfinkel, the head of Child and Adolescent Psychiatry. Garfinkel was the principal investigator for a $250,000 Ciba-Geigy study of Anafranil, an antidepressant, to determine if the drug was effective for obsessive-compulsive disorder in adolescents. Unfortunately, Garfinkel was not the most scrupulous researcher.  According to newspaper reports, Garfinkel falsified data, submitted forms for psychiatric evaluations that didn’t actually take place, and instructed his research assistant to give therapy to subjects even though she had no medical training.  For this Garfinkel wound up in federal court, where he was sentenced to six months in federal prison, six months of home detention, 400 hours of community service, and was fined $214,000.

Sound familiar?  It gets better.  Even more impressive than Garfinkel’s fraud were the actions taken by University of Minnesota administrators to protect him.  After the whistleblower that alerted the university was fired, the Dean of the Medical School, David Brown, made a secret agreement with Garfinkel to keep the university investigation hidden for nearly four years.  The university spent nearly $180,000 in legal fees to maintain that secrecy.  When the FDA got involved, the university refused to share its findings until the FDA had them subpoenaed. The university later claimed in a press release that it had cooperated with the FDA – a claim that an FDA official told the Star Tribune he found “offensive.”  He said, "This is not what I would characterize as cooperation."

You can find newspaper coverage of the Garfinkel case here.  Coming up next: the case of James Halikas.

1 comment:

  1. Michelle Rennie was fired from her research assistant position at the University of Minnesota, now referred too as "study coordinator." The dismissal followed her alleged attempt to slander Dr. Barry Garfinkle, the chief of child psychology at the university's medical school. She accused Garfinkle of providing misleading information in a study of the effects of Anafranil, on children with obsessive-compulsive disorder. The study was sponsored by Ciba-Geiga, the drug company that manufactured the medication and which was trying to win FDA approval. Rennie was dismissed after a closed-door university committee exonerated Garfinkle and discredited the research assistant. Garfinkle's vindication saved the study and also saved the U $250,000 in funding from Ciba-Geiga. However, this was not the story's end. Eventually, the courts became involved and Garfinkle was found guilty on felony charges related to his falsification of data in the study. As it turned out, Rennie had not slandered Garfinkle. Instead, she herself had been slandered, as part of a university cover-up intended to help Ciba-Geiga market Anafranil while simultaneously preserving the university's financial relationship with the company.

    Garfinkle and his friends and colleagues at the Office of the General Counsel were not interested in arriving at the truth. They were interested in being first in line at the bank.

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