Saturday, April 12, 2014

The Forgotten History of the University of Minnesota Department of Psychiatry: From Felony Conviction to FDA Disqualification

The recent research scandals out of the University of Minnesota’s 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 (for yet another episode of misconduct, this time in the Department of Surgery), the Department of Psychiatry hosted two spectacular cases of research wrongdoing, both of which resulted in faculty members being disqualified 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.”

The University of Minnesota was still under fire for covering up the Garfinkel fraud in 1993 when yet another psychiatric scandal emerged.  Dr. James Halikas, a tenured professor in the Department of Psychiatry, had gotten permission from the FDA to test a drug called gamma hydroxybutyrate, or GHB, for opiate addiction.  He began by recruiting uneducated Hmong refugees who did not speak English.  The Hmong patients had become addicted to opium in Laos, where the drug is often used as a painkiller. Although they had come to the university to get methadone maintenance treatment, the patients had discovered that the methadone clinic was closed to them.  Why?  Because Halikas had decided that Southeast Asians were taking up too many spots at the clinic.  He was only admitting non-Asians.

According to the FDA, Halikas enrolled ten of those Hmong patients in his GHB study.  Although they complained bitterly that GHB didn’t work and repeatedly asked for methadone, it was not until a formal complaint was lodged by another faculty member, Dr. Sheila Specker, that an investigation was triggered.  It soon became clear that Halikas had never actually obtained informed consent from his subjects.  In fact, it is not even clear that the subjects even knew they were in a research study.  (This was not because Halikas didn’t know better; he was a member of the university’s Institutional Review Board.)  According to a later investigation by the FDA, several of the subjects were severely depressed and at risk of suicide, and should have never been enrolled in the study, even if they had given their consent.  Although Halikas told the Star Tribune that GHB is “so mild that it has been used in Europe as a children’s sedative,” it is in fact a central nervous system depressant that is sometimes used as a date rape drug.  At the time of the study it had been linked to seizures and coma.  The FDA found that Halikas had dispensed it in dangerously high doses.

According to the Star Tribune, although the university investigated the complaint about Halikas, it did not inform state licensing officials who have jurisdiction over the drug program.  Nor did it bar Halikas from conducting research.  That did not happen until 2000, when the FDA formally “disqualified” him as a clinical researcher.

By that point, of course, the current Seroquel scandals at Minnesota were getting started.  The new chair of the Department of Psychiatry, Charles Schulz, was working on the “smoke-and-mirrors” study of Seroquel that would get him into trouble later, when internal AstraZeneca documents were unsealed in litigation.  And a within another few years, his colleague, Stephen Olson, was recruiting subjects into the CAFÉ study of Seroquel, which resulted in a grisly death for at least one subject, Dan Markingson.

Misconduct this egregious happens only because university officials make it possible.  Over a twenty year period, University of Minnesota administrators have done their best to protect the faculty members at fault, punish the whistleblowers, and above all, keep the wrongdoing secret.  And unless that changes, Minnesotans can look forward to more fraud, more deception, and more injuries and deaths.

Note: This was originally posted on Mad in America on December 12, 2012.  As we continue our call-in campaign and other actions in coming weeks, I will be reposting other older posts, as a reminder of all the unanswered questions surrounding the Markingson case.

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