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
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