University of Minnesota Psychiatry: A Pattern of Research Abuse

Carl Elliott, MD, PhD
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On Monday evening, KMSP News aired a report of yet another mentally ill man whose alarming story mirrors that of Dan Markingson, who was coerced into an industry-funded antipsychotic study at the University of Minnesota and committed suicide in 2004.

The man, identified as Robert, says that he was pressured into a pharmaceutical industry study of an unapproved antipsychotic drug called bifeprunox. The psychiatrist in charge of the study was Dr. Stephen Olson — the same researcher in charge of the study in which Markingson died.

“I was incompetent and didn’t know what I was doing,” Robert told the KMSP reporter, Jeff Baillon.  “Then, they say you have a giant medical bill and if you do the research, you won’t have this giant medical bill.”

Robert says he was told that bifeprunox was safe, yet the FDA soon rejected the drug, asking the sponsor to look into the death of a research subject who had died of liver failure shortly after taking it. Several months later, the sponsor halted all bifeprunox studies.

The side-effects of bifeprunox were so severe that Robert considered suicide. He went to the Fairview emergency room three times, once by ambulance, yet Olson apparently dismissed his symptoms as “psychosomatic.”  Olson told the sponsor that Robert’s symptoms were probably not related to bifeprunox.

Dr. Michael Carome of Public Citizen, and former Deputy Director of the Office of Human Research Protection, says the case is so alarming it deserves a federal investigation. I agree. In fact, I have been trying to get the University of Minnesota IRB to investigate this case since early January.  (You can see my letters here and here.)  I have no confidence whatsoever that the IRB plans to give this case or any others a fair review.  According to this letter, which I obtained through an open records request, the IRB has been aware of serious problems with research in the Department of Psychiatry at least since 2009.

Nor do I have any confidence that the university plans to open the lid to any further investigation.  I filed an open records request for selected Serious Adverse Event (death and injury) reports in October 2013. So far, of the 54 studies I identified, I have received Serious Adverse Event Reports for only three. One, of course, was for the bifeprunox study in which Robert was enrolled.

Former Governor Arne Carlson has written to the Board of Regents asking how many research subjects have died or been serious injured in psychiatric clinical trials at the university.  That’s a question that will never be answered until the university is forced to give up those records.

9 COMMENTS

  1. Dr. Stephen Olson should work for the VA hospitals where they do a more thorough job of covering things up. Personally I think we are seeing the post-modern attitude towards humans which is that they are organic machines of no appreciable value–in most cases. This is all slightly psychopathic. On the other hand I believe these types have always been around. The sluggishness with which this sort of behavior is investigated is also remarkable unless one is in one of these vast entities. Of course the University of Minnesota does not wish to scare off any rich source of income like the corporations.

    You know back in the ’60’s it only took rumors to get the psychedelics banned; and even research was prohibited. And yet it has been determined they are barely toxic. Safer than an Advil. There was no money to be made with these drugs. Same goes for most of the illegal drugs. But illegal they do make money and lots of it. Banks have been saved with drug money!

    Thus we have legal crime which you are pointing out; and illegal crime. Both pay. Money is king in the West. A psychiatrist giving a patient LSD would be arrested, tried and sent to jail. Justice. A doctor in effect murdering a mentally ill person goes on to the next experimental subject. Don’t rock the boat. Ethics are a nuisance.
    Yes, we have all these investigative agencies but they are on a leash. Looking into this stuff one can become jaded.

    This doctor should lose his license and then go on to jail. But he probably won’t. How much money does he bring in for the University? There are always persons in the shadows that know the DA’s . . . it is a case of insufficient evidence. Lack of proof. Surely he is good sincere doctor. And like the head of the VA working hard . . . Well, those are the stories. The tales. The good lies.

    • Clinical studies should be taken out of the hands of pharma and doctors/institutions which get any donations from them whatsoever. FDA drug approval process also needs urgent reform otherwise we will never be able to say if the drug from your doctor will help you or kill you and the doctor will likely not know himself. This is particularly egregious in psychiatry but other fields are no better (e.g. Tamiflu).

  2. Doctor Elliot, thank you for your persistence and your ethical commitment around this issue, a commitment that is rare. As the previous commenter points out, what happened to Dan M. and this latest victim takes place because, more and more, human beings are seen as nothing but profit centers.

    Those who control psychiatry have no regard for the sacredness of human life at all. Our society will fall apart if we continue allowing corporate (and individual) greed to dominate us.

  3. Thank you for your efforts in exposing the wrongdoing of psychiatric research. I believe that anyone who is taking prescription psych drugs is a research subject since none of these drugs have been proven to be safe and effective. Apparently most people think this is just fine because what else can you do with the mentally ill? Please keep up the good work, Dr. Elliot!

    • Apparently most people are just as good as Nazis if that would really be the case. But I think in reality most people simply don’t know. They believe in the system and ethics of doctors and even if things like that come out they see it as single case scandals rather than a symptom of a bigger issue.

  4. Dr. Elliott,

    I have nothing to add to the comments except to say thank you so much for what you are doing. I am sure speaking out like this has put you in a very tough position and to do what you do in spite of it deserves our thanks big time.

  5. Dr. Elliot, Thanks for letting so many of us who care about truth in ethical matters have the opportunity to share in remembrance of Dan Markinson, who was suffering and deserved compassion and professional expertise, but died because of callous wrongdoing. Because of posturing for money and for maintaining unquestioned authority over others like himself.

    Like anyone and everyone not on the inside for benefiting from such schemes. Us and all those who would not collaborate in systematic abuses and their concealment.