Out here in Minnesota, where the snow is gently falling, many of us are hunched over our computers, puzzling over a document just posted by the state Board of Social Work. It concerns the death of Dan Markingson (or as the document calls him, “Client #1”). Markingson, of course, was a young man under a commitment order who was coerced into a profitable Seroquel marketing study at the University of Minnesota over the objections of his mother, and whose condition spiraled downward until he committed suicide. The Minnesota Board of Social Work has just issued an “agreement for corrective action” for Jeanne Kenney, the study coordinator for the CAFÉ study in which Markingson died.
It is an odd document. On the one hand, it contains a number of remarkably damning findings. For example, despite the fact that Kenney had no formal medical training, she apparently administered prescription drugs to research subjects and made formal judgments of the side-effects. She frequently assessed the severity of potentially dangerous adverse events such as akathisia, and sometimes she even assigned the job to a social work intern she was supervising. According to the Board, her record-keeping was “devoid of any clearly articulated, consistent set of treatment goals” and she omitted crucial information relevant to suicide prevention. When Markingson’s mother, Mary Weiss, left “alarming voicemail messages” about her son’s condition, Kenney did not respond adequately. Kenney also made significant mistakes about medication dosage and a medical diagnosis, and these mistakes remained in the chart until well after Markingson’s suicide, when Kenney went back and changed them. To top it all off, Kenney often signed the chart with the initials of a physician.
It also appears as if Markingson was enrolled in the CAFÉ study without his consent. On March 17, 2004, the study sponsor warned investigators of a new risk of Seroquel – specifically, the hyperglycemia and weight gain now known to be common side-effects of many atypical antipsychotics. Kenney was supposed to notify all study subjects of this new danger and ask for their agreement to remain in the study by signing a revised consent form. But Kenney failed to do this. As the Board points out, this failure to communicate this new information “effectively invalidated” Markingson’s informed consent.
Yet on the other hand, the punishment handed out by the Board is hardly adequate to the offense. Kenney will be required to complete 18 hours of continuing education over a period of nine months. In fact, the document makes it very clear that no formal disciplinary action is being taken against Kenney. The document merely represents an “agreement for corrective action.” According to the document, Kenney claims that the study was “supervised by a national sponsor and approved by the University of Minnesota through its institutional review board,” and that she was “acting under that supervision and in accordance with the protocols that had been approved.” In other words, she was just following orders.
Up to this point, University of Minnesota administrators have uniformly defended the CAFÉ study and its investigators, Stephen Olson and Charles Schulz. The Board of Regents refused a request for an external inquiry. Mark Rotenberg, the General Counsel, has weighed in vigorously on several occasions. The Vice-President for Research, Tim Mulcahy, has also made his opinion known. In 2011, Aaron Friedman, the Dean of the Medical School and Vice-President for Health Sciences, sent an email to the faculty making it clear where he stood on the matter. “As a result of this case, our department of psychiatry has experienced significant scrutiny and withering criticism over the past five years, and through it all, the faculty of the department have performed remarkably well in fulfilling its mission,” Friedman wrote, singling out Olson and Schulz for praise. “I see the Regents’ statement as the end of the University’s review of this specific patient’s case.”
Yet as the Board of Social Work has shown, it may not be so easy to put an end to this case. These findings concern only one study and one subject, but Kenney was apparently the study coordinator for a number of clinical trials at the University of Minnesota. For example, in a deposition given for a lawsuit about the death of Dan Markingson, Kenney stated that she was the study coordinator for the CATIE study — a large, NIMH sponsored trial that has been enormously influential. If Kenney was unqualified to perform her tasks as study coordinator for the CAFÉ study, it stands to reason that she was probably unqualified for the CATIE study as well. And that raises questions of concern not just to the NIMH, but to the FDA and the Office of Human Research Protection.
Mad in America hosts blogs by a diverse group of writers. These posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.
I’m only two paragraphs into this and am too baffled to keep reading right now. Tampering with patient documents post-mortem and forgery? Both of these are felonies. Why isn’t this person in prison? Has anyone involved in this “issue” ever bothered to report her to the authorities?
Ahh, after finishing reading this it appears that the “authorities” that people keep taking their complaints to are the University of Minnesota and other professionals.
These people are breaking laws. They belong in criminal courts. The goal should be to collect all of the evidence and convince a prosecutor to take the case. Forgery, for instance, is a felony under all circumstances.
Sadly, complaints about this case have been lodged with just about every imaginable body, from the FDA, NIH and HHS OIG to the Minnesota Board of Medical Practice. But you are exactly right. These people belong in criminal courts.
Well then the first step is to notify the prosecuting attorney in that area and provide him with the needed evidence of crimes committed during this study.
Carl, I saw the film Off Label. Thanks for the update on this case.
What Dan Markingson suffered was a crime against humanity.
I hope the prosecution and punishment go much, much further.
Thanks. I agree, Off Label is a great film, and I hope others can see it.
The reason stuff like this happens is that the victims (us) are not perceived as human beings. We are in the position slaves were in in the 19th century. If a slave owner beat his “property” to death, it was considered a very big deal if he was given a five-dollar fine.
Our movement for resistance to psychiatry has to address this somehow, in the same way all other oppressed people in this country have done.
All of the movements that we say we model ourselves after took very vocal and very strong stands. They were very visible. Every time I state that we need to be more forceful I’m bombarded with statements like, “Oh we have to build bridges between us and the people running the system,” or “We have to be careful not to make ‘them’ upset because then they won’t listen to us.” Well, the fact is, they don’t listen to us at all anyway and this is a prime example. This woman should, by all laws, be in jail but instead there she is, heading up more “studies” at the university.
You point to a fundamental dilemma between the urgency of the issues, and the fact that making progress on these issues requires time and patience.
Even if I often advocate building bridges, it is obvious that trying to build bridges with Torrey, Lieberman, Nemeroff or Kenney would be a waste of time.
But I don’t see an opposition between being more forceful and building bridges with other people, on the contrary those bridges are what will bring force to your ideas.
The bridges have to be built with people who care more about outcomes than about their pet business/ideology. That is the “silent majority”. Especially when trying to educate about the mind, you will only have credibility with that audience if you master the art of constructive and creative dialogue.
Preaching to the choir with force will not advance any cause if the pews are empty.
Sounds like manslaughter to me. Criminal charges?
Classic response of not my problem. No one is responsible because someone else should have been.
The social worker was not trained, so is not responible, as the psychiatrist should have been supervising. The psychiatrists are not responsible, as they are only required to be involved if adverse events are found.
The supervisors are not responsible, as they cannot know what everyone is doing every second of every day.
And to some degree that is true. BUT of course one must only practice within there training and they must be held accountable for taking reasonable precautions to protect people. Doctors in hospitals do not supervise everthing a nurse does all the time, but they do need to do somethign to try and make sure that patients are being treated appropriately, according to the instructions they give. They must also visit the patient regularly to monitor side effects themselves and not simply leave it all up to nurses. This case is however, worse as Social workers have no training in medication, and yet they had no problem at all putting her in this role. She is responsible for practising at levels she is not trained to do. And of course those that PAID her to be in that role are also definately responsible for allowing her to be in that role. Above all else, when it comes to the LEVELS of errors made, here, one needs to be held responsible and acountable. And of course if one wants the profession to be respected, then they need to hold them to account. Can’t be much more shameful than to be a social worker at the moment. One wonders how many social workers are truly happy with the outcome here. Is that how they want to be seen??
Association between Seroquel or quetiapine,and hyperglycemia (diabetes).
There is concern Seroquel,like other atypical antipsychotic drugs, has the potential to cause metabolic disorders, particularly hyperglycemia (excess sugar) and diabetes. Atypical antipsychotics cause the body to metabolize fat instead of carbohydrates, leading to insulin resistance to the excess carbohydrates. At the same time they promote fat accumulation.I was a patient back in 1996-2000 who was a subject of Eli Lilly’s Zyprexa ‘viva’ Zyprexa’ off label sales promotion.I was given it as an ineffective costly treatment for PTSD It gave me diabetes as a side effect.
Eli Lilly made $68 BILLION on Zyprexa!
One of the underlying problems is that our society allows the medical profession to police itself. In spite of the overwhelming evidence that the medical profession is incapable of actually being accountable for maintaining it’s own ethical standards; and protecting patients. Doctors simply do not report colleagues who provide unethical clinical care to Medical licensing boards. In the rare instances doctors are brought before licensing boards, rarely do they lose their medical license. Doctors who ignore the Ethical Guidelines of the medical profession and whose medical care (or lack thereof) harms patients, are tolerated by their colleagues. In psychiatry, unethical practitioners are elevated to positions of authority in the APA and AACAP, are active in formulating public policy, determining what the standards of care are, and are given federal grants to conduct research. The primary mechanisms for accountability are in the control of the medical profession, which brings us back to the beginning: medical professionals rarely report unethical conduct of other medical professionals; and apparently are even less likely to conduct adequate unbiased investigations when reports are made and it becomes necessary. The underlying conflict of interest in having medical professionals police themselves is that being accountable would initially increase the premiums they pay for malpractice insurance.