April 11, 2013 | 7
All that is necessary for the triumph of evil is that good men do nothing.
One month ago, Mike Howard, family friend of Dan Markingson, who committed suicide while participating in a clinical trial at the UMN, launched a petition requesting that Governor Mark Dayton launch an independent investigation of research misconduct in the university’s psychiatry department. Since that time, the petition has garnered almost 2000 signatures, from a range of people, including mental health professionals, families affected by mental illness, both non-affiliated Minnesota residents, and from prominent scholars from all over the world. A sampling of comments follows, below.
This Monday, the University of Minnesota dropped a bombshell of an announcement—that Mark Rotenberg, the General Counsel, would be leaving to pursue a similar opportunity at Johns Hopkins University in Baltimore.
This announcement has taken many observers by surprise…yet the Minnesota Post notes that the petition has been signed by “a veritable Who’s Who of top academics here and abroad,” after consent documents from different patients surfaced that were inexplicably identical, raising more alarming questions about possible research misconduct. The Post continues, “And so it is perhaps natural for his departure to occur while he’s in the headlines.”
The Star Tribune spoke with Rotenberg about how he “has navigated the dual roles of general counsel, defending the U as well as investigating its wrongdoing.” Rotenberg responded, “You need on the one hand to be a defender, an adviser, a counselor, a trusted partner…And on the other hand, you must also be a government lawyer who protects the public interest when the client is engaged in, or alleged to be engaged in, bad acts. If you fail at either task, you’re not doing your job.”
President Kaler stated that Rotenberg “has epitomized the kind of integrity and accountability that all public institutions like ours strive for.” As the comments on the petition reveal, not everyone shares that assessment.
What do you make of this turn of events?
Signatories to the petition include three former editors of the New England Journal of Medicine, former editor of the British Medical Journal, the editor of the Lancet, and numerous scholars from all over the world.
Here is a representative sampling of comments. If you wish, you can add your voice to the petition.
The protection of research participants is an issue that concerns everyone.
Francoise Baylis Dalhousie University, Halifax, Canada
As an American academic residing and teaching ethics in Israel, I am concerned about the possibility of such serious misconduct and suspected cover-up in a respected American university, especially one supported by the state!
Norm Zohar Bar-Ilan University, Jerusalem, Israel
I am a professional bioethicist, and to me the attitude of the university to bend any rule to forestall an investigation is appalling.
Christian Munthe University of Göteborg, Sweden
This is exactly why the Nuremberg Code was developed and why the principle of informed consent is #1 on the list of 10 standards.
Elisabeth Clark Montreal, Canada
I’m a University of Minnesota alum and I’m outraged by the school’s response to this scandal… There is substantial evidence of multiple forms of misconduct, some of which are felonies. The trial’s coordinator has been censured. The Minnesota legislature passed a law to avoid some of these exploitative practices in the future…
To call this merely shameful would be wholly inadequate. There must be a thorough and independent investigation of the University’s treatment of Dan Markingson, its conduct in related litigation, and its attempts to intimidate critics into silence. If, as it appears, University employees committed criminal acts, they should be prosecuted. And if the University’s counsel withheld documents and/or knowingly produced altered or faked documents in litigation, those attorneys should be disbarred.
Matt Lamkin Stanford University
Attended U of MN Medical School. then U of MN Psychiatry Residency – ashamed of the Psychiatry Department – have been in private practice since 1977 – Have seen first hand the hijacking of Psychiatry by BigPharma.
David Bransford MD Grand Rapids, Mn
As a faculty member at a University (Penn State) now notorious for failing to investigate abuses, I find the refusal of the University of Minnesota to confront this scandal sadly familiar. Granted that the abuses that occurred here were of a very different nature unfolding in very different circumstances, our experience should nonetheless be evidence enough for any institution that the only way forward when abuses have occurred is a thorough, transparent investigation conducted by an independent authority.
Jesse Ballenger Pennsylvania State University, State College, PA
The institutional stonewalling on the part of University of Minnesota, and the further horror of suing Mary Weiss for legal fees is staggering. Please investigate this case.
Sarah Lewis Dover, NH
As a bioethics and law professor, I have been profoundly disappointed and dismayed by the lack of serious investigation by the University of Minnesota and various US agencies mandated to protect human research subjects into what happened in the Dan Markingson case and in other cases of alleged breaches of research ethics and research subject protection standards at the University of Minnesota. There clearly are sufficient indicia to warrant a full fledged investigation, yet the University and other agencies seem to be hiding behind formal procedural rules to avoid any further inquiry. This is unacceptable for any academic institution, let alone a publicly funded institution.
Trudo Lemmens University of Toronto, Canada
The largest employer in the state should take better care of Minnesotans.
George Hoagland Duluth, MN
It is a blatant misuse of state, economic, and institutional power that has resulted in at least one death.
Matt Levine Minneapolis, MN
An independent investigation has now become absolutely necessary. The scandal is shameful. The response of the administration of the University of Minnesota has been even more shameful. By the way, I did my postdoctoral fellowship in bioethics at the University of Minnesota
Jing-Bao Nie University of Otago, New Zealand
I am a graduate (CLA, 1981) and ashamed of the way the University continues to handle this tragic case. According to the Board of Regents, Minnesota is committed “to the advancement of learning and the search for truth….” Let the whole story about Dan Markingson and the clinical trial come to light. The protection of research subjects is a matter of great public import that demands public accountability.
Joseph Davis University of Virginia, Charlottesville
As an academic psychiatrist and a director of a psychiatry residency program, I am appalled by the circumstances surrounding this case. While I was deeply concerned about the recruitment and management of this particular study and the death of this patient, I am perhaps even more alarmed by the attempts to avoid and/or distort an appropriate and objective inquiry. When there is morbidity and mortality associated with any clinical interaction, we are obligated to make sure that we do anything and everything to make sure it doesn’t happen again. Many times this means asking for help and accepting constructive criticism. I urge the University of Minnesota to do the right thing: appoint an external panel to conduct a thorough, independent and transparent investigation.
Hal Elliott, MD East Tennessee State U, Johnson City, TN
Society deserves honesty and transparency from researchers and the pharmaceutical companies funding them.
Nancy Hokkanen Bloomington, MN
As an historian who has written on US experiments in both Tuskegee and Guatemala, it is imperative that when injustice happens it be acknowledged and investigated. This is not something we must do only for the past.
Susan Reverby Women’s and Gender Studies Wellesley College
If the University has nothing to hide then an investigation into the death of Dan should be welcomed by them. Ensuring that those who are vulnerable are protected from harm is a cornerstone of research ethics – the fact that a young man who was vulnerable died during a research project demands that the circumstances leading to his death are investigated. It’s the least the University ought to do. To threaten Dan’s mother with legal action to cease her campaign smacks of the worse kind of insensitivity and arrogance.
Phillipa Malpas University of Auckland, New Zealand
The lack of transparency and willingness to look into how research and clinical trials are conducted is, in itself, a breach of trust that casts a pall on the university and the psychiatric community. As a psychiatrist, I am deeply concerned about the widespread complicity between the profession and the pharmaceutical industry.
Laurence Kirmayer McGill University, Montreal, Canada
As a researcher, I am horrified by so many elements of this abuse of power. We must not let this go unacknowledged and unpunished, or the future of all research is at stake. People cannot make safe, well-informed decisions to participate in research if they do not know their interests will be protected. Thank you for your time and attention.
Erin Morgan Center for Victims of Torture, St. Paul, MN
I’ve been following this story, open-mouthed, as its unfolded. The very least that can be done is to shine some light into what are apparently some very murky corners.
Iain Brassington University of Manchester, England
This petition is important for more reasons than space will allow to list. Having known another participant in the Cafe study and how he and his family were treated by the researcher and the coordinator is disgusting. It was stay in the study at all costs, no recommendation for a second opinion, and no referral for any psychiatric help if he didn’t stay in the study. For the University of Minnesota to have conducted this charade for so long that they were not responsible is incomprehensible. If Governor Dayton will not listen then this petition needs to go to Washington DC.
Peter Richardson Roseville, MN
I am a researcher and advocate regarding the rights of human subjects enrolled in clinical trials research. This petition is important because we need to carefully investigate every case of possible conflict of interest. In this case, the circumstances surrounding Dan’s Markingson death are extremely serious and shouldn’t be overlooked. As citizens, we need to know that every trial is bringing a potentially new drug or treatment to the table and that the researchers are not conducting them enticed by the prospects of short term financial gain. Protecting subjects’ rights is critical because without their altruistic participation no drug development would be possible. Research subjects are assuming risks to benefit us all. The least we can do is to make sure these risks are minimized by avoiding, or investigating, every case of research malpractice. This petition won’t bring Dan back but it can make a big service by contributing to minimize some of the behaviors that killed him in the first place.
Roberto Abadie City University of New York
“When I taught at the U some years ago, we had to undergo research ethics training because of the unethical conduct of John Najarian. How did the Psychiatry Department avoid the training? Do you really want the great University of Minnesota to become an academic pariah?”
Helen Longino Stanford University
I was the editor of the British Medical Journal and have a long standing interest in research misconduct and experience of many cases. I’d have thought that the University itself would have been keen to investigate this case–because there is clear evidence that things went badly wrong and the University would surely want to learn from a bad experience. Much might be learnt. Sadly I’ve encountered many examples of universities being unwilling to run the risk of finding serious problems with their own staff, which is why in this case an independent inquiry may be needed–but the University will have to cooperate.
Richard Smith former editor, British Medical Journal, London
I don’t care much for evil.
Jed Wolfe Los Angeles, CA
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