Anatomy of a Broken System: U of MN and the Dan Markingson Story

I’ve been following this case of alleged research misconduct at the U of MN for some time. I don’t usually like to ask my online friends to support causes that are of personal interest to me, but this an extremely disturbing situation that gets to heart of protecting people who participate in clinical research–so potentially all of us. A very troubled young man is dead and serious questions remain regarding whether he should have been enrolled in a study at all and about the egregious failures of the study coordinator,* the U of MN IRB (Institutional Review Board, the ‘independent’ group of reviewers charged by law with ensuring human subject protection), and the investigators in this case. A summary can be found here.

The University claimed ‘sovereign immunity’ from prosecution as an ‘agency’ of the state, so the Minnesota courts dismissed the case. The IRB was also declared immune from prosecution under sovereign immunity. The University then sued the victim’s mother for court costs in an apparent effort to discourage further suits.

There is an international call for the Governor of Minnesota to order an independent investigation of this situation from researchers, bioethics professionals, patient advocates and people who fear a similar thing could happen to their loved ones. If the U has nothing to hide, this investigation will exonerate them. If the alleged misconduct is true, this family deserves answers and the U of MN needs to clean up its act.

Medical research has a long and sometimes inglorious history in general and at the U of MN in particular. This is not the first time the psychiatry department at the U of MN or their affiliated physicians have been accused of wrongdoing (see New York Times article here).  To prevent the abuses of the past, rules and regulations have been instituted that must be applied every time if the public is to have trust in the process. When the system fails it is critical to know how and why so that changes can be made. Given the history of failures at the U of MN, one can only assume this is institutional negligence that needs urgent attention.

If you have the time and would like to read more specifics of the Markingson case from Dr. Carl Elliott, an MD bioethicist at the U of MN, please click on the link above and/or the supplementary links below. If, after reading about the case, you agree an independent investigation is warranted, please sign the petition hereIf you feel so compelled, please share on your Facebook pages or other social media sites. Remember, this is a call for an independent investigation–not a witch hunt. If there was no wrongdoing, the U of MN has nothing to fear.

For more information and analysis of this case and some of the serious issues it raises:

Original St. Paul Pioneer Press coverage of the story: http://www.twincities.com/ci_9306735?nclick_check=1

Carl Elliott’s thorough expose in Mother Jones: http://www.motherjones.com/environment/2010/09/dan-markingson-drug-trial-astrazeneca

Carl Elliott’s ongoing blog updates: http://loathingbioethics.blogspot.com/ and http://www.madinamerica.com/author/celliott/

 

Researchers and Bioethics Experts weigh in:

http://www.psychologytoday.com/blog/fetishes-i-dont-get/201303/the-worst-all-possible-irb-worlds

http://blogs.law.stanford.edu/lawandbiosciences/2013/03/14/the-markingson-case-investigate-the-university-of-minnesota/

Five part series on the case in Scientific American: http://blogs.scientificamerican.com/molecules-to-medicine/2012/12/11/a-clinical-trial-and-suicide-leave-many-questions-part-1-consent/

*The study coordinator in this case, a social worker who worked for an independent clinical research organization (CRO) contracted by the U of MN to manage the study, had no formal medical training. Years after the internal investigation of this case by the U of MN cleared everyone of wrongdoing, documents surfaced due to the efforts of outside investigators, that indicated the coordinator had tampered with evidence, including forging doctor’s signatures. A  disciplinary hearing found her guilty of tampering with documents and forgery (felonies for the rest of us).  Her punishment?  18 hours of CME training on ethics.  Seriously.
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