More scholars call for U to investigate clinical trial suicide

Judy Stone - Author of “Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators”

University of Minnesota President Eric Kaler and the University Senate received a letter last week calling for an investigation into the practices surrounding the suicide of Dan Markingson and to see how future similar tragedies could be prevented. The suicide occurred while Markingson was participating in a clinical trial at the University.

Prominent scholars, ethicists, clinical researchers and specialists in health law and human rights from all over the world signed the letter.

The University has not adequately addressed concerns in the past or more recent revelations. These include:

•   If the social worker or research coordinator was sanctioned by the State of Minnesota Board of Social Work for her role in the case, why weren’t her supervising physician principle investigators similarly sanctioned?

•   Several people with family treated on this trial have come forward with “evaluation to consent” forms that bear identical responses. This strongly suggests that the forms were duplicates and were not the responses of the subjects prior to their enrollment — a serious violation of ethics.

•   Serious conflicts of interest have become apparent, casting doubt on both the approval process and on efforts to examine the case. It is rather like the fox guarding the henhouse.

•   There were apparent Health Insurance Portability and Accountability Act violations, with Markingson having been enrolled three days before he signed a consent form.

•   How could a person who was declared incompetent and institutionalized consent for a clinical trial? The Minnesota Legislature was also troubled by this, subsequently passing “Dan’s Law,” which bans researchers from recruiting most psychiatric patients into drug trials if they are under a commitment order.

While the University has insisted that it has been exonerated by outside investigations previously, this is simply not true. The Food and Drug Administration did a remarkably superficial review before many of these increasing concerns came to light. Former University General Counsel Mark Rotenberg asserted that the attorney general’s office had reviewed the Markingson case and found no fault with the University.

We now know that never happened. Minnesota Deputy Attorney General Karen Olson confirmed to Markingson’s mother that her office “has not made any independent investigation or determination regarding the care rendered to your son.”

Responses from the University have been disingenuous at best. As a result of ongoing questions, more than 3,000 people from all over the world have signed on to a petition calling on Gov. Mark Dayton to order an investigation of Markingson’s death.

The University needs to recognize that its stonewalling is creating further adverse publicity for itself. This story has even been picked up by the British Medical Journal. I was a clinical researcher for more than 25 years and now write about research ethics in a series for Scientific American. I know what happened at University was wrong, which is why I will continue to call attention to this injustice.

Is this the legacy — similar to that of the latest Tuskegee syphilis study or HeLa scandals — that the University wants? If not, and to set a positive, responsible example for its students, the University must appoint an independent and transparent review panel, as requested by Trudo Lemmens, Scholl Chair of Health Law and Policy at the University of Toronto, et al. Wishing alone will not make this problem go away for the University. Positive, honest responses might.