Wednesday, March 13, 2013

Latest on the Markingson Case at U-Minn

I have previously reported on this case:

A recent update is provided by Dr. Judy Stone on the Scientific American blog:

My own views on this case are very nicely summarized by Dr. Stone so I will simply quote her conclusion:

It is difficult in this case, as with much of life, to tell with total certainty “where truth lies.” The reluctance on the part of the Office of Research, the Office of the President, the Office of the Counsel, and the Board of Regents of UMN to fully and transparently examine new evidence is extremely troubling, though. Without such a transparent examination, there is no guarantee that the clinical investigational staff did not commit breaches of research ethics and of law, and has not continued to do so, perhaps putting other vulnerable patients at undue risk.

When I started reading about this case, it was as an academic endeavor, seeking a case study for my blog. I did (and do not) not know any of the parties involved. Yet the more I have learned, the more outraged I have become.

I am angered by the thinly veiled threats towards Dr. Elliott (e.g., Mr. Rotenberg’s “What is the faculty’s collective role in addressing factually incorrect attacks on particular University faculty research activities?”

I am saddened by what appears to me to be violations of the trust of vulnerable patients and of research ethics. As I have become immersed in the case, it has become clear that it provides a lifetime of study and discussion about what not to do during the course of a clinical trial. It is also clear to me that more patients than Mr. Markingson likely were harmed at the UMN by: enrolling participants with contested ability to consent; having financial incentives that encourage keeping someone on a trial when it appears they are not responding well; approving and supporting protocols that have seemingly disproportionate risks....
And, unfortunately, it appears that UMN believes, as do many other institutions, that protecting itself from scandal and its consequences comes first and foremost and that, like the big banks, that it is too big to be punished.

All I would add to this apt summary is that U-Minn appears to have adopterd the strategy of stonewalling, and by doing so successfully evading initial investigation into their possible lapses. Then, as more and more information accumulates that there really was a fire to explain the smoke, they continue to point back to the fact that the initial, incomplete investigations exonerated the U. as a reason not to inquire into any new concerns--as well as to keep insisting all this is water under the bridge. Meanwhile they continue to place pressure on Dr. Carl Elliott as the faculty member who has refused to be silenced.

Dr. Elliott informs me that the latest step on behalf of the Markingson family is an on-line petition, which can be found here:

A brief reminder as to what all this is doing on this blogsite. The initial charge against U-Minn is that their psychiatry department was getting a lucrative grant from a drug company to do an investigation of several antipsychotics, and to "prove" that the company's drug was the best. The company complained that the U was enrolling subjects too slowly and therefore threatened to end the grant. Under this pressure, it appears, a person who could not give valid consent was enrolled in the trial, was kept on one of the drugs despite continuing to deteriorate, with protests from his mother repeatedly ignored, till he finally committed suicide. If the facts are as alleged, and as further supported by information subsequently released, this seems an especially egregious case of academic physicians being distracted from their duties toward patient care and medical science by the lure of industry funding.


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