March 2

U of Minnesota Officials Have No Shame!

Mary Weiss forcefully responds to a specious letter by the Vice President of research at University of Minnesota, Timothy Mulcahy, who tried to absolve the University and its psychiatric researchers from culpability in the horrific suicide of her son, Dan Makingson.
Despite being floridly psychotic, Dan was coerced into a clinical trial  from which the University Dept. of Psychiatry profited. Those responsible cannot shrug off the fact that Dan’s suicide was the result of violations of ALL standards of medical research ethics.
Timothy Mulcahy had the audacity to state in a letter to the Minnesota Daily:
"The University’s human research protection program is recognized as one of the best in the country, and its record speaks for itself."
Research record of U. of Minnesota:
"A University of Minnesota study in the late 1940s injected 11 public service employee volunteers with malaria, then starved them for five days. Some were also subjected to hard labor, and those men lost an average of 14 pounds. They were treated for malarial fevers with quinine sulfate. One of the authors was Ancel Keys, a noted dietary scientist who developed K-rations for the military and the Mediterranean diet for the public."
If the  President’s Bioethics Council is serious about examining clinical trial ethics violations and coming up with useful recommendations, this is the case that they should examine closely. If, "The University’s human research protection program is recognized as one of the best in the country…" as is claimed by its V-P of research, then we can expect numereous other preventable tragedies such as  Dan Markinson’s suicide. 
The fact is, if those responsible for Dan’s coercive recruitment and refusal to heed his mother’s warnings and withdraw him–if they "get away with impunity" other preventable tragedies will happen again and again.
Vera Hassner Sharav


Mary Weiss responds to VP Mulcahy

2011 / 03 / 02
By Mary Weiss – Daily reader

I am Mary Weiss, mother of Dan Markingson, who died while in a University of Minnesota clinical drug study. In a Feb. 24 letter to the editor published in the Minnesota Daily, “The Markingson case deserves better from the Daily ,” R. Timothy Mulcahy, vice president for research at the University, states, among other things, that the University did not profit from the study in which Dan died.

So, this study was revenue neutral? Does the University not profit from their clinical drug research? Who would possibly believe this?

Mulcahy states non-University psychiatrists found no wrongdoing. Of course they found no wrongdoing: These psychiatrists were paid to find no wrongdoing by virtue of the fact that they were “expert witnesses” for the University. Other medial professionals have since disagreed with this assessment.

Dr. Harrison G. Pope, Jr., professor of psychiatry at Harvard Medical School, said about the study, “There is virtually no evidence that this vulnerable, severely psychotic and mentally incompetent patient was capable of understanding the study to which he was consenting.”

Or take the statement of James I. Hudson, also a professor of psychiatry at Harvard, who summed up his professional opinion of the doctor who conducted the study, saying, “Dr. [Stephen] Olson’s errors, omissions, improper acts and failures were to a reasonable degree of medical certainty, a substantial contributing factor and a proximate cause of Mr. Markingson’s death.”

Dr. Keith A. Horton, licensed psychiatrist in the state of Minnesota, said in his expert testimony, “It is my opinion that this case represents a violation of biomedical standards upon which there is a widespread consensus for informed consent and human subjects’ protection.”

Mulcahy states also in his article, “The University is steadfast in its commitment to the protection of all research subjects.”

If this had been the case, “Dan’s Law” — which was passed unanimously in both the Minnesota House and Senate in 2009 — would have been entirely unnecessary.

This law now prevents anyone on a stay of civil commitment from entering a psychiatric clinical drug study and also prohibits any doctor from putting his or her own patients into his or her own clinical drug study.

Also, Mulcahy states that “proper care was provided” to Dan. I don’t think many people would consider it “proper care” when on April 9, 2004, Easter Sunday — less than a month before he died — Dan was psychotic, and I, his distraught mother, left voice messages for Olson and also Jeanne Kenney, the study’s coordinator.

I said, “Do we have to wait for him to kill himself or someone else before anyone does anything?” thinking for sure someone would call me  back in the morning and re-hospitalize Dan.

Unbelievably, no one responded — though Kenney did write my message verbatim in her study file. Evidently, the outcome of the study was more important than making a patient well or keeping him alive.

Also, Mulcahy states that no laws were violated by the University. In fact, the University was given immunity by a Hennepin County judge who cited the Minnesota law which states “[Minnesota] and its employees are not liable for … a loss caused by the performance or failure to perform a discretionary duty.”

Horton also said, “It is my opinion that no university or medical center should tolerate or condone the improper, coercive, unethical practices documented in the case of Dan Markingson. Correction measures should be instituted to prevent future injuries to vulnerable patients.”

But no correction measures have been taken. And the University still tolerates and condones improper, coercive, unethical practices.

What is it going to take for them to change? I really don’t know. Hopefully not the death of another parent’s precious child.


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