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.
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.
MINNESOTA DAILY
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.
