(AP Photo/The Star Tribune, Renee Jones Schneider)
For some background on this matter please see my earlier post on the petition to Governor Dayton calling for an independent investigation of the suicide of Dan Markingson.
Since that time more than 2500 people have signed the petition including citizens of Minnesota, and students, faculty, and alumni of the University of MInnesota.
Also among the signers are three former editors of the highly regarded New England Journal of Medicine; the editor of the Lancet - a highly respected British medical journal, a former editor of the British Medical Journal and the former health and disability commissioner of New Zealand as well as more than 200 experts in medical ethics and related disciplines. Others include a medical historian with expertise in the Guatemala syphilis studies, which resulted in an apology by President Obama in 2010, and one with expertise in the infamous Tuskegee experiments.
In his recent opinion piece on the Star-Tribune, Dean Friedman hypothesizes that "The University of Minnesota research case is not a scandal."
The first thing that pops up on the web for a definition of scandal is:
scandal (noun): An action or event regarded as morally or legally wrong and causing general public outratge.
synonyms: disgrace, shame
Based on the signatures and qualification of those calling for an independent investigation, I'd say that this situation qualifies eminently as a scandal.
The fact that the Dean starts his piece with this semantic argument indicates how weak his case really is.
But there is more...
Dr. Friedman states:
"The story may be familiar to some readers. For years, Elliot has focused his energy on this single issue. Yet as Elliot clamors for more examination, he seems to feel no responsibility to accurately report what has already been done."
a) Dr. Elliot has contributed greatly to our understanding of what I will delicately call the academic-medical-pharmaceutical complex using the Markingson case as well as many others to make major contributions to the medical ethics field. To belittle his efforts is unworthy of a medical school dean.
b) "accurately report what has already been done" This statement is almost laughable. Dr. Elliot has published copious documentation in this case on ScribD, as well as on his website. All we have gotten from the university is the same boilerplate denials. The tactic is simply to deny and stall and then to claim: "well that happened a long time ago."
In Dr. Friedman's own words:
"Nine years later, it is time to stop blaming our university and our researchers."
What really galls me is the following statement by Dean Friedman:
"Judge the university not on unfounded accusations, but on careful examination of the facts surrounding this case, and on the scale of the groundbreaking advancements taking place across our campuses every day."
I've already indicated who has carefully examined the facts (Elliot) and who is in denial of them (Dean Friedman) but this final argument that we should just forget about the Markingson scandal because of the "groundbreaking advancements taking place across our campuses every day" is preposterous.
Because advances are made we should ignore the plight of mistreated clinical trials patients. They are just so much broken crockery to sweep away?
And what is even worse about this argument - Dan Markingson did not die on the altar of "groundbreaking advancements" but in the service of a pharma sponsored trial of a drug (Seroquel) that can only be described as a marketing study.
For more information, gentle readers might want to consult the artlcle by the Strib's Maura Lerner and Janet Moore. There they will learn that in 2009, documents revealed in litigation against AstraZeneca illustrated that Dr. Charles Schulz, head of the U of M's psychiatry department and a highly paid Astra Zeneca consultant had inaccurately represented the benefits of Seroquel in both research presentations and press releases. The groundbreaking work of Dr. Schulz actually established that Seroquel was no more effective than older, existing drugs such as Haldol (haloperidol).
Someone seems to have forgotten about first, do no harm and other ethical matters, Dr. Friedman.
It is critical for the University of MInnesota to regain its good name and to take steps to see that something like this never happens again.
To defend the behavior of the University in the Markingson case is a fool's errand.
Part of mausoleum of canon Guilain Lucas (1628)
Photo credit: Wikimedia Commons
Dr. Mulcahy's original letter appeared in the Minnesota Daily. I'd encourage interested readers to read it as well as my own comments at the end of the article. With the permission of Mary Weiss, I here reprint her letter. It should receive widespread attention in the community. Steps should be taken, including an independent investigation, to assure that such incidents do not occur in the future. To argue that what happened is not illegal is a far cry from the Hippocratic Oath: First do no harm.
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
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.