A December 21, 2014 article in the Minneapolis Star-Tribune updated an ongoing example of how the leaders of health care may seek to silence their critics. The article updated the career trajectory of Dr Carl Elliott, a
Background - the Dan Markingson Case
We first blogged about this case in 2011. The case itself dates from 2003, and first got media attention in 2008. A good quick summary appeared in the Center for Law and Bioscience blog out of the Stanford Law School.
Dan Markingson – a vulnerable, psychotic young man – was forced to choose between enrolling in a Pharma-funded drug study or being involuntarily committed (in other words, locked up). A UMN [University of Minnesota] doctor enrolled him in the study despite having just determined that Dan 'lack[ed] the capacity to make decisions regarding [his] treatment,' rendering it highly unlikely that Dan could have given valid informed consent to participate. As Dan's mother, Mary Weiss, observed his mental condition deteriorating, she repeatedly tried to have Dan removed from the trial – at one point asking 'Do we have to wait until he kills himself or someone else before anyone does anything?' But the UMN co-investigators in the drug study refused to terminate his participation. Shortly after Ms. Weiss made her desperate plea, Dan Markingson killed himself by cutting his own throat.Dr Elliott, an expert in bioethics who had concentrated on issues such as the effect of conflicts of interest and commercial influences on clinical research, started probing the death of Mr Markingson after the 2008 media reports.
Some of what Dr Elliott found appeared in a May 23, 2014 article in Science. He concluded that previous efforts to investigate the death of Mr Markingson were flawed.
Elliott came to believe that every investigation—not only by FDA but also by the Minnesota Board of Medical Practice, the university's IRB, and its general counsel's office—had been flawed or incomplete. FDA did not seek Weiss's perspective, the views of Markingson's caseworker, or interview staff at the halfway house who had interacted with Markingson, for instance. (FDA would not comment on the Markingson case for this story.) Nor did the agency examine conflicts of interest. Weiss's lawsuit was dismissed not on its merits, but because the university's IRB and Board of Regents were deemed immune from liability thanks their role as state employees. (The judge did argue that informed consent was obtained appropriately, because Markingson had signed the consent form and had not been declared mentally incompetent by a court.)
Furthermore, he found reasons to think that the problems with the trial in which Mr Markingson died were not unique. He and a colleague
heard from other individuals who insisted that they had been harmed in UMN psychiatric drug trials or had witnessed others' mistreatment. One man said he had worked in the psychiatric units of the hospital where Markingson was treated. Another identified herself as a counselor for teenagers. Elliott heard from parents, who said their son or daughter had enrolled in a study under pressure.
Thus, Dr Elliott and others concluded that the university should do a thorough investigation of the case,
In November 2010, eight faculty members, including Elliott and [McGill University bioethicist Leigh] Turner, wrote a letter to the university's Board of Regents, requesting an independent, university-commissioned investigation into the Markingson case.
The Punishment of a Dissident
As the Science article noted, former Minnesota Governor Arne Carlson said that the
university hired Elliott because it 'found him to be one of America's most outstanding bioethicists. The moment he comes up with something that is sensitive to them, he becomes the village idiot.'
In fact, as we noted in 2013, in a 2012 post in the Center for Law and Bioscience blog, not only did university officials rebuff the call for a new, thorough investigation of the untimely death of Mr Markingson, but the university general counsel, who had been operating at the heart of this case, appeared to threaten the leading bioethicist dissident, Dr Carl Elliott:
After Carl Elliott, the University of Minnesota bioethicist, refused to drop the matter, [university chief counsel] Rotenberg asked the university’s Academic Freedom and Tenure Committee to take up the question of '[w]hat is the faculty[’s] collective role in addressing factually incorrect attacks on particular university faculty research activities?' – a question that appeared both to accuse Elliott of 'factually incorrect attacks' and to call for some unspecified action to 'address' them. Other faculty, including the president of the Minnesota chapter of the American Association of University Professors, viewed this as an attempt to intimidate Elliott into silence. If so, it backfired. The story ended up in the press, putting the Markingson case back in the public eye and once again making the University of Minnesota look really bad.The December 21, 2014 Star-Tribune article reported that university administrators seem to be out to get Dr Elliott once again. First, it interviewed the university's chair of psychiatry,
[Dr S Charles] Schulz, the department chair, says he can’t even bear to read Elliott’s published accounts anymore. 'It’s too painful,' he said.
Both he and Olson say that Elliott gives only one side of the story and that he ignores the facts that don’t support his case.
'I think [people] believe that because Carl Elliott is a professor of bioethics and a member of the Center for Bioethics, that he must be telling the truth,' said Olson. But 'he’s not pursuing this in an academic way. I don’t think it’s conduct that becomes a faculty member and a peer.'
What is not academic or unbecoming about investigating the death of a vulnerable psychiatric patient during a clinical trial is not clear. Then,
University officials have not been amused. They accuse Elliott of whipping up hysteria with 'false and unfounded' allegations, and undermining research efforts in the process. And while the university hasn’t tried to fire him, it has reprimanded him for 'unprofessional conduct,' a move that he’s now challenging under the tenure code.
Again, rather than investigating the death of Mr Markingson, or at least responding to specific allegations, university administrators have set about to punish their own distinguished faculty member who wondered why a vulnerable patient died during a university run clinical trial.
So far, academic freedom has protected Elliott’s job. But last winter, the university claims, he crossed a line. It accused him of using a 'fabricated letter' in a speech about the Markingson case at Hamline University and demanded that he issue a retraction.
The 2004 letter, addressed to Weiss, Markingson’s mother, appears to be from a university lawyer disputing her right to her son’s medical records. The U says it’s a forgery; Elliott says he doesn’t believe it, and he refused to issue a retraction. He called it an attempt to discredit Weiss, adding: 'I won’t be part of it.'
Elliott received a letter of reprimand in August from Dr. Brooks Jackson, the current dean of the Medical School, citing him for 'significant acts of unprofessional conduct.' The reprimand is on appeal.
The evidence that the letter was a forgery was not apparent. Yet while they pursue their own faculty member for his investigation of Mr Markingson's death, university managers still apparently have not addressed the many problems in the university's version of the story of Mr Markingson's death, from the fragmentary nature of previous investigations to the problems just revealed in a Scientific American blog with the knowledge of an expert witness for the university in the lawsuit brought by Mr Markingson's mother against it.
Dr Carl Elliott is a respected physician bioethicist who has uncovered problems with commercial contract research organizations doing human research (see our blog posts here and here), and has written a critically acclaimed book, White Coat, Black Hat (reviewed here by Dr Howard Brody on his blog.) Yet his previous work counted for naught when he dared look into possibly unethical clinical research done at his own university. As noted in the Star-Tribune article,
Within the U’s Center for Bioethics, where he has worked since 1997, he says the tension is so palpable that he dreads setting foot in his office. He does most of his work from coffee shops.
In my humble opinion, it appears that top university managers have put their personal interests ahead of the mission of their university, the role of their faculty members in upholding that mission, and even the welfare of patients who put their trust in the university's academic medical center. The hard life that Dr Elliott has lead since he started to challenge his own university's administrators show how the anechoic effect is generated. As long as leaders of academic medical institutions, and other health care organizations can put their own interests ahead of the mission, health care professionals and other academics who object are likely to have their lives made miserable, possibly lose their jobs, or worse. How many will have both the courage, and the resources to stand up for what is right under such a threat.
True health care reform would turn leadership of health care organizations over the people who understand and are willing to uphold the mission of health care, and particularly willing to put patients' and the public's health, and the integrity of medical education and research when applicable, ahead of the leaders' personal interests and financial gain.
ADDENDUM (30 December, 2014) - Post corrected. Dr Elliott trained as a physician but is not a psychiatrist.
ADDENDUM (30 December, 2014) - also see comments on the 1BoringOldMan blog.
Dr. Elliot's experience is similar to what I have seen. There is no way to get around it, when you speak up for the truth and it's against the business interests of the medical center and university, you will get hammered.
Plain simple truth that can't be avoided. That is the price you must pay to do what is right.
More Doctors need to accept this and yet do the right thing. Because "I will be ostracized" is not an excuse for violating the trust given to the doctor by the patient.
Healthcare is not like buying a used car where buyer beware is the mantra. If it is true that healthcare institutions are untrustworthy and MDs contribute, I think much of what we see on TV advertising is evidence of a false claim.
It is outrageous and appalling that this behavior continues. There is no way that any change will occur in the medical industry as long as the whistle blowers are the ones being punished!
Fabulous post, Roy. Perhaps your readers can be enlisted to help provide tangible support Dr Elliott in his struggle against such outrageous attacks by the University. (He'll of course need to let us know if there is some way outsiders can be useful.)
At the same time, let's not allow the awful attacks on Dr. Elliott to overshadow the University's unconscionable refusal to address his concerns about the patient's death, and about the "research" itself. As terrible as one patient's death may be, it also highlights the larger perils of a for-profit research agenda, and so needs to continue to be held up to the light -- so that future "subjects" can avoid harm due to sponsor (and "investigator") greed.
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