Summary of the Case
A good quick summary of this case just appeared in the Center for Law and Bioscience blob 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.
Our most recent (2011) post on the case was here. In it we also noted that there was reason to think:
- The design of the controlled trial was flawed.
- Financial conflicts of interests may have influenced the trial investigators' actions, particularly their questionable enrollment of Mr Markingson in the trial and their retention of him in it despite his apparent clinical deterioration.
Despite that, when bioethicists and the University of Minnesota called for a new investigation of the trial and what happened to Mr Markingson, the university rebuffed them.
Worse, as detailed in a 2012 post in the Center for Law and Bioscience blog, not only did university officials rebuff this call, 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, 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.
New Evidence Unearthed
In 2013, Dr Elliott made public what may be important new evidence in the case. As summarized by the Minneapolis Star-Tribune,
The professor, Carl Elliott, says he has obtained consent documents for two separate schizophrenic patients that appear to be exact copies — not just in the subjects’ apparent replies, but in the positions of the lettering on the pages.
Elliott said it is improbable that separate patients would provide identical responses to the questionnaire, which includes open-ended questions about the risks and requirements of clinical research. And that, he said, raises questions about whether the university was really examining patients to determine their ability to consent to research.
One crucial question about the case is how a patient who was actively psychotic - out of touch with reality - could give true informed consent to participation in a drug trial. These new documents suggest major irregularities in the process used in the trial to assure that patients did give informed consent.
Furthermore, as reported by the Minnesota Daily, other documents that Dr Elliott found suggested problems with records that related to whether study investigators would have had legal authority to access Mr Markingson's medical records, also suggesting major problems with trial administration.
These documents, unknown until recently, suggest new concerns with how the study in which Mr Markingson was enrolled, and during which he died, was run. Yet, the University of Minnesota's official response to them, once again orchestrated by university counsel Mark Rotenberg, attacked the legitimacy of the documents (and indirectly, attacked Prof Elliott again), as reported by the Star-Tribune,
the university’s general counsel, Mark Rotenberg, challenged the authenticity of the documents and disagreed that study recruiters failed to obtain proper and independent consent from mentally ill patients.
'I am challenging these allegations directly,' he said. 'We have no reason to believe the consent forms were prepared inappropriately.'
As Matt Lamkin wrote in the Stanford Law and Bioscience blog, the University's responses all through this case have been focused not on the welfare of patients, maintaining the trust of research participants, or the integrity of clinical trials, but on the legal defense of the University and its leaders
Despite all this (and much more), the University has never acknowledged any errors or taken any disciplinary action related to the Markingson case and has repeatedly rejected calls for an independent investigation. That’s probably because from the start the University has handled this case as a litigation matter. Rather than trying to determine whether there were problems with the way its personnel treated Markingson, the University has focused on minimizing its potential liability. Accordingly, the University appears to run every inquiry related to the case through the office of its General Counsel, Mr. Rotenberg. When Carl Elliott (my mentor as a grad student at UMN) wrote a damning article about the case in Mother Jones, the University’s response came from Rotenberg. When UMN bioethicists called on the University’s Board of Regents to launch an independent investigation, the Regents deferred to Rotenberg. Not surprisingly, he declined.Note that this still begs the question of who the client is. Is it the university, or the university's leaders?
When you turn to your lawyer, you’re going to get a particular kind of response. The GC isn’t in a position to take an objective look at the circumstances. He’s an advocate. His role is not to make sure the client has conducted itself ethically, but to minimize the client’s risk. Asking your lawyer to respond to allegations of wrongdoing is like asking your PR flacks to do so. Their job is to make their clients look good, not to make sure they’ve acted properly.
Furthermore, as Mr Lamkin pointed out, the general counsel would appear to have a conflict of interest. It may be he has an interest in defending his own actions, as well as those of his client(s), whether they are the university, its leaders, or both.
In addition to Mr. Rotenberg’s role as the University’s top defender and advocate, there is another reason he cannot impartially consider requests for an investigation: the General Counsel’s Office is an important player in some of the disturbing events at issue. As noted above, Rotenberg himself has been accused of attempting to intimidate and silence the bioethicist who has most doggedly sought an investigation. The University’s lawyers are also responsible for the disgraceful silencing of Markingson’s mother, Mary Weiss. After avoiding liability by arguing the University was immune from suit, these lawyers then threatened to force Weiss – whose son had died in a University doctor’s 'care – to pay the University’s legal costs of some $57,000. The University used that threat as leverage to get Weiss to forgo an appeal of the trial court’s decision.
So as the University continues to refuse any new consideration of this this seemingly never-ending case, Dr Elliott has posted an online petition calling for an outside investigation. We will see how Mr Rotenberg reacts to this.
A very troubling aspect of this case is that it has shown that the university leadership has seemed to care, at best, more about fending off litigation than upholding the university's mission. The mission of the university is supposed to be discovering and disseminating the truth in a spirit of free inquiry. Added to the mission of medical schools and university teaching hospitals is taking good care of patients, and putting the patients' interests ahead of all other concerns. Yet, in this case, university leaders have not seemed to care whether in their haste to push back legal liability they were stepping on their faculty's academic freedom and free speech, the integrity of the medical research done at the university, and most importantly the rights of their patients and research subjects. Furthermore, it is not clear whether they mainly feared the impact of litigation on the university, or how litigation might actually end up holding them accountable.
As Dr Judy Stone wrote in her Scientific American blog,
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.
Again, note that UMN cannot itself believe or protect. People acting ostensibly on its behalf may have been protecting themselves from scandal, and believing that the size and status of their institution gave them, the leaders, impunity.
The case of Mr Dan Markingson is a continuing reminder that to reform health care, health care organizations need to be lead by people who put the health care mission first and are willing to be accountable for that mission. I hope that eventually there is an honest investigation of this case, and a commitment to reform based on its conclusions.
See additional thoughts from Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, on the 1BoringOldMan blog, on the Periodic Table blog, and last but certainly not least, many comments by Dr Carl Elliott on the Fear and Loathing in Bioethics blog.