This series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotics at the University of Minnesota, his ultimate suicide while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, we’ve looked at issues of “good clinical practices” and ethics: consent, investigator responsibilities, and conflicts of interest. In the last post, we examined the University’s response. Now we return to the importance of careful documentation of consent.
Since I last wrote on the lapses in good clinical practices at the University of Minnesota, involving the suicide of a clinical trial participant, Dan Markingson, more disturbing documents have come to light, provided and contextualized by Professor Carl Elliott. Hard to imagine, I know…but this single case can provide a lifetime of lessons on clinical trial conduct, oversight, and ethics.
This week’s episode looks at several mysterious documents, asks why some are only appearing now, and brings you more questions raised by their contents.
First, look at these HIPAA consent documents:
What do you notice?
One lacks a signature, and the Fairview Hospital medical records department is both certifying its authenticity and that there was no signed HIPAA consent page on Dan’s record. The second form—is signed and dated. The only explanation, woefully unsatisfying, comes from family friend Mike Howard, who noted: “Mary [Weiss]’s attorneys as well as Mary had received about three (3) different "Certified" sets of records and each one was different or had pages added or subtracted. So much for certification of study records.”
Now note the date on the HIPAA consent. There are a couple of concerns with this document. The first, is that this dated consent was never given to Mrs. Weiss nor her attorneys in her suit against the university. How did this magically appear in 2011, only in response to a complaint by Mr. Howard alleging misconduct by Dr. Olson?
Mark Rotenberg, counsel for the UMN, in defending Dr. Olson and the university against charges by Mike Howard, responds to Mr. Howard's complaint (almost a year later) by noting that the HIPAA consent was signed November 24. In that same letter, Mr. Rotenberg further notes that Dan consented to participation in the trial on November 21. So I read this as the University’s counsel confirming Mr. Howard’s assertion that Markingson’s mental health records had been released to the study coordinator, working as an agent of AstraZeneca through Dr. Olson, without Dan having signed a HIPAA release. Howard reiterates, “There is absolutely no paper document or record anywhere that states Dan agreed to be interviewed by Jean Kenney, Liz Lemke or anyone else connected with the CAFE' study. No record in any of his hospital notes indicating that he possibly gave ‘verbal’ authorization to anyone connected with the CAFE' study to approach him.”
I await Mr. Rotenberg’s explanation. [His office was contacted by me for this story].
There is another problem with the HIPAA consent, which, in and of itself, could represent a felony. The HIPAA regulation “requires that an Authorization contain either an expiration date or an expiration event.” This has neither. It appears that the University is at risk for significant civil and criminal penalties. A second CAFE Study family provided Carl Elliott with an identical, unsigned HIPAA consent form, and again with no expiration.
“Evaluation to Consent” forms
The next document mystery involves these forms in which Jean Kenney, the social worker responsible both for study recruitment and a psychiatric evaluation regarding a “volunteer’s” ability to understand and consent to participation, administered to patients.
Look at these evaluation forms:
What do you notice?
They appear identical, except for initials on one, suggesting they might have been xeroxed and used as a template.
Then a 3rd form appeared:
It, too, is identical--but lacks initials or a hospital unit number. But it was given to Dr. Elliott by someone who, as yet, feels a need for anonymity. Other families have contacted Dr. Elliott or posted on the Community Alliance for Ethics in Minnesota Psychiatry Facebook page that they have identical forms as well, though this has not yet been definitively confirmed.
What do these duplicate forms mean?
The HIPPA forms are troublesome because they indicate possible breaches of patient confidentiality regarding psychiatric illnesses. The requirement for an expiration date was a federal requirement at the time of the study, as verified by the HIPAA web site. Each of these problems is potentially a felony.
The seemingly duplicated evaluations to consent are even more problematic. It is implausible that patients gave identical responses to these questions of their understanding and ability to consent. Using duplicated forms would call into question the competence of the patients to consent, a contested point in Mary Weiss’ suit against the UMN. As Dr. Elliott notes, the “evaluation to consent” forms have been submitted to official research oversight bodies, which have relied on them to make judgments about the conduct of the studies.”
I would extend the concerns further. If the investigators allowed their staff to use identical forms and claim that different patients provided identical answers, then this would be far more evidence they provided inadequate oversight and did not fulfill their responsibilities as Principle Investigators. It would also call into question the work that this team did on other clinical trials, including the NIH funded CATIE trial.
The university is state and federally funded. Given that, a bit of transparency would seem in order. One of the most troublesome aspect of this case for me is the response of the University to questions being raised. In 2010, eight faculty members sent a letter to the Board of Regents requesting an outside investigation. None was done.
Dr. Elliott has bravely persisted in methodically raising concerns as new evidence emerges, each time posting documents of concern on Scribd for anyone to evaluate. He is still requesting an outside investigation. Instead of doing so, the University has brushed aside Dr. Elliott’s concerns. In the latest example, Dr. Frances Lawrenz, the Associate Vice President for Research replied to the emergence of this new evidence:
“Our research misconduct policy has a 'statute of limitations' of 7 years...Since the matters covered in your letter occurred more than seven years ago, the material you present is outside the purview of the policy. In addition, your concerns about the consent evaluation process and possible HIPAA violations do not appear to fall under the definition of research misconduct (i.e., alleged fabrication, falsification or plagiarism), regardless of when the events occurred.”
[Note: I attempted to reach Dr. Lawrenz for comment and was told she would not speak with me.] I am unpersuaded with the response I subsequently received via the PR person apparently directed to call me by Mr. Rotenberg’s office.
It is difficult in this case, as with much of life, to tell with total certainty “where truth lies.” The reluctance on the part of the Office of Research, the Office of the President, the Office of the Counsel, and the Board of Regents of UMN to fully and transparently examine new evidence is extremely troubling, though. Without such a transparent examination, there is no guarantee that the clinical investigational staff did not commit breaches of research ethics and of law, and has not continued to do so, perhaps putting other vulnerable patients at undue risk.
When I started reading about this case, it was as an academic endeavor, seeking a case study for my blog. I did (and do not) not know any of the parties involved. Yet the more I have learned, the more outraged I have become.
I am angered by the thinly veiled threats towards Dr. Elliott (e.g., Mr. Rotenberg’s "What is the faculty's collective role in addressing factually incorrect attacks on particular University faculty research activities?"
I am saddened by what appears to me to be violations of the trust of vulnerable patients and of research ethics. As I have become immersed in the case, it has become clear that it provides a lifetime of study and discussion about what not to do during the course of a clinical trial. It is also clear to me that more patients than Mr. Markingson likely were harmed at the UMN by: enrolling participants with contested ability to consent; having financial incentives that encourage keeping someone on a trial when it appears they are not responding well; approving and supporting protocols that have seemingly disproportionate risks, e.g. “The Use of Quetiapine (Seroquel) in the Treatment of Social Phobia: Public Speaking Environment.”
And, unfortunately, 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.
HIPAA image: purpleslog/Flickr