Monday, April 5, 2010

U. Minnesota--Evading Responsibility for Reprehensible Behavior

My esteemed ethicist colleague at the University of Minnesota, Carl Elliott, deserves credit on many points. He's been an astute commentator on the corrupting influences of corporate cash on medical practice and research. He also has considerable courage--willing to point fingers and name names not only among our own bioethics colleagues who accept industry money, but also at his own institution when it misbehaves (as unfortunately it has tended to do often of late).

I had heard a bit in the past about the Dan Markingson case in Minneapolis, but until Carl recently gave a lecture on the topic (at the National Undergraduate Bioethics Conference a week ago at the University of Puget Sound, Tacoma, WA), I didn't quite grasp all the essential pieces. The public record is nicely summarized in a newspaper article and in Ed Silverman's summary on Pharmalot:
Carl himself added a few extra details that will be forthcoming, he tells me, in a new book he's working on. The following account includes all the details I am aware of from these various sources.

Dan Markingson was the only son of Mary Weiss and seemed to be perfectly balanced mentally. She was therefore shocked when she traveled from Minnesota to visit him in California in the summer of 2003 and found him claiming that aliens had damaged his house and that a secretive world order was planning a "storm" in which Dan would be ordered to kill people. With some difficulty she managed to get him back to Minnesota and then (when his delusions became worse and he started to talk about killing Mary as part of the "storm") took him to the local hospital on Nov. 12, 2003. The hospital had no psychiatric beds open and transferred Dan to the University of Minnesota Medical Center, Fairview.

Dan was evaluated at Fairview by a faculty psychiatrist, Dr. Stephen Olson. Dr. Olson petitioned the court to commit Dan involuntarily because he was unable to make decisions about his care and posed a danger to himself or others. Within a week, however, Dr. Olson was telling the court a different story, saying that Dan had improved enough to warrant a new recommendation. The court agreed and dropped the involuntarily commitment order, contingent upon Dan's adhering to his doctor's treatment program. That program, it now turned out, was to participate in a national study of anti-psychotic drugs called CAFE. According to the study, Dan would be randomly assigned to one of three standardly used drugs for psychosis, Seroquel, Zyprexa, or Risperdal (in the end, it was found, he was randomized to Seroquel).

These events take on a different coloration when you look at some of the relevant financial arrangements. The U. Minn. Department of Psychiatry had agreed to participate as one of the 26 sites in the CAFE study, and if they completed their role in the study, stood to earn $327,000, some of which would go personally to Dr. Olson. Specifically, Dan Markingson as a research subject was worth $15,000 to the University. AstraZeneca, sponsor of CAFE, had been on Minnesota's case earlier for insufficient subject enrollment. (The protocol called for newly diagnosed schizophrenics who had never been treated previously with drugs, a difficult-to-identify group.) Until Minnesota launched a special unit in its hospital specifically to screen all patients for potential research enrollment, the company had threatened to eliminate them from CAFE, putting their hoped-for funding in jeopardy.

From Mary Weiss's viewpoint, things were not going well at all. She was flabbergasted when told that her son, who was delusional and far from his normal self, suddenly was sufficiently competent to consent to a research trial. As she visited him over the ensuing weeks, she became convinced that whatever drug he was randomized to was simply not working, and that he needed a different treatment. She wrote numerous letters and protested in person to the Department of Psychiatry, which ignored her input totally. (It is pretty standard for psychiatrists, in my limited experience, to decide that the family members of psychiatric patients are either mentally disturbed themselves, or else are part of the environment that may have caused the psychiatric disorder in the patient, leading them to view the family member more as an enemy than an ally in therapy.) On May 8, 2004, Dan Markingson killed himself by mutilating his own body with a knife, leaving a note behind, "I went through this experience smiling!"

Dr. Olson and his colleagues expressed regret but not surprise that such a severely disturbed patient should have committed suicide, and noted that the research study could not have caused the death, as the three drugs were all in common use and in almost all circumstances, Dr. Olson would have started Dan on one of those three drugs, trial or no trial. In theory the research trial was to Dan's advantage because it assured closer monitoring. From Mary's point of view, Dan had been effectively coerced into the trial, being told that he'd be committed again unless he consented, and was unable at that point in time to make rational decisions about enrollment or nonenrollment. While the trial did not perhaps dictate the initial treatment, it certainly became a factor in keeping Dan on a treatment for many months while (as per Mary) his symptoms actually were worsening, as the University stood to lose their funding if he had been taken off the study drug.

The next to last chapter was that Mary Weiss sued the University and Dr. Olson. The court threw out the suit against the University arguing statutory immunity for a state institution. She collected, she said, $75,000 in a settlement with Dr. Olson which only went to pay her outstanding legal bills.

The last chapter is an especially sad commentary on the University as poor citizen of the community. Having gotten off the hook via statutory immunity, we would have expected the University to declare victory and retire from the field. Instead the U. took the unusual step of countersuing Mary Weiss to collect $57,000, which it claimed were its own legal fees in defending against her suit. Mary had no money to defend herself against the countersuit. She was forced to reach a settlement with Minnesota, one provision of which was to promise not to appeal her original ruling.

What are we to make of this countersuit? In HOOKED I discuss the phemonenon of SLAPP, "strategic lawsuit against public participation." A SLAPP happens when a powerful party with deep pockets but with a very weak legal position sues a citizen who's making noise about the issue in a way that's uncomfortable for the powerful party. The suit may have no real legal merit and is almost sure to lose when and if it comes before a judge. But the weaker party has no financial ability to pursue the lawsuit to its conclusion, and is forced to settle as quickly as possible. This usually is a strategy for sending a chilling message to anyone bold enough to criticize the powerful party--don't do it, says the message, or you may just find yourself entangled in a lawsuit from which it will take all of your money to extricate yourself. In this specific case, the purpose of SLAPP might have been to prevent an appeal that the University feared it would lose, especially if the behavior of Dr. Olson was viewed in light of the financial conflicts of interest.

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