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No more Dan Markingsons

A few weeks ago I gave a talk in Seattle in which I pointed out that science is not sufficient to define moral behavior. A substantial part of that talk was a catalog of atrocities, such as the Tuskegee syphilis experiment. I said that in purely scientific terms, that was a good experiment; if the subjects had been mice, for instance, setting aside an untreated control group to study the progression of the disease would have been considered an essential part of smart experimental design. One could still argue that the needs of the many outweigh the needs of the few…if one were willing to distance oneself from the humanity of the subjects.

Yes, one can always retreat to the excuse that these were cases of bad science, where the scientists violated the rules of their own profession. But where do the ethical guidelines come from? Not science.

Dan_Markingson

I missed a trick, though. I talked mainly about old cases, when there’s a clear case of the conflict between ethics and science playing out right now, right at my home university: the case of Dan Markingson, the young man who was enrolled in an experimental pharmaceutical study and kept there, even as his mental illness worsened, and who eventually committed suicide.

There’s a new article by a bioethicist on this case.

markingson2

The research abuse in this case is so stunning that when I first learned about it I could scarcely imagine it happening anywhere, much less at the university where I work. In late 2003, psychiatric researchers at the University of Minnesota recruited a mentally ill young man named Dan Markingson into a profitable, industry-funded research study of antipsychotic drugs. The researchers signed him up over the objections of his mother, Mary Weiss, who did not want him in the study, and despite the fact that he could not give proper informed consent. Dan was acutely psychotic, plagued by delusions about demons, and he had repeatedly been judged incapable of making his own medical decisions. Even worse, he had been placed under an involuntary commitment order that legally compelled him to obey the recommendations of the psychiatrist who recruited him into the study.

For months, Mary tried desperately to get Dan out of the study, warning that he was getting worse and that he was in danger of committing suicide. But her warnings were ignored. On April 23, 2004, she left a voice message with the study coordinator, asking, “Do we have to wait for him to kill himself or someone else before anyone does anything?” Three weeks later, Dan committed suicide in the most violent way imaginable. His body was discovered in the shower of a halfway house, his throat slit so severely that he was nearly decapitated, along with a note that said, “I went through this experience smiling.”

You know, I’ve been impressed with my university on many occasions: their commitment to academic freedom has been exemplary, my interactions with the university’s lawyers (I’ve had a few of them…) has always left me satisfied that they are fair and pragmatic. But this is a failure not just of the scientists involved, but the administration of the university. It’s an embarrassment.

Yet for three years the University of Minnesota has managed to bluster and stonewall its way through all the criticism, insisting that it has already been exonerated. Even when the state Legislature passed “Dan’s Law” in 2009, banning psychiatrists from recruiting mentally ill patients under an involuntary commitment order into drug studies, the university continued to insist it had done nothing wrong.

I suspect that the stonewalling is out of fear of opening the door to legal action against a university that is already struggling with constantly dwindling support from the legislature. But it’s necessary that they confront this issue and deal with it honestly — it’s the only way to restore confidence with UM’s ethical culture, and it’s the only way to make sure there are no future Dan Markingsons.

And it’s that last bit that is the important concern.

Comments

  1. ohioobserver says

    I assume (perhaps erroneously) that the university has a research ethics committee ro some such, which had to approve of the study and its recruitment methods before any funds could be accepted or disbursed. Did the just drop the ball, or did they roll with it because the corporate payoff was large?

  2. chigau (違う) says

    …recruiting mentally ill patients under an involuntary commitment order into drug studies…

    It’s mind-boggling that this would even occur to a scientist.
    or should I say “scientist”.

  3. unbound says

    Words can’t describe how I feel as a parent. To be able to do nothing for your child and met with essentially indifference is truly enraging.

    I sincerely hope the university gets their act together to prevent anything remotely like this from happening again. There needs to be protocols where parents or spouses have the ability to be heard and not shoved out of the way.

  4. Pteryxx says

    I followed up some links after someone in the Lounge brought it up (here) last week:

    New questions about identical patient consent forms – MinnPost

    Last month, University of Minnesota bioethicist Dr. Carl Elliott, who has written about the Markingson case extensively, raised concerns in his blog, Fear and Loathing in Bioethics, that the “evaluation to consent” form found in Markingon’s file appears to have been filled out in identical ways to the consent form in another patient’s file.

    If the forms were filled out identically, it would mean that the patients had not been individually evaluated to determine whether they were mentally capable of giving their consent to be in the study. Markingon’s mother, Mary Weiss, has long contended that her son was incapable at the time of giving informed consent. Indeed, in the days leading up to his enrollment in the study, he had been found repeatedly incompetent of consenting to treatment.

    Summary of the investigation as U MN’s top attorney leaves for a new job – MinnPost

    St. Paul native Markingson stabbed himself to death in 2004 while enrolled in a U of M clinical trial of the antipsychotic Seroquel. His mother had objected vehemently and repeatedly to his participation, insisting that he was suicidal and incompetent to give informed consent. The researchers conducting the trial, U of M bioethicist Carl Elliott wrote, had financial incentives for enrolling patients.

    U of M bioethics professor Carl Elliott has written extensively about the case, on his blog, Fear and Loathing in Bioethics, in national publications and in his most recent book, “White Coat, Black Hat: Adventures on the Dark Side of Medicine.”

    After his first major piece was published in Mother Jones, a group of faculty asked the university Board of Regents to order an independent investigation. Two years ago after the regents declined, Rotenberg controversially addressed the U of M’s Academic Tenure and Freedom Committee, asking whether the faculty had a role in “addressing factually incorrect attacks on particular university faculty research activities?”

  5. Jubal DiGriz says

    A very good post, and a very good article. I think there isn’t enough serious public discussion on research and medical ethics… more my camp/your camp arguments that make less and less sense as new areas of research are developed. And it seems that pressure due to profit motive was a factor in going for a more efficient rather than human research path, which more public and more frequent can help prevent.

    But I have a quibble on the wording of the last paragraph and the post headline: we actually need more Dan Markingsons, or rather just the one back. He was a person, not a disease or research protocol. It seems wrong to conflate his name with the abuse done to him, or the condition he suffered from.

  6. says

    Perhaps a quibble, perhaps a bit more than that.

    I cannot agree that the Tuskeegee study — which was not in fact an experiment since it had no intervention arm — was good science apart from the ethics. The natural history of syphilis was already well known; and a completely curative intervention became available during the course of the study. There was no need to maintain an untreated group for many years in order to establish the efficacy of penicillin. In fact, in a situation such as that, there is no need for a control group at all. The analogy is with parachutes. We already know, beyond doubt, that if you fall 5 miles you will have a bad outcome. There is no need for a control group to prove that parachutes work.

  7. DLC says

    This sort of thing should never happen. Medical authority to consent should not automatically fall to the Parents without some sort of investigation to prevent abuse, but it most certainly not be automatically given to whichever doctor has a study he needs to fill. Further, continued degradation of health while in the study should have automatically removed him from the study. And finally, where was the “currently best available practice” here ? Do psychology studies not fall under medical ethics ?

  8. says

    Thanks so much for this post. The family is asking for additional support to sign their petition for an independent investigation. I support this because I work with patients who desperately rely on clinical research and the integrity of the U of MN’s commitment to participant safety needs to be restored if patients are to have any confidence in engaging in studies.

    Ohioobserver at #1–this is perhaps the most disturbing part of the story. The IRB tasked with providing oversight stated on the record in court that their job was to ensure that the sponsor and investigators had a safety plan in place–not to directly protect human subjects. This is an unfortunate interpretation of their role and one that–if clearly spelled out in informed consent docs–would probably significantly discourage study recruitment. If the role of the IRB is simply to rubber stamp what the sponsors and PIs want to do, they are pretty much useless. Sadly, many IRBs these days seem to be more concerned about protecting their institutions from liability than in protecting patients.

    The Office for Human Research Protections (OHRP) found no wrongdoing in this study after their initial investigation, but they are 1.) Pretty much toothless* and 2.) Not fully aware of some of the subsequent evidence of forgery and document manipulation that have since come out. This is why another investigation is critical.

    *I work within a research network comprised of multiple rare disease research consortia. The PIs for two of these consortia have documented ethics violations and yet had no problem receiving more funding from the NIH. One was involved in the notorious Jesse Gelsinger case and the other was actively involved in a fraud lawsuit for misappropriation of federal research funds AT THE SAME time she was funded to lead her (now defunct due to financial mismanagement) consortia. It can be mind-boggling, but a ‘clean bill of health’ from the federal agencies tasked with research integrity is hardly impressive. Sigh.

  9. says

    It is important to note that the primary function of an institutional review board (sometimes incorrectly called an ethical review board) is to reduce the likelihood that the sponsoring institution will be sued. They legal agencies, not ethical or humanitarian, mandated under federal law (Title 45 Part 46 Subpart A, a.k.a. “The Common Rule”) to make sure that human experimentation remains within legal limits. Given the university’s obstinacy, I suspect that they are pretty secure that the law has been followed and so have no legal liability.

    Advocating for the participants falls under the job description of a community advisory board. Unfortunately, these are NOT mandated under law, and many research groups do not have them. Worse, many corporate sponsors will not do business with research groups that have a CAB, for just this kind of reason.

  10. says

    We are a paranoid bunch us psychotics. And this kind of practice will be seen as validation for those that suffer in silence and avoid treatment out of paranoid fear of being forced out of their independence, or drugged against their will etc.

  11. Eristae says

    After Dan’s suicide, it got even worse. When Mary’s lawsuit against the university was dismissed on technical grounds of “sovereign immunity,” the university lawyers filed a legal action against her called a “notice to assess costs,” demanding that she pay them $57,000 in legal fees. Yes, you read that correctly: The U tried to force the mother of a suicide victim to pay it $57,000.

    ?!?!?!?!

  12. chakolate says

    FYI, PZ, when you block-quote like that on the website, it doesn’t come through on the RSS feed, so that it looks like what you’ve posted is all your own writing.

  13. says

    So, you’re going to blame the University because one person — a person who should likely have been in inpatient care — wasn’t adequately supervised and committed suicide.

    Not gonna fly — if this guy wasn’t competent to consent to anything, why was he in the community, and why wasn’t his mother (or another qualified person) supervising him?

  14. Ben says

    PZ, I saw your Seattle lecture on Youtube a few days ago. The contention that science is insufficient to provide an ethical framework is based on the fact/value dichotomy in philosophy. While I think you are speaking strictly in terms of science as a study of the natural world, this contention about the limitations of science is often used by others to extrapolate into the contention that critical reasoning is insufficient to provide an ethical framework. This often then leads to many claiming that religious faith is a justifiable basis for establishing morality. I think it’s important to note that while science seen as “the process of critical reasoning as applied to the study of the natural world” can’t be the basis of morality, critical reasoning broadly can and should be such a basis. In this case and the cases you cited, the experiments can be condemned by noting the tendancy of American society to promote its citizens to use individual material gain as the fundamental justification for all of their actions.

  15. ekwhite says

    WMDKitty@13:

    So, you’re going to blame the University because one person — a person who should likely have been in inpatient care — wasn’t adequately supervised and committed suicide.

    Not gonna fly — if this guy wasn’t competent to consent to anything, why was he in the community, and why wasn’t his mother (or another qualified person) supervising him?

    You realize that your post comes across as nothing but victim blaming, don’t you? You did read in the OP that Dan Markingson’s psychiatrist enrolled him in the study even though he was not capable of consent? He was being supervised, and his supervisor betrayed him.

    Why in the hell did the PI accept this man as a test subject when he was incapable of consent? Why did they not exclude him from the test when he was clearly getting worse, and when they were getting complaints from his mother? If you read further, you would also have noted that he was in a halfway house when he committed suicide. Damn right this is the university’s fault.

  16. Pteryxx says

    because one person

    The one person’s case points to evidence of a systemic problem; specifically, what appear to be duplicated consent forms. I linked the article in #4 above. Again: (bolds mine)

    Last month, University of Minnesota bioethicist Dr. Carl Elliott, who has written about the Markingson case extensively, raised concerns in his blog, Fear and Loathing in Bioethics, that the “evaluation to consent” form found in Markingon’s file appears to have been filled out in identical ways to the consent form in another patient’s file.

    If the forms were filled out identically, it would mean that the patients had not been individually evaluated to determine whether they were mentally capable of giving their consent to be in the study. Markingon’s mother, Mary Weiss, has long contended that her son was incapable at the time of giving informed consent. Indeed, in the days leading up to his enrollment in the study, he had been found repeatedly incompetent of consenting to treatment.

    “Most alarming of all,” wrote Elliott, “the ‘answers’ supposedly given by the research subjects appear identical. But the new form has no date, no subject ID, no subject initials, and no mention of Unit 12, the ward in Fairview Hospital where Dan Markingson was hospitalized.”

    “I find these documents so alarming that they demand an investigation,” he concluded. “How many research subjects in the Department of Psychiatry have this same form in their charts? Were any of those subjects in studies subject to federal oversight, such as the CATIE study? Did any of those subjects suffer serious injuries or death?”

  17. noastronomer says

    If the UoM won’t investigate, perhaps the District Attorney should?

    /rhetorical

    @WMDKitty

    You’ve inadvertently answered your own question, though perhaps you can’t see it.Perhaps Dan *should* have been in inpatient care and perhaps he *should* have been adequately supervised. But he wasn’t and the reason he wasn’t is because he was in the trial.

    Mike.

  18. says

    All I’m saying is, someone dropped the ball long before this dude was ever signed up for clinical trials or studies. As in, the circumstances leading up to his enrollment and subsequent suicide should never have been allowed to occur!

    Also, why was the psychiatrist the one to supervise? It seems like a very clear conflict of interest — a parent or family member, who knows the person’s needs and quirks, and has no financial stake in hir treatment or outcomes, should have been supervising this man. If, by some chance, a parent or family member was not available or capable of caring for the patient, he should have been in an inpatient setting, rather than the clearly-inadequate “halfway house”.

    If his psychiatrist, the trials, or the university played any provable part in contributing to this death, they should be held responsible, as allowed under US law.

  19. Usernames are smart says

    Also, why was the psychiatrist the one to supervise? It seems like a very clear conflict of interest ~.

    If his psychiatrist, the trials, or the university played any provable part in contributing to this death, they should be held responsible, as allowed under US law.WMDKitty #18

    Seems like this is the case where there needs to be a strong firewall between the treating psychiatrist/physician and the study. The former should in no way benefit from or be linked to the latter.

    From the cheap seats ($20?!) where I’m sitting, at least two people need to be in PMITA Prison (and have their license to practice stripped): the psychiatrist and whomever was ultimately in charge of (and responsible) for the study. Throw in the chain of folks who were supposed to be responsible for ensuring the safety of the participants and who failed and you got yourself a set.

    Also, obviously, there needs to be some protocol that ensures this sort of thing cannot happen again due to negligence or lapse in judgement, hence the PMITA penalty + destroyed careers as a warning to those who come after.

  20. Matrim says

    @michelemanion, #8

    How in the flying fornication does a major university have such an incompetant IRB? Hell, I go to a small private school that does little in the way of research and their IRB is positively tyrannical (as it should be, by thunder!)

  21. WharGarbl says

    @WMDKitty
    #18

    the circumstances leading up to his enrollment and subsequent suicide should never have been allowed to occur!

    Yes, the psychiatric researchers should not have recruited a mentally ill young man named Dan Markingson, sign him up over the objections of his mother, and abusing the fact that he had been placed under an involuntary commitment order that legally compelled him to obey the recommendations of the psychiatrist who recruited him into the study.
    Yes, it all her stupid and lazy mother who didn’t tried desperately to get him out of the study.

    Note: Bolded part all appeared in the article.

    Also, why was the psychiatrist the one to supervise? It seems like a very clear conflict of interest — a parent or family member, who knows the person’s needs and quirks, and has no financial stake in hir treatment or outcomes, should have been supervising this man.

    Let me iterate one quote in the article.
    “he had been placed under an involuntary commitment order that legally compelled him to obey the recommendations of the psychiatrist who recruited him into the study.”

  22. arbor says

    I don’t think that the University of Minnesota should be allowed to host any research at this time. Everyone involved with this, from the researchers and staff through the university’s administration and board, should be fired, prosecuted, shunned, and plagued by Anonymous.

    Inexcusable.

  23. arbor says

    And let’s not forget about punishing the company that paid for the research and this young man’s murder.