How to become a non-person

The behavior of the University of Minnesota keeps sinking to new lows. In the case of Dan Markingson, they recruited a mentally ill young man into an experimental pharmaceutical treatment, his condition worsened, and he committed suicide. He was a person who needed help, not to be roped into the position of a guinea pig, but you know there is big money behind clinical trials sponsored by pharmaceutical companies (but not enough, apparently, to cover adequate monitoring and care for test subjects).

My university has made a statement about another test patient.

His medical record shows extreme anxiety and paranoia, a history of head injuries and lengthy battle with alcoholism. It is highly inappropriate for him to be put in the media spotlight as a spokesperson for clinical trial safety.

That’s just…I was temporarily speechless.

So a person with a history of alcoholism is not appropriate as an example of poor clinical trial safety, but he was just fine for a test of experimental drugs?

Can we now expect the university to recruit more mentally ill people as experimental subjects, since if they’re harmed by the experiment, their prior history makes them inappropriate victims who can’t complain?

Isn’t the purpose of informed consent rules and ethical guidelines specifically to protect those who are most vulnerable to exploitation? That statement says the reverse: that those who are most vulnerable have the least opportunity for redress.

I may have to stop wasting my time with zebrafish. Apparently, I can do all kinds of horrible experiments on humans, as long as they’re fearful, have a history of substance abuse, and have been banged about a bit. It’s a bit like those stores that sell damaged goods — canned food with slight dents, or clothes that have small stains — for dirt cheap. Damaged people, too, apparently have far less worth.


  1. says

    I do have to say, this is as far as I know unusual within the borders of the U.S. Most IRBs are diligent most of the time and most investigators take ethics seriously. The exceptions, however, are indeed often shocking. And yes, I do feel that psych meds are in general a problem area. But that’s a very long story.

  2. Jackie the social justice WIZZARD!!! says

    In what world does that make sense?

    One where money matters and people without it don’t.

  3. twas brillig (stevem) says

    I’m confused, all discombobulated. Wasn’t that drug being tested to see if would help that person that became a victim of poor administration? Is PZ objecting use of such people to test such drugs? How could you test such drugs on healthy, well informed test subjects? How can you try to fix something that ain’t broken? If the University is trying to victim-blame for running the test so badly that it went horribly wrong, that’s a different issue than the criteria chosen for choosing test subjects. I’m sorry, any issue involving Head Injury gets me all discombobulated.

  4. karmacat says

    There are a ton of articles on the issue of consent and patients with psychosis. So these researchers should have known better. And what kind of results are they getting if they are using patients who have more than one diagnosis. You can’t interpret results very well if the patients have more than one diagnosis. If a patient is actively drinking, that is going to affect how the medicine works and of course can cause dangerous interactions. I don’t know which is worse, that these researchers are so unethical or so stupid. In the first case, the university was sued but was the psychiatrist also sued? There is justification to sue the doctor treating the patient even if it is part of a research study.

  5. freemage says

    Giliell, professional cynic -Ilk-

    19 February 2015 at 8:57 am

    Wait, the fact that drug trial safety horribly failed this man should not be used for talking about drug trial safety? In what world does that make sense?

    Why, the same one where it makes sense to cover up sex abuse in order to protect the reputations of the victims by not exposing them to the spotlight, of course. In short, the world of institutional CYA thinking.

  6. Johnny Vector says

    My university has made a statement about another test patient.

    According to the news report referenced, the statement came from Dr. Olson, not from the University. Which is small consolation given that why was he still working for the university after Dan Markingson died?

    Still, maybe there’s hope they’ll do the right thing this time, and send Olson off to some skull-shaped island somewhere. Maybe he can team up with Wakefield and torture people of all ages.

  7. says

    It should be noted that IRBs (Institutional Review Boards, sometimes erroneously called Ethical Review Boards) are comprised of lawyers and scientists who have two concerns: to make sure research follows scientific standards (you don’t want to spend $50 million and get something that cannot pass peer review) and to make sure the sponsoring institution does not get sued. All of an IRB’s decisions are made through those filters, and any consideration of ethics or safety is incidental. UM is fighting bad press, but I expect that the lawyers on their IRB have already determined that everything was sufficiently legal.

    The only real answer here is to demand the creation of a Community Advisory Board, a group of volunteer (and thus, in theory, independent) science-minded community members who will oversee the informed consent process and advocate for study participants. Unfortunately, this would also require that the University give up a lot of its study funding, as many drug companies refuse to work with sponsors that have CABs. Think on that for a moment.

  8. microraptor says

    Wait, the fact that drug trial safety horribly failed this man should not be used for talking about drug trial safety? In what world does that make sense?

    In a world where mass shootings can’t be used for talking about gun control. Good thing we’re not like tha- oh, wait.

  9. says

    @8 True, lawyers infest IRBs in a bad way, but they aren’t typically members. In order not to get sued, you have to conform to ethical standards as promulgated in the Code of Federal Regulations. So to that extent, they are on the right side. Also, many IRBs do include community representatives, and at least one outside member is required. And most university based research is funded by federal sources or foundations, not drug companies.

  10. says

    @cervantes #10 – While they may not be members of the Bar Association and thus are not lawyers in a technical sense, every IRB I’ve looked at has had a large number of legal experts paid to make sure that approved research follows the law. Again, IRBs exist to cover the sponsoring institution’s ass and any concern for the well-being of study participants is coincidental.

    I have been a participant in human medical experiments (specifically, two HIV vaccine studies), I sit on the CAB for the Seattle HIV Vaccine Trials Unit, and I have friends who sit on other CABs associated with HIV research. Right now, our unit’s boilerplate informed consent document is about 16 double-sided pages, broken into several sections, each of which requires the prospective participant to initial. We have worked hard over the years to make sure that the text is both comprehensive and easy to read: there is no fine print, no hidden gotchas, and the rights of participants to leave the study at any time, for any reason, without repercussions, are clearly spelled out in their own section and mentioned in several others.

    To contrast, I recently saw the informed consent documents for a cancer research sponsor that has been resisting setting up a CAB: it was more than 50 double-sided pages, small print, big words that were never defined, and participant rights were buried in an unrelated section towards the middle of the document. There were no places where a prospective participant could stop and ask questions, no confirmations of “Do you understand what you just read? If not, please talk to your intake clinician before continuing.” Most of those 50 double-sided pages were about indemnifying the sponsor against lawsuits and malpractice, and had nothing at all to do with informing the participant’s consent. That is what an IRB does.

    The problem is that CABs are pretty rare. They are pretty much mandated with HIV research; community oversight and advocacy was one of the demands made by ACT-UP and other such groups. When AIDS first appeared, the revelations of the Tuskegee Syphilis Experiments were still on a lot of people minds, and with AIDS being found in the US mainly in gay men, sex workers, IV drug users and dark-skinned illegal immigrants, there was great fear of where medical research on “social undesirables” could lead. In other fields of human medical experimentation, they are almost non-existent, which leads directly to the kind of tragedies that PZ is talking about. The problem is that a lot of IRBs see CABs as meddlers who will expose the sponsoring institution to unacceptable risks, and a lot of research funders don’t want to have to deal with oversight not absolutely required by law. Informing participant consent, treating them ethically and respecting their humanity are all unacceptable expenses.

  11. says

    @ChristineRose #12 – At a guess, the participant himself released his records to support the claim that he should not have been allowed to enter the study. Once the information has been legitimately made public, HIPPA no longer applies and comment by others becomes fair use.

  12. says

    Yeah Gregory, that ICF does sound like it’s designed to obscure rather than inform. But as I say, that is not typical. At my institution the IRB insists on readable ICFs and they are seldom more than about 3 pages. Again, I think your experience is not the norm.

  13. Michael Kimmitt says

    And we all wonder why some folks don’t buy into human trials on other topics. Because of course it is unpossible that this is a larger cultural issue in the way science is implemented currently.

  14. Ichthyic says

    it is unpossible that this is a larger cultural issue in the way science is implemented currently.

    or maybe it’s just that you’re full of shit, as usual.

    can’t wait for your inevitable ban.

  15. Michael Kimmitt says

    Can’t wait for your discovery of the shift key. We all have these little things to look forward to.

  16. Michael Kimmitt says

    I honestly feel the tiniest shred of pity, given how you’re characterizing your pathetic desire for pointless personal conflict as something other than a sign of a profoundly stunted emotional state.

    My point was quite clear — the two are of precisely equal value, except that mine is harmless and funny and yours is just very very sad.

  17. abb3w says

    @15, Michael Kimmitt

    Because of course it is unpossible that this is a larger cultural issue in the way science is implemented currently.

    @”This Unscientific Age”, Richard Feynman

    Anyway, I have to argue about flying saucers on the beach with people, you know. And I was interested in this: they keep arguing that it is possible. And that's true. It is possible. They do not appreciate that the problem is not to demonstrate whether it's possible or not but whether it's going on or not.