Fetishes I Don't Get

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The Worst of All Possible IRB Worlds

What you can do to help protect people who become medical research subjects.

On a Friday afternoon, I usually prefer to pour a glass of wine, make a nice casserole, and play Dr. Pangloss, meditating on how I live in the best of all possible worlds. Never mind the large pile of laundry, our unfinished tax returns, and a congested sinus that has me fantasizing about taking a drill to my face.

But today, I'm stuck in a meditation on how we seem to be living in the worst of all possible worlds where IRBs are concerned.

Let's review: Institutional Review Boards (IRBs) were set up with the ostensible goal of protecting people who became subjects of medical research. They were set up out of the recognition that researchers have a bad habit of thinking that good intentions inevitably pave the way to heaven. (Aphorisms don't apply to smart people, right?)

Today, many social scientists are quite reasonably fed up with the way in which IRBs have evolved to the point where they attempt to hyper-regulate our work, often forcing us to adhere to systems that make no sense for our disciplines. Historians like me have refused to engage with IRBs when we conduct oral histories, knowing we are sometimes asked to do things like anonymize our subjects, ask all our subjects the same questions, or destroy our records after a few years. (If you want to read about how abused social scientists have been in the history of IRBs, I highly recommend Zack Schrag's Ethical Imperialism. Also check out Zack's blog.)

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Meanwhile, IRBs do not appear to be functioning as they should to protect people of the really dangerous kind of medical research they were designed to manage. I can give you lots of evidence for this. I could point to the work my colleagues Ellen Feder, Anne Tamar-Mattis and I have done on prenatal dexamethasone, or to the work Carl Elliott has done tracking what happened to a young man named Dan Markingson in a University of Minnesota drug trial. (More on Markingson in a bit.)

But instead I'll point to a report [PDF] from the National Council on University Research Administrators which shows something terrifying: that the federal office charged with meta-protection of people who become research subjects -- the Office for Human Research Protections (OHRP) -- has slowed down enough to make you want to glance out the window to see if, in fact, the bus is still in motion at all.

This report from the National Council on University Research Administrators is not coming from a bunch of bitchy patient advocates like me, Ellen, Anne, or Carl. No, it's coming from university administrators -- the people who normally fear getting spanked by the OHRP. If the people who fear the spanking are telling us that mom and dad seem to have left us home alone with no signs of returning, um, Houston we have a problem.

Good social science research, notably that conducted by Laura Stark for her book Behind Closed Doors, has shown that in fact IRBs have never been primarily about protection of people who become research subjects. They've been primarily about liability protection for the institutions. Anyone who has had to deal with an IRB, as an applicant or as a complainant, can tell you this is true.

That said, we're now at the point where we seem to really be dropping all pretense of protection of subjects. It's seriously scary.

Take the situation Carl Elliott has been tracking at the University of Minnesota. For several years, Carl has been following what happened to one young man, Dan Markingson, who was given the choice of involuntary commitment for profound mental illness (including delusions) or enrollment in what amounted to a marketing trial for AstraZeneca being run by psychiatrists at the University of Minnesota. Dan “chose” to become a guinea pig for pharma’s treasure hunt.

Carl's Mother Jones article on this is a must read. It shows how completely screwed over this young man was -- as was his mother, Mary Weiss, who tried desperately to get him out of the trial, into actual medical care, before he killed himself or someone else. Dan ended up committing suicide in an extremely gruesome manner. It resulted in the kind of autopsy no mother should have to read, especially when she had been telling the study’s managers Dan’s life might end like this if they didn’t get Dan out of that study into good care.

Since Carl started joining Dan's mother and local journalists in raising serious questions about this IRB-approved trial within the University, his central administration has been coming after him. In a particularly Orwellian turn, they even tried to use the Academic Freedom committee to shut him up. It didn't work. Carl has kept investigating, and most recently he has discovered something really worrisome: the consent forms for the trial appear to show signs of extremely suspicious duplication from one patient/subject to the next.

This is just the latest reason to be very, very suspicious of what happened in this whole trial and in the investigations that have followed. A couple of months ago the social worker in the trial was subject to "corrective action" by the State Board of Social Worker after they found that, in the study, she had done such things as herself write doctors' initials on forms (um, isn't that forgery?), make medical diagnoses, and ignore the red flags being waved frantically by Mary Weiss, Dan Markingson's mother.

You don't have to take my word on all this, or Carl's. A lot of really smart people have looked into what Carl and others have found and have concurred that this whole scene seems to be shot-through with misconduct, bad judgment, and now possible cover-ups. You can read Dr. Judy Stone's excellent series on the case in Scientific American, Dr. Howard Brody’s summary for his Hooked blog’s readers, the latest blog from Matt Lamkin of Stanford Law School, or any number of smart journalists' reporting on the subject.

So what have we got in this country today? Well, it seems what we've got here is a case where many researchers get mistreated at the start of IRB work -- in the name of subject protection, but actually primarily in the service of liability protection for institutions -- and then some people who are subjects get mistreated during medical research, only to have no real recourse for justice because the OHRP doesn't give a damn about post-harm justice and because university administrations aren't interested in protection of people who they use as research animals, they're interested in lawyering up to make us all shut up.

I would argue that the mistreatment of social scientists and the failure to really police dangerous medical studies are two sides of the same coin: both cases show how IRBs and the OHRP are failing to focus on what really matters -- the protection of human subjects in genuinely dangerous research.

I think in cases like this, our tendency is to say "we need major reform." And that is true. But I can tell you as an historian who has taught and studied the history of human subjects research, what will make that major reform happen is widespread outrage over a single case. That's the only way this work ever gets done.

So now I'm going to do what I almost never do, and ask you to sign a petition. It is a petition to the governor of Minnesota, asking him to investigate what has happened at the University of Minnesota over this case. The petition is organized by a good friend of Mary Weiss. Mary and her family want you to sign it. You can meet Mary and hear her tell her story here, in an excerpt from the film Off Label.

Help make Dan Markingson and Mary Weiss’s story the story that forces state- and national-level examination of the misuse and abuse of the IRB system. Help us send a message, too, to the University of Minnesota administration that coming after whistleblowers of medical research abuse is no way to run a public institution of higher learning.

Please sign the petition.

Alice Dreger, Ph.D., is a Professor of Clinical Medical Humanities and Bioethics at Northwestern University's Feinberg School of Medicine in Chicago.

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