Why we regulate (Or: what does Daniel Markingson have to do with Leslie Groves?)

petition started by Mike Howard has been circulating, calling for the University of Minnesota to investigate the clinical trial in which Daniel Markingson was enrolled at the time he committed suicide. I won’t attempt to give comprehensive treatment to Dan’s plight (which has already been covered in detail by my betters—see below for a list of some of my favourite articles); a (very) brief summary follows:

Daniel Markingon, a troubled and psychotic young man, was given a choice between involuntary commitment for his homicidal behaviour, and participation in the AstraZeneca-sponsored CAFE Study run through the University of Minnesota. Dan’s behaviour during the trial became increasingly erratic, but his mother, Mary Weiss, was unable to secure help for her son from the study coordinators. Dan killed himself with a box cutter.  Since then, the University of Minnesota has resisted attempts to establish an inquiry into the circumstances leading up to Dan’s death, despite increasing evidence of conflicts of interest and gross negligence in the running of the trial and the treatment of Dan.

This leads me to a recent post on the Institutional Review Blog. Zachary Schrag, in writing about signing the petition, cites Leslie Groves’ supervision of the construction of the Pentagon to prompt the intuition that “[o]versight committees can be at once nitpicking about small matters and inattentive to large concerns.” He then moves to half-chide, half-caution Carl Elliott, who has (at times single-handedly) pursued an investigation of the CAFE Study—an investigation of his own employer. Schrag concludes we risk creating more burdens for social scientists while doing nothing about issues in modern research ethics “But what is that compared to a chance for justice for Dan Markingson? I will sign the petition.”

The post is interesting, if bizarre, in the way if makes a sharp left-turn after the story about Groves. That Schrag signed the petition is laudable, but his concerns about the petition are harder to understand.

Carl, as quoted by Schrag, is no doubt aware of the way that IRBs can do nothing to protect research subjects. I’m sure he’s aware that more regulation can be burdensome, as Alice Dreger has pointed out, on social scientist and others whose methods are not necessarily those with which IRBs should be concerned.

Yet the concerns raised by Schrag are encapsulated in what it means for the fight against UMinn to fail to achieve its stated ends. Sure, there is a situation in which an investigation occurs into the CAFE Study, and nothing changes.  But that’s a failure condition. Justice for Dan can be achieved in some sense by a mere investigation or a successful petition, but that’s small beer compared to a legacy of change in Dan’s name.

This would be odd enough in itself, but what is more strange is the use of General Groves and the Pentagon as an example of how oversight can target the wrong things. Groves was bought in to save the Pentagon project. Many things over time have been contested about the General, but the thing beyond question is his character as a hardliner for achieving the goals of the projects he managed.  It was on this basis that Groves was later given the Manhattan Project—if anyone could harness frontier physics and the industrial capital of an entire nation in the pursuit of a weapon literally from the mind of a science fiction author, it was him.

So the episode Zachary is either misplaced, or he misses a crucial point in bringing it up. The Pentagon was already well over budget by the time Groves arrived on the scene, and Groves took the project from a floundering endeavour to a completed building. Concerns about the budget were a) already known in 1942, and b) weren’t important as far as Groves himself was concerned.  The oversight committee didn’t overlook the “larger stuff,” because that larger stuff was precisely why Groves was deployed.

Zachary overlooks that the budgetary problems in Groves’ case were acceptable to the House Committee only so long as he got the job done in time. That was his ultimate end; his telos, and the budget was in many ways secondary to Groves’ ability to get the Pentagon up and running. The telos of the IRB at UMinn is not being fulfilled. IRBs like the one that reviewed the CAFE study are not ensuring that research is pursued commensurate with the rights of participants. To paraphrase Carl, the oversight of clinical trials at UMinn failed because of “industry-funded university investigators ignoring research regulations, repeatedly failing to meet their ethical obligations, and fearing no sanctions whatsoever.” The rules exist and we know the mandate—but we aren’t able to provide oversight consistent with that mandate and that is a huge problem.

Budgets were, at least to a reasonable degree, ancillary to the overall project to build the Pentagon.  Research ethics is not, and ought not to be an optional extra to clinical research.

So it follows that Carl, I’m sure, would be very concerned if regulation made life worse for other researchers while not protecting people like Dan. This would be a failurebecause the legitimate aims of research and the IRB would still not be served. If the University of Minnesota repsonds to an inquiry by making life harder for geographers while failing to better secure against the terrible circumstances of Dan’s death, than we still fail to achieve justice for that troubled young man that died almost a decade ago.

The choice of case matters. Here, Zachary equates Dan’s life with the blown out budget of building the Pentagon.  But the blown out budget wasn’t the main concern in 1942—or at least, not in the same way. Dan’s life, and the lives of those who participate in trials after him (including the trial at UMinn currently being pursued by AstraZeneca), is the concern. Research that succeeds at the cost of unacceptable, uninformed risks to vulnerable people isn’t good research (whereas overbudget research might still be good research).  Making sure that doesn’t happen, as I read it, is Carl’s mandate.  Anything else is failure.

That’s why you should sign the petition, and that’s why you shouldn’t let your involvement end there.  Call your congressman, follow clinical trials in your own jurisdiction, and always ask for integrity from the research process. Make sure the aims of research are met, and met in the right ways. Make those big issues as important to researchers as the dust on the floor was to Groves.

Some light reading:

Carl Elliot, “The Deadly Corruption of Clinical Trials,” Mother Jones, September 2010

Ed Silverman’s coverage at Pharmalot

The Markingson archives at Mad In America

Judy Stone’s coverage at Scientific American: parts one, two, three, four, and five

Matt Lamkin, “The Markingson Case: Investigate the University of Minnesota,” Law and Biosciences Blog, March 2013

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