Dan Markingson was a schizophrenia patient who was enlisted in a University of Minnesota trial of an experimental drug — and he killed himself horrifically while in the experiment. The university has just now made a policy change that excludes people from research trials who are restrained under a 72-hour emergency hold.
That’s nice.
Markingson killed himself in 2004, and it’s taken 11 years to get this minor, and honestly, rather obvious change in policy. Why has it taken so long? Perhaps this attitude by Brian Herman, vice president for research, explains some of the problem.
Such patients “are in a situation where they are highly emotional because they have been brought in and they are restricted in their ability to do things,” Herman said. “It could be viewed by some … that they weren’t necessarily completely of free will to make a decision about whether to participate” in research.
It could be viewed by some…? Who are these wild-eyed radicals who think that maybe people who are being confined because they might be of danger to themselves or others, who are at such risk because of a serious mental health crisis, might not be in the best state of mind to carefully evaluate a detailed scientific procedure and provide informed consent? Yeah, they might be under observation because their loved ones are concerned that they might harm themselves, but only some wacko anti-science liberal would doubt that they’d still make wise decisions to serve their self-interest.
Some, huh. It seems to me that the kinds of people who don’t see that as obvious ought to be excluded from making policy decisions that involve some rudimentary comprehension of basic ideas in ethics.
But that’s just me. I guess I’m one of those rare “some”.
That sounds like language designed by the university’s lawyers to fend off potential litigation.
PZ, you’re being unfair. That’s a university administrator you are quoting. You can only expect so much “thought.”
Why did it take 11 years? Why not ask Steven Pinker:
I can agree with him on “sacredness”, but full steam ahead on science, and damn dignity and social justice? That’s just wrong.
AlexanderZ @ 3:
This well demonstrates what goes so wrong with much of Pinker’s thoughts. No dignity? No social justice? No thought at all to possible harms? All of that is pretty much what has already ended in unnecessary tragedy, and Dan Markingson is not the only person lost to such shortsighted indifference.
Sure, sacredness can get tossed out the window, along with sowing panic with no reason at all. What Pinker is suggesting is to conveniently toss out all other human concerns, and that’s not a good thing, regardless of how important specific research might be. When you need to experiment on people, ethics should most certainly be a priority.
To be fair, continuing that paragraph from Pinker:
Yet we don’t have such safeguards in some cases. Maybe he just doesn’t know what he’s talking about, and his views themselves aren’t so terrible. That would at least cast things in a somewhat different light.
But…..
What does that mean? If if they’re foreseeable, why would we wait until “they arise”? Why should I interpret the phrase “can be dealt with as they arise” as if it means this stuff is already solved and no biggie (so we should “get out of the way” which is supposed to be the main lesson), or that we’re actually going to do something to prevent them, or at least that we’ll try to be careful and minimize them whenever possible?
What to do about unforeseeable harms? Is it pointless or meaningless (or even paranoid, conspiratorial, superstitious, etc.) to think about things like that … or what about them?
I would’ve thought the last thing we need are so-called scientists talking back to so-called ethicists, by means of confusing analogies. I expect you’d usually get the so-called ethicists first, and the frothing reactionaries would only appear some time later.
Oh, you what you really meant is that we need the latter more…. I don’t know about that either. What are they supposed to be good for?
There are a lot of articles out there looking at people with mental illness being able to consent to research. If the research involves medicines, then the person needs a rather level of competency and understanding to consent to research. If a patient is still in the hospital involuntarily then it is highly unlikely they can consent. I don’t know what those doctors were thinking
Call me a nit-picky lawyer, but I thought that involuntary restraint in a mental institution automatically triggered the need for assessing if that person had the capacity to handle his or her own estate (financial and legal decisions). Giving consent requires the legal capacity to do so. Minors cannot, correct? Why would people under protective restraint due to mental issues automatically be considered able to consent?
Of course, the inability to consent in such cases is likely of short duration, and may well be presumed to return when the person is released. In Ontario, a further assessment is required at time of discharge,
What am I missing here?
The really hard aspect to this is that it’s crucial that we do medical research on people who are not legally competent — if we say that it is simply unethical to do any such research, then we’ll never be able to improve treatments. But having said that, we can’t take the opposite approach and simply ignore consent.
It’s not easy to work out from the article linked exactly what happened to Markingson or why “advising a judge” was “potentially coercive” (I’m not saying it wasn’t, but there seems to be a big leap in logic there) or what the particular issues identified in the trial were (especially as the article says that most of the other trials were subsequently approved to resume — in fact only one trial was canned, and it wasn’t due to ethical concerns). If anything, it appears to me that U Minnesota chose to suspend all trials on 72-hour hold patients until review — as a legal safety measure — but after review have allowed most of the trials to progress, which means they haven’t adopted a blank rejection of all studies on 72-hour hold patients…and the article doesn’t actually list what new measures have been put in place to prevent repeats of what happened to Markingson.
Whoops. On further reading U Minnesota has decided to end all trials recruiting people on 72-hour holds. I’m not defending the trial that Markingson was involved in, but this new policy strikes me as a retrograde step and not as “obvious” a correct step as suggested. As I said above, if this research is declared unethical by definition, then there will be zero research on treating acutely mentally ill people — and I think this is one of the groups that most desperately needs good research.
What I think they needed to do was develop a strong protocol for research on 72-hour hold patients — a previously known guardian (i.e. not someone identified for the purposes of recruitment into the trial) who can make the decision when the patient is incapable, tight observation on any recruited patients to prevent self-harm, and an independent ethical approval process for the trial with a separate independent ethics panel to assess individual recruitment applications, and so on. I get the feeling the university just decided to reject the whole field of research rather than work out an ethically defensible protocol.
@ chrislawson
OK, now you’re talking. My point was that the patient, pretty much by definition, cannot give real consent. If this condition is short, you could wait it out. If it is long term, there should be a guardian of some sort out there. THAT person could give consent. Clearly, that model will still have issues, but I feel it would be the way to go. Some person, one hopes is on the patient’s side, would think about it and proceed in the best interests of the patient.
I really don’t see why that would be such a bad thing.
Wait, you’re being restrained for 72 hours because you’re not being deemed competent to handle your affairs but you’Re being deemed competent enough to participate ina trial? That’s just fucked up.
+++
re: Pinker
He would have become a medical genius if it weren’t for those meddling ethicists…
For anyone who’s interested, here’s an article with more of the story about Dan Markingson: http://m.motherjones.com/environment/2010/09/dan-markingson-drug-trial-astrazeneca
It’s really horrific.
Giliel@12: “re: Pinker
He would have become a medical genius if it weren’t for those meddling ethicists…”
As it is, he’ll just have to be satisfied with his demonstrated genius at self-promotion.
It should be viewed that way by any competent and ethical IRB. Any protocol that recruits patients that have a reduced ability to give consent should be scrutinized very carefully to ensure that the subjects have greater than usual protection built into he protocol. This is not new. There is a large body of research regarding minors, the elderly, undeserved populations and the mentally ill. An IRB’s sole purpose is to protect the rights of the subject, not rubber stamp every new drug trial.
I don’t see how the original act could have been considered ethical under current guidelines. Aren’t psychiatric patients a vulnerable population that should receive added protection when being considered for clinical trials? How can you enroll someone who can’t give informed consent without the explicit consent of their next of kin? How is a study that doesn’t allow a medication that is failing to be stopped or changed ethical? The whole thing seems like a mess.
Why’s Pinker talking about what we “should not” do? Isn’t all our behavior hard-coded into our genes? Or is that just gendered behavior? But concern for others is gendered….
lizzie@13: thanks for that link. The article certainly makes some very damning claims — it really does look like the trial Markingson was enrolled in was ethically broken on several levels.