“The SUPPORT defenders are going to be on the wrong side of history. And what’s shocking is that they don’t recognize that.”
I nodded in agreement to this email from Lois Shepherd of the University of Virginia. Lois had sent it a couple of days after we had met in Washington at the August 28th federal hearing convened in response to heated debate over the ethics of the large NIH-funded SUPPORT study of very premature babies. (The basics of the SUPPORT controversy are described here; the meeting transcripts and videos just became available here.)
The tense, day-long event in Washington had been organized by the federal Office for Human Research Protections (OHRP), and Lois and I were there, with like-minded representatives from the advocacy group Public Citizen, to encourage follow-through on enforcement following ORHP’s findings of inadequately informed consent in SUPPORT. In our spoken remarks, we reiterated the conclusion of the New England Journal of Medicine letter we had organized with Ruth Macklin: OHRP had been right in its determination that SUPPORT consent forms lacked critical, required information. About half the study forms had led parents to believe that their baby would get the same care whether in or out of the study—an astonishing claim for a study that randomized very premature babies to various controlled research interventions in order to determine relative risk of those potentially life-saving interventions.
And yet, although history will likely find SUPPORT’s defenders wrong on the facts, that side appears to be winning the regulatory battle. Ordinarily OHRP doesn’t retract enforcement and hold a big public event to let critics lean on the agency charged with medical research ethics oversight, as happened here. But led by a number of prominent bioethicists—most notably John Lantos and Ben Wilfond—SUPPORT’s defenders have effectively forced OHRP into a corner. Indeed, under Lantos, Wilfond, et al., and in the name of biomedical progress, “Bioethics” is being employed via the SUPPORT controversy to deliberately reduce long-standing protections for subjects of medical research.
In Washington, presumably knowing they couldn’t really defend those obviously deficient consent forms, SUPPORT’s defenders collectively pushed a party line that went roughly like this: improvements in patient care through medical science require that we not scare potential enrollees out of studies by going into gruesome detail about risks, especially when clinical care itself is full of risks that doctors often fail to mention.
Some SUPPORT defenders even suggested that clinical care is somewhat “random”—because it isn’t based on enough good evidence, and because patients end up rather randomly in this or that clinic, each clinic idiosyncratic in its practices—ergo being allegedly “randomly” subjected to interventions in normal clinical care is essentially equivalent to being in a randomized controlled study of such interventions. Why require special consent for medical research, full of frightening discussions of risk, when medical clinics are such a mess in terms of science and consent? To do so would only risk slowing advancement in patient care!
I know. But keep breathing and stay with me.
Now, I realize that, as a federally-funded study, blessedly-free of pharma funding, SUPPORT would seem, at first glance, to have nothing to do with the recent back-and-forth at this website between Rob MacDougall and Carl Elliott about ethicists being paid by pharma. But I think, in fact, when you look at the MacDougall-Elliott exchange, and look at how the conversation about SUPPORT played out in Washington, you see clear parallels. You see that growing split I’ve pointed to within Bioethics, between defenders of the medical research industrial complex and us Impact Ethics types.
In case you missed it, two blog entries ago, Rob MacDougall made the argument that it’s perfectly okay for academic “ethicists” to function as “representatives” for pharma because, he says, everybody deserves a moral representative and “accepting all partial [i.e., biased] voices into bioethics debate” has inherent value.
One entry ago, Carl Elliott responded that there are some roles—like being a paid shill for corrupt corporations—that are fundamentally incompatible with being a decent scholar. If people like Glenn McGee want to work for companies like CellTex—or people like Art Caplan want to sell pharmaceutical companies “development of articles for peer-reviewed journals positioning the underlying issues”—then let’s at least not pretend these people are doing “bioethics” in any scholarly sense of the term. Real scholars don’t get paid to defend pre-ordained positions.
I don’t think it’s hard to see that what’s happened with SUPPORT is that the study’s apologists are functioning as paid representatives, not of pharma in this particular case but of the medical research industrial complex. Lantos, for example, works for a hospital that is part of the research network involving SUPPORT—a network Public Citizen has been asking the government to investigate following revelations over SUPPORT. Meanwhile, Wilfond is funded by the NIH.
And who is on the other side of Lantos et al., pushing for the rights of patient-subjects, now pushing against the NIH’s leaders who have been vigorously defending SUPPORT? Yeah, it’s us Impact Ethics types again.
So let’s go back to Lois’s implied question: How could the bioethicist defenders of SUPPORT not see they have the facts about the consent documents so wrong? To answer this, it helps to contrast MacDougall’s (industrial complex’s) and Elliott’s (Impact Ethics’) positions using a theological analogy.
MacDougall is hesitant to judge anybody’s acts as sinful, wanting instead to guess that perhaps we all have some reasonable motive in our souls for our deeds. The bioethicists who have functioned as SUPPORT apologists take a position much like MacDougall’s: they point to the good intentions of the researchers (and, by analogy, presumably themselves), to the importance of science, to the value of evidence-based medicine, and to a love of patients, especially babies. And what do they conclude, after this soul-searching? “We’re good people, with good values, and good souls.” All good.
Elliott, by comparison, is interested in acts when he judges good and evil. And when you look at acts, what can you do but conclude that OHRP was right about SUPPORT? Informed consent didn’t happen, no matter how nice you people are.
Needless to say, I’m with Elliott in terms of how we have to judge each other. As an historian (and Susan Reverby and I testified together for the hearing as historians), I grow weary of people trying to know and thus to judge people by motivation, when really all we can know is acts.
Besides, who gives a damn whether somebody is nice inside? Who cares if he loves science, patients, and babies? We ought to care about whether he shills for a corrupt industry, whether he accurately presents evidence in a case, whether he obtains informed consent. This is what patients and subjects would reasonably care about. Moreover, how on earth would you federally regulate a soul? Of course, maybe the fact that you can’t is part of the appeal of moving Bioethics towards judging souls rather than acts.
(originally posted at Impact Ethics September 11, 2013)