Report on the HHS meeting of August 28, 2013
For folks who could not attend last week’s meeting held by the U.S. Department of Health and Human Services (or who ran into the problem of the live-stream cutting in and out), here is a run down of what I think were the most salient elements. This is based on notes I took at the meeting and has not been fact-checked against transcripts or other recordings, so if you find yourself wanting to react to something I’ve written here, I encourage you to check the original records.
The ultimate reason for this meeting was the determination by Office of Human Research Protections (OHRP) of failure of appropriate informed consent in the SUPPORT study of very premature babies. Fascinatingly, among those speakers who have previously claimed OHRP was wrong in its finding of inadequate consent (John Lantos, David Magnus, Benjamin Wilfond, Jeffrey Drazen, etc.), not a single one reiterated criticism of OHRP’s findings when he got up to speak. In fact, when OHRP Director Jerry Menikoff pressed Lantos, Magnus, and others on this point, they did not fight back. Thus, it would appear everyone now admits OHRP was right: the consent forms were inadequate.
Based on their to-date publications and their remarks at the meeting, it seemed pretty clear that what the pro-SUPPORT bioethicists (Wilfond, Magnus, Lantos, etc.) have been seeking is to avoid sanctions for the SUPPORT researchers, not actually winning the argument over consent in this case. If I’m right about their goals, they indeed seem to have gotten what they wanted, which explains why they seemed happy at the meeting in spite of Menikoff pushing them to admit they’ve backed off. It doesn’t look right now as if OHRP is going to do anything more about SUPPORT: parents won’t be notified that they were misinformed about risk in the study and uninformed about the study’s purpose; the IRBs that let these lousy consent forms suffice will go unpunished and even unexamined. The Guys in Charge have apparently decided that good intentions plus a plea of ignorance of the law will suffice.
Well, the courts will likely decide otherwise. Actually, everybody at the meeting in the know said the growing lawsuits over SUPPORT will likely be settled before ever going to court—because the researchers simply have no case. Lois Shepherd and George Annas both made the important point, in their formal remarks, that it isn’t up to HHS, OHRP, or Magnus and Lantos to decide what our rights are as subjects of research. Shepherd referred to state laws and this little thing called the U.S. Constitution. (View her testimony.) There is also a body of court decisions that matter here; Annas, for example, pointed to the Burton case. (Read Annas’ testimony here and view his presentation here.) Once again, it’ll apparently be the lawyers who will be cleaning up the ethical messes, although this time in closed-door settlements.
There was at least one suing lawyer in attendance at the meeting, but he stayed in the background while two sets of parents got up and spoke to how they were misled during SUPPORT enrollment. One mother stated that when she was presented with something called “SUPPORT,” she naturally assumed the clinicians were offering support for her and her baby. This was Sharissa Cook, the only African-American to speak formally all day. (View her testimony here.)
In our remarks earlier in the day, Susan Reverby and I had cautioned against over-using the Tuskegee Syphilis Study as a metaphor, but both of us could not help but be struck by the power of having a black woman from Alabama present to say her boy-child was in a study without her being really informed that it would mean he was treated differently from babies not enrolled in the study. (You can read my and Susan’s remarks here or watch my presentation of them here.)
Listen: I’m not calling anybody a racist, but if white researchers want the black people they experiment on to be part of the conversation, maybe the researchers could notify the subjects and their families that we’re having this conversation, so they could come join us? Our government seems to have had enough resources to send Homeland Security forces out after us critics of SUPPORT, with lights and sirens, for daring to speak to the press at the lunch break, so you’d think it could afford a few letters to some of the people whose babies were experimented on, huh?
Earlier in the day, Mike Carome of Public Citizen had already pointed out that the whole meeting was based on two fallacies: (1) that the interventions in SUPPORT, including masked oximeters and randomization to particular oxygen levels regardless of other health considerations, would be found in ordinary NICU care; (2) that we are in a new era of research that requires special new regulations or interpretations. (View his presentation here.) Unfortunately, Carome’s points seem to have been used by the pro-SUPPORT crowd to mean we should not bother to talk about what went wrong in SUPPORT and instead talk about how to keep informed consent from getting in the way of other, forthcoming modern studies.
A couple of presenters, including Charles Natanson of the NIH, presented fascinating analyses of “misalignment” in SUPPORT and similar studies. (View.) Basically what these analyses showed is that randomization of critically ill patients to extreme ends of clinical interventions gets you both bad and useless data. Natanson observed that studies like SUPPORT amount to “a physiological experiment” as opposed to a medical experiment; in other words, all you find out from these studies is how a body reacts to some particular, atypical, controlled event, not how a critically-ill patient in a very complicated care setting ought to be treated, because the controlled arms are extreme and extraordinary and are not being compared to what really happens in complex critical care.
The way the meeting was set up, we spoke in the order in which we had made application to speak. As a consequence, most of us who were worried about protections of subjects spoke in the morning (we had been quick to apply), and the afternoon was loaded with speakers who are worried that OHRP and regulatory protections are going to get in the way of research. Make no mistake—the folks pushing against OHRP regulation are not evil pharma types. These are well-intentioned, thoughtful, eager researchers who truly believe that evidence-based medicine is our only hope, and that worrying patients to pieces over risk analyses will scare them out of critically important studies in which they might ultimately be safer. Several perversely dragged out a Cochrane analysis showing that patients are often better off in studies than in non-research clinical care, as if this is somehow proof that patient-centered care requires pushing people into studies. They seem not to get that a good outcome for someone enrolled in a study can never justify failure to conduct a study ethically.
But a party line emerged among this crowd: Patients are rarely told by their doctors about all the risks of and absence of evidence-base for clinical interventions offered to them (true enough), therefore there’s no point in scaring them out of studies by disproportionately talking about those risks during research enrollment. In other words, we’ve been withholding information from patients in the clinic, doing crappy clinical work based on very little data, so the way we make up for this sin is to push patients into studies to figure out what really works, and if we tell them too much about risk they’re not going to participate. The strangest thing was how so many of the speakers really did use a confessional, “admitting to sin” tone when they talked about not telling patients the truth about absence of evidence-base and presence of risks in the clinic, and how they thought getting everybody into studies was the proper atonement for this ongoing clinical sin.
Many on this side seemed to agree that if you’re at risk for Adverse Outcome X in the clinic in ordinary care, there’s no need to warn you about risk of Adverse Outcome X when you’re enrolled in a study. In other words, researchers should simply hope that your doctor told you about the risks you were facing, because the researcher isn’t going to do it when she enrolls you in the study of that care! (Yowza. Way to push disclosure duty to the previous guy in the chain.) Magnus appears to believe that even risk of death can count as “minimal risk” in a study, if you are at risk of death in the course of ordinary clinical care. I don’t know a lot of people other than professional ethicists like Magnus who would see risk of death as a “minimal risk.”
Menikoff’s back-and-forth conversations with speakers confirmed what I had heard about Menikoff elsewhere, namely that the only thing Menikoff (and thus OHRP) is really concerned with is consent: so long as a reasonable lawyer would feel you had been informed and given consent, researchers can do whatever they want in terms of dangerous and perhaps useless studies. This is, needless to say, a rather minimalist take on research ethics, but it may help explain why the OHRP is doing so little under Menikoff.
While the NIH representative on the panel—Kathy Hudson, who really should have been excluded given her pre-stated interest in stopping the OHRP from doing its oversight job—spent her time doing whatever she could to push research at all costs, Bob Temple of the FDA asked good, smart questions, clearly indicating that he thought it was possible to do really good research without diminishing protections for people who become subjects. Menikoff, the third member of the “panel,” sometimes seemed to suggest that if “the people” want to back off on protections of subjects, as a dedicated public servant he might follow that wish.
Never mind that the people on whom these experiments will be conducted are pretty much unaware this conversation is even going on. “The people” speaking to Meninkoff are mostly the researchers and their paid bioethicist lap-dogs, plus a rag-tag few of us critics who bothered to show up on our own dimes. By all appearances, the “bioethicists” who can be counted on to smooth away all awkward or time-consuming ethical concerns are the ones who will continue to be chosen for groups like the OHRP advisory board and the Presidential Commission for Bioethics. They know their role, and, boy, do they play it well.