For those closely following the litigation over this clinical trial, a few updates. On January 22, the district court ruled on defendants’ motions to dismiss plaintiffs’ third amended complaint. That complaint named as defendants the director of the IRB, the chair of the IRB, the other members of the IRB (“the IRB defendants”)—all in their individual capacities; the PI of the trial, in his individual capacity; Masimo Corporation, the manufacturer of the oximeter used in the trial; and fictitious defendants (ABC Health Care Providers #1-100; ABC Individuals #1-100; and XYZ Entities #1-100). The complaint stated seven counts: products liability and negligence against Masimo; negligence, negligence per se, lack of informed consent, and breach of fiduciary duty against the IRB defendants and the PI; and wrongful death against all defendants.
This is post is part of The Bioethics Program’s ongoing Online Symposium on the Munoz and McMath cases, which I’ve organized, and is cross-posted from the symposium. To see all symposium contributions, in reverse chronological order, click here.
Had the hospital not relented and removed the ventilator from Marlise Munoz’s body, could the Munoz fetus have been brought to term, or at least to viability? And if so, would the resulting child have experienced any temporary or permanent adverse health outcomes? Despite some overly confident commentary on both “sides” of this case suggesting a clear answer one way or the other—i.e., that there was no point in retaining the ventilator because the fetus could never be viable or was doomed to be born with catastrophic abnormalities; or, on the other hand, that but for the removal of the ventilator, the “unborn baby” was clearly on track to being born healthy—the truth is that we simply don’t know.
Before getting into the limited available data about fetal outcomes in these relatively rare cases, a bit of brush clearing. The New York Times juxtaposed reports about possible abnormalities in the Munoz fetus with the hospital’s stipulation about the fetus’s non-viability in ways that are likely to confuse, rather than clarify:
Lawyers for Ms. Muñoz’s husband, Erick Muñoz, said they were provided with medical records that showed the fetus was “distinctly abnormal” and suffered from hydrocephalus — an accumulation of fluid in the cavities of the brain — as well as a possible heart problem.
The hospital acknowledged in court documents that the fetus was not viable.
Whether intentionally or not, the nation’s newspaper of record implies — wrongly, I think — that the hospital conceded that the fetus would never be viable because of these reported abnormalities. In court, the hospital and Erick Munoz stipulated to a series of facts, including that Marlise was then 22 weeks pregnant and that “[a]t the time of this hearing, the fetus gestating inside Mrs. Munoz is not viable” (emphasis added). The hospital conceded nothing at all about any fetal abnormalities. In short, the Times, and many other commentors, have conflated “non-viability” as a function of gestational age with “non-viability” as a way of characterizing disabilities that are incompatible with life. As I read this stipulation, the hospital was not at all conceding that the fetus would never have been viable, had the ventilator remained in place. Rather, given the constitutional relevance of fetal viability, the hospital was merely conceding the banal scientific fact that the Munoz fetus was, at 22 weeks, not currently viable. There is nothing surprising in the least about the hospital’s “concession” about “viability” in the first sense, above: 22-week fetuses are generally not considered viable. Continue reading
UPDATE: Following Friday’s court order (discussed below), the hospital today (Sunday, Jan. 26, 2014) removed the ventilator from Marlise Munoz, who has met the criteria for brain death since Nov. 28, 2013.
Two high-profile, rapidly evolving cases involving death by neurological criteria — better known as “brain death” — raise vexing and sometimes novel legal, ethical, and medical questions at the edges of life and death. I’m organizing an online symposium on these cases over at The Bioethics Program Blog, and will be cross-posting my contributions here, beginning with this introduction to the symposium, which brings readers up to date with legal developments through today. Please contact me if you’re interested in participating.
The Marlise Munoz Case
On November 26, 2013, Erick Munoz found his wife, Marlise, unconscious on their kitchen floor. She was then 14 weeks pregnant with their second child. Erick resuscitated her and she was transported, alive, to John Peter Smith Hospital, where she was placed on a ventilator to assist her breathing and given other life-sustaining treatment. Not long thereafter, however, Erick says that the hospital told him that Marlise was brain dead.
Although Marlise did not have a written advance directive, according to Erick, both he and Marlise had
worked as paramedics during their marriage, and thus were knowledgeable of and had personally witnessed injuries that resulted in death, including brain death. Erick and Marlise frequently discussed their requests, beliefs and desires with each other, and expressed clearly to each other, family members and friends, their respective desires not to be resuscitated should either of them become brain dead.
Erick requested, with the “full support” of Marlise’s parents, that the ventilator be removed from her body and that he be given possession of it for burial.
The hospital refused. It argued that § 166.049 of the Texas Advance Directives Act (TADA) — which provides that “a person may not withdraw or withhold life-sustaining treatment under this subchapter from a pregnant patient” — prohibits it from removing the ventilator. It was not entirely clear whether the hospital believed that Marlise was in fact dead or not. The media was reporting as late as December 24 that the hospital had said that Marlise was in “serious condition,” and the hospital had not released Marlise’s medical records, which Erick said would show a diagnosis of brain death, to him.
After the jump, this week’s developments in the Munoz case, the McMath case, and a list of symposium participants.
Bonjour de Toulouse, where I’m visiting this month at the Institute for Advanced Study (IAST), which is hosted by the Université de Toulouse Capitole and physically (and in many senses conceptually) situated inside the Toulouse School of Economics. That setting is a particularly good one for this post on markets in human tissue.
In early October, I wrote about a rule that the Department of Health and Human Services has proposed that would amend the National Organ Transplant Act (NOTA) to criminalize compensation for providing peripheral blood stem cells (PBSCs) given through apheresis. Compensating those who allow their bone marrow to be aspirated — the other major source of hematopoietic stem cells (HSCs) — is already explicitly criminalized under the statute. At the end of the post, I promised to follow up with a second post on why I’m skeptical about this rule, as a matter of policy. This is that post.
But before discussing appropriate policy for addressing the problem of the 3,000 Americans who die each year for want of a bone marrow transplant, and for reasons I’ll explain near the end of my post, I want to say something about one particular person: Professor Nalini Ambady, a Stanford social psychologist who, about one year ago, began an international search for a compatible, willing HSC donor to treat her leukemia.
Because she is South Asian, and because few Asians and other racial and ethnic minorities are listed in the U.S. bone marrow registry — South Asians comprise only 2% of the U.S. registry — she had a difficult time finding a match. She nevertheless found 12 potential matches in the U.S. bone marrow registry, and apparently at one point had scheduled the transplant. In the end, however, half were ruled out as imperfect matches — and each of the remaining six matches declined to donate.
Having exhausted the U.S. registry, Ambady and her supporters sought a match in South Asia registries — but even fewer people are registered in that region than in the U.S. Of India’s 1.2 billion people, for example, only about 45,000 are registered. Nevertheless, a potential thirteenth match was found in an Indian registry. He matched at least 6 of 10 HLA markers; he would need a blood test to determine whether he was a complete match. Unfortunately, after a worrisome week of silence about whether he was indeed a complete match, Ambady and her family learned that the potential donor had backed out.
And then a potential fourteenth match:
Weeks later, it happened with another potential match for Nalini, this time an 8/10 and so an even likelier match. This man wanted to watch someone else donate their bone marrow before making up his mind. A registry chief actually arranged this for him in early May. Somehow, it wasn’t persuasive enough. He, too, decided not to donate.
Professor Ambady died on October 28 after eight compatible or potentially compatible registered donors ultimately declined to donate.
Apparently, declining to donate after agreeing to be listed in a registry and being found to be a match is quite common. According to one registry chief, the attrition rate is 50% in the U.S., Europe, and India. Would a financial incentive have tipped any of these vaccillating prospective donors towards a decision to donate? Although we can’t say, this is an eminently answerable question. Unfortunately, the Department seems uninterested in learning whether a compensation scheme would save lives — or have ill or counterproductive effects — or not.
In its Notice, the Department lists the following policy reasons for expanding NOTA’s list of “organs,” the exchange of which for valuable consideration is prohibited, to include PBSCs: (1) preventing commodification; (2) curbing opportunities for coercion of PBSC providers and (3) exploitation of PBSC recipients; (4) encouraging altruistic donations, and (5) decreasing the likelihood of disease transmission resulting from paid donations. My responses to these arguments are after the jump. I end with some thoughts about alternative policy tools for increasing the supply of PBSCs in the absence of a legal compensation scheme.
I’m sorry to report that Adrienne Asch, director of the Center for Ethics at Yeshiva University and the Edward and Robin Milstein Professor of Bioethics, died yesterday of cancer. A social psychologist by training (but no relation to Solomon Asch), Professor Asch’s scholarly focus was the ethical, legal, and social implications of human reproduction, especially as it intersects with disability studies. An interdisciplinary scholar (as most bioethicists are), she taught courses at Wurzweiler School of Social Work, Cardozo School of Law, and Albert Einstein College of Medicine.
I didn’t always agree wth Adrienne, but she was an important scholar. As Sam Bagenstos noted, her death is “a huge loss for the disability world.” Among other things, she challenged pro-choice scholars and activists to rethink the implications of some of their policies and theories for people with disabilities in present and future generations. Here is one example of many.
Adrienne was also a lovely person. Some years ago, I picked her up from Wellesley (where she then taught) and drove her to Dartmouth (where I was a college senior) for a brief visit. It was, from start to finish, an epic fail on my part. In my defense, her assistant gave me terrible directions, I was then unfamiliar with the joy that is Boston rush “hour” traffic (including the fact that it begins at 3pm and lasts until 7pm), and this was before either cell phones or GPS. Nevertheless, what was supposed to be a three-hour drive that left time for her to change clothes at the hotel before her first talk became a four-hour tour during which I grew increasingly anxious about the prospects of getting her to the church on time, as it were. Adrienne was blind (hence my driving her), and this raised the additional issue of what to tell her, and when, about our travels. Ever the intellectual and mentor, as soon as she got into the car, she wanted to hear about the honors thesis I was writing. Alas, I turned out to be utterly incapable of navigating Boston’s traffic and discussing French existentialism at the same time, and soon we were hopelessly lost. I stopped at a gas station for directions (remember when you had to do that?), but by then we had hit rush hour traffic. We finally reached the highway and I managed to make up some time. As we discussed all manner of topics bioethical, I did the math and figured that if I, ahem, flirted with the speed limit, I could just have her to her talk on time.
The New Hampshire state police were not accommodating of this plan, however. Mere yards from our final exit I saw flashing lights in my rearview mirror. Feeling the car slowing down as I pulled over, Adrienne asked brightly, “Oh, are we there?” Mortified, I told her that no, in fact, I was being pulled over for speeding and that we would now certainly be at least a few minutes late for her talk. She would have been well within her rights to be furious with me, but was instead remarkably understanding. (The administrative director of Dartmouth’s Ethics Institute, by contrast, chided me for acting unethically by speeding.) Here‘s a great interview with Adrienne that captures some of her personality, as well as her views about disability and her experiences living with a disability.
[Cross-posted at The Faculty Lounge]
The Affordable Care Act continues to be a popular topic of discussion amongst Bill of Health contributors, who also recently touched on issues of drug approval, vaccine improvements, and provider decision making.
Frank Pasquale tweeted an article about the extremely low-cost health insurance policies that will be available to some people under the Affordable Care Act. Millions of people will be eligible for free-premium plans, but an associated risk is that people will opt for these at the expense of plans that cover necessary care. (11/4)
Art Caplan tweeted his agreement with Robert Kuttner’s blog post about the Affordable Care Act. Building on private insurance was a mistake, according to Kuttner, whereas simply extending Medicare would have been a more favorable approach. (11/4)
Art Caplan also tweeted the results of a new study from Costa Rica suggesting that just one dose of the HPV vaccine might be enough to protect women from the virus. In his tweet, Caplan suggests that such a change might make the vaccine, which is currently taken in three doses, more widely accessible around the world. (11/4)
Michelle Meyer posted an article about the difficult balance between the FDA approval process and patient needs. The author describes his experience as part of a promising trial for a treatment for polycystic kidney disease, only to be let down by the Administration’s decision not to approve the drug. (11/2)
Frank Pasquale tweeted the results of a study revealing that half of clinical decision support (CDS) alerts are inappropriately overridden by providers. CDS alerts highlight things like patient allergies, drug interactions, etc., and can be potentially dangerous when erroneously ignored. (11/3)
Amitabh Chandra posted an article comparing the rollout of the Affordable Care Act to that of Massachusetts’s healthcare program in 2006. The author highlights, among other things, differences in the laws themselves, the websites designed to implement them, and the political context of the time. (10/30)
By Sara Providence
This round-up features our bloggers’ key tweets from the past two weeks, ranging from the Affordable Care Act to issues of life and death:
Frank Pasquale tweeted the article, “40 Percent of Doctor Practices Unsure About Obamacare Exchanges.” According to the author, more than 80% of doctors participating in a study were unsure about how they would be paid by the exchange plans, and 40% don’t know if they’ll accept the plans at all. (10/8)
Art Caplan posted the article “Euthanasia for emotional pain: Mercy or a ‘culture of death’?” The harrowing piece continues the conversation about the ethics of assisted suicide, this time through the lens of a transgender man’s story. (10/7)
Frank Pasquale tweeted the article “When the Machine That Goes Ping Causes Harm: Default Torts Rules and Technologically-Mediated Health Care Injuries.” In the piece, author Nicolas Terry discusses the liability questions brought to light by the increased use of technology in healthcare delivery. (10/7)
Michelle Meyer tweeted a blog post by Josiah Neeley, called “How to Avoid Defaultmageddon: Randomize Obamacare.” Written before the government shutdown, it discusses the potential utility of allowing the Affordable Care Act to continue as planned in some states but not in others, in order to observe its effects. (10/3)
Richard Epstein tweeted his piece, “Government overreach threatens lives.” In light of an appeal of the 2012 decision in Regenerative Sciences LLC v. United States, he expresses the opinion that the FDA’s decision to review each individual stem cell procedure performed is bad policy. (10/2)
Stephen Latham tweeted about his appearance on the Melissa Harris-Perry show on MSNBC. He was featured as a discussant in a conversation about the book “Knocking on Heaven’s Door: The Path to a Better Way of Life” by Katie Butler, which addresses the idea that a longer life is not necessarily a better one. (9/28)
On October 2, in the midst of the government shutdown—either HHS somehow managed to convince itself that the rule was “necessary for the protection of life” or, more likely, it had already been scheduled for printing—HHS quietly published a Notice of Proposed Rulemaking. The proposed rule would effectively moot the recent Ninth Circuit case of Flynn v. Holder by criminalizing the compensation of bone marrow donors, even when the life-saving stem cells are extracted through a newer, minimal risk procedure. In this post, I’ll explain the medicine, the Ninth Circuit’s decision, and what HHS proposes to do in response. In my next post, I’ll have some reaction to HHS’s policy arguments, about which I’m skeptical, and perhaps a few thoughts about where plaintiffs might go from here.
Section 301 of the National Organ Transplant Act (NOTA) of 1984 criminalizes the transfer of “human organs” for “valuable consideration.” Reimbursement of reasonable out-of-pocket expenses associated with travel and lost wages are okay—as are, since the 2008 amendment of NOTA, paired living donor chains—but any other “valuable consideration” that might incentivize sources of organs is not. Under NOTA, as amended,
‘human organ’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation
(emphases added). HHS has since added to this list “intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.”
So-called “bone marrow transplants”—in reality, infusions of hematopoietic (blood) stem cells (HSCs)—are often life-saving procedures for those with, for example, leukemia or aplastic anemia. (See these sobering statistics compiled by the Institute for Justice, which represented the plaintiffs in Flynn.) When NOTA was passed, the only way to obtain HSCs was through bone marrow aspiration using a long needle thick enough to suck liquid marrow directly from the donor’s pelvic bone. HSCs are then harvested from the marrow. The procedure is done under general anesthesia and so the donor is subject to the usual risks of anesthesia. Although the donor can return to usual activities in two to seven days, discomfort may linger for up to two weeks. Continue reading
Legal academics who work across disciplines sometimes find themselves in the uncomfortable position of explaining to their stunned colleagues the process by which second- and third-year law students, armed with author c.v.s, decide what gets published and where.
Well, get ready to get your schadenfreude on. For the past 10 months, John Bohannon, a contributing correspondent for Science magazine, has been conducting a sting of (other) science journals and their peer review processes. Much like the famed Sokal hoax, Science submitted to 304 journals a bogus paper written by a fictitious researcher from a nonexistent institution. The paper described “the anticancer properties of a chemical that [the fictitious researcher] had extracted from a lichen,” and according to Bohannon, “[a]ny reviewer with more than a high-school knowledge of chemistry and the ability to understand a basic data plot should have spotted the paper’s short-comings immediately” and rejected it promptly. And yet, over half of the journals accepted the paper. Recall that the bogus paper purports to report on the discovery of the anticancer properties of lichen. Let the prospect of bogus cancer research published in peer reviewed medical journals sink in. Continue reading
In late May, I wrote the following:
Yesterday, the Social Science Genetic Association Consortium, an international consortium that pools and conducts social science research on existing genome-wide association study (GWAS) data, and on whose Advisory Board I sit, published (online ahead of print) the results of its first study in Science. That paper — “GWAS of 126,559 Individuals Identifies Genetic Variants Associated with Educational Attainment” — like much human genetics research, has the potential to be misinterpreted in the lay, policy, and even science worlds. That’s why, in addition to taking care to accurately describe the results in the paper itself, including announcing the small effect sizes of the replicated SNPs in the abstract, being willing to talk to the media (many scientists are not), and engaging in increasingly important “post-publication peer review” conversations on Twitter (yes, really) and elsewhere — we put together this FAQ of what the study does — and, just as important, does not — show. So far, our efforts have been rewarded with responsible journalism that helps keep the study’s limits in the foreground.
I had no role in the GWAS itself; that credit goes to SSGAC’s extraordinarily meticulous scientists. I did, however, have a strong hand in the FAQs. And so I am really pleased that in a new editorial, the editors of Nature (not for nothing, Science’s main competitor) highlighted our FAQ as an example of best practices in behavioral genetics research and science communication. They write:
For clarity, scientists would do well to follow the example of the Social Science Genetic Association Consortium. In June, this group published a paper on genetic variants associated with educational attainment (C. A. Rietveld et al. Science 340, 1467–1471; 2013). Accompanying this was a nine-page Frequently Asked Questions document that, in plain, easy-to-understand language, addressed such questions as why the researchers did the study, what they found and what the implications of the work are — and are not (see go.nature.com/7mov2j). The document spelled out that the consortium had not found ‘the gene’ for educational attainment, that each genetic marker found has only a very small effect on length of schooling, and that any policy response based on that single study would be premature.
Scientists cannot be held responsible every time someone misinterprets their work. But simple steps such as these could help to prevent and address some of the potential distortions of behavioural genetics — and could help to ensure that society continues to support the work.
For more on taboo science—including IQ, race, violence, and sexuality—see Erika Check Hayden’s accompanying article, which discusses our Science GWAS in the IQ category and (elsewhere in the article) quotes Duke lawprof (and new Conspirator!) Nita Farahany and Bill of Health guest contributor Yaniv Erlich. Now if we could only get popularizers of science to understand that their lay audience will rarely know that they are “oversimplifying” that science.
[Cross-posted at The Faculty Lounge]
The op-ed, which will appear in tomorrow’s print edition, is online here. It’s co-authored with Christopher Chabris (who happens to be my husband). Here—where I’m writing only for myself—I thought I’d say a bit about what motivated us and elaborate on a few points whose force may have been blunted by the process of condensing our thougts into our allottted 1,000 words.
The news hook for the article was an August memo leaked to Fox News in which the Obama administration announced that it is looking to hire behavioral scientists to help shape policy. Notwithstanding that the explicit model for this initiative is the U.K.’s “Behavioral Insights Team,” formed in 2010 by Conservative Prime Minister David Cameron, in the U.S., some on the right went completely off the rails about the Obama announcement.
A typical reaction was from Fox News’s Monica Crowley, who described the initiative as “really frightening,” “insane,” “outrageous,” “unconstitutional,” “an Orwellian horror show”—and all of the aforementioned mostly because, so far as I can tell, she believes that nudges constitute a form of “psychological warfare” akin to “what our military does to our enemies.” There are certainly legitimate criticisms of nudges to be made by both the right and the left, but that they are a form of Communist mind control is not among them. (For starters, even if nudges did rely on something like subliminal messages, those messages have been shown to have no effect on consumer behavior, much to the chagrin of marketers.)
The impetus for our piece, then, was to disabuse the Crowleys of the world (or at least that portion of them who are open to persuasion on this matter) of that notion, and then to offer some affirmative reasons why conservatives and libertarians should embrace the nudge (its preservation of all options in the choice set; its ability to incentivize personal responsibility; its efficiency), especially relative to its often perfectly viable alternative: the shove. (To that end, the piece was originally intended for a periodical with a right-of-center audience but wound up in the L.A. Times, where some of it may admittedly amount to preaching to the choir.)
In making our case…
By Sara Providence (PFC Intern)
As another way to keep you up to speed on what’s happening in the world of health policy, we’ll be compiling relevant tweets from our bloggers and posting them here on a bi-weekly basis. Take a look:
Richard Epstein (@RichardAEpstein) tweeted a policy report from the Manhattan Institute concerning FDA regulation of stem-cell procedures. The report rebuts, among other arguments, the FDA’s position that stem-cell treatments are within its purview of preventing communicable diseases. (9/24)
Frank Pasquale (@FrankPasquale) tweeted an article about potentially limited choice of provider under the new health law. According to the authors, the Affordable Care Act keeps premiums low by restricting the number of doctors and hospitals available to patients. (9/24)
Arthur Caplan (@ArthurCaplan) tweeted about the “exploitation of women in poor, underdeveloped nations for surrogacy,” alongside his post of this article. The piece describes the growing phenomenon of wealthy Chinese families paying American women to be surrogate mothers. (9/23)
Michelle Meyer (@MichelleNMeyer) tweeted an article about Penn State’s decision not to sanction employees for non-compliance in a wellness plan. Employees were previously required to respond to a controversial survey administered by a health management company, or pay a fine. (9/18)
Arthur Caplan (@ArthurCaplan) tweeted a piece about continuing bias against gay blood donors. “Gay-rights advocates are fighting to amend the U.S. ban on blood donations by gay and bisexual men, which dates from the first years of the AIDS epidemic,” the author writes. (9/16)
Update: In other SUPPORT news today, a second group of bioethicists has written to the NEJM in, ahem, support of OHRP’s original criticisms of the SUPPORT trial. Readers may recall that another group of prominent bioethicists had previously published a letter in the NEJM in support of SUPPORT.
OHRP today announced details of the public meeting it previously said it would convene to address the SUPPORT trial and similar trials comparing two or more standard-of-care interventions in which subjects are randomized.
From an OHRP email:
On June 26, 2013, the Department of Health and Human Services (HHS) announced in the Federal Register an August 28, 2013 public meeting to seek public input and comment on how certain provisions of the Federal policy for the protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context.
HHS specifically requests input regarding how an institutional review board (IRB) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects in the informed consent process.
HHS is seeking participation in the meeting and written comments from all interested parties, including, but not limited to, IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, and the regulated community at large. The meeting and the written comments are intended to assist HHS, through the Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), in developing guidance regarding what constitutes reasonably foreseeable risk in research involving standard of care interventions such that the risk is required to be disclosed to research subjects. HHS is seeking input on a number of specific questions but is interested in any other pertinent information participants in the public meeting would like to share.
More details and deadlines after the jump.
UPDATE: A class action lawsuit has been filed in federal court against UAB providers and IRB members on behalf of infants enrolled in the SUPPORT study (through their parents). The Amended Complaint, which was filed May 20, can be found here. In addition, here are two more sets of reactions to the SUPPORT study in the NEJM, both in defense of it, from a group of prominent bioethicists and from NIH. Here is a new post from John Lantos at the Hasting Center’s Bioethics Forum blog. And here is coverage of the most recent developments in the New York Times. I’ll continue to aggregate links as warranted.
Regular readers may recall that recently, OHRP sent a determination letter to one of multiple sites (the University of Alabama at Birmingham (UAB)) involved in an RCT (the SUPPORT study) of optimal oxygen levels for premature infants (prior coverage here, here, and here). OHRP’s criticism itself led to considerable criticism among many research ethicists and physician-researchers (see, e.g., here, here, and here), as well as the SUPPORT researchers themselves (here), while others defended OHRP to varying degrees (here, here, and here).
Now, in a new letter to UAB, OHRP clarified that it has no objections to the study design; its objections, instead, pertain to what parents were told in the informed consent documents. Then, in a remarkable move, it announced that it is suspending its compliance actions against UAB, and plans no further action vis-a-vis other SUPPORT sites, pending its issuance of new guidance to address the risks that must be disclosed when conducted clinical trials like SUPPORT. OHRP promises not only the usual notice and comment period following the draft guidance but also an open public meeting, presumably in advance of the draft.
As the OHRP letter itself suggests, the fight within the research ethics community over the SUPPORT study can be seen as part of a larger conversation about the future of human subjects research regulation in the learning healthcare system. OHRP’s guidance-making process in this matter will clearly be one to watch.
In my last post on Maryland v. King, I suggested that both proponents and opponents of King should find the philosophical case for a universal DNA database stronger than they might otherwise have thought. Obviously, moving in that direction — or even including mere suspects in a database — would raise legal questions that merit (and, one hopes, receive) further consideration by the Supreme Court. But how likely is it that the Court will have another opportunity to consider the constitutionality of a statute that continues to draw the line at arrestees?
The Supreme Court’s decision in King was necessarily limited to the fact pattern presented by Maryland’s particular statute authorizing the collection of DNA from arrestees. For instance, the Court repeatedly noted that the Maryland statute at issue limited DNA collection from arrestees to those who had been “charged” (not, in fact, merely arrested) with “serious crimes,” defined as crimes of violence or burglary, or attempts to commit these crimes. (Although Justice Scalia expressed skepticism that, under the Court’s analysis, it would or could find in any subsequent case a limiting principle preventing the collection of DNA from, say, those arrested for traffic violations, it is of course possible that the Court could find such a distinction.) The Court also noted that in Maryland, samples may not be processed or added to the database until after arraignment, when a judicial officer “ensures that there is probable cause to detain the arrestee.” The presence of probable cause, and the arrestee’s corresponding reduced expectation of privacy, were “fundamental” to the Court’s decision to uphold the collection of DNA from “arrestees.” The Court also noted that samples must be expunged if the arrestee is not convicted. Finally, the Maryland statute strictly limits use of the DNA database to solving cold cases and identifying remains and missing persons; use of the database for other purposes (research, to test for paternity, to analyze health or other traits) is criminalized. The Court explicitly said that a database that was not so limited would raise additional privacy concerns that would require a new analysis.
As usual, it’s more likely that the Court will have another opportunity to examine the constitutionality of DNA collection from arrestees if a circuit split arises regarding one or more of these or other practices. And that, in turn, depends, on how widely states and the federal government vary in their authorizing statutes. An Urban Institute report from May 2013 suggests that variation is, in fact, widespread on these potentially constitutionally relevant factors:
Seriousness of offense
Of the 28 arrestee DNA states, 13 collect DNA from those arrested or charged with any felony; 14 (like MD) collect only from a subset of felonies, typically involving violence, sexual assault, or property crimes; 7 collect from anyone arrested or charged with select misdemeanors; 1 (OK) collects from “any alien unlawfully present under federal immigration law”; and the federal government accepts profiles of any arrestee and any non-US citizen detained by the US government. In addition, 2 states collect DNA immediately upon arrest only if the arrestee has been previously convicted of a felony (CT) or other qualifying crime (TX).
Disclaimer: I’m not a Fourth Amendment person. Rather, my interest in King is in its implications for policies for the use of DNA in the criminal justice system. I spent the better part of a year after my Ph.D and before beginning law school helping to research and edit a book on DNA and the criminal justice system and co-authoring its final chapter with the book’s editor, David Lazer. Although that was ten years ago now, most of the major policy issues in this area have not much changed over the last decade. So, with that caveat, and an invitation to readers to point out anything I say that is out of date or otherwise inaccurate, here are a few quick thoughts on King.
The majority and dissenting opinions spill most of their respective ink taking contrary positions on the primary purpose served by collecting DNA from arrestees. The majority somehow manages to argue with a straight face that the primary purpose (and indeed, to guess from its analysis, apparently the only purpose) of collecting DNA from arrestees is to identify the body of the arrested individual sitting in the booking room. As Justice Scalia wrote in dissent, this claim by the Court “taxes the credulity of the credulous” (slip op. dissent at 1). The clear primary purpose and actual use of statutes authorizing the routine collection of DNA from arrestees is to solve other cases than the one “at bar,” if you will, in the booking room.
One might have thought that the Court went out of its way to avoid finding that the primary purpose of the DNA collection at issue is “to detect evidence of ordinary criminal wrongdoing,” (Indianapolis v. Edmond, 531 U. S. 32, 38 (2000), in order to avail itself of the “special needs” exception to the Fourth Amendment’s usual requirement that searches be conducted pursuant to individualized suspicion. But no. The Court ultimately concludes that the special needs cases “do not have a direct bearing on the issues presented in this case, because unlike the search of a citizen who has not been suspected of a wrong, a detainee has a reduced expectation of privacy” (slip op. at 25). In upholding the state’s power to collect DNA from arrestees, then, the Court relied on — along with the minimally intrusive nature of the search — the arrestee’s reduced expectation of privacy. Indeed, the Court deemed the latter feature “fundamental” to its analysis (id. at 24).
Consider, then, that no such reduced expectation of privacy can be attributed to an even larger class of individuals who are indirectly included in DNA offender databases: the relatives of arrestees (and others who are directly included in offender databases).
The U.S. Supreme Court ruled this morning, in Maryland v. King, that it is constitutional under the Fourth Amendment’s protection against “unreasonable” searches and seizures for the state to compel collection of DNA from arrestees. The probable cause required to arrest someone under the Fourth Amendment permits fingerprinting and taking photographs during the booking process, and the Court held that collecting DNA (limited to 13 loci in supposed “junk DNA”) was not relevantly different. The decision was 5-4, with Kennedy writing for the Court and joined by Chief Justice Roberts and Justices Thomas, Alito, and Breyer. Justice Scalia dissented in his usual spirited way, joined by Justices Ginsburg, Sotomayor, and Kagan.
I suspect that one or more Bill of Health bloggers will have some analysis of this decision once they’ve had the chance to digest it. In the meantime, here is a still-relevant primer I co-authored in 2004 on legal and ethical debates involving DNA and the criminal justice system (including issues related to both offender DNA databases and post-conviction access to potentially exculpatory crime scene DNA). Note that Justice Breyer, in addition to being the Court’s resident patent expert (except him to play a large role in the upcoming Myriad gene patenting decision), has been following debates about DNA and the criminal justice system for some time. He authored Chapter 2 of the book I just linked to.
Although I promised that I was done commenting on the artist-cum-policy wonk who claims to make 3-D “masks” of unknown individuals from their discarded DNA, Matthew Herper of Forbes has taken the criticisms of her (and the media covering her project) articulated by me and others directly to the artist. I confess that her response does not make me feel any better. Even if you’re “only” engaging in art, it seems to me that when that art has an obvious science policy message — indeed, one that you invite — you have some obligation to be clear about how “speculative,” as she puts it, your art is. But when you decide to move from the world of art into the world of science, and to start leading policy discussions based on your speculative art and working with forensic examiners? Then you really have a strong duty to be very clear about what your work can and cannot do. That means, among other things, taking care when talking with the media, and correcting the media if they get it wrong.
Yesterday, the Social Science Genetic Association Consortium, an international consortium that pools and conducts social science research on existing genome-wide association study (GWAS) data, and on whose Advisory Board I sit, published (online ahead of print) the results of its first study in Science. That paper — “GWAS of 126,559 Individuals Identifies Genetic Variants Associated with Educational Attainment” (plus supplemental data) — like much human genetics research, has the potential to be misinterpreted in the lay, policy, and even science worlds. That’s why, in addition to taking care to accurately describe the results in the paper itself, including announcing the small effect sizes of the replicated SNPs in the abstract, being willing to talk to the media (many scientists are not), and engaging in increasingly important “post-publication peer review” conversations on Twitter (yes, really) and elsewhere — we put together this FAQ of what the study does — and, just as important, does not — show. So far, our efforts have been rewarded with responsible journalism that helps keep the study’s limits in the foreground. Perhaps the DNA artist should consider issuing a similar FAQ with her speculative art.
This post is part of Bill of Health‘s symposium on the Law, Ethics, and Science of Re-Identification Demonstrations. You can call up all of the symposium contributions here. We’ll continue to post contributions throughout the week. —MM
In your open letter to me, you write:
No one is asking you to be silent, blasé or happy about being cloned (your clone, however, tells me she is “totally psyched”).
First things first: I have an ever-growing list of things I wish I had done differently in life, so let me know when my clone has learned how to read, and I’ll send it on over; perhaps her path in life will be sufficiently similar to mine that she’ll benefit from at least a few items on the list.
Moving on to substance, here’s the thing: some people did say that PGP participants have no right to complain about being re-identified (and, by logical extension, about any of the other risks we assumed, including the risk of being cloned). It was my intention, in that post, to articulate and respond to three arguments that I’ve encountered, each of which suggests that re-identification demonstrations raise few or no ethical issues, at least in certain cases. To review, those arguments are:
- Participants who are warned by data holders of the risk of re-identification thereby consent to be re-identified by third parties.
- Participants who agree to provide data in an open access format for anyone to do with it whatever they like thereby gave blanket consent that necessarily included consent to using their data (combined with other data) to re-identify them.
- Re-identification is benign in the hands of scholars, as opposed to commercial or criminal actors.
I feel confident in rejecting the first and third arguments. (As you’ll see from the comments I left on your post, however, I struggled, and continue to struggle, with how to respond to the second argument; Madeleine also has some great thoughts.) Note, however, two things. First, none of my responses to these arguments was meant to suggest that I or anyone else had been “sold a bill of goods” by the PGP. I’m sorry that I must have written my post in such a way that it leant itself to that interpretation. All I intended to say was that, in acknowledging the PGP’s warning that re-identification by third parties is possible, participants did not give third parties permission to re-identify them. I was addressing the relationship between re-identification researchers and data providers more than that between data providers and data holders.
Second, even as to re-identification researchers, it doesn’t follow from my rejection of these three arguments that re-identification demonstrations are necessarily unethical, even when conducted without participant consent. Exploring that question is the aim, in part, of my next post. What I tried to do in the first post was clear some brush and push back against the idea that under the PGP model — a model that I think we both would like to see expand — participants have given permission to be re-identified, “end of [ethical] story.” Continue reading