“Brains on Trial”: Research on Groups & Concern for Individuals

By Matthew L Baum

What are the implications of advances in brain science for the justice system? This was the topic of a panel discussion held Tuesday at MIT’s McGovern Institute and moderated by Alan Alda in conjunction with the premier of his new PBS special, “Brains on Trial”. The  discussion ranged from using fMRI for lie-detection to using it to help determine the reliability of an eye-witness.

In general, the panel rightly pointed out practical limitations of these technologies. Panelist Nancy Kanwisher highlighted, for example, that research on lie-detection is done in a controlled, non-threatening environment from which we may be unable to generalize to criminal courts where the stakes are high.

While I was sympathetic to most of this discussion, I was puzzled by one point that the panel raised several times: the problematic nature of applying data based on a group of people to say something about an individual (e.g., this particular defendant). To present a simplified example: even if we could rigorously show a measurable difference in brain activity between a group of people who told a lie in the imager and a group of people who told the truth, we cannot conclude that an individual is lying if he shows an activity pattern similar to the liars. Since the justice system makes decisions on individuals, therefore, use of group data is problematic.

To me, this categorical objection to group data seems a bit odd, and this is why: I can’t see how group data is conceptually different from ordinary circumstantial evidence. Read More

Art Caplan: In Defense of GMOs

Bill of Health contributor Art Caplan has a new opinion piece in the Chronicle of Higher Education. In “Genetically Modified Food: Good, Bad, Ugly,” Caplan argues for the unrealized promise of GMOs:

[…] commercial farming of oranges and grapefruit is in dire peril from an insect-borne bacteria that causes a disease known as “citrus greening.” An uncontrollable fungal blight is destroying the banana crop around the world. Coffee rust is knocking out plants in Central and South America. Diseases like rice blast, soybean rust, stem rust in wheat, corn smut in maize, and late blight in potatoes destroy at least 125 million tons each year of the world’s top five foods. The damage done to rice, wheat, and maize alone costs global agriculture $60-billion per year. The effects are especially catastrophic in the developing world, where 1.4 billion people rely on these foods.

There is a way to get rid of such otherwise unstoppable plant diseases, which waste scarce resources, bring about malnutrition and starvation for hundreds of millions, and cost the world economy billions of dollars. Genetically modified organisms.

Specifically, engineering plants to resist the diseases. So why don’t the folks bearing the bad news about GMOs make a connection to the huge problems that could be fixed by genetic engineering? The answer is the bungling mismanagement of a potentially useful breakthrough technology by the GMO industry, alongside market forces that produce GMOs friendly to pesticides rather than hostile to fungi. [….]

Bad management thus turned a technology that should have been greeted as a way out of chemically based farming into a public-relations nightmare.

Read the full article here.

End the Ban on Blood Donation by Gay Men

By Dov Fox

86 members of the U.S. Congress have requested an end to the federal policy that prevents men who have had sex with men from giving blood. Advances in blood screening technology have discredited the medical justification for this exclusion. And our country’s current critical blood shortage makes it dangerous for public health.

The antidiscrimination objection is more complicated. The policy wasn’t born of illicit motivations and doesn’t seriously disadvantage gay men. That it doesn’t reflect bad intentions or effects, does not, however, vindicate the policy on equality grounds. The blanket exclusion, independent of individual risk levels, reflects a disparaging stereotype that gay men are sexually promiscuous or use illegal drugs, I argued in an op-ed last week. I have elsewhere called this objectionable social meaning the expressive dimension of donor deferral.

Secretary Sebelius should answer the congressional plea to end our exclusionary blood donation policy. In the meantime, those who already enjoy the opportunity to help save lives can serve the causes of public health and social equality by making an appointment to give today.

Rape and Abortion: Negating a Myth

Cross-post from bioethics.net.

Sabine Hildebrandt, MD
William Seidelman, MD
Arthur Caplan, PhD

A recurring assertion in the ongoing debate on abortion in the United States is the statement that pregnancy is an uncommon consequence of rape. Rep. Trent Franks, R-Ariz., has recently argued on the floor of the House of Representatives that an exception for rape wasn’t necessary in a proposed law banning abortions after 20 weeks because “the incidence of rape resulting in pregnancy are very low.”

Why do so many Americans believe this claim? Where does it come from?

Read More

Art Caplan: Anti-Smoking Advocates Have Misused Science

Art Caplan has a new piece at time.com discussing a recent study that examines the scientific evidence behind claims that smoking in public harms non-smokers–and finds it wanting:

[…] as a new paper by tobacco control proponents Ronald Bayer and Kathleen E. Bachynski of Columbia’s School of Public Health, in the respected journal Health Affairs shows, the left can play games with science too. And when it does, it needs to be called out for doing so since shaping science to fit moral goals, even laudable ones, weaken the trust and credibility of the most respected source we have for facts in public policy debates—science.

Read the full column.

Art Caplan: Ease US Blood Supply Shortage by Lifting Gay Donor Ban

Art Caplan has published an opinion piece at NBCNews.com calling for an end to the ban on blood donation by gay men in the United States:

The United States is facing a health care crisis.

Our supply of blood is dangerously low. The American Red Cross reports that across the nation blood donations were down an estimated 10 percent in June — about 50,000 fewer donations than in May.

In the face of a blood supply shortage that is bad and likely to get worse, there is a group of people — gay men — who might ease the situation, if only they were allowed to help.

Gay men who want to donate blood are forbidden because of an outdated, non-scientific regulation that bans anyone who has had sex “even once” with another man since 1977.

It is long past time to let those who want to help others by donating blood do so.

Read the full column.

OHRP Suspends Compliance Action Against SUPPORT Study Sites Pending Public Hearing & Guidance

By Michelle Meyer

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.

“Measuring the Un-measurable”

By Scott Burris

A couple weeks ago, I was in a conference room at a global health organization, all ready to give my talk on monitoring and evaluating legal health interventions. The chief of the organization’s formidable M&E operation was my host, and after briefly going through my bio he wound up his introduction by describing me as “the guy who will be telling us how to measure the un-measurable.”

Perfect.

In that one flourish, he captured the biggest barrier to more and better research on the impact of laws and legal practices on health: the cultural belief that law is different from other forms of individual and institutionalized human behavior and belief, so that it, alone, must perforce remain an evidence-free zone.  This is certainly a tragedy of low expectations if ever there was one.  Uncertainty is part of any hard decision, but if people in the organization I was visiting were talking about defining the optimum treatment regimen for a particular disease, they would take for granted that the deliberations of the decision-makers would be guided by a substantial evidence base. Yet when the question is what package of laws and legal practices create the best environment for preventing the same disease, or encouraging people to seek treatment, they see nothing strange about proceeding entirely on intuition and experience.

As Evan Anderson and I have recently written, the importance of law to health, and the overall success in properly evaluating its impact, belie this continued cultural prejudice. Law can be hard to evaluate, but so are most other influences on our behavior and environment.  In a number of areas of legal intervention, researchers have found ways to measure the hard-to-measure and produce credible findings that have shaped policy.  They have done so in ways that respect the prosaic realities of practical science work:  developing reliable measures and data and deploying them within robust designs is not the work of individuals, it’s not cheap, and it is not quick.  Where legal evaluation has thrived, it has done so because enough money was available for long enough to support multiple lines of inquiry by multiple teams of researchers. Careers, or stands of careers, could be built, and competition and disagreement could drive rigor and relevance.

This week, PHLR is celebrating one very tangible result of investment in the field: the publication of Public Health Law Research: Theory and Methods, which was conceived by the PHLR Methods Core and edited by Alex Wagenaar and me.  The book, which was written both as a methods class text book and a general reference work, is an important piece of field-building, in that it tries to define the basic good practices of PHLR.  But I think it does more: Alex, whose work on crash law exemplifies all that legal monitoring and evaluation can be, has led the production of a book that we can drop on the desk of every person in every funding and health services organization who thinks that measuring law is measuring the un-measurable.

Maryland v. King, Low-Stringency DNA Database Searches, and the Case for a Universal Database

By Michelle Meyer 

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).

Read More

Science, Art, Policy, and the Importance of Good Science Communication

By Michelle Meyer 

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.