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Gay men who want to donate blood are forbidden because of an outdated, non-scientific regulation that bans anyone who has had sex “even once” with another man since 1977.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

GM Crops and the Environment

By Joanna Sax

I’ve become increasingly interested in GM crops, in general, after the recent Petrie-Flom Conference on the FDA in the 21st Century.

I know there is a lot of discussion and controversy about genetically-modified (GM) crops.  I want to pick-up on a topic that is related to GM crops – that is, the environment.  The May 2nd issue of Nature includes a special section on GM crops.  Part of this section provides information on the environmental advantages of GM crops.  Most of the GM crops contain DNA that allows them to be resistant to herbicides or insects.  It turns out that a study showed that there was a 6.1% reduction in the use of herbicide between 1996 and 2011 on crops of herbicide-resistant cotton compared to the amount of herbicide that would have been used to treat conventional crops.  See Natasha Gilbert, A Hard Look at GM Crops, 497 Nature 24, 25 (2012) (I believe this article is free if you search for it on the Nature website).  A reduction in the amount of herbicide used to treat our fabric or food sources may have environmental advantages.  Less herbicide run-off into waterways.  Less herbicide for animals to consume.  See id.

Other scientific data provide inconclusive results about environmental impacts.  Some studies look at whether transgenes are spreading to weeds or non-GM crops.  For example, husbandry techniques of cross-breeding may unknowingly cross breed a non-transgenic line with a transgenic line and thereby create a transgenic line.  Now, a GM crop will be grown without the farmer even knowing it.  See id. at 24, 26.  And, if the GM crop has some sort of negative environmental impact, then a farmer may unwittingly be creating potential harm to the environment.

One thing I want to raise with this post is the importance to incorporate multiple areas of study – biology, environmental studies, genetics, health, regulation, etc. – to determine how we advance our understanding of GM crops.  I imagine that many readers of this blog are much more familiar with GM crops than me, so I welcome your comments.

Hair, Stress, and the Law

A new study has found a relationship between cortisol levels in our hair and prevalence of metabolic syndrome (a cluster of abnormalities that increase the likelihood of developing diabetes and heart disease). Here’s how the New York Times describes the study:

High levels of cortisol — the so-called stress hormone — have been associated with cardiovascular disease in some studies, but not in others. This may be because measuring cortisol in blood or saliva at one point in time may pick up acute stress, but it fails to account for long-term stress. . . . Now Dutch researchers have assessed cortisol levels over several months by analyzing scalp hair samples. . . . The researchers measured the cortisol content in hair samples corresponding to roughly three months of growth from 283 older men and women, average age 75. They also gathered self-reported data about coronary heart disease, stroke, peripheral artery disease, Type 2 diabetes, lung disease, cancer and osteoporosis. . . . Compared with those in the lowest quarter for cortisol, those in the highest quarter had about three times the risk for cardiovascular disease and diabetes.

In the actual paper, the researchers say little or nothing about “stress,” and if I recall correctly, the relationship between cortisol and stress can be complicated. But the research raises the possibility that we will someday identify reliable measurements of chronic stress over time. Of course, we may need more than just your hair. But in what I call the experiential future, such evidence—combined perhaps with other physiological, neurological, and psychiatric data—may enable us to make better assessments of chronic stress levels than we can now.

Better measurements of chronic stress could transform the way we measure damages in tort cases and measure punishment severity in criminal cases. Billions of dollars change hands every year based on difficult-to-verify assertions about pain and stress. Similarly, we adjust the severity of incarceration by changing the duration of sentences and pay almost no attention to the very different ways in which prisoners experience confinement. Measurements of stress levels could also help determine when an interrogation tactic constitutes torture.

Of course, forensic techniques encourage people to use countermeasures. In the cortisol-hair study, for example, one measurement was apparently affected by rates of shampooing while another was not. So I’m not suggesting there will be a silver bullet that solves all measurement problems. When evaluating the scientific research, however, it is important to remember just how bad we are at measuring stress levels now, despite the fact that we make such assessments every day. The technology need hardly be perfect to represent an improvement.

Talking to Your Baby

By Joanna Sax

In President Obama’s State of the Union address, he discussed creating affordable pre-school to all children.  Studies have shown that early childhood education is associated with academic success.  This is an important policy initiative; it’s also very expensive.

In an effort to reduce the disparity in the academic profiles of children, there may be some initiatives that can be started while the proposal for publicly funded early childhood education works its way through Congress.  One approach that is being tested is talking to your baby.

recent NY Times article described a scientific study concerning how talking to your baby is correlated with achievements in school.  It turns out, according to the article, that low-income parents of children speak fewer words to their babies compared to high-income parents and that by the time the children are of school-age, the children from poorer families have heard millions of fewer words.  This means that by the time the child is 3, they have heard 10s of millions of fewer words and the article suggests that this is correlated with IQ and academic success.

This is an issue that can be addressed!  Creative problem solving can be used to create programs to educate lower-income parents to talk more to their babies.  The increase in words alone might provide advantages to lower-income children that they didn’t have before.  This study provides a good example of the application of a scientific study to address social, health and economic issues.