Month: May 2013

ACA Final Rule on Wellness Plans

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By Leslie Francis

On May 29th, HHS issued the final rule governing wellness incentives in group health plans. While the incentives themselves are not a surprise, the scope they are given is worthy of ongoing attention. Wellness incentives have been controversial because of their potential for intrusion into individual choice, their subtle (or not so subtle) coerciveness, their valorization of a particularly model of health, and the possibility that they will impose differential burdens and costs on people with disabilities or other disfavored groups. The final rule attempts to meet these objections in several helpful ways.

Nonetheless, the final rule still will allow programs that are differentially burdensome as a result of factors other than health status. It will also allow programs under which it is more difficult for some than for others to obtain rewards because of their states of health. In programs that give rewards for health outcomes, alternatives must be available for those who do not meet targets—but the reasonableness standard for these alternatives permits requirements that may be differentially burdensome so if they are medically appropriate and follow the recommendations of the patient’s personal physician. HHS supports wellness programs as engaging individuals in their health, as encouraging them in healthy behaviors and discouraging them in unhealthy behaviors, and as incentivizing people to make use of recommended health care services such as screenings. Read More

Unapproved GMO wheat found in Oregon; Japan cancels US wheat imports.

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By Nicholson Price

One fear about GMOs is that they will escape whatever controls are placed them and end up in the wild.  A version of that story appears to have come true in the wheat industry this week, when the USDA announced that farmers in Oregon had discovered an unexpected and unapproved patch of Roundup-Ready genetically modified wheat in a conventional wheat field.  Monsanto developed Roundup-Ready wheat (which is not resistant to its Roundup herbicide) and tested it between 1998 and 2005, but it was never approved for sale and was discontinued.  Japan has cancelled or suspended orders of wheat from the Pacific Northwest in response.

h/t to Grubstreet; see also recent posts on GMOs and the environment and on Monsanto’s patent protection of GMOs.

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

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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.

Introducing Guest Blogger William MacAskill

The Petrie-Flom Center Staff Leave a comment

William MacAskill is the Founder and President of 80,000 Hours, an advisory service for careers that make a difference. He is also the cofounder and Vice-President of Giving What We Can, a DPhil student in moral philosophy at Oxford University, a contributor to Quartz and The Atlantic, and has recently returned from Princeton on a Fulbright scholarship.

Publications:

“Replaceability, Career Choice, and Making a Difference,” Ethical Theory and Moral Practice. Forthcoming.

“The Infectiousness of Nihilism,” Ethics. Forthcoming.

“To save the world, don’t get a job at a charity; go work on Wall St,” Quartz (February 27, 2013).

“The best advice you’ll never hear in a graduation speech,” Quartz (April 18, 2013).

Peter Singer, Ira W. DeCamp Professor of Bioethics at Princeton University, recently discussed Will’s work in his TED Talk, “The Why and How of Effective Altruism.”

Public Policy Considerations for Recent Re-Identification Demonstration Attacks on Genomic Data Sets: Part 1 (Re-Identification Symposium)

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By Michelle Meyer

This post is part of Bill of Health‘s symposium on the Law, Ethics, and Science and Re-Identification Demonstrations. We’ll have more contributions throughout the week. Background on the symposium is here. You can call up all of the symposium contributions by clicking here. —MM

Daniel C. Barth-Jones, M.P.H., Ph.D., is a HIV and Infectious Disease Epidemiologist.  His work in the area of statistical disclosure control and implementation under the HIPAA Privacy Rule provisions for de-identification is focused on the importance of properly balancing competing goals of protecting patient privacy and preserving the accuracy of scientific research and statistical analyses conducted with de-identified data. You can follow him on Twitter at @dbarthjones.

Re-identification Rain-makers

The media’s “re-identification rain-makers” have been hard at work in 2013 ceremoniously drumming up the latest anxiety-inducing media storms. In January, a new re-identification attack providing “surname inferences” from genomic data was unveiled and the popular press and bloggers thundered, rattled and raged with headlines ranging from the more staid and trusted voices of major newspapers (like the Wall Street Journal’s: “A Little Digging Unmasks DNA Donor Names. Experts Identify People by Matching Y-Chromosome Markers to Genealogy Sites, Obits; Researchers’ Privacy Promises ‘Empty’”) to near “the-sky-is-falling” hysteria in the blogosphere where headlines screamed: “Your Biggest Genetic Secrets Can Now Be Hacked, Stolen, and Used for Target Marketing” and “DNA hack could make medical privacy impossible”. (Now, we all know that editors will sometimes write sensational headlines in order to draw in readers, but I have to just say “Please, Editors… Take a deep breath and maybe a Xanax”.)

The more complicated reality is that, while this recent re-identification demonstration provided some important warning signals for future potential health privacy concerns, it was not likely to have been implemented by anyone other than an academic re-identification scientist; nor would it have been nearly so successful if it had not carefully selected targets who were particularly susceptible for re-identification.

As I’ve written elsewhere, from a public policy standpoint, it is essential that the re-identification scientists and the media accurately communicate re-identification risk research; because public opinion should, and does, play an important role in setting priorities for policy-makers. There is no “free lunch”. Considerable costs come with incorrectly evaluating the true risks of re-identification, because de-identification practice importantly impacts the scientific accuracy and quality of the healthcare decisions made based on research using de-identified data. Properly balancing disclosure risks and statistical accuracy is crucial because some popular de-identification methods can unnecessarily, and often undetectably, degrade the accuracy of de-identified data for multivariate statistical analyses. Poorly conducted de-identification may fail to protect privacy, and the overuse of de-identification methods in cases where they do not produce meaningful privacy protections can quickly lead to undetected and life threatening distortions in research and produce damaging health policy decisions.

So, what is the realistic magnitude of re-identification risk posed by the “Y-STR” surname inference re-identification attack methods developed by Yaniv Erlich’s lab? Should *everyone* really be fearful that this “DNA Hack” has now made their “medical privacy impossible”? Read More

An Open Letter From a Genomic Altruist to a Genomic Extrovert (Re-Identification Symposium)

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By Michelle Meyer

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

Dear Misha:

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:

  1. Participants who are warned by data holders of the risk of re-identification thereby consent to be re-identified by third parties.
  2. 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.
  3. 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.” Read More

Too Young for Sex, But Old Enough for the Sex Offender Registry, Part II

Michele Goodwin 1 Comment

By Michele Goodwin

This post is the second in a three part series on the use of criminal law to police teen sex.  The first part can be viewed here.

In recent years, thousands of judicial proceedings against children result in teens as young as thirteen being adjudicated as sexual predators and placed on sex offender registries.  The problem in the United States is that statutory rape laws create per se rule violations with respect to all sexual intercourse involving children.  My research reveals that children as young as 11 have been prosecuted as both the victim and sex offender.  In some states, even sexual touching involving consenting minors breaks the law. In other words, sex with a person under the age of majority or age of consent (depending on the specific state legislation) is always crime.  In a recently published Wisconsin Law Review article found here, I argue that such prosecutions can and often do lead to absurd results.

In Utah, which serves as a relative example, a child who commits “more than five ‘separate acts’ of sexual touching,” even without sexual penetration, could be convicted for “aggravated sexual abuse of a child.” In South Dakota, a minor can be adjudicated a delinquent and guilty of first-degree rape for one act of sexual penetration, regardless of consent if the consenting party is under thirteen.. Wisconsin’s statutory rape law reads similarly. These matters are particularly thorny in their application against children because legally a child cannot consent to sexual intercourse. In some states, including Utah, adolescent fondling constitutes sexual abuse of a child just as attempts to touch the buttocks, breasts, or “intent to arouse or gratify the sexual desire.” Even consenting children will always be deemed “victims” in states that take this approach.

According to the CDC, nearly 50% of high school teenagers have had sexual intercourse.  In fact, by the 9th grade over 30% of girls and nearly 40% of boys have had sex.  In conservative states like Mississippi and South Carolina, pre-teen boys report the highest rates of pre-teen sex (19.1% and 17.1%, respectively).   Along with reporting sexual activity, white teens report the highest rates of combining sex with alcohol.

CDC studies expose the gaps in how parents view and understand youth sexuality. An American Broadcasting Company (ABC) News survey investigating parental and teens attitudes on sex places has some startling findings.  Consider this: while nearly ninety percent of parents surveyed confirmed that they spoke with their teens about sex, only forty nine percent of teens believed such conversations took place.

However, adolescent sexual activity raises questions for the law.  Should teens be prosecuted for committing the crime of rape if they engage in consensual sexual intercourse with children of their own or near age?  Is it ethical to prosecute children similarly to adults for having sex with other children?  More to come in Part III.

 

 

Worth Reading This Week

Nicolas P. Terry Leave a comment

By Nicolas Terry

More on Liability for Failure to Vaccinate

acaplan

As of Friday, June 28, this post is closed to further comments. We want to thank the many readers who have engaged in a vigorous and civil discussion on the recent posts to the Bill of Health that engage questions related to the debate over vaccines. In general, we do not moderate discussions on the site. However, due to an increasing number of comments that violate our policies regarding abusive and defamatory language and the sharing of personal information, we are closing these posts to comment.

Art Caplan discusses his recent Bill of Health post over at WBUR’s Here and Now.  Take a listen.

Monsanto v. Bowman: Patents on GMO Seeds

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By Nicholson Price

Monsanto has been receiving quite a bit of press recently.  Marchers in over 400 cities protested the company and the GMOs it makes took place a few days ago, arguing that foods should be labeled if they contain GMOs.

More broadly relevant to the biotech industry and GMOs generally, a few weeks ago, the Supreme Court released its 9-0 opinion in Bowman v. Monsanto, No. 11-796.  This case shores up the patent-law foundation for the GMO seed business (as was widely expected), but also takes an interesting turn involving intent and self-replicating technology in general. Read More