Category: Bioethics

Sex, People with Disabilities, Prostitution, and Universal Health Care: Reflections on “The Sessions”

I. Glenn Cohen Leave a comment

[Cross-Posted at PrawfsBlawg]

One of my favorite initiatives at Harvard Law School, where I teach, is that faculty members get to offer an optional 10-12 student not-for-credit “First-Year Reading Groups” on a topic of interest to them that is related to law in some way but not too law-class like. I’ve taught a reading group on bioethics and law through film that pairs films with papers/topics in bioethics (e.g., A.I. with readings on personhood, Minority Report and neuroscience and law and predicting criminality, Dirty Pretty Things and organ sale and exploitation, The Constant Gardener with clinical trials in the developing world, Eternal Sunshine for the Spotless Mind and therapeutic forgetting and “cosmetic neurology” and many others…)

Next year I will add The Sessions, a film I found very enjoyable starring John Hawkes, Helen Hunt, and William H. Macy from last year that I also found very bioethically interesting. The film is based on a true story and follows Mark O’Brien, a poet who lives in an Iron Lung due to complications from Polio. After unsuccessfully proposing to his caretaker, and believing the end of his life may be nearing, he decides he wants to lose his virginity. He hires Cheryl Cohen-Greene, a professional sex surrogate, who will offer him a maximum of six sessions but makes clear to him this is therapy not romance. I will stop there to avoid ruining the film, but on to the bioethics…

There are fairly clear issues raised about commodification, exploitation, the difference between sex therapy and prostitution, that I have written about in various forms in various places. These are certainly interesting issues but familiar enough. What the film newly prompted me to think about, though, is actually universal health care. In particular, as I have written about indirectly in a couple of papers, what would some of the most prominent theories explaining why we need universal health care say about whether the state should pay for sex therapy (or perhaps even prostitution) for people with disabilities like Mark who find themselves otherwise unable to have sex?

For example, in his wonderful book Just Health, my colleague Norman Daniels, coming from a more Rawlsian tradition (i.e., a liberal tradition focused on promoting liberty and distributive justice through giving priority to the worst-off), grounds the state’s role in promoting health in the obligation, as a matter of political justice, to ensure access to the “normal opportunity range” to pursue the “array of life plans reasonable persons are likely to develop for themselves.” Although Daniels’ focus is on health care, it seems to me that sexual satisfaction is also part of that normal opportunity range and part of a life plan most of us would like to pursue.

Similarly, Martha Nussbaum in her great book Frontiers of Justice, writing from a more aretaic (i.e., Aristotelian, focusing on character and virtue) perspective, has argued that the state’s role is to enable human flourishing by raising people above the threshold level on a number of “capabilities.” Among these she mentions “bodily integrity,” as including “having opportunities for sexual satisfaction and for choice in matters of reproduction.” I have previously discussed how this kind of approach may justify funding reproductive technologies, but it seems to me as though it also fairly directly establishes an argument for funding Mark’s attempts to lose his virginity.

Now this is meant to be provocative, of course. And for some this is no doubt a reductio ad absurdum against universal health care. Fair enough. But for those who believe there is a moral case for funding universal health care, does the argument also lead to funding these kinds of sex therapies? Health is important, of course, but let’s be frank (and my parents can stop reading at this point) so is sexual satisfaction, and both seem to me essential parts of the normal opportunity range and/or human flourishing.

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HIPAA and the Medical Records of Deceased Nursing Home Patients

Leslie Francis Leave a comment

By Leslie Francis

[this is a cross post from HealthLawProf]

Warning: some of this post is HIPAA-wonky. But read on: the punch line is that HIPAA does not protect the living or the dead from blanket release of medical records to their personal representatives—unless state law provides otherwise or patients have thought to specify in advance that they do not want anyone to see the record or parts of it and state law gives them this opportunity. This means that the default position is that personal representatives may see highly sensitive health information, including mental health records or sexual or reproductive histories: veritable skeletons in family medical closets.

In an important recent decision, the 11th Circuit has held that the federal Health Insurance Portability and Accountability Act (HIPAA) preempts a Florida statute that gave spouses and other enumerated parties the right to request the medical records of deceased nursing home residents. Opis Management Resources v. Secretary, Florida Agency for Health Care Administration, 2013 U.S. App. LEXIS 7194 (April 9, 2013). The nursing homes had refused to respond to requests for records made by spouses and attorneys-in-fact, arguing that these requesters were not “personal representatives” under Florida law. The requesters filed complaints with HHS’s Office for Civil Rights, which determined that the refusals were consistent with HIPAA. The Florida Agency for Health Care Administration issued citations against the homes for violating Florida law, and the homes went to court seeking a declaratory judgment that the Florida statute was preempted by HIPAA.

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Caplan on Cloning Human Embryos

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Art Caplan has a new column out spurred by the announcement that researchers at Oregon Health Sciences University have successfully cloned human embryos.  Recognizing the possible ethical concerns and calling for immediate bans on human reproductive cloning (not cloning for stem cell research), Caplan hopefully notes: “Through cloning you can take a disabled or sick person’s DNA from one of their body cells, insert it into a human egg from which the DNA has been removed, fuse the cell electrically (the technique used in Oregon) and create an embryo from which cells can be grown that are identical matches to what the sick or disabled person needs.”

Take a look at the full column here.

Tough Advice to Swallow from the NYT Ethicist

Holly Fernandez Lynch Leave a comment

Take a look at the answer this physician received about breaking his promise of confidentiality to a patient.  The New York Times’ Ethicist describes this as a modern problem, but it seems to me this is age-old.  And although the confession was not medical, the nature of the doctor-patient relationship and the historical trust it has cultivated can’t be ignored.  The Ethicist says he expects vehement disagreement, and that’s one thing he’s right about for sure.

Privacy and Progress and the Deidentification of Whole Genome Sequence Data

The Petrie-Flom Center Staff Leave a comment

[Posted on behalf of Elizabeth Pike and Kayte Spector-Bagdady from the Presidential Commission for the Study of Bioethical Issues – and cross-posted here.]

In the most recent issue of the Hastings Center Report, Drs. Amy Gutmann and James Wagner of the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission), contributed to the lively debate surrounding the identifiability of genetic data. In Found Your DNA on the Web: Reconciling Privacy and Progress, Gutmann and Wagner, Chair and Vice-chair respectively, argue that the paradigm of identifiability has become less relevant to individual privacy protections than restrictions on access and use.

In their commentary, Gutmann and Wagner continue the public deliberation of the Bioethics Commission’s report, Privacy and Progress in Whole Genome Sequencing, in which the Bioethics Commission took a forward-looking approach to the privacy concerns raised by whole genome sequencing—issues that have come to the forefront of this important science.

Under current law, health information that is deidentified—information for which there is “no reasonable basis” to believe it can identify an individual or that has been stripped of traditional identifiers—is afforded different legal protections than identifiable health information. However, whole genome sequence data are unique to only one person, making them more vulnerable to reidentification.

Recent articles have cast doubt on the extent to which whole genome sequence data can be deidentified. For example, in Identifying Personal Genomes by Surname Inference, published in Science in January, Melissa Gymrek, et. al. successfully uncovered full identities of 50 individuals.

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The Oregon Health Study and the Medicalization of Health Policy

dgoldberg Leave a comment

According to the website, the Oregon Health Study “is the first randomized controlled  experiment to examine the causal effects of having some type of insurance coverage versus having no insurance at all.”  The findings, released a few days ago, have unleashed a storm of commentary on what the investigators did and did not find in terms of links between coverage and health outcomes.  Writing  over at The Incidental Economist, Harold Pollack quotes Joseph Newhouse for the notion that the “Oregon Medicaid experiment ‘is a Rorschach test of people’s views on the ACA.’”  After the jump, I am going to try to defend that claim, although likely not in the way that good readers of Bill of Health might expect.

So here’s the funny thing: even though I am an attorney, an historian, and a bioethicist who researches health inequalities, stigma, and social justice, I actually am less of an expert on the delivery of health care services than virtually every blogger here, and likely a goodly portion of the readership, too.  When interviewing for a job as a prawf some years ago, I was asked for my opinion on the fate of the ACA (then still in Congress), and I had to shrug and say that I really was not up to date on all of the provisions of the bill nor of its likely passage, nor of its potential impact.  (No, I did not get the job!).

This is not because of anti-intellectualism, I believe (and hope!).  This is rather because of my engagement with the overwhelming evidence that access to health care services is simply not a prime determinant of health and its distribution in human populations.  In a seminal 2007 essay in Health Affairs, Paula Lantz, Richard Lichtenstein, and the good Dr. Pollack himself note that “Lack of access to health care is not the fundamental cause of health vulnerability or social disparities in health” (p. 1256).*  The authors go on to warn of the limits of medicalizing health policy, and suggest that if we want to use laws and policies to improve overall population health and compress health inequities, we need to go way beyond simply expanding access to basic health care services.

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Live Blogging from FDA in the 21st Century Conference, Panel 8: Food, Supplement, and Tobacco Regulation

I. Glenn Cohen Leave a comment

[Live blogging off-the-cuff, so apologies in advance for any errors in summarizing, typos, etc]

Moderated by Emily Broad Leib, Harvard Law School

Robin Craig, Leslie Francis, and Erika George, University of Utah The FDA’s Authority Over Labeling: Current Ironies and Future Improvements:

Goal is to look at FDA authority over safety and labeling of Genetically Modified (GM) foods argue that FDA should do more, and argue for human right to food approach.

By GM we mean rDNA modification not husbandry and not careful selection.

FDA has moved to use guidance and policy. In particular two are relevant here. First, in food additives there is GRAS – Generally Recognized as Safe. E.g., Cinnamon was treated as GRAS. Manufacturers can self-determine a product is GRAS without notifying FDA, or, if in doubt, request a GRAS notice letter from FDA. This was proposed in 1997 and final review never issued, but this is how they do it. Has increased frequency of GRAS review request from FDA. But the process is voluntary and relies entirely on info from producer not scientific separate work by FDA.

In 1992, FDA issued a policy document related to GM foods. Stated no scientific evidence that GM foods have more safety concerns than existing husbandry techniques, so GM technology is NOT material information. This was NOT a conclusion that GM foods were GRAS.

In 1996, FDA issued a guidance for GM foods. Consultation process to determine whether there are material differences between GM version and non, voluntary process, encouraged to get consumer trust. Like GRAS totally voluntary, totally reliant on FDA data. 95 reported consultations between 1996 and 2012.

Alliance for Biointegrity v. Shalala, challenged in 2000 in D.D.C., court deferred to agency on safety questions and whether the info on GM was “material” and therefore needs to be disclosed.

Where would FDA get authority to regulate GM foods? May pose allergy risks? May be relevant to nutrition or quality. Maybe an additive not GRAS. But each of these arguments apply to specific GM food not GM foods as a whole.

Their argument: Consumers have a right to know so they can make their own consumption risks, and consumer or religious views are not merely preferences but a ground for the information that is material to consumers.

On why this is best understood as Human Right to Food. Adequate right to food is an HR right framed after WWII about enough food that is not adulterated and not against your faith or ethics (kosher, halal, vegan) and respectful of environment. U.S. is not part to Socioeconomic rights convention, which is most explicit protection of this right, but are signatories to other treaties that protect the right more indirectly.

Whole Foods has moved ahead on this as have others. Even if not a worry as GRAS, consumption may be inappropriate. We need a national strategy. More of a precautionary take that understands material to matter to consumers.

Jennifer Pomeranz, Yale, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels:

Obesity and diabetes is the big problem in public health. And also people showing nutritional deficiencies because too much processed food. Current labeling is misleading makes people think food is healthier than they are. This is a unique public health problem. FDA has very weak authority and power here.

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Art Caplan on Plan B and Kermit Gosnell

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Art Caplan has a new Viewpoint article out in Time discussing Plan B’s impact on late trimester abortion:

Gosnell was a stop of last resort for woman late in their pregnancies. They sought an abortion past the point of fetal viability — a choice illegal in Pennsylvania and throughout the United States. For these women, Gosnell and his ilk are their only option.

But regardless of the outcome of Gosnell’s trial, the need for late trimester abortion is going to disappear. Even surgical abortion will be a thing of the past, as the abortion clinic slowly gives way to pharmaceutical abortion.

More and more women will be using cheap and readily available emergency contraception, not abortion. The FDA just announced that Plan B can be sold over-the-counter to buyers as young as 15. Other women will use mifepristone when they choose to end a pregnancy within the first seven weeks. They won’t be faced with the choice of a third trimester abortion because they will be able to easily access pharmaceutical options. The awful horror of Gosnell will disappear not as a result of legislation or protests or even trials but as a result of affordable pills that are easy to use.

Take a look here.

Sleep No More: Sleep Deprivation, Doctors, and Error or Is Sleep the Next Frontier for Public Health?

I. Glenn Cohen 1 Comment

[Cross-Posted at Prawfsblawg]

How often do you hear your students or friends or colleagues talk about operating on very little sleep for work or family reasons? In my case it is often, and depending on the setting it is sometimes stated as a complaint and sometimes as a brag (the latter especially among my friends who work for large law firms or consulting firms). To sleep 7-8 hours is becoming a “luxury” or perhaps in some eyes a waste – here I think of the adage “I will sleep when I am dead” expresses that those who need sleep are “missing out” or “wusses.” My impression, anecdotal to be sure, is that our sleep patterns are getting worse not better and that many of these bad habits (among lawyers) are learned during law school.

One profession that has dealt with these issues at the regulatory level is medicine. In July 2011, the Accreditation Council for Graduate Medical Education (ACGME) – the entity Responsible for the accreditation of post-MD medical training programs within the United States – implemented new rules that limit interns to 16 hours of work in a row, but continue to allow 2nd-year and higher resident physicians to work for up to 28 consecutive hours. In a new article with sleep medicine expert doctors Charles A. Czeisler and Christopher P. Landrigan that just came out in the Journal of Law, Medicine, and Ethics, we examine how to make these work hour rules actually work.

As we discuss in the introduction to the article

Over the past decade, a series of studies have found that physicians-in-training who work extended shifts (>16 hours) are at increased risk of experiencing motor vehicle crashes, needlestick injuries, and medical errors. In response to public concerns and a request from Congress, the Institute of Medicine (IOM) conducted an inquiry into the issue and concluded in 2009 that resident physicians should not work for more than 16 consecutive hours without sleep. They further recommended that the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission work with the Accreditation Council for Graduate Medical Education (ACGME) to ensure effective enforcement of new work hour standards. The IOM’s concerns with enforcement stem from well-documented non-compliance with the ACGME’s 2003 work hour rules, and the ACGME’s history of non-enforcement. In a nationwide cohort study, 84% of interns were found to violate the ACGME’s 2003 standards in the year following their introduction.

Whether the ACGME’s 2011 work hour limits went too far or did not go far enough has been hotly debated. In this article, we do not seek to re-open the debate about whether these standards get matters exactly right. Instead, we wish to address the issue of effective enforcement. That is, now that new work hour limits have been established, and given that the ACGME has been unable to enforce work hour limits effectively on its own, what is the best way to make sure the new limits are followed in order to reduce harm to residents, patients, and others due to sleep-deprived residents? We focus on three possible national approaches to the problem, one rooted in funding, one rooted in disclosure, and one rooted in tort law. I would love reactions to our proposals in the paper, but wanted to float the more general idea in this space.

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Why North Dakota’s Ban on Genetic Selection Matters (Online Abortion and Reproductive Technology Symposium)

I. Glenn Cohen 6 Comments

[Ed Note: Posted on behalf of Jaime King]

On March 26, 2013, North Dakota Governor, Jack Dalrymple, signed into law two of the nation’s most restrictive abortion bills. The first, HB 1456, prohibits providers from performing an abortion once a fetal heartbeat can be detected, which can be as early as six weeks gestation (Fetal Heartbeat Ban).  The second, HB 1305, prohibits providers from knowingly performing abortions sought solely because of the sex of the fetus or because the fetus has been diagnosed with a genetic abnormality or the potential for a genetic abnormality (Sex and Genetic Selection Ban).

Much of the press coverage and discussion of these unprecedented laws has focused on the Fetal Heartbeat Ban. This is largely because the prohibition eliminates nearly all access to abortion in the state and poses a direct challenge to a woman’s right to choose to have a pre-viability abortion free from undue state interference, as delineated in Planned Parenthood v. Casey.   Viability has typically been established around 24 weeks gestation, which is generally considered the end of the second trimester. The sweeping nature of this prohibition essentially negates the impact of a prohibition on sex or genetic selective abortions, as testing for those conditions, even with non-invasive prenatal testing techniques, cannot be performed reliably prior to nine or ten weeks gestation. By that point, the Fetal Heartbeat Ban would already prohibit any form of selective abortion.

But we should not ignore this law, as it is the more insidious of the two. As a direct threat to abortion access for all women, the Fetal Heartbeat Ban is very likely to be found unconstitutional, short of a complete overturning of Roe v. Wade. The Sex and Genetic Selection Ban, however, is subject to more debate. Since Roe, we have largely assumed that women can have an abortion for any reason prior to viability, but the courts have never directly addressed the issue.  Recent polls have found that over 3/4 of Americans would support bans on sex selective abortions,[1] and five states have already passed sex selection bans.[2]  The question of whether a woman’s reason matters is upon us.

Opening the door to permit states to invade and assess women’s private thoughts regarding her reasons for having an abortion strikes directly at the heart of the reproductive liberties protected by the Fourteenth Amendment. If states can regulate access to abortion based on a woman’s reasons for having it, they can significantly limit access in a piecemeal fashion – slowly and deliberately circling in on the right. Read More