Sex Selection or Gender Selection? Queering the Ratio Question

I am at a fantastic event at Yale I co-organized on Intersections in Reproduction: Perspectives on Abortion, Assisted Reproductive Technologies, and Judicial Review with some amazing scholars present and excellent papers being presented. Like many people who have thought about sex selection, I would have imagined I have thought through most of the issues from most perspectives. What I love about these gatherings is that they always prove me wrong.

Today two very interesting questions were raised about a common argument raised about sex selection, the risk that it will result in unbalanced sex ratios. Our discussion, I would say, “queered” the typical claim in two interesting ways, and I am curious what others think (to be clear these were my thoughts on questions raised, not putting words in their mouths).

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Is Finding Malaysia Airlines Flight MH370 Worth 52,192 years of children’s lives?

[Note: This post is meant to be provocative and press a public policy question in the most thought-provoking way possible. Losing a loved one is among the most heart-wrenching experiences in a life time and my heart goes out to all those with loved ones on the flight waiting for answers. But one of the major points of this post is to highlight our tendency to spend more on identified lives not statistical ones for just these kinds of reasons and ask if it is justified.]

The search for Malaysia Airlines Flight MH370 is likely run to “Hundreds of Millions of Dollars” according to the most recent estimate from ABC News. This is based on extrapolation of the difficulties involved and the experience of searching for Air France 447 which cost 50 million USD. Let’s take a conservative estimate of 100 million USD to find the plane, probably on the low end. Let us put aside the possibility that even with that expenditure the plane will never be found, again an assumption that counts against the argument I will be making. This is 100 million dollars spent, roughly speaking, on “helping.” It is very unlikely that there are any survivors, so I don’t think this can reasonably be thought of as “life-saving” (I will assume it is not, but if it were  that wouldn’t make that much of a difference in the argument I will offer though it will require confronting the question of Should the Numbers Count for life saving?).

Instead the money is being spent (1) to satisfy the somewhat diffuse curiosity/grief of those who have watched this in the media, (2) to give answers to the very deep need for closure of the loved ones of those flying on these planes, and (3) to learn about what went wrong and potentially determine whether there is a systemic problem with these planes that might affect other planes.

All of those are worthy goals. But are they worth 100 million USD? In the category of “helping” or “life-saving” what else could we do with the money? Let me draw on one estimate mentioned by Ezra Klein in the WaPo and Don Taylor at the Incidental Economist from a paper by Tammy Tengs “Five Hundred Life Saving Interventions and Their Cost Effectiveness

I chose the cheapest intervention, influenza vaccines for children age 5+ which is estimated to cost $1,300/life year saved in 1993 dollars. I then updated that to 2013 dollars with a conversion calculator to generate a cost of 1915.89 USD per life year saved (it may also be that this intervention is now cheaper than it was at the time of Teng’s paper). I then divided 100 million dollars by that number to get my 52,192 life years saved for children estimate. That is fairly back of the envelope and there are lots of tweaks you would do to get a more exact figure, but it is close enough to make the point: Why are we spending so much on Malaysia Airlines search when we could be saving so many lives?

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NEJM Editorial on Murthy for Surgeon General (with some further editorial comments by me)

Our friends at the New England Journal of Medicine have a great editorial chastising Congress and the White House for potentially bowing to the NRA’s pressure not to confirm Vivek Murthy for Surgeon General. The whole thing is worth a read but here are a couple of key paragraphs.

This is the first time that the NRA has flexed its political muscle over the appointment of a surgeon general. The NRA has taken this action even though the surgeon general has no authority over firearm regulation and even though Murthy made it clear in his testimony before the Senate HELP Committee that if he is confirmed, his principal focus will be on the important national problem of obesity prevention, not firearm policy. Still, 10 Senate Democrats are apparently prepared to vote against Murthy’s confirmation because of his personal views on firearms — a demonstration of just how much political power our legislators have ceded to the NRA.

The critical question is this: Should a special-interest organization like the NRA have veto power over the appointment of the nation’s top doctor? The very idea is unacceptable.

Despite the continuing American tragedy of mass shootings — Newtown, Aurora, Fort Hood, Virginia Tech — the NRA has redoubled its efforts to prevent enactment of stricter firearm regulations. Lawmakers who run afoul of the NRA face political retribution. By obstructing the President’s nomination of Vivek Murthy as surgeon general, the NRA is taking its single-issue political blackmail to a new level. With the record of past surgeons general as their guide, senators should do what is right for the health of our country by confronting the NRA and voting their own conscience. Dr. Murthy is an accomplished physician, policymaker, leader, and entrepreneur. He deserves the President’s continued backing and should be confirmed.

I think this is very well said and largely sympathetic. The one point on which I will slightly veer off course (disagree with is too strong) from NEJM has to do with the connection between gun safety and health. I do think it is legitimate to view gun safety and firearm deaths as a HEALTH issue, even if not particularly a HEALTH CARE issue. It is a staple part of public health regulatory studies, along with drugs, alcohol, obesity, and tobacco. While we have the CDC as a kind of public health federal executive power, as its name suggests communicable and non-communicable disease has always been its focus. I think it would be great if we understand the “top doc” of the United States’ role as being about HEALTH and not just HEALTH CARE, so I would not (and to be clear I don’t think NEJM has) draw too strong a line between these two in an attempt to salvage this nomination. Doctors (not exclusively of other actors in the system, of course) should view themselves as agents of HEALTH not just HEALTH CARE, and I would hate for Murthy or other doctors’ efforts in the broader sphere to be dismissed as “frolicks” or “extracurricular.”

 

Inaugural Issue of the new Journal of Law and the Biosciences Now Online (Free Access)

I am very pleased to announce the the first-ever issue of The Journal of Law and the Biosciences is now online. I serve as one of three Editors In Chief (along with Nita Farahany and Hank Greely). The journal is a co-production of Harvard, Duke, and Stanford Law schools and Oxford University Press and is the first peer-reviewed journal of its kind.

Here is the table of contents for the first issue:

Edward S. Dove, Bartha M. Knoppers, and Ma’n H. Zawati, Towards an ethics safe harbor for global biomedical research, J Law Biosci (March 2014) 1 (1): 3-51 doi:10.1093/jlb/lst002

Rebecca Dresser, Public preferences and the challenge to genetic research policy, J Law Biosci (March 2014) 1 (1): 52-67 doi:10.1093/jlb/lst001

Hannah Maslen, Thomas Douglas, Roi Cohen Kadosh, Neil Levy, and Julian Savulescu, The regulation of cognitive enhancement devices: extending the medical model, J Law Biosci (March 2014) 1 (1): 68-93 doi:10.1093/jlb/lst003

Timothy Caulfield, Sarah Burningham, Yann Joly, Zubin Master, Mahsa Shabani, Pascal Borry, Allan Becker, Michael Burgess, Kathryn Calder, Christine Critchley, Kelly Edwards, Stephanie M. Fullerton, Herbert Gottweis, Robyn Hyde-Lay, Judy Illes, Rosario Isasi, Kazuto Kato, Jane Kaye, Bartha Knoppers, John Lynch, Amy McGuire, Eric Meslin, Dianne Nicol, Kieran O’Doherty, Ubaka Ogbogu, Margaret Otlowski, Daryl Pullman, Nola Ries, Chris Scott, Malcolm Sears, Helen Wallace, and Ma’n H. Zawati, A review of the key issues associated with the commercialization of biobanks, J Law Biosci (March 2014) 1 (1): 94-110 doi:10.1093/jlb/lst004

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Peter Orszag on Medical Malpractice Reform that Works

Peter Orszag has a nice piece on the future of medical malpractice reform. In it he gives a big shout-out to former Petrie-Flom fellow (now Cornell Law Prof) Mike Frakes and discusses papers Mike worked on while at the Center. Hopefully policymakers are listening. From Orszag’s piece:

Capping damages for medical malpractice can do little to solve this problem, but changing the standard against which doctors are evaluated would. In particular, doctors should have a safe harbor from malpractice suits if they follow evidence-based protocols published by a professional medical association. The Center for American Progress and others have proposed exactly this type of approach, and have also provided details about how it could work.

Professor Michael Frakes of Cornell Law School has done pathbreaking research on the benefits of moving away from customary-practice rules. In a new analysis, Frakes and Anupam Jena, a professor of health-care policy at Harvard Medical School, examine how malpractice laws affect mortality rates, avoidable hospitalizations, adverse events to mothers during childbirth and other measures of health-care quality. They then assess two types of reforms: changes to damages caps and changes to the local customary-practice standard.

FDA, Mitochondrial Manipulation, Three Parent Children, and the NY Times

In yesterday’s NY Times Op-Ed page Marcy Darnovsky writes about FDA’s consideration of mitochondrial manipulation therapies later this week. As she describes it:

The F.D.A. calls them mitochondrial manipulation technologies. The procedures involve removing the nuclear material either from the egg or embryo of a woman with inheritable mitochondrial disease and inserting it into a healthy egg or embryo of a donor whose own nuclear material has been discarded. Any offspring would carry genetic material from three people — the nuclear DNA of the mother and father, and the mitochondrial DNA of the donor. 

As she writes in her opinion:

Some media accounts about these techniques have misleadingly referred to “saving lives,” as if they were aimed at people who are sick and suffering. Others have failed to note how very few women would be candidates for even considering them. And they could turn to safer and simpler alternatives. An affected woman could adopt or use in vitro fertilization with another woman’s eggs. Of course, the resulting child would not be genetically related to her, but neither would the child be put at grave risk by an extreme procedure.

The F.D.A. advisory panel says that its meeting will consider only scientific aspects of mitochondrial manipulation and that any “ethical and social policy issues” are outside its scope. But those are precisely the issues that we must address. Simply being able to do something doesn’t mean we should do it.

That conclusion is a bit pat, though I don’t fault her too much given how tight op-ed word limits are, and maybe a tad reactionary. I do think she raises an interesting point about how this is not saving lives, though I think so for different reasons.

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Public Lecture at Radcliffe Institute “The Ethicist’s and The Lawyer’s New Clothes: The Law and the Ethics of Smart Clothes” now Available on Youtube

As part of a public lecture series at the Radcliffe Institute on “Smart Clothes” I delivered a public lecture entitled “The Ethicist’s and the Lawyer’s New Clothes: The Law and Ethics of Smart Clothes.” The lecture is now available for viewing on youtube. As the promotional materials described the lecture: “From enhanced exosuits for members of the armed services to clothing that spies on you, I. Glenn Cohen focuses on legal and ethical issues pertaining to the future of smart clothes.” While CNN coverage of the lecture focused on the surveillance aspects of these clothes, I think the discussion of exosuits and enhancements may be more interesting to BOH readers.

International Aid, Public Health, and Corruption

My wonderful HLS colleague Matthew Stephenson has just launched the Global Anticorruption Blog (GAB). As it happens, his first two posts may be of interest to BOH readers, especially those  may be of interest to readers interested in international aid for public health projects, of the sort supported by the Gates Foundation.  The first post argues that the extent of corruption in these projects is much larger than the Gates Foundation and others acknowledge.  The second post contends that one reason for lowballing of corruption estimates is political: these projects depend substantially on public funding, and political support for health aid may be undercut by candid assessments of the extent of the corruption and fraud problems. Both the posts and the blog are well worth a read.

DC Circuit Upholds FDA Authority Over Stem Cells

Earlier this week, the D.C. Circuit upheld the FDA’s authority to regulate stem cells (for a good news report see here). The company in question, Regenerative Sciences, had received a warning letter from FDA, which the company challenged claiming that its use of stem cells as therapy was not prohibited by existing federal law and that the FDA lacked authority to regulate it. They lost before the district court and appealed to the D.C. Circuit.

In a unanimous decision (by judge Griffith for himself, Judge Srinivasan and Edwards) the D.C. Circuit affirmed this decision. Here are some key passages: Continue reading

Sleep versus Training: The NY Times on Surgical Work Hours

Pauline Chen at the NY Times Blog has an article on cut backs on the number of hours of training for young surgeons.

According to her story:

“For the past decade, in response to increasing pressure from politicians, unions and sleep experts, the Accreditation Council for Graduate Medical Education, the organization responsible for accrediting American medical and surgical training programs, has been working to cap the hours that residents work. In 2011 the council passed the strictest limits yet. To maintain their accreditation, residency training programs had to abide by a 22-page set of scheduling rules that limited all in-hospital work including any elective “moonlighting” jobs to 80 hours per week, mandated the number of hours “free of duty” after different “duty periods” (eight hours off after 16-hour duty periods and 14 hours off after 24-hour duty periods) and even specified the timing of “strategic napping” in no uncertain terms (after 16 hours of continuous duty and between the hours of 10 p.m. and 8 a.m.).

While most residency programs chafed under the exhaustively detailed regulations, surgical training programs had particular difficulty adopting the new mandates. For nearly a century, surgical residency had been a period of both intensive experience and increasing responsibility under the guidance of more experienced surgeons. More recent research has affirmed that approach, demonstrating the strong link between a surgeon’s operative skill, the number of operations performed and patient outcomes. With limits set on their time at the hospital, young surgeons-in-training had fewer opportunities to care for patients or scrub in on operations. While previous generations of trainees had the luxury of participating in at least one operation a day, new trainees had only enough time to be involved in two or maybe three operations each week.

Calculating the number of hours “lost” by cutting back on in-hospital time, surgical leaders estimated that young surgeons-to-be were now missing out on as much as a year’s worth of experience”

She relies heavily on an new Annals of Surgery Article, wherein, as Chen reports,

“Researchers sent questionnaires to the directors of subspecialty fellowship training programs and asked them to comment on the bedside and operating skills of the young surgeons enrolling in their programs. These fellowships are a kind of high-level and often prestigious surgical “gap year” where young surgeons who have completed the basic five-year surgery residency can delay independent practice to pursue an additional year or two of training.

The results were abysmal. Fewer than half of the young surgeons could operate or make clinical decisions on their own. Nearly a third of them were incapable of performing even the most basic operations like a gallbladder removal on their own. And a quarter were unable to recognize the early signs of complications.

Even in areas of surgery where the young surgeons had had supplementary online learning modules during their residency, they performed poorly, with more than half unable to perform basic maneuvers.”

While acknowledging that “some observers have criticized the study for being self-serving – most respondents also noted that the young surgeons’ deficiencies resolved after additional training under their auspices —” Chen’s article reads largely as an attack on these new residency work hour rules.

Since I have written on the subject of these residency work hour rules with sleep specialists earlier this year in the Journal of Law, Medicine, and Ethics, it may be unsurprising that I take a somewhat different view.

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House and Senate Pass Bill Allowing HIV+ People to Donate Organs

In a week where most of the health law news has been, shall we say, less than hopeful for those of us who like the idea of robust health insurance expansion, as the Washington Blade reports there was one bright spot for progressive health policy: The House and Senate passed the HOPE (HIV Organ Policy Equity Act) which, if signed by the president, will authorize the HHS Secretary and OPTN to investigate and (if the research supports it) allow HIV+ individuals to donate organs to HIV+ individuals. You can read the full text here. The most relevant paragraph is

Clarification

In adopting and using standards of quality under paragraph (2)(E), the Organ Procurement and Transplantation Network may adopt and use such standards with respect to organs infected with human immunodeficiency virus (in this paragraph referred to as HIV), provided that any such standards ensure that organs infected with HIV may be transplanted only into individuals who—(A) are infected with HIV before receiving such organ; and(B) (i)are participating in clinical research approved by an institutional review board under the criteria, standards, and regulations described in subsections (a) and (b) of section 377E; or (ii) if the Secretary has determined under section 377E(c) that participation in such clinical research, as a requirement for such transplants, is no longer warranted, are receiving a transplant under the standards and regulations under section 377E(c).

A few quick reactions: (1) What fascinating co-sponsors across the aisle: Sens. Barbara Boxer (D-Calif.) along with Tammy Baldwin (D-Wis.), Tom Coburn (R-Okla.) and Rand Paul (R-Ky.) as original co-sponsors. In the House, Reps. Lois Capps (D-Calif.) was lead sponsor and Andy Harris (R-Md.) was an original co-sponsor. (2) This is a good step forward, but one wonders whether limiting the potential recipients to HIV+ folks is itself wise. I can easily imagine cirucmstances where an individual who faces death would prefer an HIV+ organ even if it will carry with it a significant chance of HIV infection. Perhaps I don’t know enough about the immunology here and there is something I am missing (and commentators please help educate me and other readers). One might indeed wonder if, in some weird way, the bill now creates a disability discrimination (I say that because the Supreme Court has in its jurisprudence treated HIV as capable of causing a major life impairment under the Americans with Disabilities Act) in favor of those with HIV, because only they are potentially eligible for a certain pool of organs that may become available. That’s probably not actionable (as I understand it the ADA does not protect non-disabled people from discrimination in favor of the disabled), but it is at least quite curious. (3) Is this a portent of things to come from the administration? Relaxation of the much-reviled ban on gay men donating blood? Or will this “win” for the community (and to be clear the HIV+ community and the gay community are by no means isomorphic) going to sop some of the pressure on the blood ban?

If You Could Take a Pill to Greatly Reduce Your Chance of HIV Infection, Would You?

I have been a bit slow on blogging recently due to moving to a new house at the start of a semester (remind me why I thought *that* would be an OK idea again?) but I did want to share this very interesting piece from the New Yorker by Christopher Glazek “Why Is No One On the First Treatment To Prevent H.I.V.?

At Petrie-Flom we held a great panel discussion right when this PrEP (pre-exposure prohylaxis) treatment (and the OraQuick home HIV test) came out, and you can watch it here. (The event featured  Robert Greenwald, Director of the Center for Health Law and Policy Innovation; Douglas A. Michels, President and CEO, OraSure Technologies, Inc; David Piontkowsky, Senior Director for Medical Affairs, HIV and HIV Global Medical Director, Gilead Sciences, Inc; Kenneth H. Mayer, Medical Research Director, Co-Chair of The Fenway Institute; Kevin Cranston, Director, Bureau of Infectious Disease, Massachusetts Department of Public Health; Mark Barnes, Partner, Ropes Gray, Lecturer in Law, Harvard Law School.)

As the New Yorker Article describes (and full disclosure, I sat on an IRB that oversaw a good chunk of this research at Fenway Health at one point in my career, so I am not a disinterested observe)  the use of of the drug Truvada for PrEP has some pretty impressive figures from the clinical studies:

while adherence is a concern, as it is with condoms, Truvada offers H.I.V. protection that is more effective than any other method short of abstinence. In the N.I.H. study, for example, 5.2 per cent of the placebo group “seroconverted,” or became H.I.V. positive, compared with 2.9 per cent of the Truvada group. That’s a forty-four-per-cent added protection over-all—better than inconsistent condom use. More impressively, patients who maintained a detectable amount of the drug in their system were protected at a rate of ninety-five per cent. (A later statistical analysis estimated that the drug would need to be taken four times a week to offer protection in that range.) Grant said that people in the study who took the drug four to seven days a week “were absolutely protected. We didn’t have anyone seroconvert in our cohort in the United States.”

 

Taking Truvada to prevent H.I.V. comes with very few risks. In the N.I.H. study, one in two hundred people had to temporarily go off the pill owing to kidney issues, but even those people were able to resume treatment after a couple of weeks. While bone-density loss occasionally occurs in Truvada takers who are already infected with the virus, no significant bone issues have emerged in the PrEP studies. And though about one in ten PrEP takers suffer from nausea at the onset of treatment, it usually dissipates after a couple of weeks. According to the U.N. panel’s Karim, Truvada’s side-effects profile is “terrific,” and Grant said that common daily medications like aspirin and birth control, as well as drugs to control blood pressure and cholesterol, are all arguably more toxic than Truvada.

 

Perhaps more important, drug resistance has not been observed in people who were H.I.V.-negative when they began treatment. “We’re not seeing people getting infected who are actually taking the drug,” said Grant. “There are people who take the drug home with them and choose not to take it; they get infected, but you’re not going to get drug resistance from something that stays in a drawer.” Some patients who entered the trials turned out to already have an H.I.V. infection that was too recent to be caught by a blood test. These subjects showed a small amount of drug resistance, which is why the F.D.A. now requires doctors to conduct an H.I.V. test before putting their patients on PrEP. The larger resistance threat, though, comes from the ten million H.I.V.-positive people around the world who take antiretrovirals for treatment, including, in some cases, Truvada. “The best way to prevent drug resistance is to prevent H.I.V. infection entirely,” said Grant. “We know that when we prevent a case of H.I.V., we’re preventing a lifelong risk of drug resistance.”

But that just prompts the mystery, why aren’t more people taking the drug?

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“How I Stopped Worrying and Learned to Love Test Tube Meat (and Started Thinking It May Be Immoral NOT to Eat It)” Or “Hooray For Chickie Nobs!!??!!”

If you were watching television this week you may have seen this clip of a taste test for hamburger meat grown in a “test tube” in London discussed here. The meat was grown from stem cells from existing cows used to grow 20,000 strands of tissue. Costing more than $330,000 to make, with funding by google Co-Founder Sergey Brin, the day where this will be available at your grocery store or served at your fast food franchise is far away. But it may come sooner if we conclude that there may be a moral duty to develop and eat this kind of meat rather than animal-grown meat and press our governments to start funding this work. What is the morality of test tube meat consumption?

Sometimes narrative can be a way into ethics so consider this bit from one of my favorite novelists (and Canadian public intellectuals) Margaret Atwood from her novel Oryx and Crake. She imagines a dystopian future that includes the the consumption of “Chickie Knobs” in one scene:

“This is the latest,” said Crake.

What they were looking at was a large bulblike object that seemed to be covered with stippled whitish-yellow skin. Out of it came twenty thick fleshy tubes, and at the end of each tube another bulb was growing.

“What the hell is it?” said Jimmy.

“Those are chickens,” said Crake. “Chicken parts. Just the breasts, on this one. They’ve got ones that specialize in drumsticks too, twelve to a growth unit.

“But there aren’t any heads…”

“That’s the head in the middle,” said the woman. “There’s a mouth opening at the top, they dump nutrients in there. No eyes or beak or anything, they don’t need those.”

To be clear the test tube meat unveiled earlier this week is not a Chickie Nob, it is grown from stem cells rather than being a cow with extra parts and brains missing (Atwood is silent on some characteristics of the Chickie Nob that may matter ethically such as whether it feels pain or is sentient), but I think many will react to the test tube meat the same way: disgust. Some in bioethics, like Leon Kass, think there can be a “Wisdom of Repugnance.” In my own work I have been a persistent skeptic on this theme. For me repugnance and disgust are good and should be cultivated as reactions for that which we deem immoral, but should be broken down and overcome for those things which we conclude are morally worth pursuing. Thus repugnance is a tool whose proper deployment depends on prior moral conclusions. In the case of test tube meat, whatever repugnance we feel is one we should get over and media, government, etc, should help us do so.

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Anthony Weiner, Sexting, Medicalization, and Legal Moralism, Or (To Be Provocative) “What’s So Wrong About Sexting?”

Like most people, I am both amused and shocked by the latest Anthony Weiner sexting revelations and scandal. It is like a car crash where it is hard to look away even though you know you should.

Most germane to Bill of Health’s readership, I am fascinated by the “medicalization” of Weiner’s behavior by some sectors, this CNN clip with therapists is to me a good example. The words “sexual addiction,” “exhibitionism,” comparisons to alcoholism, “not in control of his actions” are bandied about. This to me has fascinating echoes of the medicalization of homosexuality in the 70s and also the medicalization of the choices made by the transgendered. There like here the strategy is fraught. The patient has to perform the “sick role” as a way of excusing himself from responsibility and/or earn governmental support.

The comparison, though, prompts the following question (and yes I am purposefully trying to be provocative so take it with the appropriate grain of salt): As with homosexuality, what is the underlying problem here that calls out for condemnation? Is this merely legal moralism rearing its head again? What’s so Wrong About Sexting?

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Cahn and Carbone on Selling Eggs for Research in California

Naomi Cahn and June Carbone had a very nice op-ed in the L.A. Times on Saturday entitled “Leveling the Field for Human Egg Donors.” Their topic is a bill co-sponsored by four female Democratic legislators that would allow women to sell their eggs for research, just as men can sell their sperm. They largely endorse the bill, but make three interesting recommendations:

1) Better study and tracking of the health implications for donors. The hormones used have been associated with potentially severe reactions, and women undergoing egg retrieval risk infection and bleeding. There are currently no funds for research on the long-term effects, and little government oversight. California should require tracking and follow-up studies to assess the health risks of egg donation, regardless of the purpose for which the eggs are provided.

2) Researcher responsibility for ensuring that recruitment practices do not exploit women. Researchers should have a duty to oversee clinic recruitment practices and to report on their efforts.

3) Research protocol sensitivity to potential competition for a limited supply of donors. Researchers should prioritize efforts to acquire excess eggs rather than solicit new ones. Where recruitment of new donors is necessary, researchers should avoid practices that would limit the supply for reproductive purposes.

As always they are eloquent and thoughtful. On (2) I suspect our views on what counts as exploitation differ (for mine see this article).  Continue reading

New JAMA paper “The Looming Threat of Liability for Accountable Care Organizations and What to Do About It”

The Journal of the American Medical Association (JAMA) has just posted online (ahead of print) a new article by Ben Harvey and I entitled “The Looming Threat of Liability for Accountable Care Organizations and What to Do About It.” We discuss the Accountable Care Organizations (ACOs) that that the Affordable Care Act seeks to incentivize, the malpractice and other liability claims they may, and how the lack of an Employee Retirement Income Security Act (ERISA) shield of the kind enjoyed by Managed Care Organizations will impact the liability environment ACOs will face. We also discuss self-help remedies available to ACOs as well as potential congressional intervention to deal with these issues.

9th Circuit Strikes Down Arizona 20 Week Fetal Pain Abortion Ban: Some Reflections on the Opinion

[Cross-Posted at Prawsfblawg]

Yesterday, the 9th Circuit (a panel of Berzon, Schroeder, Kleinfeld) struck down as unconstitutional Arizona’s ban on abortion at 20 weeks. As the court described the statute:

The challenged portion of Section 7, codified at Arizona Revised Statutes § 36-2159, reads:

A. Except in a medical emergency, a person shall not perform, induce or attempt to perform or induce an abortion unless the physician or the referring physician has first made a determination of the probable gestational age of the unborn child. In making that determination, the physician or referring physician shall make any inquiries of the pregnant woman and perform or cause to be performed all medical examinations, imaging studies and tests as a reasonably prudent physician in the community, knowledgeable about the medical facts and conditions of both the woman and the unborn child involved, would consider necessary to perform and consider in making an accurate diagnosis with respect to gestational age.

 B. Except in a medical emergency, a person shall not knowingly perform, induce or attempt to perform or induce an abortion on a pregnant woman if the probable gestational age of her unborn child has been determined to be at least twenty weeks.

 The stated purpose of the Act is to “[p]rohibit abortions at or after twenty weeks of gestation, except in cases of a medical emergency, based on the documented risks to women’s health and the strong medical evidence that unborn children feel pain during an abortion at that gestational age.” H.B. 2036, sec. 9(B)(1). The Act lists a number of legislative findings in support of the assertions in the purpose provision, with citations to medical research articles. See H.B. 2036, sec. 9(A)(1)–(7).

After Nebraska passed the first of these kinds of bills in 2010, Dr. Sadath Sayeed and I wrote about them in Fetal Pain, Abortion, Viability, and the Constitution, for the peer-reviewed Journal of Law, Medicine and Ethics in 2011 on the constitutionality and normative justifiability of these statutes. This is the first case of one of these statutes to reach a Circuit court decision on the merits, so I thought I would offer some thoughts. This will be from the perspective of a scholar not an advocate, though given that I have argued that these statutes should be held unconstitutional I don’ t pretend to be disinterested.

Judge Berzon’s opinion for the panel takes about as strong a stance against these statutes as possible. She presents this as an easy somewhat “paint-by-numbers” case of unconstitutionality based on prior precedent. Her logic is Roe and Casey make viability an absolutely cut-off for restricting abortions. Viability has to be decided according to the Court by physicians in individual cases. This is a restriction and not a regulation of abortion. The restriction covers pre-viability fetuses. Therefore it is unconstitutional.

That is strongly put, but only by completely ignoring the fetal pain aspects of the case. Indeed to read her opinion one would scarcely know that fetal pain is at issue. As we argued in our article, and I put it even more succinctly in an op-ed in the Washington Post last year:

The fetal-pain bills do not directly challenge the Supreme Court’s judgment. Instead, they assert a new theory for outlawing abortion. The Nebraska bill states that “by twenty weeks after fertilization there is substantial evidence that an unborn child has the physical structures necessary to experience pain.” The legislatures passing these laws say that preventing this pain is a compelling state interest that justifies prohibiting abortion.

Hence, the loophole: Although the Supreme Court has identified preserving fetal life after viability as a compelling interest, the justices have never said it is the only one.

These statutes might be thought of as asking the courts to find that preventing pain to fetuses is also a compelling state interest. Alternatively, states may argue that, although preventing pain is not compelling on its own, it becomes so when combined with the state’s interest in preserving fetal life before viability.

Thus, I think Judge Berzon writes a strong opinion only by blinding the reader to what is new and difficult here.

By contrast, I think Judge Kleinfeld’s concurrence does a better job of wrestling with the hard issues. His opinion echoes four points we make in our article:

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Sperm Donation, Anonymity, and Compensation: An Empirical Legal Study

[Cross-Posted at Prawfsblawg]

In the United States, most sperm donations* are anonymous. By contrast, many developed nations require sperm donors to be identified, typically requiring new sperm (and egg) donors to put identifying information into a registry that is made available to a donor-conceived child once they reach the age of 18. Recently, advocates have pressed U.S. states to adopt these registries as well, and state legislatures have indicated openness to the idea.

In a series of prior papers I have explained why I believe the arguments offered by advocates of these registries fail. Nevertheless, I like to think of myself as somewhat open-minded, so in another set of projects I have undertaken to empirically test what might happen if the U.S. adopted such a system. In particular, I wanted to look at the intersection of anonymity and compensation, something that cannot be done in many of these other countries where compensation for sperm and egg donors is prohibited.

Today I posted online (downloadable here) the first published paper from this project, Can You Buy Sperm Donor Identification? An Experiment, co-authored with Travis Coan, and forthcoming in December 2013 in Vol. 10, Issue 4, of the Journal of Empirical Legal Studies.

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

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

[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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