2017’s Word Of The Year In Health Law And Bioethics: Uncertainty

This is the first post by Carmel Shachar and I. Glenn Cohen that appears on the Health Affairs Blog in a series stemming from the Sixth Annual Health Law Year in P/Review event to be held at Harvard Law School on Tuesday, December 12, 2017.

2017 was a year of tremendous uncertainty for many areas of public policy. Health care policy was no exception, most prominently with an almost successful push by Congressional Republicans to radically revise the Affordable Care Act (ACA). Medical research and bioethics also faced uncertainty, with the struggle to ethically engage with new technologies and to better understand the boundaries around self-determination. As we look over the past year and anticipate the coming one, the overarching question remains: Is it possible to run a health law and health care system given this level of flux?

Healthcare Policy in Flux

2017 saw a new presidential administration and Congress. Seeking to capitalize on the Republican control of the White House and both Houses of Congress, Congressional Republicans sought to make good on their campaign promise to “replace and repeal” the ACA. The proposed legislation would have dramatically reshaped our health care landscape, including ending Medicaid’s financial status as an entitlement program, and undercutting the health insurance Marketplaces championed by the Obama administration. Despite the fact that the ACA is not yet a decade old, this would have been a seismic shift in the way many Americans receive their health care. […]

Read the full post here.

We will be discussing these issues and more at the Sixth Annual Health Law Year in P/Review conference, held on December 12, 2017, at Harvard Law School in Cambridge, MA. If you find these issues interesting, we invite you to join us as the event is free and open to the public (registered required). For those unable to join us in Cambridge, some of our conference presenters will participate in a blog series to follow  at the Health Affairs Blog. Stay tuned!

TOMORROW, 11/9! Book Launch: Specimen Science – Ethics and Policy Implications

Book Launch: Specimen Science: Ethics and Policy Implications
November 9, 2017 12:00 PM
Countway Library, Lahey Room
Harvard Medical School, Boston, MA

In September 2017, MIT Press will publish Specimen Science: Ethics and Policy Implications, co-edited by Holly Fernandez Lynch (outgoing Petrie-Flom Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera. This edited volume stems from a conference in 2015 that brought together leading experts to address key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The conference was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center  for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.

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Book Launch: Specimen Science: Ethics and Policy Implications

Book Launch: Specimen Science: Ethics and Policy Implications
November 9, 2017 12:00 PM
Countway Library, Lahey Room
Harvard Medical School, Boston, MA

In September 2017, MIT Press will publish Specimen Science: Ethics and Policy Implications, co-edited by Holly Fernandez Lynch (outgoing Petrie-Flom Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera. This edited volume stems from a conference in 2015 that brought together leading experts to address key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The conference was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center  for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center.  It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.

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TODAY, 10/16 at 5 PM: Health Law Workshop with I. Glenn Cohen

October 16, 2017 5:00 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Cops, Docs, and Code: A Dialogue Between Big Data in Health Care and Predictive Policing” by I. Glenn Cohen & Harry S. Graver

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich at law.harvard.edu.

I. Glenn Cohen is Professor of Law and Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Glenn’s current research projects relate to health information technologies, mobile health, reproduction/reproductive technology, research ethics, rationing in law and medicine, health policy, FDA law and to medical tourism – the travel of patients who are residents of one country, the “home country,” to another country, the “destination country,” for medical treatment. His past work has included projects on end of life decision-making, FDA regulation and commodification.

 

TODAY, 9/11 at 5 PM: Health Law Workshop with William Sage

September 11, 2017, 5-7 PM
Hauser Hall, Room 104

Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “Fracking Health Care: The Need to Safely De-Medicalize America and Recover Trapped Value for Its People”

William M. Sage is James R. Dougherty Chair for Faculty Excellence at the University of Texas-Austin Law School and Professor (Department of Surgery and Perioperative Care) in the Dell Medical School.

Thank You for Five Great Years!

Five years ago today, the first post went up on Bill of Health. Since then, the blog has received over 980,000 unique page views from 220 countries, helping to further the discussion of issues in health law policy, biotechnology, and bioethics and to publicize opportunities in the field. Over 3,100 posts have covered everything from ethical issues with bioengineered interspecies organ transplants to potential medical malpractice concerns with artificial intelligence to fetal personhood and the Constitution to analysis of surrogacy arrangements gone awry to food safety issues in China.

As the field has changed over the past five years, so too has the blog. We’ve developed collaborations with other organizations and blogs, hosted a series of blog symposia, blogged “live” from conferences, and expanded the participation of our center’s diverse Fellows. In celebration of our anniversary, this month we will feature posts that highlight these past contributions and new posts that explore the development of issues in health law policy, biotechnology, and bioethics over the past five years.

Our most popular posts, based on total unique page views, reflect the diversity of topics Bill of Health covers: Read More

Two Views About the Gene Editing ‘Breakthrough’ that Are Not Getting Enough Attention (IMHO)

As has now been well-covered in the news, Nature just published a paper from Mitalipov’s lab at the Oregon Health and Science University that used CRISPR/Cas 9 gene editing to correct the MYBPC3 mutation associated with hypertrophic cardiomyopathy — a heart muscle disease that affects 1 in 500 people. The more impressive element of the story is that by doing the alteration simultaneous with the sperm fertilizing the egg (not after fertilization) they were able to avoid the mosaicism that problematized early attempts in China — in mosaicism not all cells are repaired due to failure in the editing. The media coverage thus far, sadly but predictably, has focused on the soundbite of “designer babies” and “hope and hype” (indeed as my friend Hank Greely has suggested perhaps “overhype”.) These are worthy narratives to tell, to be sure, but here are two other narratives that I think are not getting the air time they deserve:

(1) The Importance of Genetic Ties: This use of CRISPR/Cas 9, as with most reproductive technologies, are attempts to allow those with disease-causing genes or other obstacles to reproduce genetically to do so. Investment and development of these technologies reifies the importance of genetic ties, as opposed to the kinds of ties associated with adoption, step-parenting, etc. It confuses a right to be a genetic parent, with a right to be a parent. We might have one right or both, but we should be clear they are different rights claims. Françoise Baylis has written eloquently about this issue in the context of In Vitro Gemetogenesis, and others (myself included) have mused on what claims the infertile have on society to have the state pay for these kinds of technologies instead of adopting. The National Academies report on gene editing suggested that clinical use of gene editing to eliminate disease be restricted to cases where there is an “absence of reasonable alternatives,” but does not take a position on when adoption is a reasonable alternative. Of course, in the U.S. at least, adoption is not easy and not available for everyone and there are a ton of interesting normative questions I have gestured at (including whether it matters for “reasonability” whether the child is of a certain age, race, or lacks developmental delay).

(2) The Importance of Embryo Sparing: A different alternative to gene editing in some cases is to fertilize large numbers of embryos and engage in preimplantation genetic diagnosis to eliminate those embryos that carry the disease-causing genes. There is a lot of obstacles to doing this: the fact that women may not retrieve enough eggs to do this, the cost (physical and financial) of repeated egg retrievals and PGD, the fact that this may not work for all genetic problems, etc. But one problem that vexes some is that this results in the destruction of large numbers of embryos (“discard” is sometimes used as the euphemism). Gene editing may be a solve for this problem. The Mitalipov group in their Nature paper have a line to this effect, “When only one parent carries a heterozygous mutation, 50% of the embryos should be mutation-free and available for transfer, while the remaining carrier embryos are discarded. Gene correction would rescue mutant embryos, increase the number of embryos available for transfer and ultimately improve pregnancy rate” (emphasis mine). This raises to me a very interesting question: some religious conservatives have tended to oppose both attempts to transform the human genome & embryo destruction (especially in the stem cell debate context). Could gene editing offer an olive branch to them as an alternative to the “greater evil” of routine PGD plus discard? Does it matter that to get to a place where we could achieve this we would have to actually destroy numerous embryos to perfect the research? (The Mitalipov embryos were not implanted, it seems under current U.S.  law that they could not be/) Is the right way to think about this consequentialist — destroy some embryos today to develop embryo sparing technologies to save many more tomorrow — or is this a case of complicity where the wrongfulness of the basic research taints what comes later?

John A. Robertson (1943 – 2017)

Renowned bioethics scholar, longtime University of Texas Law Professor, and frequent Bill of Health contributor John A. Robertson has recently passed away. We at the Petrie-Flom Center mourn his passing, and our Faculty Director I. Glenn Cohen writes a few words:

I saw John roughly a month ago at the Baby Markets Roundtable at UT Austin. He was, as he always was and as he still seems to me in my mind’s eye, full of electric intellectual energy, warmth, and whimsy. Every comment that I heard him make for over a decade at conferences began: “That’s so interesting…” and then he would proceed to subtly add something to whomever he responded to that was at once flattering of the idea and also five times better than what was said by original speaker. Certainly that’s how it felt when I was the person to whom he was responding.

Much will be said in coming weeks about his work—not only the centrality of Children of Choice to almost everything that has been written since on reproductive technology, but also the breadth of his work and the way in which almost every new technology soon had a wonderful take by him in print (IVF and uterus transplants most recently).

I’ll limit myself to two reflections. First, the way in which he put the field I write in (law and bioethics or law and the biosciences, depending on who you ask) on to the law school map, and with a few others (Rebecca Dresser, Alta CharoHank Greely, etc), gave it legitimacy as a real and important area of focus within law schools.

Second, and more personally, John was just about the best mentor to young scholars I have ever encountered. I met him first while I was a fellow at an ASLME event and I was blown away by the warmth and generosity of someone I considered a giant in the field (my idol if I’m honest) to a little pischer like me. Over the years I saw him do the same for countless others and I tried to do my best to palely imitate.

I can’t believe he is gone. The world seems a little darker.

Most-Cited Health Law Scholars (with an update on multiple authors)

By Mark A. Hall and I. Glenn Cohen

Based on the law faculty citation analysis done by Greg Sisk, Brian Leiter has compiled “most-cited” rankings of tenured law faculty in a number of different subject areas, but not health law.  Naturally, we would be curious to know how we and colleagues might show up in such a ranking, but more than this, we were curious how the field of Health Law as a whole would look, compared to other fields, and how well different component of health law might be reflected.  Health law (as many people conceive it) is a broad field that includes bioethics, biotechnology, medical malpractice, health care finance and regulation, health policy, and public health.

Using Leiter’s methods and the Sisk data (supplemented as noted below), we compiled a citation-count ranking of health law scholars over the five-year period 2010-2014 (which is the latest currently available from Sisk).  We classify faculty as health law scholars if publications in this field account for the bulk (roughly 2/3) of their more recent citations.  A research librarian at Wake Forest University supplemented the Sisk data by doing citation counts (using his same methods) for an additional two dozen prominent health law scholars who are not on the Sisk list because they are at lower-ranked schools (below the top 70) or are based at schools of medicine or public health.  To ensure maximum comparability between these rankings and those already existing for other legal fields we conformed to Leiter’s presentation, which entailed, among other things, rounding citations to the nearest ten and estimating the age of those ranked.  Read More

The Best-Laid Plans For Health Care

This new post by Petrie-Flom’s Faculty Director I. Glenn Cohen appears on the Health Affairs Blog as the first entry in a series that will stem from our Fifth Annual Health Law Year in P/Review event to be held at Harvard Law School on Monday, January 23, 2017.

“The best-laid plans of mice and men often go awry.” This phrase, adapted from the 1785 Robert Burns Poem “To a Mouse” and made as the source of the title of a Steinbeck novella, may become the mantra for health policy in 2017.

The Affordable Care Act (ACA) was the largest and most ambitious alteration to American health policy in a generation. By the middle of 2016, it appeared to be largely “settling into place,” and the quartet of Supreme Court encounters with the law have by now been largely resolved. The Constitutional commerce and taxation clause challenges of NFIB v. Sebelius have been decided, with the Court weakening Medicaid expansion and causing other problems, albeit not ones that threatened the vitality of the overarching statutory scheme due to preservation of the individual mandate.

The decision in King v. Burwell left funding for the insurance Exchanges intact. Controversy over the contraceptive coverage requirements stemming from the Act remains, with the Court punting on the extent to which its analysis from Burwell v. Hobby Lobby ought to apply to challenges raised by other types of objectors in Zubik v. Burwell, leaving the litigants with a strange “Can’t you guys just work this out on remand?” sort of resolution. […]

Read the full post here!