Authors

I. Glenn Cohen is the James A. Attwood and Leslie Williams Professor of Law at Harvard Law School and current Faculty Director of the Petrie-Flom Center. A member of the inaugural cohort of Petrie-Flom Academic Fellows, Glenn was appointed to the Harvard Law School faculty in 2008. Glenn is one of the world's leading experts on the intersection of bioethics (sometimes also called "medical ethics") and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Glenn has spoken at legal, medical, and industry conferences around the world and his work has appeared in or been covered on PBS, NPR, ABC, CNN, MSNBC, Mother Jones, the New York Times, the New Republic, the Boston Globe, and several other media venues. He was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34).

Initial Quick Thoughts on the Announcement of the Birth Through Mitochondrial Replacement in Mexico

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The science media is abuzz about the birth of a child using mitochondrial replacement techniques in Mexico to Jordanian parents at the hands of NY Doctors. A few quick reactions (I am heading to this unrelated NAS/IOM Committee meeting tomorrow evening so may have some more thoughts when that settles down).

  • This is the first time this particular technique has been used to produce a live, but I am not sure from an ethical standpoint the arguments are all that different. That said, for those deeply interested in the more philosophical question of harm to children and the propriety of best interests argument in light of Parfit’s Non-Identity Problem (my take here and here) it may matter whether mitochondrial replacement is done through Pronuclear Transfer or Maternal Spindle Transfer as argued quite well here.
  • The fact that the doctors are from New York, the Patients are from Jordan, and the procedure took place in Mexico is not insignificant. This is a form of medical tourism, a topic I wrote a book on, most similar to cases of fertility and stem cell therapy tourism I cover in the latter half of the book. Absent making domestic prohibitions extraterritorial, something that I argue is permitted by international law and justified in some instances, there is very little that a home country can do about this. The going abroad is likely in part at least a function of some U.S. laws on the subject Eli Adashi and I wrote about for JAMA prohibiting FDA from considering approval of the technology.
  • As I wrote on this blog in February in relation to the IOM report “whatever the US policy in a world where medical tourism is possible and other countries adopt their own systems, so long as not everyone adopts the approach of the US some of these problems will manifest no matter what. So this is about harm reduction not harm avoidance.” This was a bit quicker than even I thought, but is not surprising. More generally if your concern about MRT is harm to offspring and transmission to future generations, people born elsewhere through the technology will inevitably enter the United States and/or marry, and procreate with U.S. citizens who themselves become U.S. citizens. To sound a bit X-Files about it “THEY WILL BE AMONG US!” This is a great example of the limits of unilateral regulation in a world of globalized health care.
  • Interesting that it was a male birth. This may be coincidence or in keeping with the IOM recommendation that only male embryos be transferred (to get rid of germ line transmission). Eli Adashi and I raised some ethical questions in Nature about whether that was an ethically problematic form of sex selection or not but in the reporting I have seen so far it has not been clear that they used only male embryos on purpose.
  • I wish we could stop calling it in the media “Three Parent IVF” or “Three Parent Reproduction.” That assumes the answer to what I think of as a subtle and interesting set of questions — is the mitochondrial donor a “parent” and what sense of the word do we mean.

More soon, I hope!

NIH Announces Plans for new Rules for Funding Chimera Research (Human-Animal Mixtures)

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As reported by Science, today the NIH announced plans to lift a preemptive year long moratorium on funding chimera research – that which mixes human and animal cells, often at the embryonic stage.

Here is a snippet from the Science article about the new proposed NIH process:

According to two notices released today, NIH is proposing to replace the moratorium with a new agency review process for certain chimera experiments. One type involves adding human stem cells to nonhuman vertebrate embryos through the gastrulation stage, when an embryo develops three distinct layers of cells that then give rise to different tissues and organs. The other category is studies that introduce human cells into the brains of postgastrulation mammals (except rodent studies, which won’t need extra review).

These proposed studies will go to an internal NIH steering committee of scientists, ethicists, and animal welfare experts that will consider factors such as the type of human cells, where they may wind up in the animal, and how the cells might change the animal’s behavior or appearance. The committee’s conclusions will then help NIH’s institutes decide whether to fund projects that have passed scientific peer review.

The devil will, of course, be in the details. It will be interesting to see how much NIH takes a more categorical approach as opposed to more case-by-case rule making like in the Institutional Review Board or ESCRO setting. Read More

Whole Women’s Health, First Take: On the Major Victories and On Technocratic vs. Kulturkampf Approaches to Abortion Litigation at the Supreme Court

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I have just made my way through all 107 pages of Whole Women’s Health v. Hellerstedt,  the Supreme Court’s decision this morning to invalidate Texas’ H.B. 2 admitting privileges and surgical center regulations as undue burdens on the abortion right. Full disclosure I filed an amicus brief arguing for this result.  The case was 5-3 with Justices Thomas, Alito, and Chief Justice Roberts in dissent.  I am sure I’ll have a lot more to say after I’ve read through the opinion 3 or 4 more times. Here’s what’s clear to me though even on a quick read.

First, this is a major victory for opponents of Targeted Regulation of Abortion Provider (TRAP) laws. Armed with this opinion they will have a much easier time in the lower courts challenging such laws. Among other things,  (1) the Court signals much less deference to legislatures than in Gonzales and prior cases (see p. 21 of Opinion); (2) the Court instructs that “The rule announced in Casey, however, requires that courts consider the burdens a law imposes on abortion access together with the benefits” conferred (p. 19) ; (3) the Court clarifies the “large fraction” language from Casey as to what is an undue burden in a way favorable to opponents of these regulations. Let me quote the majority here:

Casey used the language “large fraction” to refer to “a large fraction of cases in which [the provision at issue] is relevant,” a class narrower than “all women,” “pregnant women,” or even “the class of women seeking abortions identified by the State.” 505 U. S., at 894–895 (opinion of the Court) (emphasis added). Here, as in Casey, the rele- vant denominator is “those [women] for whom [the provi- sion] is an actual rather than an irrelevant restriction.” Id., at 895. (p.39)

Contrast that with Justice Alito’s long discussion in his dissent as to his understanding (with the pizzaz that shows why he is such a good writer) in a footnote:

The Court, by contrast, applies the “large fraction” standard without even acknowledging the open question. Ante, at 39. In a similar vein, it holds that the fraction’s “relevant denominator is ‘those [women] for whom [the provision] is an actual rather than an irrelevant re­ striction.’ ” Ibid. (quoting Casey, 505 U. S., at 895). I must confess that I do not understand this holding. The purpose of the large-fraction analysis, presumably, is to compare the number of women actually burdened with the number potentially burdened. Under the Court’s holding, we are supposed to use the same figure (women actually burdened) as both the numerator and the denominator. By my math, that fraction is always “1,” which is pretty large as fractions go.

Second, it is remarkable how differently these sets of opinions read from, let’s say, the gay marriage cases or even Gonzales v. Carhart. All the opinions, except perhaps Justice Ginsburg’s very short concurrence, are decidedly in the “technocratic” mode of writing as opposed to what we might call the “kulturkampf” mode that characterized much of Justice Scalia’s dissents on these kinds of issues. These opinion are written for lawyers not the public. I would have to do a proper count to be sure but it seems to me that something like 2/3 to 3/4 of the total pages of these set of opinions are devoted to issues that only lawyers will be able to engage in — res judicata/claim preclusion, severability, third-party standing, as-applied versus facial challenges, and the cogency of tiers of scrutiny.

Read More

NPRM Symposium: Quick Take on New Analysis of the Comments on the NPRM to Amend the Common Rule (and the Challenge for Bioethics and the Public)

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The Council on Governmental Relations (COGR), with support from the Association of Public and Land-grant Universities (APLU), undertook “to review and analyze the 2,186 public comments submitted in response to the 2015 Federal Policy for the Protection of Human Subjects” or “Common Rule” Notice of Proposed Rulemaking (NPRM).

I am going to discuss some highlights of their just released report, but this is far from exhaustive and you should read the whole report.

For the non-cognoscenti this is the most important revision to the rules for U.S. human subjects research since their inception. The report is largely unfavorable to several key proposed rule changes on my first read, but you should read it yourself to make up your own mind.

I’ll share some choice passages from the analysis

The results of our review (Table 2) find significant opposition to most major proposals, with mixed support for mandated use of a single IRB and extending the Common Rule and greater support for the concept of standard security safeguards. In addition, a number of responses suggested that the NPRM is overly complex, poorly written, and not supported by data; highlighted areas that could have a substantial impact on a final rule but were not included in the NPRM (e.g., proposed security safeguards, a consent template, a list of minimal risk studies and a decision tool); and suggested that some of the proposals would adversely affect human health with little perceived benefit.

Turning to Biospecimens, where we had a conference last year that will soon generate a book with MIT press:

The majority of responses, approximately 1,520, addressed one or more of the proposed changes detailed above involving non-identified biospecimens. Of these responses, 94 – 100% of patients and members of the research community, including researchers, universities, medical centers and industry, opposed the changes. Those commenting suggested that the proposed changes will significantly reduce the availability of biospecimens for research, will have a significant negative impact on medical advances, and will adversely affect human health. Per one patient, “I am asking for life saving policy not life ending policies.” From a biorepository, “Respecting autonomy at the expense of patient lives is a significant ethical concern.”

More surprising was their finding that “Among members of the general public, 55% opposed and 45% supported one or more of the major proposed changes related to biospecimens.” (They do a better breakdown of the various sub-constituencies in the report).

Turning to “broad consent” for biospecimen use:

Read More

Planned Parenthood And Fetal Tissue Sale: Manufactured Controversy And The Real Ethical Debate

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This new post by I. Glenn Cohen appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

In 2013 the Center for Medical Progress appeared to have secured tax-exempt status for a fake company it set up called Biomax Procurement Services. The company’s “representatives” contacted the non-profit women’s health provider Planned Parenthood staffers and led them into conversations that were secretly recorded. The result, according to their website (as reported by CNN), was “a 30-month-long investigative journalism study by The Center for Medical Progress, documenting how Planned Parenthood sells the body parts of aborted babies.”

The videos were edited down and released slowly in a way designed to paint Planned Parenthood in the worst light. While some have called it a “hoax,” that’s not a word I would use in this case. When I think of great journalistic hoaxes I think of Orson Welles’s War of the Worlds (though more recent historical work suggests that the panic it caused may have been mythological). Instead what happened here, I want to suggest, is what I will call a “manufactured controversy.” [..]

Read the full post here.

Some Very Preliminary Thoughts on Whole Women’s Health v. Hellerstedt (Texas Abortion Case) Argument

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By I. Glenn Cohen

It is always dangerous to try to glean too much from oral argument, and I have only read the transcript (no recording yet) of today’s argument in Whole Women’s Health v. Hellerstedt, and finally I filed a brief in this case on the side of the law’s challengers so I may be suffering from some motivated reasoning. But with all those caveats, here goes:

Justice Scalia’s passing seems to have radically transformed this oral argument and likely this case. The 3 firm anti-abortion votes on the court (Alito and Roberts from their questions and earlier positions, Thomas we can infer from his earlier positions) left over after Justice Scalia’s passing seemed very much to be playing a defensive game. Many of their questions were aimed at convincing others on the Court (especially Justice Kennedy, the swing voter on these matters) to remand the case back to the lower court, much more so than focusing on giving Texas an outright win.

Appellant’s Counsel Toti’s argument barely was able to get to the merits questions in the case. Instead Justices Roberts, Alito, sometimes joined by Kennedy in these questions, repeatedly asked about evidence in the record on when various clinics closed, re-opened, and what evidence there was for the reason behind it. Toti tried to make use of the timing to her advantage as did the Justices more supportive of her side, but there was a lot of push on why this element of the record was not better developed. She was also repeatedly asked questions regarding the evidence on the capacity of remaining clinics to absorb extra patients needing abortions and what was developed in the record.

The same was true to a lesser extent in Appellee’s Counsel Keller’s argument. Justice Kennedy in particular focused on a line of questioning at page 44 of the argument that may also be significant in terms of remanding the case without resolving it:

“But I thought an underlying theme, or at least an underlying factual demonstration, is that this law has really increased the number of surgical procedures as opposed to medical procedures, and that this may not be medically wise?” Read More

Does the NAM Recommendation of Sex Selection for Mitochondrial Replacement Therapy Violate the Equal Protection Clause (Part III on my take on the NAM report)

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As I said in one of my earlier posts today one of the most interesting parts of the NAM report on mitochondrial replacement therapy was its recommendation that only male embryos be implanted and not female ones. The argument is that this will eliminate the risks of germ-line transmission of anything untoward. I will leave it to others more versed in the risk factors to discuss whether this is an over-reaction (the UK did not adopt this in their recommendation) or reasonable. In the last post I discussed why politically/ethically this may get them in some hot water, but here  I want to raise a different question. Would such a recommendation be unconstitutional?

If FDA were to adopt this rule it would clearly be state action. It seems to be a state-law that favors one gender (males) over another (females) in that only males can be produced in this way. If that is right, under existing Supreme Court precedent it would be judged under “intermediate scrutiny.” To pass intermediate scrutiny, the challenged law must further an important government interest by means that are substantially related to that interest. Would this rule satisfy that test? Read More

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part I Summary)

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By I. Glenn Cohen

As readers know I’ve written on mitochondrial replacement therapy and its attendant ethical and regulatory issues. Today the National Academy of Medicine (formerly known as the IOM) released a terrific report today with its recommendations. I’ll have a second post with my reactions but here is a summary from the report of their recommendations. The big headline is they have recommended FDA largely move towards allowing it to go forward under a regulatory pathway with restrictions, the most important of which is the transfer only of male embryos (to avoid germ-line issues).

In the NAM’s own words:

Recommendation 1: Initial clinical investigations of mitochondrial replacement techniques (MRT) should be considered by the U.S. Food and Drug Administration (FDA) only if and when the following conditions can be met: Read More

Identified versus Statistical Lives at the Movies

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Imagine you had 10 million dollars to spend to save the life of one person whose name you knew or 10,000 whose name you didn’t? How would you spend it? What would you think of a government policy that chose to save the 1 person rather than the 10,000? I would think pretty badly of such a government, but that’s exactly what happens in some popular new movies. And the expectation of the filmmakers (and my own take on audience reaction) is that the audience cheers.

sq_martianFirst, The Martian (spoiler alert) where America spends tens of millions and diverts the entirety of the space program to bring back one man left behind on Mars. Second, the new movie 33, which I have not seen yet but is based on a true story involving the successful attempt to save 33 Chilean miners trapped in a mine collapse at a huge financial cost. Read More