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

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)

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. Continue reading

Whole Woman’s Health – Some preliminary thoughts on benefits, purposes, and fetal status

The Supreme Court’s decision in Whole Woman’s Health is sure to be dissected in the coming days, weeks, and months.  In the meantime, I wanted to quickly reengage the discussion about the status of the “purpose prong” of Casey and what, if anything, Whole Woman’s Health tells us about it.  While Justice Breyer’s analysis in the majority opinion does not seem to be couched expressly in terms of Casey’s purpose prong, the majority’s willingness to assess the applicable laws’ benefits may ultimately be purpose dressed in different clothing.  If there is not sufficient evidence of a law’s benefit, there could be a problem.

As a quick refresher, recall that Casey prohibits laws that have either the purpose or effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus.  While most folks can readily associate Casey’s “undue burden” test in terms of abortion restrictions that have the effect of placing obstacles, Priscilla Smith and Caitlin Borgmann, have written about courts seemingly ignoring Casey’s other mandate that laws should not have the purpose of even trying to place such obstacles (regardless of whether they succeed in creating that effect).  This avoidance of the purpose prong coupled with great deference to the asserted justifications of the legislature (without the kind of benefits inquiry seen in Whole Woman’s Health) has historically led to many TRAP (targeted regulation of abortion provider) laws being upheld.

Continue reading

Sex Markers in Official Documentation – Between Biology and Self-Identification

A recent civil action filed by LAMBDA Legal highlights a debate ongoing for the past several years on the issue of “sex-markers” in official documentation to the U.S courts. In different instances, plaintiffs and interest groups have sought to challenge the state’s sex-binary classification system when issuing official identification documents such as passports, birth certificates, driver’s licenses and more. Litigation and advocacy around sex-markers in official documentation may be roughly distinguished between groups advocating for easier access to the existing Male /Female categories (“M/F”), mostly by and for the trans community, and to groups asking to break the M/F distinction altogether in favor of an unspecified category: ”X”/”MF”/Unknown/Unspecified. This group is not seeking better access to the existing M/F categories, but is rather pursuing the goal of creating an all-inclusive new category for those who do not identify as males or females, sometimes also referred to as “third sex” or “third gender”.

These challenges were sometimes fruitful in generating administrative adjustments. For example, in 2011 it became possible to mark “X” instead of M/F on passports in Australia. In 2013 Germany approved a change in legislation that allows leaving the “sex” checkbox in birth certificates empty. These developments were presented very positively in the media with headlines like: “Germany got it right by offering a third gender option on birth certificates” in the Guardian, or: “Germany allows ‘indeterminate’ gender at birth” in the BBC, that portrayed them as victories for intersex and LGBT activists. Although the wish to open up sex categories in official documentation seems to be in line with progressive politics, some Intersex advocacy organizations have had misgivings about this line of advocacy. One argument is that being an Intersex or a Trans person does not necessarily dictate a non-specified gender identity and so conjoining intersexuality and transgenderism with non-specified gender identity is incorrect to say the least.

Continue reading

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)

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? Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part II My First Take)

By I. Glenn Cohen

My last post was a summary of the NAM’s Recommendations on Mitochondrial Replacement Therapy (MRT). Now here is my take on the report. But keep in mind the report was just released and all I could give it was a quick read, so these are really more like initial impressions: Continue reading

The “Ashley Treatment” – Thoughts about Avoiding Sexualization

Ashley is young woman who was born in 1997 with a severe mental and physical disability that prevented her from ever eating, walking or talking by herself. Her mental capacity was also not expected to develop further than that of an infant. In 2004, When she was six and a half years old, Ashley‘s parents and the Seattle Children’s hospital physicians who had been treating her sought to perform on Ashley a novel medical intervention that would include hormonal treatment for growth attenuation, surgical removal of her breast buds, and a hysterectomy. This surgical intervention was presented as beneficial to Ashley by allowing her parents to take care of her longer and postpone institutionalization. The removal of breast buds and hysterectomy were meant to spare Ashley the pain and discomfort of menstruation and the development of fully-developed breasts, and also to “avoid sexualization” in order to make her less vulnerable to sexual abuse when she was ultimately institutionalized. Continue reading

Fetal Personhood and the Constitution

By John A. Robertson

The Rubio-Huckabee claim that actual and legal personhood start at conception has drawn trenchant responses from Art Caplan on the medical uncertainty of such a claim and David Orentlicher, drawing on Judith Thomson’s famous article, that even if a fetus is a person, woman would not necessarily have a duty to keep it in her body.

Their debate claim that the fetus is already a legal person under the constitution also deserves a response, for it has no basis in positive law.  In Roe v. Wade all nine justices agreed that the use of “person” in the Constitution always assumed a born person, and therefore that the 14th Amendment’s mention of person did not confer constitutional rights until after a live birth.  In the years since Roe, when the make-up of the court has changed, no justice has ever disagreed with that conclusion, including those who would overturn Roe and Casey. Continue reading

Abortion and the Fetal Personhood Fallacy

By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

Marco Rubio, Mike Huckabee, and other politicians continue to assert a common fallacy about abortion—because human life begins at conception, fetuses are persons, and abortion must be prohibited. Indeed, Huckabee and Rubio claim that the U.S. Constitution requires such a result.

But they are wrong. And not just because people disagree about the beginning of personhood. The flaw in the Rubio/Huckabee logic was pointed out more than 40 years ago, even before the U.S. Supreme Court recognized a constitutional right to abortion in Roe v. Wade. In “A Defense of Abortion,” Professor Judith Jarvis Thomson correctly observed that even if we assume that personhood begins at conception, it does not follow that abortion must be banned before the fetus is viable. Indeed, as she wrote, a ban on abortion before fetal viability would be inconsistent with basic principles of law. Continue reading

Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?

Given that it was the subject of my first ever blog post on Bill of Health, I am very pleased to share my new paper: “Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?” which has just been published in the Journal of Law, Medicine, and Ethics (it is behind a paywall, but there is a version they have allowed me to post on SSRN that has all the text but not the formatting that can be freely downloaded).

This paper is likely to piss off people both on the Left and the Right of the abortion issue, which I think of as a feature not a bug ;), but in any event I hope will prompt a good conversation. Here is the abstract:

There was a moment in the 2012 campaign, when Mitt Romney attempted to “pivot” to the center and get away from the statements of those like Todd Akin who made comments about how in cases of “legitimate rape,” the victims’ bodies “have ways to try and shut that whole thing down.” The way Romney did his pivot was to make clear that while he was against abortion, he would, of course, make an exception for women who had been raped or whose pregnancy was the result of incest. This has become something of a moderate orthodoxy among those who oppose abortion. Continue reading

Bioethicist Art Caplan: Actress Sofia Vergara Can’t Destroy Her Embryos

A new piece by contributor Art Caplan on NBC News:

Nick Loeb and Sofia Vergara once were a huge item. Today, they are back in the tabloid press because of a dispute over frozen, human embryos.

The 42-year-old actress and star of “Modern Family,” one of the top-earning women in Hollywood, announced her engagement to the wealthy, 40-year old businessman in 2012. Last May, Vergara announced they had split amid a host of abuse allegations.

Their squabble now has grown to include Loeb suing Vergara in California to prevent her from destroying two frozen female embryos, which court documents say they created using in vitro fertilization in November 2013. […]

Read the full article here.

Bioethics on the Ballot

In addition to the closely-watched senate and gubernatorial candidates, 146 ballot questions were up for vote yesterday in 42 states across the nation. Below is a review of the some of the most pressing bioethics issues on the docket and the latest information on what passed according to Politico’s Ballot TrackerContinue reading

Personhood Measures in the 2014 Election Cycle

By Jonathan F. Will
[Cross-posted at The Conversation]

Citizens of three states had the opportunity to vote on measures considered by many to be adverse to abortion rights during the November 2014 election cycle.  While the personhood efforts in Colorado and North Dakota failed, the Tennessee electorate approved an amendment making clear that their state constitution does not protect a right to abortion, and expressly authorizing the state legislature to regulate abortion services.

Unlike the amendment that passed in Tennessee, the state constitutional amendments proposed in Colorado and North Dakota said nothing explicitly about abortion.  Instead, the measures sought to extend the protections associated with a “right to life” to human beings at all stages of development.  Of course, by extending this aspect of legal personhood to the preborn, abortion necessarily becomes problematic.  But these types of personhood measures have failed in every state to attempt them, including Mississippi, which is considered by many to be the most conservative (and anti-abortion rights) state in the country.  So why are personhood measures failing even while the Tennessee amendment passed?  Continue reading

Legal Personhood in the New Argentine Civil and Commercial Code

By Martín Hevia

The Argentine Congress has just passed a new and unified Civil and Commercial Code. The new Code will be effective as of January 2016. The Code covers topics from torts and contracts to family law and in vitro fertilization. It is a massive volume of almost 2700 articles – it is, however, shorter than the current Code, which includes almost 4000 articles -.

One of the main issues in the new Code is the definition of legal personhood. Article 19 of the new Code states that “Human personhood starts with conception”. This wording has been strongly critized because “conception” has been frequently defined as “fertilization.” Critics argue that Art. 19 may imply an obstacle for assisted reproductive technologies: in vitro embryos may be considered “legal persons”, comparable to a live human person. Thus, they may be taken to have the same right to life. In fact, this argument has been accepted by some courts. For example, in 2002, the Supreme Court of Argentina prohibited the production, distribution, and commercialization of Imediat, an emergency contraceptive because of its perceived abortive effects it is considered to violate the right to life, which is regarded as an absolute right that preempts any other right.  For the Court, life begins with the union of the gametes, namely, with fertilization and before implantation. A similar line of reasoning was followed by the Ecuadorian Constitutional Court in 2004.

In contrast, defenders of the wording of Article 19 argue that it should be read together with Article 20, which states that “time of conception is that between the maximum and the minimum length of pregnancy”. This may mean that there cannot be conception outside a woman´s body. Thus, conception is to be understood as “implantation.”  Continue reading

Colorado Personhood Version 4.0

By Jonathan F. Will
[Cross-posted at Hamilton and Griffin on Rights.]

This November citizens of Colorado will have an opportunity to vote on a proposed amendment (Amendment 67) to their state constitution that would define the words “person” and “child” in the Colorado Criminal Code and Colorado Wrongful Death Act to include “unborn human beings.”  Similar personhood measures were rejected by a margin of 3-to-1 by Colorado citizens in 2008 and 2010, and a proposal in 2012 failed to receive the requisite signatures to get on the ballot.  Is this version 4.0 all that different?

A New Strategy

In short, the language is different, but not in ways that ought to matter for those concerned about the implications for reproductive rights.  I was initially surprised that a fourth personhood proposal was able to secure enough signatures to get on the ballot when the third measure was not.  After speaking with a reporter from Colorado, it became clear that the strategy this time around was very different.

This most recent personhood effort rode the wave of momentum generated by the 2012 story of a Colorado woman, hit by a drunk driver, who lost her pregnancy in the eighth month of gestation (a boy she had named Brady).  At that time, Colorado did not have a law on the books that permitted the drunk driver to be prosecuted for the death of the fetus.  Amendment 67, advertised as “The Brady Amendment” was offered as a solution, and there was no trouble generating over 100,000 signatures.  Even without Amendment 67, Colorado has since passed a Crimes Against Pregnant Women Act, which criminalizes (with varying degrees of punishment) the termination of a woman’s pregnancy without her consent.  This new law does not define the fetus as a person, expressly permits women to choose to have abortions, and certainly is not considered to go far enough for those in favor of sweeping personhood measures.  Amendment 67 was thus still viewed to be necessary by some. Continue reading

Art Caplan New Op-Ed: When Does Human Life Begin?

Art Caplan has a new Op-Ed on The Council for Secular Humanism about when human life begin.

From the piece:

“When does human life begin? For those in the “personhood” movement in the United States, there is no doubt about when that happens—it is at conception, when the sperm meets the egg. The personhood movement has gained a foothold among antiabortion activists who are looking to pass laws that define embryos as people with full rights. Personhood advocates aim to outlaw all abortions, along with in vitro fertilization, embryonic stem-cell research, and emergency contraception. Granting embryos personhood would also mean that someone who killed a pregnant woman at any stage in her pregnancy would be at risk of prosecution for a double homicide. And in those states that restrict a woman’s right to utilize a living will if she is pregnant, no living will could apply from the moment of conception..”

Read the full article.

Art Caplan Says Vasectomy Has No Place in Plea Deal

Art Caplan has a new opinion piece on NBCNews on the controversy over the case of Jessie Herald, in which he was offered a plea bargain that involved sterilization for a reduced sentencing. From the piece:

Jessie Lee Herald was facing five years or more in prison after a crash in which police and prosecutors said his 3-year-old son was bloodied but not seriously hurt. But Herald cut a deal. Or more accurately, the state agreed to reduce his sentence if he would agree to be cut. Shenandoah County assistant prosecutor Ilona White said she offered Herald, 27, of Edinburg, Virginia, the opportunity to get a drastically reduced sentence if he would agree to a vasectomy. It may not be immediately clear what a vasectomy has to do with driving dangerously and recklessly. It shouldn’t be. There is no connection.

Read the full article.

Animals are Already Legal Persons: On Steven Wise, the Nonhuman Rights Project, and Misguided Personhood Debates

The New York Times Magazine has just published an interesting piece on the Nonhuman Rights Project and Steven Wise, whose mission is to change the common law status of at least some nonhuman animals from “mere things” to “legal persons.”  (I have previously written on their work here).  It is widely agreed, among both advocates and opponents of Wise’s work, that granting legal personhood to animals would be revolutionary.  I think that this view is mistaken.  To understand why, it is helpful to clarify and differentiate between three possible conceptions of what it might mean to be a “legal person”—a term that is often used in imprecise ways.  Doing so reveals that animals are already legal persons, and that personhood does not itself count for very much. Continue reading

TOMORROW: Frances Kamm’s Bioethical Prescriptions: Book Talk and Panel Discussion

Please join us on February 27 at 2:00pm in Wasserstein 1019 at the Harvard Law School as we launch Professor Frances Kamm’s latest book, Bioethical Prescriptions: To Create, End, Choose, and Improve Lives (Oxford University Press, January 2014). The book showcases Professor Kamm’s articles on bioethics as parts of a coherent whole, with sections devoted to death and dying; early life (on conception and use of embryos, abortion, and childhood); genetics and other enhancements (on cloning and other genetic technologies); allocating scarce resources; and methodology (on the relation of moral theory and practical ethics).

Panelists include:

  • Frances Kamm, Littauer Professor of Philosophy & Public Policy, Harvard Kennedy School of Government; Professor of Philosophy, Faculty of Arts & Sciences, Harvard University; Former Senior Fellow, Petrie-Flom Center
  • Norman Daniels, Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Thomas (Tim) Scanlon, Jr., Alford Professor of Natural Religion, Moral Philosophy, and Civil Polity, Faculty of Arts & Sciences, Harvard University
  • Moderator: Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Associate Professor, James E. Rogers College of Law, University of Arizona

This event is free and open to the public. For questions, please contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and BioethicsEdmond J. Safra Center for Ethics at Harvard University; and the Countway Library of Medicine at Harvard Medical School; with support from the Oswald DeN. Cammann Fund.

2/27: Frances Kamm’s Bioethical Prescriptions: Book Talk and Panel Discussion

Please join us on February 27 at 2:00pm in Wasserstein 1019 at the Harvard Law School as we launch Professor Frances Kamm’s latest book, Bioethical Prescriptions: To Create, End, Choose, and Improve Lives (Oxford University Press, January 2014). The book showcases Professor Kamm’s articles on bioethics as parts of a coherent whole, with sections devoted to death and dying; early life (on conception and use of embryos, abortion, and childhood); genetics and other enhancements (on cloning and other genetic technologies); allocating scarce resources; and methodology (on the relation of moral theory and practical ethics).

Panelists include:

  • Frances Kamm, Littauer Professor of Philosophy & Public Policy, Harvard Kennedy School of Government; Professor of Philosophy, Faculty of Arts & Sciences, Harvard University; Former Senior Fellow, Petrie-Flom Center
  • Norman Daniels, Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Thomas (Tim) Scanlon, Jr., Alford Professor of Natural Religion, Moral Philosophy, and Civil Polity, Faculty of Arts & Sciences, Harvard University
  • Moderator: Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Associate Professor, James E. Rogers College of Law, University of Arizona

This event is free and open to the public. For questions, please contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; Edmond J. Safra Center for Ethics at Harvard University; and the Countway Library of Medicine at Harvard Medical School; with support from the Oswald DeN. Cammann Fund.