The House of Commons in the U.K. has now voted to permit mitochondrial DNA replacement, which enables babies to be born who have DNA from three people.
Mitochondria are the batteries of our cells that provide energy for cell division and growth. We get ours from our mother’s genes. If there is a defect in a mother’s mitochondria, it can have devastating consequences for her children, resulting in almost certain death. But, by extracting a mitochondrion from a healthy donor egg, scientists are now able to conduct a miniature organ transplant on the cellular level to create a healthy baby through in vitro fertilization. Such a baby has its parents’ genes, except for one small but crucial portion obtained from a donor.
If the House of Lords also approves, Britain will be the first nation to authorize the procedure. The United States is studying mitochondrial transplants. A series of meetings began last week at the Institute of Medicine at the request by the Food and Drug Administration.
The legal question presented was whether the payments Perez received are tax-exempt “damages” under Section 104 of the Internal Revenue Code. The court held they did not, and thus could be taxed. Judge Holmes observed that the contracts had characterized those payments as consideration for pain and suffering rather than the eggs themselves. He explained that “the injury here, as painful as it was to Perez, was exactly within the scope of the medical procedures to which she contractually consented.” Accordingly, “the payments were made not to compensate her for some unwanted invasion against her bodily integrity but to compensate her for services rendered.” Despite the pain and danger Perez incurred through the process of egg retrieval, Judge Holmes affirmed that “the money she received was not ‘damages’” because “she voluntarily signed a contract to be paid to endure” those risks. I’d be interested to learn whether readers find persuasive the Court’s provocative analogies to egg “donation”: Continue reading →
I have just been informed that a new call for proposals for the 2016 Brocher Foundation residencies has been launched. I can warmly recommend this splendid opportunity to any researcher or group of researchers in the fields of Bioethics, Medical Anthropology, Health Economics, Health Policy, Health Law, Philosophy of Medicine and Health, Medical Humanities, Social Science Perspectives on Health, Medical Ethics, or History of Medicine.
A grant by the Brocher Foundation enables international researchers to carry out their projects for a 1-4 month period at one of the most beautiful places in Europe. The Brocher Foundation’s seat is located in Switzerland at the shores of the beautiful Lake Geneva. The location is very close to the French border and to international organisations particularly relevant to the health sector, such as WHO, WTO, WIPO, UNHCR, ILO, WMA, ICRC, and others.
As NPR reported this morning, researchers in England may soon use genetic therapy to treat diseases that result from defects in mitochondrial DNA.
Mitochondria create energy for cells, and they have their own genes, distinct from the genes that help determine our looks, behavior, and other traits. Because mitochondrial activity is critical to normal cell functioning, abnormalities in mitochondrial DNA can be devastating. Some babies die in a matter of hours.
But because the therapy involves genetic manipulation, it is controversial. While critics are right to insist that we proceed carefully with genetic therapy, many of their arguments are misguided. Continue reading →
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 →
With the emergence of new techniques in the field of reproductive technology, applications arise that seem more the realm of science fiction than reality. While many have considered stem cells to be the next frontier of modern medicine, reproductive technology may offer hope to many individuals suffering with rare and unique genetic diseases.
The term “savior siblings” refers to the use of pre-implantation genetic diagnosis (PGD) and other forms of in-vitro fertilization (IVF) in order to create a sibling for the purpose of providing biological material (bone marrow, blood, etc.) that can help treat or cure an existing terminally ill child. It is estimated that up to one percent of PGD in the United States is used to create children that are tissue matches for their siblings. See here.
There has been little meaningful discussion about savior siblings in bioethical or legal circles, and there is no formal regulation governing their use or creation in the United States. This stands in stark contrast to other countries, particularly England, France, and Australia, where a regulatory framework for the use of savior siblings has arisen along with debate over their acceptability. These countries are already discussing how to ethically deal with this extremely complicated issue. Continue reading →
The announcement by Apple and Facebook that they will cover the costs of egg freezing predictably provoked some controversy—predictably because it involves reproduction and also because too many people do not trust women to make reproductive decisions.
Interestingly, the challenge to women’s autonomy can come from both sides of the political spectrum, as has happened with several assisted reproductive technologies. Scholars on the left criticized surrogate motherhood on the ground that surrogates were exploited by the couple intending to raise the child, and other new reproductive technologies are criticized on the grounds that women will feel obligated to use them rather than free to use them. Indeed, this concern about coercion drives some of the objections to egg freezing. Continue reading →
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 →
What does “access” really mean for the purposes of PPACA’s contraceptive coverage mandate?
For two years, I’ve been enrolled in Loyola University of Chicago’s Student Health Insurance Plan, provided through a Blue Cross Blue Shield Illinois (BCBSIL) PPO plan. During this time, I have had to pay out-of-pocket for my contraceptive method every month. As a student studying health law, I was aware of the ACA’s contraceptive coverage mandate, § 2713 of the Public Health Services Act, which requires non-grandfathered health insurance plans to provide access to a full range of Food and Drug Administration approved contraceptive methods without cost sharing. The contraceptive coverage mandate reflects Congress’ determination that “access to preventive services without cost sharing is necessary to achieve access to basic health care,” particularly for women, as they have unique health care needs. The contraceptive coverage mandate also states that plans and insurers may impose “reasonable medical management techniques” to control costs and promote efficient delivery of care. For example, plans may cover a generic drug without cost sharing, but impose cost sharing for the equivalent brand name drug. Even with the imposition of medical management techniques, I still could not figure out why every single woman I talked to who was on my plan had a copayment of twenty dollars or more a month.
My colleagues and I assumed our issues with contraceptives were a result of attending a religiously affiliated institution. We were wrong. Loyola has properly sought a religious exemption from providing contraceptive coverage and communicated to the students and employees that BCBSIL should be accommodating us directly, without Loyola’s involvement. However, in practice, the accommodation is failing the students and employees at Loyola University of Chicago. Continue reading →
The piece was prompted by this week’s news of the white lesbian mother who sued a sperm bank for mixing up the sample she ordered with that from a black donor. The impulse to call one’s mixed-race child a “wrongful birth” gives reason, Dov argues, to rethink the racial preferences that we tend to accept without question; race-matching should be resisted for expressing the divisive notion that single-race families should be preferred to multiracial ones and that families should be set apart by race.
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 →
The Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, responses, essays, and book reviews devoted to the examination of issues related to the intersection of law and biosciences, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB welcomes submissions of varying length, with a theoretical, empirical, practical, or policy oriented focus.
JLB is the first fully open access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.
Nonmedical sex selection is a thorny topic. Usually used to favor males, it has harmed women and resulted in sex ratio disparities in India, China, and other nations where son preference is strong. Sex selection is also troubling because it relies on infanticide, abortion, or the discarding of embryos based on their sex.
Since sex ratio imbalances are not a danger in the United States and equal rights and opportunities for women, though imperfect, are increasingly well-established, nonmedical sex selection in some circumstances, e.g., for gender variety in a family, may be more acceptable. That position, however, runs into the claim that any deliberate choice or preference about the sex/gender of offspring, even for a girl, is inherently sexist or gendered (see Glenn Cohen’s recent post). That position, however, is controversial.
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).
There are huge changes taking place in the world of biosciences, and whether it’s new discoveries in stem cell research, new reproductive technologies, or genetics being used to make predictions about health and behavior, there are legal ramifications for everything. Journal of Law and the Biosciences is a new journal published by Oxford University Press in association Duke University, Harvard University Law School, and Stanford University, focused on the legal implications of the scientific revolutions in the biosciences. We sat down with one of the Editors in Chief, I. Glenn Cohen, to discuss the rapidly changing field, emerging legal issues, and the new peer-reviewed and open access journal.
Dov Fox had a terrific post about taxes on compensation for those who donate eggs and sperm a few weeks ago in reaction to Perez v. Commissioner. I don’t have any particularly new thoughts on this area, but for those of you who haven’t already seen it, I wanted to share the excellent mini-symposium that recently concluded over on the Faculty Lounge on this topic. Kim Krawiec organized, and there’s a series of great posts by several scholars, pointing out, among other things, the strangeness of the fact that there’s still quite a lot of uncertainty about these issues, even though they’ve been around for a while and are not particularly rare. In any case, it’s very much worth reading, even for those who aren’t normally tax wonks.
Please join us for a brown bag talk with Professor Paola Bergallo, Faculty of Law, Universidad de San Andrés, Buenos Aires, and HRP Visiting Fellow. Bergallo served as an expert witness in the landmark case Artavia Murillo et al. (“In Vitro Fertilization”) v. Costa Rica, which discusses human rights definitions regarding the right to life, among other health and human rights matters. Professor Gerald Neuman of Harvard Law School will moderate.
This event is being co-sponsored by Harvard Law Students for Reproductive Justice and HLS Advocates for Human Rights.
Art Caplan has a new op-ed out on the three-parent baby issue. Here’s an excerpt:
In my view, trying the technique to fix a terrible disease even with risks of failure makes ethical sense. The FDA may ask for more studies in monkeys, but that really wont settle the safety issue in humans. Given the severity of mitochondrial diseases it is worth trying the technique.
The big worry is not so much safety, but where will allowing this form of genetic engineering lead. If we let doctors try to repair defective eggs today, who is to say they won’t be trying to make superbabies or designer babies tomorrow by transferring other genes into eggs?
The answer to that is that how far we go in engineering future generations through genetic manipulations is up to us. We can enact laws and treaties that say yes to gene therapies but no to cosmetic genetic engineering. Holding families hostage by saying they cannot try to repair broken genes to treat diseases because we worry that we cannot put steps or handrails on the slippery slope to designer babies seems wrong to me.
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).
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
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.