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!

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

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

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: Continue reading

Surrogacy, Israel, and the Nepal Earthquake

The Nepal earthquake has shocked with the devastation and suffering inflicted on a long suffering people.  Foreigners in Nepal were also affected, but most of them will be able to leave and carry on their lives without the poverty, housing, and health care deficits the Nepalese will be dealing with for years.  One sub-group of foreigners were Israelis awaiting the birth of children carried by Nepalese surrogates or the legal papers needed to bring home those infants who had already been born.  They have, of course, no moral priority over others hit by the earthquake, but their situation shines yet another light on the complexities of national surrogacy policy and surrogacy tourism.

Nepal has become a major surrogacy destination for Israelis who because they are unmarried or gay cannot obtain surrogacy in Israel.  India and Thailand had been the prime choice for surrogates, but those countries two years ago restricted surrogacy to married couples.  Indian women already pregnant with children commissioned by unmarried persons then went to Nepal to give birth.   With surrogacy available in Nepal for $30,000-$50,000, rather than $150,000 in the United States, Israeli surrogacy agencies started arranging surrogacy births there, even while Indian rather than Nepalese women are usually the carriers. Continue reading

Thailand Bans Foreign Commercial Surrogacy

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

Thailand’s interim parliament recently passed a law prohibiting foreigners from seeking Thai surrogates. The law was proposed and passed in response to several recent scandals and the growing surrogacy industry that has made Thailand one of the top destinations for “fertility tourism.” One of the most publicized controversies was “Gammy’s case,” in which a baby boy born to a Thai surrogate for an Australian man (the baby’s genetic father) and his wife was diagnosed with Down Syndrome. The couple abandoned Gammy but took his healthy twin sister.  The Thai surrogate also claimed the parents asked her to abort both children when she was seven months pregnant.  And in August 2014, authorities discovered that the 24-year old son of a Japanese billionaire had fathered at least a dozen babies by hiring surrogate mothers through Thai clinics.

The law makes commercial surrogacy a crime and bans foreign couples from seeking surrogacy services. The law does not, however, appear to prohibit non-commercial surrogacy among Thai citizens, provided that the surrogate is over twenty-five years old. Violations carry a prison sentence of up to ten years. Wanlop Tankananurak, a member of Thailand’s National Legislative Assembly, hailed the law, stating that it “aims to stop Thai women’s wombs from becoming the world’s womb.” Continue reading

TOMORROW: Patients with Passports: Medical Tourism, Law, and Ethics

Cohen_Medical_Tourism_slidePatients with Passports: Medical Tourism, Law, and Ethics
I. Glenn Cohen and Dr. Robert Klitzman

Tuesday, February 24, 5:30 – 7:00 PM ET

Carnegie Council for Ethics in International Affairs

Merrill House 170 East 64th Street, New York, NY 10065-7478

Live Video Stream HERE


Medical tourism is a growing, multi-billion dollar industry involving millions of patients who travel abroad each year to get health care.

Some seek services like hip replacements and travel to avoid queues, save money, or because their insurer has given them an incentive to do so. Others seek to circumvent prohibitions on accessing services at home and go abroad to receive abortions, assisted suicide, commercial surrogacy, or experimental stem cell treatments.

How safe are these procedures? How do you ensure that you will be protected if anything should happen?

I. Glenn Cohen is professor of law at Harvard Law School and director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics. He is the author of Patients with Passports: Medical Tourism, Law, and Ethics.

Dr. Robert Klitzman will lead the conversation. He is a professor of psychiatry in the College of Physicians and Surgeons and the Joseph Mailman School of Public Health and the director of the Masters of Bioethics Program at Columbia University.

This event is part of Carnegie Council’s Global Health Series.

Tomorrow: “Patients With Passports” Book Launch

Cohen_Medical_TourismBook Launch: Patients with Passports: Medical Tourism, Law, and Ethics

Wednesday, November 19, 2014

Harvard Law School Library
Langdell Hall, Caspersen Room
1557 Massachsetts Ave., Cambridge, MA [Map]

This event is free and open to the public. A light lunch will be served.

I. Glenn Cohen‘s new book Patients with Passports: Medical Tourism, Law, and Ethics  (Oxford University Press, 2014) is the first comprehensive legal and ethical analysis of medical tourism. Examining both the legal and ethical issues raised by medical tourism and how the two interact, it provides the best currently available data and explanations of the industry and tackles the most prevalent legal and ethical issues facing medical tourism today.

Co-sponsored by the Harvard Law School Library.

Upcoming Event: “Patients with Passports” Book Launch

Cohen_Medical_TourismBook Launch: Patients with Passports: Medical Tourism, Law, and Ethics

Wednesday, November 19, 2014

Harvard Law School Library
Langdell Hall, Caspersen Room
1557 Massachsetts Ave., Cambridge, MA [Map]

This event is free and open to the public. A light lunch will be served.

I. Glenn Cohen‘s new book Patients with Passports: Medical Tourism, Law, and Ethics  (Oxford University Press, 2014) is the first comprehensive legal and ethical analysis of medical tourism. Examining both the legal and ethical issues raised by medical tourism and how the two interact, it provides the best currently available data and explanations of the industry and tackles the most prevalent legal and ethical issues facing medical tourism today.

Co-sponsored by the Harvard Law School Library.

Should Foreigners Be Allowed to Be Listed for U.S. Organs and Other Questions about Organs Without Borders

I have a new paper in a theme issue of Law and Contemporary Problems (one of two, I’ll post the second as well when it is available) titled Organs Without Borders? Allocating Transplant Organs, Foreigners, and the Importance of the Nation State (?) This paper is related to but separate from my work on medical tourism, which has dealt among other things with “transplant tourism,” such as traveling abroad to buy a kidney.  In this work I deal with the legally sanctioned distribution of organs. It will surprise many that in the U.S. a non-resident and non-citizen may be listed on the wait list for an organ for transplantation and if he or she is so listed he or she must, as a matter of law, be given the exact same priority as a similarly situated U.S. citizen-resident. Is that policy just or unjust. These are among the topics I tackle in this article. Here is the full abstract:

Most of the discussion of market or non-market forms of allocating and procuring organs takes as its unit of analysis the nation state, or, less commonly a particular state or province, and asks what should the system look like as to this unit. In this article, the second of two articles I contribute to this issue of Law and Contemporary Problems, I want to expand the viewfinder and examine an issue that has received peculiarly little attention in the scholarly and policy discourse: the desirability of treating the nation state (or its subdivisions) as the right level of distribution for organs, whether through market systems or non-market allocation systems. I will show that when we flirt with using a more global viewfinder, a series of difficult (and thus far largely unexplored) ethical and regulatory questions arise relating the inclusion of “outsiders.” At the very end of this article I explore what relevance this analysis may have to allocation within the nation-state as well.A large number of questions could be discussed under this title, but for this article I largely limit myself to two related questions. For both I will use the U.S. as the “home country” for rhetorical clarity, but the basic issues are the same for any home country. The first issue is: Should the U.S. allow “foreigners” to be on the list of those eligible to receive organs in the U.S. when they become available, and, if so, at what level of priority? Surprisingly the current law allows them to be listed to receive organs and if they are so listed it prohibits any discrimination against them for priority based on their being foreign. Second: should the U.S. maintain its own organ distribution network that is limited to the nation state instead of participating in a more globalized system? I should emphasize that my interest here is organs that come to recipients through typical government-run (or at least government-approved) organ allocation systems rather than foreigners who come to U.S. centers and bring their own living donor.

I first describe the two issues and then offer a normative analysis of each. This cluster of issues applies equally to the current U.S. distribution system with its hostility to markets and any of the potential alterations discussed in other articles in this issue of Law and Contemporary Problems.  Continue reading

The Response to Brittany Maynard

By Lauren Taylor

29-year old Brittany Maynard has captured national headlines this week by publicly announcing her intention to end her own life on November 1st. She did so in an effort to raise funds for and awareness of the non-profit Compassion and Choices.

Maynard was diagnosed earlier this year with an aggressive brain cancer and has moved to Oregon for access to its death with dignity laws. Those laws have allowed her to be prescribed a fatal dose of medication by a physician to be taken at the time and place of her choosing. Maynard sees the prescription as a means of avoiding a potentially long, painful and de-humanizing decline in her health.

In light of Maynard’s case, virtually every major media outlet has featured a bit of medical ethics this week. Maynard’s own voice first appeared in People Magazine, announcing her intention to end her own life.  Therein, Maynard is clear that she does not consider herself to be planning for suicide.  Continue reading

New Medical Tourism Website with Info for Patients

My good friends and co-authors at Simon Fraser University have a nice new website aimed at Canadians (though useful for people from all countries) considering using medical tourism about what to think about, questions to ask, steps to take, etc (Full Disclosure: I participated in a feedback session on the website). Here is a story about the website in the National Post, and here is the website itself.

Are you my mother? The Spanish Supreme Court and surrogacy tourism

In a divided opinion (4 dissenting judges out of 9) the Civil Chamber of the Spanish Supreme Court has ruled against the inscription in favor of the intending fathers of children who are born as a result of a surrogacy agreement formed abroad. This conflict is one more in the already long list of cases caused by the phenomenon of surrogacy tourism (there are currently 4 cases pending before the European Court of Human Rights) but I think it contains some interesting features that make worth delving into it (an updated and thorough report on the legal regime of surrogacy in EU Member States can be found here).

The case involved a married gay couple from Spain (Ramón and César) who traveled to California in 2008 circumventing the current ban on surrogate motherhood in Spain. The woman who acted as the surrogate gave birth to twins that were registered as sons of the intending couple in compliance with the rules and procedures established in Section 7630 of the California Family Code (it is unknown at this point whether Ramón or César donated the sperm and, if they did, who is the genetic father). Subsequently the couple attempted to register the US birth certificate in the Spanish Consular Registry in Los Angeles but the Consul rejected it arguing that the recognition of a foreign legal act should be made in compliance with Spanish Law, and that was not the case. As I said, in Spain, surrogacy agreements, irrespective of its commercial or non-commercial nature, are legally considered null and void and legal motherhood corresponds in any case to the gestational carrier (article 10 of the Assisted Reproduction Act of 2006). That decision ignited a complex legal battle that has now come to an end, although the couple has announced their intention to make an appeal before the Constitutional Court. Continue reading

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

Going On Now: IOM Stem Cell Therapies Workshop

The IOM is hosting a workshop *right now* on Stem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings.  You can sign up via a quick online form, and they’ll immediately send you a link to the live webcast (agenda here), which will hopefully be archived.  Our own Glenn Cohen is slated to discuss stem cell medical tourism at 1:15 this afternoon.

Here’s the description from the IOM site:

Stem cells hold tremendous potential to advance health and medicine. Through replacement of damaged cells and organs or supporting intrinsic repair, stem cell offer promising treatments for debilitating diseases and conditions such as Parkinson’s disease, diabetes, and spinal cord injury. Currently, however, the evidence base to support the medical use of stem cells is still limited, with few clinical applications shown to be safe and effective. Despite the preliminary nature of clinical evidence, consumer demand for treatments using stem cells has risen, fueled by direct-to-consumer advertising of stem cell-based treatments. Clinics have been established throughout the world, both in newly industrialized nations such as China, India, and Mexico, as well as developed countries such as the United States and within Europe, that offer “stem cell therapies” for a wide range of diseases and conditions. Often provided at great expense and often promoted as established and effective, these treatments have generally not received stringent regulatory oversight, have not been tested through rigorous trials to determine safety and likely benefit, and the claims remain largely unsubstantiated by medical science. Complications from treatments have ranged from tumor formation to the death of patients. Some feel that the false claims and potential for harm to patients could significantly damage the real potential of research to produce valid stem cell therapies.

The Institute of Medicine and the National Academy of Sciences will co-host a workshop with the International Society for Stem Cell Research that will take a critical look at the practice of unproven stem cell treatments. Speakers will examine the evidence base of unsubstantiated treatment offerings and the associated research and clinical risks and concerns. Discussions will delve into legal hurdles for establishing standards and criteria to govern stem cell trials and treatments and explore a range of potential solutions for assuring the quality of unregulated therapies.

10/22: Globalization and the Future of Health Law: Harmonization or Diversity?

Petrie-Flom Center Faculty Co-Director I. Glenn Cohen will give the introduction for this event featuring Belinda Bennett, Professor of Health and Medical Law, University of Sydney.

From its earliest stages, the themes of recognizing rights and managing risks have been constant features of health law debate. More recently, globalization has become an important theme for health law. International human rights law and global public health have, for example, both become important aspects of contemporary health law. In this context, it is no longer sufficient for health law to have a purely national focus. Analyzing these trends in the development of health law, Professor Bennett considers the future development of health law and whether the trend towards globalization will lead to greater harmonization or greater diversity.

Lunch will be provided.

Monday, October 7: Kimberly Krawiec at the Health Law Policy and Bioethics Workshop

This Monday at the Petrie-Flom Center’s Health Law Policy Workshop, Kimberly Krawiec of the Duke University School of Law will discuss her paper “Reverse Transplant Tourism” (click the link to download).

All meetings of the workshop take place in Hauser Hall, Room 105, on the Harvard Law School campus, from 5:00 to 7:00pm. For the current 2013-2014 schedule of speakers, visit our website.

I. Glenn Cohen Discusses Medical Tourism on “Nightline”

Petrie-Flom Center faculty co-director and Bill of Health editor I. Glenn Cohen appeared on ABC’s Nightline last night, where he discussed the growing trend of medical tourism around the globe.

While it all sounds too good to be true, medical experts cautioned that there are serious concerns about “medical tourism” and having procedures done overseas. Glenn Cohen, co-director of the Petrie-Flom Center for Health Law Policy at Harvard University, said there is a risk of complications after post-op and said there have been documented cases of people dying or developing infections after having surgeries in foreign countries.

“There have been reported cases of people bringing back multi-drug resistant organisms, for example, from India and Sweden,” Cohen said. “There are real problems if you have to sue for medical malpractice because the tort occurred abroad, and there could be real difficulties in translation or the quality of the documents you can bring back, which may make it more difficulty to get good follow-up care back in the U.S.”

Visit ABC News online for more.

Live Blogging: The Globalization of Health Care, Legal and Ethical Issues

By Holly Fernandez Lynch

This afternoon the Petrie-Flom Center co-hosted a panel discussion (with the HLS Library and the Harvard Global Health Institute) of Glenn Cohen‘s new edited volume out from Oxford University Press, The Globalization of Health Care: Legal and Ethical Issues.  Panelists were Professor Cohen, Sue Goldie, and Neel Shah; Einer Elhauge served as moderator.  This isn’t quite *live* blogging because the event just finished, but here were some of the highlights:

  • Professor Cohen began by describing the book and its contents, noting the theme that health care is becoming global – just like everything else.  The book is broken up into five sections:
    1. Medical Tourism: This is the phenomenon of patients traveling abroad for the primary purpose of getting care, in order to save on costs or to access procedures and technologies that are not available in their home country. The number of medical tourists is high (for example in 2010, nearly a million Californian’s traveled to Mexico for care), as are the profits (it’s been estimated that India’s revenues from medical tourism are around $2.2B annually).  This section of the book addresses a variety of related issues, including lessons about accreditation and safety for medical tourists, insurance coverage and encouragement for services abroad (and travel costs), media coverage of medical tourism, distributional justice issues in terms of diverting access to care for local patients, and legal questions related to tourism for services that may be illegal in a patient’s home country. Continue reading

Racism in Transplant Denial? Or Too Few Hearts To Go Around?

Anthony Stokes, a fifteen year old kid from Decatur County, Georgia, is expected to die in a matter of months, according to his doctors at the Children’s Healthcare of Atlanta.  Maybe, they say, he will live for six months.  Who knows?  Anthony suffers from an enlarged, increasingly less functional heart.  His condition is not unusual, and a reasonably effective cure is at hand: a heart transplant. (Learn more about Anthony’s story here.)

However, Anthony has become the latest victim of a dysfunctional U.S. transplantation system, which tempts Americans with a transplant waiting list, but kicks them off if they become too sick or too old.  The problem is that there are too few organs to meet demand, and this perennial problem receives far too little attention from Congress.  Indeed, the U.S. transplantation list, coordinated by the United Network for Organ Sharing, UNOS, (a private organization that coordinates significant aspects of the U.S. transplant system) is so overcrowded that patients increasingly turn to black markets in India, China, Pakistan, South Africa, and other countries if they hope to survive.  (Learn more about that here.) Congressional hearings document Chinese prisoners dying and shortly thereafter Americans receiving organs.

Anthony’s family and some local organizations claim that racism is behind doctors refusing to place the boy on the transplant list.  Anthony is African American.  They ask, what is the harm in letting him on the list?

Continue reading

Glenn Cohen interviewed on NPR about medical tourism

Petrie-Flom faculty co-director and Bill of Health co-editor I. Glenn Cohen was interviewed last week on WBEZ’s “Worldview” about the growth of medical tourism around the world.

What happens if you need surgery, but can’t afford the tens of thousands of dollars it costs to have it done locally? You might consider flying to a different country to have the procedure done for a fraction of the price. “Medical tourism—patients traveling from their home countries to another destination for medical care—is completely transforming the health care industry as we know it,” writes I. Glenn Cohen, Harvard law professor and co-director of Harvard’s Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics. Cohen joins Worldview to talk about the growing popularity of medical tourism and how it’s impacting health care systems in popular destination countries. His most recent book is The Globalization of Health Care: Legal and Ethical Issues.

You can listen to the full program online.