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.  Read More

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. Read More

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: Read More

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. Read More

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

By Michele Goodwin

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?

Read More