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!

Introducing a new global antibiotic R&D partnership

Yesterday US HHS announced a new global partnership to fund pre-clinical antibiotic R&D, coordinated by the Boston University School of Law. The partnership is known as CARB-X, which is the abbreviation for the Combating Antibiotic-Resistant Bacteria (CARB) Biopharmaceutical Accelerator.  CARB-X is the culmination of one key part of the US National Action Plan on antibiotic resistance.  Background paper in Nature Reviews Drug Discovery.

Under the grant, BU Law will coordinate more than $350 million in new funds for R&D over the next five years, in partnership with BARDA, NIAID, the Wellcome Trust, the AMR Centre, MassBio, the California Life Sciences Institute and the Broad Institute at Harvard and MIT.  Kevin Outterson is the PI and Executive Director of CARB-X.

While the bulk of the project funds pre-clinical R&D, we are also interested in the role of law, IP and other innovation incentives, using the unique dataset that CARB-X will generate.

Legal Dimensions of Big Data in the Health and Life Sciences

Please find below my welcome speech at last-weeks mini-symposium on “Legal dimensions of Big Data in the Health and Life Sciences From Intellectual Property Rights and Global Pandemics to Privacy and Ethics at the University of Copenhagen (UCPH).  The event was organized by our Global Genes –Local Concerns project, with support from the UCPH Excellence Programme for Interdisciplinary Research.

The symposium, which was inspired by the wonderful recent  PFC & Berkman Center Big Data conference,  featured enlightening speeches by former PFC fellows Nicholson Price on incentives for the development of black box personalized medicine and Jeff Skopek on privacy issues. In addition we were lucky to have Peter Yu speaking on “Big Data, Intellectual Property and Global Pandemics” and Michael J. Madison on Big Data and Commons Challenges”. The presentations and recordings of the session will soon be made available on our Center’s webpage.

Thanks everybody for your dedication, inspiration, great presentations and an exciting panel discussion.

“Legal Dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics”

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Bioethicist Arthur Caplan: Using Genetically Modified Mosquitoes To Fight Zika Is The Right Thing To Do

A new piece by Bill of Health contributor Art Caplan on Forbes:

When most of us think of mosquito control, we think of repellent, sprays and DEET. You might think long sleeves, window screens or mosquito control trucks, too. We’ve gotten pretty used to the idea that mosquitoes live around and among us–even when those mosquitoes carry diseases like West Nile, dengue, malaria and Zika. The best we can do to avoid their pesky, and sometimes lethal, bites is make our bodies unreachable or unappetizing.

The Zika outbreak sweeping through South America, Central America, Mexico and the Caribbean–and steadily moving north–has made mosquito control a top priority for national and international leaders, including the CDC and WHO. Transmitted primarily by the bite of the female Aedes aegypti mosquito, Zika has been linked to microcephaly in babies born to mothers infected during their pregnancies, as well as Guillain-Barré syndrome, which causes paralysis and even respiratory failure. Zika can get into the blood supply. A few cases of Zika appear to have been sexually transmitted. […]

Read the full article here.

Intelligent Transparency and Patient Safety: New UK Government Patient Safety Plans Launched

By John Tingle

One thing is clear when commentating on patient safety developments in the UK is that there is hardly ever a dull moment or a lapse of activity in patient safety policy development .Something always appears to be happening somewhere and it’s generally a very significant something. Things are happening at a pace with patient safety here.

On the 3rd March 2016 the Secretary of State for Health,The Rt Honourable Jeremy Hunt announced a major change to the patient safety infrastructure in the NHS with the setting  up from the 1st April 2016 of the independent Healthcare Safety Investigation Branch. In a speech in London to the Global Patient Safety Summit on improving standards in healthcare he also reflected on current patient safety initiatives.This new organisation has been modelled on the Air Accident Investigation Branch which has operated successfully in the airline industry. It will undertake, ‘timely, no-blame investigations’.

The Aviation and Health Industries
The airline industry has provided some very useful thinking in patient safety policy development when the literature on patient safety in the UK is considered. The way the airline industry changed its culture regarding accidents is mentioned by the Secretary of State in glowing terms. Pilots attending training programmes with engineers and flight attendants discussing communications and teamwork. There was a dramatic and immediate reduction in aviation fatalities which he wants to see happening now in the NHS. Continue reading

Patient safety perspectives from other countries: introducing the WHO Geneva safe childbirth checklist

By John Tingle

Healthcare providers and policy makers can avoid the expense of reinventing the wheel if they try and look beyond their shores for solutions to patient safety problems. In the UK the work of the patient safety unit of WHO in Geneva helps NHS healthcare providers through the development of patient safety tools and other projects. The  WHO multi-professional patient safety curriculum guide is one example. The learning from error – video and booklet is another. Recently launched by WHO is the Safe Childbirth checklist and guide to implementation.

The Checklist will be a useful patient safety tool in developing, transitioning and developed countries. The scale of the problem is very disturbing. WHO calculate that in 2013, 289,000 women died during and following pregnancy and childbirth, and 2.8 million new-borns died within 28 days of birth. Most of these events could have been prevented and mostly occurred in low resource settings. Women and their babies are being very conspicuously failed by health systems which should be helping them. Continue reading

Zika Messes with Texas

Photo: Texas + Fence

Flickr Creative Commons—Adam Simmons

By Gregory M. Lipper

For an ambitious, aggressive disease like Zika, Texas is an ideal home. Earlier this week we learned that Zika—a nasty virus that has spread to over 25 countries—was transmitted by sex to a resident of Dallas. Six more cases of Zika have also been confirmed in Harris County, Texas. The appearance of Zika in Texas may be happenstance, but Texas’s health policies will make it easier for Zika to spread. Among other problems, Texas (1) fails to teach students about safe sex and reduces access to affordable, effective contraceptives; (2) has blocked access to Medicaid for up to 2 million low-income residents; and (3) is trying to restrict if not eliminate access to safe abortion. Not a bad place for a communicable disease that can spread through sex and cause birth defects.

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New Developments in the Guatemala STD Experiments Case

In the late 1940s, US government scientists, in collaboration with Guatemalan counterparts, were involved in a horrible array of experiments on human subjects in which a variety of vulnerable groups in Guatemala were intentionally infected with syphilis, gonorrhea, and chancroid and left without treatment. [For more on how they ended up in Guatemala and the ethics of intentional infection studies, see my work here and here.] The experiments were done without consent and without scientific rigor, violating both contemporaneous and modern ethical standards.  They were not uncovered, however, until a few years ago when a historian discovered the files in the midst of doing archival research on one of the scientists, who had also been involved in the Tuskegee syphilis study in the US.

Since her discovery, the US and Guatemalan governments have both issued apologies and reports condemning the studies (here and here), and the US pledged a relatively small amount of money to support the Guatemalan government’s efforts to improve surveillance and control of H.I.V. and other sexually transmitted diseases in that country. However, individual compensation to the victims of the experiments and their families has not been forthcoming; the victims calls for a voluntary compensation program to be established have gone unheeded, and they have also been unable to prevail in court, for a variety of jurisdictional and technical reasons.

As Glenn Cohen and I argued following the victims’ first court loss in 2012, compensation is a moral imperative.  We expressed support for a voluntary compensation program, but in its absence, alternative mechanisms of justice are essential.  Therefore, we were heartened to hear that a petition for the victims was just filed in the Inter-American Commission on Human Rights in Washington, D.C., by the Office of Human Rights for the Archdiocese of Guatemala, represented by the UC Irvine School of Law International Human Rights Clinic and The City Project of Los Angeles.  The petition claims violations of the rights to life, health, freedom from torture, and crimes against humanity under both the American Declaration of the Rights and Duties of Man, and the American Convention on Human Rights, as well as the denial of a right to a remedy for human rights violations.

There are still a number of hurdles ahead, not the least of which is determining which individuals would actually be entitled to compensation, as the record keeping in the initial experiments was so poor and so much time has passed.  But we are heartened that advocates are still pressing forward for these victims and hope that justice, though certainly delayed, will not continue to be denied.

More information on the petition is available here.

Why aren’t we talking about the Syrian refugees’ health?

Special guest post by Nicholas J. Diamond

The Hill is abuzz with talk over the Syrian refugee crisis and whether refugees should be allowed to resettle in the U.S. A group of former national security experts from both Republican and Democrat administrations recently urged Congress to allow refugee resettlement in the U.S. In contrast, Texas recently filed a lawsuit against the Federal government in an effort to prevent the arrival of a family of Syrian refugees scheduled to arrive in Dallas.

But the political buzz has been ignoring a significant fact. The refugee crisis is not just a political matter. It also poses serious health risks for the refugees themselves.

Let’s start with physical health. While migration in general introduces various health risks, forced migrations like the Syrian refugee crisis create particularly acute concerns. A forced migration tends to impact large numbers of people—an estimated 9 million Syrians have fled their homes since 2011. The rapid movement of this many people causes massive disruptions in all aspects of life, including the availability of food and potable water, basic health services, shelter, and proper sanitation, to name just a few. Continue reading

Identified versus Statistical Lives at the Movies

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. Continue reading

Artemisinin: Worthy of Nobel Prize, but Growing Concerns About Resistance

Artemisinin, a drug used to treat malaria, has been a recent topic of public discussion after its discovery was recognized with the Nobel Prize in Physiology or Medicine on October 5. The 2015 prize was awarded to three researchers who developed treatments for parasite-caused diseases, with half the award going to Youyou Tu, who is credited with the discovery of artemisinin. Artemisinin has benefited hundreds of millions of people around the world. Yet the recognition for artemisinin’s discovery comes at a time when public health officials are becoming more concerned about its ongoing effectiveness and struggling to implement policies to slow the spread of artemisinin resistance. Continue reading

Research Ethics Extravaganza: New Draft CIOMS Guidelines

As if the proposed revisions to the Common Rule weren’t enough to process, the Council for International Organizations of Medical Sciences (CIOMS) just released its proposed changes to the current CIOMS Ethical Guidelines for Biomedical Research (last revised in 2002).  CIOMS invites public comments until March 1, 2016, at which point the CIOMS Working Group will process and review them and submit the final document to the CIOMS Executive Committee for approval.

According to CIOMS, most guidelines have been substantially revised in this draft, several have been merged, and new guidelines have been added.  The proposal also merges the guidelines for biomedical research with those for epidemiological research, and the scope has been broadened from biomedical research to health-related research with humans.

A busy and exciting time in research ethics!

The Impact of Broccoli II and Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: A grand finale of a juicy patents tale?

I am pleased to announce our recent paper entitled “The Impact of Broccoli II & Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: The grand finale of a juicy patents tale?”, which is available on SSRN, and forthcoming in Biotechnology Law Report, Vol. 34, Number 3 (June 2015), pp. 1-18.

Our analysis deals with a seminal judgment on the controversial and sometimes even emotionally debated European “Broccoli” and “Tomato” patents, which has captivated the European patent and plant science communities for many years: On March 25, 2015, the EBA of the European Patent Office (EBA) finally issued its much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”), clarifying the exclusion from patentability of essentially biological processes, such as conventional crossing and selection, and in particular its impact on the patentability of claims for products resulting from such processes. The so-called “Tomato II” case concerned an invention entitled “method for breeding tomatoes having reduced water content and product of the method,” whereas the so-called “Broccoli II” case involved an invention of a “method for selective increase of the anticarcinogenic glucosinolates in brassica species”. Continue reading

No Jab, No Pay: Australia’s Misguided Approach to Vaccine Refusal

Australia’s recently announced “no jab, no pay” policy offers a potent reminder of the all-too-common tendency to penalize vulnerable populations for public health problems. Like many other countries, Australia has experienced a worrisome increase in the number of families deciding not to vaccinate their children.  In response, the government of Prime Minister Tony Abbott has announced a program of carrots and sticks. The carrots include increased payments to physicians to incentivize them to urge families to vaccinate their children. The sticks include tightening the religious exemption (Australia does not provide an exemption for personal belief) and the “no jab, no policy” which will deny families whose children aren’t vaccinated certain income-based childcare and family tax benefits.

Governments have long used the denial of public benefits – traditionally public education – to push parents to vaccinate their children.  Studies have shown that laws conditioning attendance in schools and daycares on vaccination can increase vaccination rates, although the particular formulation of the law (especially how difficult it is to receive an exemption) matters.

To be sure, laws that require children to be vaccinated to attend schools or daycare impose heavier burdens on poor families who are more apt to need daycare and are less able to homeschool their children. Still, these laws reach broadly, especially when they apply to private schools. Homeschooling remains relatively rare. Significantly, school-based vaccine laws do not single out low-income families. Continue reading

The Place of Human Rights in Global Health Policy

Guest Post by Professor John Tasioulas

The international community is currently in the process of formulating the Sustainable Development Goals that will guide the post-2015 development agenda. Many UN bodies, NGOs, governments and members of civil society have in the past stressed the vital need to embed the SDGs in a human rights framework. However, in July 2014,  the UN’s Open Working Group on Sustainable Developments Goals, of which UK Prime Minister David Cameron is co-chair, issued an outcome document that largely shunned use of the words ‘human rights’.  Some have interpreted this as a major set-back for the role of human rights in the post-2015 development agenda. Indeed, one distinguished human rights lawyer, speaking at the Harvard Human Rights Program’s recent 30th anniversary event, was moved regretfully to announce that human rights are now out of fashion. The absence of any serious engagement with human rights in the outcome document is disturbing and highlights the urgent need to clarify the role that human rights should play in the development agenda.

In an article published in the Lancet, Effy Vayena and I focus specifically on the place of human rights in global health policy. Understanding human rights in the first instance as universal moral rights, we argue for two main propositions. First, global health policy needs to attend to more than just human rights, vitally important though such rights are. For example, it needs to encourage compliance with duties people have to themselves (e.g. to maintain a healthy diet and exercise regimen) and to foster health-related common goods (e.g. a compassionate culture of organ donation or participation in clinical trials). Human rights do not all by themselves exhaust the values that should guide global health policy.

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Highlights from the Consortium of Universities for Global Health Conference: Part III

By Guest Blogger Dan Traficonte 

In this third blog post covering my visit to the Consortium of Universities for Global Health Conference, I highlight some research from the conference focused on the importance of considering local social practices and belief systems into health policies and interventions.

Faduma Gure, a Master’s student in Interdisciplinary Health Sciences at the University of Ottowa, conducted fieldwork in Somalia to explore awareness of and attitudes to emergency contraception and their implications for health interventions. Somalia’s high fertility rate, high maternal mortality ratio, and low contraceptive prevalence rate coupled with restrictive abortion laws make addressing the lack of family planning services an extreme challenge. In conflict or post-conflict settings like Somalia, emergency contraception can be critical for pregnancy prevention, yet Somalia remains one of the few countries in the world without a registered progestin-only emergency contraceptive pill.

Ms. Gure conducted a qualitative, multi-methods study comprised of structured interviews with key informants, including physicians, non-governmental officials, government officials, local Somali pharmacists, and married and unmarried Somali women. Most participants showed little knowledge of existing family planning methods or emergency contraception, however, once contraception was described, all participants expressed tremendous enthusiasm for expanding access to post-coital contraceptive methods in Somalia. All participants expressed that an available emergency contraceptive would fill a major gap in reproductive health service delivery, and all government officials interviewed indicated that emergency contraception could easily be incorporated into the existing health system.

It is a common belief—and often a misconception—that people in conflict-torn and impoverished countries like Somalia reject modern medical technologies due to conflicting local practices and beliefs. Ms. Gure’s preliminary research indicates that the lack of emergency contraception in Somalia does not result from local beliefs, but from lack of knowledge and access to the technology.

Dan Traficonte is a 1L at Harvard Law School interested in the intersection of global health and international development.

Highlights from the Consortium of Universities for Global Health Conference: Part II

By Guest Blogger Dan Traficonte 

In this second blog post covering my visit to the Consortium of Universities for Global Health Conference, I highlight some fascinating new research on the relationship between global poverty and population health.

Dr. Joseph Dieleman from the Institute for Health Metrics and Evaluation at the University of Washington presented his research on national poverty rates of 129 countries and their effect on mortality. Typically in the global health literature, a country’s wealth serves as a predictor of population health outcomes—that is, wealth means health. However, the relationship between poverty and health outcomes has not been systematically evaluated in cross-country studies because of insufficient data. Dr. Dieleman sought to address this relationship and show how poverty can explain variation in health using 22 complete poverty and health data series.

Building on the World Bank’s International Comparison Program dataset of 800+ household surveys, Dr. Dieleman used covariates and intertemporal trends to generate a complete data series for 129 countries for 1990-2013. To predict national poverty rates at 51 different income thresholds, 20 variants of three models were supported by out-of-sample validation to choose the best model. Finally, Dr. Dieleman incorporated health data into his model using fixed-effects linear regression techniques to test how national poverty rates are associated with changes in adult and child mortality. Continue reading

Highlights from the Consortium of Universities for Global Health Conference: Part I

By Guest Blogger Dan Traficonte

Recently, the Petrie-Flom Center sent me to the 6th Annual Consortium of Universities for Global Health Conference in downtown Boston, where students, researchers and health professionals from around the world gathered to network and share ideas. The conference’s focus covered a broad range of pressing global health issues, including the Ebola crisis of 2014, food security, and the impact of climate change on the health of populations worldwide. I was able to meet and chat with many people doing fascinating work in the global health field, and I will highlight here a few of the most interesting presentations linked directly to issues of law, governance, and health policy.

Dr. Pooja Agrawal from the Yale School of Medicine presented her research on the impact of the Affordable Care Act on health insurance access, coverage, and costs for refugees resettled in the United States. Dr. Agrawal’s research sought to assess the relationship between refugee resettlement patterns and improvements to health insurance access created by the ACA—specifically, are refugees in the United States generally able to benefit from the enactment of Medicaid expansion and implementation of healthcare insurance exchanges?

Using a cross-sectional analysis of 2012 refugee resettlement data from all 50 states, Dr. Agrawal compared resettlement trends for states that have expanded Medicaid and implemented exchange schemes and those states that have not. The results of this analysis indicate that in 2012, more refugees were resettled to states that have not expanded Medicaid or created state health insurance exchanges. Though there is currently no data on the effect of these differences on refugee health outcomes, these results implicate important policy concerns: specifically, the architects of refugee resettlement policies may choose to consider between-state variation in access to insurance as a result of the ACA in devising resettlement strategies. Dr. Agrawal’s research highlights an often-underemphasized area of intersection of law and social policy, and calls for more research on the impact of the ACA on refugee populations in the United States.

Dan Traficonte is a 1L at Harvard Law School interested in the intersection of global health and international development.

Biosecurity in a Globalised World Conference: The Adoption of the Revised International Health Regulations – 10 Years On


In 2015 it will be 10 years since the adoption of the revised International Health Regulations (IHR). To mark this important anniversary, QUT’s Australian Centre for Health Law Research is pleased to invite you to Biosecurity in a Globalised World: The Adoption of the Revised International Health Regulations – 10 Years On.

The conference will be hosted by the Australian Centre for Health Law Research at Queensland University of Technology’s Gardens Point campus in Brisbane from 27-28 July 2015.

The conference will provide a forum for scholars and policy makers to discuss and present on the progress achieved through the IHR to date, and the important work yet to be done.

The keynote address will be delivered by Professor Lawrence O. Gostin, Founding O’Neill Chair in Global Health Law, Georgetown University, USA.

Themes to be discussed at the conference include:

  • Development of IHR core capacities
  • Regulatory responses
  • Securitisation of infectious disease outbreaks
  • Human rights
  • Papers from all disciplines and areas of expertise are welcome.

For further information please visit

If you have any questions, or require any assistance, please contact

TOMORROW (3/11): Identified versus Statistical Lives: An Interdisciplinary Approach Book Launch

Identified_Lives_posterBook Launch: Identified versus Statistical Lives: An Interdisciplinary Approach

March 11, 2015 12:00 PM

Wasserstein Hall, Room 2012 Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Identified versus Statistical Lives: An Interdisciplinary Approach is an edited volume that grew out of the 2012 conference “Identified versus Statistical Lives: Ethics and Public Policy,” cosponsored by the Petrie-Flom Center, Edmond J. Safra Center for Ethics, and the Harvard Global Health Institute. The essays address the identified lives effect, which describes the fact that people demonstrate a stronger inclination to assist persons and groups identified as at high risk of great harm than those who will or already suffer similar harm, but endure unidentified. As a result of this effect, we allocate resources reactively rather than proactively, prioritizing treatment over prevention. Such bias raises practical and ethical questions that extend to almost every aspect of human life and politics.

The book talk and discussion will feature:

  • I. Glenn Cohen, co-editor, Petrie-Flom Faculty Director, Professor of Law at Harvard Law School
  • Norman Daniels, co-editor, Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Nir Eyal, co-editor, Professor of Global Health and Social Medicine (Medical Ethics), Harvard Medical School

Co-sponsored by the Harvard Law School Library, with support from the Harvard Global Health Institute.