Ethics for CRISPR and the Big Leap Forward

By Kelsey Berry

This week, a research group in China published a paper describing a significant step forward in one application of the genome editing technique CRISPR: they used it to modify the genome of non-viable human embryos. Now, the scientific community finds itself grasping for ethical and legal foundations in order to evaluate the implications of this work and its possible extensions. Bioethicists and philosophers have been laying these foundations for years. Yet, the key problem, as always, is in translation: as we shift from science fiction to scientific reality, the robust and rigorous literature on the ethics of human population enhancement must find its way to usefully inform the policy debate and scientific practice. Translation between these camps can be thorny, but it must start with convergence on the issues at stake. Here’s a quick primer on the issue:

The spark: A team out of Sun Yat-sen University in Guangzhou led by Junjiu Huang used the CRISPR technique in non-viable human embryos to modify the gene responsible for a potentially fatal blood disorder. Leading journals Science and Nature denied the group publication on ethical grounds; the paper can be found in Protein & Cell. This is the first time that the CRISPR technique has been used to modify the human germline; however, the team specifically selected non-viable embryos in which to conduct the experiment in order to side step some of the most pressing ethical concerns.

The technology: CRISPR, which stands for “clustered regularly interspaced short palindromic repeats” refers to DNA loci that contain repeated base sequences, separated by other sequences called spacers. These spacers are like memories from previous exposure to a virus, and they tell the biological system which invaders to look out for and destroy – a key part of an adaptive immune system. In 2012, a team led by Doudna and Charpentier showed that CRISPRs could also be used to zero in on DNA sequences of their choosing simply by introducing synthetic guide RNA that matched the DNA sequence they wished to target. The CRISPR system would then slice up the targeted DNA sequence, either knocking out a gene entirely or allowing researchers to insert a “patch,” which if incorporated into the DNA sequence would modify the target gene. Since 2012 this technique has been shown to work in several organisms, including in human cells.

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 this year,  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.

Continue reading

Medicare’s Costly Drug Problem

By Zack Buck

Last week, Dr. Salomon Melgen, an ophthalmologist who practices in North Palm Beach, Florida, was indicted on Medicare fraud charges. Melgen was charged with a variety of crimes, with prosecutors alleging he falsely diagnosed patients and falsified their files. Melgen’s name may be familiar. Last year, he was reported to be the provider with the highest total of Medicare Part B reimbursements in 2012, reportedly reimbursed by Medicare for more than $20 million, a substantial percentage of which was directly based upon his prescriptions for, and administration of, the drug Lucentis.

But the allegations against Melgen highlight a deeper challenge facing Medicare.

Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we are joined by Michelle Meyer, Professor and Director of Bioethics Policy in the Union Graduate College–Icahn School of Medicine at Mount Sinai Bioethics Program. We primarily discussed the ethics of digital experimentation and e-Research, with an eye to controversies over Facebook and OkCupid and the launch of innovative research platforms such as ResearchKit.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Bioethicists Art Caplan & Tom Mayo: Lawmakers have no business legislating end-of-life decisions

A new piece by contributor Art Caplan along with Tom Mayo in The Dallas Morning News:

This week, the Texas Legislature considered restoring to pregnant women a right every other adult Texan already enjoys: the right to make health-care treatment decisions in an advance directive or through the next-of-kin who speaks for them.

House Bill 3183 would eliminate all vestiges of the “pregnancy exclusion” from Texas’ Advance Directives Act. If it passes, the bill would remove the basis on which a Fort Worth hospital in 2013 kept brain-dead and pregnant Marlise Muñoz on life support for two months. This was done despite her husband’s insistence that his wife would not want to be hooked up to machines under those circumstances.

Eventually, a trial court agreed with her husband and declared that the pregnancy exclusion and the entire Advance Directives Act did not apply to a patient once she had died. That was only after Marlise Muñoz’s family had to endure the unimaginable pain of watching her corpse deteriorate before their eyes. Little wonder that they support “Marlise’s Law” and were in Austin to testify in support of the bill. […]

Read the full article here.

Think Tanks on Prescription Drug Coverage – Missed Opportunity

By Lydia Stewart Ferreira

Two Canadian think tanks – the C.D. Howe Institute and the Institute for Research on Public Policy – recently issued contradicting reports on whether prescription drug plans should be age-based or income-based.

As background, medications prescribed outside a Canadian hospital setting are not covered by Canada’s medicare system. They are financed through a patchwork of private and public drug insurance plans that only provide coverage for select populations. For example, up until the late 1990s, people 65 and older received universal, public drug coverage in most provinces. But with population aging, the public liability associated with age entitlements has become a major concern for governments. Four Canadian provinces have discontinued their age-based programs, which covered most of the cost of medications for seniors, and replaced them with income-based programs, which protect all residents against catastrophic drug costs. Other provinces have started to move or are considering moving in this direction.

The C.D. Howe Institute think tank concluded that provincial drug plan benefits based on age are ‘outdated’ and drug plan benefits should be based on income instead. “[I]ncome-based plans are a better alternative for cash-constrained provinces and offer more equitable access to public benefits.”

Continue reading

Larissa

Larissa MacFarquhar has been a staff writer at The New Yorker since 1998. Her subjects have included John Ashbery and Edward Albee, among many others. Before joining the magazine, she was a senior editor at Lingua Franca and an advisory editor at The Paris Review. She is working on a book about extremely ethical lives.

RSVP

Harvard U Effective Altruism presents: Derek Parfit discusses altruistic giving

PArfitFacebook RSVP

When: Tuesday, April 21, 6:00pm Where: Harvard campus, Science Center E

Oxford and Harvard philosopher Derek Parfit is described by Encyclopaedia Britannica as “the most important moral philosopher of the 20th and early 21st centuries”.  The New Yorker called his books “the most important works to be written in the field in more than a century.”  He will be discussing personal identity, future generations, ethics  and Effective Altruism in a fireside chat moderated by ethicist Nir Eyal, Associate Professor of Global Health and Population at the Harvard T.H. Chan School of Public Health.

This event is co-sponsored by Harvard University Effective Altruism (HUEA) and Harvard College Effective Altruism (HCEA), and is open to the public.

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

A new piece by contributor Art Caplan on NBC News:

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

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

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

Read the full article here.

What Does Indiana’s Religious Freedom Law Mean For Health Care?

A new post by the Petrie-Flom Center’s Executive Director Holly Fernandez Lynch on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

By now, we’ve all heard the commotion around Indiana’s new Religious Freedom Restoration Act (RFRA), although it appears that the public’s fickle attention has already moved on to other matters. Despite some headlines to the contrary, the law originally said nothing explicitly about discrimination on the basis of sexual orientation. It focused exclusively on religious freedom, allowing the government to impose a substantial burden on “any exercise of religion” only if it is able to demonstrate that burdening the person in question is the least restrictive means of furthering a compelling governmental interest.

In line with the Supreme Court’s opinion in Hobby Lobby, which held that corporations are persons capable of exercising religion, the Indiana law defines “person” to include individuals, organizations organized for religious purposes, and business entities that “may sue and be sued” and exercise “practices that are compelled or limited by a system of religious belief held by: (i) an individual; or (ii) the individuals; who have control and substantial ownership of the entity, regardless of whether the entity is organized or operated for profit or nonprofit purposes.” […]

Read the full article here.

China stops using executed prisoners as a source of organs for transplants

By Lydia Stewart Ferreira

According to the Lancet, China will stop using executed prisoners as a source of organs for transplants as of January 1, 2015. After January 1, 2015, “only voluntary donated organs from civilians can be used in transplants.” This decision was officially announced December 3, 2014 by Jiefu Huang, the former vice-Minister of Health at a seminar of China’s Organ Procurement Organization. While China needs to be commended for this government initiative, I find the fact that this initiative takes effect in 2015 quite shocking.

China has one of the largest organ transplant systems in the world, yet it has one of the lowest levels of organ donation – with a rate of 0.6 per 1 million people. In a 2011 Lancet article, Huang and colleagues reported that 65% of transplants in China used organs from deceased donors, more than 90% of whom were executed prisoners. The Lancet also reports that since 1984, it has been legal in China to harvest the organs of executed prisoners with the consent of the prisoner or their family. It was not until 2007 that China implemented its first legal regulatory framework for the oversight of their organ transplant system. In 2013, China went on to establish a national electronic organ allocation system.

Clearly, China has had a government endorsed organ procurement system. However, this procurement system has been internationally condemned by medical, scientific and human rights organizations. There were concerns about coercion, exploitation, undue inducement, non-existent consent, unjustified paternalism and the corruption of organ allocation. This organ procurement system used by China was legal under Chinese law. It is not clear to what extent illegal organ procurement – through transplant tourism and the black market sale of organs – was and is also taking place in China.

Continue reading

Worth Reading This Week

By Nicolas Terry (comments to @nicolasterry on twitter)

Remembering Alan Wertheimer: Not Only a Philosopher’s Philosopher but a Lawyer’s Philosopher

When I was young I wanted to be Alan Wertheimer. When I first read him as an undergrad in courses in ethics and in law and philosophy he was one of the twentieth century writers in the field I most admired (along with Bernard Williams, Joel Feinberg, and a few other august names). His clarity, his insight, and his thinking on topics like exploitation and coercion served to me as a model for what I wanted to do with my life.

Thus it was a true honor to, like Emily, get to know him personally over the last few years. To all the superlatives about him that jump out from the page I can add that in real life he was a real mentsch, an amazing reader and mentor, who I will miss very much.

What is perhaps most impressive about Alan is that he was not only a consummate philosopher’s philosopher, but also a lawyer’s philosopher. A quick search I did for his work in the secondary sources database in Westlaw show 442 separate law papers citing to his work. He has had a significant impact on not only bioethics, but contracts, law and sexuality, constitutional law, and the legal profession. Indeed, as a parting salute to this great thinker let me highlight one of his papers that never achieved the recognition I think it deserved (it inspired some of my own writing): The Equalization of Legal Resources from 1988 in Philosophy and Public Affairs.

Goodbye Alan, you will be missed, but very much remembered.

Webinar, 5/6: Policy Surveillance and Public Health

May 6, 2015 at 12 p.m. ET

Policy surveillance is the ongoing, systematic collection, analysis, and dissemination of data about laws and policies. There is a long tradition of conducting “50 state surveys” to identify laws of public health significance, but the methods for creating these surveys are largely unscientific. Unlike this traditional legal research, policy surveillance uses systematic quantitative and qualitative coding to create scientific datasets and track policies over time. Throughout the past year the Robert Wood Johnson Foundation’s Public Health Law Research program, the Network for Public Health Law, ChangeLab Solutions and the CDC Public Health Law Program have been exploring policy surveillance through a Delphi process and within their programs. This webinar will present the findings from that Delphi study and will explore the role of policy surveillance in understanding the impact of law on public health.

Presenters include:

  • Jennifer Ibrahim, PhD, MPH, Associate Director, Public Health Law Research program, Associate Professor, College of Public Health at Temple University
  • David Presley, JD, Policy Surveillance Manager, Public Health Law Research program
  • Matthew Penn, JD, MLIS, Director, Centers for Disease Control and Prevention, Public Health Law Program
  • Donna Levin, JD, Director, Network for Public Health Law (Moderator)

Register here.

TWO Upcoming Events (5/7-5/9): “After Hobby Lobby: What Is Caesar’s, What Is God’s?” & “Law, Religion, and Health in America”

Pre-Conference Session

Hobby_Lobby_slide_270_174_85“After Hobby Lobby: What Is Caesar’s, What Is God’s?”
May 7, 2015, 4:00 – 6:00 PM
Wasserstein Hall, Milstein East BC
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]

As prelude to the 2015 Petrie-Flom Center Annual Conference, “Law, Religion, and Health in America,” please join us for a pre-conference session examining the role of religion in the American public sphere. Our expert panel will discuss the nature of conscience and conscientious objection, religious freedom, and religious accommodation from philosophical, theological, historical, legal, and political perspectives.

Panelists:

  • J. Dionne, Jr., Columnist, The Washington Post; Senior Fellow, The Brookings Institution
  • Diane L. Moore, Senior Lecturer on Religious Studies and Education and Senior Fellow at the Center for the Study of World Religions, Harvard Divinity School
  • Charles Fried, Beneficial Professor of Law, Harvard Law School
  • Frank Wolf, Representative, Virginia’s 10th Congressional District, U.S. House of Representatives, 1981-2015 (retired)
  • Moderator: Daniel Carpenter, Freed Professor of Government, Harvard University and Director, Center for American Political Studies at Harvard University
  • Moderator:  Glenn Cohen, Professor of Law, Harvard Law School and Faculty Director, Petrie-Flom Center

The panel will be followed by a light reception at 6PM.

This event is free and open to the public, but seating is limitedRegister online!

 Full Conference:
stethoscope_bible_slide“Law, Religion, and Health in America”
May 8-9, 2015
Wasserstein Hall
Milstein East ABC

Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA [Map]

Religion and medicine have historically gone hand in hand, but increasingly have come into conflict in the U.S. as health care has become both more secular and more heavily regulated.  Law has a dual role here, simultaneously generating conflict between religion and health care, for example through new coverage mandates or legally permissible medical interventions that violate religious norms, while also acting as a tool for religious accommodation and protection of conscience. 

This conference will identify the various ways in which law intersects with religion and health care in the United States, understand the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

Highlights:

Keynote Lecture: Religious Liberty, Health Care, and the Culture Wars

Plenary Session: The Contraceptives Coverage Mandate Litigation

The conference is free and open to the public, but seating is limited. View the full agenda and register online!

The pre-conference session is co-sponsored by the Petrie-Flom Center and the Ambassador John L. Loeb, Jr. Initiative on Religious Freedom and Its Implications at the Center for American Political Studies at Harvard University.

The 2015 Petrie-Flom Center Annual Conference, Law, Religion, and Health in America, is supported by the Oswald DeN. Cammann Fund.

Remembering Alan Wertheimer

By Emily Largent

A week ago, I received the sad news that Alan Wertheimer had passed away. Alan made many important contributions to the philosophical literature, including Coercion and Exploitation. And while Alan would tell you that he did not identify as a bioethicist, he made significant contributions to the bioethics literature as well. I am certain his work will continue to be influential in many areas.

On a personal note, Alan was a mentor and friend. I truly appreciated his intellectual generosity and his many kindnesses toward me.

I met Alan while I was a pre-doctoral fellow in the Department of Bioethics at the NIH. My initial impressions of him were shaped by the vivid and incisive hypotheticals he offered for our consideration; the pointed questions he asked in the Department’s Works in Progress sessions (which have a reputation for “combative collegiality”); the thoughtful and rapid comments he made on manuscripts; and a surprisingly competitive bowling outing that Alan took with the Department of Bioethics fellows. Continue reading

King of the Tribe

Larry Tribe is stirring up trouble, and to do it, he’s relying in part on an argument I made (and Justice Kennedy seemingly adopted) in King v. Burwell. But Tribe’s King isn’t at all the same as my King. (And we don’t yet know what the Court’s King will look like.) Here’s the story.

In arguments before the D.C. Circuit on April 16, Tribe argued on behalf of several private and state intervenors that the EPA’s proposed Clean Power Plan exceeds the agency’s jurisdiction. The proposed rule would require states to enforce tough limits on their power plants’ carbon dioxide emissions, but if any state didn’t want the regulatory task, the Clean Air Act (CAA) would allow that state to turn the regulatory regime over to federal regulation within the state’s borders. In addition to arguing that EPA lacks jurisdiction to regulate power plants under the relevant statutory provision (CAA § 111(d)), Tribe argues that the proposed rule would violate the anti-commandeering doctrine by giving states a Hobson’s choice; either they must incur extreme regulatory costs themselves, or they must turn over their power systems to an undefined federal regulatory scheme that is, practically speaking, very unlikely to function well. No rational state, Tribe argues, would choose the unknown and likely dysfunctional federal scheme, especially in a realm as important and sensitive as electric power.

In testimony before the House Energy and Commerce Committee and in an online debate with his Harvard Law School colleagues Jody Freeman and Richard Lazarus, Tribe has analogized his anti-commandeering argument to the anti-coercion questions that Justice Kennedy asked in King (questions that seemed to arise from my amicus brief). Tribe’s point, as far as I can tell, is that the federal government is threatening the states with a federal fallback option that is likely to wreak havoc on the states’ energy systems.

Continue reading

Quality Measures and Doctor Behaviors

by Vadim Shteyler

Efforts to improve health care quality under the ACA have been directed towards expanding EHR use and health IT, improving care delivery by promoting care coordination and population health, and laying incentives for providers to meet quality measures. The 33 ACO quality measures include 8 measures to evaluate preventive care, 12 measures to address goals of managing 4 common diseases, and 7 to assess patient satisfaction. Though quality improvements have not been consistently shown, studies have found modest Medicare spending reductions. In fiscal year 2013, CMS began reducing health care reimbursement rates to hospitals with excessive 30-day readmission rates, as generalized by their readmission rates for heart attacks, heart failure, and pneumonias. These were extended to include readmission rates for hip and knee surgeries in fiscal year 2015. And, as readmissions were estimated to account for $17.5 billion of Medicare costs in 2012 (in part attributable to insufficient discharge services, access to outpatient care, and follow-up), efforts to curb them are expected to continue.

The ACO quality measures have been criticized for being too process oriented (as opposed to outcomes oriented). And, undoubtedly, so few quality measures can’t encapsulate all of health care. Noted shortcomings of readmission rates as a valid indicator of quality include that they do not differentiate between planned and unplanned readmissions and they don’t adequately control for different case-mixes between hospitals. As psychiatric illness is often poorly recorded in medical records, it is a major confounder that may impact different hospitals differently. In this blog post, I add the speculative concerns of a medical student from limited experiences on the wards. Continue reading