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.

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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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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.

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‘The Week in Health Law’ Podcast

By Nicolas Terry

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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

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.”

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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.

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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.

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.

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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.

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Check out the latest news from the Petrie-Flom Center!

Check out the April 17th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

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2015-2016 Petrie-Flom Student Fellowships

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas. More information on our current fellows and their work, is available on this website.

Eligibility: The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements.  Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs at Harvard to wait until after their first year to apply.
Resources: The Center will award each fellow a $1,500 stipend, paid at the end of the academic year once all fellowship requirements (including submission of an acceptable paper) are completed. Additionally, fellows may be eligible to request additional funding to cover reasonable costs associated with their research projects (e.g., copying, publications, conference fees, travel).
Application: Applications will be accepted on a rolling basis until 9AM, Friday, August 7, 2015. Notifications of awards will be made by August 21, 2015.

View the full requirements and application instructions on the call for applications.

 For more on news and events at Petrie-Flom, see the full newsletter.

How to Fix Our Hospital Pricing Problem (and How Not To)

Guest post by Erin Fuse Brown
[Cross-posted from Center for Law, Health and Society Blog]

Last month, Slate columnist Reihan Salam wrote a provocative article about outrageous hospital prices that are driven, according to Salam, by greed, avarice, and market power. Salam gets a few things dead right, namely his diagnosis that we have a massive hospital pricing problem that is bleeding us dry and that the problem is largely caused by growing hospital market power. However, he misses the mark when laying out policy recommendations to curb monopoly-driven hospital prices.

The solutions

Antitrust:  Salam favors using antitrust enforcement to prevent health care consolidation and to reduce barriers to entry for competition. The biggest problem with antitrust enforcement is that it can do little to reverse or break up existing monopolies. Antitrust laws will be unable to help the vast majority of hospital markets that are already concentrated. Second, even with its improving success rate in court, the FTC simply cannot prevent or police the ongoing wave of hospital mergers, resulting in price increases up to 40% price increases in some areas. To be sure, increased antitrust enforcement is a necessary element of the strategy to control hospital prices to stem the tide of consolidation that is driving prices upward. But antitrust is no silver bullet, especially for hospital markets that have already become noncompetitive. Continue reading

My Plan to Avoid the Ravages of Extreme Dementia

Guest Post by Norman L. Cantor
Professor of Law and Justice Nathan L. Jacobs Scholar Emeritus
Rutgers School of Law – Newark

The first signs of my friend Gertie’s descent into dementia were mild — confusion about days of the week and memory loss about recent events. These were troubling but understandable phenomena in my then 84 year-old friend. Aging inevitably entails some cognitive decline. Over time, though, her symptoms of mental deterioration worsened — disinterest in pursuits like reading and listening to music that had once occupied and entertained her, forgetting not just long-time friends, but even her devoted husband who had died years earlier, and obsessive repetition of certain thoughts and phrases. Now 89, Gertie barely recognizes the devoted caregivers around her. She cannot recall her distant or recent past, she no longer knows who or where she is. Gertie remains physically tenacious, with no life-threatening maladies. While dependent on assistance for dressing, eating, ambulating, bathing, and toileting, Gertie may continue in her mentally detached and dysfunctional limbo for years more.

I am determined to avoid Gertie’s fate. So I am now contemplating how to respond if and when I am diagnosed with early Alzheimer’s. My prime object is to avoid the precipitous mental deterioration accompanying advanced Alzheimer’s or similar dementia. My aversion is not based on prospective emotional distress and suffering. While some people in sharp mental decline may experience anxiety, frustration, embarrassment, confusion, or agitation, some, like Gertie, seem placid and indifferent to their debilitation. My aversion is grounded rather in my abhorrence of reduced mental function to a degree I deem intolerably demeaning. Such a status is unacceptable to me whether or not I would experience distress in a future demented state.

Keep in mind that I spent my work career as an academic. My personal satisfaction and self-image have flowed largely from intellectual functions like observation, reflection, and analysis. Inability to understand and process information is, for me, an intolerably undignified status. This preoccupation with future mental dysfunction reflects unwillingness to soil the lifetime image to be left with my survivors. I care mightily about posthumous recollections of my personality and I seek to shape my life trajectory (including a dying process) in a way that preserves a modicum of dignity. Continue reading

Mainstreaming Medical Legal Partnerships (MLPs)

Last week, I had the opportunity to speak at the 10th Annual Summit of the National Center for Medical Legal Partnership in McLean, Virginia. The summit brought together more than 400 people working to “mainstream” medical legal partnerships (MLPs). The theory of change is that through these partnerships, the health care sector can begin to more systematically address social, behavioral and environmental determinants of health. Particularly on behalf of patients who are low-income, legal professionals address root causes of illness by working with utilities companies, landlords, social service agencies and the court system.

Concretely, MLPs are programs in which civil legal aid agencies, health care organizations and public health departments cooperate to train their staffs, treat individuals and identify population level problems. Most often, it is civil legal aid agencies that provide expertise in the laws around housing and public benefits, and spend their resources to ensure access to housing subsidies, food benefits, health insurance and employment. Some law firms also contribute pro bono time to the cause, as do some law schools in the form of clinics.

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Ending Institutional Corruption Conference, May 1 & 2

On Friday, May 1, and Saturday, May 2, several Petrie-Flom Center affiliates will participate in the Edmond J. Safra Center for Ethics at Harvard University conference “Ending Institutional Corruption,” held in the Milstein Rooms in Wasserstein Hall at Harvard Law School. Participants include:

  • Christopher T. Robertson, Academic Fellow alumnus, speaking on “The Institutional Advantages of Courts, and the Potential of Litigation, as a Solution to Institutional Corruption”
  • Christine Baugh, 2014-2015 Student Fellow, conference co-organizer
  • Aaron S. Kesselheim, affiliated faculty member, speaking on “Trends in the Use of Expedited Drug Review and Approval Designations at the FDA”
  • Judge Nancy Gertner, affiliated faculty member, speaking on “The Limits of the Criminal Sanction”

For a full description of the conference, a complete agenda, and registration information, click here!