Bioethicist Art Caplan: Planned Parenthood’s awkward clash

A new opinion piece by contributor Art Caplan in The Chicago Tribune (free registration required):

Planned Parenthood finds itself under attack by anti-abortion activists. Not much new about that. But the terrain of the battle has shifted. The way in which fetal tissue for research is obtained at Planned Parenthood clinics is now center stage.

Planned Parenthood stands accused, as a result of a sting operation launched by anti-abortion political operatives, of selling “baby parts” for profit. Edited videos show individuals pretending to be tissue brokers discussing with Planned Parenthood doctors how to get fetal tissue, the cost for tissues, techniques for increasing the chance of obtaining particular tissues and other related issues. The doctors do not come across well. Discussions are in restaurants, there is wine on the table, the attitudes are cavalier and the doctors don’t seem to pick up on the cues that they are getting set up. […]

Read the full article here.

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

Check out the July 24th 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:

November 4, 2015 1:00 – 5:30 PM  
Harvard Law School

Please join us for an afternoon of reflection on the life, work, and enduring influence of Professor Alan Wertheimer (1942-2015). Professor Wertheimer was a leading philosopher of law and bioethics, making critical contributions to clinical research ethics; theories of coercion, undue influence, and exploitation; consent in a variety of contexts, and much more. This tribute event will feature leading scholars discussing and engaging with Professor Wertheimer’s many contributions, and exploring how he influenced their own work.

At the time of his death in 2015, Alan Wertheimer was Senior Research Scholar in the Department of Bioethics at the National Institutes of Health. He was Professor Emeritus of Political Science at the University of Vermont, where he taught from 1968 to 2005 and was honored as University Scholar in 1995-1996. Before retiring from UVM, he was also John G. McCullough Professor of Political Science. He authored  Coercion (Princeton University Press, 1987), Exploitation (Princeton University Press, 1996), Consent to Sexual Relations (Cambridge University Press, 2003) and Rethinking the Ethics of Clinical Research: Widening the Lens (Oxford University Press, 2011). He was twice a Visiting Professor at the Harvard Kennedy School of Government, and held fellowships at the Institute of Advanced Study, Princeton (1984-85) and the Program in Ethics and the Professions, Harvard University (1989-90).

This event is free and open to the public but seating is limited and registration is required. Register now online

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

Check out the July 10th 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:
AGENDA NOW AVAILABLE!
Specimen Science: Ethics and Policy Implications

November 16, 2015
8:00 AM – 5:00 PM

Harvard Law School
Room TBD 

Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data. However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.

Please join us for a symposium to discuss the key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery. The experts at this day-long event will cover key topics, such as historical, legal, and international perspectives; donor attitudes, researcher perspectives, and institutional considerations; broad vs. specific informed consent; privacy, ownership, and control; use of specimens collected through mandatory newborn screening; research with discrete and insular populations; and others. Conference papers eventually will be published as an edited volume with a major academic press.

For a full agenda and to register for this event, visit our website

This event is a collaboration between Case Western Reserve University, the Petrie-Flom Center at Harvard Law School, and the Multi-Regional Clinical Trials Center at Harvard. It is supported by funding from the National Human Genome Research Institute.

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

Medical Device Tax: Back in the News Post-King

By Gregory Curfman

Just when the Affordable Care Act (ACA) has won a second major Supreme Court victory in King v. Burwell, conservative critics of the ACA are back on the attack, this time directing their ire towards the medical device tax. Having lost the battle on subsidies, they are now focusing on the device tax as the prime target in their attempt to overturn parts of the ACA. This 2.3% excise tax levied on the medical device industry is stipulated as one of the tax provisions in the ACA. The rationale is that since the ACA provides coverage for many more people, thus bringing more business to the industry, it is reasonable to ask the industry to pay something back to support the programmatic mission of the ACA.

From the beginning, the medical device industry has strongly objected to the excise tax, claiming it will stifle innovation by taking away funds that would otherwise be used for new product research and development. For example, Dr. Thomas Stossel of Harvard Medical School, a conservative voice on health issues, recently wrote: “A 2.3 percent tax on sales can easily mean the difference between commercial success and bankruptcy: borderline profits become losses and investors flee to less risky ventures. Brute force taxes destabilize the fragile innovation ecosystem.” Continue reading

Onward And Upward For The ACA After King v. Burwell

Christie Hager, a speaker at the Petrie-Flom Center’s “King v. Burwell and the Future of the Affordable Care Act” conference on April 1 has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision. From the piece: 

Chief Justice Roberts, in the majority opinion in King v. Burwell, confirmed that the only insurance spiral now is one onward and upward for the millions of Americans who will benefit from the peace of mind and protections of the Affordable Care Act (ACA) as passed by Congress and signed by President Obama.

Among the many benefits of the ACA, Exchanges have been operating in some form to increase coverage in every state since 2013. Millions of lives have been changed or saved as a result. Many legal theorists and Supreme Court observers are rightly praising the sound legal reasoning and Constitutional principles in action that led to upholding key aspects of the Affordable Care Act (again).

It is a stark example of the relationship among the three branches created by the Constitution: Legislative drafting and passage, Executive implementation, and Judicial interpretation of language that in this case may have been less than clear. Additionally, the practical implications of the Court’s decision also are particularly salient. […]

Read the full piece here.

Reproductive Malpractice and the U.S. Military

Check out the new op-ed at HuffPo by Bill of Health bloggers Dov Fox and Alex Stein on the unfair treatment of American servicewomen (and their children) under the Feres doctrine should they fall victim to medical malpractice during their pregnancy or delivery. Fox and Stein call for SCOTUS to fix the loophole it left open in the 1950 case, or for Congress to “set up a fund for compensating children whose disabilities were caused by substandard care at military medical facilities.”  Take a look at the full post here.

King v. Burwell And The Importance Of State Politics

David K. Jones of the Boston University School of Public Health and a speaker at the Petrie-Flom Center’s “King v. Burwell and the Future of the Affordable Care Act” conference on April 1, has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision. From the piece: 

The Supreme Court’s decision in King v. Burwell brings an important chapter of the Affordable Care Act’s (ACA) implementation to a close. The fight about health reform is not over, with Republican presidential candidates promising to repeal the law while supporters of the law push for Medicaid expansion and the development of Accountable Care Organizations.

But it is important to pause and reflect on what we have learned the last five years. This is uncharted territory for supporters of comprehensive health reform who for so many decades studied why legislation was so difficult to enact rather than how complicated it is to implement. […]

Read the full piece here.

King v. Burwell And A Right To Health Care

Bill of Health contributor Gregory Curfman has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision in King v. Burwell in the broader context of Americans’ right to care. From the piece:

Do Americans have a fundamental right to health care? This oft-debated question is timely given the Supreme Court’s stunning ruling yesterday in King v. Burwell, in which health insurance subsidies on the federal exchange were upheld in a 6-3 decision.

Here I will place the King v. Burwell opinion in the larger context of to what extent Americans are provided a right to care. The Constitution itself does not stipulate a general right to health care, but a patchwork of rights to certain aspects of health care have emerged over time from both constitutional and statutory law.

Read the full piece at the Health Affairs Blog!

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

Check out the June 26th 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:
PFC_Logo_300x300APPLICATIONS OPEN!
2015-2016 Petrie-Flom Center Student Fellowship

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 Petrie-Flom Center Student Fellowship is a competitive one-year program designed to support Harvard graduate students interested in pursuing independent scholarly projects related to health law policy, biotechnology, and bioethics. With intensive mentorship from Petrie-Flom Center affiliates, student fellows are expected to produce a piece of publishable scholarship by the end of the academic year, at which point they are awarded a modest stipend. Student fellows blog regularly at Bill of Health, the Center’s blog, where their work receives substantial public exposure; participate in and organize Center events; and enroll in the Health Law Policy and Bioethics Workshop, which provides the opportunity to interact with leading scholars in the field.

Applications will be accepted on a rolling basis until 9AM, Friday, August 7, 2015. Notifications of awards will be made by August 21, 2015. For more information, please visit our website.

For further questions, contact Administrative Director Cristine Hutchison-Jones, chutchisonjones@law.harvard.edu.

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

Tackling Medicaid In Massachusetts

This new post by Jeffrey Sánchez appears 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.

The Affordable Care Act (ACA) provides a number of tools to address longstanding problems in our fragmented health care system. At the national level, the Centers for Medicare and Medicaid Services (CMS) are redefining Medicare through initiatives that promote payment and delivery reform, such as Shared Savings and Value-Based Purchasing. States are also seeking their own opportunities to move away from inefficient systems that reward volume over quality. In particular, state Medicaid programs have the potential to play a major role in these efforts.

Given the number of individuals Medicaid covers, it has the biggest potential impact in improving health care. Medicaid covers more than 1 in 5 Americans, funding more than 16 percent of total personal health spending in the United States. With ACA Medicaid expansion, enrollment increased in 2014 by 8.3 percent and led to an increased overall Medicaid spending growth of 10.2 percent. Total Medicaid spending growth in 2015 is expected to be 14.3 percent with a 13.2 percent enrollment growth. This is not an insignificant portion of both state and federal health care dollars. Thoughtful and concerted reforms to Medicaid have the potential to reduce spending and improve care quality. […]

Read the full article here.

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

Check out the June 12th 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:

NOW HIRING!

Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics

This is a newly created full-time position for a post-doctoral employee fellow in clinical research ethics to support the work of the Petrie-Flom Center at Harvard Law School in its collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, Harvard’s Clinical and Translational Science Center. The fellow must have strong knowledge of clinical research and its regulation, with particular interest in the regulatory, ethical, and practical aspects associated with recruitment and retention of research participants. The position will provide the opportunity to interact with a wide range of stakeholders, such as IRB members, administrators, investigators, institutional leadership, patient advocates, and other community members. This position allows for a maximum of 10% effort in furtherance of the fellow’s own research agenda(s) in related fields. Illustrative projects include the following:

  • Defining the clinical trials recruitment problem, including cataloguing various barriers to recruitment, outstanding data needs, and possible solutions, and developing a research agenda
  • Evaluating whether there are ways to prioritize trials and allocate research participants as a scarce resource
  • Considering innovative trial designs as a potential mechanism to address the recruitment problem
  • Developing a recruitment/retention toolkit to help investigators develop successful recruitment/retention plans
  • Addressing the proper parameters of remuneration to subjects
  • Developing surveys to learn more about participant motivations, expectations, and concerns
  • Conducting additional empirical research to develop knowledge that can improve clinical trial recruitment/retention

For more information and to apply, view the full job description!

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

How Institutional Review Boards Can Support Learning Health Systems While Providing Meaningful Oversight

This new post by Mildred Solomon appears 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.

Increasingly, health systems are studying their own practices in order to improve the quality of care they deliver. But many organizations do not know whether the data they collect at the point of care constitutes research, and if so, whether it requires informed consent. Further, many investigators report that institutional review boards (IRBs) place unreasonable burdens on learning activities, impeding systematic inquiry that is needed to enhance care.

As a result, some commentators have argued that our human research participant protection regulatory framework needs a dramatic overhaul. Yet, it is not the regulations that must change.

Instead, IRBs should educate themselves about quality improvement and comparative effectiveness research, exempt studies that qualify for exemption, and provide waivers to informed consent, when that is appropriate. At the Department of Health and Human Services, the Office for Human Research Protections (OHRP) must clarify the regulations that have an impact on this type of research, create better guidance about how IRBs should regulate such research, including illustrative case studies to guide IRBs.

Read the full post here.

Journal of Law and the Biosciences (JLB): Call for Harvard Student Submissions

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish  the  Journal  of  Law  and  Biosciences  (Oxford University Press), an online, open-access, peer-reviewed journal. JLB includes a New Developments section, comprised  of  brief  summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie-­Flom Center is responsible for providing the New Developments for one issue per annual volume.

We are currently seeking Harvard graduate students to contribute papers to be published in JLB’s New Developments section in early 2016. In previous years, New Developments have been generated from scratch specifically for JLB, based on selection from submitted proposals. This year, we are taking a different approach by publishing already complete (or to-be-completed by the deadline) original student papers (such as student notes, course papers, etc.) written by graduate students from any Harvard school.  New Developments are limited to 5000 words, including footnotes and references,  and  should  be  on  a  topic  of  relevance  to  law  and  the  biosciences,  in particular a topic of relatively recent concern, controversy, or change. They should focus on  describing  the  issue  at  hand,  explaining  why  it  is  relevant  to  scholars  and practitioners, and providing analysis and questions for further consideration.

Interested students should submit their papers and CVs for consideration no later than September 7, 2015 (earlier  is  welcome). Up  to  four  papers will be selected for publication in the New Developments section of JLB. Applicants will be notified by the end of September. Selected students will receive comments on their papers by the end of October, and will also be responsible for providing comments to the other selected students. Revisions will be due by the end of November, and final submissions to JLB will be due by the end of December 2015.

Please send all application materials, and direct all questions, to Holly Fernandez Lynch, hlynch@law.harvard.edu.

Upcoming Event (6/30): Visible Solutions – How Neuroimaging Helps Law Re-envision Pain

brain_pain_slide_270_174_85Visible Solutions:
How Neuroimaging Helps Law Re-envision Pain

Tuesday, June 30, 2015
8:00 AM – 5:00 PM
Wasserstein Hall, Milstein West A
Harvard Law School [Map]

Can brain imaging be a “pain-o-meter” that tells courts when a person is in pain? Can fMRI help us discern whether intractable chronic pain is “all in your head” or all in the brain – or will it require us to reconsider that distinction? Leading neuroscientists, legal scholars, and bioethicists will debate standards and limits on how the law can use brain science to get smarter about a subject that touches everyone.

Panelists include: Continue reading

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

pfc-web-logoCheck out the May 28th 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:

NEW EVENT!

glassesofwine_slidePetrie-Flom / Center for Bioethics Reception at ASLME 38th Annual Health Law Professors Conference

June 4, 2015 7:30 – 9:30 PM
Hilton St. Louis at the Ballpark
1 South Broadway, St. Louis, MO

Come learn more about the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School at this jointly-hosted dessert reception at the 2015 annual ASLME Health Law Professors Conference.

We hope to see you there!

For more information, please contact Brooke Tempesta at Brooke_Tempesta@hms.harvard.edu.

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

Yale Law School Seeks Executive Director for New Health Law Center

YaleLaw_300x300

Solomon Center for Health Law and Policy Yale Law School

Executive Director

The Yale Law School is delighted to announce the launch of the Solomon Center for Health Law and Policy, an exciting new Center at Yale Law School dedicated to training the next generation of health law leaders—academics, CEOS, lawyers, and government officials—and having an impact today on the most important health care issues.

The Solomon Center is seeking applications for the position of Executive Director. The Solomon Center coordinates a diverse program of activities that serve students and scholars at Yale and contribute both locally and internationally to the study of health law—with a particular focus on health governance, industry and the practice of medicine.

The Executive Director, under the supervision of the Solomon Center faculty director, Professor Abbe Gluck, will be responsible for managing the day-to-day activities of the Center.  This will include working with and helping to select student and post-graduate fellows, planning events, including workshops and the annual conference, maintaining the website, building the center’s national reputation, working on grants, supervising scholarship and projects of the center, mentoring health law students, working with the many colleagues, organizations, and interested individuals with whom the Solomon Center collaborates, both within the Law School, across Yale University and outside the University.  The Executive Director will be an ambassador of the Center. He/she must be outgoing and a self-starter and will be responsible for building a broad network for the program.

Some specific responsibilities of the Executive Director/ Fellow include the following: Continue reading

Petrie-Flom is hiring a new postdoctoral fellow in clinical research ethics!

PFC Logo-RGB-Round-Otlns-NewPetrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics

Job Description

This is a newly created full-time position for a post-doctoral employee fellow in clinical research ethics to support the work of the Petrie-Flom Center at Harvard Law School in its collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, Harvard’s Clinical and Translational Science Center. The fellow must have strong knowledge of clinical research and its regulation, with particular interest in the regulatory, ethical, and practical aspects associated with recruitment and retention of research participants.  The position will provide the opportunity to interact with a wide range of stakeholders, such as IRB members, administrators, investigators, institutional leadership, patient advocates, and other community members. This position allows for a maximum of 10% effort in furtherance of the fellow’s own research agenda(s) in related fields.  Illustrative projects include the following: Continue reading

Neuroethics Seminar Videos Available Online

In case you couldn’t attend in person, be sure to check out the videos from the Neuroethics Seminar series at the Center for Bioethics at Harvard Medical School! Topics include:

  • Hacking the Brain: Neuroenhancement with Noninvasive Brain Stimulation
  • Does Brain-Based Lie Detection Belong in American Courtrooms?
  • Does Brain Difference Affect Legal and Moral Responsibility?

View these videos and more here.

Rutgers Journal of Bioethics: Call for Papers (8/30)

From the Rutgers Journal of Bioethics:

As members of the Bioethics Society of Rutgers University, we hope to raise general awareness of issues in bioethics within the Rutgers community by method of discussion and publication. Although the beliefs and opinions regarding bioethical issues of this group are not unanimous, we are united by our ardent belief that the student population at Rutgers should be made aware of the implications of biological research, medicine, and other topics of bioethical controversy. In order to bring to light these issues, we are now accepting any papers that fall under the vast umbrella that is bioethics. All papers will be considered for possible publication. Some example subjects are medical treatment, biological warfare, research ethics, medical sociology, social justice, history of medicine/science, medical case analysis, eugenics, gene therapy, human cloning, medical malpractice, and healthcare policy; however, you are not limited to these topics.

DEADLINE: AUGUST 30, 2015

Continue reading

International Neuroethics Society Student Essay Contest: Deadline 5/20!

Remember to submit your 2000 word essay for consideration in the INS Student Essay Contest.  The top two submissions will be awarded:

  • $250 Michael Patterson Travel Stipend to attend the 2015 INS Annual Meeting in Chicago, IL (Oct 15-16), where there will be special networking opportunities,
  • One year free INS student membership,
  • Essay published in the Kopf Carrier (Newsletter of Kopf Instruments) as part of the “Neuroethics in Neuroscience Series” edited by Judy Illes (Director, National Core for Neuroethics, UBC),
  • Essay fast-tracked for peer-review if it (or a subsequent draft) is subsequently submitted to the American Journal of Bioethics Neuroscience (AJOB-N); separate submission would be required.

Who can apply: All current post-secondary students of any nationality; a student is defined as anyone enrolled in a degree granting program (undergraduate, graduate, or professional) during the 2014-2015 academic year.

Requirements: Essays must be 2000 words or less, written in English, and double spaced.  Cover page and essay should be saved as a single file in the format “Surname_INS_Student_Essay_Prize.doc” and emailed to administrator@neuroethicssociety.org with the subject line: “INS Student Essay Prize”.  Additional requirements can be found on the INS website.

Selection Criteria: Essays will be judged on originality of argument, rigor of defense, and quality of prose; a short-list will be generated by the Student Essay Prize Judging Committee and the top two selected from the shortlist through forum discussion.

Deadline: 5 p.m. ET on May 20, 2015