Call for Abstracts! 2016 Annual Conference: Big Data, Health Law, and Bioethics

Close-up of fiber optic cables

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2016 annual conference, entitled: “Big Data, Health Law, and Bioethics.”  This year’s conference is organized in collaboration with the Berkman Center for Internet and Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.

Conference Description

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data). Continue reading

Introducing the 2015-2016 Petrie-Flom Student Fellows

The Petrie-Flom Center is pleased to welcome our new 2015-2016 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research.

Deak_peopleDalia Deak is a second year student in the Department of Health Policy and Management at the Harvard T.H. Chan School of Public Health. She received her BS in Biomedical Engineering from the University of Virginia, where she focused primarily on computer science in biomedical engineering and issues at the intersection of technology, health policy, and public health. After receiving her undergraduate education, Dalia joined the Brookings Institution as a Research Assistant where she worked on their medical device evidence and innovation portfolio. While at Brookings, Dalia co-authored a report for the U.S. Food and Drug Administration on the implementation of a unique device identification system that would support postmarket surveillance and enhance patient safety. Dalia’s current research interests lie at the intersection of medical device and drug policy and public health law.

Guo_people2Elizabeth Guo is a third year student in the JD/MPH Program at Harvard Law School and the Harvard School of Public Health. Her interests lie at the intersection of law, health care reimbursement, and biopharmaceutical regulation. Elizabeth graduated from Harvard University with a BA in social studies, focusing on the bioethics of assisted reproduction in China. Prior to law school, she was a senior associate at Avalere Health working with life science clients on a range of health policy topics, including Medicare coverage and reimbursement, biosimilar regulation, and healthcare quality programs. Elizabeth is a student editor of the Journal of Law and Technology and a member of the Mississippi Delta Project’s Food Policy Initiative.

Katherine Kwong is a second-year student at Harvard Law School. After receiving her B.S. in Biology from the University of Minnesota, she went on to receive her Master of Public Health degree in Public Health Genetics from the University of Washington. She decided to attend law school to further her interest in the intersection of health, the life sciences, bioethics, and the law. Katherine’s current research interests include the interactions between the unique characteristics of genomic data and existing protection frameworks.

Kelly_peopleMichael Anne Kyle is a doctoral student at the Harvard T.H. Chan School of Public Health. She holds a BS from Georgetown University and an MS from the University of Pennsylvania, both in nursing. She is interested in the reorganization of the clinical delivery system with a view to achieving policy goals related to access, quality, and value. Prior to returning to school, she served as the founding executive director of a nonprofit organization focused on care coordination and regional policy and planning in Newark, New Jersey, where she helped establish a Medicaid Accountable Care Organization. In addition to working as a critical care nurse, she has worked on antipoverty programs related to health and social services, including access to prescription medications, family strengthening, financial inclusion, and reentry.

Sandoe_peopleEmma Sandoe is a second year PhD student in Health Policy studying Political Analysis and is interested in studying Medicaid policy and state political decision-making around Medicaid  and long-term care financing and policy priorities. Prior to starting at Harvard she worked for the Centers for Medicare & Medicaid Services serving as the Medicaid spokesperson and working on HealthCare.gov communications as well as the Center for Medicare and Medicaid Innovation. She also worked in the Department of Health and Human Services Budget Office as the Affordable Care Act coordinator and at the Center for American Progress. She earned a Masters in Public Health from George Washington University and attended UC San Diego for undergraduate studies.

Sudai_peopleMaayan Sudai is an SJD candidate at Harvard Law School. She holds both a B.A and an LL.B from the University of Haifa, as well as an LL.M from Harvard Law School. Maayan’s current research agenda examines the interaction between law, science and society, mainly through a critical lens and combining multiple disciplines, such as the history of medicine, law and social change and health law and bioethics. More specifically, Maayan’s dissertation explores the legal struggles of patient advocacy movements against medical institutions in the US. While her interest in this field grows out of years of experience as a leading advocate for the intersex rights’ movement in Israel, her current research focuses on the American intersex rights’ movement struggle to change medical guidelines through the Court. In the future, Maayan plans to further explore the struggles of other relevant social movements representing other conditions, like anorexia, mental and intellectual disabilities, and more.

NOW AVAILABLE: FDA in the 21st Century: Get 30% Off When You Order through the Press!

lync17118_frontJust out from Columbia University Press, FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies! This volume, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen, stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

Use promo code FDA21 and save 30% if you order now at the Columbia University Press website!

And join us at Harvard Law School on October 28 for a book launch and panel discussion featuring editors Holly Fernandez Lynch and Glenn Cohen!

Thank you for 3 great years!

Three years ago today, we launched the Bill of Health blog to create a one-stop-shop for readers interested in news, commentary, and scholarship in the fields of health law policy, biotechnology, and bioethics. We have been thrilled at the blog’s success and reach so far.

A few quick stats:

  • We have 90 contributors from 49 institutions around the globe.
  • More than 350,000 unique visitors from more than 200 countries have visited the blog since it was first launched.
  • The blog gets more than 17,000 page views per month.
  • We’ve clocked in over 2,000 blog posts covering a wide range of topics:
    • Health insurance, health care finance, health care reform
    • Reproductive health and rights
    • Pharmaceutical regulation
    • Food safety and regulation
    • Human subjects research
    • Personhood and animal rights
    • General health law, policy, and bioethics

As a sample, here are the top five most viewed posts from each academic year:

2012 – 2013

  1. The High Cost of Health Care: Why Some Pay $240 for a $9 Bottle of Pills, by Jonathan Darrow
  2. Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?, by Jonathan Darrow
  3. Liability for Failure to Vaccinate, by Arthur Caplan
  4. Discrimination in the Doctor-Patient Relationship, by Holly F. Lynch
  5. At $28,000 a Dose, How Effective Is Acthar?, by Jonathan Darrow

2013 – 2014

  1. Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON, by Jonathan Darrow
  2. Taking China’s Food Safety Problem Seriously (I), by Ching-Fu Lin
  3. Medical Marijuana Delivery May Not Be As “Eazy” As It Seems, by Arielle Lusardi
  4. Taking China’s Food Safety Problem Seriously (II), by Ching-Fu Lin
  5. Ethical Concerns, Conduct and Public Policy for Re-Identification and De-identification Practice: Part 3, by Daniel Barth-Jones

2014 – 2015

  1. Highlights from the 21st Century Cures Act, by Rachel Sachs
  2. Savior Siblings in the United States, by Zachary Shapiro
  3. New browser app shines light on conflicts of interest, by Christine Baugh
  4. A New Cholesterol-Lowering Drug at What Price?, by Kate Greenwood
  5. Pain on the Brain: A Week of Guest Posts on Pain Neuroimaging & Law by Amanda C. Pustilnik

Thanks to our many contributors – and to our readers!  We look forward to many more years of growth.  And always, if you have any comments or suggestions, make sure to send them our way: petrie-flom@law.harvard.edu.  Happy reading!

Glenn and Holly 
Bill of Health Co-Editors

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New DTCA Guidance — Enough to Empower Consumers?

Bill of Health contributor Christopher T. Robertson has a new Op-Ed out in the New England Journal of Medicine:

As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn’t mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product’s risks as well. Since it’s not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a printed magazine ad. Companies have tended to comply with this requirement by supplementing colorful, persuasive ads with one or two pages of dry text providing the required disclosures, often simply using language that the FDA has approved for other purposes, such as package inserts for prescribers. But research shows that most patients who attempt to read these disclosures find them difficult to understand, and many don’t even try to make sense of them.1 Now, the FDA is in the process of adjusting its DTCA rules, aiming to provide greater assurance that patients receive due warning of the most significant risks — but its tweaks probably don’t go far enough to really empower consumers to make smart decisions about the drugs they put into their bodies. […]

Read the full article here.

Bioethicist Art Caplan: Marco Rubio And The GOP’s Dangerous Misconception On When Life Begins

Bill of Health Contributor Art Caplan has a new piece up on Forbes:

Does human life begin at conception? For Marco Rubio and some other politicians now running for the presidential nomination in the GOP herd, the answer is yes. There is no doubt in their mind about when life begins. Amazingly despite indifference to science regarding other matters like evolution and climate change, they invoke science on behalf of their advocacy of what might best be called “conceptionalism.” And given what science shows the law must protect every new life.

Those lobbying for conceptionalism aim to outlaw all abortions, no matter how an embryo is conceived. Even if a mentally ill 12-year-old woman is raped by her predatory father, killing an embryo, if one results, ought not be a legal option in their view. When life begins at conception murder is never an option, Rubio and his fellow-travelers aver. [..]

Read the full article here.

Bioethicist Art Caplan: All Hat, No Cattle—The False Hope of Right-to-Try Laws

Bill of Health contributor Arthur Caplan and Alison Bateman-House have a new piece up in Harvard Health Policy Review:

Are right-to-try laws a good idea? In 2014, they began appearing throughout the United States, first in Colorado and now in 23 states, with several more considering passing versions of this popular legislation.

At first glance these bills may seem worth enacting. Right-to-try (RTT) laws promise terminally ill patients that they can obtain experimental drugs or medical devices in their quests to save or extend their lives. These investigational medical products are still in development and have not yet met the requirements set by the Food and Drug Administration (FDA) in order to be approved for sale or use in the United States. In some cases, the products are still being tested and patient access would primarily be by enrolling in a clinical trial – something terminally ill people may be too unwell to do. Less commonly, the products have completed clinical testing and are waiting for an approval verdict from the FDA. In either case, RTT laws are about providing terminally ill patients access to unapproved drugs or devices. […]

Read the full article here.

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

JLB coverThe 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 Notes & Developments section, comprised  of  brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie­Flom Center is responsible for providing the Notes & Developments for one issue per annual volume.

We are currently seeking Harvard graduate students to contribute papers to be published in JLB’s Notes & Developments section in early 2016. In previous years, Notes & 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.  Notes & 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.

Bioethicist Arthur Caplan: Euthanasia in Belgium and the Netherlands: On a Slippery Slope?

Bill of Health Contributor Art Caplan and Barron Lerner have a new piece up in JAMA Internal Medicine:

The slippery slope is an argument frequently invoked in the world of bioethics. It connotes the notion that a particular course of action will lead inevitably to undesirable and unintended consequences. Saying no to the original action, even if that act is moral in itself, may, in light of the slope that looms, be the ethical thing to do.

Slippery slope arguments have been especially pervasive in discussions of euthanasia, in which physicians actively end patients’ lives, and physician-assisted dying (or physician-assisted suicide), in which physicians supply medications to patients that enable them to end their own lives. The concern, fueled by the German experience with racially motivated euthanasia in the last century, has been that approving either of these procedures for a few individuals will inevitably lead to overuse and abuse. […]

Read the full article here.

GOP Confusion Over Stem Cell Research

Bill of Health Contributor Dov Fox has a new article up on the Huffington Post:

Republican candidates convened last night for the first debates of the 2016 campaign. The presidential hopefuls disagreed on every topic they faced — immigration, health care, foreign policy, gay rights, the economy — all but one, that is. Their differences of opinion disappeared each time they were asked about the controversy over the recent release of an undercover video with Planned Parenthood. On the issue raised by that edited film clip, the candidates came together in a rare consensus.

All 17 — from Ted Cruz to Carly Fiorina — staunchly opposed research that uses tissue cells from aborted or miscarried fetuses. The candidates unanimously called for Congress to end its support of Planned Parenthood over its contribution to that research, with some like Louisiana Gov. Bobby Jindal joining party leaders who would force a government shutdown over that issue. This, after Senate Republicans earlier this week failed to clear a procedural vote to defund. […]

Read the full article here.

Planned Parenthood Did Nothing Wrong – But there is a darker side to the human tissue trade

Our blogger Michelle Goodwin has a piece up on Politico:

Republicans on Capitol Hill, and now GOP presidential candidates like Donald Trump and Jeb Bush, are jumping over each other to defund Planned Parenthood because it transfers fetal tissues to researchers at cost. But if Americans want the benefits of biotechnology—helpful surgeries, cosmetics, vaccines, Alzheimer’s treatment and pharmaceutical drugs—they and their elected representatives need to learn a few basic facts about how these social services and products are derived from human tissue research.

The latest assault on Planned Parenthood comes after graphic video clips were released over the past three weeks purporting to show the non-profit organization nefariously trading fetal body parts for profit. Despite a move by Senate Democrats to block the defunding bill on Monday, Sen. Ted Cruz and Donald Trump are joining together to try to shut down the government if Planned Parenthood gets federal money. Just yesterday, Jeb Bush railed against “the hard-to-fathom $500 million in federal funding that goes to Planned Parenthood—an organization that was callously participating in the unthinkable practice of selling fetal organs.” […]

Read the full article here.

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.