2017 Petrie-Flom Center Annual Open House

2017 Petrie-Flom Center Annual Open House
September 13, 2017 5:30 PM
HLS Pub, Wasserstein Hall, 1st floor
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics to learn about what the Petrie-Flom Center does and how people can get involved. Faculty Director I. Glenn Cohen will review our sponsored research portfolio, introduce our staff and fellows, including new Executive Director Carmel Shachar, and describe various opportunities for students and others. In addition, our partners including colleagues from the Center for Bioethics at Harvard Medical School and the Center for Law, Brain & Behavior at Massachusetts General Hospital spoke about their programs and activities, including the Master of Bioethics program in the Center for Bioethics at Harvard Medical School. And of course we will eat, drink, and make merry!

This event is free and open to the public.

The Open House reception will immediately follow the lecture “The Neurolaw Revoltion” by Francis X. Shen, Senior Fellow in Law and Applied Neuroscience, at 4pm. Learn more about the lecture here!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School.

Federal “Right to Try” Legislation – Perpetuating a Misguided Skepticism Towards the FDA

Cross-posted from the CRITical Thinking blog.

By Jeanie Kim

The “right to try” (RTT) movement presents a narrative that pits patients against the FDA. Supporters of RTT, powered by the libertarian Goldwater Institute, have pushed for laws that let terminally ill patients bypass regulators to access unapproved treatments.

As of September 2017, 37 states have enacted RTT laws. Earlier this year, the Senate and the House introduced federal RTT bills, and on August 3, 2017, the Senate unanimously passed an amended RTT bill without an opportunity for debate. There is pressure on the House to follow suit, but it is unclear whether the House will consider the originally introduced RTT bill (“RTT 1.0”) or the Senate’s amended version (“RTT 2.0”), or even take up the legislation at all.

Despite the recent legislative backing, RTT is not a new concept. It is a variation on an age-old skepticism towards the FDA that has been around as long as the agency’s inception. At the core of RTT is the previously rejected, yet persistent argument that the FDA’s approval standards for safety and efficacy should not matter for terminally ill patients who have nothing to lose [1]. Continue reading

TODAY, 9/11 at 5 PM: Health Law Workshop with William Sage

September 11, 2017, 5-7 PM
Hauser Hall, Room 104

Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “Fracking Health Care: The Need to Safely De-Medicalize America and Recover Trapped Value for Its People”

William M. Sage is James R. Dougherty Chair for Faculty Excellence at the University of Texas-Austin Law School and Professor (Department of Surgery and Perioperative Care) in the Dell Medical School.

Is Your Medical Bill “Eligible for Sharing?” New research on Christian Health Care Sharing Ministries (HCSMs)

By Aobo Dong

As the future of Affordable Care Act (ACA) hangs in the balance amid political deadlock in Washington, more Americans are signing up for Christian health care sharing ministries (HCSMs) – a growing alternative to traditional health insurance. Instead of paying a monthly premium to insurance companies, most members of HCSMs write monthly checks directly to other members in need. If you are on the receiving end, chances are you may be surprised with a wave of letters, flowers, and prayer cards wishing you well. However, not all medical bills are “eligible for sharing.” Most HCSMs exclude pre-existing conditions, as well as any conditions or medical expenses caused by “unbiblical lifestyle” involving using drugs/alcohol or having sex outside of heterosexual marriage. Also, if you are an adopted child with disabilities or an undocumented immigrant, some ministries explicitly exclude you from participating at all. Continue reading

Be Very, Very Concerned About What Allergan Just Did

Yesterday, it was announced that Allergan had transferred the ownership of the patents on its billion-dollar drug Restasis, used for the treatment of chronic dry eye, to the Saint Regis Mohawk Tribe. The Tribe then exclusively licensed the drug back to Allergan, in exchange for tens of millions of dollars in both licensing and royalty fees. Although it may not sound like it, this transfer is potentially huge news in the drug pricing world. It is also extremely complex, and its full implications have yet to be determined.

Enormous caveat before we begin: I am by no means an expert on tribal sovereign immunity. I may well be wrong here. (In fact, I would very much like to be wrong here.) There is little (any?) case law on sovereign immunity’s impact in the Hatch-Waxman area, and much of what follows is extrapolated from case law on tribal sovereign immunity both in IP and in other contexts, state sovereign immunity in the IP area, and discussions with other law professors. Please let me know if this is your area of expertise and you believe I’ve gotten the analysis wrong!

In short, if repeated and taken to its logical conclusion, this transfer has the potential to prevent most invalidity challenges to drug patents. Would-be generic competitors could not seek to initiate inter partes review (IPR) actions before the Patent and Trademark Office (PTO). They could not bring declaratory judgment actions in federal court. And – both most importantly and most unclear – they could not bring Paragraph IV invalidity counterclaims under Hatch-Waxman, preventing generic companies from independently challenging patents’ invalidity and potentially requiring us all to wait until the very end of patent expiration to experience generic competition.

Continue reading

First, Do No Harm: NGOs and Corporate Donations

By Clíodhna Ní Chéileachair

Last year Médecins Sans Frontières (MSF) refused free vaccinations for pneumonia from Pfizer, who had offered the medicines as a corporate donation to the humanitarian organisation. The explanation MSF provided (available here) makes for an interesting, if uncomfortable read. Looming large is the lengthy history of negotiations between MSF with the only manufacturers of the vaccine, GlaxoSmithKline and Pfizer. MSF claim that the only sustainable solution to a disease that claims the lives of almost a million children each year is an overall reduction in the cost of the vaccine, and not one-off donations that come with restrictions on where MSF may use the medicines, and a constant power disparity between the parties, where Pfizer may release the medication on their own timeline, and revoke access as they see fit.

Continue reading

Lewis Grossman on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!twihl 5x5

We talk with Lewis A. Grossman, a professor of law at American University and Of Counsel at Covington & Burling. Lewis is on sabbatical during academic year 2017-18, serving as a Law and Public Affairs (LAPA) Fellow at Princeton University. He teaches and writes in the areas of American legal history, food and drug law, health law, and civil procedure. He has also been a Visiting Professor of Law at Cornell Law School.

Our Lightning Round touches on nursing home arbitration (resources herehere, and here), the decline in the number of FDA warning letters, EEOC wellness program regulationsingle payer, and the resilience of the exchanges.

Our conversation with Lewis focused on the history of empowered patients and American health libertarianism. Activists played a major role, as his fascinating article AIDS Activists, FDA Regulation, and the Amendment of America’s Drug Constitution shows.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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

Introducing the 2017-2018 Petrie-Flom Student Fellows

The Petrie-Flom Center is pleased to welcome our new 2017-2018 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.

Clíodhna Ní Chéileachair is an LL.M student from Ireland at Harvard Law School, and holds a BCL degree in Law and Philosophy from University College Dublin. Prior to her masters, she worked as a teaching assistant in criminal law, company law and the philosophy of law in University College Dublin and as a paralegal in a corporate firm, with a focus on healthcare litigation and employment law. Her primary research interests are in the intersection of feminist legal theory and health law, ethics and the philosophy of law, particularly in relation to questions of consent and objectivity. For her Fellowship project, Clíodhna will study the manner in which health law and policy intersects with issues of personhood and autonomy in the context of pregnancy.

Aobo Dong is an M.T.S. candidate in Religion, Politics, and Ethics at the Harvard Divinity School. He graduated from Wesleyan University, where he majored in Social Studies and examined the alliance between American evangelicals and the GOP in his honors thesis. At Harvard, his research interests have shifted toward reconciling potential conflicts between religion and the modern human rights discourse, particularly in terms of sexuality, health, and other social-economic rights. He is also a junior fellow at the Science, Religion & Culture (SRC) program. For his Fellowship project, Aobo will investigate the legal and ethical challenges surrounding the fast-expanding healthcare cost-sharing ministries (HCSMs) that provide members with an alternative to traditional insurance models.

Gali Katznelson is a M.Be. candidate at the Center for Bioethics at Harvard Medical School. She completed a bachelor’s degree in Arts & Science at McMaster University in Ontario, Canada. Her research interests include the ethics of emerging healthcare technologies. For her Fellowship project, she will focus on physician perceptions of the use and regulations of mobile health applications.

Yusuf Lenfest is an M.T.S. candidate in Islamic Studies at the Harvard Divinity School. He pursued undergraduate and graduate education at the University of Vermont (BA) and the London School of Economics (MSc) in the fields of literature, philosophy, and comparative politics. He is trained as a jurist in the Maliki school of law, in which he is qualified to issue fatwa, and he also completed advanced training in the fields of legal theory and theology under the tutelage of renowned Mauritanian scholar Shaykh Abdallah Bin Bayyah. For his Fellowship project, Yusuf will examine bioethical issues in contemporary Islamic legal and religious thought.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of August. The selections feature topics ranging from the characteristics of pre- and post-approval studies for drugs granted accelerated approval by the FDA, to a review of policy options to reduce brand-name drug prices, to characteristics of clinical studies used for FDA approval of high-risk medical device supplements. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Reducing Branded Prescription Drug Prices: A Review of Policy Options. Alexander GC, Ballreich J, Socal MP, Karmarkar T, Trujillo A, Greene J, Sharfstein J, Anderson G. Pharmacotherapy. 2017 Aug 14. [Epub ahead of print]
  2. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study. Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. Ann Intern Med. 2017 Aug 1;167(3):145-151.
  3. Impact of the Black Triangle Label on Prescribing of New Drugs in the United Kingdom: Lessons for the United States at a Time of Deregulation. Horton DB, Gerhard T, Davidow A, Strom BL. Pharmacoepidemiol Drug Saf. 2017 Aug 31. [Epub ahead of print]
  4. Effect of US Food and Drug Administration’s Cardiovascular Safety Guidance on Diabetes Drug Development. Hwang TJ, Franklin JM, Kesselheim AS. Clin Pharmacol Ther. 2017 Aug;102(2):290-296.
  5. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. Naci H, Smalley KR, Kesselheim AS. JAMA. 2017 Aug 15;318(7):626-636.
  6. Health Insurance Coverage and Health – What the Recent Evidence Tells Us. Sommers BD, Gawande AA, Baicker K. N Eng J Med. 2017 Aug 10;377(6):586-593.
  7. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements. Zheng SY, Dhruva SS, Redberg RF. JAMA. 2017 Aug 15;318(7):619-625.

States Tackle Youth Sports Concussions – New Data!

By Benjamin Hartung, JD, Joshua Waimberg, JD, and Nicolas Wilhelm, JD

While brain injuries and studies associated with professional football get the majority of media attention, student athletes, especially young football and soccer players, are also at risk for similar brain injuries. Each year, as many as 300,000 young people suffer from traumatic brain injuries (TBIs), more commonly known as concussions, from playing sports.

State governments have responded to the problem of brain injuries in youth sports by adopting laws aimed at reducing the harm that comes from injuries that occur during team practices or events. Delaware was the first state to pass a regulation relating to youth TBIs in 2008, with Washington State following shortly after in 2009. In the years since, all states have passed youth TBI laws, many modeled after the Washington law, that mandate when student athletes are to be removed from the field, how parents should be notified in the event of a concussion, what training is required of athletic coaches, when a student athlete may “return-to-play,” and who may allow this return to the field. Continue reading

Thank You for Five Great Years!

Five years ago today, the first post went up on Bill of Health. Since then, the blog has received over 980,000 unique page views from 220 countries, helping to further the discussion of issues in health law policy, biotechnology, and bioethics and to publicize opportunities in the field. Over 3,100 posts have covered everything from ethical issues with bioengineered interspecies organ transplants to potential medical malpractice concerns with artificial intelligence to fetal personhood and the Constitution to analysis of surrogacy arrangements gone awry to food safety issues in China.

As the field has changed over the past five years, so too has the blog. We’ve developed collaborations with other organizations and blogs, hosted a series of blog symposia, blogged “live” from conferences, and expanded the participation of our center’s diverse Fellows. In celebration of our anniversary, this month we will feature posts that highlight these past contributions and new posts that explore the development of issues in health law policy, biotechnology, and bioethics over the past five years.

Our most popular posts, based on total unique page views, reflect the diversity of topics Bill of Health covers: Continue reading

Julia Powles on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!twihl 5x5

We talk with legal scholar and journalist Dr. Julia Powles. At Cambridge, Julia was associated with the Centre for Law, Medicine and Life Sciences and Centre for Intellectual Property and Information Law, and a Research Associate of the Faculty and Computer Laboratory. She is now a Research Fellow at Cornell Tech and NYU Law School, in New York City.

Julia has done some deep dives into dubious methods of data acquisition by Google, focusing on Google subsidiary Deep Mind’s NHS data grab. Our conversation starts with Hal Hodson’s reporting on Deep Mind for the New Scientist. Julia explains the findings of the Information Commissioner and the subtle intersection of the Data Protection Act 1998 and the “boot out” to the Caldicott Guidelines. The relevance to the U.S. is confirmed with discussions of the “first mover” advantages in establishing data market power, the problems associated with the privatization of public health data, and the “transparency paradox” associated with big data companies.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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

What if Trump Censors Climate Science? Scientific Research Policy and Law under the Trump Administration

Cross-posted from the Take Care blog.

By Dov Fox

Global warming embarrasses President Donald Trump’s insular creed of “America First.” The National Oceanic and Atmospheric Administration recently confirmed all-time record-high temperatures and sea levels around the world. Yet President Trump has promised that the United States will be virtually alone in refusing to honor the commitments it had made in the Paris climate agreement. Indeed, his administration has systematically deregulated previous efforts to reduce greenhouse gas emissions, while dismantling efforts to protect the country’s air, water, and wildlife.

More elusive threats to climate science are lurking behind the scenes. The Trump administration ordered the Environmental Protection Agency (EPA) to shut down its climate webpage, gagged EPA and U.S. Department of Agriculture employees from using terms like “climate change” and “emissions reduction” in any written communications, and forbade scientists there from discussing their (taxpayer-funded) research with anyone outside of the agency. The White House has at the same time defunded climate science and terminated ongoing studies into environmental threats ranging from the toxicity levels of Midwestern streams to the health risks of Appalachian mining. Continue reading

Navigating the Research-Clinical Interface in Genomic Medicine: Challenging the Traditional Dichotomy Between Research & Clinical Care

By Susan M. Wolf & Wylie Burke

Translational genomics challenges the traditional view that research and clinical care are distinct activities that should be governed by separate norms, rules, and law. Beginning with the Belmont Report and emergence of regulations governing the conduct of research with human participants, the conventional view has been that there are fundamental differences between research and clinical care, necessitating distinctive ethical frameworks, regulatory oversight, and legal analyses.

However, a new paper published in Genetics in Medicine reports the first empirical test of this conventional dichotomy in the context of genomics. The paper analyzes empirical data collected by surveying investigators conducting major NIH-funded genomics research projects in the NHGRI/NCI-supported Clinical Sequencing Exploratory Research (CSER) Consortium. Those investigators report their actual practices, experiences, and attitudes in navigating the research-clinical interface. These results reveal how the research-clinical boundary operates in practice and cast serious doubts on the adequacy of the conventional dichotomy. Continue reading

Current trends in clinical negligence litigation in the National Health Service (NHS)

By John Tingle

NHS Resolution (the new operating name for the NHS LA, National Health Service Litigation Authority) occupies a central role in the NHS clinical negligence claims environment. They manage clinical negligence claims on behalf of NHS trusts (hospitals) and other bodies. They also provide indemnity cover and have an increasing role in assisting the NHS with risk management and patient safety.

NHS Resolution have recently published their Annual Report and Accounts which contains important data, trends, case studies and other information on clinical negligence and patient safety. This report also very clearly signals the new more inclusive, upstream, closer to the problem approach that NHS Resolution is now taking to its work.

Facts, figures and trends Continue reading

2017 Petrie-Flom Center Annual Open House

2017 Petrie-Flom Center Annual Open House
September 13, 2017 5:30 PM
HLS Pub, Wasserstein Hall, 1st floor
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics to learn about what the Petrie-Flom Center does and how people can get involved. Faculty Director I. Glenn Cohen will review our sponsored research portfolio, introduce our staff and fellows, including new Executive Director Carmel Shachar, and describe various opportunities for students and others. In addition, our partners including colleagues from the Center for Bioethics at Harvard Medical School and the Center for Law, Brain & Behavior at Massachusetts General Hospital spoke about their programs and activities, including the Master of Bioethics program in the Center for Bioethics at Harvard Medical School. And of course we will eat, drink, and make merry!

This event is free and open to the public.

The Open House reception will immediately follow the lecture “The Neurolaw Revoltion” by Francis X. Shen, Senior Fellow in Law and Applied Neuroscience, at 4pm. Learn more about the lecture here!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School.

Tenure-Track/Tenured Health Law Position at IU McKinney

The Indiana University Robert H. McKinney School of Law invites applications for a tenure-track/tenured faculty position. We invite applications from entry-level and experienced scholars. The position primarily would involve teaching courses in the Health Law curricula and participation in the scholarly and student-centered activities organized by the law school’s Hall Center for Law and Health.

Applicants should indicate what Health Law courses they could offer and any additional courses they would be interested in teaching. Interested candidates should submit their application (cover letter, CV including three references, and writing sample) at https://indiana.peopleadmin.com/postings/4442

All applications received by September 25, 2017, will receive full consideration.

We are committed to achieving excellence through intellectual diversity and strongly encourage applications from persons of color, women, persons with disabilities, the LGBT community, veterans, and members of other groups that are under-represented on university faculties. The law school is an Equal Opportunity/Affirmative Action Institution and offers domestic partner benefits.

Back To School Special Part 2 on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!twihl 5x5

Our annual Back To School Special returns in time for a new semester. In this second part, we welcome TWIHL All-Stars Erin Fuse BrownZack Buck, and Jessica Roberts. In this part, topics included state health laws in the time of Trump, price and cost issues, ERISA, MIPS, a fraud and abuse case to watch, and genetic “property” statutes.

We ended with some general thoughts about what we learned from the reform and repeal saga of the past seven months. In the spirit of the Sage of Baltimore, H.L. Mencken, Frank recommended Gabriel Lenz’s Follow the Leader as a reflection on the limits of democracy. And be sure to follow our guests who are on Twitter at @efusebrown and @jrobertsuhlc.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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

REGISTER NOW! Behind Bars: Ethics and Human Rights in U.S. Prisons

Behind Bars: Ethics and Human Rights in U.S. Prisons
November 30 – December 1, 2017
Harvard Medical School campus
Longwood Medical Area, Boston, MA

The United States leads the world in incarceration. The “War on Drugs” and prioritizing punishment over rehabilitation has led to mass imprisonment, mainly of the nation’s most vulnerable populations: people of color, the economically disadvantaged and undereducated, and those suffering from mental illness. Although these social disparities are striking, the health discrepancies are even more pronounced. What can be done to address this health and human rights crisis?

This conference will examine various aspects of human rights and health issues in our prisons. In collaboration with educators, health professionals, and those involved in the criminal justice system—including former inmates, advocates, and law enforcement—the conference will clarify the issues, explore possible policy and educational responses, and establish avenues for action.

Registration for the conference is required. To learn more and to register, please visit the HMS Center for Bioethics website.

This event is cosponsored by the Center for Bioethics at Harvard Medical School, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Human Rights Program at Harvard Law School.

New CBO Analysis: Cutting Subsidies Would Backfire on Trump

By Wendy Netter Epstein 

The cost-sharing reduction payments are an essential component of the ACA.  These payments reduce out-of-pocket costs for lower income enrollees so that individuals can actually use their insurance coverage and not be prevented from seeking care because of a high deductible or a copay they can’t afford.  President Trump has been threatening since he took office to end these payments.  And there is at least some possibility that he has the authority to do (see House v. Price).

Politically speaking, Trump’s goal in threatening to end these payments is either to hasten what he sees as the inevitable demise of Obamacare—or at least to use the threat of ending the payments to hold the feet to the fire of those who have resisted “repeal and replace.”  Either way, Democrats have widely condemned Trump’s threats and the instability they cause in the market. Continue reading