REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. Continue reading

Tom Price Endangers Women’s Health

In today’s NYTimes, Jill Horwitz and I have an Op-Ed describing why Donald Trump’s selection of Tom Price for secretary of health and human services is a particular threat to women’s health. Read it here!

From the Op-Ed:

With the selection of Representative Tom Price as secretary of health and human services, President-elect Donald J. Trump has taken a giant step toward undermining the health of American women.

It is regrettable, but not surprising, that Mr. Trump has nominated a strident opponent of abortion. It is also no surprise that Mr. Price, an orthopedic surgeon from Georgia, earned a zero rating from Planned Parenthood, an organization he’d like to defund, despite its role in providing preventive health services. […]

Read the full article here!

Naughty or Nice 2016? on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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Here it is! Naughty or Nice 2016?, our irreverent but also quite serious annual survey of who or what has been nice or naughty in health law and policy during the last year. Our experts make some great picks and dig deep into the underlying policy coal and candy. Plus, of course, our “surprise” bonus round as we pick who we would like to welcome singing carols outside our homes! Enormous thanks to our guests: Glenn CohenNicole HuberfeldElizabeth Weeks LeonardJessica Roberts, and Lindsay Wiley.

And a very happy holiday season to all our listeners. See you in ’17!

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, Tunein 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

Missed opportunities to learn from patient deaths in the NHS

By John Tingle

The National Health Service (NHS) in England’s quality regulator, the Care Quality Commission (CQC) has recently published a highly critical report on the way patient deaths are investigated in the NHS. The investigation follows events at the Southern Health NHS Foundation Trust where a number of failings were identified in the way patient deaths were identified and investigated. Certain groups of patients including people with a learning disability and older people receiving mental health care were far less likely to have their deaths investigated by this Trust. The Secretary of State for Health called for a CQC investigation into how acute, community and mental health NHS facilities across the country investigate and learn from deaths. The findings of the report are not good and major improvements in this area are needed across the NHS.

There are failings in openness, transparency and missed opportunities to learn important patient safety lessons. Families of patients and carers told the CQC reviewers that they often have a poor experience of investigations and are not always treated with kindness, respect, honesty and sensitivity. The CQC states that across their review they were unable to identify any NHS healthcare facility that could demonstrate good practice across all aspects of identifying, reviewing and investigating deaths and ensuring that learning from the events is implemented. Continue reading

New Book – Electronic Health Records and Medical Big Data: Law and Policy

Guest Post by author Sharona Hoffman

hoffman-cover-1-002I am pleased to post that my new book, “Electronic Health Records and Medical Big Data: Law and Policy” was recently published by Cambridge University Press.  The book enables readers gain an in-depth understanding of electronic health record (EHR) systems, medical big data, and the regulations that govern them.  It is useful both as a primer for students and as a resource for knowledgeable professionals.

The transition from paper medical records to electronic health record (EHR) systems has had a dramatic impact on clinical care.  In addition, EHR systems enable the creation of “medical big data,” that is, very large electronic data resources that can be put to secondary, non-clinical uses, such as medical research, public health initiatives, quality improvement efforts, and other health-related endeavors.  This book provides thorough, interdisciplinary analysis of EHR systems and medical big data, offering a multitude of technical and legal insights. Continue reading

LIVE ONLINE TODAY @ NOON: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions

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Webinar: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions

Monday, December 19, 2016, 12:00 – 1:00pm

WATCH LIVE ONLINE!: http://petrieflom.law.harvard.edu/events/details/president-elect-trumps-health-policy-agenda

Submit your questions to the panelists via Twitter @PetrieFlom.

Please join the Petrie-Flom Center for a live webinar to address what health care reform may look like under the new administration. Expert panelists will address the future of the Affordable Care Act under a “repeal and replace” strategy, alternative approaches to insurance coverage and access to care, the problem of high drug prices, innovation policy, support for scientific research, and other topics. The panel will discuss opportunities and obstacles relevant to President-elect Trump’s proposals, as well as hopes and concerns for health policy over the next four years. Webinar participants will have the opportunity to submit questions to the panelists for discussion.

Panelists

  • Joseph R. Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute
  • Lanhee J. Chen, David and Diane Steffy Research Fellow, Hoover Institution; Director of Domestic Policy Studies and Lecturer, Public Policy Program; affiliate, Freeman Spogli Institute for International Studies, Stanford University
  • Douglas Holtz-Eakin, President, American Action Forum
  • Moderator:Gregory Curfman, Editor-in-Chief, Harvard Health Publications

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Genomic Testing, Reflective Equilibrium and the Right Not To Know

Almost any test can return incidental results. An incidental result is something demonstrated by the test but not an answer to the test’s original question. Trying on a new pair of trousers, for example, can tell you whether or not they fit. It can also return the incidental result that the holiday feasting hadn’t been as kind to your waistline as you had hoped. Incidental results in genetic testing can be even more alarming. Whether done for clinical or research purposes, genetic tests can reveal a range of mutations, markers and predispositions far beyond the range being tested for. As technology advances, it expands the breadth of possible results.

Incidental results can often impart life changing information. Many can be a cause for dramatic but potentially life saving medical intervention: the presence of BRCA1 and BRCA2 variants that indicate an increased risk of breast cancer, for example.Where incidental results suggest that a patient might have an increased risk of developing a condition in the distant future, that information might allow them to act immediately to mitigate that risk. Genetic testing might also reveal inherited or inheritable mutations that could be crucial information for a patient’s entire family. Even outside the realm of disease, a genetic test might reveal something that could have huge psychological or social ramifications for a patient: for example, a test might reveal true paternity. However, the potentially life altering nature of some of these findings, in contexts where they are not being looked for or even expected, has led to questions about whether they should be revealed to the test subject at all.

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Patients in Research: What the Professionals Don’t Get

Guest Post by Rebecca Dresser

When scientists and doctors get together to talk about accelerating medical advances, someone inevitably brings up the need for more research subjects.  Not enough patients are participating in clinical trials, experts complain.  If more patients were part of medical studies, we could make more progress in treating disease and improving human lives.

Why do relatively few patients join studies?  The National Academy of Sciences and similar groups blame the problem on regulatory impediments and an inadequate supply of physician-researchers willing to ask patients to enroll in trials.  They want more funding to support physicians’ research efforts, and they want review committees like IRBs to streamline their work.

But these measures won’t be enough to fix the problem.  To really understand why patients don’t enroll in trials, and why many who do enroll drop out early, you have to ask them. I know, because I was one of the patients who turned down a trial.

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Zack Buck on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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This week’s podcast features conversation with University of Tennessee Professor Zack Buck. His recent research suggests an interesting fiduciary approach to dealing with the problem of over-treatment and also ponders the best way to deal with the “financial toxicity” that results from related phenomena.

Zack’s work is archived at SSRN. He has creatively approached the problem of overtreatment in a series of articles, focusing on ways that health care finance and regulation can be reformed in order to better calibrate incentives for optimal care. His work includes “Furthering the Fiduciary Metaphor” and “Caring Too Much: Misapplying the False Claims Act to Target Overtreatment.”

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, Tunein 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

Outpatient Psychiatric Treatment: The Duty to Prevent Patient Suicide

By Alex Stein

In Chirillo v. Granicz, — So.3d —- (Fla. 2016), 2016 WL 4493536, the Florida Supreme Court formulated an important rule for psychiatric malpractice cases. Back in 2001, the First District Court of Appeal decided that psychiatrists assume no liability for an outpatient’s suicide because it is generally unforeseeable. Tort liability, it held, can properly be imposed on a psychiatrist only for a custodial psychiatric malpractice. According to the First District, an inpatient’s suicide is foreseeable and psychiatrists can effectively prevent it by restraining the patient. Lawlor v. Orlando, 795 So.2d 147 (Fla. 1st DCA 2001).

The Florida Supreme Court has now overruled Lawlor. Continue reading

Public Health under the Trump Administration

By Wendy E. Parmet

The recent report by the National Center for Health Statistics showing a decline in life expectancy in the U.S. in 2015 highlights a point largely overlooked in post-election discussions about health policy under the Trump Administration. The significant increases in health insurance coverage under the ACA have not resulted in population-wide improvements in life expectancy. This is not because the coverage increases aren’t important; without question they have made a difference in the lives of millions. Rather, it’s because health care plays a relatively small role in determining population-level health outcomes.  More important are the so-called social determinants of health, the “conditions in which people are born, grow, work, live and age, and the wider forces and systems shaping the conditions of daily life.” This suggests that the new Administration’s economic, educational, environmental, labor, and housing policies will have more to say about the health of Americans than its proposals for replacing the ACA or reforming Medicare and Medicaid.

Public health policies, and public health law, can also have a major impact on population health. Several years ago, the CDC published a list of the “Ten Great Public Health Achievements in the 20th Century,” which it credited with adding 25 years to life expectancy in the U.S. The list included immunizations, control of infectious diseases, family planning, reductions in tobacco use, work-place and motor-vehicular safety and safer and healthier foods. These goals and other public health objectives, including reductions in opioid use and obesity, remain paramount to preventing further reductions in life expectancy.

To date, little attention has been paid to the incoming administration’s views on most of these issues. Although Trump has nominated Rep. Tom Price to be Secretary of HHS, he has yet to name his picks for the head of CDC or for Surgeon General. The Trump transition website does not mention public health; nor did many public health issues, other than the opioid epidemic, receive much notice during the election. Continue reading

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

By Ameet Sarpatwari 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 November. The selections feature topics ranging from industry funding of cancer patient advocacy organizations, to the shared responsibility between the FDA and CMS, to active surveillance of follow-on biologics. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Abola MV, Prasad V. Industry Funding of Cancer Patient Advocacy Organizations. Mayo Clin Proc. 2016;91(11):1668-1670.
  2. Bauer SR, Redberg RF. Improving the Accelerated Pathway to Cancer Drug Approvals. JAMA Intern Med. 2016 Nov. [Epub ahead of print]
  3. Califf RM, Sherman RE, Slavitt A. Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS. JAMA. 2016 Nov 29. [Epub ahead of print]
  4. Robertson C, Kesselheim AS. Regulating Off-Label Promotion – A Critical Test. N Engl J Med. 2016 Nov 2. [Epub ahead of print]
  5. Sarpatwari A, Gagne JJ, Levidow NL, Kesselheim AS. Active Surveillance of Follow-on Biologics: A Prescription for Uptake. Drug Saf. 2016 Nov 12. [Epub ahead of print]
  6. Xu J, Gill R, Cruz M, Staffa J, Lurie P. Effect of US Food and Drug Administration-Approved Pediatric Labeling on Dispensing of Extended-Release Oxycodone in the Outpatient Retail Setting. JAMA Pediatr. 2016;170(11):1103-1104.

TOMORROW (12/9)! Paying Research Participants: Ethical and Regulatory Parameters

Rolled up US paper banknote in a test tube rack representing the costs of medical research

Paying Research Participants: Ethical and Regulatory Parameters
December 9, 2016 8:00 AM – 12:30 PM
Milstein East ABC (2036), Wasserstein Hall
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

Description

This symposium will bring together a variety of experts to discuss key ethical and legal questions regarding offers of payment to research participants. Panels will cover:

  • Why payment is offered to research participants
  • Regulatory parameters governing payment
  • Whether payment to research participants should be considered exceptional, compared to payment in other contexts
  • How offers of payment affect participants
  • How to define coercion and undue influence with regard to paying research participants
  • Which factors should be considered when evaluating proposed payments
  • The problem of low payment

This event is free and open to the public, but space is limited and registration is required. Register now!

Working Agenda

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Westworld and Bioethics

[WARNING: Spoilers below]

On Sunday, HBO’s Westworld finished its run. Though I thought some of the early episodes were arguably a bit of a failure as television (and my partner almost jumped off the bandwagon of making this one of “our shows”) IMHO the show finished very strong.

But whatever you thought of it as television, the show is wildly successful at raising a series of bioethics issues. There have been a bunch of other very good treatments of some of these issues in the last couple of decades – A.I., Ex Machina, Humans, Battlestar Galactica all come to mind – that touch on some of these issues. But, what I loved about Westworld is its lack of direct moralizing on these subjects, and how it leaves the viewer puzzling through them in a much more naturalistic way: I have been thrust in this unfamiliar world, and now I am trying to use my ethical compass to get my bearings.

Once upon a time I discussed Bioethics and the Martian, and my aim is to do the same here. I thought one way to share why I think the show is so successful as a text for bioethics exploration was to develop a “mock exam question” on the subject. This is really written more like an oral exam, with follow-up questions. The goal is not entirely fanciful since I do teach a course that uses films as texts to explore bioethics and the law.

Here goes: Continue reading

DNA: Donors Not Anonymous

Special Guest Post by Wendy Kramer
[In response to Sperm donor anonymity and compensation: an experiment with American sperm donors, published in the Journal of the Law and Biosciences.]

My son Ryan and I were contacted by Family Tree DNA in 2004, as they thought that their new commercial DNA testing capabilities might be useful to Ryan, and to the others in our community of donor conceived people at the Donor Sibling Registry. At that time we thought it might be possible to find out more about one’s ancestry and countries of origin. Ryan was excited to learn more about his “invisible” paternal ancestry, so quickly agreed to swab his cheek, send in his sample and see what he might learn. He may have been the first donor-conceived person to throw his DNA into a public DNA database, making himself available to connect with previously unknown genetic relatives.

At first, he did learn a bit more about his paternal ancestry, specifically about countries of origin. He learned that he was mostly English, with some Irish and even a bit of Icelandic (which he thought was pretty cool). He also matched with people on his 12 and 25 Y Chromosome DNA markers, which meant that common ancestors related them from hundreds or even thousands of years ago. And for 9 months he was content with that little bit of information. Continue reading

New Hastings Center Special Report – NFL Player Health: The Role of Club Doctors

On November 21, 2016, the Law & Ethics Initiative of the Football Players Health Study at Harvard University, led by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, published a Special Report in the Hastings Center Report, entitled NFL Player Health: The Role of Club Doctors. The Special Report consists of multiple parts.

First, the Special Report includes the Law & Ethics Initiative’s main article, entitled A Proposal to Address NFL Club Doctors’ Conflicts of Interest and to Promote Player TrustThis article focuses on the principal recommendation of our recent report, Protecting and Promoting the Health of NFL Players: Legal and Ethical Analysis and Recommendations, for addressing the conflicts of interest inherent in the current structure of NFL player healthcare, in which club medical staff provide services to both the club and players.

The article proposes to “resolve the problem of dual loyalty by largely severing the club doctor’s ties with the club and refashioning that role into one of singular loyalty to the player-patient.” Specifically, club physicians would be replaced by two sets of medical professionals: the players’ medical staff, with exclusive loyalty to the player, and the club evaluation doctor, with exclusive loyalty to the club. Continue reading

Will Medicare Reform be a Republican Obamacare?

By Shailin Thomas

As the health care community waits with bated breath to see what will become of the Affordable Care Act under the Trump administration, Republicans in Congress have set their sites on another health-related initiative that has been on their wish list for years: reforming Medicare. While Trump promised throughout his campaign not to change the fundamental ways in which Medicare works — in part to appeal to older voters, who overwhelming would like the program to stay as it is — shortly after the election, “modernizing Medicare” appeared as a priority on the transition website for the new administration.

The reform many Republicans are pushing for — championed by Speaker of the House Paul Ryan (R-WI) — is privatization along the lines of Medicare Advantage. Instead of providing for full insurance coverage through the government, as traditional Medicare currently does, Ryan’s proposal would have eligible patients purchase insurance from private companies with financial assistance from the government. The theory is that by having private insurers provide coverage, Medicare will capture efficiencies of the private market, while simultaneously offering consumers more choice in the coverage they receive.

After Paul Ryan first unveiled this plan in 2011, the Kaiser Family Foundation released a report detailing the significant fiscal problems with this “modernized” vision of Medicare. According to the Foundation’s analysis, the average out-of-pocket expense for beneficiaries increase from $5,630 under the current system to $12,500. The reason for this increase, according to the Congressional Budget Office, is that providing coverage is actually more expensive for a private insurer than it is for the government.  The proposal faces other economic challenges as well, and ironically, some of them stem from its close resemblance to Obamacare.

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Unified Patents and Brexit: Britain’s Back on Board

By Seán Finan

After several failed attempts, years of protracted negotiations and a glacial ratification process, it seemed as if Brexit would finally put an end to the nascent European Unitary Patent. Last week, however, the UK confirmed its intention to ratify the Unified Patent Court Agreement and to move forward with the plans for the creation of a single European Patent. If the UK goes ahead, the agreement would only be a German ratification away from coming into force. This means that we could see a single European patent by 2017.

So, what is the European Unitary Patent? How would it interact with the current patent regime in the EU? What would its introduction mean for the future of pharma and biotechnology in Europe?

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What is the Right Number of Unsafe, Ineffective Drugs for the FDA to Approve?

Later today, the Senate will begin voting on the 21st Century Cures Act, which passed the House overwhelmingly last week. I’ve blogged repeatedly about the Act (most recently here), and many academics and commentators are rightfully worried about the Act’s efforts to lower FDA approval standards in different ways. I write here to put some of these concerns more plainly (and more bluntly), by asking a simple question: what is the right number of unsafe or ineffective drugs for the FDA to approve? I would like to hear the Act’s supporters answer this question. Below, I offer some thoughts of my own on how we should think about and evaluate this question.

More generally, when we think about FDA approval of new pharmaceuticals, we have to consider how the FDA should balance Type I and Type II errors. You may think the FDA ought to focus on minimizing the number of unsafe or ineffective drugs that it approves (minimizing Type I errors). After all, we don’t want the FDA putting its stamp of approval on drugs that harm patients or that don’t work. Over time, this would lead to an erosion of public trust in the FDA as a tool for consumer protection. More generally, this is the entire reason we’ve given the FDA its powers to begin with. Scandals involving unsafe or ineffective drugs prompted Congress to give the FDA more, greater powers over the years, in large part to prevent such products coming to market in the first instance.

Instead, you may think that the FDA should focus on minimizing the number of safe, effective drugs it fails to approve (minimizing Type II errors). In other words, it is worse for the FDA to deny patients access to a drug that is safe and effective than it is for the FDA to approve a drug that later turns out to be unsafe or ineffective. On this view, the FDA should still perform some screening against drugs with significant safety signals or against drugs with no plausible mechanism of action, and perhaps should require post-market surveillance studies, but the FDA ought to be enabling sick patients to access drugs more quickly. This view of the FDA’s role places greater responsibility on insurers, physicians, and patients to gather, process, and act on information about a drug’s safety and efficacy.

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