‘The Week in Health Law’ Podcast

By Nicolas Terry

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Nic welcomes studio guests law professor Barbara Evans & bioethicist Eric Meslin. The primary topic is the future of research and its regulation, leading to a broad-ranging discussion that includes the future of the FDA, emerging research models, and how consent & autonomy fit into this changing ecosystem. Eric mentioned an interesting article by Neal Lane and you should check out some excellent contributions by Barbara dealing with the FDA and Genomic Tests and other regulatory issues.

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 RadioTunein 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

Doubling Down on Prosecutorial Discretion

By Zack Buck

Health care entities should be “on high alert” following the Southern District of New York’s decision in Kane v. Continuum Health Partners that I blogged about here earlier this month.

The case, which serves as the first and most consequential interpretation of when an overpayment is “identified” for purposes of False Claims Act (FCA) liability, provides a measure of much-needed guidance for attorneys and compliance officers in an area that is rife with confusion. But not too much.

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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.

Affective Forecasting and Genetics

by Zachary Shapiro

Psychological research on “affective forecasting,” studying individuals’ ability to predict their future emotional states, consistently shows that people are terrible at predicting their ability to adapt to future adversity. This finding has particular significance for medical decision-making, as so many serious health decisions hinge on quality-of-life judgments, generally made by an individual balancing risks and benefits they perceive of a future state that is likely to result from a given therapeutic regime.

Much of the research on affective forecasting has focused on high-stakes events, restricting study participation to those likely to find the study event particularly significant, such as tenure-track faculty, registered voters, or sports enthusiasts. Despite a growing body of research on forecasting biases in the medical domain, little work has previously systematically considered such biases in clinical genetics. However, as the prevalence of genetic testing has increased, scholars have noticed forecasting deficiencies with increasing regularity.[1]

While evidence suggests that those who receive genetic testing, whether they are non-carriers or carriers of specific genes, differ in terms of short-term general psychological distress, their long-term distress levels do not differ significantly. Results of research into the affective reactions of patients undergoing predictive genetic testing suggest that, in general, psychological outcomes are not as negative as one may expect.

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Interpreting Fiorina’s Comments on Vaccination Law

I’ve started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She’s Right, analyzes GOP presidential candidate Carly Fiorina’s recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina’s remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others’ views, especially on contentious issues like vaccination.

A Very Special ‘The Week in Health Law’ Podcast

By Nicolas Terry

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TWIHL presents its first Back to School Special. We asked some wonderful health lawyers what were the compelling additions to this Fall’s health law curriculum. The answers are diverse and fascinating. To hear their explanations look for episode 22 when you subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app.

We are extremely grateful to the following (with links to their recommended topics):
Micah Berman – PBS Unnatural Causes
Erin Fuse Brown – Physician Self-Referral Updates (STARK)
Glenn Cohen – Egg freezing and egg banking: empowerment and alienation in assisted reproduction
Brietta Clark – Pickup v. Brown
Nicole Huberfeld – Armstrong v Exceptional Child Center Inc. 
Elizabeth Weeks Leonard – King v. Burwell
Frank Pasquale – Narrow Networks
Ross Silverman – Should childhood vaccination against measles be a mandatory requirement for attending school? Yes
Norman G. Tabler, Jr.–  Can an Arbitrator Rule Against a Hospital for Not Violating the Anti-Kickback Statute?
Nicolas Terry – North Carolina State Board of Dental Examiners v. Federal Trade Commission

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.

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

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.

‘The Week in Health Law’ Podcast

By Nicolas Terry

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All grown up! TWIHL’s 21st episode-thanks for all the support! This week we discussed the FDA, tobacco regulation, and the 1st Amendment with Micah Berman, who is on the law and public health faculties at Ohio State. You can find many of Professor Berman’s fine publications here.

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 RadioTunein 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

The 21st Century Cures Act, HIPAA, Big Data, and Medical Research

By Nicholson Price

The 21st Century Cures Act is a big deal; the House passed it handily, and we’re still waiting to see what the Senate does.  A lot has been written about what it does in terms of changing FDA review processes, and a fair bit about the lovely increase in funding for NIH (see Rachel Sachs’ blog posts here, here, and here).  These are tremendously important.

But another provision in the bill has been getting much less play: the way it changes HIPAA to enable large-scale research, which is also a big deal all by itself. Continue reading

The US 2020 HIV/AIDS Strategy and the Limits of ACA

By Leslie Francis

On July 30, the White House announced the updated 2020 HIV/AIDS strategy. The admirable vision of the strategy is that “The United States will become a place where new HIV infections are rare, and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity, or socio-economic circumstance, will have unfettered access to high quality, life-extending care, free from stigma and discrimination.”

This said, the strategy reflects continuing concerns about the numbers of people who do not know their HIV status, who do not have access to effective treatment, and who do not take advantage of preventive strategies. Demographic groups especially at risk include men having sex with men, African American men and women, Latino men and women, people who inject drugs, youth age 13-24, people in the Southern United States, and transgender women. The strategy emphasizes care coordination, coordination between health care and other social services such as housing, treatment as prevention, and pre-exposure prophylaxis. Notable initiatives since the 2010 HIV/AIDS strategy include interagency efforts to address the intersection of HIV and violence against women, a DOJ and CDC collaboration to publish a comprehensive examination and best practices guide on the intersection between HIV and criminal laws, and demonstration projects funded through the HHS Minority AIDS Initiative Fund. Continue reading

The Unintended Effect of Medicare on the Law of Torts

By Alex Stein

If you are familiar with about a thousand medical malpractice decisions and can’t think of an accident that might surprise you, read Stayton v. Delaware Health Corporation, — A.3d —- 2015 WL 3654325 (Del. 2015). Another reason for reading this new decision of the Delaware Supreme Court is that it has delivered an important precedent: the Court decided that the collateral source rule does not cover medical costs written off by Medicare. Continue reading

What Should the Future Look Like for Brain-Based Pain Imaging in the Law? Three Eminent Scholars Weigh In

By Amanda C. Pustilnik, Professor of Law, University of Maryland Carey School of Law; Faculty Member, Center for Law, Brain & Behavior, Massachusetts General Hospital

What should the future look like for brain-based pain measurement in the law?  This is the question tackled by our concluding three contributors:  Diane Hoffmann, Henry (“Hank”) T. Greely, and Frank Pasquale. Professors Hoffmann and Greely are among the founders of the fields of health law and law & biosciences. Both discuss parallels to the development of DNA evidence in court and the need for similar standards, practices, and ethical frameworks in the brain imaging area.  Professor Pasquale is an innovative younger scholar who brings great theoretical depth, as well as technological savvy, to these fields.  Their perspectives on the use of brain imaging in legal settings, particularly for pain measurement, illuminate different facets of this issue.

This post describes their provocative contributions – which stake out different visions but also reinforce each other.  The post also highlights the forthcoming conference-based book with Oxford University Press and introduces future directions for the use of the brain imaging of pain – in areas as diverse as the law of torture, the death penalty, drug policy, criminal law, and animal rights and suffering.  Please read on!

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Neuroimaging as Evidence of Pain: It’s Time to Prepare

By Henry T. Greely, Edelman Johnson Professor of Law, Stanford Law School; Professor (by courtesy) of Genetics, Stanford Medical School; Director, Program in Neuroscience & Society, Stanford University

The recent meeting at Harvard on neuroimaging, pain, and the law demonstrated powerfully that the offering of neuroimaging as evidence of pain, in court and in administrative hearings, is growing closer. The science for identifying a likely pattern of neuroimaging results strongly associated with the subjective sensation of pain keeps improving. Two companies (and here) recently were founded to provide electro-encephalography (EEG) evidence of the existence of pain. And at least one neuroscientist has been providing expert testimony that a particular neuroimaging signal detected using functional magnetic resonance imaging (fMRI) is useful evidence of the existence of pain, as discussed recently in Nature.

If nothing more is done, neuroimaging evidence of pain will be offered, accepted, rejected, relied upon, and discounted in the normal, chaotic course of the law’s evolution. A “good” result, permitting appropriate use of some valid neuroimaging evidence and rejecting inappropriate use of other such evidence, might come about. Or it might not.

We can do better than this existing non-system. And the time to start planning a better approach is now. (Read on for more on how)

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Of Algorithms, Algometry, and Others: Pain Measurement & The Quantification of Distrust

By Frank Pasquale, Professor of Law, University of Maryland Carey School of Law

Many thanks to Amanda for the opportunity to post as a guest in this symposium. I was thinking more about neuroethics half a decade ago, and my scholarly agenda has, since then, focused mainly on algorithms, automation, and health IT. But there is an important common thread: The unintended consequences of technology. With that in mind, I want to discuss a context where the measurement of pain (algometry?) might be further algorithmatized or systematized, and if so, who will be helped, who will be harmed, and what individual and social phenomena we may miss as we focus on new and compelling pictures.

Some hope that better pain measurement will make legal disability or damages determinations more scientific. Identifying a brain-based correlate for pain that otherwise lacks a clearly medically-determinable cause might help deserving claimants win recognition for their suffering as disabling. But the history of “rationalizing” disability and welfare determinations is not encouraging. Such steps have often been used to exclude individuals from entitlements, on flimsy grounds of widespread shirking. In other words, a push toward measurement is more often a cover for putting a suspect class through additional hurdles than it is toward finding and helping those viewed as deserving.

Of Disability, Malingering, and Interpersonal Comparisons of Disutility (read on for more)

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