Month: September 2017

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

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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.

American Beverage Association v. San Francisco: When the First Amendment Jeopardizes Public Health

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Crossposted from the Public Health Law Watch blog. 

By Micah Berman, Wendy E. Parmet, and Jason A. Smith

Last week, while the health law world focused on the Republicans’ renewed attempt to repeal and replace the ACA, the Ninth Circuit struck an ominous blow to public health. As we have noted previously, federal courts in recent years have relied on an increasingly expansive interpretation of the First Amendment to prioritize the rights of commercial speakers over the health and safety of the public.  This new-found appreciation for commercial speech has resulted in decisions striking down a wide-range of public health regulations and has led food and beverage companies to make “ever-bolder arguments aimed at limiting longstanding government authority to protect the public’s health.” In American Beverage Association v. City and County of San Francisco, those bolder arguments were accepted by the court, putting public health regulations in greater peril.

American Beverage Association concerned a challenge to a 2015 San Francisco ordinance requiring certain advertisements of sugar-sweetened beverages (SSBs) to display over at least 20% of the area of the advertisement a warning stating: “Warning: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco.”

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Understanding the Neuroscience and Philosophy of Consciousness

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By Yusuf Lenfest

Think of the last few times you’ve had a very lifelike dream. Running, reading, or having conversations with others, are all activities that might happen during a particularly vivid dream. But would this be considered consciousness? Surely being in a state of sleep is not the same as being in a waking state; but if you are able to communicate, to attend a lecture, perhaps even to give a lecture whilst you sleep, what does this mean in terms of your brain’s activity? Very deep in the sleep cycle, a person may not respond immediately to touch or sound or any other sensory stimulus. That is, they may not wake up, though it cannot be ruled out that an external stimulus might influence the sub-conscious mind and hence their dream. We’ve all had the experience of hearing an alarm “in our dream” which is really our real alarm, yet our mind re-interprets it and incorporates it into our dream until we regain consciousness, i.e., wake up. What if you couldn’t wake up from your unconscious state? And if so, what would this mean for how your brain processes your thoughts? In effect, what would it mean for your lived reality if you could only live in your mind?

Beyond being a fun thought experiment, these may be some very relevant questions now that doctors have treated a vegetative-state patient with an experimental therapy leading him to regain partial consciousness.

It was reported yesterday in National Geographic, Popular Science, the Guardian, and elsewhere that a 35-year-old man who had been in a persistent vegetative state (PVS) for 15 years has shown signs of consciousness after receiving a pioneering therapy involving nerve stimulation. The French researchers reported their findings to the journal Current Biology. Led by Angela Sirigu, a cognitive neuroscientist and director of the Institut des Sciences Cognitives Marc Jeannerod in Lyon, France, a team of clinicians tried an experimental form of therapy called vagus nerve stimulation (VNS) which involves implanting a device into the chest designed to stimulate the vagus nerve. It works by giving off miniscule electrical shocks to the vagus nerve, a critical brain signal that interfaces with parasympathetic control of the heart, lungs, and digestive tract.

So again, what does it mean to be conscious?

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Book Launch: Law, Religion, and Health in the United States

The Petrie-Flom Center Staff 2 Comments

Book Launch: Law, Religion, and Health in the United States
September 27, 2017 12:00 PM
Wasserstein Hall, Milstein West A (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In July 2017, Cambridge University Press will publish Law, Religion, and Health in the United States, co-edited by outgoing Petrie-Flom Center Executive Director Holly Fernandez Lynch, Faculty Director I. Glenn Cohen, and Elizabeth Sepper, Professor of Law at Washington University School of Law. This edited volume stems from the Center’s 2015 annual conference, which brought together leading experts to identify the various ways in which law intersects with religion and health care in the United States, examine the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

About the book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else – patient or physician, secular or devout – interested in how US law interacts with health care and religion.

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Orphan Drugs Designations and Approvals have Something to Say about Risks

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This brief essay examines data from the U.S. Orphan Drug Act, including specifically the FDA designations of an indication for a drug to treat an orphan disease, and the likelihood that once the designation is made, the FDA will approve the drug for that indication. This is one empirical measure of the risks associated with the development of new drugs to treat U.S. defined orphan diseases.  Note that 75 percent of all novel cancer drugs approved in the United States from 2010 to 2016 qualified as orphan products.    The essay also reports the average time between the FDA designation and the FDA approval for orphan indications.

The main findings are that since 2010, the average time from orphan designation to approval is 5.3 years, and the likelihood of FDA approval for an orphan indication, which varies over time and across business cycles, was .22 from 1990 to 2017, and since 2010, was .25.

The essay concludes with a comparison to other studies of the risks of drug development.

On January 5, 1983, the U.S. Orphan Drug Act became law as Public Law 97-414. Over the past 34 years the Act has been amended numerous times, often extending or expanding the benefits, which currently include a 50 percent tax credit for qualifying clinical trials, exemptions or discounts on prescription drug user fees, an easier and faster path to FDA approval, and seven years of marketing exclusivity for an approved orphan indication. Read More

TODAY, 9/25 at 5 PM: Health Law Workshop with Francis Shen

Jennifer Minnich Leave a comment

September 25, 2017, 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “How Dangerous are Youth Sports for the Brain? A Review of the Evidence”

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich at law.harvard.edu.  

Francis X. Shen is the third Senior Fellow in the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center. He is an Associate Professor at the University of Minnesota Law School, where he heads the Shen Neurolaw Lab. He also serves as Executive Director of Education and Outreach for the MacArthur Foundation Research Network on Law and Neuroscience.

Professor Shen completed his BA in economics and English at the University of Chicago in 2000, his JD at Harvard Law School in 2006, and his PhD in government and social policy at Harvard University and the Kennedy School of Government in 2008. During graduate school he was a doctoral fellow in the Harvard University Multidisciplinary Program in Inequality & Social Policy, supported by the National Science Foundation. From 2007-09, he was a teaching fellow, lecturer, and assistant director of undergraduate studies in the Harvard Department of Government and received five Certificates of Distinction for Excellence in Teaching from Harvard’s Derek Bok Center. Read More

Special Deals for States?

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By Christopher R. Robertson

Over at HuffPo, Craig Konnoth has a short-but-smart piece exploring the Constitutionality of the logrolling deals now underway to persuade Alaska Senator Lisa Murkoswki to support the latest effort to repeal Obamacare.  Would other states have a right to object to a deal that showered special benefits on Alaska?  Konnoth explains how an “equal sovereignty” principle has emerged in recent Supreme Court decisions, and suggests that it may provide some grounds for challenging this sort of special treatment.

I am left wondering about the longstanding practices of states requesting and receiving waivers from the Federal government.  For example, Maryland has for decades enjoyed a Medicare waiver, which allows it to regulate prices.  Massachusetts has a $52B waiver to put its Medicaid members in accountable care organizations.   Do these violate equal sovereignty too?

Maybe the answer is that all states are treated equally in their right to apply for such waivers, under several explicit statutory vehicles, which have yielded several hundred such applications.  These are not simply bribes to secure votes in Congress.  On the other hand, some of these waivers were very much the result of politically-charged negotiations between conservative governors (such as Indiana’s Mike Pence) and the Obama administration, who granted these waivers as a way to expand insurance coverage.  Maybe that’s not so different than what Murkowski is demanding?

On related questions, also check out Brian Galle’s piece over at Medium.com.

Triple Canopy and Evolving Standards of Materiality Under the Civil False Claims Act (FCA)

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By Joan H. Krause

[Cross-posted from L3: Long Leaf Law Blog]

In Universal Health Services v. United States ex rel. Escobar (UHS), the Supreme Court upheld the Civil False Claims Act (FCA) theory of “implied certification,” under which the submission of a claim for reimbursement “implies” that the claimant is in compliance with the statutes, regulations, and contract provisions necessary for that claim to be paid. Escobar was filed by the parents of a young woman who died after receiving Medicaid-covered mental health treatment from a Massachusetts clinic that violated state licensing and supervision regulations. Her parents alleged that the clinic’s claims were fraudulent because they implicitly (and falsely) represented that the facility was in compliance with the relevant provisions. A district court dismissed the suit, but the First Circuit reversed. In a unanimous opinion written by Justice Thomas, the Supreme Court held that where a defendant “makes specific representations about the goods or services provided, but knowingly fails to disclose . . . noncompliance with a statutory, regulatory, or contractual requirement[,] . . . liability may attach if the omission renders those representations misleading.”  But cautioning that such misrepresentations must be “material to the Government’s payment decision,” the Court reversed and remanded because the First Circuit had applied an impermissibly broad test.

Escobar was not the only federal appellate case to grapple with implied certification in recent years. In 2015, the year the First Circuit considered Escobar, no fewer than four federal appellate cases confronted the theory. Arguably the most important of these cases, at least from the standpoint of national security, was United States ex rel. Badr v. Triple Canopy, Inc., a Fourth Circuit case reversing the dismissal of a suit alleging that a military contractor had falsified marksmanship scores for Ugandan security guards hired to protect Al Asad Airbase in Iraq. Noting that the contract did not expressly condition payment on marksmanship, the district court had concluded that the claims did not contain any factually false statements. The Fourth Circuit disagreed, upholding the allegations under the theory of implied certification. Perhaps due to the tragic facts and sympathetic plaintiffs, or perhaps in recognition of the important role Medicare and Medicaid FCA cases now occupy, the Court instead chose to review Escobar rather than Triple Canopy. Nevertheless, in light of Escobar, Triple Canopy was reversed and remanded for further proceedings. On May 16, 2017, the Fourth Circuit issued its long-awaited decision on remand.

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Democratized Diagnostics: Why Medical Artificial Intelligence Needs Vetting

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Pancreatic cancer is one of the deadliest illnesses out there.  The five-year survival rate of patients with the disease is only about 7%.  This is, in part, because few observable symptoms appear early enough for effective treatment.  As a result, by the time many patients are diagnosed the prognosis is poor.  There is an app, however, that is attempting to change that.  BiliScreen was developed by researchers at the University of Washington, and it is designed to help users identify pancreatic cancer early with an algorithm that analyzes selfies.  Users take photos of themselves, and the app’s artificially intelligent algorithm detects slight discolorations in the skin and eyes associated with early pancreatic cancer.

Diagnostic apps like BiliScreen represent a huge step forward for preventive health care.  Imagine a world in which the vast majority of chronic diseases are caught early because each of us has the power to screen ourselves on a regular basis.  One of the big challenges for the modern primary care physician is convincing patients to get screened regularly for diseases that have relatively good prognoses when caught early.

I’ve written before about the possible impacts of artificial intelligence and algorithmic medicine, arguing that both medicine and law will have to adapt as machine-learning algorithms surpass physicians in their ability to diagnose and treat disease.  These pieces, however, primarily consider artificially intelligent algorithms licensed to and used by medical professionals in hospital or outpatient settings.  They are about the relationship between a doctor and the sophisticated tools in her diagnostic toolbox — and about how relying on algorithms could decrease the pressure physicians feel to order unnecessary tests and procedures to avoid malpractice liability.  There was an underlying assumption that these algorithms had already been evaluated and approved for use by the physician’s institution, and that the physician had experience using them.  BiliScreen does not fit this mold — the algorithm is not a piece of medical equipment used by hospitals, but rather part of an app that could be downloaded and used by anyone with a smartphone.  Accordingly, apps like BiliScreen fall into a category of “democratized” diagnostic algorithms. While this democratization has the potential to drastically improve preventive care, it also has the potential to undermine the financial sustainability of the U.S. health care system.

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The U.S. Drug Price Catastrophe and the Central Planner

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By Aobo Dong

If you are fortunate enough to have an insurance plan with extensive coverage and low co-pays for prescription drugs, chances are you may not be overly concerned with the U.S. drug price catastrophe. For millions of Americans without such a plan, getting the much-needed prescribed medicine often involves frustrating multi-player exchanges between the pharmacy, the insurance company, and the doctor, due to complications such as drug pricing and pre-authorization.

The NYT recently launched an investigation into a simple question: “Why Are Drug Prices So High?” One surprising revelation from the study is that deep drug pricing problems may have been contributing to the ongoing opioid crisis, as insurers restrict patient access to less addictive alternatives. For instance, UnitedHealthcare stopped covering Butrans – a drug that had successfully helped Alisa Erkes to ease her excruciating abdominal pain for two years – just to lower its own expenses. Instead, Alisa’s doctor had to put her on long-acting morphine – a drug in a higher category for risk of abuse and dependence than Butrans. However, since it costs the insurance company only $29 a month, UnitedHealthcare covered it with no questions asked. Read More