Co-Blogged by Christopher Robertson and Kelly McBride Folkers (research associate at the Division of Medical Ethics of the NYU School of Medicine)
In 2014, Arizonans overwhelmingly voted in favor of a ballot referendum that claimed to allow terminally ill patients the “right to try” experimental drugs that have not yet been approved by the Food and Drug Administration (FDA). Despite the policy’s broad support, it has yet to help a single patient in Arizona obtain an experimental drug that they couldn’t have gotten before. Thirty-seven other states have also passed right to try bills, but likewise have seen little real impact for patients.
“Right to try” has moved to the federal stage, as the U.S. Senate unanimously passed such a bill last August without even holding a hearing. The House Energy & Commerce Subcommittee on Health considered the bill in an October hearing, but it failed to garner much enthusiasm among committee members. Vice President Mike Pence has advocated for a federal right to try law, and he recently met with FDA Commissioner Scott Gottlieb and House leadership to encourage pass of the bill this year. Continue reading →
The passage of the Republican tax reform bill affects the health care industry in ways that might be confusing and unpredictable for tens of millions of Americans. Due to political rhetoric and inaccurate portrayal of the bill, it seems as if the Individual Mandate – an essential element in the ACA – has been fully repealed. Nonetheless, as Health Affairs rightly points out, Section 5000A still remains in the statute to require “minimal essential coverage” for all individuals. Therefore, although the tax bill repealed the tax penalty for not having insurance coverage, the law still technically mandates individuals to acquire health insurance. Moreover, the tax penalty repeal will not take effect until the 2019 tax year, so individuals who are uninsured for more than 2 months in the 2018 tax year may still be liable for paying the tax penalty, unless future laws and regulations, or an executive order from Trump, indicates otherwise.
Under the new regulatory landscape, what could be some potential repercussions for Health Care Sharing Ministries (HCSMs)? These ministries, largely run by evangelical Christians who believe in the merit of private cost sharing, have been benefiting from the Individual Mandate since the inception of the ACA. Under Section 5000A, HCSM members are exempt from paying the tax penalty. The dearth of legal exemptions available and the widespread dislike of Obamacare among white evangelical communities in America likely fueled the rapid growth of HCSMs in recent years. Members pay their monthly “shares” to each other to cover health insurance expanses, without going through a central insurance or governmental agency for redistribution. Continue reading →
Let’s call it for what it is: Placing prisoners in solitary confinement is tantamount to torture and it needs to stop.
The practice of placing incarcerated individuals in solitary confinement dates back to the 1820s in America when it was thought that isolating individuals in prison would help with their rehabilitation. Yet, over the past two centuries, it has become clear that locking people away for 22 to 24 hours a day is anything but rehabilitative. Solitary confinement is so egregious a punishment that in 2011, the U.N. Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment condemned its use, except in exceptional circumstances and for as short a time as possible, and banned the practice completely for people with mental illnesses and for juveniles.
Despite its barbarity, the United States continues to place thousands of people, including individuals with mental illnesses and children, in solitary confinement, sometimes for decades. Thirty years ago, Dr. Stuart Grassian, who recently spoke at Harvard Medical School’s “Behind Bars: Ethics and Human Rights in U.S. Prisons” conference, evaluated 14 individuals placed in solitary confinement and found the same symptoms in many of them: hypersensitivity to external stimuli; perceptual disturbances, hallucinations, and derealisation experiences; affective disturbances, such as anxiety and panic attacks; difficulties with thinking, memory and concentration; the emergence of fantasies such as of revenge and torture of the guards; paranoia; problems with impulse control; and a rapid decrease in symptoms immediately following release from isolation. Taken together, Dr. Grassian proposed that these symptoms amount to a pathopsychological syndrome.
Over the past few years, more and more global health luminaries and leading NGOs have called for a Framework Convention on Global Health (FCGH), for using the strongest instrument of international law to advance the quest for health equity.
In the globalization era, the highest attainable level of health cannot be achieved by States acting on their own. A FCGH treaty would facilitate the coordinated global effort needed to achieve the highest attainable level of health everywhere. It would reform global governance for health to enhance accountability, transparency, and civil society participation and protect the right to health in trade, investment, climate change, and other international regimes, while catalyzing governments to institutionalize the right to health at community through to national levels.
The FCGH Alliance membership includes more than 30 organizations and individuals from Africa, Asia, Latin America, North America, and Europe that believe that unconscionable global and local health inequities are fundamentally unjust.
We know this is an ambitious undertaking, but we are convinced that a FCGH would be a historical shift in global health.
This is the latest of a series of cases involving disputes between ex husbands and ex wives (or in some cases unmarried former partners) regarding the disposition of cryopreserved pre-embryos. These cases, that have been percolating in a large number of states for what has now been 25 years (!) and have come out in a myriad of ways on a myriad of theories as Eli Adashi and I recently detailed in the Hastings Center Report.
One thing many of these cases have in common, though, is that the Courts have avoided reaching the fundamental federal Constitutional question I wrote about now 10 years ago in the Stanford Law Review: Does the party opposing the implantation of embryos upon dissolution of the marriage have a right not to procreate recognized by the federal Constitution? I have argued that we need to realize we are talking about possible rights (plural) not to procreate and in particular separate out:
The right to be a gestational parent
The right not to be a gestational parent
The right to be a genetic parent
The right not to be a genetic parent
The right to be legal parent
The right not to be a legal parent.
This case demonstrates well why such a distinction is important.
Not since Rene Descartes gazed from his garret window in early 17th-century Paris and wondered whether those were men or hats and coats covering “automatic machines” he saw roaming the streets has the issue of personal identity and your cranium been of such import. Descartes feared a world that he alone occupied due to deception by the devil. Today we face a different mind-body challenge in the form of a devil we know: Italian neuroscientist Sergio Canavero. He recently announced that the first human head transplant is imminent.
For bioethicists, the moral critiques of this surgery practically write themselves: Are we merely our bodies? How can a person so ill as to wish to trade in his lifelong corporeal companion be considered competent to consent to such a drastic procedure? How can family members consent to donate a body that they could very well run into — and recognize — at the beach or gym? What if a left-handed person received a right-handed body? What if a lifelong Chicago Bears fan woke to find himself attached to the green-and-gold-tattooed torso of a former Packers fan? Would transplant recipients need to buy whole new wardrobes? Who will pay? […]
Early last summer, Facebook removed Women on Web’s page for ‘promoting drug use’. The Amsterdam-based organization connects women with doctors who prescribe the pills necessary for medical abortions and provides information on taking abortion pills, on contraception and on accessing abortion services in states where access to safe abortions is restricted or illegal. This followed an earlier interaction in which Facebook removed a photo of the organization’s founder, Rebecca Romperts, superimposed with instructions on the use of the pills. Facebook later apologized and reinstated the Facebook page, claiming that the removal was an error, and that the page served Facebook’s function of allowing individuals to organize and campaign for the issues that matter most to them.
Leaving aside the question of whether it was indeed an error, WoW have never existed without controversy. In February of last year, their sister organization Women on Waves made headlines when their boat was detained by the Guatemalan authorities while campaigning in Guatemalan waters. Women on Waves provides medical abortions to women once they are in international waters and thus operating under Dutch law, which allows abortions up to 21 weeks. Both organizations will provide access to abortion services up to 9 weeks, using a combination of medicines – misoprostol and mifepristone – which together induce abortion. The WHO estimates that the drug combination is used by 26 million women globally per year and is recommended as an abortifacient up to 9 weeks of pregnancy. Women on Waves are one of many organizations that aim to allow women to access abortion services that are either explicitly illegal, or practically unavailable in their home countries. There are risks associated with taking the drug combination, but these are minimal, and far riskier is the danger of leaving women with access to illegal abortions which is often the reality of full abortion bans. In Guatemala, 65,000 women have illegal abortions every year, with a third of that number admitted to hospitals from complications associated with the backstreet procedure. A medical abortion before 10 weeks is safer than childbirth, and as safe as a natural miscarriage. Both drugs have been on the WHO’s list of essential medicines since 2005. Studies show a high level of effectiveness in self-sourced and administered abortion pills, such as the service offered by Women On Web, and outcomes generally compare favorably with in-clinic administration. Underscoring the importance of safe access to the drug combination, use of the pills is often studied as a self-administration method alongside getting punched in the stomach, taking herbs or homeopathic medicines, deliberately taking a high dose of hormonal pills, alcohol and illegal drugs.
Last year, I had the good fortune to present at the Petrie-Flom Center’s conference on transparency and I started with an anecdote about a congressman who decided to wait rather than take his son immediately to the emergency room after he injured himself. The congressman assumed his son only had a sprain, but he had actually broken his arm. So why the wait? Because of a difference in his co-pay. In an interview, the congressman argued for policies to push consumers to understand—and be exposed to— healthcare costs in order to make better decisions about their care: “Way too often, people pull out their insurance card and they say ‘I don’t know the difference or cost between an X-ray or an MRI or CT Scan.’ I might make a little different decision if I did know (what) some of those costs were and those costs came back to me.”
The congressman’s policy prescription is becoming reality: last year, the largest Blue Cross Blue Shield plan Anthem announced a new policy where it would deny coverage for care provided in an emergency room that was later deemed non-emergent (except in certain circumstances). It seems a far cry from simply charging an ER co-pay, but Anthem argues it has seen a rise in non-emergency care being provided in emergency rooms. How are patients supposed to know if the ache or pain they are experiencing is not an emergency? Apparently there is a spreadsheet of over 1,900 ailments that Anthem considers non-emergent.
The Petrie-Flom Center is pleased to welcome Oliver Kimto the Bill of Health as our newest contributor!
Oliver is an adjunct professor with the University of Pittsburgh School of Law and a policy consultant in Washington, DC. He has over fifteen years of federal and state legislative and policy experience, including serving for eight years as a senior advisor to Senator Debbie Stabenow (D-MI) and two as deputy director for the Special Committee on Aging under Chairman Bill Nelson (D-FL). He was selected for the Woodrow Wilson foreign policy fellowship, the AcademyHealth Health Policy in Action award, the Hartford Foundation Change AGEnt program, and the American Council of Young Political Leaders’ international exchange program. He received his BA from Indiana University, JD from University of Minnesota, and LLM from the Georgetown University Law Center.
Recently, people in Vermont have been talking about launching a Safe Injection Facility (SIF) to address drug harms arising with the opioid epidemic. With more deaths than ever, trying new approaches make sense — especially “new” approaches like SIFs that have two decades of solid international evidence of efficacy behind them. Several cities are actively considering the same intervention.
One of the biggest barriers is uncertainty about how federal drug control authorities will react. Although there are reasonable arguments that SIFs for public health do not violate the Controlled Substances Act, and the national opioid task force has broadly called for extraordinary action, there has been no explicit support from the Trump administration and no effort to carve out space in the law from Congress. Continue reading →
The House of Commons Committee of Public Accounts (Committee of Public Accounts) has recently considered the issue of managing the increasing clinical negligence costs in NHS (National Health Service) hospitals in a report. They make a number of important recommendations as well as putting into the spotlight a number of developing trends and themes. The report is linked to a report recently published by the National Audit Office on managing clinical negligence costs.This report is closely examined by the Committee with witnesses giving oral and written evidence.
The high cost of clinical negligence litigation
The report begins with a statement on the high and increasing cost of clinical negligence which sets the scene and tone for the rest of the report The Committee has raised concerns about the rising costs of clinical negligence on a number of previous occasions going back as far as 2002. The questions and answers of witnesses called by the Committee do reveal some very interesting and telling insights into the issues and the problems faced. Continue reading →
The Jaharis Health Law Institute is accepting applications for a Faculty Fellow in Health Law and Intellectual Property. We will be starting interviews in the coming weeks, so please get all applications in ASAP.
Established in 1984 and supported by the Mary and Michael Jaharis Health Law Institute (JHLI), DePaul’s health law program has consistently ranked among the top in the nation. JHLI offers students coursework that reflects the diversity of health law from community health to high-tech health care, making DePaul a leader in the education of future generations of health law partners, policy makers and critical thinkers.
About the Fellowship:
An endowment at the DePaul University College of Law funds a faculty fellowship program for scholars to create and disseminate scholarship and teach courses where two dynamic legal fields are increasingly intersecting—intellectual property and health law. The fellowship is designed to encourage scholars interested in entering a career in legal academia in these fields. The Jaharis Faculty Fellow will work with and be mentored by faculty from DePaul’s nationally-ranked Mary and Michael Jaharis Health Law Institute (JHLI) and Center for Intellectual Property Law & Information Technology (CIPLIT®). Continue reading →
As detailed in Part 1, Ontario government just enacted the Health Sector Payment Transparency Act, a Canadian first in terms of transparency. The act requires that “transfers of value” (or payments), related to medical products (drugs and medical devices), between a payor and a recipient be reported to the Health Ministry. The Act gives the Ministry unprecedented powers to require, analyze, and publish such data online.
A Transformational Act?
Will this act radically transform the practices and the public knowledge that we have about the financial relations of the medical industry? The effective implementation of the regulations will tell us. However, the fact that Innovative Medicines Canada (formerly known as Rx&D, IMC is the organization representing the interests of the pharmaceutical industry in Canada, like PhRMA in the US) has concerns about the Act is a rather positive sign that this legislation might result into pro-social changes. IMC is invoking both ideological concerns (industry’s interactions with HCPs imply cooperation rather than influence) and logistical concerns (“if the threshold for payments is low, a sales representative could easily lose a receipt and forget to report it”), as well as its own commitment to limiting undue influences. Continue reading →
Drug overdose is a leading cause of death in Americans under 50. Opioids are responsible for most drug-related deaths killing an estimated91 people each day. In Part I of this three-part series, I discuss how the President’s Commission on Combatting Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In Part II I explore how the Commission dismissed medical interventions used successfully in the U.S. and abroad such as kratom and ibogaine. In this third part of the series, I explain how the Commission ignored increasingly proven harm reduction strategies such as drug checking and safe injection facilities (SIFs).
In its final report released November 1, 2017, the President’s Commission acknowledged that “synthetic opioids, especially fentanyl analogs, are by far the most problematic substances because they are emerging as a leading cause of opioid overdose deaths in the United States.” While speaking before the House Oversight Committee last month, the Governor of Maryland Larry Hogan stated that of the 1180 overdose deaths in his state this year, 850 (72%) were due to synthetic opioids. Street drugs are often contaminated with fentanyl and other synthetics. Dealers add them to heroin, and buyers may not be aware that they are consuming adulterated drugs. As a result, they can be caught off guard by their potency, which contributes to respiratory depression and death. Synthetic opioids such as fentanyl are responsible for the sharpest rise in opioid-related mortality (see blue line in Fig. 1 below). Continue reading →
While Canada is often viewed positively for its public, comprehensive, universal, and accessible health care system, not all is rosy. Canada often lags behind other countries in terms of pharmaceutical policies. Sometimes, this is advantageous (e.g., delaying the approval of a product to wait for more clinical data or real-world efficiency, so to better assess risk-benefit and determining the maximum selling price), but more often simply a problem: until recently, transparency in Canada was more a buzzword than a strong and assumed government stance.
However, a few days ago in Ontario, the omnibus Strengthening Quality and Accountability for Patients Act received royal assent, thus enacting the Health Sector Payment Transparency Act. This clearly marked the beginning of shedding light on the financial relationships and payments to health care providers and organizations made by the medical industry (pharmaceutical and medical device companies), the explicit goal being to strengthen patient trust in the health care system (including research and education activities) by allowing patients to assess whether their health care providers are subject to influence by industry and to foster more informed choice. While the United States enacted the Physician Payments Sunshine Act (PPSA) in 2010, which requires payment disclosure, this is a first in Canada.
A bioethicist by training, he is particularly interested in the marketing of health products and the resulting moral responsibility of regulators and industries. While his undergraduate studies in physics led him to pure science, his interest in the field of health and bioethics grew during his experiences in the pharmaceutical industry, where he worked for 6 years in clinical research and regulatory affairs, as well as in business intelligence, sales, and marketing.
His research also focuses on patient engagement in research by exploring ethical and logistical dimensions as well as providing guidance for capacity development of future researchers. Jean-Christophe is also interested in how researchers can engage the general public to reflect on the most pressing ethical issues of our time, including by mingling arts and bioethics to advance these reflections in the public space. He will be the new Managing Editor of the Journal of Law and the Biosciences beginning January 2, 2018.
A friend and I had been vaguely entertaining the idea of ordering genetic testing kits for some time. Then, Black Friday happened. My friend called me to share that 23andMe was on sale, 50% off, for 1 more hour! Typing our credit card information into Amazon, we tossed around some half-reasoned arguments in favor of our impulsive purchases: “this’ll be a fun science experiment”, “what if we catch something preventable in time to make lifestyle changes?” and, “we really should be contributing our data to research for the public good.” Within minutes, two kits were ordered and thanks to the magic powers of Amazon Prime, these boxes appeared on our doorsteps within days. Few things in life are as exciting as receiving a mail delivery, but as we unwrapped our packages, finding the words “Welcome to You” plastered on our shiny white Pandora’s boxes, somehow our excitement began to dwindle. One month later, our boxes remain unopened.
Genetic testing is clearly something we should have given more thought before the marketing geniuses got the best of us. Here are some questions anyone considering taking a direct-to-consumer (DTC) genetic test should answer (ideally before buying the test):
A special holiday, near-double episode of TWIHL, featuring a return visit from Andrea Matwyshyn, Professor of Law at Northeastern University, co-director of NEU law school’s Center for Law, Innovation, and Creativity (CLIC), and a US-UK Fulbright Commission Cyber Security Scholar (2016-2017). In addition to her appointment on the law faculty, she is a professor of computer science (by courtesy).
The episode focused on AI, regulation of cutting edge medical devices, and security. We mentioned, in passing, explainable AI, European regulation to require it in certain settings, the general problems raised by AI in health care, and recent developments regarding both mental health apps and devices. Andrea developed her idea of the “Internet of Bodies,” making a compelling case that the law of software liability needs to evolve to address the high stakes of software failure in critical medical devices. We concluded with some year-end reflections on the annus horribilis we shall gladly bid adieu in 10 days. In the meantime, happy holidays to all our listeners!
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 RadioTunein, 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.
There is a lot of interest in civil commitment these days, as a possible tool to fight two big health problems. As we continue to watch the rates of opioid-related deaths climb, and in the wake of an unfunded emergency declaration by President Trump, some policymakers are looking to involuntarily commit overdose survivors for drug treatment. On the gun violence side, experts like Jeffrey Swanson have argued for applying gun-access restrictions that now cover people subject to long-term civil commitment to those subjected to short-term civil commitment.
With those kinds of ideas in the air, it is important to recognize how little modern data we have on commitment and its effects. In a recent article in the Washington Post discussing commitment for opioid treatment, Michael Stein and Paul Christopher emphasize how little we know. I entirely agree on the need for more research, and offer a couple of things to help.
The first is the Policy Surveillance Program’s LawAtlas dataset that maps civil commitment laws across all 50 states and the District of Columbia. If we’re going to examine these laws and their impact, this is the place to start. We also put out the call to anyone interested in studying this to work with us not only to update this data through 2017, but also to make sure we’re mining these laws and their characteristics for the right information in these circumstances — Are we asking the right questions? Continue reading →
Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids kill an estimated 91 Americans each day and are responsible for most drug-related deaths in the US. This public health crisis requires solutions that are supported by science and reason instead of emotion and political ideology. In Part I of this three-part series, I discuss how the President’s Commission on Combating Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In this second part of the series, I explore how the Opioid Commission ignored medical interventions that are used successfully in the U.S. and abroad. In Part III, I will discuss non-medical interventions such as drug checking and safe injection sites. The Commission’s failure to consider these options is likely driven by emotions such as fear and disgust rather than a careful review of scientific evidence.
Medical marijuana is currently accepted in 29 U.S. states and the District of Columbia. It is also permitted in at least 10 countries. However, the Opioid Commission outright rejected calls to consider the use of medical marijuana as an alternative to opioids for managing pain. Prior to the Commission’s first meeting, it solicited input from industry and members of the public on how to address the opioid crisis. In response, it received over 8,000 public comments. According to VICE News, which obtained the documents by submitting a Freedom of Information Act (FOIA) request, most comments were submitted by individuals urging the Commission to “consider medical marijuana as a solution to the opioid epidemic.” A spokesman for the Office of National Drug Control Policy, a body of the Executive Branch that provides administrative support to the Opioid Commission, reports receiving “more than 7,800 public comments relating to marijuana.” Despite these comments, in its final report, the Commission dismissed the notion that marijuana should play a role in treating chronic pain and opioid addiction. Its report cited a recent study from the American Journal of Psychiatry, which concluded that marijuana use was associated with an increased risk of opioid abuse. However, this study relied on data that was collected over twelve years ago. One of its authors, Columbia Medical School Professor Mark Olfson, told CNN that if the data were collected today, they could yield different results.