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.
Speakers will examine the role Washington, D.C. plays in cancer research and treatment—through politics, legislation, and lobbying as well as by incentivizing and protecting research—and the ways cancer is shaped outside the federal government, including through private entities such as cancer centers and insurance companies, and through state governments. The conference will address special challenges in drug development and pricing as well as how cutting-edge advances in cancer treatment—including precision medicine, immunotherapy, and improvements in the genetic profiling of tumors—interface with existing and proposed government regulations. Speakers will also consider how disparities and inequalities impact cancer research, regulation, and treatment.
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.
Anne Case and Angus Deaton shocked the world with their 2015 report that noted an increase in all-cause mortality among middle-aged white non-Hispanic men and women in the United States. This pattern is not occurring in other groups within the United States and Europe. Their report, and others since then, have linked this trend to so-called deaths of despair (death from suicide, chronic substance use, and overdoses) and their linkage to other determinants of health (education, labor markets, marital patterns). A recent update to the report makes it clear that this trend is no longer limited to any particular geographic region within the United States.
This year’s NUSL Center for Health Policy and Law annual conference and associated scholarship will bring together experts, policymakers, and academics to discuss the causes behind such trends, and to explore potential political, policy, and legal responses for addressing broader determinants that affect the physical and mental health of Americans dying from these diseases of despair. Deeper examination into similar patterns among diverse populations, as well as analysis of continuing racial, ethnic, and socioeconomic disparities, will be central to the discourse.
The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.
Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Continue reading →
In the complex web of restrictions on abortion access, parental consent laws and judicial bypass mechanisms play a small, but hugely significant part. States are entitled to enact parental consent and notification laws in relation to abortion care for minors, as long as they allow minors to ‘bypass’ this requirement judicially, an attempt to account for the myriad circumstances in which it will be impossible, difficult or dangerous for teens to tell their parents about their pregnancy and their wish to end it. Finding different justifications in different contexts, some laws appeal to the perceived immaturity of the individual in arriving at a decision without adult intervention; other legal schemes emphasize the critical importance of respecting the family unit, and by extension, the ability of parents to determine the medical treatment their child will receive. The exact stats, state by state, are available here.
The patchwork regime which governs the US rules on abortion access, administered by local courts presiding over the individual applications of pregnant teenagers, is a highly dysfunctional one, where standards of judgment can be entirely capricious. Judges are, after all, not medical professionals, nor are they therapists, health experts or developmental psychologists. The standard criteria pronounced upon by a judge at a bypass hearing is whether the minor is ‘mature enough, and well enough informed to make her abortion decision, in consultation with her physician, independent of her parents knowledge’ or that ‘even if she is not able to make this decision independently, the desired abortion would be in her best interests’. The gateway for unchecked judicial discretion is gaping. Markers of maturity are wholly subjective determinations, as are the metrics to determine whether a minor is sufficiently informed, or where her best interests lie. After all, for a staunchly anti-abortion judge, it is entirely possible that no-one could be informed about the process of abortion and yet rationally seek it, or that it could never be in an individual’s best interests to receive abortion care as a minor. The controlling law doesn’t foreclose on these possibilities.
By Margaret Waltz, PhD, R. Jean Cadigan, PhD, Anya E. R. Prince, JD, MPP, Debra Skinner, PhD, and Gail E. Henderson, PhD
Age is an important consideration in medical screening, but calls forpopulation basedpreventive genomicscreening programs do not mention an upper age limit. Should such programs employ upper age limits, as occurs in other clinical screenings, on the assumption that older individuals would not benefit clinically? To address this question, our Genetics in Medicine paper analyzed data from GeneScreen, a research study of preventive genomic screening aimed at adults. We focused on how the researchers who designed the study and 50 individuals who joined the study understood and valued age in relation to screening.
GeneScreen used a screening panel of 17 genes associated with 11 rare conditions for which treatment and/or prevention options were available, like Hereditary Breast and Ovarian Cancer, Lynch Syndrome, and Long QT Syndrome. GeneScreen researchers initially suggested an upper age limit, reflecting the assumption that older individuals were unlikely to clinically benefit from the results. One clinician worried that without an upper age limit, GeneScreen might reinforce the desire for screening among older adults and the misconception that screening “does a lot of good when you’re 80.” This was reconsidered when they discussed familial benefit. As one researcher said, participation “might not actually save the 80-year-old that we test, but [it] could save his grandchildren.” The recognition of familial benefit motivated the decision to not exclude adults based on age.
From this report, I learned that in Germany and the Netherlands, incarceration is seen as a last resort for individuals convicted of crimes. Alternative non-custodial sanctioning and diversion systems such as fines and task-penalties exist – and are effective. In 2010, 6% of sanctioning resulted in incarceration in Germany and in 2004, 92% of sentences were for two years or less. These incarceration systems are organized around the principles of resocialization and rehabilitation. Time spent in prison is meant to be as similar as possible to community life, and incarcerated people are encouraged to cultivate relationships within and outside of prison. In prison, individuals can wear their own clothes, structure their own days, work for pay, study, parent their children in mother-child units, vote, and return home occasionally. In these systems, respect for persons, privacy, and autonomy are strongly held values. Solitary confinement is rarely used, and cannot exceed four weeks a year in Germany, and two weeks a year in the Netherlands.
The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. 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.
Joining the ever growing circle of workplace misconduct targeting women’s bodies is the revelation that Representative Trent Franks (R-Ariz.) will resign his seat amid allegations that he solicited two female staffers to serve as gestational carriers and bear his children. In a characteristically defensive resignation letter, Franks bemoans the difficulties he and his wife experienced in forming their family, detailing their multiple miscarriages, failed attempts at adoption, and ultimately joy at the birth of twins with the help of a “wonderful and loving lady” who carried the couple’s children to birth. Wanting to grow their family when the twins reached three, the congressman admits that he “broached a topic that, unbeknownst to me until very recently, made certain individuals uncomfortable.” Those individuals were subordinate female employees who have the right to work in an environment where their boss cannot ask without warning, “Will you be my surrogate?”
Aside from the obvious addition to the constellation of misconduct premised on the assumption that the female body is fair game in service of male desires, this latest affront holds an irony that should not be lost on us, as well as lessons for the broader regulation of assisted reproductive technologies. As to irony, Arizona is one of a dozen states that outlaws surrogate parenting arrangements. The state’s family code provides, “No person may enter into, induce, arrange, procure or otherwise assist in the formation of a surrogate parentage contract.” This means that surrogacy agreements are unenforceable at law, but legal experts report that intended parents – like the Franks – are willing to take the risk and hope a court will recognize their legal parentage either before or after the children are born. While Rep. Franks did not reveal if his surrogacy contract was executed under Arizona law, odds are he and his wife sought judicial approval of their parental rights in the state he represents in Congress. Continue reading →
2017 was a year of tremendous uncertainty for many areas of public policy. Health care policy was no exception, most prominently with an almost successful push by Congressional Republicans to radically revise the Affordable Care Act (ACA). Medical research and bioethics also faced uncertainty, with the struggle to ethically engage with new technologies and to better understand the boundaries around self-determination. As we look over the past year and anticipate the coming one, the overarching question remains: Is it possible to run a health law and health care system given this level of flux?
Healthcare Policy in Flux
2017 saw a new presidential administration and Congress. Seeking to capitalize on the Republican control of the White House and both Houses of Congress, Congressional Republicans sought to make good on their campaign promise to “replace and repeal” the ACA. The proposed legislation would have dramatically reshaped our health care landscape, including ending Medicaid’s financial status as an entitlement program, and undercutting the health insurance Marketplaces championed by the Obama administration. Despite the fact that the ACA is not yet a decade old, this would have been a seismic shift in the way many Americans receive their health care. […]
We will be discussing these issues and more at the Sixth Annual Health Law Year in P/Review conference, held on December 12, 2017, at Harvard Law School in Cambridge, MA. If you find these issues interesting, we invite you to join us as the event is free and open to the public (registered required). For those unable to join us in Cambridge, some of our conference presenters will participate in a blog series to follow at the Health Affairs Blog. Stay tuned!
One of the more contentious bioethical and legal issues is about the beginning of human life. Nor is it difficult grasp why, for beyond political rhetoric it is a subject of considerable philosophical and legal debate and raises a number of questions which are profoundly difficult to answer. Biomedicine can roughly differentiate when life becomes viable, that is, at which point a fetus could survive as an infant if a mother gave birth prematurely; it can likewise recognize potential complications either in the development of the fetus or the health of the pregnant woman. Yet other questions are not as easy to answer, precisely because they tend to fall more in the spectrum of philosophy or personal belief: what constitutes a human being? What is a person? Is a potential life accorded the same rights as an actual life? For that matter, are there rights to begin with automatically, or are there criteria that must be met in order to procure rights? In short, questions that strike at the very core of who we are.
A number of these questions were debated by Muslim theologians and legal scholars in the pre-modern world when considering contexts of abortion or issues surrounding paternity. In the modern world, these questions have grown to include in vitro fertilization and surrogacy amongst others. Muslim scholars continue to grapple with these bioethical questions as the medical sciences grow more advanced and technology allows us to have ever more control over the basic aspects of reproduction, growth, and development. Per the question, When does human life begin? for example, Mohammed Ghaly analyses in an important article, “The Beginnings of Human Life: Islamic Bioethical Perspectives” some of the newer discussions and positions Muslim scholars have taken vis-à-vis contemporary bioethics and independent legal reasoning (ijtihad). Complementing this discussion is also a seminal article by Ayman Shabana, “Paternity Between Law and Biology: The Reconstruction of the Islamic Law of Paternity in the Wake of DNA Testing.” Shabana shows how classical rulings pertaining to paternity issues continue to hold higher authority, even despite the advent and availability of modern technology that would ostensibly challenge that authority. This is interesting for a number of reasons, not least of which is the possible change in perspective with regard to how religious authority is derived and its relationship to the medical sciences. Continue reading →