Presentation: “Regulating Black-Box Medicine.” To request a copy of the paper in preparation for the workshop, please email Jennifer Minnich at jminnich at law.harvard.edu.
Nicholson Price is an Assistant Professor at the University of Michigan School of Law, where he teaches Patents, Health Law, and first-year Property, among other courses. He was previously Assistant Professor at the University of New Hampshire School of Law. From 2012 to 2014 Nicholson was an Academic Fellow at the Petrie-Flom Center, where he studied innovation in the pharmaceutical industry, personalized medicine, and the issues surrounding secondary findings in genomic research. His work has been published in Science, the Harvard Journal of Law and Technology, Nature Biotechnology, the Boston College Law Review, and the Hastings Center Report, among others.
Nicholson received his JD from Columbia Law School in 2011, where he was a James Kent Scholar, was Submissions Editor of the Columbia Science and Technology Law Review, and twice received the Julius Silver Note Prize. He received his PhD in Biological Sciences, also from Columbia University, in 2010. He holds an AB in Biological Sciences from Harvard College. After law school, he clerked for Judge Carlos T. Bea of the U.S. Court of Appeals for the Ninth Circuit, and was a Visiting Consortium Scholar at the UCSF/UC Hastings Consortium on Law, Science and Health Policy.
Neuroscientist John Cacioppo, who has spent much of his career working on loneliness, defines “loneliness” as “perceived social isolation.” Similarly, Masi, et al. (following Russell, et al. 1980) define “loneliness” as “the discrepancy between a person’s desired and actual social relationships.” As Masi, et al., point out, there is a distinction to be made between loneliness, on the one hand, and social isolation, on the other, although the two phenomena may indeed often go together. Whereas social isolation “reflects an objective measure of social interactions and relationships,” loneliness “reflects perceived social isolation or outcast.” Following Peplau & Perlman 1982 and Wheeler, et al. 1983, they go on to point out that “loneliness is more closely associated with the quality than the number of relationships.” (It’s important and timely to note that the 2016 Nobel Laureate in Literature, Bob Dylan, brought out one application of this conceptual distinction in his song, “Marchin’ to the City,” when he sang: “Loneliness got a mind of its own / The more people around the more you feel alone.”)
The health risks posed by loneliness are several and can be severe. Loneliness can contribute to increased risk of coronary heart disease, cardiovascular disease, and stroke. In a 2016 systematic review and meta-analysis in Heart, Valtorta, et al., reported that “poor social relationships were associated with a 29% increase in risk of incident CHD [coronary heart disease] and a 32% increase in risk of stroke.” And in a March 2015 meta-analysis in Perspectives on Psychological Science, Holt-Lunstad, et al., reported that a substantial body of evidence supports the following two claims:
Loneliness puts one at greater risk for premature mortality. In particular, “the increased likelihood of death was 26% for reported loneliness, 29% for social isolation, and 32% for living alone.”
The heightened risk for mortality due to “a lack of social relationships” (whether reported loneliness, social isolation, or living alone) is greater than the risk due to obesity.
The surging opioid epidemic is a threat to the nation’s public health. This year the CDC reported that mortality from drug overdose reached an all-time high, with the annual death toll more than doubling since 2000. Yet in the backdrop of this epidemic, the country also faces ongoing shortages of a different sort–too few organs for transplantation. Every day, approximately 22 people die while waiting for an organ to become available. To some it is not a surprise–or at least not inconceivable–that the fastest-growing source of organ donors is being fueled by the national spike in drug overdoses. This first post will help delineate the scope and scale of the situation. My follow-up will discuss the ethical considerations and ramifications for public policy.
To start: the numbers. The Organ Procurement and Transplantation Network (OPTN) makes domestic transplant data publicly available online, which currently extends from 1994 to September 30th, 2016. Two decades ago, 29 organ donors died from a drug overdose.* In just the first nine months of this year, that number has climbed to 888 donors. Even with a quarter of the calendar year left to be counted, 2016 has already surpassed previous record set in 2015 (Figure 1).
One might question whether this trend is an illusion–perhaps a rise in the incidence of donors who had overdosed reflects an increasing number of transplants. But the data suggest the opposite. Also plotted in Figure 1, the percentage of total organ donors who died from overdose (maroon diamonds, right-sided Y axis) has not remained constant–instead, the percentage has steadily increased. Two decades ago, overdose caused the deaths of 0.6% of all organ donors; this year, it is the cause of death among 12.0% of organ donors nationwide. The rising percentage means that not only are more victims of drug overdose donating organs, but that the pool of organ donors is increasingly composed of such individuals. Continue reading →
John James, PhD, became involved in the movement to bring greater attention to patient safety and rampant medical errors by way of tragedy. In 2002, Dr. James lost his 19-year-old son as a result of problematic care provided by cardiologists at a hospital in central Texas. A toxicologist by training, Dr. James taught himself cardiology in order to piece together the events that led to the death of his son despite an extensive evaluation by a team of cardiologists. His journey is chronicled in his book, “A Sea of Broken Hearts: Patient Rights in a Dangerous, Profit-Driven Health Care System.” From there, Dr. James became an advocate for patient safety and a crusader against medical errors. His website is called Patient Safety America.
Major media outlets around the globe extensively covered the recent British Medical Journal article showing that medical errors are the third leading cause of death in the US. In 2013, Dr. James published a related paper in the Journal of Patient Safety that showed how nearly 440,000 lives per year are lost to medical errors in the American healthcare system.
I wanted to provide Bill of Health readers with a summary of how Dr. James’s paper in many ways pre-saged and perhaps even exceeds the recent BMJ article. A KevinMD article provides further context in this debate.
We start with a special request to TWIHL listeners this week: please consider donating to Partners in Health’s Haitian hurricane relief efforts. It’s always a good time to donate to PIH.org, but especially now, in the wake of apocalyptic levels of destruction. In the southwest peninsula, over one million people are cut off from food, clean water, and medical care.
Our guest this week is Allison Hoffman, Professor of Law at UCLA School of Law and an expert in health care law and policy. Professor Hoffman’s work examines the Affordable Care Act, Medicare and retiree healthcare expenses, and long-term care. We discussed Allison’s recent work on long-term care, including the soon-to-be-published piece “Reimagining the Risk of Long-Term Care,” in the Yale Journal of Health Policy, Law, and Ethics. This is a particularly important topic in the wake of the collapse of the CLASS Act–an infrequently-lamented but very important shortcoming of the ACA.
The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw