pills

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariAviva Wang, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from a discussion of antitrust as a tool to address patent thickets, to an analysis of the relationship between price and efficacy for recently approved cancer drugs, to an examination of the viability and implications of preemption challenges to state laws restricting medication abortion.

A full posting of abstracts/summaries of these articles may be found on our website.

Read More

Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

AI in Digital Health: Autonomy, Governance, and Privacy

The following post is adapted from the edited volume AI in eHealth: Human Autonomy, Data Governance and Privacy in Healthcare.

By Marcelo Corrales Compagnucci and Mark Fenwick

The emergence of digital platforms and related technologies are transforming healthcare and creating new opportunities and challenges for all stakeholders in the medical space. Many of these developments are predicated on data and AI algorithms to prevent, diagnose, treat, and monitor sources of epidemic diseases, such as the ongoing pandemic and other pathogenic outbreaks. However, these opportunities and challenges often have a complex character involving multiple dimensions, and any mapping of this emerging ecosystem requires a greater degree of inter-disciplinary dialogue and more nuanced appreciation of the normative and cognitive complexity of these issues.

Read More

Abstract glitch with word SCAM on 100 Dollar bill. Concept art for Online scam.

Rethinking Senior Scams?

By James Toomey

Many people, including, it seems, most advocates for law reform, assume that older adults are uniquely vulnerable to scams, and indeed that senior scams are a unique social problem demanding a unique legal solution. But in “The Age of Fraud” (forthcoming in the Harvard Journal on Legislation, winter 2023), about which I’ve blogged here before, I reported the results of an empirical study suggesting that, in fact, younger adults were as much as three times more likely to engage with scammers during the first year of the COVID pandemic than older adults.

One possible implication of this finding — if indeed it is generalizable — which I discuss but don’t commit to in the paper, is that more people are more vulnerable to scams — and the polished tactics of psychological manipulation used by scammers — than has been generally appreciated. But if scams are not a bounded problem of those who are in some sense more psychologically vulnerable (as older adults are thought of in, at least, the popular imagination), we might want to rethink scams — what they are, how we fight them, and how we treat and think about their victims.

Read More

Magazines on wooden table on bright background.

Citational Racism: How Leading Medical Journals Reproduce Segregation in American Medical Knowledge

By Gwendolynne Reid, Cherice Escobar Jones, and Mya Poe

Biases in scholarly citations against scholars of color promote racial inequality, stifle intellectual analysis, and can harm patients and communities.

While the lack of citations to scholars of color in medical journals may be due to carelessness, ignorance, or structural impediments, in some cases it is due to reckless neglect.

Our study demonstrates that the American Medical Association (AMA) has failed to promote greater racial inclusion in its flagship publication, the Journal of the American Medical Association (JAMA), despite an explicit pledge to do so.

Read More

Black and white photograph of the front of the Supreme Court. Pro-abortion protestors stand holding signs, one of which reads "I stand with Whole Woman's Health"

Call for Submissions: Journal of Law and the Biosciences Special Issue on Abortion Law

American law on reproduction seems likely to change, perhaps radically, in 2022, as the U.S. Supreme Court considers challenges to state laws limiting abortion. In Dobbs v. Jackson Women’s Health Organization, the Court is considering a substantive Mississippi ban on almost all abortions after 15 weeks; in Whole Woman’s Health v. Jackson and United States v. Texas, the Court is considering the more procedural Texas “bounty hunter” statute for enforcing a ban on abortions after about five weeks.

In anticipation of the Court rulings on these cases, the Journal of Law and the Biosciences will publish a limited number of submissions as a two-part special issue on this general topic. The issue will focus on abortion law, but also include near-future issues for other human reproductive practices and technologies.

Read More

Pile of papers on laptop keyboard.

Yet Another Look at Health Law Citations

By Scott Burris

Brian Leiter has published his list of ten most-cited health law professors, and there’s a slightly expanded version on this blog thanks to Mark Hall and Glenn Cohen. They both use the Sisk data, which draws solely from the Westlaw journals file.

But the field of health law makes as big a scholarly contribution outside the legal literature as in, which is important when we think of who we write for and how health law faculty are assessed. As I have in the past, I took a down and dirty look at citations beyond Westlaw journals using the Google Scholar profile. (If you prefer Web of Science, there’s this list from a couple of years ago.)

Read More

Brown Gavel With Medical Stethoscope Near Book At Wooden Desk In Courtroom.

Most-Cited Health Law Scholars in Westlaw, 2016-2020

By Mark A. Hall and I. Glenn Cohen

A few years ago, to highlight the growth and maturity of the health law field we undertook to measure and rank the scholarly impact of health law professors according to the frequency their work is cited. Our principal ranking followed the methods Gregory Sisk and Brian Leiter have used for many years to rank professors in other fields of law.

Leiter has now included Health Law in the pantheon of ranked legal fields. Accordingly, we will not undertake an independent ranking. Instead, because the data Sisk and Leiter use are restricted to professors with a primary law school appointment, we provide the following modest supplement: We replicate Sisk and Leiter’s citation counting methods for two health law professors known to be highly cited who do not have a primary law school appointment: Aaron Kesselheim and Sara Rosenbaum. (We did the same for several others, but their citation counts in the Westlaw database were below Leiter’s cutoff range). Here is the augmented ranking:

Read More

Los Angeles, California, United States. June 23, 2021: #FreeBritney rally at LA Downtown Grand Park during a conservatorship hearing for Britney Spears.

There’s More to Decision-Making Capacity than Cognitive Function

The Health Law, Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts. Though the Workshop is typically open to the public, it is not currently, due to the COVID-19 pandemic. However, many of our presenters will contribute blog posts summarizing their work, which we are happy to share here on Bill of Health.

By James Toomey

The doctrine of capacity is a mess.

From Britney Spears’s high-profile struggles to establish her own capacity to the countless, quiet challenges of so many older adults, the doctrine of capacity, which requires people to have the cognitive functioning to understand the nature and consequences of a decision in order for it to be recognized in law, is vague, normatively and medically challenging, and inconsistently applied.

This is a big deal — at stake in every capacity case is whether, on the one hand, an individual may access the legal rights most of us take for granted, to enter into contracts, buy or transfer property, or get married or divorced; or, on the other, whether the legal system will ratify a decision the “real person” never would have made.

Read More