Senior citizen woman in wheelchair in a nursing home.

Seniors’ Perspectives on Dementia and Decision-Making

By James Toomey

In order to make a decision recognized in law — to enter into or enforce a contract, buy or sell property, or get married or divorced — an individual must have the mental capacity the law requires for the decision. As people, especially older adults, develop dementia, their decision-making abilities are increasingly compromised, and the law begins to find that they lack capacity for particular decisions.

The standards governing capacity determinations, however, are notorious for being vague, inconsistently applied, and excessively curtailing the rights of those with dementia. Part of the problem, I think, is the lack of an agreed-upon normative theory for when in the course of dementia the law ought to intervene in individual decision-making. That is why, here on Bill of Health, I’ve previously called for understanding the perspectives of seniors — the population affected by the doctrine of capacity most closely and most often — on this normative question.

In my recent publication “Understanding the Perspectives of Seniors on Dementia and Decision-Making” in AJOB Empirical Bioethics, I’ve begun to do so, reporting the results of an empirical study that I conducted with the Petrie-Flom Student Fellowship in the 2018-19 academic year. The study, which involved an online survey of and interviews with older adults, revealed a heterogeneity of ways of thinking about the problem, supporting a flexible legal doctrine that would assist people in making their own choices. Notwithstanding the diversity, however, the data reveal several conclusions and tensions of interest to academics and healthcare and legal practitioners.

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a pill in place of a model globe

Preparing for Antimicrobial Resistance: Vision and Social Science Mission of the INAMRSS Network

By Timo Minssen, Kevin Outterson, Susan Rogers Van Katwyk, Pedro Henrique D. Batista, Clare Chandler, Francesco Ciabuschi, Stephan Harbarth, Aaron S. Kesselheim, Ramanan Laxminarayan, Kathleen Liddell, Michael T. Osterholm, Lance Price, Steven J. Hoffman

NB: The below contribution is an extended version of our editorial that was recently published in the Bulletin of the Word Health Organization.

The COVID-19 pandemic has raised awareness of the urgent need to improve the design of health systems, as well as the practical implementation of new strategies and technical solutions to better prepare for future pandemics. These preparations must also consider harms secondary to the pandemic, including the resulting effects on antimicrobial resistance (AMR).

While drug-resistant infections pose a well-known and severe threat to human and animal health, the COVID-19 pandemic is compounding this already problematic situation.

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Waitress wears face mask and face shield, cleans table with alcohol and wet wipe at restaurant.

The Problem with Individual-Level Interventions to Curb the COVID-19 Pandemic

By Daniel Goldberg

The failure to control the COVID-19 pandemic in the United States rests, in part, on the individualist nature of our public health responses.

Public health simply does not work well when we base our interventions on the individual level. This is known as “methodological individualism,” and the evidence suggests it is both ineffective and can expand existing health inequalities. It is problematic in any public health context, but especially in pandemic response and control.

Take, for example, the ongoing debate over mask mandates. Multiple governors have refused to issue mask mandates, instead simply requesting that people don masks. The objection, interestingly, is not to the idea of masking as a public health intervention, but to the existence of a mandate itself.

Yet a model of public health which consists of nothing more than pleading with individuals to avoid behaving in ways injurious to public health would be an abject failure. Imagine if, instead of imposing minimum requirements for clean water, we simply asked regulated industries to avoid polluting watersheds. Or perhaps instead of passing laws discouraging or even criminalizing obviously harmful behavior, we simply asked people to avoid driving drunk.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

COVID-19 and the FDA Emergency Use Authorization Power

By Anne Kapnick

The Food and Drug Administration (FDA) is responsible for protecting public health by regulating the production, distribution, and consumption of food, cosmetics and drugs.[1] In the healthcare arena (the focus of this post), the FDA strives to ensure the safety, efficacy, and security of drugs, biological products, and medical devices.[2] The FDA also ensures that the “public get[s] the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”[3] This blog post provides an overview of the FDA’s emergency authorization powers, analyzes the extent of their usage in the COVID-19 pandemic, and concludes by flagging potential concerns regarding the FDA’s management of this vast power.

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Society or population, social diversity. Flat cartoon vector illustration.

Unequal Representation: Race, Sex, and Trust in Medicine — COVID-19 and Beyond

By Allison M. Whelan*

The COVID-19 pandemic has given renewed importance and urgency to the need for racial and gender diversity in clinical trials.

The underrepresentation of women in clinical research throughout history is a well-recognized problem, particularly for pregnant women. This stems, in part, from paternalism, a lack of respect for women’s autonomy, and concerns about women’s “vulnerability.” It harms women’s health as well as their dignity.

Over the years, FDA rules and guidance have helped narrow these gaps, and recent data suggest that women’s enrollment in clinical trials that were used to support new drug approvals was equal to or greater than men’s enrollment. Nevertheless, there is still progress to be made, especially for pregnant women. In the context of COVID-19 research, one review of 371 interventional trials found that 75.8% of drug trials declared pregnancy as an exclusion criteria, a concerning statistic given that recent data suggest that contracting COVID-19 during pregnancy may increase the risk of preterm birth.

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books

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

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, 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.

Below are the citations for papers identified from the month of October. The selections feature topics ranging from a commentary calling for reconsideration of the FDA’s risk evaluation and mitigation strategy (REMS) program for mifepristone, to an analysis of clinical development times for biosimilars seeking FDA approval, to an editorial describing the challenges of using the Defense Production Act to address drug shortages. A full posting of abstracts/summaries of these articles may be found on our website.

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Vaccine.

How are COVID-19 Vaccine Manufacturers Building Trust in the FDA’s Approval Process?

Cross-posted from Written Description, where it originally appeared on October 2, 2020. 

By Rachel SachsJacob S. SherkowLisa Larrimore Ouellette, and Nicholson Price

In recent weeks, a number of articles have reported great concern around the politicization of the approval process for future COVID-19 vaccines. Public trust in public health agencies is arguably at an all-time low. After several missteps, the FDA has been working publicly to shore up public confidence in an approved vaccine once it comes out. But pharmaceutical companies themselves are now also engaging the public themselves in an attempt to build trust in their products. This is an unusual step for, of course, unusual times. What are vaccine developers doing, how should policymakers think about these efforts, and how can we encourage these lines of communication in the future?

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Society or population, social diversity. Flat cartoon vector illustration.

The Cost of Exclusion in Psychedelic Research

By Xinyuan Chen, Mackenzie Bullard, Christy Duan, Jamilah R. George, Terence Ching, Stephanie Kilpatrick, Jordan Sloshower, and Monnica Williams

In the last two decades, researchers have started to reexamine psychedelics for their therapeutic potential. Though initial results seem promising, the research has a significant shortcoming: the lack of racial and ethnic diversity among research teams and study participants.

In the 1960s, psychedelic substances such as LSD, psilocybin, and mescaline were a major part of American counterculture. Less well-known is that, concurrently, researchers were studying potential therapeutic uses of these mind-altering substances. Unfortunately, psychedelics were classified as Schedule I drugs in 1970, halting research into their therapeutic benefits.

The recent renaissance of psychedelic research shows these substances have significant capabilities for treating anxiety, depression, posttraumatic stress disorder (PTSD), and substance use disorders. But these promising results are limited in their applicability: an analysis from 2018 showed that 82.3% of all study participants in psychedelic trials internationally were non-Hispanic Whites, and only 2.5% were African-American.

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3D illustration of man with his brain highlighted

What Psychedelic Research Can Learn from Science, and What It Can Teach

By Manoj Doss

As a psychedelic researcher, I find myself increasingly frustrated by the tendency of the field to make lofty claims about the drugs that stray from the realities and limitations of the data.

For example, psychedelic research that uses neuroimaging employs measures of brain function that are, in fact, quite crude. Typically, one signal in a brain scan can mean many things (amygdala activation can occur when one is scared, happy, observing something salient, etc.).

For this reason, cognitive neuroscientists typically constrain mental activity using behavioral tasks in order to make more educated inferences regarding what is happening in the mind. Yet for some reason, psychedelic scientists believe they can infer mental function from the activity of a few tripping brains under task-free conditions. That is, participants are essentially doing whatever they want in the scanner, making the number of possible inferences one could make nearly infinite. And worse, they base their claims on outdated Freudian theory.

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America divided concept, american flag on cracked background.

Can Psychedelics Help Save America?

By Shelby Hartman

Amid a fractured political landscape, an unprecedented pandemic, and a reckoning with the country’s racist past, psychedelics may offer some hope for healing in the United States. In recent decades, a renaissance of psychedelic drug research has grown at prominent institutions like Johns Hopkins, New York University, and Imperial College London, among others.

Psilocybin, the psychoactive component in psychedelic mushrooms, and MDMA, sometimes confused with its adulterated version, ecstasy, have both been given breakthrough therapy status by the Food and Drug Administration (FDA), because they’ve shown so much promise for treating conditions for which we currently have few effective options. Psilocybin for treatment-resistant depression and MDMA for post-traumatic disorder are projected to be legal within the next five years as drugs that will be administered under the supervision of trained therapists.

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