In this paper, we examine the case of psychedelic medicine for Alzheimer’s disease and related dementias (AD/ADRD). These “mind-altering” drugs are not currently offered as treatments to persons with AD/ADRD, though there is growing interest in their use to treat underlying causes and associated psychiatric symptoms. We present a research agenda for examining the ethics of psychedelic medicine and research involving persons living with AD/ADRD, and offer preliminary analyses of six ethical issues: the impact of psychedelics on autonomy and consent; (...) the impact of “ego dissolution” on persons experiencing a pathology of self; how psychedelics might impact caregiving; the potential exploitation of patient desperation; institutional review boards’ orientation to psychedelic research; and methods to mitigate inequity. These ethical issues are magnified for AD/ADRD but bear broader relevance to psychedelic medicine and research in other clinical populations. (shrink)

This article argues that supported decision making is ideal for people with dynamic cognitive and functional impairments that place them at the margins of autonomy. First, we argue that guardianship and similar surrogate decision-making frameworks may be inappropriate for people with dynamic impairments. Second, we provide a conceptual foundation for supported decision making for individuals with dynamic impairments, which integrates the social model of disability with relational accounts of autonomy. Third, we propose a three-step model that specifies the necessary conditions (...) of supported decision making: identifying domains for support; identifying kinds of supports; and reaching a mutually acceptable and formal agreement. Finally, we identify a series of challenges for supported decision making, provide preliminary responses, and highlight avenues for future bioethics research. (shrink)

This article provides an ethical analysis of the U.S. practice guideline update on disorders of consciousness. Our analysis focuses on the guideline’s recommendations regarding the use of investigational neuroimaging methods to assess brain‐injured patients. Complex and multifaceted ethical issues have emerged because these methods alter the clinical understanding of consciousness. We address issues of false hope, patient suffering, and cost. We argue that, in spite of these concerns, there is significant benefit to using neuroimaging to assess brain‐injured patients in most (...) cases. (shrink)

Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it (...) is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration and Health and Human Services regulations. When that equipoise ends, a drug is either not approved or becomes standard care. (shrink)

Volume 20, Issue 8, August 2020, Page 83-85.

Previously diagnosed by symptoms alone, Alzheimer's disease is now also defined by measures of amyloid and tau, referred to as “biomarkers.” Biomarkers are detectible up to twenty years before symptoms present and open the door to predicting the risk of Alzheimer's disease. While these biomarkers provide information that can help individuals and families plan for long-term care services and supports, insurers could also use this information to discriminate against those who are more likely to need such services. In this article, (...) we evaluate whether state laws prohibit long-term care insurers from making discriminatory or unfair underwriting and coverage decisions based Alzheimer's disease biomarkers status. We report data demonstrating that current state laws do not provide meaningful protections from discrimination by long-term care insurers based on biomarker information. (shrink)

Over the course of human life, health care decision‐making is often interdependent. In this article, we use “interdependence” to refer to patients’ engagement of nonclinicians—for example, family members or trusted friends—to reach health care decisions. Interdependence, we suggest, is common for patients in all stages of life, from early childhood to late adulthood. This view contrasts with the common bioethical assumption that medical decisions are either wholly independent or dependent and that independence or dependence is tightly coupled with a person's (...) decision‐making capacity. In this article, we array various approaches to decision‐making along a continuum of interdependence. An appreciation of this continuum can empower patients and elucidate ethical challenges that arise when people transition between different kinds of interdependence across the life span. (shrink)

Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it (...) is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration and Health and Human Services regulations. When that equipoise ends, a drug is either not approved or becomes standard care. (shrink)

The COVID-19 pandemic has been devastating for people living with dementia (PLWD) and their caregivers. While prior research has documented these effects, it has not delved into their specific causes or how they are modified by contextual variation in caregiving circumstances.

First—before you define the dilemma, parse out principles, or vocalize about virtues—consider what caused this case.The COVID-19 pandemic has challenged us all, but particularly caregivers and the...

Truth telling to persons living with dementia is a nuanced problem that demands negotiating between the hazards of principlism and the loving deceiver’s demand to lie as needed. To ban deception, as we do restraints, would be misguided and cruel. So too to demand we always tell the truth. We ought to adopt a practice called “creative care.” It begins with the premise that person’s living with dementia are capable of creativity. Creative care breaks down the mysterious fourth wall we (...) build around persons living with dementia, especially persons with advanced dementia. It invites us to see a person living with dementia as a person who is capable of creating something beautiful. They need our time and words, not our lies and sedatives. (shrink)

Volume 19, Issue 10, October 2019, Page 86-88.

Years after the publication of “Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Disease?” I hope it continues to animate and...

The preeminence of informed consent in human subjects protections reflects Western democratic societies' ethical and political commitments to secure each citizen against both coercive and paternalistic influences of other people. Society permits adults extensive personal discretion in choices such as where to live, what to eat, how to dress, and whether to be in research. In short, individuals are afforded extensive discretion in choosing what to do and what is in their own best interests. Informed consent to enroll in research (...) is especially important because research necessarily involves procedures such as randomization and blinding that are done to assure that the project will produce generalizable knowledge. (shrink)

Supported decision making is a model of decision making in which an adult with impaired capacity enters freely into an agreement with a closely trusted person or persons (the “s...