Hundred dollar bills rolled up in a pill bottle

Aducanumab: A Bitter Pill to Swallow

By Emily Largent

On June 7, the U.S. Food and Drug Administration (FDA) used the Accelerated Approval pathway to approve aducanumab, which will go by the brand name Aduhelm, to treat patients with Alzheimer’s disease (AD). Aducanumab, developed by Biogen, is the first novel therapy approved for AD since 2003. This news has left many experts stunned.

I have at least one colleague, Dr. Jason Karlawish, who has publicly stated that he will not prescribe aducanumab. Other clinicians have said they will only prescribe it reluctantly. These are individuals who have dedicated decades of their lives to treating patients with AD, to conducting path-breaking research and serving as investigators in clinical trials, and to advocating for public policies that will better serve AD patients and their families. Many have also seen their own families affected by AD. My colleagues are hardly indifferent to the suffering wrought by AD and would like to have a meaningful treatment to offer to patients and their families. But, they have concluded, aducanumab is not it.

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Senior citizen woman in wheelchair in a nursing home.

COVID-19 and Dementia Care: Lessons for the Future

By Marie Clouqueur, Brent P. Forester, and Ipsit V. Vahia

Alongside the COVID-19 epidemic in the U.S., the country faces another public health epidemic: dementia, and particularly Alzheimer’s disease.

Currently one in nine older adults in the U.S. — 6.2 million — have Alzheimer’s disease. The number of adults with Alzheimer’s in the U.S. will increase rapidly as the Baby Boomers age — it is expected to double by 2050.

The COVID-19 pandemic has exacerbated the situation. Acute, surging demand for dementia care services will turn into a persistent problem if we do not increase our capacity for services and better support our frontline workers. We have a chance now to reflect and take action to prepare for what is coming.

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White jigsaw puzzle as a human brain on blue. Concept for Alzheimer's disease.

Detecting Dementia

Cross-posted, with slight modification, from Harvard Law Today, where it originally appeared on November 21, 2020. 

By Chloe Reichel

Experts gathered last month to discuss the ethical, social, and legal implications of technological advancements that facilitate the early detection of dementia.

“Detecting Dementia: Technology, Access, and the Law,” was hosted on Nov. 16 as part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain and Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

The event, organized by Francis X. Shen ’06 Ph.D. ’08, the Petrie-Flom Center’s senior fellow in Law and Applied Neuroscience and executive director of the Center for Law, Brain and Behavior at Massachusetts General Hospital, was one of a series hosted by the Project on Law and Applied Neuroscience on aging brains.

Early detection of dementia is a hopeful prospect for the treatment of patients, both because it may facilitate early medical intervention, as well as more robust advance care planning.

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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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Hastening Death to Avoid Prolonged Dementia

By Norman L. Cantor

The scourge of Alzheimer’s is daunting. For me, the specter of being mired in progressively degenerative dementia is an intolerably degrading prospect. One avoidance tactic — suicide while still competent — risks a premature demise while still enjoying a tolerable lifestyle.

The question arises whether an alternative tactic — an advance directive declining all life-sustaining intervention once a certain point of debilitation is reached — might be preferable as a device to avert a prolonged, unwanted limbo.

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Changing the Paradigm of Advance Directives to Avoid Prolonged Dementia

by Norman L. Cantor

In the early days of living wills — the 1970’s and 1980’s – a major objective was to avoid being maintained on burdensome medical machinery in a highly debilitated status at the end stage of a fatal affliction.  The contemporaneous legislation endorsing advance directives was typically geared to “terminal illness” (meaning likely death within 6 months).  The distasteful specter was a moribund patient tethered to burdensome interventions like a respirator or a dialysis machine despite an unavoidable, looming demise.  A common short-form living will rejected life support that “only prolongs the dying process” for a patient in “a terminal condition.”[i]

Another specter was being medically sustained in an utterly dismal quality of life – such as permanent unconsciousness without awareness or interaction with one’s environment.  The contemporaneous legislation explicitly authorized advance directives seeking to avoid medical maintenance in a permanently vegetative state.  And several landmark cases authorizing surrogate end-of-life determinations involved permanently unconscious patients. See Quinlan (N.J. 1976); Brophy, (Mass. 1986); Browning (Fla. 1990); Schiavo (Fla. 2005).

With the increasing prevalence of Alzheimer’s disease and similar degenerative dementias, the focus of advance directives has changed for some people.  The primary specter is neither an unavoidable looming demise nor the insensate limbo of permanent unconsciousness.  Rather, the emerging concern is protracted maintenance during progressively increasing cognitive dysfunction and helplessness.  For some, being mired in a demented state is an intolerably degrading prospect well before the advanced stage when the person no longer recognizes loved ones and is totally uncomprehending.

For people like me who see even moderate dementia as an intolerably demeaning status staining their life image, their advance directive may seek to facilitate death by declining even simplistic medical interventions like antibiotics.  Our hope is that death will soon ensue when an infection is left untreated or when artificial nutrition and hydration is withheld in the face of an eating disorder.  Read More

Is It Immoral for Me to Dictate an Accelerated Death for My Future Demented Self?

by Norman L. Cantor

I am obsessed with avoiding severe dementia. As a person who has always valued intellectual function, the prospect of lingering in a dysfunctional cognitive state is distasteful — an intolerable indignity. For me, such mental debilitation soils the remembrances to be left with my survivors and undermines the life narrative as a vibrant, thinking, and articulate figure that I assiduously cultivated. (Burdening others is also a distasteful prospect, but it is the vision of intolerable indignity that drives my planning of how to respond to a diagnosis of progressive dementia such as Alzheimers).

My initial plan was to engineer my own demise while still competent to do so. My sketch of methodologies and my preferred course (stopping eating and drinking) appear at: http://blogs.law.harvard.edu/billofhealth/2015/04/16/my-plan-to-avoid-the-ravages-of-extreme-dementia/. The obvious hazard in that plan is cutting short a still vibrant and satisfactory existence.

An alternative strategy would be to allow myself to decline into incompetency, but beforehand to dictate, in an advance directive, rejection of future life-sustaining medical interventions. This strategy would probably work as applied to serious maladies such as kidney disease, lethal cancer, or congestive heart failure. The disturbing issue then becomes timing. The onset of such serious maladies is fortuitous and years of lingering in dementia might precede my demise.

A further alternative would be to seek to accelerate my post-competence demise by declining not only major medical interventions such as mechanical respirators or dialysis, but also more simplistic items like antibiotics, antiarrhythmics, and artificial nutrition and hydration. My envisioned scenario is that infection would occur early (via urinary tract, skin, or pneumonia) and that this condition, left untreated, would precipitate my death. (My advance instructions would allow palliative but not curative measures.)

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Biomarker Epistemology, Cognitive Decline, and Alzheimer’s Disease

By Matthew L Baum

This past Sunday, a group of researchers reported in the journal, Nature Medicine, a preliminary technique that uses variation in blood levels of 10 fats to predict the likelihood that elderly individuals would develop mild cognitive impairment (MCI) or Alzheimer’s Disease in the following 2-3 years. The sample size was small and the results may not generalize beyond the narrow age-range and demographics of the study group (i.e. the assay is far from ready for “prime time”), but the study is an important first step towards a lower cost (vs PET imaging) and less invasive (vs spinal tap) predictive biomarker of cognitive decline*. Its publication has also triggered a flurry of discussion on possible ethical ramifications of this sort of blood biomarker. I will not attempt to address these ethical issues specifically here. Rather, I seek to highlight that how ethically troubling one views the technology to be may depend partly on the sort of knowledge one thinks these biomarkers reveal (applied epistemology at its best).

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