Tag: Alzheimer’s disease

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Outlive by Peter Attia: A Book Review

Bobby Stroup Leave a comment

By Bobby Stroup

If you want to read a book about how to guarantee a 100-year lifespan, Peter Atta’s Outlive is going to disappoint you. But if you want to learn about Medicine 3.0, the four horsemen diseases, and how you might increase your healthspan, then you should get a copy of the book today. 

Outlive is not a book on public health policy so much as it is an exploration of personal health policy. Even so, the text — existing somewhere between the genres of autobiography and medical journal anthology — offers insights relevant to any health care aficionado. Read More

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European Skew in Genetic Research Databases Won’t Abate Without More Concerted Effort

Robert Field Leave a comment

By Robert I. Field, Anthony W. Orlando and Arnold J. Rosoff

The “pangenome” project that is mapping the genetic sequences of 47 diverse human beings from around the world is a much-needed step forward for science and humanity. The lack of racial diversity in genetic databases used in research has been noted for some time, and it has raised growing concerns about the development of clinical applications based on research results. The pangenome does not eliminate these concerns, but it calls greater attention to the significant racial underrepresentation that remains in most databases currently used in research.

For genomic medicine to have widespread effectiveness, it is important that it be based on the study of a diverse pool of subjects. This is especially true in the development of “precision medicine,” in which therapies are tailored to a patient’s genetic characteristics. If a patient’s genetic traits are not represented in a database that was used for the research that led to a treatment, that treatment may be less effective or even risky for them.

Black Americans, as well as members of other racial and ethnic minorities, are most commonly underrepresented in medical research, yet they are the ones most vulnerable to the effects of such underrepresentation. This can create yet another instance of racial disadvantage in health care. However, a recent study of genetic researchers found that investigators tend to give only limited consideration to demographic diversity when selecting a database to use, with more attention paid to ease of access and other logistical considerations.

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Legal Preparedness for Aging and Caregiving

The Petrie-Flom Center Staff Leave a comment

By Sharona Hoffman

During 2013 and 2014, I endured a very difficult 18 months. Both of my parents died, my mother-in-law died, and my husband was diagnosed with Parkinson’s disease at the age of 55. As I went through all of this, I learned a great deal about getting older, getting sick, facing the end of life, and caregiving. As a result of my personal experiences and my professional background as a Professor of Law and Bioethics at Case Western Reserve University, I wrote a book called Aging with a Plan: How a Little Thought Today Can Vastly Improve Your Tomorrow.

The book addresses many legal, financial, medical, social, and other support systems for aging and caregiving. In this article, I discuss the legal documents that every American adult should have. These documents can help ensure that your finances and health care are well-managed as you age and that your wishes will be followed after death.

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Managing Cognitive Decline Concerns in the Workplace

The Petrie-Flom Center Staff Leave a comment

By Sharona Hoffman

As the American population ages, employers must contend with the growing challenge of cognitive decline in the workplace.

Cognitive decline becomes more common as individuals age. The risk of Alzheimer’s disease doubles every five years after age 65, and almost one-third of people over 85 have the disease. And, as detailed in my book, Aging with a Plan: How a Little Thought Today Can Vastly Improve Your Tomorrow, the American population is aging. By 2034, about 77 million people will be seniors, accounting for 21% of U.S. residents.

Additionally, many professionals work past retirement age. For example, over 31% of physicians are over 60, and 15% of attorneys are over 65. The average age of federal judges is 69.

Considered together, these trends substantiate concerns about the increasing prevalence of cognitive decline in the workplace. Recent research provides further support: when Yale New Haven Hospital tested clinicians on staff who were seventy and older, it found that almost 13% had significant cognitive deficits.

Older employees often bring a wealth of experience and highly refined skills to their jobs. They can therefore add great strength to the workforce. Yet, employees with cognitive decline can cause a multitude of complex challenges in the workplace. They can threaten workplace productivity, workforce morale, and even public safety.

How might employers address cognitive decline concerns? As I argue in my article “Cognitive Decline and the Workplace” (forthcoming in the Wake Forest Law Review), there are several options, but many are legally and ethically problematic.

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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

James Toomey Leave a comment

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.

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LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, Alexander Egilman, Aviva 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.

Below are the citations for papers identified from the month of July. The selections feature topics ranging from a discussion of issues related to FDA’s approval of aducanumab for the treatment of Alzheimer’s disease, to an analysis of the communication of survival data in cancer drug labels, to an evaluation of public-sector contributions to novel biologic drugs. A full posting of abstracts/summaries of these articles may be found on our website.

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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.

FDA Approves Aducanumab for Alzheimer’s Disease: An Unethical Decision?

Beatrice Brown Leave a comment

By Beatrice Brown

On June 7, 2021, the U.S. Food and Drug Administration (FDA) announced the accelerated approval of aducanumab (Aduhelm), a biologic manufactured by Biogen for the treatment of Alzheimer’s disease.

The FDA’s decision, which went against the near-unanimous opinion of its own advisory committee following its meeting in November 2020, has been embroiled in controversy over whether the available evidence demonstrated benefits that outweigh the risks of the drug. Namely, questions remain whether: 1) the conflicting evidence from the two pivotal trials is sufficient to suggest clinical benefit worthy of approval; and 2) the surrogate measure used to justify its accelerated approval is actually correlated with clinical benefit.

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Aducanumab: A Bitter Pill to Swallow

Emily Largent Leave a comment

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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COVID-19 and Dementia Care: Lessons for the Future

The Petrie-Flom Center Staff Leave a comment

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

Chloe Reichel Leave a comment

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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