Scales of justice and gavel on table.

Symposium Introduction: Health Justice: Engaging Critical Perspectives in Health Law and Policy

By Ruqaiijah Yearby and Lindsay F. Wiley

Public health scholars, advocates, and officials have long recognized that factors outside an individual’s control act as barriers to individual and community health.

To strive for health equity, in which everyone “has the opportunity to attain . . . full health potential and no one is disadvantaged from achieving this potential because of social position or any other socially defined circumstance,” many have adopted the social determinants of health (SDOH) model, which identifies social and economic factors that shape health. Yet, health equity has remained elusive in the United States, in part because the frameworks that most prominently guide health reform do not adequately address subordination as the root cause of health inequity, focus too much on individuals, and fail to center community voices and perspectives.

The health justice movement seeks to fill these gaps. Based in part on principles from the reproductive justice, environmental justice, food justice, and civil rights movements, the health justice movement rejects the notion that health inequity is an individual phenomenon best explained and addressed by focusing on health-related behaviors and access to health care. Instead it focuses on health inequity as a social phenomenon demanding wide-ranging structural interventions.

This digital symposium, part of the Health Justice: Engaging Critical Perspectives in Health Law & Policy Initiative launched in 2020, seeks to further define the contours of and debates within the health justice movement and explore how scholars, activists, communities, and public health officials can use health justice frameworks to achieve health equity.

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doctor holding clipboard.

The Latest on Never Events in the NHS in England

By John Tingle

Never Events” — medical errors that should never occur — are a major and recurring problem in health care in England.

When they do occur, they sap confidence and trust in the health care system, and can result in significant injury or death to the patient. They can result in expensive litigation. There is also a significant financial cost to the NHS, which is always short of financial resources. The patient, their relatives, and all those involved in the incident bear emotional costs, too.

In the National Health Service (NHS), Never Events are defined and listed. The list includes such incidents as a foreign body being left in a patient, wrong implant/prosthesis, and wrong site surgery, among others. Sadly, the incidence of Never Events in the NHS is still too high.

Never Events are also a major patient safety metric that helps regulators such as the Care Quality Commission (CQC) and the public judge the safety of a hospital or other health care facility.

Recent publications highlight that Never Events remain a critical and a stubbornly persistent problem for the NHS to address.

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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?

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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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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Pile of colorful pills in blister packs

Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal

By Richard Klein, Kenneth I. Moch, and Arthur L. Caplan

A new proposal out of the Goldwater Institute (GI), a libertarian think tank, advances an oversimplified critique of the U.S. regulatory process for approving medicines for COVID-19 and other diseases, with the ultimate goal of weakening the U.S. Food and Drug Administration.

You may remember the Goldwater Institute as the architect of the initial state “Right to Try” (RtT) legislation from a few years ago. The idea, marketed as increasing access to experimental medicines, was actually calculated to circumvent FDA oversight so that individuals could try still-unproven experimental medicines without what Goldwater viewed as pointless bureaucratic paternalism. RtT legislation was adopted by 41 states and ultimately by the U.S. Congress.

When former President Trump signed the Right to Try bill into federal law with great fanfare on May 20, 2018, he stated that “countless American lives will ultimately be saved.” Three years later, the promise proved to be meaningless, as evidenced by the difficulty in identifying more than a handful of individuals who have even pursued the RtT pathway, much less finding data to show that it has saved lives.

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Person in nursing home.

Long-Term Care After COVID: A Roadmap for Law Reform

By Nina A. Kohn

Between May 2020 and January 2021, 94 percent of U.S. nursing homes experienced at least one COVID-19 outbreak. And nursing home residents — isolated from family and friends, dependent on staff often tasked with providing care to far more residents than feasible, and sometimes crowded into rooms with three or more people — succumbed the virus at record rates. By March 2021, nursing home residents accounted for a quarter of all U.S. COVID-19-related deaths.

The poor conditions in nursing homes that have been exposed by the pandemic are symptomatic of long-standing problems in the industry.

Fortunately, as I discuss in-depth in a new essay in the Georgetown Law Journal Online, there are a series of practical reforms that could readily improve the quality of nursing home care, in large part by changing the incentives for nursing home providers.

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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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Home innovation technology concept illustration.

Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home

Contribute to the 2022 Petrie-Flom Center Annual Conference and subsequent book project!

Through October 14, 2021, the Petrie-Flom Center is accepting abstracts for its annual conference. The 2022 annual conference will focus on ethical, legal, and regulatory challenges and opportunities around at home digital health technology.

This conference will engage with the vision for a 21st century health care system that embraces the potential of at home digital products to support diagnoses, improve care, encourage caregivers, maximize pandemic resilience, and allow individuals to stay within the home when preferable. The goals of this conference and subsequent book project are to consider the ethical, sociological, regulatory, and legal challenges and opportunities presented by the implementation of digital products that support clinical diagnosis and/or treatment in patients’ homes over the next decade.

Interested in submitting an abstract, but want to know more about what we’re looking for? Read through the following frequently asked questions.

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doctor holding clipboard.

Transformation of Behavioral Health Care Through Section 1115 Waivers

By John Jacobi

As the Biden administration works to improve health access and transform health delivery, behavioral health reform should be at the front of the queue.

People with severe mental illness and opioid use disorder are dying young for lack of routine health care. Much of the work that needs to be done in behavioral health is developed or developing at the state level. But the Biden administration has a powerful tool for encouraging state-level innovation in the § 1115 Medicaid waiver process.

Reform through state waivers

Section 1115 waiver authority permits the Department of Health and Human Services to approve pilots and demonstrations if they are found likely to promote the objectives of the Medicaid program. Waivers, which do not require Congressional or formal regulatory enactments, permit relatively rapid cycling of innovation, in contrast to the lumbering pace of legislative or regulatory change.

While applications for waivers originate with the states, presidents have set the agenda by signaling what categories of waivers will be looked upon favorably, offering the administration the ability to put its stamp on the development of care for low-income and disabled people.

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