June, 2021 - Bill of Health

The Only Constant is Resistance to Change: A Flaw in the US Response to Public Health Crises

June 30, 2021December 14, 2021 Jennifer S. Bard Leave a comment

By Jennifer S. Bard

Law can be a wonderful tool for promoting and protecting the public’s health. But its inherent bias towards stability is poorly suited to the challenges of addressing rapidly evolving public health crises.

Two current examples — the ongoing opioid overdose crisis, and the COVID-19 pandemic — illustrate the issue starkly.

In both cases, the measures needed to address these two serious crises are hampered by one of the core weaknesses of the U.S. legal system when it comes to addressing serious, ongoing public health crises: there is no mechanism to make swift, responsive adjustments to the law in the face of changing information.

Close-up Of Stethoscope On Us Currency And American Flag.

America’s Underinsurance Crisis in the Age of COVID-19

June 29, 2021June 24, 2021 The Petrie-Flom Center Staff Leave a comment

By Dessie Otachliska

The COVID-19 pandemic has shone a light on the underinsurance crisis that has long kept millions of Americans on the precipice of financial disaster — just one unexpected illness or injury away from bankruptcy.

A 2019 Gallup poll showed that 25% of Americans reported delaying treatment for serious medical conditions due to cost concerns — the highest proportion since Gallup first began asking the question in 1991. Even during the pandemic, when medical treatment could mean the difference between life and death, studies show that nearly 1 in 7 Americans would avoid seeking medical care if they experienced key COVID-19 symptoms because of fears associated with the cost of treatment.

These statistics are unsurprising, and the concerns they underscore well-founded: the average treatment costs for COVID patients with symptoms serious enough to require inpatient hospital stays range from $42,486 for relatively mild cases to $74,310 for patients with major complications or comorbidities.

In the pandemic context, hesitance to seek medical treatment due to fear of the associated cost has proved tragically fatal. Darius Settles died after being dissuaded from seeking further COVID-19 treatment due to his uninsured status. The Nashville, TN hospital where Settles originally received care had failed to disclose the possibility that his medical costs would be covered by the federal government. And, despite the availability of reimbursement funds, the hospital nonetheless sent his widow a bill for a portion of his treatment costs.

an ambulance parked at the entrance of an emergency department

The ‘Model Minority’ Myth Puts Asian Americans’ Health at Risk

June 28, 2021June 24, 2021 Megan Shen Leave a comment

By Megan J. Shen

There is a common myth that Asians in the U.S. are successful and free from racial bias. This is often referred to as the ‘model minority’ myth.

This myth is not only inaccurate and a gross overgeneralization, but it also hurts public health efforts to address health inequities among Asians in the U.S.

Illustration of a man and a woman standing in front of a DNA helix

A Proposal for Localized Review to Safeguard Genetic Database Privacy

June 25, 2021June 25, 2021 Robert Field Leave a comment

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

Large genetic databases pose well-known privacy risks. Unauthorized disclosure of an individual’s data can lead to discrimination, public embarrassment, and unwanted revelation of family secrets. Data leaks are of increasing concern as technology for reidentifying anonymous genomes continues to advance.

Yet, with the exception of California and Virginia, state legislative attempts to protect data privacy, most recently in Florida, Oklahoma, and Wisconsin, have failed to garner widespread support. Political resistance is particularly stiff with respect to a private right of action. Therefore, we propose a federal regulatory approach, which we describe below.

The Latest on Never Events in the NHS in England

June 24, 2021June 23, 2021 John Tingle Leave a comment

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.

The Patent Trial and Appeal Board Again Survives Supreme Court Review

June 23, 2021June 22, 2021 The Petrie-Flom Center Staff Leave a comment

By Gregory Curfman

For the generic drug and biosimilar industries, the Supreme Court’s recent decision in United States v. Arthrex, Inc. comes as a relief.

In his opinion, Chief Justice John Roberts allowed the Patent Trial and Appeal Board (PTAB) to survive and to continue to provide an alternative route for generic drugs and biosimilars to gain early market entry.

Patients, who may rely heavily on these less costly alternatives for their prescription drugs, will also benefit significantly from the Court’s decision in this case.

Colorado Passes Landmark Birth Equity Bill Package

June 22, 2021June 21, 2021 Alexa Richardson Leave a comment

By Alexa Richardson

This month, activists in Colorado succeeded in passing a sweeping package of bills designed to address lack of access, inequities, and mistreatment throughout the obstetric system.

The ambitious provisions offer a new model for legislative approaches to transforming maternity care.

The bills, SB21-193, SB21-194, and SB21-101, were crafted in large part through the efforts of Elephant Circle, an organization that advocates birth justice by promoting self-determination and support for pregnant people, and tackling power and oppression. In an interview, Elephant Circle Founder and Director, Indra Lusero, described the Birth Equity Bill Package as “an opportunity to change the conversation by pulling together the broad range of issues facing pregnant people and presenting them as one coherent policy platform.”

New Market, Esplanade, Kolkata, 05-23-2021: Due to lockdown, closed market and roadside hawker stalls at S. S. Hogg Market, which usually is heavily crowded as a popular shopping arena.

A Critical Analysis of the Eurocentric Response to COVID-19: Global Classism

June 21, 2021June 21, 2021 The Petrie-Flom Center Staff Leave a comment

By Hayley Evans

The international response to COVID-19 has paid insufficient attention to the realities in the Global South, making the response Eurocentric in several ways.

The first post in this series scrutinized the technification of the international response to COVID-19. The second post looked at how the international pandemic response reflects primarily Western ideas of health, which in turn exacerbates negative health outcomes in the Global South.

This third and final installment analyzes the classist approach to the pandemic response. The international response has paid insufficient attention to the existence of the informal economy and of the needs of those who must work to eat — both of which are found more commonly in the Global South.

This series draws on primary research conducted remotely with diverse actors on the ground in Colombia, Nigeria, and the United Kingdom, as well as secondary research gathered through periodicals, webinars, an online course in contact tracing, and membership in the Ecological Rights Working Group of the Global Pandemic Network. I have written about previous findings from this work here.

“Stick to the Science”? FDA, Ethics, and Pandemics

June 17, 2021June 17, 2021 The Petrie-Flom Center Staff Leave a comment

Cross-posted from COVID-19 and The Law, where it originally appeared on February 8, 2021.

By Jonathan Iwry

Throughout the current pandemic, Dr. Anthony Fauci and other public health experts have called on the government to “stick to the science.” This was at the same time that former President Donald Trump repeatedly undermined scientific expertise and prioritized political interests over responsible public health practices. Yet the particular ways in which the Trump administration mishandled the pandemic can divert attention from more fundamental challenges confronting government actors in any emergency — challenges that respect for science alone is insufficient to address. These challenges concern the norms guiding regulators’ exercise of their power under the law, as well as the proper role of values in public health and public policy more broadly.

FDA has struggled throughout COVID-19 to maintain high standards of integrity, including independence from undue political influence. We see this most clearly in the decisions FDA has faced in applying its power to issue emergency use authorizations (EUAs) for medical countermeasures against COVID-19. FDA’s experience using its emergency powers during COVID-19 speaks to the complex relationship between science and ethics in health policy — between empirical fact finding and normative questions involving ethics and public values.

This post reflects on the ethical implications of FDA’s use of its emergency powers, and suggests opportunities for greater accountability and more systematic decision-making by health regulators moving forward.

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?

June 16, 2021June 16, 2021 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.

Month: June 2021