hospital equipment

Balancing Health Care Rationing and Disability Rights in a Pandemic

By Yolanda Bustillo and Rachel Perler

Amid the present surge of the coronavirus pandemic, it is crucial that disability rights are a factor in the development of triage protocols.

During the last week of December, the CDC recorded a record of 225,269 new coronavirus cases and 118,948 total hospitalizations. Health care systems across the country have predicted that they soon may face shortages of ventilators, personal protective equipment (PPE), and other limited resources.

In Utah, for example, hospital administrators have implemented informal triage protocols that prioritize patients based on health status, clinical factors, and the time sensitivity of their needed procedures. Hospitals in California have similarly begun rationing care.

If these dire circumstances worsen, hospital systems may apply triage protocols that deviate from best practices and impermissibly discriminate against people with disabilities.

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Hundred dollar bills rolled up in a pill bottle

AbbVie Wins First Round in Humira Antitrust Lawsuit

By Ryan Knox and Gregory Curfman

Since receiving FDA approval for Humira® (adalimumab) in 2002, AbbVie, the drug’s manufacturer, has filed hundreds of submissions to the U.S. Patent and Trademark Office for secondary patents – almost half of which were filed after 2014, just two years before the expiration of its core patent.

These patents were largely directed to methods of use and potential formulation changes, but they did not include claims that affect the clinical efficacy of the biologic, which is used in the treatment of rheumatoid arthritis, Crohn’s disease, and psoriasis, among other conditions. Instead, the purpose of the secondary patent filings was to assemble a thicket of patents, 132 in all, to prohibit competition from biosimilar companies.

And so far, the strategy has worked. AbbVie remains the sole U.S. manufacturer of the biologic, and has successfully defended its domain: in June 2020, a federal district court judge in Chicago dismissed an antitrust lawsuit against AbbVie.

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Vial and syringe.

Challenges in COVID-19 Vaccine Rollout: Lessons from the UK

By Sravya Chary

Just over a week after the United Kingdom became the first Western country to authorize the COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the U.S. Food and Drug Administration (FDA) followed suit on December 11, 2020.

This lag may prove beneficial. The United States can and should cautiously assess the United Kingdom’s vaccination strategy to avoid challenges that may impede its ability to control the virus.

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Vaccine.

Benefits and Drawbacks of Emergency Use Authorizations for COVID Vaccines

By Sravya Chary

Two COVID-19 vaccine manufacturers recently submitted Emergency Use Authorization (EUA) requests to the Food and Drug Administration (FDA) for their candidates.

While the need for a safe and efficacious COVID-19 vaccine is dire and immediate, an EUA may not be the best regulatory method to provide access. Experts warn that the EUA pathway may impede vital scientific progress needed to establish the long term safety and efficacy of investigational COVID-19 vaccines.

According to the FDA, an Emergency Use Authorization is a tool that allows an unapproved medical product to be released to the public in a health crisis given that the medical product meets statutory criteria outlined in Section 564 of the Federal Food, Drug, and Cosmetic Act.

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abortion protest outside supreme court.

Reproductive Rights vs. Reproductive Justice: Why the Difference Matters in Bioethics

By Danielle M. Pacia

When conceptualizing the pursuit of reproductive freedom, we must acknowledge the ways that our systems and structures fail Black, Indigenous and people of color (BIPOC) populations.

2020 has been a year filled with anxiety and anger over the COVID-19 pandemic’s disproportionate negative effects on BIPOC populations. Black Lives Matter protests after the unjust deaths of Breonna Taylor, Mia Green, George Floyd, Rayshard Brooks, Riah Milton, and many others whose lives ended far too soon have prompted an overdue awakening. This has caused some to reexamine racism on a personal and institutional level. Like many disciplines in our country, the field of bioethics has begun to recognize how the field reinforces racism within its scholarship.

Part of this effort includes a critical examination of the frameworks we employ when analyzing bioethical subjects and events, and how they may exclude the historical contributions and narratives of BIPOC populations. Merely acknowledging racism is not enough.

Here, I will explain the differences in the terms reproductive justice and reproductive rights and advocate use of the reproductive justice framework instead of the reproductive rights framework. Within bioethics and health law policy, there is often a lack of clarity between the terms, which, in turn, leaves their important conceptual and historical differences ignored.

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Oxygen mask as part of artificial lungs ventilation machine in surgery room, closeup.

Arizona’s Crisis Standards of Care and Fair Allocation of Resources During COVID-19

By Govind Persad

As COVID-19 cases spiked in Arizona, the state activated its crisis standards of care, which provide triage guidelines if absolute scarcity arises.

Arizona has done the right thing by adopting crisis standards of care instead of leaving these decisions about ventilators to be made ad hoc by medical staff, which presents the risk both of arbitrary and biased decisions and of greater distress for clinical staff who are forced to make decisions without a guidance framework.

Arizona’s activation of its crisis standards of care stands in contrast to most other states’ response to the pandemic, including New York, which ultimately did not activate its crisis standards of care. Even though Arizona and other states have not yet reached the stage of absolute scarcity where triage policies are invoked—and hopefully will take steps to avoid reaching it—the move has prompted discussions about fair triage policies and criticisms from some community organizations.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

To Cut Prescription Drug Spending, Stop Delays for Generic Competition

By Beatrice Brown and Benjamin Rome

Prescription drug spending in the U.S. remains high and continues to rise, accounting for about 20% of national health expenditures. While generic competition is crucial for reducing drug prices, brand-name drug manufacturers can utilize several strategies to delay such competition by increasing the length of market exclusivity for their drugs.

Although brand-name drugs only account for 18% of all prescriptions filled, they comprise 78% of total drug spending. By contrast, equally-effective, interchangeable generic drugs can offer discounts of up to 80% off their brand-name drug counterparts.

Generic competitors can only be introduced after brand-name drugs have completed their period of market exclusivity, which typically lasts 12-16 years and is largely determined by the patents covering the drug. Brand-name pharmaceutical manufacturers have strong financial incentives to prolong this market exclusivity period and delay entry of generic products.

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hospital equipment

Taking Control During COVID-19 Through Advance Care Planning

By Stephanie Anderson and Carole Montgomery

A deep divide exists in the American health care system between patients’ values and the care they receive.

Let’s start with a story – Marcus was in his mid-40’s when he underwent high-risk heart surgery during which he suffered a brain injury. Afterward, the surgeons at first reassured his family that the surgery itself was successful (his heart was working fine) in spite of his brain injury.

Unfortunately, after many days in the ICU he remained unconscious and was not able to get off the ventilator. Specialists told the family that his brain injury was severe, and he would likely not be able to carry on a meaningful conversation or live independently ever again.

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Busy Nurse's Station In Modern Hospital

A Physician Reflects on COVID-19 and Advance Care Planning

By Shoshana Ungerleider

It was the end of a 24 hour shift in the ICU when the 85-year-old woman I had just admitted with end stage heart failure began having trouble breathing. While I knew she did not desire “aggressive measures” taken to prolong her life, I wondered what that meant in the context of this moment. Even though I was a young medical resident, I knew without swift intervention, she would not be able to survive the night. I ran into the waiting room to search for her son, her medical decision maker, but he had gone home for the night.

I returned to the bedside to see that my patient was tiring as her breathing was becoming shallow and fast. She was awake and I sat down to explain why she was feeling breathless. I explained that her condition had rapidly worsened and asked if she had ever considered a scenario where she may need a breathing tube. She had not. As her oxygen levels dropped, it quickly became clear that we had to act. What wasn’t clear to me was whether this frail woman would actually survive this hospital stay, and if she truly understood what intubation and mechanical ventilation were and whether this would cause her to suffer.

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