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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hospital equipment

How Triage During COVID-19 Can be Fair to Patients with Disabilities

By Govind Persad

On March 28, 2020, the Department of Health and Human Services issued guidance regarding the application of antidiscrimination law to triage policies — that is, policies for fairly allocating scarce medical treatments, like ventilators, in the COVID-19 pandemic.

Many news outlets incorrectly portrayed HHS as prohibiting triage guidelines from considering disability. But the guidance is more nuanced.

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LOMBARDIA, ITALY - FEBRUARY 26, 2020: Empty hospital field tent for the first AID, a mobile medical unit of red cross for patient with Corona Virus. Camp room for people infected with an epidemic.

Pandemic Guidelines, Not Changed Malpractice Rules, Are the Right Response to COVID-19

By Valerie Gutmann Koch, Govind Persad, and Wendy Netter Epstein

On March 17, the Washington Post published an op-ed by Dr. Jeremy Faust, titled Make This Simple Change to Free Up Hospital Beds Now. In it, he argues that cities and states should “temporarily relax the legal standard of medical malpractice,” in order to encourage hospitals to admit, and physicians to treat, the patients who need help during the COVID-19 pandemic.

In a tweet promoting the piece, Dr. Faust expresses concern that in the absence of such a legal change, “docs will keep doing ‘usual’ low yield admissions.”

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Researcher works at a lab bench

Do Pharmaceutical Patents Generate Unique Global Health Duties?

By Govind Persad

Imagine a Harvard MBA graduate trying to decide between jobs at Pfizer and at Snapchat. Both are immensely wealthy firms. Many of Pfizer’s products benefit global health. Snapchat’s are at best neutral and may even harm health. Yet many see Pfizer as distinctively culpable for global health deficits. These arguments often depend on the fact that Pfizer holds intellectual property (IP) in pharmaceuticals, whereas Snapchat holds cash and non-pharmaceutical IP.

In a recent paper in the Yale Journal of Health Policy, Law, and Ethics, Examining Pharmaceutical Exceptionalism: Intellectual Property, Practical Expediency, and Global Health, I argue for two conclusions:

  1.  Holders of pharmaceutical IP (like Pfizer) aren’t uniquely culpable for global health deficits. Other actors (like Snapchat) who fail to use available resources–including ordinary property and non-pharmaceutical IP–to address health deficits, or who affirmatively cause health deficits, also bear responsibility.
  2. But laws requiring pharmaceutical IP holders, but not others, to address global health deficits are nevertheless justifiable. Legal responsibility needn’t perfectly mirror moral responsibility.

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Two senior women jogging in a park

What Should We Ask About Age-Based Criteria in Healthcare?

In the American health care system, age shapes patients’ options. Most people over age 65 are eligible for Medicare, which is inaccessible to almost everyone under 65.

But many providers limit older patients’ access to certain interventions—like in-vitro fertilization or organ transplants. Some clinical research studies also exclude older patients, while others stratify populations by age. And insurers in the Affordable Care Act’s individual marketplaces can legally charge older patients up to three times as much as younger patients, which has motivated calls to let people below 65 buy into the Medicare program (although these proposals use age 55 as an eligibility criterion). Many of these uses of age have generated debate in the past, and are likely to continue to generate debate in the future. Read More

Vulnerability, Coercion, and Undue Influence: From the Mud into the Muck?

According to the NPRM, “the only vulnerability that needs to be considered is vulnerability to coercion or undue influence, and not other types of vulnerability.” It therefore replaces all standalone uses of “vulnerable” with “vulnerable to coercion or undue influence.” This change is justified on the basis that it will “provide greater consistency and clarity in IRB consideration of vulnerability of subject populations in research activities and appropriate protections,” where the vulnerable populations in question are “children, prisoners, pregnant women, physically or mentally disabled persons, or economically or educationally disadvantaged persons.”

Two provisions of the Common Rule (§107.a and §111.a.3) currently discuss vulnerability without further specification, whereas one (§111.b) discusses vulnerability to coercion and undue influence. Deleting §111.b’s reference to coercion and undue influence, however, would achieve consistency while making even fewer changes than the NPRM proposes. The proposed revisions, then, rest on improved clarity rather than improved consistency.

I doubt that narrowing vulnerability by adding the terms “coercion” and (in particular) “undue influence” adds much clarity. Rather, these changes may reduce protections against research flaws other than coercion and undue influence without offering counterbalancing advantages for the research enterprise. Read More