Herndon, USA - April 27, 2020: Virginia Fairfax County building exterior sign entrance to Mom's Organic Market store with request to wear face mask due to covid-19 pandemic.

The Current COVID-19 Surge, Eugenics, and Health-Based Discrimination

By Jacqueline Fox

COVID has shown us that the burdens and inequities that characterize everyday life for many Americans are not merely vestiges of an older time, but an honest reflection of our unwillingness to treat everyone with dignity and respect.

We have undergone an ethical stress test in the last 18 months. While many people have exhibited heroic commitments to their fellow citizens, much of our governmental response is indefensible in a society that professes to care for all of its members. This implies we are not such a society.

Rather, we are a society riddled with healthism — discrimination based on health status — and eugenics — a pseudo-science that arbitrarily elevates some human traits over others, much as we do with breeding dogs and horses.

As a result, although we are armed with the power to prevent much harm, we lack the will or inclination to use that power for our most vulnerable. Instead, we place different values on people’s lives using arbitrary definitions of quality, and treat people differently based on their health status. Examples include placing a lower value on a life because a person is older, disabled, or overweight.

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Person receiving vaccine.

Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines?

Cross-posted from Written Description, where it originally appeared on June 30, 2021. 

By Lisa Larrimore OuelletteNicholson PriceRachel Sachs, and Jacob S. Sherkow

The number of COVID-19 vaccines is growing, with 18 vaccines in use around the world and many others in development. The global vaccination campaign is slowly progressing, with over 3 billion doses administered, although the percentage of doses administered in low-income countries remains at only 0.3%. But because of differences in how they were tested in clinical trials, making apples-to-apples comparisons is difficult — even just for the 3 vaccines authorized by the FDA for use in the United States. In this post, we explore the open questions that remain because of these differences in clinical trial design, the FDA’s authority to help standardize clinical trials, and what lessons can be learned for vaccine clinical trials going forward.

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Person filling syringe from vial.

Religious Exemptions to Vaccines and the Anti-Vax Movement

By Dorit Rubinstein Reiss

Two major problems with granting religious exemptions to vaccine mandates are that they are very hard to police, and that they are routinely gamed.

Religious freedom is a core value in the United States. This makes policing religious exemptions to vaccination hard – and rightly so. The government policing people’s religion raises a number of thorny issues.

The problem is that the same people who eagerly promote anti-vaccine misinformation are just as eager to misuse religion to avoid vaccinating, and have no hesitation or compunction about coaching others to do the same. And without policing, it is easy for those misled by anti-vaccine misinformation to use the religious exemption.

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The White House, Washington, DC.

What Can the Federal Government Do When States Make Dangerous Decisions?

By Jennifer S. Bard

The threat posed to the welfare, economy, and security of the United States by the rapidly spreading COVID-19 virus is as serious as any we have ever confronted.

But, at the same time that the federal government is spending billions of dollars on distributing vaccines, and exerting their authority by prohibiting evictions and requiring masks on public transportation, many individual states are not just refusing to take effective measures to stop the spread, but also are pouring gasoline on the fire by doing all they can to undermine even the remaining, weak guidelines published by the CDC. Some have gone so far as to restrict the flow of information by prohibiting public health officials from disseminating news about the vaccines provided by the federal government.

The effects of these actions not only promote the spread of COVID-19, but also fuel its mutation into new forms, and cannot be confined by any existing geographic or cartographic boundary. So how is the federal government allowing this to happen? It’s not for lack of authority.

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international connections concept art.

The Prospects for an IP Waiver Under the TRIPS Agreement

By Duncan Matthews and Timo Minssen

The informal meeting of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council today, July 6, 2021, focuses international attention once more on prospects for a waiver of the TRIPS Agreement in response to the COVID-19 pandemic.

Regardless of whether an actual TRIPS waiver ultimately comes to pass, the real significance of these efforts lies in the increased focus they have placed on the role of IP and trade secrets in improving access and affordability, and scaling-up of manufacturing and supply of vaccines and other health-related technologies. These conversations have introduced the possibility of a rethinking of the relationship between IP, innovation, conservation, and access.

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lady justice.

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

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.

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Emergency department entrance.

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

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

By

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.

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Patient receives Covid-19 vaccine.

What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)?

Cross-posted from Written Description, where it originally appeared on June 3, 2021. 

By Jacob S. SherkowLisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Recently, Pfizer and BioNTech and Moderna announced that they are seeking full FDA approval for their mRNA COVID-19 vaccines — filing, in FDA parlance, a Biologics License Application (BLA). Johnson & Johnson plans to file its own BLA later this year. But currently, all three vaccines are being distributed under a different FDA mechanism, the Emergency Use Authorization (EUA). What’s the difference, under the hood, between these two mechanisms? Why would these companies want to go through the BLA process? And what tools can policymakers use to make the EUA to BLA shift better?

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a pill in place of a model globe

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

By Ameet Sarpatwari, Beatrice Brown, 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 May. The selections feature topics ranging from an analysis of the impact of generic drug spikes on Medicaid spending, to an evaluation of where drugs are tested for FDA approval and subsequent time to marketing approval in these countries, to an assessment of how net prices of diabetes drugs are affected by brand competition. A full posting of abstracts/summaries of these articles may be found on our website.

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