One pill on mint green background.

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, 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 December. The selections feature topics ranging from a discussion of the challenges in confirming drug effectiveness after early approval, to an analysis of potential savings from a proposed policy requiring manufacturers of drugs receiving accelerated approval to pay higher rebates to Medicaid until efficacy is demonstrated, to an evaluation of the racial and ethnic representation in clinical trials supporting FDA approval of new drugs and biologics. A full posting of abstracts/summaries of these articles may be found on our website.

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Desolate winter scene.

A Timeline of Biden’s Pandemic Response, Part 4: Winter of Death (December 2021 – Present)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first, second, and third parts here.

By Justin Feldman

On December 1, 2021, the CDC issued a press release announcing that it had identified a case of the Omicron variant in the U.S. for the first time.

White House insiders admit that they were unprepared for Omicron, just as they were unprepared for Delta. Vice President Harris recently told an interviewer that the administration was caught flatfooted because their scientific advisors never warned that such variants could crop up (at least two of these advisors, Rick Bright and Celine Gounder, begged to differ).

While vaccination still provides powerful protection against hospitalization and death due to infection from Omicron, protection against symptomatic illness is weaker than before, particularly among those who have not received boosters. And though evidence is mounting that the risk of hospitalization and death is lower for each person infected compared to Delta, Omicron’s extremely high transmissibility means that a large fraction of the population will become infected in a short time period, particularly in the absence of additional public health measures.

On December 21, as the highly contagious variant started to sweep the country, President Biden delivered remarks about the new threat. For the hundred million Americans who remain unvaccinated, the president’s speech warned of the imminent risk of hospitalization and death. For the vaccinated and boosted, Biden’s message was: Keep Calm and Carry On, all will likely be fine. And for Wall Street, the speech was meant to provide a crucial piece of reassurance: There would be no federal support for public health measures that restrict commerce.

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Empty toolbox.

A Timeline of Biden’s Pandemic Response, Part 3: We Have the Tools (Sept. – Dec. 2021)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first and second parts here.

By Justin Feldman

Over the summer of 2021, concern grew that the vaccines were not providing the near-perfect protection against symptomatic disease and transmission that had first emboldened the administration to jettison other public health measures.

It was initially unclear whether the issue was Delta’s higher transmissibility or waning immunity from vaccines, as the first groups had been vaccinated nearly a year prior. There was noticeable concern from CDC, which acknowledged the “war has changed” in a set of leaked slides from July 29, 2021. Of particular concern were case reports from Massachusetts and internationally of high viral loads observed among those who were vaccinated and infected. In late July, CDC reversed course on its mask guidance and recommended indoor masking for all, including the fully vaccinated, in counties with high transmission. In late September 2021, CDC reversed course on its quarantine guidance, which had previously stated that fully vaccinated people should not quarantine after a known SARS-CoV-2 exposure.

These changing epidemiologic realities could have brought about a course correction and a push for other public health policies to complement vaccination. Instead, the administration mostly adapted by shifting its messaging.

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Vial and syringe.

A Timeline of Biden’s Pandemic Response, Part 2: A Pandemic of the Unvaccinated (May – Sept. 2021)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first part here.

By Justin Feldman

Framing vaccination as a way to opt out of the pandemic, and understanding the unvaccinated to be political enemies, has helped absolve the Biden administration of its responsibilities to protect the public’s health and facilitated the relentless push to restore “normalcy” (i.e., full economic activity).

The administration knows better: In September 2020, while the vaccines were still being tested, key figures in Biden’s orbit warned that it was unlikely vaccination alone could sufficiently control the pandemic.

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Mushrooms containing psilocybin grow in the forest.

Washington Psilocybin Bill Would Legalize Supported Adult Use

By Mason Marks

On Tuesday, Washington State legislators filed SB 5660, a bill that would legalize the supported adult use of psilocybin by people 21 years of age and older.

Sponsored by Senators Jesse Salomon and Liz Lovelett, the bill, known as the Washington Psilocybin Wellness and Opportunity Act, includes many innovative features including a Social Opportunity Program to help address harms caused by the war on drugs, a provision to support small businesses, and accommodations for people with certain medical conditions to receive the psychedelic substance at home.

I had the privilege of helping to draft the Washington Psilocybin Services Wellness and Opportunity Act with input from the Psychedelic Medicine Alliance of Washington and my colleague John Rapp of the law firm Harris Bricken. We had previously collaborated on the psychedelic decriminalization resolution adopted unanimously by the Seattle City Council.

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President Joe Biden and Vice President Kamala Harris.

From Shutting Down the Virus to Letting it Rip: A Timeline of Biden’s Pandemic Response

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. 

By Justin Feldman

Welcome to our “winter of severe illness and death.”

Hospitals are becoming overwhelmed in various parts of the U.S., and one model predicts more than 120,000 COVID deaths will occur in the first two months of 2022.

How did we get here? How is our Democratic president — who ran, in part, against Trump’s horrid pandemic response — letting the virus rip? How did we get to a point where a key organizer of the Great Barrington Declaration, a right-wing libertarian campaign opposed to public health measures, has stated that Republican and Democratic states alike have adopted policies in line with their philosophy? As hospitals fill up around the country, why are political leaders doing nothing to at least try to “flatten the curve”?

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Pink piggy bank and stethoscope on a gray background.

Medical Schools Need to Do More to Reduce Students’ Debt

By Leah Pierson

Today, the average medical student graduates with more than $215,000 of debt from medical school alone.

The root cause of this problem — rising medical school tuitions — can and must be addressed.

In real dollars, a medical degree costs 750 percent more today than it did seventy years ago, and more than twice as much as it did in 1992. These rising costs are closely linked to rising debt, which has more than quadrupled since 1978 after accounting for inflation.

Debt burdens

Physicians with more debt are more likely to experience to burnout, substance use disorders, and worse mental health. And, as the cost of medical education has risen, the share of medical students hailing from low-income backgrounds has fallen precipitously, compounding inequities in medical education.

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Vial and syringe.

Causes of COVID Vaccine Hesitancy

By Jasper L. Tran

Vaccinated individuals — like Tolstoy’s happy families — are all alike; each unvaccinated individual is hesitant for her own reason.

Prior research conducted in developed countries reveals five main individual-level determinants of pre-COVID vaccine hesitancy (commonly referred to as the 5 C model drivers of vaccine hesitancy): (1) Confidence (trust in vaccine’s effectiveness and safety, vaccine administrators and their motives); (2) Complacency (perceiving infection risks as low and vaccination as unnecessary); (3) Convenience / Constraints (structural or psychological barriers to converting vaccination intentions into vaccine uptake); (4) Risk Calculation (perceiving higher risks related to vaccination than the infection itself); and (5) Collective Responsibility (willingness to vaccinate to protect others through herd immunity).

COVID-19 vaccines see these five hesitancy determinants again, only further exacerbated by waves of misinformation promulgated on social media, including through “bot” accounts, that prey on the concerns and insecurities of an already vulnerable public.

On the one hand, irrational and unreasonable conspiracy theories about COVID-19 and its vaccine abound among the anti-vaxxers — a subgroup of science deniers. These conspiracy theories include:

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(Institute for the feeble-minded, Lincoln, Ill. / Library of Congress)

Brittney Poolaw and the Long Tradition of State-Sponsored Control of Women and Their Fertility

By Lauren Breslow

On October 5, 2021, a 20-year-old Native American woman, Brittney Poolaw, was convicted by an Oklahoma jury of manslaughter for the death of her 17-week-old, non-viable fetus.

Her conviction stands as a modern recapitulation of the historical violations that women, especially Black and Brown women, have endured regarding their fertility.

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Gavel and stethoscope.

Symposium Conclusion: Health Justice: Engaging Critical Perspectives in Health Law & Policy

By Lindsay F. Wiley and Ruqaiijah Yearby

As our digital symposium on health justice comes to a close, we have much to be thankful for and inspired by. We are honored to provide a platform for contributions from scholars spanning multiple disciplines, perspectives, and aspects of health law and policy. Collectively with these contributors, we aim to define the contours of the health justice movement and debates within it, and to explore how scholars, activists, communities, and public health officials can work together to engage critical perspectives in health law and policy.

As we described in our symposium introduction, the questions we posed to contributors focused their work on four main themes: (1) subordination (including discrimination and poverty) is the root cause of health injustice, (2) subordination shapes health through multiple pathways, (3) health justice engages multiple kinds of experiences and expertise, and (4) health justice requires empowering communities, redressing harm, and reconstructing systems. Most of the contributions to this symposium cut across more than one of these themes, but we present them here in four broad categories.

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