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

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, 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 an analysis of potential approaches for evaluating novel SARS-CoV-2 vaccine candidates after other vaccines have already been authorized; to an examination of social, cultural, and economic aspects of microbial resistance; to a study on clinical evidence supporting FDA clearance of novel therapeutics devices via the de novo pathway. A full posting of abstracts/summaries of these articles may be found on our website.

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Miami Downtown, FL, USA - MAY 31, 2020: Woman leading a group of demonstrators on road protesting for human rights and against racism.

Understanding the Role of Race in Health: Conclusions from the Symposium

By Craig Konnoth

In my introductory post to this symposium, I suggested that medicine and health tapped into a discourse of power that had the power to either harm or help. Medicine can trigger benefits in the law — what I call “medical civil rights,” where advocates rely on medicine’s language to trigger both formal legal rights and public advantage. At the same time, I acknowledged that black, indigenous, and people of color (BIPOC), are often left behind.

In a midpoint reflection, I theorized the problem through the lens of a double bind. On one hand, medicine erases the needs of BIPOC and the harms they experience — the health harms experienced by frontline medical workers, or caused by school and residential segregation — so that they cannot access medical civil rights. On the other hand, BIPOC are rendered hypervisible in contexts where medicine continues to oppress. They are used in clinical trials and tarred with xenophobia and narratives of genetic difference. What should be done?

Several authors offer solutions. I separate them into three categories: (1) community reform, (2) social and legal reform, and (3) medical reform. Of course, all of these solutions are interrelated. Legal and policy change drives medicine; medical research drives law, society, and policy — and both are driven through community activism and consciousness.

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NHS building

COVID-19 and the State of Health and Social Care in England

By John Tingle

The COVID-19 pandemic has exacerbated challenges facing the provision of health and social care in England, a recent report from the Care Quality Commission (CQC) finds.

The CQC is the independent regulator of health and social care in England. Every year they produce an assessment of the state of the country’s health and social care. The yearly lookbacks include information on trends, challenges, successes, failures and opportunities.

The most recent report analyzes service provision both pre- and post COVID-19, and draws key conclusions from this information. From a patient safety perspective, the report contains important lessons about issues the COVID-19 pandemic has brought into sharp focus. The report also highlights trailing patient safety problems that existed before the pandemic, and are still present as England grapples with the pandemic’s second wave.

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Rainbow lgbtq pride flag and trans pride flag.

Sexual Orientation and Gender Identity in Medical Records Can Reduce Disparities

By Jenna Becker

Sexual orientation and gender identity (SOGI) data is widely considered crucial to providing competent care to LGBTQ+ patients. This data can also be used to reduce health disparities among sexual and gender minority populations.

Most electronic health record (EHR) vendors are able to document SOGI data. Many health care systems across the country have been collecting SOGI information for several years. However, SOGI documentation is not broadly required. It’s time to require SOGI data collection in EHRs nationwide.

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two watercolor silhouettes.

Neurodiversity and Psychedelics Decriminalization

By Dustin Marlan

Following over fifty years of the racist and corrupt war on drugs, drug decriminalization is now a social justice issue. As I explore in Beyond Cannabis: Psychedelic Decriminalization and Social Justice, the decriminalization of psychedelic drugs, in particular, is a matter of diversity, equity, and inclusion.

Psychedelics have long been prohibited under Schedule I of the federal Controlled Substances Act. However, after successful efforts in Denver, Oakland, Santa Cruz, and Ann Arbor, there are now attempts underway to decriminalize psilocybin mushrooms and other natural psychedelics in over 100 cities across the country, including Washington, D.C., which will vote on Initiative 81 in November 2020.

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man lying on couch.

Psychedelics and America: A Digital Symposium

By Mason Marks

In 2020, the psychedelics research and policy reform renaissance is in full swing. Prohibited by federal law since the 1970s, psychedelic substances can alter how people see themselves, the world, and those around them. Clinical trials suggest they may help people overcome ingrained thought patterns associated with depression, anxiety, and addiction.

Acknowledging their spiritual and therapeutic potential, universities have established new psychedelics research programs. The Food and Drug Administration (FDA) has deemed them breakthrough therapies for depression and post-traumatic stress disorder. This designation means they could be significant improvements over traditional treatments such as selective serotonin reuptake inhibitors (SSRIs). Accordingly, the FDA has put some psychedelics on an accelerated course toward approval. Eventually, they could help millions who have not benefitted from existing therapies.

However, despite their breakthrough status, psychedelics will not become FDA approved for several years. Meanwhile, the COVID-19 pandemic is making the country’s mental health crisis worse. According to the Centers for Disease Control and Prevention, rates of depression, anxiety, substance use, and suicidal thoughts have risen in the past nine months.

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Close-up of a stethoscope on an American flag

Why Justice is Good for America’s Health

By Dayna Bowen Matthew

Justice is good for health [and] . . . health is the byproduct of justice.

— Norman Daniels, Bruce Kennedy & Ichiro Kawachi (Boston Review, 2000)

Among the most salient lessons to be learned from the coronavirus pandemic are that unjust laws produce unjust health outcomes, and that justice is just plain good for America’s health.

Health justice is the moral mandate to protect and advance an equal opportunity for all to enjoy greatest health and well-being possible. Health justice means that no one person or group of people are granted or excluded from the means of pursuing health on an inequitable basis. To achieve health justice, societal institutions such as governments and health care providers must act to advance equality, by increasing fairness and decreasing unfairness of their current and historic impacts on populations.

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doctor holding clipboard.

A Critical Race Perspective on Social Risk Targeting in the Health Care Sector

By Brietta R. Clark

Health care programs, such as Medicaid, are increasingly using social risk assessments to target certain patients or communities for interventions intended to promote health. This includes partnering with other service sectors to provide nutrition, housing or employment assistance, transportation, parenting education, care coordination, and other behavioral supports.

These social interventions are touted as a way to improve health equity, yet they do not address structural racism, a powerful determinant of health. These interventions tend not to measure racial impact, or account for how racial inequity shapes the very structures and systems upon which social interventions depend. Indeed, this inattention means that such well-meaning interventions may inadvertently reinforce racial inequity, subordination, and stigma in marginalized communities.

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The Double Bind of Medicine for Racial Minorities

By Craig Konnoth

Medicine often falls short of helping black, indigenous, and people of color (BIPOC). While many individuals successfully invoke medical framing to offer some assistance to address the serious burdens they face — as I explain in a recent article — such efforts have fallen short in the context of racial justice. BIPOC are either subject to hypervisibility — where their medical trait is made a defining characteristic of their existence — or medical erasure, where their medical needs are left unaddressed and ignored.

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computer and stethoscope

How Telehealth Could Improve — or Worsen — Racial Disparities

By Craig Konnoth, JD, M.Phil., Wendy Netter Epstein, JD, and Max Helveston, JD

Despite upping the stakes of America’s partisan divide, the pandemic has prompted bipartisan support for at least one cause — the rapid rollout of telehealth, which allows people to see their doctors by videoconference or telephone.

In last week’s executive order, the Trump Administration reaffirmed its commitment to the use of telehealth. While telehealth may be, in many ways, a panacea for access to healthcare, particularly in COVID times, we should be concerned that patients of color may be left behind.

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