Pill pack.

Fortifying the US Pharmaceutical Supply Chain

By Laura Karas

The COVID-19 pandemic triggered supply chain disruption across the globe. The United States, in particular, is susceptible to interruptions in the supply chain for pharmaceutical drugs because many of the raw materials, active pharmaceutical ingredients, and manufacturing processes needed to produce domestically marketed prescription drugs have been outsourced beyond U.S. borders.

Is it time to bring some of these processes back to our shores? This post will demystify the pharmaceutical supply chain and explore some key considerations as we head toward 2021.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Experts Question FDA Approval of Remdesivir for COVID-19

By Sravya Chary

Experts are calling into question the recent decision of the U.S. Food and Drug Administration (FDA) to approve remdesivir (sold under the brand name Veklury) for the treatment of COVID-19 and casting scrutiny as to whether the decision is truly in the public’s interest.

Evaluating and approving an effective treatment for SARS-CoV-2 virus has been a top priority for regulatory authorities, especially in the absence of a viable vaccine. On October 22, 2020, the FDA approved Veklury for the treatment of COVID-19 in adult and pediatric patients requiring hospitalization.

The FDA cited three randomized, controlled clinical trials as the evidence supporting its decision to approve Veklury. The findings from the three studies were as follows: first, that the median time to recovery from COVID-19 was 5 days sooner in the Veklury group compared to the placebo group. Second, that the odds of a research subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day treatment group than the standard of care group (the 10-day treatment group did not show a statistically significant difference from the standard of care group). Third, that there were no statistically significant differences in recovery or mortality rates between subjects in the five-day Veklury group versus the ten-day Veklury group.

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Society or population, social diversity. Flat cartoon vector illustration.

The Cost of Exclusion in Psychedelic Research

By Xinyuan Chen, Mackenzie Bullard, Christy Duan, Jamilah R. George, Terence Ching, Stephanie Kilpatrick, Jordan Sloshower, and Monnica Williams

In the last two decades, researchers have started to reexamine psychedelics for their therapeutic potential. Though initial results seem promising, the research has a significant shortcoming: the lack of racial and ethnic diversity among research teams and study participants.

In the 1960s, psychedelic substances such as LSD, psilocybin, and mescaline were a major part of American counterculture. Less well-known is that, concurrently, researchers were studying potential therapeutic uses of these mind-altering substances. Unfortunately, psychedelics were classified as Schedule I drugs in 1970, halting research into their therapeutic benefits.

The recent renaissance of psychedelic research shows these substances have significant capabilities for treating anxiety, depression, posttraumatic stress disorder (PTSD), and substance use disorders. But these promising results are limited in their applicability: an analysis from 2018 showed that 82.3% of all study participants in psychedelic trials internationally were non-Hispanic Whites, and only 2.5% were African-American.

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Pill bottles.

During the COVID-19 Pandemic, the Opioid Epidemic Continues

By Laura Karas

“The boy’s first outcry was a rueful laugh,

As he swung toward them holding up the hand

Half in appeal, but half as if to keep

The life from spilling. Then the boy saw all—

Since he was old enough to know, big boy

Doing a man’s work, though a child at heart—

He saw all spoiled. . . .

He lay and puffed his lips out with his breath.

And then—the watcher at his pulse took fright.

No one believed. They listened at his heart.

Little—less—nothing!—and that ended it.

No more to build on there. And they, since they

Were not the one dead, turned to their affairs.”

This except from Robert Frost’s 1916 poem “Out, Out—,” which portrays the sudden death of a young boy after a woodcutting accident and the onlookers’ casual acceptance of his tragic death, is particularly apropos today, more than one hundred years later, in an America that looks very different than that of Frost’s time. Between the opioid crisis and the COVID-19 pandemic, America now suffers from a surplus of needless, untimely deaths.

Just as the protagonist of Frost’s poem became the casualty of a tragic accident, so too do the many victims of the opioid epidemic become casualties in a losing battle — lives “spoiled” by substance use disorder and cut short by tragic overdose. In this post I explore the status of the opioid epidemic in light of the COVID-19 pandemic and ongoing initiatives to address opioid use disorder (OUD).

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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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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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Washington, DC – October 16, 2020: One of the many official ballot boxes placed around the city for early voters to place their completed ballots to avoid lines due to the ongoing Covid-19 pandemic.

Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws

By Melissa Lavasani

In December 2019, I proposed a ballot measure, now known as Initiative 81, which would effectively decriminalize natural psychedelics – including psilocybin and ayahuasca, which had helped me overcome postpartum depression – in the District of Columbia.

This would help ensure that other D.C. residents benefiting from natural psychedelics are not targeted by law enforcement. After tumultuous months of hard work including collecting more than 25,400 signatures from voters, Initiative 81 is on the November ballot.

I am not the usual protagonist you’d imagine as an advocate for psychedelics: I am a married mother of two with two graduate degrees and an established career working for the District of Columbia government. But I had a psychedelic experience that changed my life. In 2018, I had taken psychedelics – first psilocybin mushrooms, and then ayahuasca and San Pedro cacti – because I was desperate to overcome severe postpartum depression that came to dominate my life.

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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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