Pile of colorful pills in blister packs

Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal

By Richard Klein, Kenneth I. Moch, and Arthur L. Caplan

A new proposal out of the Goldwater Institute (GI), a libertarian think tank, advances an oversimplified critique of the U.S. regulatory process for approving medicines for COVID-19 and other diseases, with the ultimate goal of weakening the U.S. Food and Drug Administration.

You may remember the Goldwater Institute as the architect of the initial state “Right to Try” (RtT) legislation from a few years ago. The idea, marketed as increasing access to experimental medicines, was actually calculated to circumvent FDA oversight so that individuals could try still-unproven experimental medicines without what Goldwater viewed as pointless bureaucratic paternalism. RtT legislation was adopted by 41 states and ultimately by the U.S. Congress.

When former President Trump signed the Right to Try bill into federal law with great fanfare on May 20, 2018, he stated that “countless American lives will ultimately be saved.” Three years later, the promise proved to be meaningless, as evidenced by the difficulty in identifying more than a handful of individuals who have even pursued the RtT pathway, much less finding data to show that it has saved lives.

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Home innovation technology concept illustration.

Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home

Contribute to the 2022 Petrie-Flom Center Annual Conference and subsequent book project!

Through October 14, 2021, the Petrie-Flom Center is accepting abstracts for its annual conference. The 2022 annual conference will focus on ethical, legal, and regulatory challenges and opportunities around at home digital health technology.

This conference will engage with the vision for a 21st century health care system that embraces the potential of at home digital products to support diagnoses, improve care, encourage caregivers, maximize pandemic resilience, and allow individuals to stay within the home when preferable. The goals of this conference and subsequent book project are to consider the ethical, sociological, regulatory, and legal challenges and opportunities presented by the implementation of digital products that support clinical diagnosis and/or treatment in patients’ homes over the next decade.

Interested in submitting an abstract, but want to know more about what we’re looking for? Read through the following frequently asked questions.

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WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

The Many Harms of State Bills Blocking Youth Access to Gender-Affirming Care

By Chloe Reichel

State legislation blocking trans youth from accessing gender-affirming care puts kids at risk, thwarts physician autonomy, and potentially violates a number of federal laws, write Jack L. Turban, Katherine L. Kraschel, and I. Glenn Cohen in a viewpoint published today in JAMA.

So far this year, 15 states have proposed bills that would limit access to gender-affirming care. One of these bills, Arkansas’ HB1570/SB347, already has become law.

This legislative trend should be troubling to all, explained Cohen, Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. In an email interview, he highlighted “how exceptionally restrictive these proposed laws are,” adding that they are “out of step with usual medical, ethical, and legal rules regarding discretion of the medical profession and space for parental decision-making.”

Turban, child and adolescent psychiatry fellow at Stanford University School of Medicine also offered further insight as to the medical and legal concerns these bills raise over email.

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Rows of gold post office boxes with one open mail box.

FDA Expands Medication Abortion Access During Pandemic, but State Barriers Remain

By Adrienne R. Ghorashi, Esq.

Last week, the Food and Drug Administration (FDA) suspended an in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic, allowing patients to access medication abortion by mail.

Previously, the FDA REMS requirement mandated that mifepristone must be dispensed in person, forcing patients to travel to a clinic in order to pick up the medication. In light of the pandemic, the requirement would lead to unnecessary risks of COVID exposure for patients and providers, in addition to imposing logistical and financial burdens.

This FDA decision is the latest development in a battle that made its way to the U.S. Supreme Court earlier this year. In its first abortion decision since Justice Amy Coney Barrett joined the bench, the Supreme Court reinstated the in-person dispensing requirement after it had previously been blocked by a federal district court in Maryland due to the risks of COVID-19.

Advocates for abortion access are celebrating the FDA decision as a win for science and evidence-based policy rooted in a growing body of research on the benefits of medication abortion and telemedicine for abortion.

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Temporary entrance in front of New York hospital during COVID-19 pandemic.

Institutional Reforms Needed to Strengthen Health Care Post-Pandemic

By Marissa Wagner Mery

COVID-19 has highlighted that pandemic preparedness and management requires a strong, well-functioning health system.

Shoring up the health system and its workforce should be a national priority post-pandemic. First and foremost, we must recognize that the greatest asset of the health system is its people, and the system must reflect this. Second, our hospital-based, competition-driven health care landscape should be reformed to better meet the needs of our communities.

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Healthcare concept of professional psychologist doctor consult in psychotherapy session or counsel diagnosis health.

The Case for Non-Police Response to Behavioral Health Crises

By Jennifer J. Carroll and Taleed El-Sabawi

People who use drugs continue to die at staggering rates, due not only to overdose from contaminated drug supply, but also due to our persistent reliance on the carceral system to respond to behavioral health crises.

This approach stems from the state-sanctioned violence of the War on Drugs. It takes various forms, including the use of police officers as first responders to behavioral health crises (including welfare checks), the excessive police use of force, and the use of potentially lethal restraint methods to subdue agitated persons. It also manifests in police officers’ use of jail cells as tools for forced “detox” believing that coerced withdrawal while in custody will reduce overdose risk or help someone “go clean” (it very clearly does not).

Evidence-based alternatives to police response for behavioral health crises exist. However, despite being both feasible and effective, these alternatives to police intervention remain the exception, rather than the rule.

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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.

Intentional Commitments to Diversity, Equity, Inclusion Needed in Health Care

By Eloho E. Akpovi

“They told me my baby was going to die.” Those words have sat with me since my acting internship in OB/GYN last summer. They were spoken by a young, Black, pregnant patient presenting to the emergency room to rule out preeclampsia.

As a Black woman and a medical student, those words were chilling. They reflect a health care system that is not built to provide the best care for Black patients and trains health care professionals in a way that is tone-deaf to racism and its manifestations in patient care.

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medical needles in a pile

How Supervised Injection Sites Can Help Address the Overdose Crisis

By Carly Roberts

Supervised injection sites, also known as safe injection sites, are among the most effective, evidence-based harm reduction tools available to counter the opioid overdose crisis.

Supervised injection sites are legally sanctioned locations that provide a hygienic space for people to inject pre-obtained drugs under the supervision of trained staff. Safe injection sites often provide additional services including needle exchanges, drug testing (especially important for detecting lethal fentanyl-laced drugs and preventing “mass overdose” events), and referral to treatment and social services.

The opioid overdose crisis in the U.S., which had a death toll of over 45,000 in 2018, and which is predicted to worsen amid the COVID-19 pandemic, warrants a bold, brave, and thorough response. Harm reduction programs, including supervised injection sites, should be integrated into opioid epidemic response strategies in order to save lives and improve individual and community outcomes.

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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

The Myth of Psychedelic Exceptionalism

By Dustin Marlan

The “latest frontier” in drug law reform is the loosening of legal restrictions on psychedelics, such as psilocybin, ayahuasca, and ibogaine. But not all drug reform advocates are thrilled about this development.

Some are concerned that singling out psychedelics for legalization or decriminalization perpetuates the stigma surrounding other illegal drugs. Most prominently, Dr. Carl L. Hart, professor of neuroscience and psychology at Columbia University argues that all drugs “interact on receptors in the brain to produce their effects… we shouldn’t be treating some drugs as if they’re special while others are somehow evil.”

“Psychedelic exceptionalism” describes an ideology that claims psychedelics should be privileged for reform, but other purportedly more harmful drugs, like heroin and cocaine, should remain prohibited. As journalist Madison Margolin frames the question, “Should psychedelics be treated so differently from other drugs, given that any substance may have the power to soothe or scorch the human psyche, and body too?”

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New York, NY/USA - 08.31.2018: Overdose Awareness March.

Advancing a Public Health-Promoting National Opioid Policy

Register to attend “Addressing the Overdose Epidemic: Substance Use Policy for the Biden Administration” on March 24th.

By Jennifer D. Oliva & Kelly K. Dineen

“America’s drug regime is a monstrous, incoherent mess.”
– Dr. Carl L. Hart, Drug Use for Grown-Ups: Chasing Liberty in the Land of Fear (2021)

By any measure, American drug policy is an ineffective and costly failure.

The U.S. drug policy regime’s defining quality is its persistent adherence to the same approaches in the face of overwhelming evidence that they are unsuccessful, including supply-side tactics, fear mongering, and misinformation dissemination. These policies are racist by design and their myriad, negative impacts are disproportionately borne by marginalized and stigmatized communities.

The “war on drugs” and its repeated loop of lost battles have earned the nation the highest incarceration rate in the world, fomented a number of serious health issues related to drug use, and fueled a drug overdose and suicide crisis. Our shape-shifting overdose crisis recently claimed the highest number of overdose deaths ever recorded during a twelve-month period in American history.

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