Doctor, DNA, microscope concept illustration.

Reclassification of Genetic Test Results: Potential Time Bombs in the Medical Record? 

By Ellen Wright Clayton

Findings from genetic tests are not static; as knowledge advances, our understanding of the implications of these results evolves.

But what this means for physicians and their duties to patients is unresolved, as I explain with co-authors in a new article in Genetics in Medicine, the official journal of the ACMG.

There is an increasing drumbeat of support for an ethical and legal duty for physicians to reinterpret genetic test results and re-contact patients about these new understandings to improve their care.

Currently, reviewing prior medical records is by no means routine. Clinicians may review past records if they suspect that they have missed something as symptoms evolve, or that the significance of a symptom or biomarker may have changed because of new research.

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Kratom leaves and capsules.

A Sensible, Evidence-Based Proposal for Kratom Reform

By Dustin Marlan

In May 2021, the U.S. Food and Drug Administration (FDA) announced the seizure of 37,500 tons of adulterated kratom in Florida, worth an estimated $1.3 million.

But rather than focusing on the fact that the seized substance was adulterated, FDA Commissioner Janet Woodcock emphasized the alleged toxicity of kratom. This telling choice falls in line with recent efforts by the FDA to end U.S. kratom sales, distribution, and use, including a failed 2016 attempt to have kratom placed into Schedule I of the Controlled Substances Act, along with other federally prohibited drugs such as cannabis, psilocybin, and heroin.

This reactionary prohibitionism is likely to do more harm than good. Moreover, it does not reflect the state of the science, which remains unsettled as to kratom’s risks and benefits.

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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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