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.

Read More

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.

Read More

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.

Read More

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

Bold Steps Needed to Correct Course in US Drug Policies

By Leo Beletsky, Dan Werb, Ayden Scheim, Jeanette Bowles, David Lucas, Nazlee Maghsoudi, and Akwasi Owusu-Bempah

The accelerating trajectory of the overdose crisis is an indictment of the legal and policy interventions deployed to address it. Indeed, at the same time as the U.S. has pursued some of the most draconian drug policies in the world, it has experienced one of the worst drug crises in its history.

The legal and institutional system of U.S. drug control remains defined by its racist, xenophobic, and colonialist roots. It is no surprise, then, that current policy approaches to drug use have amplified inequities across minoritized and economically marginalized Americans. Reliance on the criminal-legal system and supply-side interventions have disproportionately devastated Black and brown communities, while failing to prevent drug-related harms on the population level.

The Biden-Harris Administration has an unprecedented opportunity to chart a different path. The priorities for the Administration’s approach should flow directly from its stated principles: emphasis on scientific evidence and a focus on equity.

The following key areas require immediate, bold, and evidence-grounded action.

Read More

LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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 February. The selections feature topics ranging from an evaluation of utilization and spending on different formulations of opioid use disorder medication buprenorphine, to an analysis of the impact of the 2012 circuit court ruling in United States v. Caronia on subsequent government enforcement of off-label marketing restrictions, to an assessment of key features of the relationship between public and private actors in the context of biomedical innovation during the COVID-19 pandemic. A full posting of abstracts/summaries of these articles may be found on our website.

Read More

Life preserver on boat.

Incidental Findings in Deep Phenotyping Research: Legal and Ethical Considerations

By Amanda Kim, M.D., J.D., Michael Hsu, M.D., Amanda Koire, M.D., Ph.D., Matthew L. Baum, M.D., Ph.D., D.Phil.

What obligations do researchers have to disclose potentially life-altering incidental findings (IFs) as they happen in real time?

Deep phenotyping research in psychiatry integrates an individual’s real-time digital footprint (e.g., texts, GPS, wearable data) with their biomedical data (e.g., genetic, imaging, other biomarkers) to discover clinically relevant patterns, usually with the aid of machine learning. Findings that are incidental to the study’s objectives, but that may be of great importance to participants, will inevitably arise in deep phenotyping research.

The legal and ethical questions these IFs introduce are fraught. Consider three hypothetical cases below of individuals who enroll in a deep phenotyping research study designed to identify factors affecting risk of substance use relapse or overdose:

A 51-year-old woman with alcohol use disorder (AUD) is six months into sobriety. She is intrigued to learn that the study algorithm will track her proximity to some of her known triggers for alcohol relapse (e.g., bars, liquor stores), and asks to be warned with a text message when nearby so she can take an alternative route. Should the researchers share that data?

A 26-year-old man with AUD is two years into sobriety. Three weeks into the study, he relapses. He begins arriving to work inebriated and loses his job. After the study is over, he realizes the researchers may have been able to see from his alcohol use surveys, disorganized text messages, GPS tracking, and sensor data that he may have been inebriated at work, and wishes someone had reached out to him before he lost his job. Should they have?

A 35-year-old man with severe opioid use disorder experiences a near-fatal overdose and is discharged from the hospital. Two weeks later, his smartphone GPS is in the same location as his last overdose, and his wearable detects that his respiratory rate has plummeted. Should researchers call EMS? Read More

The Week in Health Law podcast logo twihl.com

TWIHL 212: Substance Use Privacy Before and After CARES

By Nicolas Terry

In this episode, I welcome back Kirk Nahra, a partner and Co-Chair of the Cybersecurity and Privacy Practice at Wilmer Hale in DC. He has been a leading authority on privacy and cybersecurity matters for more than two decades. Mr. Nahra counsels clients across industries, from Fortune 500 companies to startups, on implementing the requirements of privacy and data security laws across the country and internationally.

And, after all this time, finally I welcome Melissa Goldstein, Associate Professor in the Department of Health Policy and Management at the Milken Institute School of Public Health at the George Washington University, where she teaches courses in bioethics (including genomics, reproductive ethics, end-of-life, and research ethics issues), health information technology policy, and public health law and conducts research on health information privacy and the legal and policy aspects of health information technology. Our excuse for getting together is that we recently co-authored a piece on the Health Affairs blog titled COVID-19: Substance Use Disorder, Privacy, And The CARES Act.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry or @WeekInHealthLaw.

pill bottle - buprenorphine / naloxone

Protecting the Vulnerable Substance Use Disorder Population During COVID-19

By Brandon George and Nicolas P. Terry

Introduction

Earlier this month, Dr. Nora Volkow, director of the National Institute on Drug Abuse identified those with substance use disorder (SUD) as a particularly vulnerable population during the COVID-19 pandemic. She highlighted the negative effects of opioid or methamphetamine use on respiratory and pulmonary health in addition to the disproportionate number of those with SUD who are homeless or incarcerated.

We detail the additional challenges faced by the SUD population and, specifically, the opioid use disorder (OUD) sub-group at this time, identify positive ameliorative steps taken by federal, state, and local governments, and recommend additional steps.

Read More