Hundred dollar bills rolled up in a pill bottle

To Address the Overdose Epidemic, Tackle Pharma Industry Influence

By Liza Vertinsky

A recently released government report estimates that 93,000 people died from drug overdose in 2020. This estimate reflects a jump in the death toll of almost 30% from 2019 to 2020, with opioids as a primary driver.

In response, President Biden has called for historic levels of funding for the treatment and prevention of addiction and drug overdose.

Transforming mental health and addiction services is a critical part of tackling the overdose crisis, but it is not enough, on its own, to address this epidemic, or to prevent a future one. We must also alter the conditions that fueled expanded use, and abuse, in the first place. As I argue in Pharmaceutical (Re)capture, a forthcoming article in the Yale Journal of Health Policy, Law and Ethics, this includes a change in how we regulate markets for prescription drugs.

To truly combat the epidemic, I suggest, we have to understand how pain became such a lucrative business and how regulators failed to protect the public health as the market for prescription opioids grew. Then, we need to put this understanding to work in the redesign of pharmaceutical regulation.

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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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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.

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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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Suboxone.

Obstacles and Advances to Accessing Medication for Opioid Use Disorder

By Marissa Schwartz

Medication for Opioid Use Disorder (MOUD), sometimes referred to as Medication-Assisted Treatment (MAT), is a life-saving, evidence-based treatment method considered the gold standard for addressing opioid use disorders. Unfortunately, however, there are a number of barriers — both legal and cultural — that prevent some patients from accessing the treatment they need.

MOUD combines the use of prescription medications (like buprenorphine, methadone, and naltrexone) with counseling and behavioral therapies to provide comprehensive treatment in an inpatient or outpatient setting.

Due to stigma toward MOUD from patients and providers, as well as an overall lack of providers certified to dispense MOUD, there are currently more prescribing rules in the U.S. for the drugs used in MOUD, like buprenorphine, than for opioids. Major legal barriers include provider limits on the number of patients to whom they can offer MOUD, restrictions on which facilities can provide in-patient MOUD treatment, and insurance pre-authorization requirements.

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Large pile of amber prescription pill bottles

How Policy Surveillance Might Help to Counter the Opioid Epidemic

By Erin Napoleon

In 2017, more than 47,000 people had died of an opioid overdose, and 2 million people were dependent on opioids. This astonishing number is attributable in part to the lack of federal and state legislation to curb the over-prescription of opioids.

Opioids first entered the US market in the late 1990s. Pharmaceutical companies’ assured physicians that opioids were less addictive than morphine and posed less dangerous side effects, and doctors began prescribing the pills at unprecedented rates.

Understanding how the dearth of federal and state legislation, coupled with prescribing patterns based on race and socioeconomic status, influence the over-prescription of opioids can potentially lead to new and innovative ways of solving the opioid epidemic that continuously threatens the United States.

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Pile of colorful pills in blister packs

Could Vioxx Make a Comeback? Recalled Drug Receives Orphan Designation

By Blake N. Shultz and Gregory Curfman

Despite a troubling history, rofecoxib (Vioxx) may be making a comeback.

The voluntary withdrawal of rofecoxib (Vioxx) from the market in September 2004 marked the end of a controversial era for a once highly profitable and widely used drug. It also marked the beginning of years of high-profile product-liability litigation that would cost Merck billions.

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Pile of colorful pills in blister packs

Promises and Perils of Prescription Drug Monitoring Programs: Workshop Report

This piece was part of a symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally posted through the Northeastern University Law Review Online Forum.

Promises and Perils of Emerging Health Innovations Blog Symposium

We are pleased to present this symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. As a note, additional detailed analyses of issues discussed during the conference will be published in the upcoming Winter Issue of the Northeastern University Law Review.

Throughout the two-day conference, speakers and attendees discussed how innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, and new models of delivery, such as accountable care organizations (ACOs), retail clinics, and medical-legal partnerships (MLPs), have entered and changed the healthcare market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, as well as improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

In the final post of the Promises and Perils of Emerging Health Innovations blog symposium, Leo Beletsky and the team from Health in Justice Action Lab provide a summary of an event held in conjunction with the Center for Health Policy and Law’s 2019 annual health law conference. The Promises and Perils of Prescription Drug Monitoring Programs (PDMPs) workshop was held on April 13, 2019 and convened experts, practitioners, experts, and other stakeholders to brainstorm strategies with the goal to “maximize the benefits of PDMPs, while minimizing harms.” Visit the Health in Justice Action Lab website (linked below) for information on this and other projects underway. 

Promises and Perils of Prescription Drug Monitoring Programs: Workshop Report

By Health in Justice Action Lab

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hand reaching for blue pills

Author Q&A: Reducing High-Dose Opioid Prescribing

Sara Heins, PhD
Sara Heins, PhD, Associate Policy Researcher, RAND Corporation

From 1999 to 2017, almost 218,000 people died in the United States from overdoses related to prescription opioids. Overdose deaths involving prescription opioids were five times higher in 2017 than in 1999, according to the CDC.

Previous research has indicated that patients who receive higher doses of prescription opioids have an increased risk of overdose and mortality. In response, several states have established Morphine Equivalent Daily Dose (MEDD) thresholds that convert opioid prescriptions to their equivalent dose in morphine and divides the total prescription by the number of days the prescription is intended to last, allowing for comparison among different opioid formulations and strengths. MEDD policies set thresholds for prescribers, which may only be exceeded in limited circumstances, such as when being prescribed to certain patient groups or as short-courses.

Sara Heins, PhD, an associate policy researcher at RAND Corporation, used policy surveillance to track MEDD policies through June 1, 2017 (data are available on LawAtlas.org). She published an article in Pain Medicine on March 13 that describes U.S. MEDD policies.

We asked Dr. Heins a few questions about her work and this recent publication. Read More

Scott Gottleib at a press conference

Commentary: Do We Really Need a New, More Powerful Opioid?

The FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC), of which I am a member, met October 12 to discuss a controversial New Drug Application (NDA) for a powerful opioid called sufentanil, manufactured by AcelRx.

Like fentanyl, sufentanil is a short-acting synthetic opioid, but approximately 5 to 10 times more potent. In the midst of the current opioid crisis, why would anyone think that the availability of another powerful opioid is a good idea?

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