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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Civil Commitment for Opioid Misuse: The Need for an Ethical Use Framework

Cross posted from the Journal of Medical Ethics Blog

By John C Messinger, Daniel J Ikeda, and Ameet Sarpatwari

In the 12 months prior to September 2020, there were over 66,000 fatal opioid overdoses in the United States, a 36% increase over the previous year. Many scholars have hypothesized that this dramatic rise was driven at least in part by conditions brought on by the COVID-19 pandemic, including increased barriers to accessing treatment for opioid use disorder and loss of social support.

As the crisis has worsened, states have scrambled to devise interventions to slow the loss of life. One strategy that has gained favor in recent years is the use of civil commitment, which enables others to petition a court to forcibly detain individuals whose opioid misuse presents a clear and convincing danger to themselves or others. Between 2015 and 2018, 25 states amended or passed new legislation related to involuntary commitment for substance misuse generally. More recently, now-President Joe Biden offered support for expansion of “mandatory rehab” on the campaign trail.

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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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Close up of the Lady of Justice statue

The Privatization of Opioid Litigation

By Dan Aaron

As the opioid litigation continues over the shadow of one of our nation’s most pressing public health crises, some criticism has been levied at private lawyers representing the cities, counties, states, and individuals harmed by the crisis. For example, see the following tweet:

Let’s work out tax and healthcare financing policy county by county, with private lawyers taking a 25% cut every time. Judge Polster seems to like this idea.

The critiques are many, but can be summarized: (1) private lawyers are being enriched; (2) private lawyers are setting opioid policy; (3) private lawyers have misaligned incentives; and (4) private lawyers will not support public health.

Arguably, all these arguments bear some truth. However, do they suggest that the opioid litigation is incorrigibly tainted and tort litigation the improper avenue to address mass torts such as the opioid crisis?

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The Opioid Crisis Requires Evidence-Based Solutions, Part II: How the President’s Commission on Combating Drug Addiction Ignored Promising Medical Treatments

By Mason Marks

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids kill an estimated 91 Americans each day and are responsible for most drug-related deaths in the US. This public health crisis requires solutions that are supported by science and reason instead of emotion and political ideology. In Part I of this three-part series, I discuss how the President’s Commission on Combating Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In this second part of the series, I explore how the Opioid Commission ignored medical interventions that are used successfully in the U.S. and abroad. In Part III, I will discuss non-medical interventions such as drug checking and safe injection sites. The Commission’s failure to consider these options is likely driven by emotions such as fear and disgust rather than a careful review of scientific evidence.

Medical marijuana is currently accepted in 29 U.S. states and the District of Columbia. It is also permitted in at least 10 countries. However, the Opioid Commission outright rejected calls to consider the use of medical marijuana as an alternative to opioids for managing pain. Prior to the Commission’s first meeting, it solicited input from industry and members of the public on how to address the opioid crisis. In response, it received over 8,000 public comments. According to VICE News, which obtained the documents by submitting a Freedom of Information Act (FOIA) request, most comments were submitted by individuals urging the Commission to “consider medical marijuana as a solution to the opioid epidemic.” A spokesman for the Office of National Drug Control Policy, a body of the Executive Branch that provides administrative support to the Opioid Commission, reports receiving “more than 7,800 public comments relating to marijuana.” Despite these comments, in its final report, the Commission dismissed the notion that marijuana should play a role in treating chronic pain and opioid addiction. Its report cited a recent study from the American Journal of Psychiatry, which concluded that marijuana use was associated with an increased risk of opioid abuse. However, this study relied on data that was collected over twelve years ago. One of its authors, Columbia Medical School Professor Mark Olfson, told CNN that if the data were collected today, they could yield different results.

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The Prescription Drug Abuse and Overdose Crisis: Focus on the Supply Chain

By Scott Burris

There’s so much we still don’t know about the prescription opioid problem. The partial remedies advanced so far reflect this:

  • Prescription Drug Monitoring Programs, which in essence define the problem as doctor-shopping patients;
  • treatment guidelines, which define the problem as doctors without expertise; and
  • crackdowns on “pill-mills,” which see the issue as physician corruption. Each of these diagnoses has an element of truth, but not necessarily enough to make the treatments effective.

One huge part of the problem has gotten far too little attention: the pharmaceutical supply chain where all these drugs start and along which they are distributed. Now, John Coleman, a former DEA officer, has given us a thorough and compelling primer on the supply chain, describing it and showing where the pressure points are for action. He is not happy about what he sees: DEA is overwhelmed, and too secretive with its data;  and the distributors are too interested in profits and far too unwilling to police paying customers. But he also sees room for action and even hope. This article is well worth a read if you are interested in the overdose problem and how to solve it:

Coleman, John J. “The Supply Chain of Medicinal Controlled Substances: Addressing the Achilles Heel of Drug Diversion.” Journal of Pain and Palliative Care Pharmacotherapy 26, no. 3 (2012): 233-50.

P.S. — One of the hopeful signs he sees was Florida’s legislation beefing up state-level monitoring and controls. This takes me back to the successful Wisconsin Cancer Pain Initiative in the 70s and 80s, which articulated the Principle of Balance in drug control and demonstrated that it was possible to have good access to pain medicine and effective control. In those days, David Joranson, the state drug controller, worked closely with DEA, using state regulatory authority to shut down docs and pharmacies who were acting outside the law. The possibility of history repeating itself is a ray of sunlight in the cloudy skies of this issue. (If you are interested in the story, here’s one place to start: Joranson, D., and J. L. Dahl. “Achieving Balance in Drug Policy: The Wisconsin Model.” In Advances in Pain Research and Therapy, edited by CS Hill Jr. and WS Fields. 197-204. New York: Raven Press, 1989.)