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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Stacks of books against a burgundy wall

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 relevant to current or potential future work.

Below are the abstracts/summaries for papers identified from the month of March. The selections feature topics ranging from the utilization and cost of naloxone for patients at high risk of opioid overdose, to off-label and compassionate drug use in the COVID-19 pandemic, to public-sector financial support and sponsorship for gene therapy trials in the U.S. A full posting of abstracts/summaries of these articles may be found on our website.

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Another Legislative Win for Opioid Death Prevention

By Scott Burris

The rising public and legislative awareness of opioid overdose has been a case study in the twists and turns of culture, risk perception and the role of evidence in policy making. An interesting case study, which does not mean I understand what happened or why.

I first got involved in overdose through Dan Abrahamson, the Legal Director at the Drug Policy Alliance. This was back in 1999 or 2000, and a group of drug researchers and drug policy people convened a meeting in Seattle to discuss the chronic, neglected problem of overdose among heroin users.  There were a few health people who were highly aware of the human and economic costs, and the scale of the problem. Karl Sporer, a San Francisco ER doc, was one of the few publishing on the problem. One of the interesting ideas discussed at the meeting was distributing naloxone, the standard antidote for opioid overdose, directly to heroin users. New Mexico, which had the nation’s highest OD death rates, was trying it as a way to deal with the great distances that divided rural heroin users from EMS assistance. With Joanna Norland and Brian Edlin, I ended up writing an analysis of the legality of distributing this prescription drug to drug users.

In the next few years, led by people like Dan Bigg of the Chicago Recovery Alliance, needle exchange programs in urban areas began naloxone programs. They were spurred in 2006 when several US cities experienced an epidemic of overdose tied to the adulteration of the heroin supply with a synthetic opioid, fentanyl. By May, 2009, 57 naloxone programs were operating in 17 U.S. states.  That year, DPA funded a group of scientists and practitioners to brainstorm on how to increase drug users’ access to this life-saving intervention.  Read More

Researchers to Lawmakers: Naloxone Distribution to Prevent Overdose Death is Cost-Effective

By Scott Burris

Phil Coffin and Sean Sullivan have published a cost-effectiveness study of interventions that equip heroin users and others to administer naloxone in the event of a witnessed opioid overdose.  Naloxone is the standard antidote, and can easily be administered by lay people with a minimum amount of training.  Family members and friends of opioid users can quickly get the drug into an overdosing user via injection or a nasal spray. In an accompanying editorial, top brass at NIDA and FDA sum up the news like this: the study

“represents a significant step in the evolution of the science in this area: a detailed analysis of the cost-effectiveness of overdose intervention with naloxone administration for heroin abusers. The authors suggest that lay naloxone administration is likely to be highly cost-effective in this setting, a robust finding that holds up under various assumptions. Future analyses that extend their findings to the setting of prescription opioids would be welcome.”

The editorial flags one of the major legal issues that gets in the way of wider naloxone distribution – its status as a prescription drug approved for use by injection. Changing this is a torturous regulatory process. In the short term, though, lawmakers can do a lot to get distribution going where it is needed.  As of July of 2012, eight states had passed laws to clearly authorize or otherwise reduce legal barriers to the prescription of naloxone to drug users and other potential good Samaritans. That leaves 42 states where programs may have trouble operating out of concerns related to prescribing a drug for a lay person to administer. LawAtlas covers the law and has examples of the legislative approaches these states have taken.

One more thing: evidence that naloxone distribution looks to be cost-effective ought to motivate lawmakers to consider these programs.  Many places don’t have them at all: a study published last year in MMWR reported, among other things, that “Nineteen (76.0%) of the 25 states with 2008 drug overdose death rates higher than the median and nine (69.2%) of the 13 states in the highest quartile did not have a community-based opioid overdose prevention program that distributed naloxone.”  In others, programs are operating but with little or no public funding to purchase naloxone, whose price has been rising precipitously (that’s another story about our creaking system for producing essential medicines).