I visited my first needle exchange program in 2001 as a teenager in New Jersey, early in my sophomore year at Princeton University. Having just returned from a summer placement in West Africa with a nongovernmental organization attempting to stem the spread of HIV, I was shocked to learn that the state had one of the highest rates of pediatric cases of HIV transmission in the country. A wealthy, educated state, home to internationally known pharmaceutical companies, universities, and medical centers, and yet our outcomes were abysmal in this regard. Why?
It was a fascinating question. A driving force was that New Jersey, like many Northeastern states, had passed laws to limit access to syringes during the 1970s heroin epidemic thinking they would reduce drug use and related harms. Instead, as is often the case with well-intentioned drug abuse policies, they backfired, leading to the overuse and clandestine sharing of drug equipment that expediently spread disease. And women heroin users, who at the time often injected drugs with the men closest to them in their lives, tragically passed it to their newborns.
The answer to the infectious disease question wasn’t about a virus; it was about drug control policies. The more I realized how our natural intuitions and impulses lead us astray with regard to drug control policies, the more fixated I became on our nation’s failed drug war. Drug war policies haven’t only been disastrous for infectious disease over the past three generations; they have also failed our nation’s communities in endless other ways: housing equality, education outcomes, income inequality, the decimation of the social fabric of urban communities of color…it is a long list. I went through a crash course of drug war history and policy in 2001, and it ultimately re-routed my medical career away from infectious disease and toward addiction. Of note, in 2001 there were less than 10,000 opioid-involved overdose deaths nationwide.
A few years later I graduated from college and deferred medical school for a year on a fellowship to study the drug war, to travel across the country and meet with patients, advocates, and policy makers. George W. Bush had just been elected president. The White House pushed to ban the use of the term “harm reduction”—which refers to a combination of principles and services to reduce harms from drug use—in federal grants. Such subterfuge pales in comparison to the anti-science stance of the recent Trump administration, but at the time the censorious intrusion into federal funding for research and academia was alarming and made headlines. In some ways it was an extension of the Reagan era “Just Say No” campaigns, well-meaning but ineffectual (and even potentially harmful). This era was an exemplar of Congress’ refusal to allow federal funds to be used for needle exchange, which still persists for the most part.
Twenty years later, we have just witnessed a historically high annual mortality rate of 100,000 dead from drug overdoses, mostly opioids, and it’s likely an undercount. In what seems to be a sea change, the current Biden administration is now touting harm reduction as one of four key pillars for responding to the opioid crisis. Key harm reduction strategies and lessons learned from around the world typically center on needle exchange programs, naloxone distribution and overdose education, drug testing kits, and supervised consumption facilities where drugs can be consumed more safely. These programs promote health and also often serve as a conduit for eventually shepherding many users into professional addiction treatment.
Are we now in a different era of compassionate, rational policies? Will it work? Many signs point to no. While the Centers for Disease Control and Prevention and the media fixedly track overdose death counts, a bigger reality is that opioid-related overdose events only lead to death around 10 percent of the time—meaning that for every 100,000 dead, there are more than a million overdoses a year. We cannot naloxone our way out of this situation. We cannot supervise the consumption of this many drugs. I remain a devout supporter of needle exchange programs because the beneficial evidence for reducing the spread of infectious disease is voluminous. And there is no credible evidence these programs promote more drug use among active users or entice new initiates to drug use. But access to safe injection equipment is not treatment. To save lives, we need to scale access to treatment. There are four to six million people who need treatment in the US, and all major federal and international agencies agree that effective treatment for opioid use disorder is medication-based (that is, methadone, buprenorphine, or xr-naltrexone). But individuals with opioid use disorder today are more likely to get help from a drug dealer than a doctor. This is not a situation we want to perpetuate.
When confusing things happen, there is a well-known maxim to help explain what is going on: Follow the money. No one is financially benefiting directly from the death of opioid users. Yet, at the same time, we have entrenched fixed interests, trade guilds, burdensome regulations, entrepreneurial charlatans, and, of greatest concern, historical inertia, which stymie efforts to close the addiction treatment gap. And of course there is also stigma. The confluence of these monied interests has thwarted long overdue regulatory reforms to address the opioid crisis. How do we get out of this?
Money speaks, but facts still matter. Every day a patient with opioid addiction (“opioid use disorder” per current diagnostic nomenclature) is on a Food and Drug Administration (FDA)-approved medication such as methadone or buprenorphine, his or her risk of death drops by about 70 percent. This is a larger effect size for reducing opioid-related mortality than any other intervention. Opioid use disorder is one of the deadliest diagnoses a person can receive because not only can annual death rates exceed 2 percent, but mortality occurs at such young ages, often in the 20s and 30s. A basic simulation that I ran suggests that five million people with opioid use disorder on medication treatment for an entire year will experience approximately 70,000 fewer deaths than five million people who go without medication-based treatment. The way to win is therefore to design a functional treatment system that can scale access to medication initiation and successful adherence and retention beyond just a few weeks or months.
The nation’s effective response to the AIDS epidemic was driven by regulatory reform, not just spending. As nightmarish as the COVID-19 pandemic has been, it has been constrained in the US by sweeping regulatory reform, not just spending. However, our nation’s response to the opioid crisis has largely been limited to marginal increases in spending for the same failed policies and mediocre treatment programs. Whether receiving free, grant-funded treatment or paying $50,000 a month in Malibu, the modal addiction treatment patient is more often provided with group attendance requirements and drug testing demands than evidence-based medication.
To effectively scale lifesaving treatment for opioid use disorder, we need regulatory reform that addresses three key domains: access, cost, and culture.
Access: Clinicians Should Win Before Dealers
The reason individuals with opioid use disorder are more likely to get help from their drug dealer than a licensed clinician is because drug dealers are ubiquitous, can be texted 24/7, discretely come to any location the customer desires, and they smile. We need to beat them at their own game. Opioid users need 24/7 immediate access to lifesaving medication that comes to them, with a smile. There have historically been hundreds of regulations preempting this possibility. Most of them have been temporarily suspended under the COVID-19 public health emergency. In this case, answers to the drug problem could be because of a virus.
One of the most perilous possibilities we now face as a nation is allowing all of these regulations to revert to their pre-COVID-19 status. Most notably, we should make permanent allowances for telehealth including for remote initial visits, including audio-only communication when video is unavailable, emergency medical licensure for clinicians, practice across state lines, mail-order delivery of medication, extended take-homes for sufficiently stable patients at methadone programs (that is, to be allowed to take home 14–28 doses of medication at a time and return weeks later, rather than daily), and reduced requirements for group attendance and in-person drug testing, neither of which have shown to reduce mortality among this population beyond medication adherence alone.
Going further, we need to create new platforms for treatment. Before COVID-19, many methadone patients drove for several hours each week to attend morning clinic daily, especially in rural areas, spending more on gas than treatment. But 90 percent of Americans live within five miles of a community pharmacy. Leveraging local access to state-licensed facilities such as pharmacies and health clinics will greatly expand access to methadone, long known to have the highest retention rates among medication options. Walk-in injection clinics for long-acting preparations of buprenorphine (or xr-naltrexone) could also be built out of these locations. Without COVID-19 for the past two years, we likely would have been hearing much more about new FDA-approved injectable buprenorphine depot products (for example, Sublocade, Probuphine, and likely soon, Brixadi) that, as long-acting formulations, offer tremendous promise to improve medication adherence. Putting dealers out of business can be accomplished by sturdy health systems, not just law enforcement.
Cost: Make Treatment More Affordable Than Drugs
Accessibility of medication and services is insufficient if patients cannot sustainably afford the cost. In response to the AIDS epidemic, new regulations allowed for the creation of AIDS Drug Assistance Programs (ADAP) in every state, providing voucher-based payments for antiretrovirals. Additionally, entitlement funding through the Ryan White Act, first passed in 1990, created dozens of innovative programs to subsidize treatment. In response to COVID-19, virtually all Americans have had access to free testing and free vaccines. Yet, patients with opioid use disorder, literally at risk of immediate death every day they go without medication, face endless insurance hassles, preferred drug lists, prior authorizations, and out-of-pocket costs that complicate easy access to medication, especially long-acting injectable formulations that can exceed $1,000–$2,000 per dose.
Creating voucher-based payments for the uninsured, enforcing mental health parity laws (for example, that insurers must cover behavioral health conditions to the same extent as general medical conditions), expanding bundled payments for wraparound services (that is, rather than fee-for-service reimbursement for medical services only), and eliminating lifetime caps on treatment access are critical to removing financial barriers to medication initiation and retention. Furthermore, public dollars and insurance reimbursement should be withheld from treatment programs that disallow, or fail to routinely help patients receive, evidence-based medication.
Culture: Just Say Yes
When I was in medical school in the 2000s, many students shied away from learning about addiction, believing it was outside the realm of medical practice. The stigma against drug use and patients often extends to stigma against providers who work in the field as well. Now that I regularly teach medical students, I ask by a show of hands who in the room has been to a funeral of a friend or former classmate who has died from an overdose. Virtually everyone raises a hand. They stay late after class to ask me questions. There is a palpable energy in the room that the students want to know how to help.
In recent years, I have supervised residents who have lost siblings, and I have lost former supervisors from my own training, to overdose death. With more than 800,000 dead from overdose deaths since 2001, every family in this country has a story. Our nation can embrace drug users without promoting drug use. We can distribute sterile syringes and naloxone kits to someone knowing that, for now, he isn’t ready to stop using. We can allow patients to stay on medication-based treatment even while they may still struggle with ongoing drug use. We can orient systems of care around long-term retention, even when it challenges our comfort levels.
For generations, many good intentions, tough love approaches, and religious convictions have overshadowed evidence-based practice regarding addiction treatment in ways that do not happen in other areas of modern medicine. As with any other field, clinical trainees should didactically learn best practices for addiction prevention, treatment, and recovery in a rigorous way and have hands-on supervised practice before they graduate and become licensed practitioners. Such a cultural shift, if successful, will require a generation of leadership in academic medical centers, health systems, and legislatures, but if we were all just taught how to say “No,” we should be able to teach “Yes” going forward.
More than 20 years into the opioid crisis—despite spending initiatives, national headlines, and mounting political pressure—we have the worst results on record. It’s time to change the rules of the game.
The author receives consulting fees and equity from Ophelia Health, Inc., a telehealth company for the treatment of opioid use disorder. He also receives research funding and consulting fees from the National Institute on Drug Abuse, the Substance Abuse and Mental Health Services Administration, and the National Quality Forum.