For, for as long as the federal government has worked to support drug treatment, it has operated on a simple principle: The goal of addiction medicine is to help people who use drugs stop completely and forever.
But with more than 100,000 Americans dying each year from drug overdoses, the Biden administration appears to be changing course. In recent years, major federal agencies have quietly but significantly opened the door to addiction treatment that, while still geared toward total elimination of substance use, recognizes that total abstinence may not be not always within reach.
In its public statements, official guidelines, new regulations, and even instructions to pharmaceutical companies on how to develop new drug treatments, the federal government is making it increasingly clear that while abstinence is not not possible, he welcomes a secondary and often similar alternative. significant objective: simply reduce consumption.
“Ideally, you don’t want people to expose themselves to a situation that could lead to overdoses and death,” said Nora Volkow, director of the National Institute on Drug Abuse, calling each case a illicit use of fentanyl is potentially deadly. . “The obvious metaphor is Russian roulette: instead of taking 28 doses of fentanyl a week, you take four – it can still kill you, but the probability is decreasing. So this is just a simple statistical question.
These changes reflect the rapidly changing climate of addiction medicine, in which harm reduction, or practices intended to limit the most acute harms of substance use among active drug users, are increasingly more fashionable.
These policies are consistent with the Biden administration’s unprecedented embrace of harm reduction tactics. But they’re also distinct: Harm reduction often focuses specifically on reducing harm among people who aren’t seeking treatment by offering needle exchanges, drug test strips, or even supervised drug use. In contrast, the new policies explicitly focus on people seeking addiction care in a medical setting. Addiction treatment providers and drug users say the new actions by government agencies simply codify a common-sense concept: Using treatment to significantly reduce drug use can significantly reduce risk, even if drug use A patient’s drug abuse does not stop completely.
“I think the public doesn’t understand how significant a reduction in consumption could be,” said David Frank, a medical sociologist and researcher at NYU. “Just like they may have seen with drinking: the difference between drinking on weekends and drinking every day can be dramatic. The same could be true, perhaps even more so, with illegal drugs. »
In an interview, Brian Hurley, Los Angeles public health officer and president of the American Society of Addiction Medicine, compared historical restrictions on drug treatment — which have sometimes led to exclusion from treatment programs from patients who continued to use drugs – to telling people about drugs. diabetics, they would be taken off treatment if their blood sugar levels increased.
ASAM has also changed its tone in favor of people who have sought help for a substance use disorder but have not completely kicked their illicit drug use, even releasing a draft document clinical orientation to increase engagement and retention levels of patients who have done so. They have not reduced their drug use to zero.
“I’m an addiction psychiatrist and I would like my patients to be completely abstinent,” Hurley said. “But I will absolutely continue to work with people to make progress, and progress will be different for different people. This might involve working with people who say, “I’ll stop using this drug, but not that drug.” This could actually be very useful and save your life. We can work on this together.
Several federal agencies that oversee drug treatment have also proposed new policies since President Biden took office in 2021, which signal a new willingness to support modes of drug treatment that significantly reduce drug use without eliminate it completely.
A project funded by NIDA studytouted by the agency in January, focused specifically on the transition from “high use” to “low use” of methamphetamine, and found that a reduction in use was associated with lower levels of craving and depression.
In December, the Substance Abuse and Mental Health Services Administration issued a notice regarding lower barrier care in an effort to “meet people where they are.” Separately, he recently completed a sweeping reform of the regulations governing methadone clinics, which recognizes in many cases that patients will not achieve total abstinence, especially not right away.
In its new guidance, the agency warns against the “punitive” use of positive drug test results – in other words, punishing patients who are not yet sober – and Yngvild Olsen, a senior SAMHSA official, called for a “culture change” in the country’s methadone clinics.
Another federal agency, the Centers for Medicare and Medicaid Services, has approved numerous waivers for state programs to offer emergency management services — essentially, paying people to stop using meth or drugs. cocaine. In many cases, programs are structured around negative stimulant tests, that is, total abstinence from these drugs. But the largest such program, California’s, makes clear that it does not penalize people who continue to use other drugs. Under the program’s rules, a patient who previously used fentanyl and methamphetamine would continue to receive rewards if they stopped using meth but continued to use fentanyl.
Perhaps most notably, the Food and Drug Administration issued guidance last year indicating that pharmaceutical companies working on methamphetamine and cocaine addiction treatments could submit trial data on criteria other than total abstinence.
“We have previously indicated that a prolonged period of negative urine toxicology results, indicating abstinence, may be a valid surrogate for clinical benefit,” the agency wrote in its guidance. “However, the FDA has not and has not indicated that the only appropriate endpoint based on urine toxicology results is the number of subjects achieving complete abstinence.”
The agency noted that it was often “impractical” to accurately measure the number of uses per day or quantity used. Instead, the agency suggested potentially measuring the number of days an individual is off in a given period as a surrogate criterion for whether a drug treatment is working.
Although technical, the changes represent a significant departure from the FDA’s typical position of using abstinence as the primary, or sole, criterion used to evaluate drug addiction medications.
The overall changes in the federal government, Hurley said, are not just symbolic.
“I think they are substantial, but they are only effective to the extent that they are operationalized on the ground,” Hurley said. In some cases, he cautioned, federal policy changes might not translate into changes in the patient experience, citing SAMHSA’s methadone clinic reforms — and the skepticism that supports that state-level regulators and individual clinics will modify their practices to exercise the flexibilities that the federal government has put in place. the regulations now offer it.
Likewise, Volkow, the NIDA director, acknowledged that the federal government has evolved — but said the changes haven’t gone far enough.
“There have been incredible changes, and the Covid pandemic, which has been one of the positives – it has changed the very restrictive ways in which we were allowed to treat people with a dementia-related disorder. opioid use,” she said.
But in some cases, like that of the FDA, she has expressed skepticism.
“I’m grateful that they’re trying to make an effort,” she said. “They say they would consider other solutions, but it’s very clear that the primary outcome – and the primary outcome is the one that’s necessary to get approval – is abstinence.”
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