WASHINGTON — Eighteen state public health directors, a growing group of physicians, and a prominent member of Congress are pushing a dramatic expansion of substance use treatment by posing a simple question: Why can’t doctors who prescribe opioids also prescribe drugs to treat opioid addiction?
Their push to deregulate use of buprenorphine, which is used to lessen opioid cravings and withdrawal symptoms, would represent a fundamental shift in U.S. addiction treatment. The medication — and addiction medicine in general — are highly regulated, largely due to fears that opioid-based treatment drugs like buprenorphine and methadone could be misused.
This week, the effort will gain support from Washington: Rep. Paul Tonko (D-N.Y.) will soon introduce legislation to allow any medical practitioner licensed to prescribe controlled substances to prescribe buprenorphine, he told STAT. Currently, physicians must undergo an eight-hour training to prescribe the drug — 24 hours for nurse practitioners and physician assistants.
“These professionals can use their training and skill and ability to provide medication for treatment of pain,” Tonko said in an interview. “But when it comes to addressing the illness of addiction, they have to jump through additional hoops.”
The bill, Tonko said, “removes unnecessary obstacles and really expands the access we’ve created to provide for treatment on demand.”
Tonko’s push — though in its early stages — gives formal backing to an effort by treatment advocates who have long argued the federal government’s response to a crisis claiming 50,000 lives each year has been irresponsibly slow and at times counterproductive.
This month, top health officials in 18 states, three U.S. territories, and the District of Columbia wrote health secretary Alex Azar urging him to relax restrictions on the addiction medication.
Deregulating buprenorphine would make it far easier for Americans to get addiction care from their own doctors instead of being pushed through bureaucratic hoops and into treatment programs of varying quality, said Dr. Andrew Kolodny, the co-director of the Brandeis University Opioid Policy Research Collaborative. Currently, just 1 in 20 doctors have obtained the license necessary to prescribe it.
“For your average person who is opioid-addicted, who may have a relationship with their primary care doctor who they know and trust,” Kolodny said, “there’s a 95% chance that doctor is going to have to say: Well, let’s find a place to send you.”
The movement, however, appears to lack institutional support from major addiction medicine groups, including the American Society of Addiction Medicine. The National Council for Behavioral Health, which represents mental health and addiction providers, has no position on the proposal.
Opponents of deregulating addiction medicine say it could encourage more people to use buprenorphine illegally. In recent years, the Drug Enforcement Administration has raided the offices of numerous physicians who prescribe buprenorphine, including a leading addiction doctor in Tennessee and the past president of the American Society of Addiction Medicine, to investigate whether the high-volume treatment facilities had effectively become “pill mills.”
Those raids have come in spite of the DEA’s own acknowledgment that most diversion — or illegal sales and misuse — of buprenorphine is effectively a means of obtaining addiction-treatment drugs. Most illegal use stems from “the failure to access legitimate addiction treatment,” the agency wrote in a 2016 report, and could be curtailed by expanding legal access to the drug.
To assuage concerns of drug misuse, advocates have pointed to France’s approach in the mid-1990s, when buprenorphine was first approved for use there. With no limits on who could prescribe the drug, overdose deaths fell by nearly 80 percent between 1994 and 2002. The successes were credited in large part to aggressive buprenorphine prescribing, though the country did contend with some buprenorphine trafficking and illegal sales.
The prevalence of HIV, which is often associated with injection drug use, also dropped from one-quarter of all injection drug users to just 6% by 2010.
American advocates say their objectives are largely the same: to mainstream addiction treatment and allow patients to obtain medication from their own doctor instead of a convoluted referral process.
Patients who use nonprescribed buprenorphine could even be more likely to succeed in treatment, said Dr. Sarah Wakeman, an addiction medicine specialist at Massachusetts General Hospital.
“The vast majority of patients now that I start on buprenorphine have tried it before on the street, mostly as a means of addiction treatment,” she said, pointing to research that suggests better outcomes for patients who had tried buprenorphine in nonclinical settings (and therefore obtained it illegally).
But arguing that diversion of a controlled substance can yield positive public health outcomes, Wakeman acknowledged, can prove politically tricky.
“We want people to be getting medication from health care providers,” she said. “The question with buprenorphine diversion is how you best reduce its nonprescribed use — and the answer is probably expanding access to treatment.”
Others have questioned whether physicians prescribing the drug without training could increase rates of patient harm, particularly if some started to take dangerous combinations of opioid-based drugs and anxiety medicines or alcohol. Prescriptions for treatment drugs, they also argue, should be coupled with services like psychosocial counseling.
“I’m not saying to you, let people die rather than let them get access,” said Mark Parrino, a longtime advocate and president of the American Association for the Treatment of Opioid Dependence, a group representing providers of methadone, an addiction-treatment and pain drug regulated even more tightly than buprenorphine. “My view is, if they get access, make sure you’re building in systemic responses that they will at some point get more than the medication.”
The division between groups like ASAM and a newer wave of addiction doctors like Wakeman has led to fears that the buprenorphine-expansion effort could resurface long-simmering tensions between providers of the few treatment drugs.
Recently, the Massachusetts drug maker Alkermes has aggressively marketed its addiction-treatment medication Vivitrol — which is not an opioid — as a “non-addictive” medication, attempting to draw a contrast with its two competitor, opioid-based medications.
And in the early 2000s, when buprenorphine was first approved, some treatment advocates, including AATOD and other methadone providers, lobbied to keep buprenorphine tightly restricted. Initially, physicians waivered to prescribe the drug could only treat 30 patients — a cap later relaxed to 100, then 275.
Tim Condon, who worked as the associate director for science policy at the National Institute on Drug Abuse, said it took substantial advocacy to prevent the DEA from classifying buprenorphine as a Schedule II drug, which would have prevented doctors from prescribing it in office-based settings.
But the limited risk associated with buprenorphine, some experts argue, does not justify an aggressive law-enforcement response or maintaining tighter regulations than for potentially addictive pain drugs.
“There are two things we should worry about,” Kolodny said. “Whether a diverted opioid is going to increase the incidence of opioid addiction, and whether or not the diverted opioid is killing people. And in the case of buprenorphine, the answer for both is no.”