Last week, President Barack Obama announced that he will seek just over $1 billion to fight opioid addiction, the majority targeted at expanding treatment. But he didn't take the one step that could immediately reduce the record-high overdose death rate: easing access to medication-assisted treatment (MAT) with methadone and buprenorphine by reducing onerous regulations.
Although the administration has been considering action for at least several years, it hasn't lifted the cap that stops doctors from prescribing buprenorphine to more than 30 patients in their first year and 100 after that. When asked by VICE on Twitter when this might happen, "Drug Czar" Michael Botticelli replied that the department of Health and Human Services (HHS) "is working on proposed regulations."
In September, the Obama administration asked all relevant federal agencies to identify barriers to expanding MAT—as well as ways to overcome them. Those answers have been submitted but not yet acted on, according to Botticelli and HHS Secretary Sylvia Burwell, who were asked about the status of change during a tele-conference on Tuesday.
This is not how an effective government responds to a deadly epidemic.
If a virus were killing people in the prime of their lives at a rate of nearly 29,000 per year—and there were drugs known to cut that death rate by half or more—those medications would quickly be made available. Regulation that stood in the way would be suspended. But because so many powerful people view "drugs to fight drugs" as suspect, thousands are needlessly dying. And while there are tremendous barriers to change, including an addiction-treatment industry that has historically resisted the use of medication, the US has actually previously scaled up MAT for addiction quite rapidly—twice.
Which makes it all the more disappointing that we're getting it so wrong this time.
For one, we are letting the best be the enemy of the good. While it would be ideal to provide medication-assisted treatment along with high-quality counseling services, most research finds little added benefit from them. And it is typically the provision of those services—not medication dispensing—that prevents rapid expansion of care. Unfortunately, for years doctors have been warned away from prescribing MAT without counseling, and they rightly fear doing so might provoke unwanted attention from the Drug Enforcement Agency. But at this point, that's exactly what we need.
After all, the vast majority of the benefit from medication-assisted treatment—especially in reducing overdose death risk—is simply pharmacology. By maintaining tolerance, both buprenorphine and methadone make it much harder for people who relapse to overdose. And since the overwhelming majority of opioid-addicted people relapse at least once, simply maintaining tolerance is life-saving, even if the person does nothing more than show up and take the drug. Without MAT, the annual death rate from opioid addiction is 2–3 percent. MAT can cut that in half—even when people continue to use drugs.
"The preponderance of the evidence is that there is no basis for concluding that ancillary services are essential," explains Dr. Robert Newman, president emeritus of Beth Israel Medical Center in New York and former assistant health commissioner for New York City. Newman helped create New York's methadone treatment system in the 1970s— the first in the world—and also helped expand it at the height of the AIDS crisis.
In just two years in the 70s, in fact, New York City went from 0 to 10,000 methadone patients—and that was full-service programs, not just medication, Newman recalls. In the 90s, prescribing was again rapidly expanded to thousands of new patients, in this case, without increasing other services. According to Newman, this resulted in saved lives, reduced HIV infection, and lower crime rates—not large scale re-sale of maintenance drugs, which is one reason supporters of strict regulation give for requiring counseling and urine testing. But in fact, those restrictions fuel the street market rather than curbing it.
Jeff Deeney, a social worker in Philadelphia for an agency that has a lengthy waiting list for MAT due to the prescribing cap, describes an elderly client who does not look like he recently served nine years in prison for bank robbery. No weapon was involved in the crime, committed in desperation to seek drugs, Deeney says. And a simple dose of buprenorphine, the client claimed, would have prevented the whole thing.
"If you want to wipe out the black market [for buprenorphine], just put up a dispensing machine," Deeney argues.
Newman adds that we shouldn't consider whether MAT with or without added services is better—but rather whether medication alone is better than no treatment. He describes how, in the 1990s, when half of IV drug users in New York were already HIV positive, he could only get permission to expand meds without counseling as a research project. And that research—and other studies since—showed that just providing methadone reduces HIV risk, cuts crime, and even helps a significant minority stabilize their lives and cease illegal drug use, on its own. Indeed, in Russia, where methadone is actually illegal, a new study suggests that it still reduces HIV risk because it lasts so long that people take fewer shots.
At this point, you might wonder if I'm basically advocating legalized pill mills. The answer is no, because safe dispensing requires oversight and good record-keeping to ensure patients get appropriate doses and are properly identified to prevent "doctor shopping." But to stop the overdose crisis quickly, we do need to expand bare bones prescribing by lifting the buprenorphine cap and deregulating methadone.
"I'm not even sure, other than stigma, why the cap is even there," says Leo Beletsky, associate professor of law and health sciences at Northeastern University. He argues no other area of medicine faces the restrictions that addiction treatment does.
Ironically, physicians can legally prescribe opioids for pain to as many patients as they want—but if the same prescription is officially written for addiction, tight regulations apply. Also, like the rest of the public, some doctors still stigmatize addicts, regarding them as inherently dishonest, even though research does not support this. By itself, of course, deregulation can't banish this deeply engrained stigma. But it will immediately give access to hundreds—perhaps even thousands—of people on existing waiting lists. And it will signal to doctors that addiction isn't just something that affects "those people"—and that they have at hand medicines they could and should be using to sustain life.
Newman suggests some creative ways to boost prescriptions. For one, hospitals could be required to offer maintenance programs as a condition of Medicare funding, which would remove the "NIMBY" problem that often stymies and delays the location of treatment centers. Emergency rooms could also be permitted to give maintenance doses of methadone or buprenorphine to people suffering from withdrawal—thereby both removing an incentive for drug seekers to fake pain and offering a first step to get people into more traditional treatment. In fact, a legislator in Maryland has just proposed a set of new laws that would require ERs to provide treatment.
This is the kind of innovative thinking we need: not more hand-wringing and fiddling with rules while people die. Conservatives often raise concerns about how regulation can harm, and the buprenorphine cap and the methadone clinic regulations are exactly the kind of expensive red tape that should have been cut long ago.
By Maia Szalavitz - Vice/Feb. 8, 2016