A History of Medication-Assisted Treatment
SHREVEPORT, LOUISIANA, a town founded on an old Caddo Indian settlement on the Red River, had a population of sixteen thousand in 1900. After prospectors discovered crude oil in the area, the Standard Oil Company established a local oil pipeline, causing an employment boom and the city’s population to nearly triple during World War I. By 1919, Shreveport supported a symphony orchestra, two colleges, five banks, a state hospital, a federal courthouse, and radio station KWKH, the first in the nation to play phonographic records over the air. Not bad for a city of forty-four thousand people. Through jobs in the oil industry, the population had more money than did neighboring communities.33
As was common in America following the Civil War, physicians in Shreveport during the early 1900s widely prescribed morphine to treat a variety of conditions, ranging from pain from a serious injury to menstrual cramps. Shreveport residents tolerated opioid use, even though it was already known to cause addiction. Given frequent morphine prescription for medical ailments, many of Shreveport’s residents developed an opioid addiction. These residents came from a variety of professional, economic, and racial backgrounds. Based on records discovered in the 1970s, people with addiction included housewives, politicians, day laborers, waiters, and pretty much every other type of professional common during that time. In an era of zealous Prohibition sentiments, most people with addiction kept their status hidden from their families and friends, with one interesting exception: many revealed their addiction to the family physician.33
Few Americans today feel confident having a frank discussion about addiction with their physician, so the patient-physician relationship of the early 1900s may seem surprising. Yet between the Civil War and 1914, physicians routinely prescribed maintenance doses of morphine to people with an addiction to ward off withdrawal symptoms and cravings, allowing people to function in their daily lives. Most maintenance prescribing occurred in private physicians’ offices, but some cities, including Jacksonville, Florida, and New York City, had federally funded morphine maintenance clinics. Morphine maintenance was so common that in 1919 the US Supreme Court heard a case on exactly that topic.33
In Webb v. United States, Dr. Webb, a physician from Shreveport, appealed his conviction of violating the Harrison Narcotics Tax Act of 1914.34 The Harrison Act, which regulated opioids and other narcotics, was largely a response to anti-immigrant hysteria because Chinese immigrants were stereotyped as smokers of opium. The Harrison Act was one of the first times the federal government regulated the physician-patient relationship. According to the text of the law, a physician could dispense opioids only “during the course of his professional practice.” Like many other physicians of his era, Dr. Webb had interpreted the Harrison Act to allow morphine maintenance. After all, it was part of his professional medical practice. Unfortunately for Dr. Webb, the Supreme Court disagreed in a five to four vote. The justices argued that morphine maintenance was not a legitimate medical practice, thereby implying that addiction was not a legitimate medical condition. Therefore, any physician prescribing morphine to a known addict was violating the Harrison Act, resulting in a criminal offense.
In 1922, the Supreme Court went even further, stating that no physician could prescribe opioids for any purpose to people with known opioid addiction; eventually, the latter case would be reversed, but by then the harm was already done. Morphine maintenance all but ceased across the country. According to historian William White, “If one were to inquire why the modern physician is so ambivalent about the addicted patient, one would only have to look at the history of 20th century medicine.”35 It was not until the 1970s that the US federal government re-permitted opioid maintenance, albeit in a highly restricted manner within methadone clinics.
Even before the Webb case, agents of the Federal Bureau of Narcotics (FBN), a predecessor to today’s Drug Enforcement Administration, preemptively interpreted the Harrison Act as banning morphine maintenance. They were busy arresting physicians, often by using informants with opioid addiction to entrap physicians in exchange for freedom. The FBN justified its actions based on the failures of one poorly run maintenance clinic: the New York City maintenance clinic. With far too high a patient-to-physician ratio, limited patient oversight, and an unreasonably high dosage of morphine prescribed, this clinic became the poster child for the supposed dangers of morphine maintenance.33
In Louisiana, despite the Supreme Court’s interpretation of the Harrison Act, the state Board of Health voted to allow Shreveport to open a morphine maintenance clinic. The board feared that an arbitrary end to the practice would cause a surge in addiction-related social problems, from unemployment to petty theft. By designating one physician to control prescriptions and by limiting dispensing to one drugstore, the board believed it could exert enough control to placate federal agents.33
Dr. Willis P. Butler was chosen to run this clinic. A soft-spoken, strong-willed Louisiana native, Dr. Butler was one of Shreveport’s most respected residents. After working as a druggist’s assistant, supporting himself through medical school, and serving as a country physician, he began an illustrious career, including serving in political positions for forty-eight years.33
Despite the general cultural animosity toward people with addiction, Shreveport’s maintenance clinic was widely lauded by the community. Dr. Butler was clearly not a quack, nor was he in it for the money since the clinic primarily provided free treatment supported by state funds. Even the sheriff and local judges believed the clinic decreased drug-related criminal behavior, making their jobs easier. Local physicians likewise appreciated the opportunity to outsource addiction care while continuing to see those same patients for other diseases. Decades later, the nonprofit Drug Abuse Council examined the clinic’s medical records and concluded, “These addicts were able to live, work, and lead quite normal and productive lives while being maintained.”33
By the end of the clinic’s first year, 460 Shreveport residents had received maintenance morphine, though this number is probably an underestimate since the clinic did not record transient people. Dr. Butler’s clinic also treated venereal diseases, such as syphilis. Importantly, if politics surrounding maintenance were to become dicey, the state would continue paying staff to treat venereal diseases while the staff unofficially managed addiction. The clinic also offered an early form of case management, helping patients find employment, for example.33
Local newspapers praised Dr. Butler’s clinic. In response to fears that federal agents would shut the clinic down, in 1920 the Shreveport Journal published an editorial supporting the clinic’s continuation. In the meantime, major reorganization was taking place in the Federal Bureau of Narcotics, with Prohibition zealots redirecting federal drug policy toward an “abstinence only” policy.33
Depending on whom you talked to in the bureau, addiction was one of two things: a moral and criminal failing requiring punishment or a disease requiring a cure through detoxification followed by education and recuperation. The FBN saw morphine maintenance as neither punishment nor cure, and thus as ineffective and dangerous. In contrast, Dr. Butler and other physicians firmly believed that addiction was a disease and that some people with addiction would never be “cured.” His staff would assess whether patients were “curable” or “incurable.” Curable patients, the majority in Shreveport, were sent to detoxification in an associated hospital followed by rehabilitation. Incurable patients were provided with daily maintenance doses of morphine, enough to keep them functional while controlling cravings and withdrawal without causing a high. As might be expected, the FBN had few problems with detoxification but battled the maintenance clinic at every turn. Within a few years, they succeeded in shutting the clinic down, leaving many people with opioid addiction no effective options.33
The bureau thought curbing the opioid supply would halt addiction; instead, it merely increased crime. According to David Musto, who served as drug policy advisor to President Jimmy Carter, the closing of early-twentieth-century maintenance clinics like Shreveport’s caused opioid prices in the illicit market to immediately spike by as much as 50 percent across the country, contributing to a thriving black market.36 One would have expected policy makers at the time to take notice, but decades passed until opioid maintenance was seriously discussed at the national level.
FROM THE HARRISON ACT in 1914 through the early 1960s, policy makers viewed opioid addiction almost entirely through a criminal lens with a goal of decreasing the supply of drugs rather than decreasing the demand for drugs. The chief public health villain of the time was Henry Anslinger, a bald-headed master of propaganda and commissioner of the Federal Bureau of Narcotics. Anslinger was responsible for perceptions of “reefer madness,” the supposed psychosis resulting from marijuana use. His propaganda resulted in a serious documentary about marijuana, which is now considered a comedy cult classic due to its unsupported horrific claims, including cannabis-induced murderous rages. Anslinger urged Congress to institute mandatory two-year drug sentences for first-time drug offenses and to make heroin sales to minors punishable by death.35
Even before maintenance clinics had disappeared, Anslinger viewed them as “supply depots” and “barrooms for addicts.” 35 With maintenance clinic closures, people suffering from addiction had few places to turn. Hospitals frequently barred patients considered “immoral,” including people with addiction. Jails and prisons were the primary addiction intake facilities of the time, giving temporary reprieve from active drug use while ostracizing people and converting some into hardcore criminals.
By the late 1920s, federal prisons were asking the federal government to segregate people with addiction, who represented most of the incarcerated population. In response, Congress allocated funds to construct two “narcotic farms,” federally funded treatment centers for prisoners that also accepted voluntary participants from the public. One narcotic farm was based in Fort Worth, Texas; the other was in Lexington, Kentucky. With barred windows and gates, the Lexington facility clearly resembled a prison, except that it housed a library and research laboratories. Unlike most prisons at the time, it also employed physicians, nurses, social workers, and therapists whose collective goal was to treat addiction. Treatment methods consisted of detoxification and convalescence, as well as vocational activities, such as farming, therapy and support groups, and recreational activities. Since it voluntarily accepted patients, the Lexington facility saw many jazz musicians make their way through too, and it earned a reputation around the country as a mecca of jazz since musicians were encouraged to practice for hours during daily treatment.37
Ultimately, 90 percent of the Lexington narcotic farm population relapsed upon release, partly due to no existing follow-up care.35 Nevertheless, research conducted at these narcotic farms proved instrumental in later advances in addiction treatment.
DR. JEROME H. JAFFE was a stereotypical scientist: pale from spending most of his time in the lab and bespectacled in gold-rimmed glasses. He was logical, analytical, and blunt—exactly the type of person you would want directing drug policy. The son of a Jewish Lithuanian immigrant grocer, he had been urged by his father to become a doctor. Instead, Jaffe wanted to become an auto mechanic but had difficulty finding a job. Rather than argue with his parents, he signed up for some premed courses at Temple University and quickly found an interest in psychology. After earning a master’s degree, he realized there were more resources available for people studying medicine than psychology, so he applied for medical school and paid his way through by playing music at weddings.38 During his last semester of medical school, he did some pharmacology research and found it fascinating.
In the early 1960s, after graduating from medical school and serving a brief internship in a Staten Island hospital, Jaffe was accepted into the clinical division of the addiction treatment center at the Lexington narcotic farm, a wing where patients volunteered to participate in addiction research. As a federal prison, the Lexington narcotic farm fulfilled Jaffe’s military obligation to work in public health service. More importantly, it allowed him to be in the same location as one of his idols, Abraham Wikler, a famous scholar of psychiatric medications.39 Jaffe would later describe the narcotic farm as the “center of the world for learning about drug addiction.”
Rather than landing in the research division at the Lexington narcotic farm, however, Jaffe was placed in a clinical position. A pharmacologist at heart, he would have much preferred the research division, but the clinical position gave him an opportunity to see opioid addiction in action, teaching him about concepts such as withdrawal, tolerance, and craving. Fortunately for Jaffe, the clinicians and researchers met regularly during lunch, cross-pollinating ideas about addiction treatment.39
To his knowledge, Jaffe had never met anyone with an opioid addiction, but he found that people with the condition were likeable and not that different from the rest of the people he knew. He also saw the brutality of opioid addiction—how difficult it was to simply “quit” once one had become dependent. Searching for a treatment, he became interested in a medication called methadone.
At the time, scientists knew little about opioid receptors in the brain, but they knew that there was something special about methadone,39 specifically that it prevented withdrawal symptoms and was well-liked by the research subjects.37 Methadone is an opioid with a long half-life, meaning its effects last a long time as it is slowly eliminated from blood plasma, thus preventing the frequent physiological ups and downs associated with shorter-lasting opioids, such as heroin. Jaffe observed that someone using heroin might seek a new dose every few hours to prevent painful withdrawal symptoms and to keep cravings at bay, but someone taking methadone would feel stable the entire day. Over time Jaffe’s faith in methadone as an addiction treatment grew, but he was also convinced that psychological treatment was needed to complement it.35,38,40
Jaffe and other scientists were likely able to study methadone’s effects, despite the federal ban on opioid maintenance treatment, because methadone formed the crux of a research study at a federally funded institution. However, the studies were not without ethical controversy. Even though prisoners had voluntarily provided consent, some prisoners may have incorrectly believed participation would cut time from their sentences.38 But according to Jaffe, it was a different era and the federal regulations of ethics in research that exist today did not exist back then.38 Additionally, a minority of Lexington participants were rewarded for their participation with morphine that they could use to get high on for special occasions and holidays.41 The Lexington narcotic farm eventually closed in the 1970s, when a national network of treatment centers supplanted it.
Jaffe was not the only one exploring methadone’s effects on opioid addiction during the 1960s. In the Upper East Side of Manhattan at Rockefeller University, Vincent P. Dole, a metabolic specialist, and Marie Nyswander, a psychiatrist, were experimenting with methods to stabilize people suffering from opioid addiction. First, the researchers tried regular heroin doses but found that heroin’s short half-life resulted in a fast return of withdrawal symptoms and cravings. Moreover, people quickly grew tolerant of heroin, necessitating higher, potentially life-threatening doses. Overall, patients seemed to grow less stable, not more stable. Next, the researchers tried morphine, but the same pattern developed as with heroin. What they needed was an opioid with a long half-life, thereby preventing the ups and downs of withdrawal and cravings, as well as an opioid that produced minimal tolerance.35,40
Like Jaffe, Dole and Nyswander studied methadone as a potential option. Because their patients already had so much heroin and morphine in their systems, they required high doses of methadone for stabilization. Yet despite the high dose, patients did not grow tolerant of methadone’s effects. Tolerance would have required ever escalating doses. Furthermore, methadone’s side effects were minimal. Most importantly, patients stopped having withdrawal symptoms and cravings long enough for them to function during the day. Like Dr. Butler decades before him, Dole believed that these patients with severe addiction had a chronic, incurable disease. Dole called his treatment method “methadone maintenance.”35,40
Having learned of Dole and Nyswander’s experiments, Jaffe’s confidence in methadone’s potential blossomed. Unlike Dole and Nyswander, however, he did not think that inpatient hospital administration of methadone was necessary. Conducting his own experiment, he wrote methadone prescriptions for his patients on prescription pads in his outpatient office. Patients would get methadone from the local pharmacy and return to his office for medication management, which included dosage adjustments, urine drug screenings, and counseling. This approach allowed Jaffe’s patients to live with their families and to participate in the workforce.42
In 1968, Jaffe opened a pilot program in Chicago called the Illinois Drug Abuse Program (IDAP), essentially a research laboratory sanctioned by the Illinois legislature.38 IDAP consisted of three alternative programs: an outpatient methadone maintenance program that clients attended daily, a brief inpatient detoxification program, and a residential therapeutic community. The therapeutic community was modeled on a program called Daytop, which itself was modeled on a notorious program called Synanon.39
Synanon was a program formed by people who identified as “ex-addicts.” Their leader was Charles Dederich, a man who would at one point attain rock-star status only to fall from public favor as a disgraced “cult” leader. Among other bizarre actions, he armed his therapeutic residential facility, required participants to shave their heads, and mandated sterilization and abortions. Synanon viewed addiction as rooted in immaturity, immorality, and irresponsibility. A rigid lifestyle of privileges and punishments to incentivize proper behavior would supposedly transform the individual into an upstanding citizen. Synanon’s best-known feature was adversarial confrontation, in which participants broke each other down and built each other back up by spewing insults until they were forced to be honest with themselves and the group.43 Unlike Synanon, the therapeutic community in Jaffe’s IDAP program kept confrontation to a minimum. Also in contrast to Synanon, Jaffe’s therapeutic community permitted the use of methadone treatment.38 Though a philosophical battle existed at the time between proponents of therapeutic communities and proponents of methadone treatment, Jaffe felt the modalities could be combined and that people who relapsed following one approach could try the other.38
A researcher at heart, Jaffe hoped to test the effectiveness of IDAP’s three modalities, so he randomly assigned patients to one of the three programs. Of course, patients had their own preferences and sometimes became frustrated with this approach. Nevertheless, IDAP quickly became popular, leading Jaffe to open a second branch serving five hundred people. Eventually even more branches were opened. Knowing that addiction is a chronic, relapsing disease, Jaffe created a special “barebones” unit for patients who had dropped out of the program or had been forced out for behavioral problems but who wanted to try treatment again. A stepping-stone to full participation, the barebones unit acknowledged the relapsing, chronic nature of addiction.39,42 In some ways, it was a precursor to “low-barrier” medication-assisted treatment programs that exist today.
WHEN ANSLINGER RETIRED IN 1964, attitudes in Washington, DC, relaxed somewhat toward drug users. The Supreme Court ruled that being addicted was not illegal, even though illicit drug possession continued to be a criminal offense. The National Institute of Mental Health, an agency predominantly concerned with health matters and filled with psychologists, took over some of the Federal Bureau of Narcotics’ responsibilities. Perhaps most surprisingly, in 1963 a presidential advisory commission recommended a treatment approach rather than a criminal justice approach to the drug problem,42 forming the seeds of a public health slant to drug policy. In retrospect, President Richard Nixon hardly seemed like the man to plant them.
Having grown up in the Anslinger era, Nixon began his presidency with what Michael Massing calls a “reflexive disgust for illegal drugs and the people who used them.”42 Nixon associated drugs with hippies, a population with whom he felt nothing in common. His presidential campaign rhetoric only described a supply-side approach—increasing the number of border control agents and cooperating internationally to halt the drug trade. Nixon was especially obsessed with destroying the “French connection,” a heroin trafficking scheme among Turkey, France, and the United States.
To serve on his domestic policy staff, Nixon chose Jeff Donfeld, who happened to be dating Nixon’s daughter. Donfeld was the opposite of a hippie: sober, affluent, and conservative. In some respects, he was a younger version of Nixon. In the White House, Donfeld worked for a former football coach, Bud Wilkinson, to whom Nixon had assigned drug policy development. Wilkinson’s plan focused on informing Americans that drugs are bad.
Even though Donfeld felt no empathy for drug users, he thought Wilkinson’s scare-tactic educational approach an ineffective solution to a complex problem. So Donfeld began reading research articles about addiction treatment on his own, including articles about methadone. His interest in methadone treatment quickly grew when he read that it was correlated with lower crime and higher employment—two key goals of the Nixon administration.38,42
The nation’s crime rate had doubled, including in Washington, DC, and Nixon wanted to be the president who curbed crime. Local criminal justice initiatives such as reorganizing DC’s courts and hiring additional police officers did not appear to be working, necessitating a new approach.
Nixon tasked his advisor, John Ehrlichman, with finding a solution. Ehrlichman, in turn, looked to his young aide, Egil Krogh, who asked Donfeld for advice. Donfeld described the methadone literature he’d read. Krogh, despite having grown up as a Christian Scientist who abstained from all mind-altering substances, was favorably impressed. To further examine the possibility of methadone as a solution to the crime problem, Krogh contacted Robert DuPont, an addiction treatment expert and psychiatrist who had experience treating addiction with methadone in the DC Department of Corrections.38,42
I recently had the privilege of interviewing DuPont, who said to me, “I believe I’m the only person in the world who has known all seventeen White House drug czars.” Clearly passionate about improving the lives of drug users, DuPont described in fascinating detail the political dynamics of methadone treatment during the Nixon era, a time when some US scholars were arguing for the adoption of the British system with legalized prescription heroin. DuPont’s experience with methadone treatment began in the Department of Corrections, because “I cared about the prisoners and I wanted to help them.”
DuPont invited Krogh to visit the Department of Corrections and to speak with patients on methadone treatment; Krogh listened sympathetically to their experiences. Impressed with DuPont’s program, Krogh helped DuPont obtain funding to open the first DC methadone clinic outside of the criminal justice system. With an air of amusement during our interview, DuPont remarked, “People say Corrections are bad guys! Hey, Corrections is where it started!”
In part, DuPont had garnered Krogh’s attention by emphasizing the link between heroin addiction and crime. In retrospect, the link between heroin addiction and crime seems obvious, but prior to Nixon the federal government tended to see both issues separately. For over a decade, DuPont had desired to develop innovative treatment programs with methadone in the Department of Corrections, but under Lyndon B. Johnson no one was interested. Johnson’s DC Crime Commission report barely even mentioned drugs.
But Nixon’s administration moved the issue of crime to the center of politics. Convinced that treatment was a way to address crime, the Nixon administration enabled DuPont to have the funding he wanted by 1969. Furthermore, Nixon’s White House worked with people from across the political spectrum to address crime. DuPont said, “I was thirty-seven, and they noticed me. I’m a Democrat, but they didn’t care about what party I was in. I didn’t care what party they were in. I was on a mission and they were on a mission.” Describing Krogh, DuPont says, “He was a wonderful guy and had a terrible outcome in his life because he was involved with the plumbers and all that stuff,” referring to Krogh’s later imprisonment for his part in the Watergate scandal.
DuPont obtained federal funding for a citywide methadone program, which almost instantly reached two thousand patients. Even though the White House, the DC mayor, and the DC chief of police all supported DuPont’s methadone program, others in the city did not. DuPont became the focus of significant negative publicity and even death threats.
One day in the early 1970s, George Allen, a reporter from a widely watched DC television station, asked DuPont for an in-person interview. During the interview, DuPont explained the methadone program’s benefits, including an already evident decrease in crime rates and overdose rates. Allen looked DuPont in the eye and said, “You’re a liar.” Shortly thereafter, Allen’s television station aired a prime-time documentary about the DC methadone clinic, in which DuPont and his program were described as a fraud.
Interestingly, Katharine Graham, the woman who owned the Washington Post and oversaw publication of the Watergate scandal, also owned Allen’s television station. Following the negative prime-time documentary, editors at the Washington Post contacted Graham, explaining that Allen was wrong and DuPont was right. The editors asked for permission to correct the record by writing a piece in the Post. Graham gave them permission to criticize the television station she owned, saying, “Do what you need to do.” According to DuPont, the Washington Post piece squashed Allen’s reputation: “Boom, end of the issue. It was extremely dramatic. He left town. He was gone.”
Unfortunately, the focus on methadone as a social tool rather than as a method of improving the quality of individual drug users’ lives lent the medication racist overtones. Many African American inner-city residents viewed methadone skeptically or with outright animosity, with prominent community leaders and the Black Panther Party claiming that methadone was an attempt by whites to control blacks.38 The Black Panthers called methadone “chemical warfare” against African Americans.44 The Congressional Black Caucus argued that substantial federal funds should be used to study the long-term effects of methadone, especially since methadone treatment was primarily available in inner-city, urban areas populated by minorities.44 Distrust of federally funded treatment programs was also due to revelations of the profound mistreatment of African American males during the Tuskegee Syphilis Study, reports of forced sterilizations, and limited government interest in sickle cell anemia.44 The Black Panther Party argued that traditional Chinese medicine, such as acupuncture, was a better alternative to methadone treatment, despite lack of evidence of efficacy. Additionally, prominent members of the black community felt that an individualized, medicalized response to addiction ignored racial and social inequalities that contributed to the condition. When I spoke with DuPont, he described an on-air radio interview he once had with Howard University, when a young activist phoned into the station and publicly called for DuPont’s death for what the methadone program was doing to the “young negro men of our city.” Once it became clear that methadone was here to stay, responses from the African American community ranged from tepid acceptance of the treatment to creation of African American–led methadone treatment centers to replacement of existing programs with alternative methods.44
The Nixon administration’s financial and political support for methadone treatment in DC represented a seismic shift in federal drug policy. For the first time, addiction treatment would be as important as stopping the illicit drug trade. Furthermore, for the first time since the Harrison Act of 1914, the federal government would fund maintenance clinics, albeit with a far more effective medication for treating addiction.
As expected, DC’s methadone clinic had a favorable effect on local crime rates. Regular methadone treatment participants were arrested less frequently than those who dropped out of the program or did not receive methadone at all. Given methadone’s local success, Krogh convinced his boss, Ehrlichman, to start a task force to discuss the feasibility of starting methadone treatment programs across the nation. Since participating agencies, such as the National Institute of Mental Health, had never expressed much interest in addiction treatment, Krogh was concerned that they would overlook methadone’s potential. So, he set up a parallel secret task force. This second task force, headed by Jaffe, was composed of health experts rather than government workers.39,42
The official government task force proposed traditional psychotherapy as the national solution to opioid addiction, reflecting the National Institute of Mental Health’s vested interests and expertise in psychotherapy. The report also expressed doubt in methadone as a treatment for addiction. In contrast, Jaffe’s task force believed that opioid addiction is usually resistant to psychotherapy alone, necessitating the addition of medication to control physiological symptoms. Jaffe’s task force also extolled methadone’s potential to stabilize “hardcore drug addicts,” turning them into law-abiding citizens.39,42 Years later, Jaffe summarized the report as saying “there are an awful lot of people waiting for treatment with methadone and you can’t just keep pretending that methadone is a small research project.”38 Additionally, Jaffe’s task force argued that the drug problem must be met through a coordinated and integrated national approach that addressed both treatment and prevention.38
Based on the two task forces’ reports, Donfeld drafted a list of policy options for Nixon’s chief domestic advisors. Donfeld praised methadone treatment as an economical and effective crime reduction method. He also proposed a $60 million increase in treatment funding, with a large share dedicated to expanding methadone treatment across the nation. But Nixon’s influential Secretary of Health, Education, and Welfare opposed methadone, proposing psychotherapy and therapeutic community approaches instead. Donfeld’s argument might have fallen on deaf ears but for a 1971 Congressional investigation into the Vietnam War. The investigation claimed that 10–15 percent of returning Vietnam veterans had heroin addiction. In response, the New York Times published “G.I. Heroin Addiction Epidemic in Vietnam” on its front page.45 There was even talk in Congress of civilly committing returning soldiers.46
Although often idealistic, Nixon was a pragmatist at heart. The Vietnam War was already unpopular; knowledge of widespread addiction among vets was threatening to push the public over the edge. Thus, Nixon was open to new ideas, especially cost-effective ones. As the methadone clinic in DC had demonstrated, one methadone clinic could treat two thousand people at a time on an outpatient basis. The other main option under discussion, therapeutic communities, required several months of residential treatment for only a few dozen participants per facility. Nixon gave his blessing to a national methadone treatment program and chose Jaffe, a Democrat, to head it. As a result, between 1970 and 1973, the number of people treated for opioid addiction increased eight-fold nationally.40 Nixon also chose Jaffe to lead a new office for coordinating drug policy, the Special Action Office for Drug Abuse Prevention, taking the drug issue out of the National Institute of Mental Health’s firm grip.42
In 1971, Nixon called drug abuse “public enemy number one,” necessitating “a new, all-out offensive.” This was the beginning of the war on drugs. For his war, Nixon requested $155 million, of which a whopping two-thirds ($105 million) would be earmarked for treatment. By 1973, the federal government would spend $420 million on treatment and prevention alone, an eight-fold increase from when Nixon took office.42 To this day, no US president since Nixon has ever requested such a large share of the drug policy budget for treatment. In an interview with PBS in 2000 about the Nixon administration, Jaffe reflected:
I had the feeling, almost from the first day, that the willingness to look at the demand side, rather than the traditional American law enforcement approach might be a transient phenomenon—that it might pass, and we would go back to our old ways of more and more law enforcement. And I was right. We have never had that proportion of federal resources devoted to intervention on the demand side. We’d never had it before, and we’ve never had it since.46
As head of the new government agency in a position referred to as the “drug czar,” Jaffe prioritized increasing the number of treatment slots and decreasing wait lists. Funding was allocated to methadone clinics in high-need cities. But clinics had to meet certain conditions, such as retention quotas. If too many patients quit, the government agency would send an investigative team and demand corrective action.42
In 1972, the agency passed regulations intended to prevent methadone diversion and ensure an adequate standard of care. Regulations detailed the minimum dosage, defined take-home conditions, and created a closed system wherein methadone could only be dispensed for addiction treatment in special methadone clinics, today called opioid treatment programs, and hospitals. These restrictions are still largely in place, though now through an accreditation system.47 And methadone for addiction treatment continues to be the most heavily restricted FDA-approved medication.
A firm believer that multiple treatment modalities should be offered and that a “one size fits all” approach is ineffective, Jaffe also expanded the growth of abstinence-only treatment programs, including therapeutic communities. He hated being associated with methadone only.42
Public backlash against methadone began quickly, and it’s a backlash that continues today. The most pressing concern was diversion to the black market. Jaffe believed the diversion issue was being blown out of proportion, especially given the positive impact methadone had on people with addiction. Adding to Jaffe’s stress, infighting was occurring at his government agency, with different people having different agendas and philosophies about drug treatment. The National Institute of Mental Health, for example, routinely refused to cooperate with Jaffe’s agency, delaying important treatment contracts. Even though Jaffe’s agency was making significant progress toward treatment expansion with wait times across the country decreasing and some treatment centers having excess capacity, methadone’s public image was negative overall.42
The federal government also continued traditional supply-side approaches of raiding and arresting drug traffickers internationally. The domestic heroin supply declined after government raids destroyed sources in several countries. The combination of treatment expansion and government raids appeared to be reducing crime rates. In 1972, the FBI released a report indicating that crime rates had fallen in 94 of the 154 cities studied, with the largest decline in Washington, DC. Since treatment had received the largest bolster in funding and personnel, it appeared that treatment, rather than government raids, was the true cause of the crime reduction. Even the DC chief of police agreed.42
Despite the visible successes of treatment policy, many politicians still favored a punitive approach. In New York, Governor Nelson Rockefeller proposed draconian mandatory sentences for drug-related crimes, including life sentences for possession. Jaffe met with Rockefeller to persuade him of the folly of punitive measures,39 but Rockefeller rejected Jaffe’s arguments, naively believing that mandatory prison sentences would encourage drug users to seek treatment. Of course, Jaffe knew that addiction did not work like this. Nixon also created the Drug Enforcement Administration (DEA) in the Department of Justice whose focus on supply-side initiatives continues today.39 And Nixon signed the Controlled Substances Act, creating a tier of restrictions for controlled substances depending on their abusability and medical value. The newly created DEA and the already established Food and Drug Administration would jointly decide the position of each drug on the controlled substance schedule. Infamously, marijuana was placed in a more restrictive schedule than some opioids.
By 1973, Jaffe felt overwhelmed with enemies. The public was increasingly antimethadone. Seeing lines of lower-income, sometimes-rowdy people in impoverished neighborhoods, the public associated methadone with crime and immoral behavior, which was ironic given that lower crime rates were attributed to methadone treatment expansion. Nonetheless, city zoning boards were denying the construction of new methadone clinics—something that still happens today.
In addition to public backlash, a clash of philosophies among federal agencies caused incessant infighting, especially between Jaffe’s agency and the National Institute of Mental Health. Moreover, Nixon was seriously considering Rockefeller’s mandatory minimum sentencing approach, with which Jaffe strongly disagreed. Jaffe’s negative opinion of mandatory sentences leaked to the press and was taken as a sign of disloyalty by the Nixon administration.39 Despite his agency’s clear successes, Jaffe sent Nixon a letter of resignation, wishing to return to his first love—research. Unfortunately, Jaffe’s departure marked the beginning of a precipitous decline in federal treatment funding and initiatives for addiction treatment.39
Under Presidents Gerald Ford and Jimmy Carter, addiction treatment funding in real terms dropped. In response, methadone clinics were closing their doors, including Jaffe’s beloved IDAP in Chicago. By 1975, attention previously paid to opioid addiction turned toward marijuana, a drug that public health experts had historically viewed as relatively benign. But parents of teenagers increasingly feared marijuana, and the “parents’ movement,” bolstered by corporate and religious donations, soon dominated federal drug policy.42,48
Nancy Reagan acted as drug policy ambassador under President Ronald Reagan with her infamous “Just Say No” movement. The administration and the message presumed that Americans simply needed drug education and willpower to prevent drug use or overcome addiction. Treatment funding policies reflected Reagan’s small government ideal—lower taxes and lower public spending. Why should the government fund treatment, especially for people who disrespect the law? Furthermore, according to the Reagan administration, twelve-step groups were free and had a spiritual approach, prompting participants to reflect on their wrongs and ask for forgiveness, a perfect approach for an administration trying to increase the morality of the nation. On a talk show in Illinois, Nancy Reagan stated, “Alcoholics Anonymous is extremely successful and it’s not federally financed. I never thought that money is the answer.”42
If the First Lady approved of any “professional” treatment, it was boot camps. She supported Straight Inc., which offered “tough love” in an enclosed, prisonlike residential environment. Proud of Straight Inc.’s approach, Nancy took Princess Diana to visit the facility. Resembling Synanon in certain respects, Straight Inc.’s methodology included public confessions, sleep deprivation, education, and constant surveillance. Parents at their wits’ ends committed their teens, expecting character transformation and sobriety. In addition to being ineffective, Straight Inc. and similar facilities were highly inequitable, only affordable to upper-class people at the cost of thousands of dollars per month. Like Synanon, they rejected methadone as “just another drug.”42,49
By 1986, the federal treatment budget in real terms was one-fifth the amount Jaffe had to work with in 1973.42 The remaining methadone clinics were characterized by long wait lists, high counselor-to-patient ratios, and crumbling buildings. Deprived of funding for ancillary programming, they offered insufficient counseling and case management. These limited services further tarnished the public image of methadone clinics, making them seem like gas stations rather than treatment centers. Even when the HIV/AIDS crisis emerged, the Reagan administration rejected methadone treatment expansion and syringe exchanges for ideological reasons. Both tools would have reduced the spread of HIV/AIDS, saving countless lives.50
That same year, the federal government instituted mandatory minimum sentences for drug offenses under the Anti-Drug Abuse Act, further dismantling the public health approach favored by Jaffe. The legislation’s cocaine-crack disparity is perhaps its most infamous element. Legislators knew that whites were more likely to use cocaine, and African Americans were more likely to use crack, a cheaper derivative of cocaine. Congress set the per gram prison sentence length for crack at one hundred times the prison sentence for cocaine, disproportionately affecting African Americans.48 The largest suffering was arguably borne by African American children, whose parents were being incarcerated at ever increasing rates, forcing children into a severely underfunded foster care system.
In 1988, Reagan replaced the agency Jaffe used to run, the Special Action Office for Drug Abuse Prevention, with the Office of National Drug Control Policy. Decades later, under the Obama administration, the Office of National Drug Control Policy would advocate for MAT. Under Reagan, however, the office was led by William Bennett, a man likened to cowboy Clint Eastwood in the film The Good, the Bad, and the Ugly, seeing only “good guys” and “bad guys” in the war on drugs. The bad guys included not only drug traffickers and dealers but also drug users and those who looked the other way.51 Moreover, Bennett viewed drug use as highly contagious, a position for which he had no scientific evidence but that presupposed the need to lock drug users away from society. He considered treatment to be the “coddling” of people who should be taught personal responsibility. Instead, he pushed for an increase in criminal justice initiatives. Like Rockefeller, he explained that even if treatment were effective, criminal justice measures would prompt people to quit drugs and enter treatment. Bennett firmly believed that people with addiction would not seek treatment voluntarily.
Therefore, in his 1989 report to the White House, now under George H. W. Bush, Bennett took pains to explain that empowering law enforcement to punish drug dealers and users was actually a demand-side tactic rather than a supply-side tactic. He also argued that shifting funds from law enforcement to treatment would be naïve since treatment programs were already overburdened—obscuring the fact that funding would lead to more treatment slots and staff, thereby enabling treatment programs to become less burdened.52 Ultimately, Bennett proposed spending three-quarters of the federal drug budget on supply-side initiatives and only one-quarter on demand-side initiatives. A small part of the demand-side initiative would be treatment.
Revealingly, when opioid overdoses hit headlines in 2015, Bennett penned an article called “Bring Back the War on Drugs.” In it he offered the following advice:
The heroin epidemic is inflicted upon us by criminal acts that produce an abundant supply of inexpensive drugs. Stopping these criminal acts will stop the epidemic. The Obama administration refuses to do this, insisting that overdose medication and treatment for heroin users and addicts are sufficient. Medication to revive dying addicts will not prevent the explosion of new heroin users, nor will it get addicts truly clean and sober. Emergency triage doesn’t immobilize the plague or prevent its spread.53
Bennett goes on to say that families with addicted loved ones know the disease is hopeless. He suggests no policies to help Americans already affected by addiction, preferring to protect the uninitiated innocents instead.53
When President Bill Clinton took office, two hundred thousand Americans were lingering on drug treatment waiting lists. More inclined toward treatment policies than Reagan or Bush, Clinton proposed a treatment budget increase, primarily by means of state grants. But Congress believed the administration should focus on drug education instead. Politicians shied away from treatment rhetoric, afraid of being perceived as “soft on crime.” At most they would support treatment in prison. Ultimately, Congress barely raised funding for treatment, with almost none earmarked to treat people with severe addictions. Democrats were losing their stamina fighting for a demand-side approach. Besides, the public appeared more concerned with marijuana. So Rahm Emanuel, the deputy director of the White House communications office, asked the Office of National Drug Control Policy to focus on marijuana instead.48
AS EARLY AS THE 1950s, when methadone’s potential was emerging in laboratory and clinical experiments, some governmental research organizations were apprehensive about its safety. Heroin, too, had originally been touted as a safe pharmaceutical, and now it was a national scourge. Organizations ranging from the American Bar Association to the American Medical Association to the National Research Council’s Committee on Drug Addiction debated the pros and cons of methadone. Dole and Nyswander, the two scientists who had extensively studied methadone treatment and argued for its expansion, viewed these debates as tainted by political concerns that should have no role in scientific discussions. When the Federal Bureau of Narcotics, which had always been vehemently against opioid maintenance treatment, was eventually replaced by the Drug Enforcement Administration, the DEA adopted its predecessor’s distrust of methadone.54,55
Given methadone’s precarious political and social positions, and despite the Nixon administration’s support for methadone, governmental research organizations began an intensive search for alternative addiction treatment medications in the 1970s. They largely focused on antagonists, a class of medications that do not activate opioid receptors in the brain. Antagonists block the brain’s opioid receptors, thus preventing a high. One promising candidate was naltrexone.55 Even though one could technically overdose by using large amounts of opioids while on naltrexone, such a situation was very unlikely given that naltrexone would block an opioid high, thus rendering any opioid use pointless.
The FDA approved naltrexone for opioid addiction treatment in 1984 under the brand name ReVia. But ReVia never really took off among patients or physicians. The problem was you had to take it at home daily, and unlike methadone, it did little for opioid cravings and did not prevent withdrawals. So taking ReVia demanded a tremendous amount of motivation knowing it would block a high without the other benefits of methadone.55
Decades later, the FDA approved a long-lasting injectable version of naltrexone under the brand name Vivitrol. Unlike ReVia, which lasts for only twenty-four hours, Vivitrol lasts for twenty-eight days—leading some health providers to tell their patients: “Make one good decision per month, take Vivitrol.” Vivitrol is commercially more successful than ReVia, both because patients can better adhere to the medication regimen and because pharmaceutical representatives have targeted criminal justice institutions.56 Drug courts, prisons, and jails have traditionally opposed methadone and buprenorphine treatment for ideological and practical reasons, but they increasingly view Vivitrol as an appropriate medication for addiction treatment—its main selling point being that it is not an opioid.56 However, as a more recent medication, extended-release naltrexone has a smaller evidence base than methadone or buprenorphine-naloxone.57 Few studies have directly compared the efficacy of extended-release naltrexone to other forms of MAT, but existing studies suggest similar efficacy to daily buprenorphine-naloxone for patients.58,59 Still, extended-release naltrexone appears to have a higher dropout rate after treatment initiation, and dropout may lead to relapse and overdose.58,60 Additionally, a recent study found that during medication utilization, buprenorphine was more protective against opioid overdose than extended-release naltrexone.60 Therefore, it seems that activating the opioid receptors in addiction treatment is important for many patients.
RESEARCHERS AND THE National Institute on Drug Abuse were considering the possibility of buprenorphine for addiction treatment during the 1980s and the 1990s. Like methadone, buprenorphine is an opioid, meaning it activates the opioid receptors in the brain, keeping cravings and withdrawal symptoms at bay. Unlike methadone it has a “ceiling effect,” meaning that after a certain dosage its effect plateaus, so people have little reason to take too much. As a result, buprenorphine is far less likely than other opioids to lead to respiratory depression, making it one of the safest opioids with a far lower overdose risk than others.61,62 Furthermore, buprenorphine has greater affinity for the brain’s opioid receptors than other opioids, meaning it binds more tightly to the receptors, so it displaces other opioids already on the brain’s receptors, after which it blocks the effects of subsequent opioids.62 Finally, even though buprenorphine has greater affinity for the opioid receptor, it actually has weaker intrinsic activity at the opioid receptors relative to methadone, meaning it creates less cellular activity, so people with opioid use disorder (OUD) taking buprenorphine as prescribed are less likely to feel euphoria than people taking methadone as prescribed.12
Buprenorphine had previously been approved in the United States and France as a pain management medication, albeit at a different dosage and frequency than for addiction treatment. For years in France, it had been prescribed off-label, meaning doctors were prescribing it for addiction treatment without approval. The HIV/AIDS crisis, associated with syringe sharing, eventually propelled France toward prioritizing opioid addiction treatment, resulting in France being the first country to formally approve buprenorphine for that purpose in the 1990s. Buprenorphine’s approval and widespread availability was associated with an 80 percent decrease in French deaths from heroin overdose.63,64 These statistics were hard for American politicians and researchers to ignore.
American researchers and regulators were carefully watching the French story unfold. But to meet the stringent US regulatory requirements, more studies of buprenorphine’s efficacy and safety were needed. So, for one of the first times in US history, an American government agency, the National Institute on Drug Abuse, collaborated with a pharmaceutical company, Reckitt & Colman, to test and bring a pharmaceutical to market.55 In 2002, the FDA approved buprenorphine for addiction treatment, marking the first approval of an opioid for this purpose since methadone in 1972. It was approved under two brand names: Suboxone, which also contained the abuse-deterrent ingredient naloxone, and Subutex, which lacked naloxone but was more appropriate for some populations, such as pregnant women.
In my interview with DuPont, I asked him whether the FDA approval of buprenorphine was as politically contentious as the expansion of methadone into addiction treatment. He responded, “Buprenorphine never had anything like the methadone problem. It was never particularly controversial. You didn’t have people saying that you got to kill this guy because he’s treating people with buprenorphine. That never happened. But buprenorphine is a really interesting story because it’s so different from methadone. Methadone is a program, and buprenorphine is a prescription. That’s a big deal.”
Anticipating buprenorphine’s FDA approval, the DEA, which continued to be unsupportive of maintenance treatment, rescheduled buprenorphine from Schedule V to Schedule III on the federal list of controlled substances. This made the medication more heavily regulated since Schedule III is more restrictive than Schedule V. Even though addiction treatment does require a higher dosage of buprenorphine than is required for pain treatment, DEA transcripts reveal that the rescheduling decision was primarily based on the target population—people with addiction versus people with pain. Unfortunately, people with addiction are significantly less sympathy-endearing. Despite overwhelming objection from the medical community, the DEA wrote, “Simply stated, providing an abusable substance to known drug abusers imparts enhanced risks [sic].”65 Not for the first time, treatment for a substance use disorder would be regulated more heavily than treatments for other chronic medical conditions. The regulatory outcome could have been even worse. In an interview with STAT News, a former director of the National Institute on Drug Abuse said it took substantial advocacy to prevent the DEA from classifying buprenorphine as a Schedule II drug.66
Additionally, the DEA worried that the opioid naïve, meaning those not already addicted to opioids, would access buprenorphine to get high. The DEA acted on this concern despite explicitly acknowledging that “the extent to which buprenorphine is able to produce euphoria and ‘good drug’ effects limits its use by opioid tolerant abusers.”55,65,67 Like Bennett, the DEA prioritized the lives of the uninitiated innocents over those who had already developed a chronic, deadly disease.
Also anticipating buprenorphine’s FDA approval, Congress began to rethink existing addiction treatment regulations. The core of the Harrison Act of 1914 was still in effect, prohibiting physicians from prescribing opioids for maintenance treatment in their offices. Methadone, for example, could only be prescribed for addiction treatment in highly regulated methadone clinics to which participants returned daily and waited in visible, stigmatizing lines. Appearing to be outside of mainstream medicine, such clinics attracted few prescribers.
Therefore, starting in the 1990s, buprenorphine’s manufacturer urged Congressional staff to amend existing law, an effort that took nearly half a decade.47 Finally in 2000, Congress passed the Drug Addiction Treatment Act (DATA). It had two goals: to increase opioid maintenance treatment availability and to prevent diversion or abuse. On balance, Congress erred too far on the side of caution, preventing buprenorphine treatment from becoming mainstream medical practice despite proof of its efficacy in increasing health outcomes and preventing overdose.67
To prevent diversion of the medication, Congress required any physician prescribing buprenorphine for addiction to obtain a waiver (sometimes called a SAMHSA waiver, after the agency that grants it, or a DATA waiver, after the statute). To obtain this waiver, physicians need special education beyond a standard medical license, typically an additional eight-hour course. Furthermore, and most atypically, in the same statute, Congress instituted patient limits, prohibiting physician practices from prescribing buprenorphine for addiction to more than thirty patients at any time. These patient limits and the education requirements did not apply to prescriptions of buprenorphine for pain management.
The thirty-patient limit applied to entire physician practices rather than to individual physicians. Therefore, if a group of three physicians shared a practice and one had already reached the thirty-patient limit, then the other physicians could not prescribe buprenorphine. Almost immediately, addiction treatment advocates and professional health organizations, including the American Medical Association and the American Society of Addiction Medicine, fought back. They called the restriction arbitrary (why thirty patients?) and dangerous, as it would prevent lifesaving treatment for countless patients. Buprenorphine was, and still is, the only medication in the United States with federal patient limits. Patient limits do not even apply to oxycodone, a medication in Schedule II, a more restrictive schedule than buprenorphine’s Schedule III. And oxycodone is often the medication that people undergoing buprenorphine treatment are trying to quit.67,*
Given the uproar of public health advocates, Congress amended the rules somewhat in 2005, making the thirty-patient limit apply to individual physicians rather than to entire physician practices.68 In 2006, after renewed pressure from public health advocates and professional organizations, Congress changed the rules again. This time, individual physicians could prescribe buprenorphine to thirty patients at a time during their first year of having a DATA waiver, and beginning in year two, they could request an expansion, prescribing up to one hundred patients at a time.69 Senator Orrin Hatch praised the amendment to DATA, saying, “It is clear this [thirty-patient] cap needs to be raised. To make an analogy, a doctor would not turn away a broken arm because he or she had already fixed thirty arms that month! The doctor would not stand for it, and neither would society. The same should be true for physicians treating drug addiction. Given that the destructive effects of drug addiction are so much greater than a broken arm, we should strive to ensure that the healing hands of doctors are not bound by unintended mandates.”70
But even with the new rule, wait lists for buprenorphine treatment formed across the country.71 And wait lists could last a long time. Addiction, after all, is a chronic condition, so a patient can occupy a prescribing slot for years. Unsurprisingly, limited legal access to buprenorphine contributed to buprenorphine prescription sharing, a form of illicit diversion, between family members and friends. Reports emerged of family members and friends forced to negotiate who would take the only available slot, sometimes with tragic consequences. Many people began purchasing buprenorphine illicitly on the street, often to begin recovery or to prevent “dope sickness” or withdrawal symptoms when they could not access buprenorphine legally. Those who sold buprenorphine on the street frequently did so to make money to buy substances, such as heroin, to get high. Others sold parts of prescriptions to afford doctor visits, especially if their doctors did not take insurance, an unethical practice among many buprenorphine prescribers who likely knew they were forcing patients into the black market.61,72–74
Illicit diversion has had terrible consequences for the treatment’s reputation, perpetuating the myth that buprenorphine is “just another drug.” According to an argument I have frequently heard from criminal justice employees, buprenorphine is sold by drug dealers on the street, so it must be the same. In response to diversion concerns, some state legislatures have proposed drastic laws to further restrict buprenorphine treatment. For example, the Indiana legislature recently considered a bill limiting buprenorphine to people addicted for more than one year and over the age of eighteen,75 despite evidence of efficacy in younger populations.76,77 The bill would also create a state registry of buprenorphine patients—something that would inevitably decrease the number of patients seeking treatment. Methadone is underused in part because people with previous criminal justice system involvement fear being on a government “watch list.” Previous proposed bills in Indiana also attempted to encourage physicians to prescribe extended-release naltrexone (i.e., Vivitrol), which the bills called a “non-addictive” medication, rather than buprenorphine.78 Enraged, one Indiana addiction psychiatrist told me during an interview, “Politicians should stop dictating my job!”
By 2016, the media was widely reporting on the opioid crisis, focusing on overdoses among upper- and middle-class white Americans. In response, the federal government was taking the opioid crisis seriously. The Obama administration had selected Michael Botticelli as its “drug czar,” the position originally held by Jaffe. Botticelli had a history of alcohol addiction that in his early life had resulted in an arrest for driving under the influence. In recovery himself, Botticelli prioritized MAT expansion, calling it “our best hope of making a difference [in overdose deaths].”79,80 In the Obama administration Nora Volkow continued to head the National Institute on Drug Addiction. A world-renowned physician (and great-granddaughter of Russian socialist revolutionary Leon Trotsky), she has repeatedly called opioid addiction a “brain disease” that can be effectively treated with medications.81
In this climate of public health initiatives, politicians began to shed their fear of appearing soft on crime by openly demanding treatment expansion. Emboldened, governors from some of the hardest hit states, such as Vermont, initiated novel programs to expand MAT access.82 Unlike the Nixon administration, the Obama administration, at least in its rhetoric, prioritized drug users’ health over the effect of drugs on crime or unemployment. Recovery of the drug-using individual seemed to be as important as community prosperity.
In 2016, President Barack Obama signed the Comprehensive Addiction and Recovery Act, which for the first time significantly reformed buprenorphine regulations. The act permitted nurse practitioners and physician assistants to prescribe buprenorphine for addiction treatment, subject to any additional rules imposed by the states. For more than a decade, the previous federal law, DATA, had barred physician assistants and nurse practitioners from prescribing buprenorphine, even when states allowed them to prescribe oxycodone. Today, there are still too few nurse practitioners and physician assistants treating addiction, but the Comprehensive Addiction and Recovery Act represents a significant opportunity to expand the addiction treatment workforce.83
The new law also permitted a very small percentage of physicians, basically those with board-certified addiction treatment specialization, to treat up to 275 people at any time with buprenorphine.83 Though a step forward, the law continues buprenorphine’s status as the only medication to which patient limits apply. The topic of loosening buprenorphine’s regulations is now once again picking up speed. In 2019, top health officials in eighteen states, three US territories, and the District of Columbia wrote to health secretary Alex Azar urging him to relax restrictions. In the letter, the undersigned argue the following:
The DATA 2000 regulatory framework was implemented prior to the current wave of opioid addiction. The limitations in the legislation and regulations have been intended to preserve safety and to promote comprehensive care. The need for buprenorphine has grown exponentially, while the supply of waived prescribers’ pales in comparison. . . . Ideally, legislation should be passed eliminating the waiver requirements and allowing all practitioners who are registered with the Drug Enforcement Administration (DEA) to prescribe controlled substances to also prescribe buprenorphine for the treatment of OUD. Researchers in policy have noted that the waiver requirements are burdensome and reduce prescribing. They have also suggested that deregulating buprenorphine would help in reducing stigma associated with treating OUD.84
In 2016, Obama signed the 21st Century Cures Act into law, promising $1 billion to state addiction treatment and prevention initiatives.85 In his 2016 proposed budget, Obama allocated more drug policy dollars toward demand-side initiatives than any other president since Nixon, even though Nixon’s percentage allocation toward treatment was still greater.86,87
Thus far, President Donald Trump has done far less to address opioid addiction, though he has only been in office for a few years. Trump’s commission on the opioid crisis did suggest MAT expansion—a good sign.88 Likewise, Trump’s FDA commissioner, Scott Gottlieb, has openly encouraged MAT expansion and development of new addiction treatment medications.26 But given existing restrictions on methadone and buprenorphine, pharmaceutical companies are unlikely to view addiction treatment as profitable.47 Moreover, Trump has declared opioid addiction a national health emergency without the funding to address the emergency. Trump’s most positive impact on the opioid crisis so far has been signing into law the SUPPORT for Patients and Communities Act in October 2018. The law included important changes to previous Medicaid restrictions on the number of funded beds in residential treatment centers but did not substantially increase funding to address the crisis. Keith Humphreys, a well-regarded health services researcher who worked on passing the law, said it had “many small sanities” but reflected the ongoing disagreements between Democrats, who traditionally want greater government involvement in addressing public health crises, and Republicans, who traditionally want less.89 Basically, the parties found agreement on “second tier issues.” Most alarmingly, the Trump administration continues its efforts to dismantle the Affordable Care Act, including by quashing Medicaid expansion. Yet without health insurance, evidence-based addiction treatment is an elusive fantasy for millions of Americans.90
ACCESS TO ADDICTION TREATMENT today is far less rosy than the above policy trajectory may imply. Decades of research studies have clarified MAT’s lifesaving potential beyond any reasonable doubt. Yet methadone remains inaccessible to most Americans. Many states have only a handful of methadone clinics and one state, Wyoming, has none.91 When available, methadone clinics often resemble Soviet breadlines—a result of stringent legal regulations separating methadone treatment from office-based practices and requiring daily visits, coupled with clinics only staying open for a few hours each day. Methadone clinics are widely criticized for providing inadequate behavioral health and case management services, often due to inadequate funding.47 This combination of lines and limited service further cements the public perception of methadone clinics as ineffective fueling stations. Yet unbeknownst to much of the public, methadone has the strongest evidence base of any opioid addiction treatment.13,22,92
Buprenorphine, despite the attention afforded it by the Obama administration, is still only prescribed by a minuscule percentage of practicing physicians: approximately 2 percent.93 It is typically only available in white, middle-class, and upper-class residential areas93 and rarely in rural areas.93–96 Even though extended-release naltrexone has no patient limits or special prescribing requirements, only 1 percent of Americans in opioid addiction treatment receive it.97 And most damning of all, only 20 percent of Americans with opioid addiction receive any treatment whatsoever.98
Failed drug policies are often the result of misguided goals. For decades, the federal government focused on decreasing the total number of Americans who start illicit drug use, particularly casual marijuana users who represented the majority of illicit drug users. Policies included wasting billions of taxpayer dollars on ineffective educational programs about the dangers of drugs,99 incarcerating people for minor drug offenses, and targeting foreign drug sources with military action. Of course, evidence-based prevention policies should be implemented, but historically US prevention policies have been more motivated by political grandstanding and emotion than by science. Furthermore, the focus on criminal justice supply-side initiatives has stigmatized addiction, preventing treatment-seeking behavior by people with addiction, treatment provision by providers, and treatment funding by policy makers.
In contrast, a goal of managing chronic, severe drug addiction would have necessitated a far different set of policies. People addicted to opioids are typically aware of the drug’s dangers. They have frequently already lost their jobs, broken their families, or been involved in the criminal justice system. They continue to use opioids because addiction, by definition, is a disease of compulsive use despite negative consequences, not because they are unaware of the negative consequences or because they are bad people. Educating people with an addiction about the dangers of drugs or putting them in jail are therefore largely ineffective. Likewise, simply restricting the supply of one opioid often leads to substitution with other opioids or other drugs—sometimes more dangerous ones. So, shutting down unscrupulous pain clinics has shifted people with an existing opioid addiction toward heroin, and heroin is increasingly sold on the street mixed with fentanyl, a significantly more dangerous opioid implicated in the rising rates of overdose deaths.
Our history of top-down, overly restrictive, punitive national policies has also permeated the current addiction treatment system. According to interviewees, patient-centered care, a hot topic in health care, seems to have barely entered the walls of residential and outpatient addiction clinics. Patients are routinely kicked out of treatment for relapse, leaving them with few options other than street purchases, and they are given limited or no choice in the type of care they receive. As one former drug user recently told me, “Treatment centers often resemble prisons more than health care centers.”
Despite rhetorical progress in which politicians and the public increasingly call addiction a “disease,” our culture’s punitive approach toward addiction continues to limit the availability of evidence-based treatment options and person-centered approaches. Not surprisingly, peer-led support groups of current and former drug users remain the most popular recovery support tool, sometimes feeling like the only bastion of compassion toward people with substance use disorder in a judgmental world. Unfortunately, even those in peer support groups often believe that MAT is just another drug.
* It is exactly this legal anomaly that prompted my initial foray into public health research, leading to my dissertation and eventually this book. As a trained attorney, I had difficulty understanding how a Schedule III medication was harder to access than a deadlier and more addictive Schedule II medication. Only one factor seemed to explain the anomaly: stigmatization of the patient population.