Doing Methadone Right



Italian version

Nadelmann, Ethan A., and Jennifer McNeely "Doing
Methadone Right," Public Interest 123 (1996):83-93

Heroin looks like it is here to stay. Since the 1960s, millions of Americans have used heroin. Most stopped, with or without treatment, at some point. But there are an estimated half a million Americans addicted to heroin and a comparable number using it with some regularity. Heroin use grew rapidly during the 1960s, leveled off during the 1970s and 1980s, and now appears to be increasing again. Hospital emergency rooms saw an 80 percent increase in heroin-related episodes between 1990 and 1993.1 The average purity of heroin purchased on the streets has increased from about 5 percent during the mid-1980s2 to 40 percent today3 -- and in New York City, Philadelphia, and Newark, New Jersey, it’s over 60 percent.4

Heroin availability is up, and prices are down.5 Street drug ethnographers report that heroin use is on the rise in cities and communities around the country, and that many new heroin users are working, white, and middle-class. Hopes for an international solution to the heroin problem have clearly been dashed: Opium is now cultivated throughout the world, with new countries joining the list of producing countries each year, and U.S. Customs Service officials admit that they are lucky to detect 10 percent of the heroin entering the country.

Heroin is a powerful drug. Like other opiates, it provides very effective relief from pain and a strong sense of well being. Quitting heroin is a lot like quitting cigarettes. It’s not that hard if you have not done it for too long or too regularly. It’s generally easier for those who have a lot going for them and who thus have strong incentives to stop. Most heroin users, like most cigarette smokers, do try to quit. Most eventually succeed, although few do so on their first attempt. Many quit for months or years, only to start up once again.

The best treatment

There’s no best way to quit heroin, cigarettes, or any other bad habit. But decades of scientific research have provided us with good information on what strategies work best for most people.

When it comes to quitting heroin, the evidence is in. In 1990, the National Academy of Sciences’ Institute of Medicine found that “methadone maintenance has been the most rigorously studied [drug treatment] modality and has yielded the most incontrovertibly positive results.”6 Methadone, an opiate agonist, wards off withdrawal symptoms and suppresses drug craving among opiate addicts by stabilizing blood levels of the drug and its metabolites.7 At proper doses, methadone lets addicts function normally, without making them “high,” and can be safely consumed for decades with remarkably few bad side effects. In addiction treatment, methadone is typically consumed orally, once a day. Most methadone programs provide counseling, some medical care, and other ancillary services in addition to the drug. The objective of treatment, at least in principal, is to help addicts get their lives together and stop using illegal drugs, not to achieve total drug abstinence.

Methadone is to heroin users what nicotine skin patches are to tobacco smokers. Both deliver “addictive” drugs -- albeit drugs that pose virtually no health risks -- in a form designed to reduce associated harms to consumers and others. Both have proven effective in reducing more dangerous forms of drug consumption. Both are readily integrated with most living styles. Consumed orally or transdermally, neither provides addicts with much of the effect on mood or cognition experienced with injected heroin or smoked cigarettes. But both are potentially available in other forms -- injections, nasal sprays, and inhalers -- that may be more effective for some users.

In its review of the federal methadone regulations last year, the Institute of Medicine concluded:

The effectiveness of methadone treatment of opiate addicts has been established in many studies conducted over three decades. Methadone- maintained patients show improvement in a number of outcomes...Consumption of all illicit drugs, especially heroin, declines. Crime is reduced, fewer individuals become HIV positive, and individual functioning is improved.8

Methadone, like heroin and other opiates, can cause physical dependence if taken on a regular basis. But “addiction” to methadone looks far more like a diabetic’s “addiction” to insulin than a heroin addict’s addiction to street heroin. Many methadone patients hold good jobs, and are responsible parents. They can safely drive motor vehicles and operate heavy machinery. They are, when prescribed adequate doses of methadone, practically indistinguishable from Americans who have never used heroin or methadone.

But the Institute of Medicine also reached another conclusion:

Current policy...puts too much emphasis on protecting society from methadone, and not enough on protecting society from the epidemics of addiction, violence, and infectious diseases that methadone can help reduce.9

That report, and other studies before and since, indicate that the provision of methadone to heroin addicts trying to quit, and its use in drug treatment and medical settings, has been handicapped by federal and state regulations, ignorance of scientific research, prejudice against methadone users, and ideological assumptions that contradict common sense and good medical practice.

One hundred fifteen thousand Americans are now in methadone treatment.10 If methadone were readily available, many tens and perhaps hundreds of thousands more would probably trade their illicit heroin habit for a legal methadone dependence. In Amsterdam, for example, where methadone is provided more liberally than in the United States, the ratio of methadone patients to heroin addicts is better than 6 to 10.11 In the United States, the ratio is about 2 to 10.12 Getting even a fraction of these unserved addicts into methadone treatment would mean significant reductions in heroin-related death, disease and crime, and substantial savings in government expenditures devoted to these problems.

The early years

There were great hopes in the mid-60s when Vincent Dole and Marie Nyswander of Rockefeller University discovered that methadone effectively reduced, or even eliminated, heroin craving among addicts when consumed daily on a long-term, maintenance basis. By the late-60s, heroin-related mortality was the leading cause of death for 15-35 year olds in New York City, serum hepatitis cases were up, and a record number of addicts were being arrested for drug- related crimes.13 President Richard Nixon and others were looking for a quick fix. They saw methadone as a way of reducing demand for heroin and the problems -- especially crime among addicts -- that accompany it. Under the active leadership of federal officials and treatment providers, methadone programs expanded rapidly. In 1968, there were fewer than 400 patients in methadone treatment. By January 1973, there were 73,000.14

But, as might be expected, methadone was oversold. The media called it a “Cinderella drug” and a “magic bullet.” Programs expanded a bit too quickly, and the quality of treatment began to suffer. Dole and Nyswander’s guidelines for proper methadone prescribing were not always followed. Both the public and many treatment providers wrongly believed that heroin addicts would only need to use methadone for a few months to quit their habits. Many providers gave doses that were too small, so their patients continued to use heroin and engage in related criminal behavior. A number of patients sold their methadone to heroin users on the illicit drug market. At some clinics, patients started hanging around outside, setting the stage for the NIMBY (not in my backyard) complaints that now block the establishment of new methadone clinics. Methadone acquired a reputation for being part of the drug problem, rather than part of the solution.

Notwithstanding these problems, much of methadone’s promise held true. Work by researcher Herman Joseph shows that when New York’s methadone census increased (by about 20,000) between 1971 and 1973, drug arrests dropped by almost 25,000 (from 40,000 in 1971 to 15,100 in 1973), and complaints to the police for robbery, burglary and grand larceny -- crimes usually associated with addiction -- dropped by 77,000 (from 350,000 to 273,000).15 Drug dependency deaths also dropped dramatically, as did serum hepatitis cases among drug injectors.16 Methadone was not singularly responsible for these dramatic results, but dozens of studies have since confirmed that enrollment in methadone programs is associated with dramatic reductions in crime, death, and disease -- including HIV/AIDS and hepatitis -- especially in properly run programs that prescribe adequate dosages, that do not detoxify patients prematurely, and that otherwise operate according to scientific standards.

The most regulated drug

Following rapidly on the heels of methadone’s expansion came extensive regulations on its administration. Methadone is now the most highly regulated drug in the United States -- more tightly controlled than morphine, cocaine, amphetamine and many other prescription drugs that are far more toxic. Like other narcotic drugs, methadone is regulated at the federal level by the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). But, unlike any other drug, the actual circumstances under which methadone can be used to treat addiction are dictated and enforced by these federal agencies, along with the Substance Abuse and Mental Health Services Administration (SAMHSA).17 Additional (and more restrictive) regulation is often imposed by states, counties, and municipalities.

Some of the regulations have proven useful in establishing minimum standards of service and guidelines for proper usage. But many are a hindrance to the effective employment of methadone. All methadone programs, regardless of location or clientele, are subject to similarly rigid staffing, security, documentation, and treatment requirements, all of which have little to do with quality treatment. Doctors can’t prescribe methadone outside of designated treatment programs. Decisions usually left to doctors and their patients -- including dose level, admission criteria, time spent in treatment, and a host of other treatment specifics -- are dictated by federal, state, and local regulations.

Methadone maintenance patients -- many of whom stay in treatment for 20 or 30 years -- are often subject to stricter supervision than convicted probationers and parolees.18 Urine tests are required of all patients, regardless of time in treatment. Take- home medication is tightly controlled according to federal guidelines and is available in liquid form only.19 All patients in standard methadone programs must come to the clinic at least weekly for their medication. In some states, even model patients -- who hold steady jobs and have been drug-free for years -- are required to show up at the clinic daily. Methadone patients can’t fill their prescriptions at the pharmacy, even if they’re traveling, and vacation time away from the clinic is tightly controlled. Some programs insist on withdrawing patients from methadone when they become pregnant, even though continuing methadone is the medically recommended course of treatment.20 Most remarkably, eight states have no methadone programs whatsoever.21

Poor treatment

At the same time, federal and other regulations have not been effective at holding methadone treatment programs to basic standards of good medical practice. The General Accounting Office’s 1990 Report on methadone noted that it is considered by the federal government’s primary drug research agencies to be the most effective treatment method for heroin addicts.22

But the GAO also warned that many programs are not effectively treating heroin addiction.23 A 1992 study of data from a national survey of methadone programs, conducted by Thomas D’Aunno and Thomas Vaughn of the University of Michigan’s Institute for Social Research, found that one-half of the programs encouraged patients to detoxify after only six months in treatment,24 notwithstanding abundant evidence that premature detoxification results in a return to heroin use in 80 percent to 90 percent of cases.25

Equally pervasive is a “less is more” approach to dosage levels. In the early methadone trials, Dole and Nyswander found 80 to 120 milligrams of methadone to be the average effective daily dose. Study after study over the past two decades has demonstrated that adequate dosing -- typically 60 to 100 milligrams per day and sometimes more -- results in better treatment outcomes, including improved retention of patients in treatment, reduced illicit drug use (of heroin and cocaine), and lowered incidence of HIV.26 Yet the D’Aunno and Vaughn study found that a full 68 percent of clinics kept patients at an average dose of 50 milligrams or less,27 well below the minimum recommended dose.28 Some of these dosage restrictions are required by state and local regulations, while others reflect either ignorance on the part of program doctors or willful disdain of the scientific evidence.

Lessons from abroad

There’s no question that following through on the recommendations of the Institute of Medicine report, which called for easing the methadone regulations while leaving the basic clinic system in place, could significantly reduce drug use and heroin-related death, disease, and crime, even among the many addicts who use both heroin and cocaine.29 The United States could gain much just by making its existing methadone clinics deliver treatment more effectively. But even more could be gained by going a step further and adopting the methadone policies that have spread in recent years throughout Europe, Australia, New Zealand, and even Hong Kong.

In these countries, national and especially local health authorities have recognized that methadone can be a highly effective tool for reducing the spread of HIV and serum hepatitis among drug users. Steps have been taken to attract and retain a higher proportion of illicit drug users in treatment by making methadone as easily available to heroin addicts as possible and by easing stringent restrictions on methadone dose levels.

But what most distinguishes methadone maintenance approaches abroad is the role of general practitioners and pharmacists in methadone provision and patient supervision. In the United States, general practitioners and pharmacists are virtually barred by federal regulations from playing any role in methadone maintenance; the only exceptions involve a few "medical maintenance" experiments that permit some long-term methadone recipients to transfer from traditional methadone clinics to hospital-based physicians. By contrast, thousands of general practitioners throughout Europe and Australia are now involved in methadone maintenance.30 In Belgium and Germany this is the principal means of methadone distribution.31

Foreign innovators pioneered "low-threshold" programs, which make oral methadone readily available with fewer conditions, and often minimal ancillary services, to heroin addicts. These programs may not be as effective as the best full-service programs in keeping patients off heroin and away from criminal activity, but they are more successful in establishing contact with illicit drug users who are fearful of the rigorous requirements and the intrusiveness of more comprehensive programs. Not surprisingly, low-threshold programs are much less expensive and, thus, can accommodate many more heroin addicts than more full-service programs. (In the United States, only 7 percent of methadone treatment costs are spent on the drug itself.)32 Studies show that low-threshold patients substantially reduce their drug use and typically fare better than do illicit drug users not enrolled in any programs.33 Low-threshold programs now operate in several cities in Europe, Australia, and Asia. Low-threshold “methadone buses,” which dispense methadone and related services at designated times and locations each day, can be found in a number of European cities.34 These mobile programs make methadone more readily available to addicts and help avoid the NIMBY protests that so often accompany new methadone clinics.

Foreign developments in methadone maintenance haven’t been entirely ignored in the United States, but they also haven’t been implemented to great effect. Methadone buses are used in Baltimore, Maryland and Springfield, Massachusetts, but they operate much like traditional full-service programs. Low- threshold "interim clinics," which provide methadone without extensive ancillary services, have been approved by federal regulators as a short-term option for addicts on waiting lists for traditional methadone programs.35 But Beth Israel Medical Center in New York City, the only provider of interim services, was forced to close its interim clinic in 1993, and there has yet to be another interim clinic opened anywhere in the United States.

Opposition to the clinic came primarily from defenders of established programs, who often object to relatively low-service methadone programs on the grounds that they are less effective than more "comprehensive" methadone programs in reducing illicit drug use and other undesirable drug-related behavior. Providers also worry that a successful “bare bones” program would mean funding cuts for their full-service programs. But given the explosion of the HIV/AIDS epidemic among heroin users and solid evidence that even methadone alone is effective, it’s hard to excuse established methadone providers for blocking the expansion of a potentially lifesaving intervention. In New York City, where half of injecting drug users are HIV positive, only one new methadone clinic has opened since the mid-1970s, while several have closed.