by ETHAN NADELMANN & JENNIFER MCNEELY

HEROIN looks like it is here to stay. Since the 1960s, millions of Americans have used heroin. Most stopped, with or without treatment, at sonie point. But there are an estimated half-million Americans addicted to heroin and a comparable number using it with some regular-ity. Heroin use grew rapidly during the 1960s, leveled off during the 1970s and 1980s, and now appears to be increasing again. Hospital emergency rooms savv an 80 percent increase in heroin-related episodes between 1990 and 1993. The average purity of heroin purchased on the street has increased from about 5 percent during the inid 1980s to 40 percent today—and in New York City, Philadelphia, and Newark, New Jersey, it's over 60 percent.

Heroin availability is up, and prices are down. 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 in-ternational 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 even-tually 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 Acadeniy of Sciences' Institute of Medicine found that "methadone maintenance has been the most rigor-ously studied [drug treatment] modality and has yielded the most incontrovertibly positive results." 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. 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 pro-vide counseling, some medical care, and other ancillary ser-vices in addition to the drug. The objective of treatment, at least in principle, is to help addicts get their lives together and stop using illegal drugs, not to achieve total drug absti-nence.

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 liv-ing styles. Consumed orally or transdermally, neither provides addicts with much of the effect on mood or cognition that is 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 posi-tive, and individual functioning is improved.

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 insu-lin than a heroin addict's addiction to street heroin. Many methadone patients hold good jobs and are responsible par-ents. They can safely drive motor vehicles and operate heavy machinery. They are, when prescribed adequate doses of metha-done, 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 inethadone, and not enough on protecting society from the epidemics of addiction, violence, and infectious diseases that metha-done can help reduce.

That report, and other studies before and since, indicates 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 ideo-logical assumptions that contradict common sense and good medical practice.

One hundred fifteen thousand Americans are now in methadone treatment. If methadone were readily available, many tens and perhaps hundreds of thousands more would probably trade their illicit heroin habit for a legal methadone depen-dence. In Amsterdam, for example, where methadone is pro-vided more liberally than in the United States, the ratio of methadone patients to heroin addicts is better than six to ten. In the United States, the ratio is about two to ten. Getting even a fraction of these unserved addicts into methadone treat-ment would mean significant reductions in heroin-related death, disease, and crime, and substantial savings in government ex-penditures devoted to these problems.

The early years

There were great hopes in the mid 1960s when Vincent Dole and Marie Nyswander of Rockefeller University discov-ered that methadone effectively reduced, or even eliminated, heroin craving among addicts when consumed daily on a long-term, maintenance basis. By the late 1960s, heroin-related mortality was the leading cause of death for 15 to 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. 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 offi-cials 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.

But, as might be expected, methadone was oversold. The media called it a "Cinderella drug" and a "magic bullet." Pro-grams expanded a little too quickly, and the quality of treat-ment 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 mar-ket. At some clinics, patients started hanging around outside, setting the stage for the NIM BY (not in my backyard) com-plaints 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 prom-ise 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). Drug-dependency deaths also dropped dramatically, as did serum hepatitis cases among drug injec-tors. Methadone was not singularly responsible for these dra-matic 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 pre-scribe adequate dosages, that do not detoxify patients prema-turely, and that otherwise operate according to scientific stan-dards.

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 fed-eral 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 (SAM HSA). Additional (and more restrictive) regulation is often imposed by states, counties, and municipalities.

Some of the regulations have been useful in establishing minimum standards of service and guidelines for proper us-age. 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, docu-mentation, and treatment requirements, all of which have little to do with quality treatment. Doctors can't prescribe metha-done outside or 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. Urine tests are required of all patients, regardless of time in treat-ment. Take-home medication is tightly controlled according to federal guidelines and is available in liquid form only. 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 preg-nant, even though continuing methadone is the medically rec-ommended course of treatment. Most remarkably, eight states ha.ve no methadone programs whatsoever.

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 Ac-counting 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.

But the GAO also warned that many programs are not effectively treating heroin addiction. 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, notwithstanding abundant evidence that premature detoxification results in a return to heroin use in 80 percent to 90 percent of cases.

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 de-cades 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. Yet the D'Aunno and Vaughn study found that a full 68 percent of U.S. clinics kept patients at an average dose of 50 milligrams or less, well below the minimum recommended dose. Some of these dosage restric-tions 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 recom-mendations of the Institute of Medicine report, which called for easing 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 ad-dicts who use both heroin and cocaine. 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 au-thorities have recognized that methadone can be a highly ef-fective tool for reducing the spread of HIV and serum hepati-tis 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 pos-sible and by easing stringent restrictions on methadone dose levels.

But what most distinguishes methadone maintenance ap-proaches abroad is the role of general practitioners and phar-macists 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. In Belgium and Germany, this is the principal means of methadone distribution.

Foreign innovators pioneered "low-threshold" programs, which make oral methadone available with fewer conditions, and often minimal ancillary services, to heroin addicts. These programs may not be as effective as the best full-service pro-grams 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 rigorous require-ments and the intrusiveness of more comprehensive programs. Not surprisingly, low-threshold programs are much less expen-sive 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.) 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. Low-threshold pro-grams now c2erate in several cities in Europe, Australia, and Asia. Low-threshold "methadone buses," which dispense metha-done and related services at designated times and locations each day, can be found in a number of European cities. These mobile programs make methadone more readily available to addicts and help avoid the NIMBY protests that so often ac-company 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. But Beth Israel Medical Center in New York City, the only provider of interim ser-vices, 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-ser-vice 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 pro-grams. 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.

What is needed is not just full-service programs but a di-versity of lower-cost, low-threshold options that make metha-done treatment a realistic option for the hundreds of thou-sands of heroin addicts who are not reached by the present treatment system. Physician prescribing and low-threshold treat-ment make methadone available to heroin addicts who live far from methadone clinics, allocate counseling and other services more efficiently, and are less intrusive, less stigmatizing, and more flexible than traditional clinics. They remove the "ball and chain" from methadone treatment and make it more at-tractive to middle-class addicts who are most worried about their jobs, reputations, and family responsibilities. Perhaps most importantly, allowing more physicians to prescribe methadone would help involve the mainstream medical community in the treatment of drug addiction.

A red herring

Why hasn't the United States capitalized on these foreign innovations? A major obstacle is the Drug Enforcement Ad-ministration. Federal drug-enforcement agencies have opposed drug-maintenance programs for addicts since early in this cen-tury. Physicians who had prescribed morphine for maintenance were driven from practice during the early years of drug pro-hibition, in tl,e late 1910s and early 1920s. In the 1960s, drug-enforcement agents tried to block early experiments with methadone, and even now they provide only reluctant support for methadone maintenance, arguing that any loosening of re-strictions on methadone prescribing would result in a bigger illicit market in diverted methadone and more methadone over-dose deaths.

Although some methadone patients sell their methadone, the magnitude of the problem has been greatly exaggerated. In a recent response to the Institute of Medicine report, Gene Haislip, director of the DEA's Office of Diversion Control, overstated the evidence, citing 344 deaths involving metha-done in 1992 when only 13 deaths that year could be traced to methadone alone. Furthermore, the restrictive measures supported by the DEA have not even proven effective. A 1986 study of methadone diversion by Barry Spunt and his col-leagues at National Development and Research Institutes, Inc. concluded that the two diversion-control measures at the dis-posal of treatment providers—namely restrictions on take-home medicine and punitive dose reduction for patients who sell their methadone—are harmful to patients and have minimal effect on methadone diversion.

The illicit market in methadone is the predictable result of insufficient methadone availability. "A black market has been created," notes methadone's founder, Vincent Dole, "because there is an unmet demand and because political propaganda and community opposition have made it impossible, to open more clinics." But the illicit market in methadone may not be all bad. Methadone is simply not a drug of choice, and cases of diverted methadone going to first-time opiate users are exceedingly rare. Most buyers of diverted methadone are ac-tive heroin users who won't or can't get into a methadone program. As the Institute of Medicine concluded, after its careful review of methadone regulations and diversion, "the risks to public safety and public health of diverted methadone do not outweigh the benefits of making methadone treatment more readily available." Even former "drug czar" Lee Brown, as director of the Office of National Drug Control Policy, gave his tentative support to the regulatory revisions recom-mended by the Institute of Medicine. But the DEA continues to fight for even more onerous, inefficient, and expensive methadone regulations; thus far it has prevailed.

Less regulation, better treatment

The poor utilization of methadone in the United States represents a clear case of politics trumping science and the interests of public health. With some 500,000 heroin addicts in the country, any method that is proven effective in reduc-ing heroin use and heroin-related disease, death, and crime needs to be made as readily available as possible—especially when it's safe and relatively inexpensive. Moreover, we need not just more "full service" methadone treatment programs but also easy access to methadone for addicts who don't re-quire or want the counseling and other services.

Methadone, in short, should be deregulated and put back into the hands of the medical community. Let the FDA regu-late methadone just like ahy other prescription drug. Allow physicians to prescribe methadone to addicts as part of gen-eral practice, and encourage cooperation between primary health-care providers and drug-treatment specialists. Let metha-done be picked up in pharmacies—just like every other medi-cation in this country. And leave the specifics of methadone treatment to be dictated by patient need and provider exper-tise, not by government micromanagement. Ensuring that methadone is prescribed according to accepted medical and scientific standards is an appropriate role for clinical-practice guidelines and formal quality assurance systems, which need not be governmental.

If you call addiction a disease, think of methadone as the equivalent of insulin. If you call addiction a bad habit, treat methadone like the nicotine patch. Either way, there's no good reason for making methadone a ball and chain. The only argu-ment against all this—that it might stimulate the illicit market in methadone—is a red herring. The best way to eliminate the illicit market in this very effective medicine is to make metha-done as readily available as possible to any heroin user who wants it. There's virtually no downside—just clear benefits.