Methadone maintenance programs in the United States and Canada are now treating about 9,000 former heroin addicts. The data from these studies amply document the safety of this medication and its efficacy in stopping heroin addiction when it is given under good medical control. Detailed statistics have been collected in New York city by our central data office and made available to the independent evaluation committee directed by Dr. Frances Gearing. This committee has recommended continued support and expansion of the maintenance programs. The New York State Narcotics Addiction Control Commission has allocated an increased proportion of its next year's budget to maintenance treatment, and political leaders have called for an immediate expansion of maintenance programs in New York to a caseload of 25,000.
It would seem from all this that the only remaining problems of the methadone programs are to live with prosperity, and forget old arguments, now obsolete. The future, however, will not be this easy. The projected expansion of methadone programs to 25,000 in the next three years or sooner will confront us with difficulties of greater magnitude than any that we have met during the first six years of this work. The problems will be administrative, not medical. The larger that the programs become, the more they will interact with other social agencies and political interests.
For example, if the programs in New York city grow to 25,000, they will be responsible for twice as many individuals with antisocial problems as the total present caseload of the Department of Corrections. How are criminal addicts to be treated and under whose control? General rules for bringing 25,000 criminal addicts into methadone treatment certainly do not exist at present. Is it proper for a judge to force treatment on an addict by sentencing him to a maintenance program? Is it advisable for a physician to accept patients on these terms? I would say definitely no to both of these questions. The rights of addicts must be respected, and the importance of abstinence programs must be recognized. I would object to the imposition of methadone maintenance treatment just as strongly as I have objected in the past to its unavailability when the needs of motivated volunteers could not be met.
Our responsibilities will also have common ground with the duties of narcotics control bureaus. With a caseload of 25,000, methadone programs will be dispensing approximately 9 million doses per year of a potent narcotic. We know that this medication is therapeutic when taken by the right person in a good medical program, but we also must recognize the need for adequate control of its usage. Law enforcement agencies of federal, state, and city governments quite properly have been concerned with the dangers of diversion and misuse of this medication. We must work with them to reduce this danger to a minimum.
So far, we have done well in our programs to ensure good medical control, but I am not sure that we have solved the problem for 25,000 patients. We have efficient, computerized record systems with continuous accountability for all patients, and treatment units that are small enough for all patients to be known personally. We would welcome suggestions from concerned agencies as to how our system of follow-up and data control could be improved without diminishing the effectiveness of the rehabilitation program. As to the medication, we have always insisted that it be dispensed in a form suitable for oral use only, and in the past three years we have been testing various noninjectable tablets which, in addition to medical advantages, can be more accurately controlled by identifying code numbers.
We have given much thought to the quantity of medication that should be dispensed to patients to take at home. Unreliable patients obviously should be required to take all medication under direct observation, but to impose this rule on all patients would be counterproductive. Crime reduction is correlated with rehabilitation. Certainly it would be against the public interest to make the dispensing rules so restrictive that a responsible patient could not hold a full-time job. Here again is a need for communication between law enforcement agencies and medical treatment programs.
We have in common the goal of enabling previously criminal persons to lead socially acceptable, crime-free lives. This will not be done simply by dispensing methadone. If crime is to be reduced significantly, we need an effective rehabilitation program, and this includes specifically the authority to dispense a week's supply of medication to responsible working patients whose conduct in treatment has shown that they merit this trust. At the same time, we must use this authority with good judgment, and recognize the concern of law enforcement agencies that this medication be used only as prescribed.
Under the best circumstances it will be difficult to maintain effectiveness of the rehabilitation services with a rapid expansion to 25,000. How can we be sure that the programs will continue to be as effective as they are now when the number is five times as great? Methadone programs could grow into cumbersome bureaucracies treating more patients than are now being treated by all of the federal, state, municipal, and private programs combined, or, alternatively, methadone might be dispensed without any attempt at rehabilitation. Neither extreme would provide good treatment for addicts. How are quality standards to be maintained?
At the moment, methadone programs are subject to controls exercised jointly by the Bureau of Narcotics and Dangerous Drugs and by the Food and Drug Administration, their authority being based on the proposition that the treatment is still only experimental. Privately, officials of these bureaus concede that the inherent safety and efficacy of the medication are no longer in doubt, but hold that the fiction of experimental status is needed as a legal basis for preventing misuse. There is some merit in their contention, but in any event, the IND permit which now serves as a license for methadone treatment cannot be retained indefinitely as a control device. Expansion to a caseload of 25,000 in New York, and an equal number elsewhere in the country, is inconsistent with the concept of experimental status. Either the treatment is experimental or it is ready for large-scale use, but not both.
Methadone programs have already brought out strong differences in opinion as to how the treatment should be regulated, and even as to the capacity of the medical profession to define its own standards. The pessimists see only disaster if private physicians are allowed to prescribe methadone, and therefore insist upon controls by governmental agencies with power to prosecute offending physicians. The optimists see addiction becoming part of the inventory of chronic diseases, like diabetes and arthritis, some cases needing institutional care, while other cases are treated by physicians in general practice. It is futile to argue the assumptions that underlie these positions, but this much is clearly before us: Either the leadership of the medical profession and administrators of methadone programs will work together to guide an orderly expansion of methadone services, or the pessimists that view the medical profession as incompetent will win by default.
Let us review the evolution of methadone treatment in New York to learn what we can about the administrative problems in expansion (Fig 1--not shown). During the first two years, a few of us working together informally provided good medical services for a small, research-sized group (10 to 50 patients). Like teachers in a one-room school, we knew each patient personally. The ones in trouble were seen more often, the successful ones, less often; all were followed closely enough for us to know what they were doing. With growth to the pilot-program stage (50 to 500), and even more so on becoming a large service program (500 to 5,000), our administrative structure changed. No longer could any single person know all of the patients or have time to hear their problems. Administrators by necessity delegated the actual treatment to other physicians, and gave their own time to budgets and the details of staff work, laboratory services, data control, and public relations.
The net effect has been a healthy decentralization of the program into small treatment units (50 to 150) which retain the personal qualities of the original research-sized group. The theater for the patient's rehabilitation is his own clinic. These are small enough for him to be known as an individual and independent enough for him to respect the authority of the physician in charge (Fig 2--not shown).
With decentralization, the rehabilitation techniques have also become diversified in details - another healthy trend. While general standards of medical practice have been maintained by the sharing of administrative services - data control, central laboratories, staff meetings, and consultations - local units have developed their own styles of counseling. The data and laboratory services could easily be extended to private practitioners affiliated with institutional programs if administrators of existing programs and officials of government wished to encourage this trend. Many rehabilitated patients now being carried on publicly funded programs could pay a reasonable fee for continued treatment by private practitioners.
The problem before us is that decentralization of methadone programs, and specifically the inclusion of private practitioners in the system, would diminish the power of governmental agencies to regulate the treatment. At stake is control over a large program with a growing budget (for the country as a whole, perhaps $100 million per year by 1973) and with political significance at all levels of government. Decentralization of services might bring treatment to more addicts, but it would weaken the bureaus. History fails to disclose a precedent in which any bureau has cooperated in a reduction of its power.
Another concern for the future, this one internal to the medical profession, is the rivalry that has existed between different theories of addiction and different modalities of treatment. With growth to 25,000-patient size, methadone programs might be seen as a threat to the existence of programs using other techniques. This is wrong. We must find ways to work together in the public interest. Those of us who have been directly involved in methadone programs are well aware of the need for other programs, especially those that can prove effective in preventing heroin addiction.
We do not forget that 18% of the patients admitted to methadone programs in New York city during the past six years have been discharged as failures. Although this is a relatively low failure rate as compared to what appears to be the dropout from other programs, the problem becomes a major one for society as the methadone program grows. What is to be done to control the antisocial behavior of 5,000 addicts discharged as failures from a group of 25,000 admitted to methadone treatment?
Analysis of the case histories of patients discharged from methadone programs in New York city shows that few of them, if any, were pharmacological failures. These patients were discharged for persistent and disruptive antisocial behavior, or for persistent abuse of non-narcotic drugs (alcohol, barbiturates, amphetamines) for which methadone has no blockade effect, but even in the worst cases the regular use of heroin was stopped while the patients were taking their daily dose of methadone. This means that additional techniques for control of psychopathic behavior and for treatment of non-narcotic abuses must be developed if the overall program is to be made more effective. Combinations of methadone blockade with residential support and various psychotherapeutic techniques are now being studied by research groups in New York and other cities. We need this research, and a climate of scientific objectivity. We need reliable data on the effectiveness and the cost of non-methadone techniques alone and in combination with blockade treatment.
All of these problems have been with us in some degree since the beginning of the methadone research. Our relation to other social agencies, the maintenance of quality standards and reliable statistics, the effort to separate medicine from politics, the rivalries and jealousies among professionals, have always complicated the basic problem of treating addicts. With growth in size of methadone programs, these divisive problems will be intensified, but can be met with good will and good medical leadership.
There is however a serious danger that treatment programs will become subordinated to power struggles. So far the programs have been effective because their direction has been medical. The procedure has been developed by physicians with personal experience in treatment of addicts, not by governmental agencies or the medical administrators chosen by them. The success of this treatment in rehabilitation of addicts will decline significantly if methadone programs cease to be medical institutions, and instead become the instruments of another bureaucracy.
I call upon the leaders of our major medical institutions, the deans and professors of medical schools, the administrators of teaching hospitals, the officials of medical societies, to take an active interest in the treatment of heroin addicts. The medical profession cannot ignore the leading cause of death in urban adolescents and young adults. Enough research has been done to show how heroin addicts can be treated successfully in a medical setting. If we apply what we know now, effectively and on a large scale, we can begin to control heroin addiction and related crime in our large cities.
This investigation was supported by grants from the Health Research Council (City Of New York Department of Health) and the New York State Narcotic Addiction Control Commission. Conclusions stated herein are not necessarily those of the commission.
Nonproprietary and Trade Names of Drug
Methadone: Adanon, Althose, Amidone, Dolophine.
Medical Association, 215 (1971):1131-1134.
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