Drug Abuse

Section IX Opiate Maintenance

METHADONE MAINTENANCE

GROWING SUPPORT FOR METHADONE MAINTENANCE

Because of the difficulty of curing opiate dependence, there has been increasing support for methadone maintenance as the most effective means of managing such dependence. Methadone maintenance programs are multiplying at a brisk rate, and this treatment approach is receiving an increasing measure of official approval and support. In fact, it is fair to say that the substitution of methadone for heroin has become the favoured response to heroin dependence.

It seems to be undeniable that methadone maintenance is presently the means by which the largest number of heroin dependents can be removed, to a significant extent, from dependence on the illicit market in heroin and from involvement in drug-related crime. There is considerable variation in the results that are claimed for methadone maintenance on various measures of success—retention in the program, reduction in illicit drug use, reduction in crime, increase in gainful employment, and general social and personal adjustment. The retention rates of 80 per cent and better that are claimed for some programs are considerably higher than the general average. Moreover, retention rates reflect varying criteria of admission and compliance. Nevertheless, the poorest rates of success on any of the above measures in methadone programs, given the total numbers who can be beneficially affected, would appear to suggest that the total effectiveness of this method of managing opiate dependence is superior to other forms of treatment or management. As yet there has not been a basis for estimating the potential effectiveness of a satisfactory antagonist for opiate narcotics since such antagonists are still in the development and testing stage. (See Section VIII General Observations Concerning Treatment above and Appendix A.2 Opiate Narcotics and Their Effects, "Opiate Narcotic Antagonists".)

Some programs with a drug-free goal, particularly some of the therapeutic communities, do claim success rates which compare favourably to those in methadone maintenance but they are suitable for a much smaller proportion of addicts, and the results are based on the performance of a highly selected population with a particularly good prognosis for this particular form of treatment.

Thus the superiority of methadone maintenance as a means of managing opiate dependence lies essentially in the numbers or proportion of the total addict population with which it can apparently deal. It must be recognized that there is a high rate of dropout from methadone programs (and indeed from virtually all other programs as well), in some cases as high as 50 per cent,' and also that there is a significant amount of illicit drug use and unemployment among those who remain in the programs, but the overall proportion of those who can be kept substantially out of the illicit heroin market and usefully employed is impressive. It is estimated that with adequate facilities at least 40 per cent of the heroin-dependent population in the United States could be stabilized on methadone maintenance.2 On the other hand, it is felt that therapeutic communities could deal effectively with at the very most ten per cent of the total addict population.3

CONCERNS ABOUT METHADONE MAINTENANCE

While methadone maintenance has its strong supporters, and they are increasing in number, many people have serious misgivings about it and some are strongly opposed to it. The most vocal critics are those who favour a drug-free goal for treatment, in particular, those who favour the technique of the therapeutic community They contend that it is essential to take the drug-dependent person off drugs altogether and not to encourage him in his reliance on them. They see methadone maintenance as simply catering to the desire of the drug user and evading a real solution of his problem.

There is also a very real concern that while methadone maintenance may result in a reduction of drug-related crime and some undermining of the illicit market in heroin, it may lead to an overall increase in opiate dependence. There is concern that we are creating a legal supply of a new opiate narcotic from which there will inevitably be diversion to an illicit market. There is also concern that because of the availability of methadone maintenance people will be more willing to run the risk of opiate dependence by experimenting with heroin or other opiate narcotics, and that once dependent they will be less inclined to make the effort to become abstinent. Many fear that methadone maintenance will not displace the use of illicit heroin but will merely add to or compound the overall problem of opiate dependence.

There is no doubt that the increasing availability of methadone for the treatment of opiate dependence in withdrawal therapy and maintenance has brought problems as well as benefits. There are four primary dangers in connection with the use of methadone. The first is the danger of making patients dependent on methadone when they do not yet have an opiate dependence. This can result from failure to make adequate tests for dependence. This danger is greatest when a physician who administers or prescribes methadone does not have access to the necessary laboratory facilities for urinalysis. Successive daily urinalyses to determine whether heroin is being used daily is one, although by no means the only, indicator of heroin dependence. It cannot be said, however, that every reasonable precaution is being taken to avoid a mistaken diagnosis of dependence if urinalysis is not available. Persons who are not yet dependent on opiate narcotics may be made dependent on methadone as a result of unwillingness to turn them away when they present themselves for treatment. Sometimes the reasoning in such cases is that where a person is experimenting with heroin and there is every likelihood that he will become dependent it is better to remove him from the illicit market at the first opportunity rather than run the risk of losing him for a considerable period of time.

The second danger is the diversion of legal supplies of methadone to an illicit market. This danger is greatest where methadone is prescribed instead of being administered on the premises under supervision. There has been evidence of the creation of an illicit market in methadone and the creation of primary methadone dependence through over-prescribing by physicians in some areas. There is also concern that the extensive use of methadone maintenance will lead to an illicit market in methadone as a result of a growing demand for the drug and the refusal to make it legally available to those who are not yet dependent. The reasoning is that if heroin-dependent persons are willing to accept methadone in substitution for heroin, the drug can be expected to be increasingly sought after by drug users. In this way, it is said, making methadone maintenance widely available is likely to increase the total clientele for opiate narcotics and the total amount of opiate dependence. It is not only introducing another dependence-producing drug but it is making it legally available. Thus it is facilitating or encouraging the development of opiate dependence.

The third danger is that experimentation with heroin will be encouraged by the erroneous belief that methadone offers a 'cure' if heroin dependence results. There is concern as to whether drug users understand the full implications of methadone maintenance—that it not only produces dependence but a dependence that is confirmed and reinforced by regular daily administration. There is an insufficient understanding that methadone maintenance itself involves a dependence, albeit one which relieves the opiate dependent of the need to seek his drug in the illicit market. People who think of methadone maintenance as a 'cure' are very gravely mistaken. It is not a cure but a substitution of one dependence for another—a dependence which is as fully tenacious as that of heroin and perhaps more.

The fourth danger is that a heavy reliance on methadone maintenance will discourage treatment personnel and patients from pursuing the more difficult goal of abstinence or additional goals, like the ones that are pursued and often attained through serious therapeutic efforts: a sense of responsibility, of commitment, of understanding of the self and its limitations and the like. (It is noteworthy, however, that there is increasing evidence in American therapeutic communities of resort to methadone maintenance by a certain number of the staff and members, although it is not possible to estimate the effect of this development on the traditional goals and general effectiveness of the therapeutic community.) There is concern that if we commit ourselves unreservedly and overeagerly to this method of treatment we may gradually abandon our efforts to seek means of effecting cure. As official support concentrates on methadone maintenance, there may be less support available for the more expensive approaches to treatment with a drug-free goal. At a time when public health costs constitute a very large and increasing proportion of government budgets, one of the great attractions of methadone maintenance to governments is its relatively low cost.

There is also concern that we do not know enough about the long-term effects of methadone, although it is thought to be unlikely that they will turn out to be more harmful than those of heroin. There has also been relatively little attempt to determine the effect of methadone on psychomotor functions involved in driving or the handling of other machinery. At the present time we are allowing persons on methadone maintenance to drive automobiles, operate other potentially dangerous machinery, and perform other types of complex tasks without adequate assurance that this is a safe or reliable procedure. As well, there is little systematic information regarding the interaction of methadone with alcohol and other drugs used medically and non-medically. The possibility of enhanced behavioural or physiological toxicity is of particular concern.

THE COMMISSION'S POSITION ON METHADONE MAINTENANCE

In its Treatment Report the Commission expressed cautious support for the increased availability of methadone maintenance under suitable controls. It acknowledged the criticism of this form of treatment or management of opiate dependence, especially from those favouring the therapeutic community, as well as its essentially experimental nature, but concluded, "for better or for worse, methadone maintenance provides to date the cheapest and most effective weapon we have for dealing with large-scale heroin dependence," (p. 30). The controls recommended by the Commission, which are also referred to in the present report in Appendix G.1 Methadone Control Program of the Government of Canada, consisted essentially in the requirement that, as a general rule, methadone should be administered only by physicians affiliated with and acting under the general supervision of an accredited specialized clinic equipped with the necessary laboratory facilities and other ancillary services.

In view of continuing concern about methadone maintenance and the introduction of a control program by the Federal Government the Commission has reviewed its position since the Treatment Report.

Notwithstanding the concerns expressed above, methadone maintenance continues to win support. Its major claims, apart from relative cost, are that it can handle large numbers, and it can, in a significant degree, take them out of the illicit market and drug-related crime and permit them to function in a reasonably effective manner. These are the major social objectives in connection with heroin dependence today. In the large urban centres of the United States people are more concerned about the increase in crime as a result of heroin dependence than they are about the effect of dependence on the individual. If they cannot cure the dependence they at least desire to reduce drug-related crime. A certain proportion of persons on methadone maintenance may still commit crime because of a general pattern of criminal behaviour, but they have less reason to commit the crime required to support their opiate habit.

The danger that a heavy emphasis on methadone maintenance will discourage efforts to pursue treatment with a drug-free goal is only a matter of real concern to the extent that the latter treatment offers a significant chance of success. We must not abandon our efforts to effect cure but we must be realistic about the present prospects. The experience with treatment goals of abstinence has been very discouraging and justifies the generalization that heroin dependence is virtually incurable. There are very few documented cases of individuals who have remained abstinent after release from imprisonment or civil commitment. While the success rate claimed for therapeutic communities is often high, on closer examination the number who respond favourably are seen to be a very small proportion of those who originally make contact with such communities. A high proportion of those who make contact turn away when they realize what is involved. A further high proportion drop out, or 'split', after a short period in the community. The founder of Synanon himself expressed the opinion that only about one in ten of those who seek help from the community would be benefited by it.4 As noted previously in this section observers have estimated that therapeutic communities are not likely to be suitable for more than ten per cent of the opiate-dependent population.5 Certainly it is essential that a sufficient number of them be supported for those who can benefit from them. It is generally agreed, however, that they could not make a sufficient impact on the overall problem of opiate dependence to remove the need for some other form of management. Moreover, methadone maintenance can always be regarded as a stabilizing and transitional measure that enables a person to withdraw from the illicit market and drug-related crime and to fashion the elements of a reasonably normal life; it does not preclude the subsequent pursuit of cure, if the dependent person feels able to make the necessary effort. As noted above, methadone maintenance is in fact being used by members of therapeutic communities.

For these reasons—and despite the very real concerns expressed above —we see no alternative but to continue to make methadone maintenance available to as many opiate dependents as possible for whom it is appropriate.

It must, however, be surrounded by suitable controls to reduce the dangers referred to above as much as possible. In view of the introduction of the Federal Government's methadone control program since the publication of the Commission's Treatment Report it is necessary to re-examine the question of control.

Before dealing with this subject we wish to emphasize again that the potential of antagonists as a means of managing opiate dependence has not yet been developed, although there are promising indications, and the concentration in the foregoing discussion on methadone maintenance and the therapeutic community is not intended to suggest that in the long-term the options are necessarily confined to these two forms of treatment or management.

THE METHADONE CONTROL PROGRAM OF THE FEDERAL GOVERNMENT

The methadone control program introduced by the Federal Government in 1972 following the recommendations of a Special Joint Committee on Methadone established by the former Food and Drug Directorate of the Department of National Health and Welfare and the Canadian Medical Association, as well as the recommendations of this Commission in its Treatment Report, are described in detail in Appendix G.1 entitled Methadone Control Program of the Government of Canada. There reference is made to the abuses which gave rise to governmental concern, the recommendations of the Special Joint Committee, the recommendations of the Commission, the announcement of the proposed methadone control policy by the Minister of National Health and Welfare, the new Narcotic Control Regulations respecting the use of methadone, the policy guidelines developed by the Health Protection Branch of the Department of National Health and Welfare, the manner in which the new control policy has been implemented, the number of specialized treatment units approved, and the number of physicians, both affiliated with such units and unaffiliated, who were authorized as of November 1972, to use methadone in maintenance and withdrawal therapy or in withdrawal therapy only.

What emerges from a consideration of these developments is that the Federal Government has had to try to reconcile two objectives: the need to make methadone sufficiently available in Canada for the treatment of opiate dependence, and the need to surround it with sufficient control to reduce the dangers of abuse or misuse as much as possible—in particular, the danger that persons who are not yet dependent will be introduced to opiate dependence through methadone, the danger of diversion to an illicit market through "prescription shopping" or over-prescribing, and the danger that the opiate dependent's problem may be aggravated by inadequate administration and failure to monitor illicit drug use.

At the present time there is a conflict between the need to make methadone sufficiently available to meet the requirements of the opiate-dependent population and the need to surround its availability with all reasonable controls. Although the idea of assuring effective controls and good medical practice in the use of methadone through a system of accredited clinics or specialized treatment units with which private physicians must be affiliated is a good one in theory, it has encountered certain practical difficulties. There has been a significant increase in the number of special treatment units suitable for accreditation but there are not yet enough to make such a system workable at the present time. (See Appendix G.1 Methadone Control Program of the Government of Canada.) There are not sufficient organized and fully-equipped methadone programs in Canada today to make it feasible to restrict the use of methadone to physicians who are able to establish an affiliation with an accredited treatment program. There are too many localities that would not be adequately served if that rule were enforced today. Nor apparently has it been considered practicable to restrict its use to physicians who have access to the necessary facilities for urinalysis nor to insist that methadone be administered under supervision and only prescribed in the most expectional circumstances.

In effect, the Federal Government has had to abandon, at least temporarily, the idea of a control system based on accredited treatment units or programs and settle for a system which gives it a closer monitoring control over physicians. It is highly doubtful if the policy which has been implemented can meet the control objectives of a safe and effective use of methadone which were originally announced. An effective system of controls requires adequate laboratory facilities to confirm opiate dependence and to monitor the use of illicit drugs, administration under supervision as opposed to ordinary prescription, and the necessary resources for follow-up and evaluation. There is no particular magic in the notion of a specialized clinic or treatment unit; the necessary facilities can exist or be accessible to physicians outside of such a clinic or unit; but they will generally only be available within an organized program.

JURISDICTIONAL ISSUES

The Federal Government feels that it is under some constitutional restraint. (See Appendix F.1 The Constitutional Framework for a general discussion of the distribution of legislative jurisdiction with respect to nonmedical drug use.) It clearly has the jurisdiction, in virtue of its criminal law power, to restrict the availability of harmful substances and to impose conditions upon their use, but it does not have a general jurisdiction to establish and regulate treatment facilities outside of the criminal law system and other specific areas of federal constitutional responsibility, such as the armed forces, immigration, and Indian affairs. As indicated in Appendix F.1, the general jurisdiction with respect to health services is provincial, and there is a serious doubt, for reasons of constitutional policy, whether the Federal Government could successfully invoke its general power under the "Peace, Order and Good Government" clause as a basis for the delivery of treatment services in the field of non-medical drug use, even if it were politically prepared to do so. In the present constitutional climate of Canada, with the strong provincial insistence on jurisdiction with respect to matters of health and social welfare, it is unlikely that such an initiative would appear desirable or feasible. The provision of facilities for the treatment of opiate dependence and other adverse effects of non-medical drug use would involve an incursion of a comprehensive nature into the complex field of health and social welfare services. The proper treatment of heroin dependence involves much more than simply making drugs available. It involves a whole network of services, including institutions and professional personnel over which the provinces have regulatory jurisdiction.

The Federal Government could consider providing the necessary facilities to make methadone available under properly controlled conditions. Its right to impose various conditions upon the distribution of dangerous substances would appear to include the right to provide that such substances will not be available except through government owned or sponsored facilities. But there is a difference between mere distribution and treatment, which is what is involved in the use of methadone in maintenance or withdrawal therapy. The latter is not simply the distribution of a dangerous substance but the delivery of a health service.

Another important consideration in connection with a federal attempt to regulate the use of a drug by physicians is that while the Federal Government may validly impose conditions upon the use of a drug, the general jurisdiction to regulate the practice of medicine is provincial. In regulating the distribution of drugs by physicians the Federal Government does come very close at times to regulation of the practice of medicine. It is one thing, from a policy point of view, to say that a particular drug shall not be available for use by any physician, as in the case of thalidomide. It is another thing to say, as in the case of methadone, that only physicians specially authorized by the Federal Government shall have a right to use it. When the Federal Government imposes conditions upon a physician's right to use a certain drug, in the exercise of its jurisdiction to restrict the availability of harmful substances, it does not usurp the provincial jurisdiction to regulate the practice of medicine.° But the control contemplated by the new federal methadone regulations involves a judgment on the professional competence and responsibility of individual physicians. Moreover, the federal approval of specialized treatment units and the authorization of physicians necessarily involve a consideration of the manner in which methadone is to be used as a matter of good medical practice. (The Guidelines referred to in Appendix G.1 contained clear suggestions in this regard.)

Nonetheless, once it is conceded, as it must be, that the Federal Government has jurisdiction to prescribe the conditions upon which a certain drug may be made available for use by physicians, there would seem to be no limit to the nature of the conditions that can be imposed so long as they are genuinely related to a concern with the availability and use of a dangerous substance and not to the assumption of a regulatory jurisdiction over a course of treatment in the interests of a certain theory of treatment efficacy.

Of course, there may be a close relationship in practice between the two concerns—protection of the patient from harm and treatment efficacy—and it may often be difficult, if not impossible, to draw the line between them. Clearly, a requirement that there be proof of opiate dependence before methadone is used relates to a bona fide concern for the harm that may be caused by a dangerous substance. On the other hand, a requirement that there be certain ancillary services for purposes of follow-up and social rehabilitation may appear to go beyond issues of safety into questions of treatment efficacy. Yet even such questions can be seen as part of a general concern to limit the use of methadone to the extent that is absolutely necessary. Thus there would not appear to be a serious basis for challenging federal jurisdiction to enter into details of treatment as conditions upon which a particular drug will be made available.

The decision to pass upon the qualifications of individual physicians to administer methadone could involve the Federal Government in some awkwardness with the medical profession and the provincial governing bodies. In fact, as indicated in Appendix G.1 Methadone Control Program of the Government of Canada, the Drug Advisory Bureau consults with relevant provincial bodies, the Methadone Advisory Committee is representative of the interests of the medical profession, and the Department had not, as of November 1972, refused any application for authorization, although some temporary authorizations were withdrawn during the summer of 1972 by agreement between the Bureau and physicians. The federal policy appears to be to encourage the adoption of satisfactory standards and practices but to refuse or withdraw the right to use methadone only in cases of clear abuse, and even then, the withdrawal of the right has been brought about by negotiation. This reflects the concern which the federal authorities feel about effective interference with the right to practice medicine, even as a necessary incident of their clear jurisdiction to control the availability of harmful substances. The monitoring of methadone prescription by the Bureau of Dangerous Drugs is only calculated to detect cases of extreme abuse. It cannot monitor good medical practice in the use of methadone. If there were to be a more confident and rigourous evaluation of professional competence or experience in the use of methadone, to meet generally accepted criteria of good medical practice in this area, it would have to be exercised by provincial authorities, or at least by some federal-provincial cooperative mechanism.

COMMENTARY ON THE FEDERAL CONTROL PROGRAM

As indicated in Appendix G.1, the federal methadone control program started out with a firm affirmation of and commitment to the requirement of affiliation with a specialized treatment unit, but it has had to adjust, at least as an interim measure, to certain operational realities.

As we say above, there is no magic in a requirement of affiliation with an approved treatment unit or program. It is a means, however, of assuring good medical practice in the use of methadone since such practice cannot be assured simply by a review of prescription records. This was the thinking behind the Commission's recommendation of the requirement of affiliation in its Treatment Report, and presumably it was also the thinking behind the recommendations of the Special Joint Committee, which expressed the view that methadone therapy should only be carried out as a general rule within specialized treatment programs. (See Appendix G.1.) Physicians who are not affiliated with such a program may be capable of good medical practice in the use of methadone, but in our opinion they are not adequately equipped for such purpose unless they have access to the necessary laboratory facilities to confirm dependence and monitor illicit drug use, and have the necessary training and specialized clinical experience and also probably, unless they have the support of the necessary ancillary services to supervise and assist the social rehabilitation of the patient. Specialized programs may also lack these facilities but they are more likely to be able to provide for them. Such programs may also be guilty of poor medical practice in the use of methadone, but with their specialized personnel and facilities they should be less exposed to this possibility.

One thing that emerges very clearly from a consideration of our experience with treatment so far is the necessity of adequate after-care and follow-up to assist the patient to establish a new pattern of life. Methadone maintenance which consists simply of the daily dispensing of drugs may do some good but it is not sufficient. The individual must find satisfactory employment and establish new relationships. Proper treatment requires follow-up over a long period by people who care and who can devote the necessary effort to solving the practical problems involved in the restructuring of a life. Virtually all treatment today suffers fom a lack of sufficient follow-up with the problems of social reintegration. There is a great need for enough trained personnel to assist in this task and for a receptive attitude on the part of society.

There is some contention that methadone maintenance will be effective even without ancillary services if the goal is simply to remove a person from dependence on the illicit market and drug-related crime, but help in putting together the elements of a stable life would seem to be essential to ensure against relapse into the life of the criminal addict through attraction of the old associations, if not the illicit drug, and also to lay the basis for the possibility of cure.

In addition to these ancillary services directed to social rehabilitation, there is also a need for a research and evaluation component in methadone programs. We are in need of further research information in numerous areas, such as the determination of optimal doses, maintenance side effects (including changes in intellectual functioning and psychomotor skills), interactions with other drugs, and the treatment potential of longer-acting methadone derivatives. At least some of this research would best be conducted in a clinical setting, or in a clinically-associated experimental program. Facilities for adequate research and evaluation are most likely to be available to an organized and properly equipped clinical program.

Despite differences in opinion on the necessity or even the desirability of urinalysis to confirm dependence and to monitor illicit drug use, we are still firmly of the view that it is essenial in order to minimize the risks of creating dependence where none yet exists and of aggravating opiate dependence by allowing methadone to be a convenient adjunct to heroin dependence. Once again, it appears to be clear that many physicians are unlikely to have immediate access to the necessary laboratory facilities unless they are affiliated with an accredited treatment program. Although the omission of a requirement of urinalysis by the Federal Government in the implementation of its program may have seemed justified on grounds of temporary practical necessity—that an insistence on it would severely reduce the availability of methadone maintenance at the present time—we do not think it can be justified as a permanent policy. It is noteworthy that the most experienced special programs in the country regard urinalysis as essential.

Furthermore, as noted in Appendix A.2 Opiate Narcotics and Their Effects, extremely simple techniques are available for the preliminary extraction of urine on ion-exchange paper, which obviates the need for immediate access to chemical analysis facilities. After the extraction (which requires only the most rudimentary personnel training and supplies) the dried paper can be taken or mailed to a central laboratory for routine urinalysis. The transportation of actual urine samples is totally unnecessary. If medical support staff were instructed in the application of this simple procedure, and appropriate central analytic services were provided (either on a provincial or federal basis), urinalysis would not present a significant practical problem for the individual clinician, regardless of his location and affiliations.

In many methadone maintenance programs in North America, patients are required to urinate while under direct observation. We do not feel that this humiliating practice is appropriate or necessary. Accurate urine temperature measures, taken immediately after urination in privacy, would likely detect any attempt by the patient to substitute another sample for his own, and such measures should be taken routinely.

To reduce the dangers of "prescription shopping" and diversion to an illicit market, as well as eliminating the opportunity for the patient to reduce or avoid the prescribed dose (e.g., to facilitate the effects of illicit heroin use), the administration of methadone should be under supervision.

For those cases where it is necessary because of distance or other compelling reason to provide the patient with a prescription, pharmacists should be requested to directly supervise its administration on the premises. Where, in exceptional cases it is necessary to send a supply to a remote location, such as a logging camp, a responsible person in such location should be asked to directly supervise administration. There would undoubtedly be some practical problems to be solved before a decentralized pharmacy-based methadone administration system could be put into general operation. Some pharmacists might object to such a program, and may prefer not to be involved in routine supervision of methadone administration to heroin addicts in their stores. If daily urine samples were required of patients, as well as daily supervised drug administration, it would be greatly advantageous to have both functions performed at the same location. Consequently, in order for a pharmacy-based distribution system to be an improvement on the central clinic approach, it would also be necessary for the pharmacist to be responsible for obtaining urine samples on the premises. This added responsibility could conceivably lead to significant staff and space problems in certain pharmacies.

There are clear indications that the potential problems inherent in a pharmacy-based methadone administration and urine collection system are not insurmountable, and that solutions can often be facilitated at the local community level. Such a system has been in practice on a small scale in Edmonton for over a year. This program, involving six volunteer pharmacies, is no longer considered a temporary or experimental treatment component, but a regular part of the services available in that community. All patients must initially attend the central clinic routinely, but if sufficient progress is demonstrated, certain individuals are allowed the option of obtaining and consuming methadone under supervision at certain designated local pharmacies. In some instances, pharmacists take urine samples, as well. Other similar programs are in operation in the United States.

It would appear that generally where methadone is administered for maintenance rather than withdrawal therapy it should be administered at sufficiently high doses to block the effects of heroin; otherwise it may simply make it easier for the opiate dependent to maintain his habit in the illicit market by supplementing his supply of heroin and removing some of the pressure of "hustling". Erratic dose administration may aggravate a problem of opiate dependence by facilitating rather than eliminating the continued use of heroin. However, some flexibility should remain in the selection of dose at the clinical level, since we do not yet have adequate information for establishing the optimal dose to be employed. There is currently considerable controversy in this area, and further research is clearly needed. (See Appendix A.2 Opiate Narcotics and Their Effects, for a summary of methadone pharmacology.)

Longer acting derivatives of methadone, which extend the "coverage" to two days or more, are currently being developed and tested. Such compounds would significantly reduce the expense and inconvenience of supervised administration. However, certain problems remain to be solved, and it seems unlikely that methadone itself will be replaced in routine maintenance in the immediate future.

RESPONSIBILITY FOR ESTABLISHING THE NECESSARY TREATMENT CAPACITY

Since the introduction of the Federal Government's Methadone Control Program there has been a significant increase in the number of organized methadone treatment programs (see Appendix G.1 Methadone Control Program of the Government of Canada), but there does not appear to be sufficient capacity, with suitable controls, to meet the potential demand for such treatment in the country (see Appendix H Treatment Capacity in the Provinces).

It is impossible to determine from the records of the Drug Advisory Bureau whether there is sufficient capacity in the country as a whole to meet the real need for methadone maintenance. To do this it would be necessary to know the potential capacity of each approved treatment unit, as well as the capacity of authorized physicians, in relation to the estimated population of opiate dependents in their area. There are too many unknowns. Methadone programs in Canada do not maintain waiting lists as they do in the United States. They do not report the extent to which they are obliged to refuse applicants who meet their criteria for admission. It is a safe assumption, however, that the potential demand for methadone maintenance by qualified applicants exceeds by several times the number who are presently being treated in this way.

Apart from the question of capacity, however, we are obviously not yet beginning to approach the potential for the use of methadone maintenance in the management of opiate dependence. Opinions vary as to the proportion of the opiate dependent population that could be effectively treated with methadone maintenance. Some are considerably more optimistic than others. As indicated earlier in this Section a conservative estimate in the United States is that about 40 per cent of heroin dependents who are not incarcerated or in other forms of treatment could be persuaded to respond to methadone maintenance programs with reasonably strict controls.'' There appears to be a general consensus that methadone maintenance is likely to be acceptable to four or five times as many heroin dependents as therapeutic communities. It is estimated that at the end of 1971 in the United States there were 40,000 heroin dependents in methadone maintenance programs and 8,000 in therapeutic communities out of a total estimated population of 375,000 opiate dependents.8

In Canada, we estimate that there are less than 1,500 opiate dependents in methadone maintenance. The capacity of all programs is severely restricted by limitations of staff and financial resources. The two oldest and most experienced programs in the country, the Narcotic Addiction Foundation of British Columbia and the Addiction Research Foundation in Ontario, accommodate between them not more than 500 regular patients on methadone maintenance.

We have an impression that there is not yet a firm, governmental commitment to development of the capacity required to meet the potential demand for methadone maintenance in Canada. This lack of initiative and support to some extent reflects the misgivings which are still felt by many treatment professionals concerning this form of opiate dependence management—misgivings which have been referred to above—but it would also appear to reflect concerns of a jurisdictional and financial nature.

The Federal Government takes the position that it cannot assume the initiative for the creation of treatment facilities; that this is a matter of provincial responsibility. It can, however, assume a good deal of initiative, in consultation with the provinces, to encourage the development of new facilities and to participate in the financing of them. The provinces, on the whole, appear somewhat apathetic about establishing the necessary facilities for the treatment of drug dependence. This can be explained in part by uncertainty as to whether there is any form of treatment worth supporting. It is no doubt also due in substantial measure to concern about the cost.

It might appear more prudent to take the view that we should still regard this form of treatment as in the experimental stage, but there is a real danger in the present lack of certainty and full-bodied commitment. We should always adopt an experimental approach to methadone maintenance (as to other forms of treatment), in the sense that it should be accompanied by research and evaluation, but there should be a firm commitment now to make it as fully available as possible under proper controls. There is no virtue in a half-hearted policy. Such a policy may rescue a small percentage of opiate dependents from the illicit market but it cannot have a significant impact on the overall problem. So long as we are administering methadone to hundreds of patients we have passed the experimental or tentative stage. There is no good reason not to go all the way. There are definite dangers in a policy of legal availability of opiate narcotics, but once embarked upon it we should do what is necessary to obtain the maximum advantage from it. We should create the capacity and the outreach that will draw as many heroin dependent persons into it as possible.

If methadone maintenance is to be made available under properly controlled conditions and at a reasonable cost to the addict it must receive the financial support of government. The provincial governments have the primary responsibility for assuring these conditions of availability, although they may well call on the Federal Government for assistance. But someone has to assume responsibility for seeing that there is a proper program wherever it is needed.

We believe that the necessary government initiative must be taken to make it possible for all physicians authorized to use methadone to be affiliated with an organized program having the necessary specialized staff, laboratory equipment and ancillary services. We see grave risks in allowing the development of methadone maintenance through administration by private physicians without a control system based on affiliation with clinics that are adequately staffed and equipped, The experience of other countries, such as Great Britain and Sweden, is that if maintenance is left to private physicians there is a serious danger of abuses resulting in epidemic spread of use. We therefore strongly recommend that there be the necessary federal-provincial cooperation to establish the clinics or treatment units required to assure that methadone maintenance can be made available under properly controlled conditions to as many heroin addicts in Canada as possible. What is required is a national system of clinics or treatment units with a coordinated approach to monitoring and information exchange to prevent "prescription shopping" or "double doctoring".

Despite all efforts it may not be reasonably possible because of the widespread areas which must be served to require affiliation of all physicians, but at the very least the government should require evidence, as a condition of authorization, that a physician has made reasonable efforts to establish affiliation or that it is practically impossible for him to do so.

MONITORING OF METHADONE PATIENTS

Certain practical, ethical and legal questions arise in considering the mechanics of an effective national methadone monitoring system. It is well known that many heroin users are unwilling to identify themselves to medical authorities for fear of subsequent legal repercussions. Consequently, a significant number of such individuals register for methadone maintenance under pseudonyms; this practice is acknowledged by many clinicians involved in methadone maintenance and is usually not considered cause for serious concern from the treatment standpoint. Many clinicians feel that stressing positive personal identification early in treatment, or requiring it as a prerequisite to acceptance in a program, often impedes therapeutic progress and would likely deter many heroin users from accepting methadone maintenance. However, effective monitoring obviously requires an accurate system of identification to prevent an individual from obtaining methadone from more than one source.

Prescription and other authorized use of methadone is currently monitored by the Bureau of Dangerous Drugs, and, consequently, associated information is potentially available to law enforcement authorities. We feel that in light of the incriminating nature of the personal information collection inherent in the methadone monitoring process, such data should not be accessible to law enforcement officials unless some specific infraction of the methadone control regulations is involved. Such data should not be used for identifying, for law enforcement purposes, persons who are or have been users of illegal drugs, such as heroin. We feel that methadone prescription monitoring must be conducted by a regulatory body which is separate from law enforcement. If some infraction of prescription or program registration regulations is detected, the monitoring body should have the option of rectifying the problem through treatment channels, if strict legal action is not considered by them to be necessary or appropriate. Furthermore, pharmacists should be prohibited from releasing identifying information to anyone but the designated monitoring authorities. The responsibility for initial identification of the patient must rest with the medical authorities conducting the clinical program. As we have suggested elsewhere in this report, effective monitoring of medical use of all prescription drugs would be facilitated by the inclusion of the patient's social insurance number and the physician's registration number on the prescription.

The United States Special Action Office for Drug Abuse Prevention (SAODAP) has proposed a "Unique Identification System", based on a computerized footprint analysis and centralized data bank, which allows positive detection of duplicate registration in methadone maintenance programs without personal identification of the patient. Each person, when he enters a methadone program, provides a footprint sample, and is assigned an arbitrary identification number. Registration in different programs is detected if a second footprint sample from the same individual is submitted to the central clearinghouse. Individuals are never personally identified in these government records. This system is currently on limited experimental trial in Washington, D.C. and some surrounding areas, and is reportedly functioning satisfactorily. We do not recommend this system for Canada at this time, but do suggest that the development of the program in the U.S. be carefully observed. This system should be reconsidered at a later date if there is sufficient change in the present heroin and methadone situation in this country.

RELATIONSHIP OF METHADONE MAINTENANCE TO OTHER TREATMENT PROGRAMS

Concern for the individual—and for the effect on others of a steadily increasing opiate-dependent population—demands that we persist with our efforts to find effective means of achieving cure. Most observers feel that the path to success lies along the lines of a multi-modal approach in which methadone maintenance is only one of several approaches. In this multi-modal approach, designed to help the patient to find the way that is most congenial to him, methadone maintenance can play a stabilizing and transitional role. It can take the pressure and stress of living in the illicit market off the drug user, and give him the opportunity to begin to try to reorganize his life, to find work, to build new relationships, and generally to recover a new sense of self-worth. Thus stabilized and supported, the individual may then be more amenable to other approaches directed to helping him to give up drug altogether. Many will argue that it is illusory to think you can move towards a drug-free goal by starting off with methadone maintenance since this reinforces the reliance on drugs. So long as the individual can obtain the drug at little inconvenience and no cost he is not going to think seriously about giving up drugs. The answer to this may be that the individual cannot have very promising prospects for cure until some relief of stress and some relative stability have been introduced into his life.

HEROIN MAINTENANCE

If methadone maintenance is to be generally available, the question that inevitably arises is, why not heroin maintenance? In approving methadone maintenance we have approved a policy of legal availability of an opiate narcotic for maintenance purposes. Why not, then, heroin maintenance as well?

There are reasons why methadone maintenance is preferred to heroin maintenance: the fact that it is longer-acting, produces less euphoria and is effective when administered orally. All of these are thought to make it more compatible with normal functioning. It has not been proved in controlled tests that persons can function more effectively on oral methadone than on intravenous heroin, but this is the assumption of those who favour methadone, and it is a reasonable inference from the fact that methadone requires less frequent administration and produces less peak psychotropic effect.

Many physicians are strongly opposed to the intravenous administration of a drug if it can be avoided because it is regarded as a potentially dangerous procedure. Opponents of heroin maintenance point out that after a time it can become very difficult to find suitable places in the body for intravenous administration. They also stress the difficulty of establishing and stabilizing the dose level required to keep the dependent person out of the illicit market. Tolerance develops to heroin much more readily than to methadone. Finally, there is the difficulty of detecting the illicit use of heroin under heroin maintenance.

There can be little doubt, however, that fewer opiate dependents can be reached with methadone maintenance than could be reached with heroin maintenance. An American authority has estimated that about twice as many would respond to heroin maintenance.'

While the movement in Great Britain has been away from heroin maintenance towards methadone maintenance (although the extent to which methadone is administered intravenously removes much of the significance of the change), heroin maintenance is still used to attract into treatment opiate-dependent persons who will not accept methadone. (See Appendix G.2 Some Aspects of the "British System".) The reasoning is that once the clinics have made effective contact with such persons, they can be more easily persuaded to go onto methadone, or even to attempt abstinence. This was the reasoning behind our recommendation in the Treatment Report that heroin maintenance be permitted on a controlled, experimental basis, as a treatment adjunct to be used in exceptional cases. After expressing certain misgivings and degrees of support for this proposal among the members of the Commission, we said: "On balance, however, we believe that the availability of heroin maintenance will increase the capacity of the overall treatment process to win patients from the illicit market and for this reason it is a justified experiment." [P. 22.]

The Canadian Medical Association and the Federal Government expressed themselves as opposed to the proposal, although their rejection was not accompanied by any particular attempt to articulate reasons. This deep-seated, and almost instinctive, opposition becomes increasingly difficult to reconcile with the growing official commitment to the alternative policy of legal availability of opiate narcotics in the form of methadone maintenance. It may be that one of the unspoken reasons for opposition to the proposal of a controlled experiment with heroin maintenance is that it will attract American addicts into Canada, in much the same way as Canadian addicts were attracted to Great Britain by the "British system" in the 1960s. This need not be the case if suitable controls are exercised. With the greatest respect for those who rejected our proposal we reaffirm our belief that it would be a useful experiment under the controlled condition specified in the Treatment Report as follows:

As in the case of methadone maintenance we believe that heroin should be administered only by physicians accredited to specially authorized treatment centres, and then only after a panel of three physicians in the centre have approved such administration. It should be administered on the premises, and the patient should be required to remain on the premises until he is judged fit to leave. [P. 21.]

A similar experiment in heroin maintenance has been advocated by the Vera Institute of Justice in New York. The following are selected passages from a summary of its proposal entitled "Heroin Research and Treatment Program" (1972):

. . . the proposed experimental program would test a new treatment approach for addicts who have failed on methadone . . . .

. . . It would not involve prolonged heroin maintenance. What is being proposed is an experiment where heroin would be used for limited periods of time in order to attract, retain and stabilize patients who would subsequently be transferred within one year to treatment such as methadone maintenance, abstinence, or a narcotic antagonist (naloxone or cyclazocine) . . . .

. . . In contrast to the British system, all heroin used in the program would be administered within the clinic under close supervision to prevent its sale or diversion . . .

One of the research objectives of the program would be "to compare the effectiveness of a treatment program that employs heroin (in combination with injectible methadone) as a treatment drug with a methadone maintenance program".3 Up to now there have not been any published studies in Great Britain (where there is a natural laboratory for such purposes) of the comparative effects of heroin and methadone maintenance on the capacity to function in a socially acceptable manner, although there are some studies presently in progress. The reason for the lack of such studies in Great Britain may well be the heavy reliance on intravenous rather than oral methadone.

At the time of writing this report the Vera Institute of Justice had not yet been able to obtain the necessary approvals for its proposed experiment from, federal and state regulatory agencies.

For the present, our recommendation is not that heroin maintenance be made as generally available as methadone maintenance, but that it be something which approved treatment units should be able to resort to as a transitional measure to attract from the illicit market opiate dependents who will not respond to methadone.

The controlled experiment with heroin maintenance would be directed to its use as a last resort in selected difficult cases when every reasonable effort has been made to withdraw the addict from the illicit market by other means.

NOTES

Methadone Maintenance
1. M. Krakowski and R. G. Smart, "Report on the Evaluation of the Narcotic Addiction Unit's Methadone Maintenance Treatment Program," Unpublished manuscript, Project C 214, Substudy No. 492, Addiction Research Foundation, Toronto, 1972, p. 4.
2. W. H. McGlothlin, U. C. Tabbush, C. D. Chambers and K. Jamison, "Alternative Approaches to Opiate Addiction Control: Costs, Benefits and Potential," Paper prepared for the U.S. Department of Justice, Bureau of Narcotics and Dangerous Drugs, February 1972, mimeographed, p. 21.
3. Ibid., p. 40. See also Section X The Therapeutic Community.
4. E. M. Brecher & the Editors of Consumer Reports, Licit and Illicit Drugs: The Consumers Union Report on Narcotics, Stimulants, Depressants, Inhalants, Hallucinogens, and Marijuana—Including Caffeine, Nicotine, and Alcohol (Boston: Little, Brown, 1972), p. 78.
5. See note 3 above.
6. R. v. Gordon, 49 C.C.C. 272.
7. See note 2 above.
8. McGlothlin et al., "Alternative Approaches to Opiate Addiction Control," pp. 5-6.

Heroin Maintenance
1. W. H. McGlothlin, U. C. Tabbush, C. D. Chambers and K. Jamison, "Alternative Approaches to Opiate Addiction Control: Costs, Benefits and Potential," Paper prepared for the U.S. Department of Justice, Bureau of Narcotics and Dangerous Drugs, February 1972, p. 34.
2. Vera Institute of Justice, "Heroin Research and Treatment Program," New York, May 1972, (mimeographed), pp. 1-2.
3. Ibid., p. 5.