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Drug Legalization and Harm Reduction

Drug Prevention Document

On the Final Report of the "Programme for a Medical Prescription of
Narcotics" in Switzerland

 Preface  by Dr. Med. Ernst Aeschbach

"I welcome the recent announcement of the Federal Council of Switzerland that no further decisions on the use of heroin for addicts will be taken before mid 1997, I. e. after completion of an evaluation of the projects by the Swiss Government and WHO.

Dr O. Schroeder, President of the International Narcotics Control Board (INCB), Commission on Narcotic Drugs, March 1996.

The Board regrets that, before the evaluation by WHO of the outcome of the Swiss experiment, pressure groups and some politicians are already promoting the expansion of such programmes in Switzerland and their proliferation in other countries."

Report of the International Narcotics Control Board 1997, 367, February 1998.

From 1994 to 1996, Switzerland conducted a scientific experiment of prescribing heroin to addicts.  This experiment, involving 800 addicts, continued after the end of a trial period.  The heroin trials should be “medically controlled”, “scientifically accompanied”, and, according to repeated declarations of high-ranking government officials, they should not serve as an insidious foothold for the legalization of drugs.

The international community of nations was extraordinarily critical of the projects from the very beginning. Repeatedly, well-founded doubts regarding the aim and the effects of the trials were expressed. During the session of the Commission on Narcotic Drugs (CND) in Vienna in March 1997, numerous delegations sharply criticized the Swiss heroin trials and the obvious efforts to legalize drugs.

Regardless, the Swiss Federal Council actively fought the Swiss referendum “Youth Without Drugs” - which would have halted the heroin trials - by referring to the alleged success of those trials. In December 1997 the Federal Council decided to expand the heroin trials with no limitations to the number of participants. In recent months, the project directors and evaluators traveled to different countries, including Australia, and various European cities to promote heroin distribution as a new kind of treatment. This was before the independent evaluation by the World Health Organization.

In the most recent report of the INCB in 1997, Switzerland was sharply criticized. The report doesn’t call the projects “heroin projects” anymore, but “heroin distribution” according to the new reality.

Because of the advertising campaign of private and official proponents of heroin distribution programs, there is an increasing hope among authorities in Europe that the Swiss model could contribute to a solution of their drug problems.

This hope is more than deceptive, which is demonstrated by the available brochure by Dr. Ernst Aeschbach concerning the accompanying scientific research of the heroin trials. The brochure contributes to a rational, careful scientific discussion of the Swiss heroin projects by illuminating their serious design and methodological flaws.

Dr. med. Hans Köppel

Chairman Swiss Doctors Against Drugs

Dr. Med. Ernst Aeschbach

Spezialarzt FMH für Psychiatrie und Psychotherapie
 Im Schilf 6
CH - 8044 Zurich
Switzerland
 
Phone   ++411 350 4999
FAX     ++411 350 4998
email: aeschbach@compuserve.com

On the Final Report of the "Programme for a Medical Prescription of Narcotics" in Switzerland

Analysis of the Scientific Value of the Evaluation

Ernst Aeschbach, M.D., specialist for Psychiatry & Psychotherapy FMH

The evaluators have presented their final report on the Swiss heroin distribution projects and it has received considerable support by the mass media. Subsequently euphoric claim of success has been spread around the world. Many interested people who are critical of the projects and their results called for more comprehensive information. Those responsible have not responded. This paper summarizes the scientific criticism of the projects. In its introduction it describes the development of the heroin distribution projects and the importance of their political setting in Switzerland. In the body of the paper is the analysis of the results published in the Second Preliminary Report and the Final Report of the evaluators.

I. INTRODUCTION

In February 1991 the Swiss Federal Council formulated its strategy to reduce the drug problem in Switzerland. At that time, heroin distribution projects were explicitly rejected. Nevertheless, in May 1992 the Federal Council authorized under extreme political pressure heroin distribution projects on condition that they were evaluated scientifically. These projects were launched in December 1993 and were limited to an experimental period of three years. The final evaluation was to provide information about how a heroin distribution could complement existing treatment for drug addicts.

The creation of the heroin distribution projects must be seen against the background of the current debate on drug policy in Switzerland. Since the end of the 1980s members of political parties, members of Parliament, private associations and interested parties have advocated decriminalization of cannabis use, distribution of heroin to addicts and even the legalization of all drugs.[1] What all these demands had in common was the erroneous assumption that drug problems are caused by the conditions under which drugs are consumed, not by the substances themselves.

These advocates strongly supported the introduction of heroin distribution projects. The Zurich government even went so far as to allow the closing down of the open drug scene only after heroin distribution was approved. Requirement for accompanying scientific evaluation was more or less regarded as a necessary evil, but there was no real interest in its results.

Soon after the Federal Council’s decree criticism arose concerning the limited number of participants, the conditions for participation and its limitation to heroin distribution only. Therefore many people regarded these projects as a step towards a policy of free distribution of all kinds of drugs. They feared that the legal provision of drugs would destroy the addicts’ motivation to choose detoxification and rehabilitation treatment. In fact, heads of existing therapeutic institutions report a substantial decrease in applications. In recent years on occasions their institutions have had less than 50% of their facilities used even though there is no evidence of an equivalent decline in drug use in Switzerland.

II. BASIC CONSIDERATIONS

1.   The final report on the experiments for medical prescription of narcotics, published in July 1997, is based on several reports which are not yet available. Studying the final report raises many questions which cannot yet be fully answered. When the reports mentioned above are available, a further critical analysis must be made.

2.   According to the Federal Council, the decision to approve heroin distribution projects lies within its competence. It is based on article 15c of the narcotics law, which regulates the use of narcotics for scientific research. According to the Federal Council’s opinion, the approval can be granted by decree for an experiment limited in extent and time. The introduction of permanent heroin distribution projects, however, will require a revision of the federal law. According to the Federal Council’s decree, abstinence is the primary goal of all prevention and treatment measures. In the general experimentation plan for the medical prescription of narcotics, the Federal Office of Public Health (BAG) designated abstinence as the primary goal. The achievement of abstinence is thus the primary criterion for evaluating the success of any heroin distribution project.

3.   According to established scientific standards, results of surveys must be published in scientific journals, thus making them available for discussion and review by experts. Yet those responsible for these projects presented them to the public as success stories. In these presentations they repeatedly stressed that abstinence could only be regarded as one criterion among others. In the revisions of the plan for the projects, they no longer refer to abstinence. Instead, they identified the primary aim as the testing of new treatment measures. Such an unspecific and general objective confused their purposes and obscured the criteria for evaluating their accomplishments.

4.   The Federal Office of Public Health (BAG) has repeatedly pointed to the favorable evaluation of the Projects by experts of the World Health Organization (WHO). The International Narcotics Control Board of the United Nations (INCB) severely criticized this BAG action and emphasized that allegedly favorable statements on these Projects had been quoted out of context and from an unpublished report. INCB specifically put forward their objections to political manipulation of the Projects in order to expand heroin distribution and that, while they cooperate with Swiss authorities on international drug control programs, they have not endorsed the Projects.

5.   Ever since the Projects were initiated, the principal impetus for their adoption and implementation has been political pressure to devise a plan for easy and unlimited access to heroin, to offer other drugs, like cocaine, to addicts and to facilitate their home use.[2], [3] In the context of a separate study, even cocaine cigarettes were distributed to users, and the authorities reported that the project activity was welcomed by participants. In the final report of the Heroin Distribution Projects, there reference is made to positive effects of a lowered threshold and widened freedom of movement of the participants. After publishing the final report, the proponents have suggested new initiatives aimed at the introduction of heroin distribution projects to include 8,000 to 9,000 addicts. No modus operandi for implementing this proposal has yet been made public, nor has the general public or the medical community been consulted about the terms and conditions for distribution, the therapeutic objectives and the anticipated time limits for participation.

III. THE HEROIN DISTRIBUTION PROJECTS: OBJECTIVE AND IMPLEMENTATION

As pointed out above in the Introduction, the principal purpose of the Projects was to examine the effects of medically controlled heroin distribution on addicts, comparing their condition—e.g., addictive behavior, health, social attitudes and living conditions—on entering the Projects with that at completion. Its objective was to ascertain whether heroin distribution had a more positive effect on the participants and was more beneficial to society than narcotics distribution projects based on morphine or methadone. In order to evaluate those effects, the data came primarily from interviews with participants and the records of the distribution centers, supplemented by some medical, social and economic investigations. In the evaluation report, the principal therapeutic objective of the Projects defined was to enable participants to live an independent and responsible life, free of drugs. However, in the same part of the report, this objective is qualified by a statement that this objective could not be attained by all participants and that abstinence is an alternative or substitute treatment, whose use should be considered after weighing various factors, not merely the user addiction to heroin.

The significance of these explanations can only be understood in a broader context. The proponents of the Heroin Distribution Projects have repeatedly asserted that addiction must be understood as a phase or temporary period in someone's life which is overcome by a "tendency for spontaneous healing".[4] Such messages have been propagated by the Federal Office of Public Health (BAG) in large posters set up all over the country which tell addicts that they can succeed in withdrawal. In this context, therapeutic treatment is not required in the Heroin Distribution Projects, with the user just surviving and waiting for spontaneous healing.

Participation in the Projects was supposed to be limited to those "severely addicted" to heroin. By definition, this was to include those with a history of failure in other therapeutic programs. It is they who were to benefit from public health distribution of heroin. Additional qualifications included (1) being at least 20 years of age, (2) having a history of at least two years of addiction, (3) participating in at least two earlier unsuccessful treatment experiences and (4) inability to cope with his or her social environment.

Available data indicate that a substantial number of participants did not meet these criteria. According to the information provided in the Evaluation Report chapter, "Analysis of the Results", the background records on the participants indicate that they made little effort to use other available treatment opportunities.

Moreover, the concept of "severely addicted" merits critical analysis. It has been used to refer to those with a long history of addiction, in poor health and unwilling or unable to abandon drug use. It begs the question of the impact of recent Swiss drug policy decisions on the drug problem and how it has contributed to greater drug abuse and more "severely addicted" people, instead of supporting treatment programs which aim at withdrawal from drug use and rehabilitation of drug users. Expert studies of therapeutic methods universally emphasize the importance of early intervention[5], with preference given to abstinence oriented therapies. [6]

In addition, the term "therapy" as applied in the Projects warrants further analysis. Is the distribution of heroin the only "therapy" provided under the Projects or were other forms of treatment provided routinely to the participants? The available Evaluation Report does not answer this question. It is clear that the participants could request psychological counseling and psycho-social care; however, the authors of the Report point out that the staff of the Projects was not large enough to provide such care systematically to the participants. Thus, it cannot be presumed that such therapies were regularly provided under the Projects.

From the available Report, it can not be ascertained whether or not the therapies were part of an abstinence oriented treatment program as required under the authorization of the Federal Council. Indeed, the data provided in the Report on long-term participation in the Projects by the same addicts and the emphasis given to them need, for long-term distribution efforts, lead to a contrary conclusion.

One final concern with the implementation of the Heroin Distribution Projects relates to the lack of standardized treatment methodology. In its absence, the effects of psycho-social care cannot be evaluated.

IV. METHODOLOGICAL DEFICIENCIES

1. Basic Comments on the Scientific Methodology

In modern medical and scientific practice, there is established methodology for measuring the effectiveness of treatment regimes which invariably include control groups and precisely defined procedures which can be replicated. This methodology allows investigators to discern the relative effectiveness of one treatment in comparison to another. The principle of the control group requires that, when a group of participants is prescribed therapy, its results are to be compared with the results from another group which did not receive comparable treatment. In addition, participants are assigned to the respective group on a random basis so that external factors can be minimized; if the participants are permitted to choose for themselves in which group they wish to participate, this decision can be influenced by personal, not scientific, factors, and thus the results can be contaminated. To reduce the possibility of judgmental errors in project evaluation, the "double blind" procedure provides that all participants undergo the same medical treatment and that the evaluators be informed in detail about any variations in therapy regime.

If control group, random and double blind procedures are not precisely applied, evaluations of therapeutic effects are termed "observant studies". Such studies compare the results on patient groups which choose their own treatment. This methodology runs the risk of being biased by external factors. In addition, assessing the results in such cases regarding the situation of the participants before and after the treatment becomes very unreliable. With the lack of a control group, it is scientifically impossible to specify the causes for the changes observed.

2. Methodology Used in the Heroin Distribution Projects

A quasi-experimental procedure was selected to deal with some aspects of the evaluation. For example, they tried to predict the probability of participants withdrawing from the Projects by appraising their personality traits before the Projects were initiated. The statistical methods applied identified independent variables as causal factors for specific results (i.e., multi-variance analysis). The second preliminary report concluded that drug users who had been using different drugs for long periods, who were in bad health and lived in poor social conditions were the first to abandon participation in the Projects. This assessment illustrates how difficult it was to involve and retain the target group of “severely addicted" in the Projects.

 From the available report, it is extremely difficult to relate the methodology used to the measured results. Of what kind and to what degree were improvements reported for participants attributable to norms and procedures of the Projects? How much of the success reported was due to medical therapy or to psycho-social care? What role did the staff of the Projects play in seeking to introduce new treatment methodology? These are basic questions whose answers cannot be found in the available evaluation report. 

3. Reliability of the Data

Available data on drug addicts are based on self-reporting by the participants and such data raise serious doubts about their reliability. Based on past experience of other studies, data on the extent of drug use, health conditions, social and criminal activity provided by the participants have not proved to be sufficiently trustworthy to be used as the exclusive or even primary source of such critically important information.[7] In the Projects, the participants were the primary source of information on their own personal situation; and, tests were only performed every two months at times agreed on with the participants. 

4. Good clinical practice[8]

Medical studies to evaluate the effectiveness of treatment methodologies are usually conducted in strict accordance with established international research standards, from initial planning to the publication of the final results, as spelled out in the rules of "Good Clinical Practice" (GCP). GCP guarantees the quality and replicability of scientific research as well as the comparability of studies on the same subject in different settings. GCP guidelines also call for the technical independence of those responsible for conducting the research or experiment as well as those engaged in the evaluation. 

In the case of the Heroin Distribution Projects, these guidelines have not been complied with. It is ironic that some of the Project managers who were not substantially involved with the evaluation made public assessments in our country as well as abroad and began to promote support for the Projects even before the evaluation was completed. 

V. ANALYSIS OF THE EVALUATION

1. Pharmacodynamics / Pharmacokinetics

One would expect the chapter in the evaluation report on the pharmacology of the various narcotic drugs used in the Projects to provide scientific data about the drugs used, and not additional information about their effects on the users nor the various forms in which the drugs can be dispensed and taken. In the report, this chapter is scientifically useless for evaluation purposes since it primarily lists the different ways in which heroin can be taken, i.e. as pills, capsules, cigarettes, suppositories, inhalation spray or injection. This is supplemented by descriptions of subjective feelings such as flashes, comfortable warmth, euphoria, and relaxed feelings. The evaluation further details the amount of heroin that participants believed sufficient for their needs and that some reported a "calming comfortable feeling" or "a comfortable intensive warmth" after an IV injection of methadone which they deemed superior to oral doses. These comments leave the impression that additional in vivo studies were designed to satisfy the subjective needs of the addicts. 

2. Number of Participants / Sample Survey

1,146 people participated in the Projects (table 1). Data on 111 participants, about 10%, were excluded from the evaluation because the participants had withdrawn from the Projects in their early stages or the data about them was incomplete. Some of those excluded had received heroin while participating in the Projects before the required entry level data about them had been officially registered. Such practices raise serious scientific and administrative questions about the efficacy of the Projects and their management. In addition, if the data on the excluded 10% had been included in the final evaluation report, the conclusions about the "maintenance rate" would have been changed markedly. 

Table 1 Sample Survey

 

Cohort A

until 3/31/95

Cohort B *)

from 4/1/95

Total

Accepted for the experiment

 

 

1146

Quick resignation, incomplete data

 

 

111

 

 

 

 

Finally evaluated

385

650

1035

*) For the Cohort B practically so far no data available. 

3. Dosage and Course

The evaluation report does not provide an overall analysis of the prescribed substances, their forms of application and their combinations. The opiates, heroin, morphine and methadone were given intravenously and orally. But, heroin can also be prescribed as cigarettes, retard pills, suppositories, liquid inhalation, aerosol and powder inhalation aerosol. All possible combinations of substances and applications were offered in the Projects, sometimes in a triple combination For example, some addicts were allowed to inject heroin, smoke it and get morphine in pill form. 

In order to compile data about the effect of the venous dosages, especially in view of the disturbing combinations of narcotics and their applications, Project managers devised the methadone equivalent formula. After three months, an average, stable dose of about 160mgs of methadone equivalent is reached. Nothing is reported about the relationship between the characteristics of the opiates and the basis for calculating the equivalent. However, there are studies which show that the analgesic effects of equivalent amounts of opiates cannot be defined.[9] 

It would have been useful to identify those cases in which participants succeeded in reducing the amount of opiates they consumed over the course of the Project and the contribution of psycho-social care to the respective result. It would also have been desirable to compare the results achieved by the different prescribed dosages. It appears that such results were not intended to be collected under the Projects since the evaluation report does not even touch upon them. It further appears doubtful that any consideration was given to dosage reduction in planning and implementing the Projects. According to the information provided by the Project leaders for the evaluation report, participants were advised of the proper dosage which they should take to reach the happy state of euphoria. 

In the evaluation report, it is pointed out that the higher the dosage provided, the more likely the participants were to continue in the Projects. There is no further explanation for this finding than the addict's preference for heroin. According to the report, dosage is deemed sufficient if it provides the participant with the subjective feeling of comfort. 

This must be compared with evaluation reports on methadone treatment for which sufficient dosage is based on scientific criteria. A methadone dosage is deemed sufficient if it satisfies opiate receptors in the brain. It has been scientifically demonstrated that a constant methadone plasma level is important for the prevention of the use of other drugs and that a contrary effect occurs when cocaine is used;[10] for example, cocaine decreases the methadone level in the brain. Adequate methadone levels thus contribute to the reduction of further drug use. [11] 

4. Bern Double Blind Study

In Bern, a Double Blind study was carried out in which one group of participants was given heroin and another morphine. After an indefinite period of time, heroin was replaced by morphine in one group and morphine by heroin in the other. The result was not unexpected; morphine users were more likely to withdraw from the Project than the heroin users. What is surprising is the comment of the evaluators that heroin was preferred because it gave a stronger high to the users, had a more balanced effect on them and caused them less frustration. 

A) Status on Entry

At the time of their acceptance into the Projects, 49% of the participants had not received any in-patient therapy for their addiction and another 26% had only one therapeutic experience. 11% had never suffered physical withdrawal, and 65% had experienced withdrawal only 1 to 5 times, 9% had never taken part in a substitution program and a further 37% had participated only once (table 2). All in all, the participants selected for the Projects had made only limited use of existing therapeutic facilities, especially when on average an addiction lasts about 10.5 years. 

The relatively good health conditions at the time of entry into the Projects is also surprising. 79% were classified as good or very good. Equally surprising is that 80% were deemed to have a good or very good nutritional state. The psychological condition of some 60% was considered good or very good, with only 2% classified as very bad. Thus, there is good reason to doubt that these participants were really "severely addicted". 

Table 2

Comparison of the Treatment Histories of  Cohort A and B at Entry

Former treatments

Cohort A

n=385

Cohort B

n=650

Total

n=1035

 

Withdrawals

 

 

 

 

none

11%

11%

11%

 

1 to 5 withdrawals

65%

65%

65%

 

more than 5 withdrawals

25%

24%

24%

 

 

md=4

md=5

md=9

Cr's V.=.01;n.s.

Residential Therapies

 

 

 

 

no residential therapy

47%

50%

49%

 

1 residential therapy

26%

26%

26%

 

more than 1 residential therapy

27%

24%

25%

 

 

md=4

md=5

md=9

Cr's V.=.04;n.s.

Substitution

 

 

 

 

no Substitution

9%

9%

9%

 

1 Substitution treatment

39%

37%

37%

 

several substitution treatments

53%

54%

54%

 

 

md=4

md=5

md=9

Cr's V.=.02;n.s.

From: Programme For a Medical Prescription of Narcotics. Final Report of the Research Representatives. Synthesis Report. A. Uchtenhagen. Table 11, page 53. Zurich 1997. 

Another confounding detail that emerged from the data is that, among those chosen to participate, 4% did not use heroin and an additional 14% were only occasional users. Since one of the prerequisites for participation was daily use of heroin for at least 2 years prior to the initiation of the Project, this 18% should not have been selected. In fact, there is approved methodology for reliably determining chronic heroin abuse; [12] had this methodology been used, it would have enhanced the credibility of the Projects. 

It should also be pointed out that 61% of the participants were being treated in methadone programs at the time the Projects were initiated. The envisioned target group for the Projects was the heroin addict who had slipped through the treatment net of therapeutic institutions. The evaluators offer no explanation for the recruitment of participants who were already in methadone programs. 

B) Effects on Participants

The course data were only given for those participants of cohort A (n=385) who took part in the experiment for at least 18 months (n=237). This fact must be taken into consideration when interpreting the results. There have practically no results for the bigger cohort B (n=650) been given yet. 

1. Physical health

In the chapter of the evaluation report on the impact of the Projects on the physical condition of the participants, there are claims of significant improvement. However, on studying the data, these improvements over the life of the Projects appear to be modest at best. It is reported that the somatic state (whatever that means) improved from 79% to 86%, but it is unclear from the data whether the change was due to the distribution of legal heroin or improved medical care. Those participants who were underweight declined from 35% to 23%; but, once again it is unclear from the data if the change was due to heroin distribution or counseling provided by social services on better nutrition. The average heroin user weighs less than non-users, and the nutritional factor was considered a secondary question in the context of this evaluation.[13] 

The reported decrease in the number of abscesses had been anticipated. However, the decrease reported is not dramatic. Only 17% were afflicted by abscesses when selected as Projects participants, and after 18 months, this had declined to 7%. A special sample study, designed to generate favorable publicity for the Projects, demonstrated a rapid decline in the number of treated abscesses from 31 in the first month of the Projects to only a few after 13-18 months. The significance of this special study is dispelled by recalling that, as pointed out earlier in this paragraph, only 17% of the participants, i.e. 40 individuals, suffered from abscesses when they entered the Projects. 

One of the strongest arguments to justify the Projects was that they would help prevent HIV. The final report on the Projects boasts that only a few cases of new infections occurred among the participants. On analyzing the data, it appears that Project managers were too easy on themselves. On the one hand, there was no requirement that participants take HIV tests. It is unclear how many were in fact tested and whether the reported information was based on medical examinations or statements by the participants themselves. If the participants had been required to take HIV tests, there would have been credible data to assess the effects. 

HIV prevention for drug addicts is a complex problem. Continuous intravenous drug abuse is a primary risk factor for becoming infected with HIV. Methadone programs can reduce the incidence of needle exchange. This is not due to basic change in behavior; but rather because methadone is less likely to be taken intravenously.[14] The danger of HIV infection from unsafe sex among drug abusers tends to be underestimated; a side effect of drug abuse is that addicts find it difficult to make effective use of precautions to avert the dangers of HIV infection.[15] The scientific community is still debating the effects of continuous heroin abuse on the progression of AIDS in HIV positive addicts,[16] but all agree on the importance of a healthy life style for combating AIDS. Nothing in the evaluation report contributes to the scientific debate. 

2. Psychical health

The report stipulates that the number of participants suffering from psychic disorders declined from 36% to 18% over 18 months. Seizures, mental disorders and behavioral problems did not require attention after the second month of treatment. These data suggest a decrease in psychiatric diseases, and it should be viewed as a positive development if psychiatric care provided under the Projects led to this improvement. 

3. Pregnancies

Drug addiction and pregnancy are especially serious problems for the mother and her child. Babies of drug-dependent mothers, when they are born, often weigh less, have a smaller than normal head perimeter, are more hyperactive, are inattentive and suffer from troubled behavior. The negative influence of the drug-dependent mother has equally important effects on her child.[17] 

Especially dreadful is the neonatal abstinence syndrome which often afflicts polytoxicomaniac mothers.[18] There is ample scientific literature about this problem, but scientists do not attribute grave consequences from it. Their conclusion is that impact of addiction on pregnancies is not substantial, except for inducing spontaneous abortions. 

4. Addictive and Risk Behavior

The data shows that 81% of the participants indicated on entering the Projects that were cocaine users, and that number declines to 52% after 12 months. However, there are indications that such assertions were only sporadically verified by urine testing. Urine testing every two months showed positive results in 10% of the cases. It should be pointed out that the only participants who were covered in the evaluation were those who remained in the Projects for at least 13 months. It must be presumed that the number of positive results would have increased if all of those who participated in the Projects had been tested. The 10% positive result is not surprising when viewed in relation to other conclusions of the evaluation report. Since various drugs have similar addictive effects on the brain and are thus exchangeable for achieving desired highs, a credible ascertain of substantial reduction in drug should be supported by periodic urine and other tests. Similarly, if addicts are provided with their drugs legally, use of drugs from illegal sources will invariably decline. 

5. Social integration

The reported improvement in the housing conditions of the participants is welcomed. However, a critical analysis is needed to identify the causes for this improvement. While the number of participants with stable housing arrangements increased from 49% at the initiation of the Projects to 69% after 18 months, there was no control group set up to ascertain whether the improvement was due to free heroin distribution, the improved financial situation of the participants or government support in locating appropriate places to live. It should also be pointed out that, for reasons unrelated to the Project, there was a surplus of rental housing throughout Switzerland at the time that the Projects were being implemented. 

A significant reduction in indebtedness of the participants is also reported. The reductions range from 5,000 to 30,000 Swiss Francs. However, there is no indication of the source of funds drawn upon to reduce these debts. As has been pointed out in previous sections of this paper, the reported changes are more likely to be attributed to the psycho-social care and services, than free heroin distribution. 

It goes without saying that the improvement of the employment situation is welcomed (Table 3). Certainly the present data have to be interpreted very carefully. The report at hand talks about employment situation and not about fitness for or ability to work as it would be the norm. Unfortunately the categories do not provide typical criteria. So the first category „working“ includes part-time and full-time workers whereas the second category includes temporary workers, people working in a household and pensioners. This makes it nearly impossible to evaluate the data. 

Table 3 Job Situation at Entry During the Course

 

Job situation

at entry

Job situation

after 6 months

Job situation

after 12 months

Job situation

after 18 months

 

(n=230; md=7)

(n=237; md=0)

(n=237; md=0)

(n=237; md=0)

working

14%

23%

31%

32%

temporary/in the household/pension

42%

51%

52%

48%

unemployed, without pension

44%

26%

17%

20%

From: Programme For a Medical Prescription of Narcotics. Final Report of the Research Representatives. Synthesis Report. A. Uchtenhagen. Table 27, page 74. Zurich 1997. 

The number of pensioners increases in the course of the experiment. (Table 4) This may be rooted in the neediness for a pension which has been stated in the course of the experiment and which might be justified. But seen from the point of view of an improved employment situation we should expect a decrease in the neediness for a pension. This problem would have been easily solved by providing the data of fluctuation (number of new pensions and number of suspended pensions). 

Table 4 Pension for Invalidity (IV-Pension) at Entry and During the Course

 

IV-Pension

at entry

IV-Pension

after 6 months

IV-Pension

after 12 months

IV-Pension

after 18 months

 

(n=233; md=4)

(n=237; md=0)

(n=237; md=0)

(n=237; md=0)

no Pension

82%

78%

76%

73%

receives Pension

18%

22%

24%

27%

From: Programme For a Medical Prescription of Narcotics. Final Report of the Research Representatives. Synthesis Report. A. Uchtenhagen. Table 29, page 75. Zurich 1997. 

6. Delinquency

Information on the delinquency rate provided by the participants themselves is indeed suspect. Doubts about the credibility of statistics unsupported by objective evidence have been raised throughout this paper. As a result, to supplement reports by the participants about themselves, the evaluators have checked police registers on some special cases. 

According to the data provided by the participants themselves, the felonies in which they were involved to obtain money declined slightly, while the number of violent crimes and those involving the use of firearms, increased. The significance of such reports cannot be assessed because the numbers are too small. 

To verify that the Projects contributed to a decline in delinquency rates, that decrease should be commensurately reflected in the data on all categories of addicts. The available data are not persuasive in this connection. Even if they were, it does not necessarily follow that the decline reported in the evaluation is due to the free distribution of heroin. It is more probable that the positive results are due to the financial aid and social services provided for those participating in the Projects. 

C) Analysis of Withdrawals from the Projects and Alternative Treatment

Through the life of the Projects, 350 of the 1,146 participants chose to withdraw. 34 others were excluded from the evaluation study because they had not been examined at the time they joined the Projects. Evaluation results are only available from cohort A, made up of 385 participants (table 5); 128 participants had already withdrawn from the cohort: of those who withdrew, 16% entered abstinence oriented therapy and 39% methadone programs. Based on the total number of participants in cohort A, i.e. 385 persons, this represents a "success rate" of 5.2% measured against the stated goal for Switzerland of abstinence from drug use. 

Table 5 Reasons for Resignation in Cohort A and B

 

Cohort A

Cohort B

 

n

%

n

%

Abstinence-oriented treatment

20

16%

46

33%

Withdrawal treatment with Methadone

2

2%

2

1%

Methadone-Substitution

50

39%

49

36%

Hospitalization

5

4%

1

1%

Moved away

3

2%

2

1%

Custody

0

 

4

3%

Exclusion

19

15%

15

11%

Abandonment by the patient

15

12%

14

10%

Other reasons

7

5%

4

3%

Died

7

5%

1

1%

Total number of resignations

128

100%

(138)1

100%

1 The numbers of resignations in Cohort B can only be compared with those of Cohort A with some reservations, since the period of observation is only 18 months for a small proportion. 

From: Programme For a Medical Prescription of Narcotics. Final Report of the Research Representatives. Synthesis Report. A. Uchtenhagen. Table 43, page 87. Zurich 1997. 

Comparative studies were made of the characteristics of those who withdrew from the Projects with those who remained. Those who left were classified in two distinct groups: (1) one group was made up of those who left the Projects to enter other therapy programs and (2) the second group consisted of those who withdrew without seeking alternative treatment. Comparison was by sex, age, duration of addiction, housing conditions, physical state, etc.. According to the evaluation report, primarily those participants who left the Projects in poor physical condition and/or were HIV positive did not seek alternative treatment. 

The comparison by age proved to be of little value because of the differences in characteristics of the various groups. The group which entered alternative treatment is made up of people who accepted an abstinence-oriented facility or enrolled in a methadone program. Some of those who withdrew without seeking alternative treatment are living drug free while others feed their habit with illegal drugs. Studies should have been undertaken to compare the motivations, goals, living conditions and personal problems of those living abstemiously and those continuing to consume drugs. As such studies have not been undertaken, we can only presume that long-term heroin addiction, daily cocaine use and poor health are the risk factors which make it difficult for addicts to reach the goal of abstinence. 

To document the results of therapy over the longer term, periodic follow-up information is needed from participants after they leave treatment. The results of the first follow-up effort was disheartening: only 12 participants who had withdrawn from the Projects were available for study. 17 have died, 5 have moved away; 9 are untraceable; and 30 have refused to respond to the questionnaire. As follow-up data is needed over a period of several years, it is doubtful that any meaningful long-term information will become available. 

In the evaluation, there are assertions that the Projects improved as they evolved. No data or statistics were presented in support of these assertions. In the report, there is no basis for comparing the relative advantage to the participants of staying in the Projects or withdrawing from them to enter alternative therapy programs. 

An evaluation of the Second Preliminary Report shows that a long-term addiction, daily cocaine use and a positive HIV status are risk factors for an early withdrawal from the project (Figures 1 and 2). This shows that the so-called severely addicted persons, that is the main target group for the experiment, have been poorly met.

Figure 1

From: The Medical Prescription of Narcotics Programme. Second Interim Report of the Research Team. A. Uchtenhagen. Illustration 3.2.1, page 95. Zurich 1996.

 

 

 

 

 

 

 

Figure 2

From: The Medical Prescription of Narcotics Programme. Second Interim Report of the Research Team. Illustration 3.2.2, page 95. Zurich 1996.

 

 

 

 

 

 

 

 

VI. CRITIQUE OF THE INTERPRETATION OF THE RESULTS

1. Maintenance Rate

In the evaluation, great emphasis was given to the high "maintenance rate" of participants in the Projects (table 6). In fact, the high rates were compared to the "maintenance rates" in abstinence oriented therapies. Such a comparison is unacceptable. To demonstrate why, an analysis of the term "maintenance rates" has to be made.

Table 6 Maintenance Rate

 

6 months

12 months

18 months

Cohort A

n=385

89%

76%

69%

Cohort B

n=650

89%

(80%)

(77%)

From: Programme For a Medical Prescription of Narcotics. Final Report of the Research Representatives. Synthesis Report. A. Uchtenhagen. Table 16, page 58. Zurich 1997. 

The final report does not contain any statement about how they want the term "maintenance rate" to be understood. Usually a participation of 75%, for example, is laid down; or  to stipulate the attendance of 2 appointments out of 3 possible ones in the treatment centers. A renunciation of these exact definitions call into doubt the applicability of such data. 

2. What is a "High Maintenance Rate" in the Context of the Projects?

The success of any therapeutic treatment must be assessed in the context of the objective set for it. The goal for all treatment is to cure disease. The therapy is designed to heal the basic disease. Acceptance by the patient is only a prerequisite for the application of the therapy. In developing new methodologies for treatment, scientists seek to achieve the best possible holistic approach and patient acceptance, but the objective of healing remains the central consideration. The proponents of the Projects present us with a deep dilemma since they are trying to use a "therapy" that fails to cure the disease it pretends to deal with. 

3. What is the Real Therapeutic Agent?

From these reflections the questions naturally arises about what is the real therapeutic agent. Do those responsible for the Projects attribute a therapeutic effect to heroin? When criticizing the results in this paper, it has been repeatedly pointed out that there is no evidence that the free distribution of heroin has been the cause for any observed change. Or, do those responsible view the Projects as the mechanism for keeping drug addicts in a therapeutic setting? If so, standardized treatment methodology should have been defined; with the specific goal set as the sustained participation of the addicts; this would have specified a precise result to be measured. These questions are not answered in the evaluation report. 

Sensitive and effective help in overcoming drug addiction requires a thorough understanding of the addiction and must be geared to the individual needs of the patient and his current problems. Each addicted person faces the daily dilemma born of his compulsion to use drugs. Again and again. Although he suffers terribly from their negative effects, he is physically or emotionally forced to continue to use them. This compulsion often becomes stronger than the will to take upon himself the painful therapy of withdrawal and treatment. Nevertheless, most addicts have the desire and hope to live without drugs. The inopportune but frequently heard phrase "drug career" is intended to describe the continuous interplay of hope and feelings of failure which obsess the drug addict, a vicious circle that leaves less and less probability of a life without drugs. 

Help for the addict which is not directed to curing the disease runs the risk of making access to drugs easier and alleviating only immediate needs. The root of the addict's problem remains unattended. Measures to be truly helpful must be applied within the framework of an overall treatment to free the user from his addiction. Otherwise, the addict and those responsible for his treatment are in danger of being satisfied with partial results, with the addict remaining exposed to the recurring danger of drug abuse. 

Physical withdrawal is the most important step toward a drug free life and can be the starting point for coping positively and successfully with the problems which the addicts face. It is thus axiomatic that all effective therapies must assist the addict to reach the goal of abstinence. This must be the gauge for measuring the effectiveness and success of any drug treatment. 

4. Can Heroin Distribution be Compared to Other Therapies?

The directors of the Projects, when they addressed the media about their work, called Heroin Distribution Projects superior to other therapies and specifically those directed to abstinence. As is evident from the comments earlier in this chapter about "maintenance rate", this comparison is unacceptable. Staying in a heroin maintenance program is no measure of its success. This is clearly demonstrated by the studies of the Swedish methadone program, which show addicts who remain in treatment for 20-30 years are still susceptible to relapses. Comparisons can only be made in relation to the success achieved in reaching defined goals, and that goal in drug therapy must be the ability to withdraw from drug use. This is the gauge for measuring the success of any treatment program.

VII. CONCLUSION

The assertions of positive results from the Swiss Heroin Distribution Projects are inconsistent with the goal of abstinence. The logical consequence of this conclusion should be the immediate termination of the Projects and a return to the well-proved treatment methodologies. This conclusion will not be influenced by any additional information made available in the planned special studies being carried out now on certain aspects of the Projects and their participants. 

Compared to the primary goal of abstinence, the 5.2% success rate of the Projects is abysmal. Because of the lack of cooperation by the participants, the planned follow-up studies cannot be expected to produce meaningful data. We should not expect any significant long term benefits from the Projects. 

The improvements in the health, social and other conditions of the addicts are welcome. However, the evaluation does not establish that they are due to heroin distribution. 

The decrease in delinquency among the participants, an often heard argument in support of the Projects, is not borne out by the statistics. The data show that whatever decrease in criminal activity by those participating in the Projects was not unique to them, but were consistent with similar patterns observed in connection with other community groups. 

The objective of incorporating the "severely addicted" as participants in the Projects was not achieved. The statistical evaluation made in the second preliminary report shows it was precisely the "severely addicted" who were the first to withdraw. Thus, heroin distribution does not appear to be an alternative treatment for the "severely addicted". 

By euphorically and uncritically announcing success for the Projects in the public media, even before the evaluation was completed, the proponents and evaluators have lost credibility. These claims are not supported by the data. The unprofessional use of the media is illustrated by the appearance of a Project Director on a television show in Australia in which he blithely proclaimed success before the Final Report of the evaluators has even been presented. This is a violation of the established scientific rules of procedure, which are intended to assure the independence of evaluators from the managers of projects. 

Switzerland would do well to return to established methodologies and therapies for treating and eliminating dependency on drugs. This solo experience with heroin distribution has provoked only concern and confusion in most of the world community. At the international level, the Commission on Narcotic Drugs (CND), whose members are party to the three United Nations Conventions on the control of narcotic drugs and psychotropic substances, have consistently and overwhelmingly rejected proposals for state distribution of heroin to addicts. 

VIII. APPENDIX

This analysis is based on the following reports: 

·     Verordnung über die Förderung der wissenschaftlichen Begleitforschung zur Drogenprävention und Verbesserung der Lebensbedingungen Drogenabhängiger vom 21. Oktober 1992. 

·     Änderungen der Verordnung über die Förderung der wissenschaftlichen Begleitforschung zur Drogenprävention und Verbesserung der Lebensbedingungen Drogenabhängiger vom 21. Oktober 1992, 1. Januar 1997. 

·   Versuche für eine ärztliche Verschreibung von Betäubungsmitteln, Gesamtversuchsplan, Ausführungsbestimmungen, Bundesamt für Gesundheitswesen, 1.11.1993. 

·     Versuche für eine ärztliche Verschreibung von Betäubungsmitteln, Zweiter Zwischenbericht der Forschungsbeauftragten, Institut für Suchtforschung Zürich, Institut für Sozial- und Präventivmedizin der Universität Zürich, September 1996. 

·   Versuche für eine ärztliche Verschreibung von Betäubungsmitteln, Abschlussbericht der Forschungsbeauftragten, Synthesebericht, Institut für Suchtforschung Zürich, Institut für Sozial- und Präventivmedizin der Universität Zürich, Juni 1997.

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