Policy makers ignoring science and scientists ignoring policy: the medical ethical challenges of heroin treatment
1PHS Community Services Society,
2Department of Anthropology and
Sociology,
3Montefiore
Harm Reduction Journal 2006, 3:16doi:10.1186/1477-7517-3-16
© 2006 Small et
al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative
Commons Attribution
A decade of research in
While the different sampling and research protocols for heroin treatment in these studies were important to the academic claims about specific results and conclusions that could be drawn from each study, the overall outcomes were quite clear – and uniformly positive. They all find that the use of prescribed pharmaceutical heroin does exactly what it is intended to do: it reaches a treatment refractory group of addicts by engaging them in a positive healthcare relationship with a physician, it reduces their criminal activity, improves their health status, and increases their social tenure through more stable housing, employment, and contact with family.
The Canadian trial (NAOMI), now underway for over a year, but not yet completed, now faces a dilemma about what to do with its patients who have successfully completed 12 months of heroin and must be withdrawn from heroin and transferred to other treatments in accordance with the research protocol approved by Government of Canada, federal granting body and host institutions. The problem is that the principal criterion for acceptance to NAOMI was their history of repeated failure in these very same treatment programs to which they will now be referred.
The existence of the results from
abroad (some of which were not yet available when NAOMI was designed and
initiated) now raises a very important question for
This essay discusses this dilemma and places it in the broader context of ethics, science, and health policy. It makes the case for continuation of the current successful patients in heroin treatment and the institution of heroin treatment to all Canadian patients living with active addictions who qualify.
"laws and institutions must go hand in hand with the progress of the human mind. As that becomes more developed, more enlightened, as new discoveries are made, new truths discovered and manners and opinions change, with the change of circumstances, institutions must advance also to keep pace with the times. We might as well require a man to wear still the coat which fitted him when a boy..."
Thomas Jefferson[1]
The Portland Hotel Society (PHS) is a non- profit social, health, and housing agency based in Vancouver's Downtown Eastside that has been active in providing services for people with active addictions for 15 years. The PHS operates a community based medical clinic treating this population with methadone maintenance, residential programs, and other approaches appropriate to people living with chronic heroin addiction. Despite the best intentions of these programs and the many fine clinicians practicing traditional addiction medicine, many in this population return again and again to heroin injecting – even in the face of the very real risks of AIDS, Hepatitis, overdose and the inevitable arrests and imprisonments associated with the illegal activities needed to get money for their habit. While many heroin users are eventually able to manage their addiction, some of the most troubled and persistent ones continue a downward slide and their continued use of heroin brings disastrous consequences. So obvious is this aspect of the heroin problem that many have said (including some police): "why not just give them the drug they seek – heroin?" Why not indeed?
On 29 January 2001, PHS, applied to the Federal Government
of Canada for legal permission to prescribe heroin in
Similar to the care of many cancer patients, the heroin treatment of opiate addiction isn't necessarily curative (i.e. having a goal of eventual abstinence from the drug); but is the best treatment option that the clinician can offer. In some of the saddest cases, it is essentially a palliative intervention aimed at reducing pain and suffering. But just as people living with cancer cannot simply enter the local pharmacy and purchase restricted drugs used in chemotherapy by medical oncologists in the treatment of cancer, so too, no one envisaged intractable heroin addicts going to the local pharmacy to purchase heroin. As patients in such a program, heroin addicts would need to be properly assessed by a qualified clinician and be able to receive the otherwise restricted treatment under vigilant medical supervision. And in order to properly supervise this form of treatment, Canadian practitioners would have to learn how to do it first hand. The start of this process has been the North American Opiate Medication Initiative (NAOMI).
The research team, led by principal
investigator Dr. Martin Schechter, an epidemiologist
and Director of the Centre for Health Evaluation and Outcomes Sciences (CHEOS),
established
The plan for the NAOMI was to
recruit 157 experimental participants and an equal number of controls from
three Canadian cities:
Importantly, even if the study
showed positive outcomes for its participants no provision was made for
continuing heroin for the study subjects after the 12-month heroin treatment
phase of the experiment. This is not to say that the patients on heroin would
be abandoned after one year. Under the study protocol, researchers planned to
switch those subjects into methadone maintenance programs or other treatments
of their choice. Recall that these same subjects were selected for NAOMI
exactly because they had repeatedly failed at methadone treatment (or other
treatment programs) in which they had not succeeded – including repeated
attempts at abstinence in traditional treatment programs [6]. The
ethical review boards at the three sponsoring institutions, the
The investigators for the NAOMI were trailblazers exploring new territory within the evolving framework of Canadian drug treatment policies based on harm reduction who were moving forward in the only way available within the regulatory framework. They could neither presume to know the results of their experiment before the science was completed, nor like previous studies in Switzerland and the Netherlands could they presume that the regulatory body would grant either an extension or expansion of the research exemption allowing heroin treatment for a time-limited period to a small group of addicted persons after the trial period. To insist that Canadian health authorities do so might have likely resulted in refusal of funding and the necessary authorization to complete the research.
Despite these complicated and
potentially compromising circumstances, the researchers directing NAOMI did not
blink as they undertook the political challenge to employ science to show
Canadians a way out of the addiction wilderness–in the classic framework of
rigorous clinical research. As public health and medical pioneers, they agreed
to draw on their symbolic capital and accumulated prestige (see [8]) of
their medical positions to discover the scientific answers that were required
to build both the scientific and the cultural railway towards formal
consideration of the institution of heroin treatment in
The NAOMI's
formal task was to answer specific research questions about the feasibility,
operational details and procedures, and a set of important clinical outcomes of
heroin provision under medical auspices. But, from the outset, this research
initiative was also implicitly and explicitly charged with the responsibility
of helping to develop a medical solution to one of the most vexing problems
facing
There have been several carefully
controlled trials of heroin maintenance that came before the NAOMI including
those performed in
There are benefits to studying the
use of a drug in different settings and the NAOMI was not an exact re-run of
previous trials. The NAOMI's particular clinical
criteria and protocol were adjusted for the
The intravenous drug using
population in
Further, in addition to the European
trials, there was nearly a century of clinical practice and experience in the
The Swiss were the first to show these effects through a careful evaluation of prescribed heroin for over 1,000 of the countries most refractory, long-term heroin addicts – targeting the most difficult of individuals who have had long-term difficulties with substance misuse and repeated failures with traditional abstinence based approaches to treatment. The Swiss studies showed unequivocally that prescribing heroin produces substantial declines both in illicit drug use and in criminal activity for this most problematic group. In addition, they provided clear evidence of improved social reintegration, i.e. better housing, more gainful employment, fewer drug associates and more contact with previously estranged families and friends. Here are some of details:
• Fitness for work improved considerably: permanent employment more than doubled (from 14 to 32%), unemployment fell by more than half (44 to 20%)
• The patients' housing situation rapidly improved and stabilized (there was in particular no homelessness)
• There was no fatal overdose due to prescribed substances
• No notable disturbances in local neighborhoods
• Significant economic benefit in terms of savings per patient-day (relating to savings in criminal investigations and prison days, followed by improvements in the state of health of the participants)
• There was a marked decrease in shoplifting (35% to 16.1%), breaking and entering (6.9 % to 0.0%), drug dealing and handling stolen goods (13.1% to 3.9%), sale of hashish (26.3% to 12.5%), sale of hard drugs (46.9% to 8.2%) based on interviews at time of admission and after 12 months of treatment
• Overall, offences dropped by 68%: Notably, this drop is not limited to short periods of time. The data from the Swiss study shows that this drop remained stable after 24 months of treatment. According to the Central Criminal Register, the number of convictions dropped by 80% [18]
The Swiss approach to heroin treatment has been criticized for being a program initiative rather than a randomized trial. But the RCT is NOT the only means to determine efficacy of new treatment strategies–indeed in public health programs it is rarely even an option. The successful introduction of methadone treatment occurred without one, likewise the widespread use of penicillin following World War II.
The Swiss health authorities
desired to move ahead quickly with a heroin project that was as much
demonstration and proof of principal as it was research per se. But many of methodological
concerns associated with their approach were addressed (in advance) by the
Swiss investigators, who went to great lengths to be conservative in their
methods and cautious in the conclusions they drew from their results [19]. All
the limitations of the study design were well recognized and repeatedly
addressed by the meticulous Swiss investigators and in no way diminished the
significance of their landmark study that revealed that alternatives to
methadone maintenance can attract and retain addicts for whom methadone has
proved unsatisfactory [20,21]. The
Swiss study was a response to an epidemic – its heroin injectors had the
highest rate of HIV infection in
The fundamental premise of all narcotic maintenance is that, for many patients addicted to opiates, the use of any one of a number of substitutes produces health and psychosocial results far superior to illicit street use or drug free treatment. Drug abstinence was never the goal for the Swiss patients, their doctors, or the Swiss Federal Office of Public Health. The original intent of the study was to improve retention of the patients in care, show improvements in the clinical course of their addiction (i.e. reduced illicit drug use and high risk injecting), and specific gains in the social outcomes associated with a diminution in the use of illegal drugs.
The outcomes from this study that
account for its public acceptance in a national referendum and the Swiss
Federal Health Department's decision to extend and expand the program by over
50%, and for a half dozen other nations to express interest in replicating the
Swiss work. The objective of reducing AIDS risk among the Swiss population was
paramount to thinking about the use of research such as this in the context of
responsible leadership in public health policy and is highly pertinent to the
situation in
Furthermore, re-enforcing the success of this strategic use of research to inform both Swiss policy and larger concepts of the scope of professional practice in addiction medicine, even the preliminary Swiss results that were decisive in persuading Dutch public health officials to initiate their own randomized study of heroin prescription in Amsterdam and Rotterdam (for 750 participants), and formed the basis of support for conducting similar programs as randomized controlled trials in Germany and in Canada.
The
The Dutch Heroin Maintenance Study was considered the most rigorous study to date (it was an RCT) and its results are fully available today. [22] Again these studies showed that it was feasible to conduct a program that made heroin medically available (for a 12 month trial period) to a group of hard core addicts with multiple prior failures in treatment. It also produced very positive results:
Adherence was excellent with 12 month outcome data available for 94% of the randomized participants. With intention to treat analysis, 12 month treatment with heroin plus methadone was significantly more effective than treatment with methadone alone in the trial of inhalable heroin (response rate 49.7% v 26.9%; difference 22.8%, 95% confidence interval 11.0% to 34.6%) and in the trial of injectable heroin (55.5% v 31.2%; difference 24.3%, 9.6% to 39.0%)." [22]
But when the Dutch trial was ended and patients had to stop the prescribed heroin and switch to methadone, many reverted to heroin use and there were serious adverse consequences for the addicts:
Discontinuation of the co-prescribed heroin resulted in a rapid deterioration in 82% (94/115) of those who responded to the co-prescribed heroin. The incidence of serious adverse events was similar across treatment conditions. Conclusions were that the supervised co-prescription of heroin is feasible, more effective, and probably as safe as methadone alone in reducing the many physical, mental, and social problems of treatment resistant heroin addicts." [22]
We will return to a discussion (in a later section of this paper) of this crucial problem in all heroin research – i.e. how to terminate the study when it is successful.
In
The main purpose of the study was to compare injectable heroin to oral methadone with respect to treatment outcomes in health, level of illicit drug use, crime, treatment retention, disengagement from drug community, employment, social connection, housing situation and ability to reach a difficult target group [24]. The total number of participants in the study was 1,120 with 560 in the methadone group and 560 in the untreated group. The first participant was enrolled in March 2002 in a randomized control trial to examine clinical efficacy of heroin in a structured treatment setting as well as its impact on crime, healthcare, cognitive-motor and neuropsychological functioning [25]. A cost benefit analysis and evaluation of the effects of two psychosocial interventions (motivational interviewing and addiction counseling) was also a part of the trial. The pharmacological component of the study was designed for 24 months with the entire study taking 36 months.
The results were
"unequivocally positive" was the conclusion reached by Federal
authorities and those of all seven participating cities where illegal drug use
was reduced, health status improved, and there was better social integration
and less criminality [26]. In
light of these results, the continuation of heroin treatment (as clinical
practice in
With approximately 150,000 people living with serious and persistent heroin addiction, three autonomous regions of Spain (Andalusia, Catalunya and Basque County) took the lead in convincing the Federal government to provide the legal framework to allow clinical trials of heroin prescription in 2001 [28,29]. From the inception of the research, the trial's researchers publicly disputed the Federal government's criteria that the patients would have heroin withheld at the end of the trial. Instead, the health authorities from the autonomous regions and the principal investigators took the firm position that it was medically unethical and inhumane to cut patients off clinically prescribed heroin once the research protocol was completed [30,31].
While the Basques have not yet been
successful in obtaining final approval for their proposed research trial from
the federal government of
Those prescribed heroin in the
experimental group made more gains than the control group receiving methadone
with respect to health and also demonstrated a corresponding decrease in criminal
activity, illicit heroin and cocaine use, drug related problems and risk
behaviors that might lead to HIV infection [28]. The
While these sampling and research protocol differences were important to the academic claims about specific results and the general conclusions that could be drawn from each study, the overall outcomes were quite clear – and uniformly positive. The cumulative international research and the massive body of work to date all point to the finding that the use of prescribed pharmaceutical heroin does exactly what it is intended to do–to reach a nearly unreachable group of people by engaging them in a healthcare relationship with a physician; reduce their criminal activity; improve their health markedly; and increases their social tenure in terms of homelessness and employment.
While there are some differences, all
of these studies and their objectives, especially
The existence of their results now
raises a very important question for
A decision point is about to be
reached for the use of heroin treatment in
We know that some patients in
heroin treatment use it as a pathway to reducing or stopping their heroin use
altogether. In several of the European studies, some individuals chose to
switch to methadone (usually in combination with program heroin) while still on
the trial. Using sufficient doses, they generally do well (at least in terms of
staying in treatment and not relapsing to heroin). Some even went into
abstinence treatment in
The Dutch have recently presented more detailed data on what happens to people ejected from heroin treatment because of the 12-month time restriction that was built into their trial (as in NAOMI). In the Dutch heroin trial, participants were considered to be "treatment responsive" if they showed a 40% improvement in at least one domain (e.g. drug use, arrests, health and mental status) where they performed poorly at the beginning of the study. Most did well. Of the group of 55 participants that completed treatment during the first year of the experimental period, 32 (58.2 %) were considered to be treatment responsive. And, as is proposed for NAOMI, even patients doing well were made to stop heroin treatment and either go onto methadone, drug free programs, or leave treatment altogether.
However, in the Dutch study a compassionate care provision was built in for safety – allowing the investigators to re-admit individuals to heroin treatment if they reverted to heroin use after the study. And most did, rather quickly. Of the "successes", 84% deteriorated within two months after heroin treatment was discontinued [35]. But most of these were re-admitted to the program, and the Dutch are now planning to institute the program as part of the available repertoire of treatment options.
The dilemma is clear – for many of these subjects (also still patients) who have responded well to NAOMI, stopping the provision of heroin will throw them back into a world of pain and high risk as they, predictably, strive to self-medicate with impure and unregulated illegal versions of heroin they can no longer receive safely under the watchful eye of a NAOMI physician. This challenge continues as a growing crisis for NAOMI and its subjects as more patients near the 12-month point.
The most widely accepted document outlining ethical standards for research at the international level is the Declaration of Helsinki [36]. There is a crucial section, paragraph 30, of the document that is pertinent to research on heroin treatment for addiction. It reads:
"At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study"[37]
The main motive for this portion of the international research guidelines is to prevent the sponsors of research trials (government, university, hospital or private) and physician collaborators from initiating research on subjects who would otherwise be unable to access the treatment offered in the research and then taking away the treatment when the research schedule is complete [36]. Similarly, the International Code of Medical Ethics of the World Medical Association (WMA) has recognized since 1949 that: "a doctor owes his patient complete loyalty and all the resources of his science"[38].
The NAOMI has strictly fulfilled the ethical requirement of the Declaration of Helsinki, particularly with regard to the clarifying footnote added to paragraph 30 by the World Medical Association in 2004:
"The WMA hereby reaffirms its position that it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care. Post-trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review [emphasis added]."[37]
The NAOMI definitely identified post-trial
arrangements and the ethical review boards of three institutions definitely
considered these arrangements in their review. However, the regulatory
framework with respect to heroin treatment for addiction left the research
designers and ethics reviewers in a difficult position of only being able to
offer, legally, already available traditional treatments that had already
repeatedly failed the patients in question. In a difficult ethical position
from the beginning, they daringly chose to carry onward because there was
simply no other option available to them if they were to stand any chance to
lay the groundwork for heroin treatment in
Although this is commonly disregarded in the scrum of international drug licensing differences and regulatory variations – i.e. many well respected medications in long term use in Europe are unavailable in the US, or items available over the counter in one country, are available only with prescriptions in another – in this case it is not profits but human lives that are at issue. The scientific facts about many key addiction initiatives are not really in question. What is in dispute is how governments, in this case the Government of Canada and its regulatory bodies, should respond to the evidence base that science has by now produced in some abundance, and the implications of that evidence for practice in Canada.
Addiction treatment policies, like any medical or public health practice, should be evidence-based. If not driven by evidence they always have the potential to lose their moral compass, especially if effective treatment that is available is withheld. The infamous US Tuskegee Syphilis Study provides a sad historical case of such treatment being withheld, in this case penicillin, that was developed after the trial began, but not made available to participants for the sake of completing the scientific study. While it may make some uncomfortable to relate this historical case to the present situation, we present Tuskegee to make the point that well-intentioned people who believe their actions to be in the best interests of people and society sometimes make unethical decisions that lead to social and medical disasters.
But closer to home in Canada, we
need only look back to the quarantined lepers of Canada that were relegated to
isolated islands, D'Arcy Island and Bentinck Island,
off the coast of Vancouver Island to die without medical or social support when
their disease was amenable to medical care. The lepers were given only rations
and coffins and the Government of British Columbia rebuffed assistance from
missionaries [39]. The
medical establishment was aware that leprosy was not acutely contagious but in
spite of this knowledge the panicked government officials exiled the afflicted
and left them to die without care. The ailing lepers were expected to bury the
dead until the banishment stopped in 1957 when the last person with leprosy
died. Only lepers of Chinese ancestry were reduced in importance to receive
this fate; the Euro-Canadian lepers from all across
A further example is seen in the
establishment of reserves or reservations for people of aboriginal ancestry,
complete with "Indian agents", that historically dictated when cattle
could be slaughtered, what crops were planted, where children were schooled and
in what language. In
The Tuskegee Study, commenced in
1932, was originally intended to take approximately one year, but continued
uninterrupted for forty years. This included a period of some twenty-seven
years after penicillin became the accepted and widely obtainable cure for
syphilis. Even then, the discontinuation of the study was precipitated not by
medicine or public heath officials but by an article by journalist Jean Heller
published on the front page of the Washington Evening Star (25 July 1972).
Twenty-five years later, on 16 May 1997, after hundreds of preventable deaths
in the original study cohort and allowing the participants to unknowingly
transmit the disease to their partners and children, President Bill Clinton
formally apologized on behalf of all of
We do not mean to demonize
research, policy makers or researchers. It is unlikely that either the
researchers or policy makers harbour any ill will towards those living with
active addictions living in the shadows of society. Similarly, those who
initiated the
One of the challenges to the
development of best practices in healthcare in
As the NAOMI reaches the end of its
first year, the first participants are due for discharge from the trial – that
is what they agreed to when they entered the study in the first place. But that
consent may need to be reexamined in the light of
subsequent evidence. And the fact that heroin addicts can only receive the
treatment they desire for a time-limited period that is dictated by research
protocol, without recourse to (for them) an effective treatment that has proven
itself in other valid studies, is (at best) ethically awkward with respect to
informed consent. Modern standards of informed consent have been developed most
substantially since the establishment of the Nuremberg Code for experiments
involving humans established in 1946 as a result of the legal prosecution of
Nazi physicians [45]. The
expectation of informed consent for human subjects is a complex issue when it
comes to marginalized individuals with active addictions whose access to the
analgesics to which they are addicted is only available through research? It
is, for example, disputable as to whether Canadian citizens addicted to heroin
that can only receive medical grade heroin in
Consider the alternative to an
evidence based medical and public health response to the problem of refractory
heroin addiction. In the
Despite the mass of decisive evidence
on the efficacy of methadone in treating opiate addiction, methadone is still
treated as a pariah drug in many parts of the world. Entire nations (e.g.
So important is the predominant
demand reduction approach in the
To learn more about this first
hand, one of us (DS) was part of a group of international experts and
practitioners in substance abuse health programs who visited the US in November
of 2005, under the United States International Visitors Program of the US Dept
of State. On one leg of that trip the group visited the Bloomberg School of
Public Health at
Later, the group visited the
National Institute on Drug Abuse (NIDA), the research-funding arm of the
Government of the
In light of the now massive body of scientific evidence supporting the efficacy of heroin treatment with thousands of patient years of experience in 5 national research trials with the Swiss having prescribed heroin to several thousand since the mid 1990's, a few hundred in the Netherlands and Germany and over 75 years of UK general medical practice–the PHS followed up its original request to Health Canada with an appeal on 2 January 2006 asking once again that community physicians in Vancouver's Downtown Eastside be permitted to prescribe heroin through a clinic for people living with active addicted to heroin but who have been unsuccessful with other clinical interventions. This appeal was made to Canadian health authorities on medical ethical grounds, asking for an exemption under Section 56 of the Controlled Drug and Substances Act (CDSA).
In a response written 14 February
2006, the Department of Drug Strategy and Controlled Substances for
"While heroin prescription has shown some promising results in Europe, sound evidence is needed to demonstrate its effectiveness in the Canadian context before Health Canada can be in a position to exempt heroin prescription for medical purposes..."
The letter points to the NAOMI study goal to determine whether heroin treatment:
"...Will improve the health and quality of life of injection drug users, reduce homelessness and decrease their interactions with the criminal justice system."
Just because the patients are addicts and the treatment is heroin, this issue for NAOMI does not exist in an ethical vacuum. We believe there is a medical ethics legal argument to be made regarding standards of care and access to effective health services for people with active addictions.
If the research in another sector
were as clear, this treatment protocol would by now be available e.g. if a new
drug for breast cancer or colon cancer were shown to be as efficacious and
effective as heroin has been shown to be, then the clinical trial would
generally be stopped and the medical program, with ongoing scientific
evaluation, would commence immediately. If this were another drug trial, say
for treating hypertension, would there even have been a statutory requirement
for a study to be repeated in
We cannot choose to use evidence
only when it suits policy objectives and ignore it when it contradicts them.
Nor can we discourage the collection of evidence base, using scientific
methods, for initiatives that are politically unpopular such as supervised
inhalation rooms. Once science has demonstrated the evidence-based outcomes for
an efficacious medical treatment, then governments have a medical legal
obligation to citizens and prospective patients to grant the legal authority to
practitioners to provide them as part of the continuum of available treatments.
The Government of Canada through the Department of Drug Strategy and Controlled
Substances at Health
The dilemma facing the NAOMI with
respect to its subjects at the end of the first phase of the trial has shown us
something very important: harm reduction is itself at a crossroads. The
potential for the medical prescription of heroin is not alone at this busy, and
dangerous, intersection of science, politics, ethics and morality as applied to
drug use and harm reduction. In a further letter to Health
"The demonstrated support of key stakeholders and partners, such as municipal and provincial health authorities and law enforcement agencies."
(Correspondence from Health
Here, the Health Canada representative makes it a condition that to obtain permission to initiate a scientific research study one would require support from municipal and state politicians along with that of state and federal police. It is difficult to imagine another parallel where a scientific research study, such as a clinical trial for a treatment for colorectal cancer, would require the study's authors or principal investigator to obtain a written endorsement from the Chief of Police, Mayor and City Council and Provincial Health Minister to proceed. It appears that the scientific method is being used as part of a government risk management strategy [46]. In the case of institutional risk management, the perceived risk is to the institution–a political risk–and the focus is on protecting the government and not the patient. Indeed it could be argued that the actual risk management issue for the Government of Canada in the case of heroin treatment is in failing to act when the scientific evidence demonstrating an efficacious treatment already exists.
Our goal has been to make the case that when it comes to addiction treatment, policy makers sometimes ignore science and scientists sometimes ignore policy. This mutual failure can be very costly. Science is but one arrow in the quiver of policy change, but it is the responsibility of a human being, acting ethically, to choose the arrow, and to decide whether and when to release it from the bow and in what direction to aim it. The NAOMI arrow is in the air, but where will it land?
While medical research is certainly
important for examining the efficacy and effectiveness of new treatments there
is more at stake in
The Canadian heroin trial, like
those that have taken place in
For much of the world, drug use and
addiction are still shrouded in a medieval cloak of moral disapproval. And many
nations' policies are still punitive and unforgiving of professionals who are
too accepting of drug use – witness the sharp attacks on Harm Reduction in the
Basic non-judgmental harm reduction ideas, almost universally seen as supportive by drug users, their families, and human rights advocates, are rejected by many authorities as "sending the wrong message" (vs. zero tolerance), as "enabling" by hardliners. In addition, the notion of "drug legalization", removing the drug issue from the realm of criminal law altogether, is used as an accusation akin to treason. And sadly, this is also true of addiction treatment in much of medical practice. Various forms of opiate maintenance treatment for serious and persistent heroin addiction already have a better prognosis than many other chronic medical or psychiatric conditions. Yet clinical and scientific ignorance, therapeutic nihilism, and medical neglect are still the norm in most of the world.
While genuflecting to the need for evidence base is part of the new high mass for policy makers and addiction treatment providers, in the case of addiction, the larger evidence base of population data is often ignored. Across the globe, most addiction treatment policy and practice have only the most tenuous relation to scientific evidence – witness the persistence of moralistic approaches based on self abnegation, religious conversion, or tough love with hardly any evidence to support them.
Addiction is a complex social issue that demands complex social solutions. The modernistic employment of science by the Canadian government to unearth incontrovertible answers to addiction is misguided. Research, in contrast to science, begins with recognition of the messiness of the constellation of issues surrounding social issues like addiction. Scientists, politicians and activists should not "expect science to decrease the complex web of their lives" [48].
The focus for the transition plan
regarding heroin prescription under NAOMI should now shift from the patients to
the trial itself. The NAOMI researchers have served
The original grant dollars provided
for the research should be supplemented by the provincial and federal
governments of
The trademark of high science, the randomized control trial, will not unshackle policy makers and politicians from the responsibility of making the difficult political decisions that are steadfastly rooted in the social world. Today, if ever, science itself does not meet its own "high" standards for disconnection from society, and even virtuous science is not really chaste – a pure science unfettered by the vagaries of society. Witness the contemporary scandals in pharmaceutical and stem cell research.
We know that the realms of science and the social are not really separate spheres:
"The adjective 'social' has been used to weaken science's claim to truth and certainty. And if you say that science is socially constructed, that is considered wrong by scientists. This tug-of-war between science and society, where one gains what the other loses, is not longer the only game in town. There is now an alternative. To the old slogan of science–the more disconnected a discipline from society, the better–now resonates a more realistic call for action: The more connected a scientific discipline, the better."[48]
All illness has a social component. The social dimension is crucial for effective medical treatment and is clearly visible, if one stops to look, in the etiology of disease as well as the quality and significance of its lived experience for the patient, their family and the community. This is true whether it is cancer, diabetes, schizophrenia, AIDS or addiction.
In the case of heroin prescription, the significance of the social context does not negate the unique place of the physician, who alone has the societal authority and responsibility to prescribe this highly restricted drug to treat disease and alleviate otherwise insurmountable pain. If medical practitioners do not shoulder their responsibility in this matter, then those with otherwise untreatable heroin addiction will be relegated to a world of unnecessary pain, forced to live at the bottom rung of society. There, they will be loathed for moral unevenness and imperfect personalities and doomed, by force of circumstance, to become a public menace and the target of law enforcement.
The addiction physician understands very well that illness is not only presented in the clinic; but instead originates and manifests itself most often in the everyday world of the addicted person and their family, a context where the physician may have little real influence. Nowhere is the social element of illness more unmistakable than in the life world of people living with addiction, and their families, where their social being is as much under threat by the tarnishing effects of a disparaging society as is their physical being by the hazards of unhealthy drugs and unhygienic needles. The person living with addictions is not alone in this position–there is a long history of illnesses that were stigmatized right out of medical practice but turned out to be quite treatable in the framework of modern medicine such as leprosy, schizophrenia, and today even AIDS. The only recourse is to thrust people living with addictions back into the medical realm and to support the practitioners who treat them humanistically.
This is not a new dilemma for medicine. In the Tate Gallery hangs a 19th century canvas, simply titled "The Doctor". It depicts a small child stricken with illness–the limp body lays helplessly on a bed in a tiny cottage while a compassionate country doctor watches over the child the whole night until the early morning sun brings some resolution to the crisis and the child awakens restore to health by the passage of time – with little the doctor can do but be there for the child and the family.
The full breadth of the physician's work often ranges far beyond the "science" of treatment and disease – often inadequate to relieve suffering, and always at the wrong end of deaths final victory. But the compassionate presence of the doctor is a crucial part of the patient's healing journey, no matter how great the suffering and regardless of the ultimate outcome.
In the lived experience that inspired the work by Fildes's (1843–1927), the outcome was tragic – the child (the artists own son) did not live to see the morning sun and died Christmas morning 1877. But the kindness of the doctor so moved the father that he painted the canvas as an homage, not to medical science but to one doctors compassion and spirit of solidarity [51,52]. That is the true art in medicine. It is time for heroin prescription to become part of that art.
1. Jefferson T: 
2. Dolphin R: A Blistering Debate.
Maclean's 1989, 41.
3. Gossop M: Research Note–Prescribing Diamorphine for Medical Conditions: A Very British Practice.
The Journal of Drug Issues 2004, 441-450.
4. Metrebian N, Carnwath
T, Stimson GV, Storz T: Survey of doctors prescribing diamorphine
(heroin) to opiate-dependent drug users in the
Addiction 2002, 97:1155-1161.
5. Wall R, Rehm J, Fischer B, Brands B, Gliksman L, Stewart J, Medved W, Blake J: Social costs of untreated opioid dependence.
Journal of Urban Health: Bulletin
of the
North America's First Heroin Prescription Program Introduced in Canada [http://www.worldpress.org/Americas/2054.cfm]
6. Bourdieu P: Language and Symbolic Power.
7. Fischer B, Rehm J, Brissette S, Brochu S, Bruneau J, El-Guebaly N, Noel L,
Tyndall M, Wild C, Mun P, Baliunas D: Illicit
Opioid Use in
Journal of Urban Health: Bulletin
of the
8. Tyndall MW, Kerr T, Zhang R, King E, Montaner
JG, Wood E: Attendance,
drug use patterns, and referrals made from
Drug and Alcohol Dependence 2005, in press.
9. Blanken P, Henriks VM, Koeter MWJ, Ree JMv, Brink Wvd: Matching of treatment-resistant heroin-dependent patients to medical prescription of heroin or oral methadone treatment: results from two randomized controlled trials.
Addiction 2005, 100:89-95.
10. Guttinger F, Gschwend P, Schulte B, Rehm J, Uchtenhagen A: Evaluating long-term effects of heroin-assisted treatment: the results of a 6-year follow-up.
European Addiction Research 2003, 9:73-79.
Degenhardt L, Topp L:
International Journal of Drug Policy 2003, 14:17-24.
11. Fuente Ldl, Toro C, Soriano V, Brugal MT, Vallejo F, Barrio G, Jimenez V, Silva T: HTLV infection among young injection and non-injection heroir users in Spain: Prevalence and correlates.
Journal of Clinical Virology 2006, 35:244-249.
12. Metrebian N, Shanahan W, Wells B, Stimson GV: Feasibility of prescribing injectable heroin and methadone to opiate-dependent drug users: associated health gains and harm reductions.
The Medical Journal of
13. Haasen C, Prinzleve
M, Zurhold H, Rehm J, Guttinger F, Fischer G, Jagsch R,
Olsson B, Ekendahl M, Manning A,
Cox G, Ryder N, Gerevich J, Bacskai
E, Casas M, Matali J, Krausz M: Cocaine
use in
European Addiction Research 2004, 10:139-146.
14. Simson GV, Metrebian N: Prescribing heroin: what is the evidence?
Joseph Rowntree
Foundation 2003,
1-60.
15. Uchenhagen A, A D-M, Steffen T, Gutzwiller F, Blattler R, Pfeifer
S: Prescription of Narcotics for Heroin
Addicts: Main Results of the Swiss National Cohort Study.
Lewis D, Gear C, Loud ML, Langenick-Cartwright D, Eds: The Medical Prescription of Narcotics: Scientific Foundations and
Practical Experiences. English edition.
16. Drucker E: Injectable heroin substitution treatment for opioid dependency.
The Lancet 2001, 358:1385.
17. Drucker E, Vlahov D: Controlled clinical evaluation of diacetyl morphine for treatment of intractable opiate dependence.
The Lancet 1999, 353:1543-1544.
18. W Vandenbrink VMH, Blanken P, Koeter MWJ, vanzweiten BJ, vanree JM: Medical prescription of heroin to treatment resistent resistant heroin addicts: two randomised controlled trials.
British Medical Journal 2003, 327:1-6.
19. Krausz PDM: German model project of heroin-assisted treatment of opiate dependent
patients-a multicentre, randomised, controlled
treatment study.
The German project of heroin assisted treatment of opiate dependent patient [http://www.clinicaltrials.gov/ct/show/NCT00268814]
20. WHO WHO: Models
of Medication Support for Opioid Addicts.
21.
22. Oviedo-Joekes E: Heroin treatment research.
In Edited by:
Small D. 2006.
23. Cordova J: Presentation of the
Office of National Control Policy. Edited by:
24. Bosch X:
The Lancet 2001, 357:1347.
25. Fischer B: Heroin-assisted treatment as a response to the public health problem of opiate dependence.
European Journal of Public Health 2002, 12:228-234.
26. March JC, Oviedo-Joekes E, Romero M, Gomez M, Rodriguez S, Leon MI, Rodriguez C: Captacion de participantes en el programa experimental de prescricion de estupefacientes en Andalucia.
Gac Sanit 2004, 18:245-247.
27. March J, Oviedo-Joekes E, Perea-Milla E: Heroin-assisted treatment–an innovative element of the drug support system.
In Edited by:
Small D. 2006.
28. Brink Wvd, Hendriks
VM, Blanken P,
29. Blackmer J, Haddad H: The declaration of
Canadian Medical Association Journal 2005, 173:1052-1053.
30. WMA WMA: World Medical Association Declaration of
World Medical
Association 2004.
31. WMA WMA: World Medical Association International Code of Medical Ethics.
World Medical
Association 1983.
Across the Generations: A History
of Chinese in
The History of Leprosy in Canada: British Columbia: D'Arcy Island [http:/ / www.leprosy.ca/ site/ c.anKKIPNrEqG/ b.747889/ k.A33E/ History_In_Canada.htm]
32. Dyck N: What is the Indian problem. The
The
33. Economist: Don't let it happen again.
The Economist 1997, 343:27-28.
34. Shweder RA: The idea of moral progress.
Philosophy of Education Yearbook 2003, 29-56.
35. Lerner BH: Sins of omission–cancer research without informed consent.
The
36. Small D, Palepu A, Tyndall
M: The establishment of
The International Journal of Drug
Policy 2006, 17:73-82.
INCB UNINCB: Report of the International Narcotics Control Board
for 2003. Edited by: Board INC. United Nations;
2003.
37. Latour B: From the world of science to the world of research.
Science 1998., 280:
38. Miller CL,
International Journal of Drug Policy 2004, 15:259-263.
2001 Report of the Auditor General
of
Fildes, Sir Luke: The Doctor [http://mchip00.nyu.edu/lit-med/lit-med-db/webdocs/webart/fildes50-art-.html]
39. The Doctor [http://www.tate.org.uk/servlet/ViewWork?cgroupid=999999961&workid=4277]
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al; licensee BioMed Central Ltd.
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