Though North America’s first heroin prescription trial is being described as successful in its early stages, it is being plagued with ethics questions regarding its research design and manner in which addicts are leaving the study.

The study, which began in February 2005, will have approximately 157 participants in Vancouver. Half of the volunteer participants were assigned to receive pharmaceutical-grade heroin (the experimental group) and half have been receiving methadone (the control group). With staggered start times for participants, some of the first group has already received treatment for 12 months before a 3 month transition period which could see them move on to a methadone maintenance program or a series of alternative treatments.

Initially, the study accepted addicts who had a documented case history of 5 years of heroin dependence, had used heroin daily for a year, were 25 years of age and older, had tried methadone more than once and lived within a mile of the study site in Vancouver’s Downtown Eastside neighbourhood. The research project is being funded by the Canadian Institute of Health Research Studies and is supported by the BC Ministry of Health and Health Canada.

The NAOMI (North American Opiate Medication Intiative) study required an exemption of Section 56 of the federal government’s Controlled Drugs and Substances Act and came a year and a half after Vancouver had opened North America’s first safe injection site. These public policy interventions came in response to a health crisis caused by infectious diseases associated with the use of addictive substances and overdose deaths in Vancouver’s Downtown Eastside neighbourhood, located minutes away from where the opening ceremonies for Vancouver’s 2010 Winter Olympics will take place.

Ethical review boards at each of NAOMI's three sponsoring institutions - the University of British Columbia, Toronto's Centre for Addictions and Mental Health and Université de Montréal approved the study. Some addicts in the community initially criticized parts of the study which required participants to give urine samples and reveal their medical histories and criminal records. The critics felt that there were too many barriers to enter the program and that it did not include enough participants to impact public health in a meaningful way.

Additionally, it was argued by participants of the study that the conditions which formed part of the study came from the requirements of the social stigmas attached to drug use rather than from a legitimate medical need to address the effects of addiction as a health issue.

Some researchers and ethicists are now arguing that the conditions placed on the study as part of its approval process could possibly lead to participants in the trial resorting back to street drugs or possibly failing on methadone maintenance.

“This is a highly scientific study which is being conducted to the highest possible standard. It is too early to comment on its findings. Though there are limits in the design of the study, the NAOMI study will generate evidence from which to inform public policy recommendations at its conclusion,” said Julie Schneiderman, spokeswoman with NAOMI, in an interview with IPS.

Dr. Ernest Drucker, a Professor of Epidemiology, Social Medicine and Psychiatry at Montefiore Medical Center at Albert Einstein College of Medicine in New York told IPS in an interview that though he supports the initiative, the safety mechanisms for the people leaving the study at the end of the trial period are inadequate from an ethical perspective.

“If the study shows effectiveness and the results are clear, the applied apparatus of higher research has to step in and ensure that there is not unneeded suffering. There could be clearly negative effects to the health of individuals and on public health generally. It would be inappropriate for academics and researchers to not to build in more adequate safeguards for participants leaving the study,” said Drucker. “There is still time to make a positive augmentation to the study and save lives. Are these research participants or are they medical patients?”

Drucker added that even though people with addictions entered the study willingly, researchers should have challenged the limitations of the study design to the government bureaucrats who approved the study. He told IPS that because people had already failed on methadone, a number of people could resort back to street drugs and jeopardize their own health and those of others.

Drucker added, “It is inappropriate for academics and researchers not to recognize and acknowledge the public health dangers associated with designing a study to fit institutional needs rather than those of human beings who should more correctly be viewed as medical patients.”

Principal Investigator of the NAOMI trial and Professor and Head of the Department of Health Care and Epidemiology at the University of British Columbia, Dr. Martin Schechter told IPS in an interview, “Though the study is ongoing, we can anecdotally observe that we are able to retain people in treatment by medically prescribing heroin to addicted people. We have had over 50,000 treatment episodes and few issues with safety. Some participants come in 2 or 3 times a day and many are using a lesser dosage than they are allowed.” Schechter also said that some participants no longer have to work in the sex trade to support their habit and some are visibly gaining weight and stabilizing their health as a result of having access to prescription heroin. He also said that the recommendations to policy makers should be based on evidence rather than emotion.

Schechter added, “For those who are critical of this study, I would ask them whether not proceeding with the study would have been better in terms of informing public policy? People have joined the study willingly.”

When asked if he would support the federal government approving the continuation of addicts on heroin prescription if they are having difficulty after leaving the trial, Schechter told IPS, “Absolutely. Every experimental therapy has issues attached to them and this one is no different. We are following the same procedures scientifically that we would with a cancer treatment.”

At issue with the NAOMI trial is that since some of the participants have already failed on methadone, leaving the study leaves some of them vulnerable to having to use street drugs to support their addiction. Dr. Tim Christie, Director of Ethics Services at Atlantic Health Sciences Corporation in New Brunswick told IPS in an interview, “Just because methadone failed previously for the research participants does not necessarily imply that it will fail when they come off of this study. It is not the same situation and the reasons could be diverse. However, from an ethics perspective it does enhance the risks to the individuals involved. It should be noted that the participants have given their informed consent as autonomous agents.”

Medical anthropologist and a Director with the Downtown Eastside based PHS Community Services Society and a supporter of the NAOMI study, Dr. Dan Small, responded in an interview with IPS by stating, “With all due respect, the idea of informed consent within the context of this study is a polite fiction - it is an artifact of the bureaucratic structures involved in the approval process of this study and does not sufficiently acknowledge the duress which the limitations of the health system and research apparatus place on individuals suffering from the serious illness of addiction.”

Dr. Small argues that what is at issue with this study is whether these individuals should be viewed as subjects of research or patients to a medical system which is meant to do no harm. “The NAOMI researchers are not neutral agents engaged in the process of scientific inquiry with guinea pigs nor should the participants be pawns in a chess game between policy makers and scientific researchers – these are human beings whose lives could be detrimentally affected or lost by leaving this intervention. Research needs to be grounded not just in empirical methods and the surface ethics and hierarchies of bureaucratic approval processes, but in deeper human values. Science and public policy are not like two ships that pass in the night. Those suffering from addiction are the walking wounded and we can’t afford as a society to parcel out kindness for a period of time and then take it away. Someone has to take responsibility for this situation and close this ethical loophole right away.”

ENDS

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