SALOME Heroin Legal Challenge
Supreme Court of British Columbia Decision
Supreme Court of British Columbia grants injunction providing access to heroin-assisted treatment to SALOME patients
|Supreme Court of British Columbia Decision||News Release - SALOME Injunction Decision|
We have launched a legal challenge to the recent decision to overturn access to life-saving medications to critically ill patients from the SALOME clinical trial. The challenge is intended to save the lives of former participants who are critically ill and will see their life-saving drugs withheld due to this decision.
Follow our progress at #SalomeTrial.
Here’s what you need to know about prescription heroin and heroin-assisted treatment (H.A.T.)
- Heroin addiction is a chronic illness, like heart disease or diabetes.
- Treatment with diacetylmorphine is a last resort for people who have tried all other treatment options without success. This applies to only approximately 10 per cent of the heroin-dependent population.
- The federal government of Canada’s decision that prevents the delivery of life-saving treatment to vulnerable addictions patients infringes on the patients’ Charter Rights, is unconstitutional, and should be struck down.
- The science supports this course of treatment. In six other similar trials, unanimous evidence shows the effectiveness of HAT for chronically-addicted people.
- Medically prescribed heroin is more cost-effective than methadone for treating long-term street heroin users, according to a recent study published in the Canadian Medical Association Journal
|Injunction - Media QA|
|Plain Language Summary of Cochrane Paper||Filed: Notice of Civil Claim||Filed: Notice Under Constitutional Question Act|
Result: Injectable diacetylmorphine was more effective than oral methadone. Because of a risk of overdoses and seizures, diacetylmorphine maintenance therapy should be delivered in settings where prompt medical intervention is available.
Result: Due to the higher rate of serious adverse events, heroin prescription should remain a treatment for people who are currently or have in the past failed maintenance treatment, and it should be provided in clinical settings where proper follow-up is ensured.
Result: Diacetylmorphine was found to be a dominant strategy over methadone maintenance treatment in each of the time horizons
Discussion: Offering treatment assisted with medically prescribed diacetylmorphine or hydromorphone to long-term treatment-refractory opioid-dependent Aboriginal people could be an effective way to attract them into and retain them in treatment as well as dramatically reduce the risk of HIV infection.
Conclusion: Supervised use of medicinal heroin can be an effective second-line treatment for this small, and previously unresponsive, group.
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Our legal challenge is on behalf of patients who are at risk. As the health provider who runs the SALOME study, the participants and former participants in the study are patients under our care. It is unethical for us to withhold evidence-based life-saving medications from our patients. The decision by Health Canada is aligned with our ethical responsibilities. Overturning the Health Canada decision prevents us from saving the lives of those who are critically ill. We do not accept this situation, so we are challenging the decision in court. Please join us.
For Immediate Release: Providence Health Care and Patients File Constitutional Challenge to Federal Government Decision
VANCOUVER, November 13, 2013 — Providence Health Care (Providence) and five SALOME patients launched a constitutional challenge today to overturn a recent decision by the federal government of Canada that prevents the delivery of life-saving treatment to vulnerable addictions patients.
Providence and the five patients filed a Notice of Civil Claim in the BC Supreme Court today jointly, requesting, among other things, a declaration that the new federal government regulations infringe on the Charter Rights, are unconstitutional, and should be struck down.
The patient plaintiffs are David Murray, Deborah Bartosch, Larry Love, Douglas Lidstrom and Charles English.
“To patients like me, diacetylmorphine (heroin) assisted treatment has proven to be life-saving and stabilizing,” said David Murray. “To deny this treatment and to go against all medical evidence – and even Health Canada’s own decision – is heartless and harmful.”
The legal action comes in the wake of Federal Minister of Health Rona Ambrose’s October 3, 2013 changes to federal regulations making diacetylmorphine a restricted substance under the Food and Drug Act, preventing it from being available through Health Canada’s Special Access Programme (SAP).
SAP is designed to let patients in exceptional cases get medications normally not available in Canada. This access is limited to patients with serious or life-threatening conditions on a compassionate or emergency basis when conventional therapies have failed, are unsuitable, or are unavailable. Through SAP, Providence doctors had requested – and received – access to diacetylmorphine for 21 of the participants exiting the SALOME research study in Vancouver, before the regulations closed off access to this treatment.
Diacetylmorphine can continue to be used for the ongoing SALOME study because permission had already been obtained by Health Canada, but cannot be used for clinical care for patients no longer in the study.
SALOME (The Study to Assess Longer-term Opioid Medication Effectiveness) is a clinical study, headed by Providence’s Centre for Health Evaluation and Outcome Sciences researchers, that tests alternative treatments for people with chronic heroin addiction who are currently not benefiting sufficiently from available treatments such as oral methadone.
SALOME compares two similar medications – diacetylmorphine, the active ingredient of heroin, and hydromorphone (HDM), a legal, licensed pain medication.
The study aims to determine alternative treatments for people with chronic heroin addiction not benefitting sufficiently from available treatments such as oral methadone.
The three-year trial is being completed in phases. So far, 75 participants have exited SALOME. Some of them have been transferred to methadone or drug-free programs and others onto oral HDM. Others critically require diacetylmorphine (heroin) assisted treatment.
“Our highest priority is patient care – to provide the best, evidence-based treatments possible,” said Dianne Doyle, President & CEO, Providence Health Care. “The patients requiring diacetylmorphine are extremely vulnerable and have tried other treatments, such as methadone and detox, numerous times, but such treatments have not been effective. Diacetylmorphine (heroin) assisted treatment is a proven treatment option that is a last resort for people who have tried all other treatment options without success. Health Canada approved our doctors’ requests based on extensive evidence. The federal government’s decision curtailed this access and our patients’ rights to proper health care.”
The science supports this course of treatment. Six similar trials comparing medically-prescribed heroin and methadone (including NAOMI) involving more than 1,500 patients have provided unanimous evidence in support of the effectiveness of this treatment for long-term heroin-dependent individuals. Data is available from six countries: Switzerland, the Netherlands, Spain, Germany, the United Kingdom and Canada.
Heroin-assisted treatment has been officially adopted in the United Kingdom, Switzerland, Germany, Denmark and the Netherlands.
Providence has retained Joseph Arvay as legal counsel in the court action. The patients joining the action are represented by Scott Bernstein of the Pivot Legal Society. Arvay is a renowned Canadian lawyer who has argued numerous landmark cases involving civil liberties and constitutional rights, including Vancouver’s Supervised Injection Site case in the Supreme Court of Canada.
“Allowing ideology to trump science – as was done by the federal government in this case – does not serve the needs of Canadians and is not consistent with our values,” said Arvay. “The precedent set in the Insite case should be guiding the federal government’s decision-making and how to meet the conditions and rights set out in our Constitution.”
Pivot Legal Society is a Vancouver Downtown Eastside-based non-profit organization that advocates on behalf of marginalized communities and persons across Canada through strategic litigation.
“We are pleased to partner with Providence in this important case,” said Pivot lawyer Scott Bernstein. “With our combined dedication to advocating for fairness, justice and evidence-based treatment, we will have the best chance at defeating these harmful regulations.”
Along with the declaration, the individuals and Providence are asking the court to strike down the regulations and allow the SAP applications for SALOME participants to be considered under the old regulations until the constitutional issues are determined by the court.
Links to More Information:
About Providence Health Care
Providence Health Care is one of Canada's largest faith-based health care organizations, operating 17 facilities within Vancouver Coastal Health. Guided by the principle, “How you want to be treated,” Providence's 1,200 physicians, 6,000 staff and 1,500 volunteers deliver compassionate care to patients and residents in British Columbia. Providence’s programs and services span the complete continuum of care and serve people throughout B.C. Providence operates one of two adult academic health science centres in the province – St. Paul’s Hospital – performs cutting-edge research in more than 30 clinical specialties, and focuses its services on six “populations of emphasis”: people with cardiopulmonary risks and illnesses, HIV/AIDS, mental health, renal risks and illness, specialized needs in aging, and urban health. www.providencehealthcare.org
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For more information:
Senior Communications Specialist – Media Relations
Providence Health Care
Tel: 604-682-2344 extension 66987
Joseph J. Arvay, Q.C.
Dr. Michael O'Shaughnessy