The development of new national standards for prescribing opioids was "scientifically rigorous," despite a flawed process for identifying financial ties between an individual who helped craft the measures and the pharmaceutical industry, a report says.
Former federal health minister Jane Philpott ordered an independent review of the guidelines in May to ensure that they were not "tainted" by industry influence. Dr. Philpott's intervention followed a story in The Globe and Mail revealing that officials at McMaster University who developed the guidelines did not honour a pledge to exclude medical experts who receive income from drug companies from voting on the standards.
Sol Stern, a family doctor in Oakville, Ont., and a member of the voting panel, has been a paid speaker and advisory board member for drug companies – which did not come to light until May 8, the day the guidelines were published.
The Canadian Institutes of Health Research, the federal agency asked to conduct the review, issued a report on Thursday, saying: "There is no evidence a COI [conflict of interest] did or could have had any real influence on the final recommendation."
Nav Persaud, a family doctor at Toronto's St. Michael's Hospital who helped craft the new standards, questioned how anybody could know for sure whether a conflict of interest did or did not have an effect on a recommendation.
The controversy around the guidelines highlights the need in Canada for more transparency on conflicts of interest in the medical community, academic and medical experts say.
Pharmaceutical companies in many countries are required to make public their payments to individual doctors, leaving Canada a laggard internationally.
"The fact that there is even the perception of a conflict of interest undermines trust and underscores the importance of having public disclosure and consistent standards when it comes to guidelines," said Andrew Boozary, a resident physician at St. Michael's Hospital who is leading a campaign called Open Pharma, which says patients in Canada should be able to check an online database to see whether their doctors have received funding from the drug industry.
"This kind of thing could well happen again, and it would be easy to avoid if the federal government was willing to move on the issue," added Joel Lexchin, a professor emeritus at York University's faculty of health and a founder of Open Pharma.
A spokesman for Health Minister Ginette Petitpas Taylor said the minister's office plans to look into Open Pharma's recommendations. "We remain open to new approaches to increase transparency for Canadians," the spokesman said.
The guidelines developed at McMaster are aimed at reversing practices established two decades ago, when pharmaceutical companies promoted the benefits of opioids and doctors began prescribing them to relieve moderate to severe pain. A continuing Globe investigation has traced the roots of Canada's opioid epidemic to the introduction in 1996 of OxyContin, a prescription painkiller made by Purdue Pharma.
The guidelines had not been updated since 2010, leaving them out of step with evidence showing that the risks associated with prescription opioids are substantial and the benefits uncertain. Canada ranks as the world's second-biggest consumer of prescription opioids, after the United States.
In its application to Health Canada for funding to update the guidelines, McMaster says, "The key to developing conflict-free recommendations" is to require all voting panel members to "have no financial or intellectual conflicts."
The research institute's review blames an "administrative oversight" for the fact that one doctor's conflict of interest did not come to light earlier. Had the doctor's industry ties been identified at the beginning of the process, the review says, the committee overseeing the guidelines would have excluded him from the voting panel. The research institute says it found the process used to develop the guidelines "scientifically rigorous despite the flaw in promptly identifying the [conflict of interest] in a single voting member."
Jason Busse, an associate professor at McMaster's department of anesthesia and co-lead of the group that drafted the guidelines, said in an e-mail that he is pleased with the review, reiterating its finding that one voting panel member's conflict of interest "did not impact the guideline's recommendations."
The College of Physicians and Surgeons of Ontario (CPSO,) the self-regulatory body for doctors in Canada's most populous province, is preparing to update its overall drug-prescribing policy to reflect the McMaster group's opioid guidelines.
The CPSO's council is scheduled to vote Friday on draft changes that direct physicians to rely on the new Canadian opioid-prescribing guidelines and similar ones produced by the U.S. Centers for Disease Control and Prevention. Both "strongly recommend" against prescribing doses above the equivalent of 90 milligrams of morphine per day for patients with chronic, non-cancer pain.
With a report from Kelly Grant