The controversy swirling around new national standards for prescribing opioids could have been avoided if Canada had laws requiring doctors to publicly disclose their financial ties to the drug industry, experts say.
The new guidelines developed by McMaster University take aim at an epidemic of addiction and accidental deaths resulting from powerful narcotic painkillers. The guidelines had not been updated since 2010, leaving them out of date with evidence showing that the risks associated with prescription opioids are substantial and the benefits uncertain.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.
The Globe and Mail has reported that one-third of the individuals who crafted the guidelines have financial ties to the pharmaceutical industry. These conflicts of interest did not come to light until McMaster posted declarations-of-interest forms on its website on May 8, the same day the guidelines were published in the Canadian Medical Association Journal. Federal Health Minister Jane Philpott has ordered an independent review to ensure that the scientific foundation of the guidelines are not "tainted by the influence of industry."
Academic and medical experts said the controversy highlights the need for more transparency on conflicts of interest in the medical community. Requiring doctors to publicly disclose remuneration from drug companies would allow the public to assess whether those financial relationships might have influenced their recommendations, said Matthew Herder, director of Dalhousie University's Health Law Institute and an associate professor in the faculties of law and medicine.
"If we're in the dark about the existence of those relationships, you can't factor that into your analysis of their research or their recommendations," Prof. Herder said. "From my point of view, there's no reason why we wouldn't want that transparency."
Disclosure is mandatory for drug companies and doctors in many countries, leaving Canada a laggard internationally. The Physician Payments Sunshine Act in the United States, passed as part of the Obama government's health reforms, requires drug and medical device companies to release details of payments they make to doctors and teaching hospitals for such things as speaking fees, research, travel and meals. The information is publicly available on Open Payments, a searchable federal database.
The database shows that one doctor received payments totalling $694,333 (U.S.) in 2015, including $10.20 for food and a beverage from one company and $2,450 in consulting fees from another company. Companies made about $2-billion in general payments to 618,000 doctors in the United States each year between 2013 and 2015, in addition to another $600-million a year to teaching hospitals, according to ProPublica, an investigative news organization. General payments cover promotional speaking, consulting meals, travel, gifts and royalties but not research.
Other countries, including France, the United Kingdom, Denmark and Portugal, have enacted similar sunshine laws as part of a global move toward greater transparency. In Canada, by contrast, the public has no idea how much money drug companies have doled out to doctors. Medical journals in Canada typically disclose whether authors of research papers have conflicts of interest, but not how much drug companies have paid them.
Nav Persaud, a family doctor at Toronto's St. Michael's Hospital who helped craft the new standards for prescribing opioids, said he did not learn that many others at the table had financial conflicts of interest until after the standards were publicly released.
"This problem could have been prevented if we had a sunshine act," Dr. Persaud said. "If these conflicts were publicly declared, it would have been clear to everyone who had conflicts."
Nine of the 28 medical experts, academics and patient advocates who crafted the prescribing guidelines received remuneration from drug companies, including Purdue Pharma, the pharmaceutical giant whose pain pill triggered Canada's deadly opioid epidemic. Sol Stern, a family doctor in Oakville, Ont., who voted on the guidelines, has been a paid speaker and advisory board member for four drug companies, including OxyContin maker Purdue.
The financial conflicts should have been disclosed at the beginning of the process, said Joel Lexchin, a professor emeritus at York University's faculty of health who has studied the prevalence of industry influence on medical guidelines in Canada, which doctors rely on for the best available clinical evidence.
The American Society of Interventional Pain Physicians, which also recently unveiled new guidelines for prescribing opioids, had panel members declare any conflicts of interest within the previous five years, which were distributed at the introductory meeting, according to the journal Pain Physician. Individuals with potential conflicts could not participate in the discussion or preparation of the guidelines but they could remain on the panel.
The Michael G. DeGroote National Pain Centre at McMaster received $618,248 from Health Canada to revise the Canadian guidelines it originally developed in 2010. The revisions took two years. University officials pledged in the application for funding to Health Canada that panel members would be asked to declare conflicts of interest within the past five years and that no one with financial ties to the drug industry would be allowed to vote on the guidelines. However, McMaster did not honour those pledges: panel members were asked to declare conflicts in the previous 24 months and Dr. Stern was allowed to vote on the guidelines, despite his financial conflicts.
Susan Emigh, director of public relations at McMaster, said in an e-mail to The Globe that the university follows the Canadian requirements for disclosing conflicts of interest. On the prescribing guidelines, however, the steering committee assigned to develop them did not become aware of Dr. Stern's conflicts until after panel members had voted, due to an "administrative error," she said. Gordon Guyatt, a professor in McMaster's faculty of health science and chair of the steering committee, has written to Dr. Philpott apologizing for not properly following the administrative procedures for reviewing conflict-of-interest declarations.
Jason Busse, an associate professor at McMaster's department of anesthesia and co-lead of the committee that drafted the guidelines, has told The Globe Dr. Stern voted the same way on every recommendation as other panel members. He also said it was an "oversight" not to expand the timeline for declaring conflicts to five years.
A Health Canada spokeswoman said the provinces and territories have primary responsibility for health care, so it would be up to them to develop an equivalent of a sunshine act in Canada.