Federal Health Minister Jane Philpott has ordered an independent review into whether new national standards for prescribing opioids are "tainted," and fresh revelations show that one third of the individuals who crafted the measures have financial ties to the pharmaceutical industry.
Dr. Philpott has asked the Canadian Institutes of Health Research, a federal agency, for an assessment of the "rigour" that went into developing the new guidelines to ensure that opioids are safely and appropriately prescribed. As well, the minister has asked McMaster University, which developed the guidelines, for a full account of the process for determining who got to vote on the guidelines and how conflicts of interest were managed.
"It's very important to make sure that the guidelines are not tainted by the influence of industry," Dr. Philpott said in an interview on Thursday. "As stewards of the public purse, we need to make sure that we are supporting the development of guidelines that we would have no reason to believe have been influenced by commercial interests."
Dr. Philpott's intervention follows a story in The Globe and Mail revealing that McMaster officials did not honour a pledge to exclude medical experts who receive income from drug companies from voting on the standards.
A further review by The Globe of declarations for all 28 medical experts, academics and patient advocates who worked on the standards reveals that nine have received remuneration from drug companies, including Purdue Pharma, the pharmaceutical giant whose pain pill triggered Canada's deadly opioid epidemic. Two of the nine voted on the guidelines and seven did not.
Jason Busse, an associate professor at McMaster's department of anesthesia and co-lead of the group that drafted the standards, said in an e-mail response Thursday evening that, "We are confident in the guideline and its recommendations and look forward to sharing a full account as requested."
McMaster's Michael G. DeGroote National Pain Centre said in its application for federal funding that "the key to developing conflict-free recommendations" is requiring panel members who vote on the standards to have no financial ties to the pharmaceutical industry.
But Dr. Busse has said the university made an exception for Sol Stern, a family doctor in Oakville, Ont., and one of 15 panel members who voted on the standards. Dr. Stern has been a paid speaker and advisory-board member for four drug companies, according to his declaration form posted on McMaster's website. Another voting panel member, patient advocate Chris Cull, has been a consultant for a company that makes an antidote for opioid overdoses. Dr. Stern and Mr. Cull declined to comment.
The pervasive conflicts of interest deepen the controversy surrounding the updated guidelines and call into question the process used to arrive at them, says an academic expert who has studied the financial dealings between doctors and drug manufacturers. The only way to avoid such questions, said Matthew Herder, director of Dalhousie University's Health Law Institute and an associate professor in the faculties of law and medicine, is to ensure that no one with a conflict of interest is involved.
"That number does not look good in any way," Prof. Herder said in an interview, referring to the nine with drug-industry ties. "Once you have a conflict of interest, which is defined as a secondary interest, such as having a financial relationship with a pharmaceutical company, that threatens to undermine your primary interest, which is to take care of patients or to write a piece of evidence-based research for prescribing guidelines."
Nav Persaud, a family doctor at Toronto's St. Michael's Hospital and a member of the voting panel, said the industry conflicts are overshadowing the issue the guidelines are meant to address: improving opioid prescribing.
"It should be absolutely clear that the guidelines are based on the best evidence, and not on industry funding," Dr. Persaud said in an interview. "Unfortunately, it's muddled now."
McMaster received $618,248 from Health Canada to update existing guidelines published in 2010 that were out of date, with research showing the risks associated with opioids are substantial and the benefits uncertain. (Initially, the university received $458,248 but Health Canada added another $160,000 to the budget last summer.)
The 2010 guidelines were aimed at addressing the root cause of the epidemic: the overprescribing of prescription painkillers. But the guidelines did little to reverse practices developed two decades ago, when doctors began prescribing opioids to relieve moderate to severe pain as pharmaceutical companies promoted their benefits. Canada remains the world's second highest per-capita user of prescription painkillers.
Seven of the nine individuals who declared industry conflicts were on the expert committee and did not vote on the guidelines. Dr. Busse said McMaster avoided the potential for their biases to influence the guideline recommendations "by ensuring that clinical expert committee members were not present when the recommendations were developed."
One of the seven is Norman Buckley, director of McMaster's pain centre. Dr. Buckley disclosed that he has received funding from two drug companies, including OxyContin maker Purdue, and that he has many patients in his clinical practice who are stable on high-dose opioids. He did not respond to a request for comment.
Lydia Hatcher, chief of family medicine at St. Joseph's Healthcare in Hamilton, Ont., and a member of the expert committee, discloses that she is a paid speaker and advisory-board member for three drug companies, including Purdue.
"I think the reality is we are all trying to do the very best for our patients, using the very best evidence we have," Dr. Hatcher said in an interview. "Just because somebody gives talks for a company doesn't mean they're biased to that drug or that company."