Officials overseeing new national standards for prescribing opioids did not honour a pledge to exclude medical experts who receive income from drug companies from voting on the measures.
Sol Stern, a family doctor in Oakville, Ont., and one of 13 panel members who voted on the standards, has been a paid speaker and advisory board member for drug companies, including the pharmaceutical giant whose pain pill triggered Canada's deadly opioid epidemic, according to his declaration form posted online last week.
Jason Busse, an associate professor at McMaster University's department of anesthesia and co-lead of the group that drafted the standards, said the group made an exception for Dr. Stern because his industry-sponsored talks represented a "balanced approach" to opioids. Dr. Stern "reassured us he had no overt bias either strongly in favour or strongly opposed to opioids for chronic pain," Dr. Busse said in an e-mail response to The Globe.
But the decision to accept Dr. Stern as a panel member has shrouded the new prescribing standards in controversy because of promises made by the McMaster group to avoid a repeat of what happened in 2010, when one-third of the panel members working on an earlier version had ties to Big Pharma, and to ensure that no one had any conflicts of interest this time around.
McMaster received $433,248 from Health Canada in 2015 to revise prescribing guidelines that were out of date for a drug whose risks are substantial and benefits uncertain. The new standards unveiled last week by the school's Michael G. DeGroote National Pain Centre are aimed at reversing practices developed two decades ago, when doctors began prescribing opioids to relieve moderate to severe pain as pharmaceutical companies promoted their benefits. A continuing Globe investigation has traced the roots of Canada's opioid epidemic to the introduction of the prescription painkiller OxyContin in 1996.
Of the 49 members on the 2010 guideline panel, 17 received remuneration from OxyContin maker Purdue Pharma and other drug companies. Purdue paid doctors, known as key opinion leaders, to help spread the word in the medical community that OxyContin posed a lower threat of abuse and dependence to patients than other painkillers because of its slow-release formula. The drug was the top-selling long-acting opioid in Canada for more than a decade.
Medical experts said anyone who gets paid to produce educational seminars about opioids by a company that makes the drugs has a conflict and should not be allowed to vote on guidelines that advise doctors on how to prescribe painkillers.
"We got into this problem because we listened to pharma-funded physicians," said Rupa Patel, a family doctor in Kingston who took over a practice with many patients on high doses of prescription opioids. "We're not going to be able to get out of this by listening to pharma-funded physicians."
In its application to Health Canada for funding, McMaster says "the key to developing conflict-free recommendations" is to require all voting panel members to "have no financial or intellectual conflicts" and "refrain from participating in activities sponsored by the marketing departments of commercial entities." Dr. Busse echoed that commitment in an interview with The Globe a year ago, saying that leaders had gone to great lengths to ensure that no one who votes on the standards has conflicts of interest. "We believe very strongly that it is quite possible for people making recommendations on guidelines to have strong conflicts of interest that can very well bias the recommendations that they make," he said.
Dr. Stern names four drug companies he has received remuneration from, including Purdue. Initially, those working on the prescribing guidelines were to declare any conflicts dating back five years, according to the Health Canada application. But the declaration forms ask individuals to disclose their industry ties for only 24 months. In hindsight, the forms should have expanded the timeline to five years, Dr. Busse told The Globe. "Not doing so was an oversight."
A spokeswoman at Health Canada said McMaster had a responsibility to craft prescribing standards "according to the highest ethical and technical standards." Questions regarding conflict issues relating to any panel members would be best addressed by McMaster, the spokeswoman said. Dr. Stern also referred questions to McMaster.
Three doctors who worked on the standards, including one who was disqualified from voting because of her own ties to Big Pharma, questioned the process for deciding who got to be a panel member, according to copies of e-mails obtained by The Globe.
Lydia Hatcher, chief of family medicine at St. Joseph's Healthcare in Hamilton, said in an interview it's "upsetting" that her conflicts disqualified her while Dr. Stern, whom she described as a good friend, was allowed on the panel.
"It doesn't make sense," she said. "Why can't I have a vote? I'm no different than Sol?"
Dr. Hatcher said she gives educational talks for a variety of pharmaceutical companies that produce everything from opioids and medical marijuana to hypertension drugs. Because she represents so many companies, she said, she feels she is "not truly biased."
Dwight Moulin, a professor in the departments of clinical neurological sciences and oncology at the University of Western Ontario, says in an e-mail to Dr. Busse that he is "confused" about the process for deciding who had voting privileges. "My understanding was that individuals were relegated to the Expert Committee if they had any association with Pharma," the e-mail says. Nav Persaud, a family doctor at Toronto's St. Michael's Hospital and a member of the voting panel, also asks Dr. Busse in an e-mail whether the original plan had been to exclude anyone with a financial conflict from the voting panel.
Dr. Busse acknowledged the decision to accept Dr. Stern as a panel member "may be controversial." But he insisted in his e-mail responses to panel members and to The Globe that Dr. Stern's votes did not change any of the recommendations on opioid prescribing. Dr. Persaud asks in his e-mail to Dr. Busse, "did you really mean to state that [Dr. Stern's] 'participation did not change any of the recommendations?'"
Meldon Kahan, medical director of the Substance Use Service at Women's College Hospital in Toronto and a member of the 2010 advisory panel, said whether Dr. Stern's participation influenced the results is impossible to say. Regardless, he added, "If you have rules on no conflicts of interest, he should not have been on the panel."