McMaster University says it did not follow proper procedures for reviewing financial conflicts of panel members who crafted new national standards for prescribing opioids.
In a letter to federal Health Minister Jane Philpott, the chair of the steering committee assigned to develop the guidelines apologized for errors that were made but said the measures are "sound" and "unbiased."
As a result of not properly following the administrative process for reviewing the conflict-of-interest forms, the letter says, a voting panel member's financial ties to drug companies were not brought to the steering committee's attention until after the recommendations had been completed.
"These errors should not have occurred and we apologize that they did," Gordon Guyatt, a professor in McMaster's faculty of health science and chair of the steering committee, says in the letter. "We are reviewing our administrative policies and practices to ensure that errors of this type do not occur again."
Dr. Philpott has ordered a federal agency to conduct an independent review to ensure the scientific foundation of the guidelines are not "tainted by the influence of industry," she said. She has also asked McMaster for a full account of the process for determining who got to vote on the guidelines and how conflicts of interest were managed.
The Health Minister's intervention on Thursday followed 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 guidelines 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.
McMaster received $618,248 from Health Canada to revise prescribing guidelines that were last updated in 2010 and out of step with research showing that the risks associated with opioids are substantial and the benefits uncertain. In its application for federal funding to update the guidelines, McMaster's Michael G. DeGroote National Pain Centre said "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.
However, one of the 15 panel members who voted on the guidelines, Sol Stern, a family doctor in Oakville, Ont., has been a paid speaker and advisory board member for four drug companies, including Purdue, according to his declaration form posted on McMaster's website.
The guidelines took two years to develop. All 28 individuals who worked on them were required to submit two declarations of conflicts – in December, 2015, and January, 2017 – and the steering committee was to review them.
Jason Busse, an associate professor in McMaster's department of anesthesia and a member of the steering committee, told The Globe the committee made an exception for Dr. Stern because his industry-sponsored talks took 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."
On Friday, Dr. Busse declined to clarify when exactly the steering committee learned about Dr. Stern's financial conflicts and referred questions from The Globe to Susan Emigh, McMaster's director of public relations. Ms. Emigh referred The Globe to Dr. Guyatt's letter.
The notes section of Dr. Stern's declaration, intended for internal McMaster use, is blank. On declarations for every other member of the voting panel, by contrast, that section is filled out, saying the steering committee "perceives no significant" financial conflicts that preclude the individual from participating.
The notes sections for seven other individuals who declared industry conflicts say: "Acknowledged potential financial and non financial COI," and approved to participate as a non-voting member on the expert committee.
A patient advocate on the voting panel also disclosed consulting work for a drug company, but the steering committee said his activities "are judged not to be significant."