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- Page navigation anchor for CMAJ and CTFPHC Require Accountability and Adherence to Guidelines for GuidelinesCMAJ and CTFPHC Require Accountability and Adherence to Guidelines for Guidelines
The CMAJ’s recent editorial on competing interests in guidelines is appropriate, but there is also a need to reform the current CTFPHC guidelines process (1).
The CTFPHC explicitly and systematically excludes substantive expert advice. This extraordinary policy has handicapped the guidelines and rendered many of them clinically outdated, misleading, and even dangerous. Most internationally recognized “Guidelines on Guidelines” emphasize the importance of adequate clinical expert and patient stakeholder advice (2-4). Including expert opinion, as per the current “Guidelines on Guidelines” (2-4), is a much-needed antidote to the CTFPHC policy.
We recognize and acknowledge the problems inherent in financial and intellectual conflicts of interest when introducing expert input. These can be disclosed and mitigated. Without content experts, these guidelines are simply uninformed literature reviews and meta-analyses, without meaningful insight or guidance in the specifics of disease biology, advances in treatment and medical technology, as well as lacking the nuances involved in interpreting inferential data which may not derive from prospective randomized trials. Many of the CTFPHC Guidelines have been strongly criticized by national specialty societies and renowned experts. (letters/position statements appended), seriously undermining the credibility of the guidelines as well as their clinical application.
Inherent in the CTFPHC approach is the ideology...
Show MoreCompeting Interests: • Dr. Gordon is a radiologist practicing breast imaging and image-guided biopsies. • Dr. Klotz reports personal fees from mirScientific, outside the submitted work. • Dr. Yaffe's lab conducts some collaborative research in the area of breast cancer imaging with GE Healthcare. Dr. Yaffe is a shareholder in Volpara Health Technologies. • Dr. Yoshida reports grants from Merck Canada, during the conduct of the study; grants from Gilead Sciences, grants from AbbVie, grants from Merck Inc, grants from Janssen, personal fees from Abbvie Canada, personal fees from Gilead Canada, grants from Intercept, grants from Genfit, personal fees from Merck Canada, personal fees from Celgene Canada, grants from Springbank, outside the submitted work. - Page navigation anchor for RE: New CMAJ policy on competing interests in guidelinesRE: New CMAJ policy on competing interests in guidelines
It’s encouraging to read that the CMAJ is going to adopt the Guidelines International Network (GIN) principles for disclosure of interests in guidelines (1) but it’s important to recognize the limitations of the principles underlying the GIN recommendations for guidelines (2). One of the main sources of concern is the use of terms such as “make all possible efforts” (Principle 1) and “should” (Principles 2-9). These are vague and open to a wide variety of interpretations by guideline developers as to how they should be applied depending on their resources and expertise. Principle 4 requires the public disclosure of interests of members of guideline development groups but does not apply to the organizations or societies that may be sponsoring the guidelines. A cross-sectional survey and review of websites of 95 national/international medical organizations that produced 290 clinical practice guidelines published on the United States National Guideline Clearinghouse found that only 1% of guidelines (4/290) contained a statement about the financial relationships with biomedical companies of the organizations producing the guidelines (3).
Principle 6 says that “when direct or indirect COIs of a chair are unavoidable”, but what does “unavoidable” mean in practice? At a minimum, the committee should be required to explain in detail why COIs are unavoidable. Principle 7 calls for “an appropriate balance of opinion” of experts with relevant COIs but does not define what con...
Show MoreCompeting Interests: In 2016-2019, Joel Lexchin was a paid consultant on two projects: one looking at developing principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel at the American Diabetes Association, for a talk at the Toronto Reference Library, for writing a brief for a law firm and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written.