Over the past years, it has become mandatory for composers of Clinical Practice Guidelines to disclose industrial relationships. This is based on the premise that disclosure of these relationships ensures the independence and scientific integrity of those involved in guidelines. Clinical practice guidelines serve as standards of care in practice, quality improvement, and reimbursement. Individual physicians use clinical practice guidelines to establish which diagnostic tests and therapeutic strategies are most appropriate in patient care. Government and third-party payers use clinical practice guidelines to determine which procedures and drugs should receive reimbursement. Hospitals use these guidelines to decide when therapies justify a major investment. The government, the public and the media use these guidelines as reference standards in the evaluation of the quality of medical practice for both hospitals and individual physicians. Accordingly, maintaining the integrity and reliability of clinical practice guidelines is crucial to society and fundamental to the practice of evidence-based medicine. Recently, Mendelson et al. (1) described the extent of conflicts of interest in clinical practice guidelines. To this purpose, the authors examined the 17 most recent guidelines launched by American College of Cardiology/American Heart Association from 2004 through 2008. Using disclosure lists, conflicts of interests were evaluated for each participant. Conflicts of interest were described as 1) receiving a research grant, 2) being on a speaker’s bureau and/or receiving honoraria, 3) owning stock, or 4) being a consultant or member of an advisory board. Also the companies and institutions reported in each disclosure were documented. It was shown that more than half (56%) of the 498 individuals reported a conflict of interest. Being a consultant or member of an advisory board was the most common type. This implies that more than half of clinical practice guideline writers served as promotional speakers on behalf of industry. A substantial number held stock in companies affected by the clinical practice guidelines. In particular, one-third (!) of the writers of the percutaneous intervention guidelines actually owned stock in companies affected by the clinical practice guidelines. Interestingly, the study (1) also demonstrated that committee chairs (or first authors) of clinical practice guidelines are significantly more involved (81%) than committee members (55%). Such findings suggest that the decision-making process for selecting chairs for cardiovascular clinical practice guidelines is seriously affected. If the leadership of professional societies were to carefully examine such appointments, it is unimaginable that such a high percentage of first authors would have financial conflicts. In protecting such relationships, professional societies usually put forward that it is always necessary to include expert individuals in order to properly balance the underlying evidence. In my opinion, it is falsely argued that non-participants in industry-sponsored research lack the expertise to interpret the complex scientific data that must be reviewed when writing the guidelines. Such statements are self-fulfilling and far from convincing. By contrast, independent experts are very well capable to objectively judge the needed evidence (if not more than biased experts!). As noted by Mendelson et al. [1], if 44% of clinical practice guidelines writers were free of financial relationships with industry, there must be other independent experts. In an accompanying Editorial comment [2], Steve Nissen (Cleveland Clinic, USA) appropriately stated that ‘For Clinical practice guidelines to be truly independent and respected, even the appearance of impropriety must be avoided. For the public, congressional oversight committees, and the media, a promotional speaker and stockholder are inherently biased and should never be permitted to serve as a clinical practice guidelines writer’. For guidelines to become the right lines, our professional society should be highly aware of these facts and act accordingly. When we fail as a profession to govern the clinical practice guidelines process, the integrity of evidence-based medicine will be seriously damaged.
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Sep 5, 2016
Erin Coughlan De Perez + 15
Open Access
