Over one-third of undisclosed industry payments made to physician-authors of American College of Rheumatology clinical practice guidelines were relevant to guideline recommendations, according to a recent review in Arthritis & Rheumatology.
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Since 2014, 56 of 89 total physician-authors across five ACR clinical practice guidelines have been paid a total of $9,728,751 from industry sources. Nineteen of 89 authors received $1,961,362 in industry payments that were directly relevant to a guideline’s recommendations, and $699,561 of these payments (35.7%) were undisclosed, according to Cole Wayant, of the Oklahoma State University Center for Health Sciences, Tulsa, and colleagues.
The ACR’s Policy and Procedure Manual for Clinical Practice Guidelines, last updated in January 2015, allows up to 49% of authors in a clinical practice guideline to have financial conflicts of interest, including intellectual conflicts of interest, and requires them to report those relationships. When the ACR creates a call for letters of interest for a guideline, it includes a list of companies and organizations that could be affected by the guideline topic. To be considered conflict free, an author must not have ties to these companies and organizations for 1 year before the deadline on the letter of interest and 1 year after a guideline is published. This policy extends to members of an ACR guideline development group, literature review team, and voting panel. Under these guidelines, an author who has any relationship with a company is considered conflicted, which counts toward this total.
Mr. Wayant and colleagues performed a cross-sectional study of five ACR guidelines published since August 2014 on axial spondyloarthritis (27 authors), glucocorticoid-induced osteoporosis (21 authors), RA (26 authors), perioperative management of antirheumatic medication (31 authors), and polymyalgia rheumatica (46 authors). Using the Open Payments Database, the researchers searched for any general (speaking fees, consulting fees, education, honoraria, travel, food, or beverage payments) research, associated research, and ownership (stocks or dividends) relationships reported by guideline authors in the 12 months before a guideline was published. The guidelines on axial spondyloarthritis, glucocorticoid-induced osteoporosis, and RA contained specific recommendations for classes of medications or branded drugs, and conflicts from authors in those guidelines were assessed to determine relevancy of those payments.
Of the 56 physician-authors who received at least one payment (62.9%), the median payment was $522. However, 51 authors reported receiving more than $1,000, 42 authors reported more than $10,000, 20 authors reported more than $100,000, and 2 authors reported more than $1 million. Overall, 14 of 56 authors (25.0%) reported having no financial conflicts of interest, but did in fact receive some payment, and $4,189,090 of the $9,728,751 (43.1%) was not reported. The researchers said that the 19 authors with directly relevant payments were members of the voting panel (11 authors), literature review team (6 authors), and core leadership team (3 authors).
Physician-authors of clinical practice guidelines receiving payments from industry is not an issue specific to rheumatology. In an interview, Mr. Wayant said that authors of clinical guidelines across many different medical specialties often work closely with industry and hold “numerous conflicts of interest.”
“If professional societies are meant to be the public face of specialty providers, one would expect the guideline authors to resemble all society members,” Mr. Wayant said. “However, we routinely find that authors of professional society guidelines have large financial conflicts of interest that exceed the national average, indicating that the views and opinions of guideline authors may not reflect the opinion of most providers.”
These financial relationships between industry and physician authors have been shown to affect research results. A Cochrane Review published in 2017 evaluating industry sponsorship and research outcomes found that studies sponsored by industry were more likely to have favorable efficacy results and conclusions, compared with studies not sponsored by industry sources (Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033). As medical societies continue to become more involved with clinical practice guidelines, recommendations from physician-authors with financial ties to industry can present a conflict of interest. Recommendations in clinical practice guidelines often affect reimbursement of a drug from insurance, and an author can vote for a drug recommendation in a guideline that may not match patient values and preferences, noted Mr. Wayant.
“These authors are fundamentally different from the average rheumatologist that stays up to date with the medical literature, in terms of financial ties to industry,” he said. “Removing the influence of for-profit companies from guideline development cannot harm the rigor of the guideline recommendations, since many medical professionals without conflicts are experts in evidence-based medicine and study appraisal.”
Being financially linked to industry does not automatically make one the most qualified candidate for deciding which therapies are best for patients, Mr. Wayant explained, and guidelines should reflect the values of patients and the medical profession, rather than industry.
“Given the importance of guidelines, [we] encourage the ACR and all professional societies to do everything possible to be above reproach and seek out authors who do not have financial conflicts to write the guidelines,” he said.
The authors reported having no funding source for the study. One author reported serving on an advisory board for Janssen involving infliximab and golimumab, for Sanofi Genzyme involving sarilumab, and receiving payment for a survey from Comsort. The other authors reported having no conflicts of interest.
SOURCE: Wayant C et al. Arthritis Rheumatol. 2020 Feb 10. doi: 10.1002/art.41224.