Many Clinical Guideline Authors Have Undeclared Conflicts

Marcia Frellick

October 29, 2018

More than one quarter (25.6%) of the authors writing clinical practice guidelines (CPGs) recommending high-priced medications failed to disclose relevant payments from drug companies, according to new research. Another study found payments disclosed in gastroenterology clinical guidelines often differed from those reported by the Centers for Medicare & Medicaid Services (CMS).

Rishad Khan, BSc, Division of Gastroenterology, St. Michael's Hospital, and Department of Medicine, University of Toronto, Ontario, Canada, and colleagues published their findings October 29 in a research letter in JAMA Internal Medicine.

They identified 18 CPGs published from 2013 through 2017 that made recommendations for 10 of the highest-priced medications in the United States. They then examined the disclosed and undisclosed payments by each drug's marketers to the 160 US-based physician authors and information from the CMS Open Payments website on payments pharmaceutical companies made to physicians.

Of the 160 authors, 50 (31.3%) declared payment from companies marketing the medication recommended in the guideline. An additional 41 authors (25.6%) received, but did not disclose, payments from the marketers.

Among all authors, the average undeclared payment value was $522 (interquartile range [IQR], $0 - $40,444) from two companies (IQR, 0 - 4).

Payments to physicians have been shown to affect clinical decisions in previous research.

Many Undisclosed Payments Were $10,000 or More

In an accompanying editor's note, Colette DeJong, MD, from the University of California, San Francisco School of Medicine, and Robert Steinbrook, MD, editor at large, JAMA Internal Medicine, point out that "many of the undisclosed payments were $10,000 or more."

None of the CPGs had complete written disclosures of all potential financial conflicts of interest (COI) under National Academy of Medicine standards, which also require appointing committee chairs or cochairs with no conflicts of interest and limiting committee members with COI to a minority, Kahn and colleagues found.

The study authors acknowledge that because they did not have access to guideline voting records, they could not determine when panel members with conflicts voted against a medication or recused themselves from voting.

Example From Gastroenterology

A related research letter in the journal by Tyler R. Combs, BSc, from the Center for Health Sciences, Oklahoma State University at Tulsa, and colleagues, reports findings from a study on COI in gastroenterology guidelines. Previous studies have examined COI in dermatology, oncology, and otolaryngology.

The researchers included 15 CPGs with a total of 83 authors identified from the American College of Gastroenterology (ACG) website. Individual payment data was found using the 2014 to 2016 CMS Open Payments database (OPD).

Of those 83 authors, 44 (53%) received industry payments and the median percentage of authors with financial COI per guideline was 50% (IQR, 50% - 75%). The average total payment received by authors was $1000 (IQR, $0 - $39,938).

Only 16 authors (19%) both disclosed financial conflicts in the guideline and had received payments according to OPD or disclosed no COI and received no payments, the authors found.

What Can Be Done?

Combs and colleagues write, "We recommend that the ACG draft new policies with specific expectations for [financial COI] disclosure among authors of gastroenterology CPGs and that large-scale efforts be made to improve the comprehensiveness and reliability of the OPD."

Editorialists DeJong and Steinbrook suggest two approaches. One is to have the guidelines written by an independent public body with funding and independence.

The second is to have public and private insurers reject guidelines that don't meet, at a minimum, the National Academy of Medicine standards.

"Unfortunately," they write, "many of the professional societies that convene panels to develop practice guidelines have financial conflicts of interest with industry themselves, and members may have conflicts related to recommendations about when to perform diagnostic tests, procedures, or surgeries from which they derive income. Robust, objective, and unbiased CPGs support improvements in patient care; the best interests of patients are the paramount consideration."

Khan has reported receiving research funding from AbbVie and Ferring Pharmaceuticals. One author has reported receiving grants from AbbVie and Janssen; personal fees from AbbVie, Takeda, and Ferring; and being an owner of and holding shares in Volō Healthcare. Steinbrook is editor at large for JAMA Internal Medicine. DeJong and Combs and colleagues have reported no relevant financial relationships.

JAMA Int Med. Published online October 29, 2018. Research letter 1, Research letter 2, Editorial

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