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Financial conflicts common, often undisclosed among authors of ASCO practice guidelines
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Authors of ASCO clinical practice guidelines frequently have financial conflicts of interest, many of which are not reported accurately, according to study results published in Cancer.
“In April 2013, ASCO released its revised policy for relationships with companies. To ensure balance, independence and transparency between health care professionals and for-profit health companies, certain restrictions were placed on the authorship of abstracts presented at ASCO meetings and of articles published in ASCO journals,” Ramy R. Saleh, MD, oncologist in the department of medicine at Princess Margaret Cancer Centre and University of Toronto, and colleagues wrote. “If the first, last or corresponding authors participated in a speakers’ bureau, had an employment relationship with the sponsor, or had a significant ownership interest, they were prohibited from presentations at meetings or publications in journals affiliated with the society.”
ASCO put the policy on hold in 2014, in response to concerns among health care professionals and pharmaceutical companies. In 2017, the society removed the restrictions, regardless of the authors’ financial relationships. However, authors still are expected to disclose relationships with for-profit health care companies in 11 disclosure categories.
In the study, Saleh and colleagues searched the ASCO website for all clinical practice guidelines for systemic treatment published between August 2013 and June 2018. They collected information on self-reported author financial conflicts of interest (FCOIs) and funding sources. They then searched the Open Payments database to determine compensation provided to guideline authors. The Open Payments program gathers and publishes data on financial relationships between the health care industry and providers.
Researchers used Cohen’s kappa statistic to assess agreement between declared and undeclared but verified FCOIs.
They identified 314 nonduplicate authors of 26 clinical practice guidelines, 184 (59%) of whom reported FCOIs. Of the remaining 130 authors, 71 were non-U.S. residents or were affiliated with a nonprofit organization and, thus, had no available Open Payments data. Among the 59 authors with available Open Payments data who declared no FCOIs, 55 (93%) had received payment from the pharmaceutical industry. Median total undisclosed payments to these authors from 2013 to 2017 was $30,500 (interquartile range, $128,925).
The researchers calculated a kappa value of .092 for concordance between disclosed and verified FCOIs. Of the 243 authors whose FCOIs could be confirmed through Open Payments, 98% (n = 239) accepted industry payment. Thirty-four authors (62%) received more than $1,000 in nonresearch funding, whereas 19 (35%) received more than $5,000. Forty-four (85%) of the 52 first and last authors received payment from industry and 14 (32%) of these payments were not disclosed.
The researchers acknowledged study limitations, including the inability to verify authors not included in the Open Payments database and potential inaccuracies in Open Payments data.
Although relevance is sometimes used as a criterion for declaring FCOI, complete transparency in the form of universal disclosure may be a safer option, Clifford A. Hudis, MD, FACP, FASCO, CEO of ASCO, and Robert W. Carlson, MD, CEO of the National Cancer Care Network, wrote in a related editorial.
“The historically but inconsistently defined standard of ‘relevance’ puts an assessment responsibility on the disclosure or on the editors and peer reviewers. It can be a bit like asking the proverbial fox to guard the chicken coop and can only raise concerns when readers discover an engagement that they believe to be relevant, despite the authors’ or editors’ and publishers’ assessment otherwise,” Hudis and Carlson wrote.
“Using relevance as a standard virtually ensures allegations of incomplete disclosure at some point,” they added. “This risks reputational harm to the entire profession, consumes time and effort by institutions and individuals, and removes the ability of guideline developers such as our organizations to consistently apply conflict management strategies. A universal disclosure standard addresses this issue by eliminating any excuse that an engagement was unrelated to the matter at hand because that later assessment would no longer matter.” – by Jennifer Byrne
Disclosures: Saleh reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures. Hudis reports employment by ASCO. Carlson reports employment by NCCN and a patent for Evidence Blocks (part of NCCN guidelines).
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