Conflicts of interest pervasive among clinical guideline authors

Despite clear policies from the National Academy of Medicine to limit industry influence on clinical guidelines, financial conflicts of interest (COI) persist among authors, two new studies found.

Advertisement

"Physicians should be aware that self-reported disclosures regarding conflicts of interest among authors of clinical practice guidelines may be inaccurate," Dr. Samir C. Grover from Saint Michael's Hospital and the University of Toronto told Reuters Health by email. "The impact of this on the recommendations contained within clinical practice guidelines is uncertain."

Previous research has shown that guidelines rarely adhere to National Academy of Medicine policies and that authors may have undeclared financial COI.

In the first study, Dr. Grover and colleagues identified the top 10 revenue medications of 2016 and assessed the adherence of 18 related clinical guidelines to three National Academy of Medicine standards: written disclosure of potential financial COI; appointing committee chairs with no financial COI; and limiting guideline authors with financial COI to less than 50% of the panel.

Of the 160 US-based authors of these guidelines, 79 (49.4%) declared receipt of a payment and 50 (31.3%) declared payments from companies marketing 1 of the 10 high-revenue medications.

An additional 41 authors (25.6%) had received, but not disclosed, receipt of payments from companies marketing 1 of these 10 medications, based on data from the Centers for Medicare and Medicaid Services Open Payments (CMS-OP) website.

Overall, 91 authors (56.9%) had financial COI, according to the October 29 JAMA Internal Medicine online report.

The median value of declared payments was $522 (interquartile range, $0-$40,444) from two companies (interquartile range, 0-4).

As for adherence to National Academy of Medicine standards, no guideline had complete written disclosure of all potential financial COI, 4 of the 18 panels appointed chairs without financial COI, and 8 limited authors with financial COI to less than 50% of the panel.

"Since we collected only several months of CMS-OP data for guidelines published in 2013, we may have underestimated the financial conflicts of interest for these guidelines," the researchers note. "Finally, we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting."

"We believe that societies that are responsible for the development of guidelines should adhere to standards, such as those recommended by the National Academy of Medicine for committee members," Dr. Grover concluded. "Furthermore, societies that develop guidelines should consider double-checking self-reported financial conflicts of interest with databases such as the Open Payments database, in order to ensure that disclosures are accurate."

In the second study, Tyler R. Combs from Oklahoma State University, Tulsa, and colleagues evaluated industry payments received by 83 authors of 15 gastroenterology clinical guidelines and their financial COI disclosure practices.

Overall, 44 authors (53%) received industry payments, and the median percentage of authors with financial COI per guideline was 50% (interquartile range, 50%-75%).

The median total payments received by guideline authors was $1,000 (interquartile range, $0-$39,938).

Only 16 authors (19%) either disclosed financial COI and had received payments or disclosed no financial COI and received no payments.

Combs told Reuters Health, "The notion of a guideline being produced without conflicted authors has largely been forgotten and instead it seems that common practice is to appropriate several unconflicted authors to balance out the presence of more senior and often highly conflicted authors to achieve the roughly 50% average. One wonders whether these specialists with significant conflicts are often most persuasive on the panel in developing guideline recommendations."

"Current practices can present obstacles to comprehensive disclosure," he said. "For example, some organizations allow guideline authors to distinguish between 'financial support' and 'competing interests.' In such cases, we found evidence where authors apparently must have used subjective assessments of relevance to guideline topics to determine what they should disclose."

"We also saw instances where physicians who authored more than one guideline . . . curated their disclosures differently for each topic," Combs said.

Dr. Tom Stelfox from University of Calgary and Alberta Health Services in Canada, who recently evaluated critical care guidelines, told Reuters Health, "(I am) stunned by the high prevalence of failure to disclose conflicts and the low adherence to National Academy of Medicine standards. Conflicts of interest related to financial relationships between physicians/scientists/health-care decision-makers, and biomedical companies have received lots of attention over the years. Just how pernicious the problem is surprising. I thought we were making more progress."

"Maybe we need to think about considering failure to disclose conflicts of interest as a form of professional misconduct," he said. "We expect physicians to secure informed consent before providing treatment to patients. We should expect physicians to disclose potential conflicts when participating in (clinical guideline) committees."

"Patient confidence in care recommendations should not be clouded by worries about potential conflicts of interest," Dr. Stelfox said. "As physicians and health-care leaders, we need to act now and ensure that conflicts of interest are both declared and managed."

Dr. Michael S. Irwig from The George Washington University, Washington, DC, recently reported similar findings related to Endocrine Society clinical guidelines. He told Reuters Health by email, "Failure to disclose conflicts of interest is a common problem that needs to be addressed by medical societies and journals."

"Disclosing conflicts of interest often does not eliminate the COI," he said. "Journals that publish guidelines need to be more transparent regarding if and how conflicts of interest are managed."

Dr. Waleed Alhazzani from McMaster University, Hamilton, Ontario, Canada, who recently addressed the management of COI in critical care guidelines, told Reuters Health there are some immediate solutions that could help overcome this scary problem: namely, professional societies that sponsor guidelines should develop strict COI management policies; should not allow panel members with financial industry COI to participate in developing the recommendations; and should develop a COI adjudication committee that can further investigate the presence of undisclosed COIs. Furthermore, Dr. Alhazzani said, "Any CPG that does not adhere to these best practices should be questioned both by scientists and publicly about the reasons to allow such violations to occur ... and it may be worthwhile to develop new CPGs on the same topics only including non-conflicted members to see if they will come up with different recommendations."

Last month the chief medical officer of Memorial Sloan Kettering Cancer Center in New York City resigned amid reports that he had failed to disclose millions of dollars in payments from health-care companies in dozens of research articles. Days later the hospital announced the appointment of a task force that will assess the institution's policies and processes for reporting and managing outside activities and industry-supported clinical trials.

—Will Boggs, MD

To read more, click herecydzqbxavdacbauw.

https://ift.tt/2ABOggx