The medical organizations that produce widely followed guidelines for the diagnosis and treatment of health conditions have largely failed to create adequate policies addressing conflicts of interest in how those guidelines are produced, an analysis found, creating a risk for biased medical advice.
In some cases, researchers found, these organizations are openly violating their own policies, further undermining public and practitioner trust.
According to the study, published April 14 in PLOS ONE, hugely influential bodies — including the American College of Obstetricians and Gynecologists, the Enhanced Recovery After Surgery Society, and the American Society of Colon and Rectal Surgeons — had no publicly identifiable conflict-of-interest policies regarding the clinical practice guidelines they publish. The guidelines inform how doctors treat their patients and can inform how insurance companies reimburse for treatments provided, affecting the health of vast numbers of people.
While 36 of the 46 organizations the researchers looked at did publish some kind of policy, only one — the British Association for Sexual Health and HIV (BASHH) — met all seven standards proposed by the National Academy of Medicine, one of the foremost independent institutions calling for reform. Bodies such as the World Health Organization, the American Heart Association, the U.S. Department of Veterans Affairs and the Centers for Disease Control and Prevention had deficient policies; 10 organizations published policies saying co-chairs could not have conflicts, then clearly violated their own policies; and only two organizations, including BASHH, required people to divest themselves of financial investments that presented a conflict of interest prior to working on a set of guidelines.
"We use a lot of guidelines, but guidelines differ a lot. … How is conflict of interest affecting guidelines, and how are they managing it?" said J. Henry Brems, an internal medicine resident at Vanderbilt University Medical Center and the lead author of the paper.
Brems pointed to the conflicting recommendations for breast cancer screening: While the American Cancer Society and the American College of Obstetricians and Gynecologists suggest screening every one to two years starting at age 40, the United States Preventive Services Task Force suggests that patients get a mammogram every two years starting at age 50.
"A question I've always had is, why? Why do they give you the different recommendations when they're all supposedly looking at the same evidence base?" Brems said. "It's gotta be the human issue."
The National Academy of Medicine has seven clear recommendations for a conflict-of-interest policy when it comes to clinical practice guidelines. Namely, individuals should disclose, in writing, any activity or interest that could represent a conflict of interest before they join a guideline development group; the guideline development group should discuss each potential conflict before work begins; each panel member with a potential conflict should explain how the conflict could influence their work on the guidelines; individuals who are accepted into the guideline development group should divest themselves and their families of financial investments that present a conflict and should not participate in any activities for entities that have an interest in the guidelines; members with a conflict should be, at most, a minority of the group; the chair or co-chairs should not have any conflicts; and, ideally, no member of the guideline development group should have a conflict of interest.
For the study, Brems and his co-authors drew from three databases that catalog clinical practice guidelines. They identified the 46 organizations that produced at least five sets of guidelines between January 2018 and the end of 2019 — in total, the 46 organizations produced 702 sets of guidelines. The researchers then searched to see whether the organizations had a publicly available conflict-of-interest policy that addressed how they produced guidelines, as recommended by the National Academy of Medicine. Then, they randomly selected five sets of guidelines from each organization, checking whether the guidelines followed the policies set forth and looking at how disclosures were made.
Notably, previous research in the Journal of Clinical Oncology suggests that authors with financial conflicts of interest may be more likely to endorse drugs in which they have a stake, while a team of researchers wrote in the Journal of Evaluation in Clinical Practice that author conflicts of interest could lead to biased clinical guidelines.
"A guideline recommendation will have a huge impact on what practitioners will do across the globe," Brems said. "No one has time to read all the evidence out there. Worldwide, people use guidelines to help them decide what to do — when to screen for a test, what test to send, how to treat common illnesses and common diseases that we see. Even beyond people, insurance companies, what they decide to approve and reimburse can be based off of guidelines, too. They have a huge influence on both the practice and the broader financial structure of medicine."
Brems suggested that bringing back the National Guideline Clearinghouse, a database from the U.S. Agency for Healthcare Research and Quality that lost funding in 2018, could help increase the level of transparency surrounding this issue. But unfortunately, he said, "the external policing of this just isn't there right now."
The study, "Analysis of conflict of interest policies among organizations producing clinical practice guidelines," published April 14 in PLOS ONE, was authored by J. Henry Brems, Andrea E. Davis and Ellen Wright Clayton, Vanderbilt University.