Guideline-Producing Groups Rarely Disclose Industry Ties

Tara Haelle

June 02, 2016

Despite having guidelines in place to manage conflicts of interest, the vast majority of medical organizations that produce clinical guidelines do not disclose the organizations' own ties with biomedical companies in their published guidelines, according to a study published online May 31 in PLOS Medicine.

The Institute of Medicine Committee on Conflict of Interest in Medical Research, Education, and Practice recommends that organizations disclose all direct and indirect funding sources with each guideline.

"These types of relationships can have undue influence because clinical practice guidelines are resource intensive to produce and are developed by a small number of expert clinicians who determine the scope of the guidelines, synthesize and interpret the published evidence base, and provide recommendations," write Paul Campsall, MD, from the University of Calgary, Alberta, Canada, and colleagues. "The potential impacts of conflicts of interest are large because clinical practice guidelines are designed to be widely disseminated and influence the practice patterns of large numbers of healthcare providers."

The researchers reviewed the websites of 95 national and international medical organizations that published a total of 290 clinical guidelines on the National Guideline Clearinghouse website during the 2012 calendar year. Then they sent a survey to those organizations, of which 68% responded, representing 58% of all the clinical guidelines. Just six organizations declined to participate, whereas 24 did not respond. Two thirds of the organizations were professional associations, and one fifth were disease or condition interest groups.

Combined information from the survey and website revealed that 63% of the medical organizations have received biomedical industry funding, yet only 1% of the guidelines included statements identifying financial relationships of the organization itself. The others did not mention it at all. Meanwhile, just 51% of the guidelines included disclosure statements from guideline committee members.

"The relationship with biomedical organizations is so widespread, and these organizations are looking for ways to fund their activities," senior author Henry T. Stelfox, MD, PhD, an associate professor of Critical Care Medicine at the University of Calgary and scientific director of the Alberta Health Services' Critical Care Strategic Clinical Network, told Medscape Medical News.

Clinicians need to be aware "that many of the organizations that develop clinical practice guidelines have relationships with biomedical companies," Dr Stelfox added. "That means there's a risk that those guidelines could be unduly influenced."

Dr Stelfox recommended that physicians look for a disclosure statement while reading guidelines, and noted that the absence of one may mean the physician should approach that guideline with a little less confidence and a little more skepticism.

"Even if providers are acting in what they believe is the patient's best interest, these relationships can have kind of unconscious influence," he said.

More than a third of the guidelines (35%) had no disclosure statement for direct funding toward the guideline's development, and 6% reported that no funding went toward the guideline's development at all. Another 31% noted no biomedical funding was received, and 6% disclosed that it was.

When asked to comment on these findings, the American College of Physicians, one of the organizations included in the study, directed Medscape Medical News to their website, where visitors can download all guidelines' committee members' disclosures. The website also includes a page on the ACP's industry relationships, including disclosure of organizational support and background detail and industry support over time. One of their recent clinical practice guidelines included the committee members' disclosures and the source of the guideline's, funding but not the organization's disclosures.

The only thing surprising about this study's findings is that so little progress has been made in better managing conflicts of interest related to practice guidelines, according to Lisa Bero, PhD, chair of Medicines Use and Health Outcomes in the University of Sydney's Faculty of Pharmacy in Australia.

"Since at least as early as 2006, there have been calls for disclosure of conflicts of interest of guideline panel members and the organizations that pay for guideline development," Dr Bero told Medscape Medical News. "I don't think there is a solid argument to support the lack of policies and disclosure."

The survey included 18 procedures for managing conflicts of interest compiled from what the Institute of Medicine, the Council of Medical Specialty Societies, and the American College of Chest Physicians recommend. Combining survey responses and website reviews, Dr Campsall and colleagues found that 80% of the organizations had a policy for managing conflicts of interest, 40% had standing committees to manage conflicts of interest for the organization, and 25% had procedures to manage violation of those policies.

However, of the 69 policies the researchers were able to review, less than half (45%) specifically addressed conflicts of interest related to developing guidelines. Among these, 78% forbade partnering with industry to fund clinical practice guidelines, 82% did not allow industry to help select committee members, and 67% did not allow biomedical companies to review the guideline before publication.

"When you're going to be having big organizations developing guidelines that are complex with lots of people involved and all kinds of relationships, then you need to have a mechanism to deal with a situation when you have a breakdown in their policy, because it's going to happen, and very few of these organizations have that," Dr Stelfox told Medscape Medical News.

And having these policies is just a first step, Dr Bero said.

"Disclosure alone does not manage or eliminate conflicts of interest," she told Medscape Medical News. "Only management strategies that reduce or eliminate the conflict can [lessen undue influence]. However, without disclosure, we cannot even determine if a conflict of interest exists."

Dr Bero pointed out that research universities have more unconflicted researchers than conflicted researchers, so guideline developers should work harder to seek out unconflicted members.

Eroding Trust?

The more thorough an organization's conflict-of-interest policies were, the less likely they were to include positive recommendations for patented biomedical products in their guidelines, relative to the other organizations (relative risk [RR], 0.91; 95% confidence interval [CI], 0.86 - 0.95). They were also 32% more likely to have guidelines with negative recommendations related to a patented biomedical product (RR, 1.32; 95% CI, 1.09 - 1.60). Those organizations' clinical practice guidelines were more likely to report disclosures for direct funding and for financial relationships of committee members, yet none of them reported the organization's financial relationship.

Inadequate management of discourses and conflicts of interest can erode trust in clinical recommendations, writes PLOS Medicine managing editor Hilda Bastian, PhD, in an accompanying editorial.

"When guideline recommendations are controversial — and that's often — suspicion quickly turns to financial conflicts of interest," Dr Bastian writes. "The perception of conflicts can call the reliability of a recommendation into question, and even more so if there was no disclosure. This new study adds fuel to those concerns."

The authors identified three key issues to better managing potential conflicts of interest in guideline development: First, they recommended that "organizations that produce clinical practice guidelines should develop conflict of interest policies to manage relationships with biomedical companies, should ensure these policies address the production of guidelines, and should make the policies available to guideline users."

Because biomedical funding directly toward a guideline or only to the organization can create conflicts of interest, full disclosure of all relationships are essential for transparency, the authors argue. Then these organizations need to have mechanisms for managing breakdowns in conflicts of interest.

"Clinical practice guidelines need to be based on solid scientific grounds and expertise," writes Dr Bastian in the commentary. "However, the science, the experts, and the organizations developing guidelines can have major financial entanglements — and that can be true of the best experts and research in the area. Managing potential conflicts well is tough in this context, but it's one of the most essential steps to making a guideline both credible and trusted."

Funding for this study came from Alberta Innovates—Health Solutions, and one coauthor is supported by a Tier 1 Canada Research Chair. The authors have disclosed no relevant financial relationships. Funding for the editorial came from the National Institutes of Health and the National Library of Medicine. Dr Bastian is a current Editorial Board member at PLOS Medicine and was a member from 2008-2011 of the GRADE Working Group. She was also a member of the working group that developed the 1999 Australian National Health and Medical Research Council guidelines on the development, evaluation, and implementation of clinical practice guidelines.

PLOS Medicine. Published online May 31, 2016. Article full text, Editorial full text

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