Friday, June 3, 2016

Guideline-producing groups rarely disclose industry ties

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 disclosure 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."…

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 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...

"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."...

"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."

1 comment:

  1. Paul Campsall, Kate Colizza, Sharon Straus, Henry T. Stelfox. Financial Relationships between Organizations That Produce Clinical Practice Guidelines and the Biomedical Industry: A Cross-Sectional Study. PLOS Medicine. Published: May 31, 2016.



    Financial relationships between organizations that produce clinical practice guidelines and biomedical companies are vulnerable to conflicts of interest. We sought to determine whether organizations that produce clinical practice guidelines have financial relationships with biomedical companies and whether there are associations between organizations’ conflict of interest policies and recommendations and disclosures provided in guidelines.

    Methods and Findings

    We conducted a cross-sectional survey and review of websites of 95 national/international medical organizations that produced 290 clinical practice guidelines published on the National Guideline Clearinghouse website from January 1 to December 31, 2012. Survey responses were available for 68% (65/95) of organizations (167/290 guidelines, 58%), and websites were reviewed for 100% (95/95) of organizations (290/290 guidelines, 100%). In all, 63% (60/95) of organizations producing clinical practice guidelines reported receiving funds from a biomedical company; 80% (76/95) of organizations reported having a policy for managing conflicts of interest. Disclosure statements (disclosing presence or absence of financial relationships with biomedical companies) were available in 65% (188/290) of clinical practice guidelines for direct funding sources to produce the guideline, 51% (147/290) for financial relationships of the guideline committee members, and 1% (4/290) for financial relationships of the organizations producing the guidelines. Among all guidelines, 6% (18/290) disclosed direct funding by biomedical companies, 40% (117/290) disclosed financial relationships between committee members and biomedical companies (38% of guideline committee members, 773/2,043), and 1% (4/290) disclosed financial relationships between the organizations producing the guidelines and biomedical companies. In the survey responses, 60 organizations reported the procedures that they included in their conflict of interest policies (158 guidelines): guidelines produced by organizations reporting more comprehensive conflict of interest policies (per additional procedure, range 5–17) included fewer positive (rate ratio [RR] 0.91, 95% CI 0.86–0.95) and more negative (RR 1.32, 95% CI 1.09–1.60) recommendations regarding patented biomedical products. The clinical practice guidelines produced by organizations reporting more comprehensive conflict of interest policies were also more likely to include disclosure statements for direct funding sources (odds ratio [OR] 1.31, 95% CI 1.10–1.56) and financial relationships of guideline committee members (OR 1.36, 95% CI 1.09–1.79), but not financial relationships of the organizations (0 disclosures). Limitations of the study include the use of the National Guideline Clearinghouse as the single source of clinical practice guidelines and the self-report of survey responses and organizations’ website postings.


    Financial relationships between organizations that produce clinical practice guidelines and biomedical companies are common and infrequently disclosed in guidelines. Our study highlights the need for an effective policy to manage organizational conflicts of interest and disclosure of financial relationships.