Nondisclosure of Financial Interest in Clinical Practice Guideline Development: An Intractable Problem?

In a Perspective linked to Stelfox and colleagues, Hilda Bastian discusses the challenges of improving transparency and management of financial conflicts of interest among committees that develop guidelines for medical practice.


Policy on Management of Conflicts of Interest Is Getting Stronger, But Is It Enough?
Clinical practice guidelines need to be based on solid scientific grounds and expertise. 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.
With hindsight, I think those of us encouraging better methodology for guideline development in the 1990s took the issue of disclosure of financial interests too much for granted. It Provenance: Commissioned; not externally peer reviewed seemed so self-evident, it got barely a mention even in national policy on guideline development [7]. Policies have been getting more detailed and much stronger, however. The US Institute of Medicine took a strong position on this the year before the guidelines evaluated in Stelfox and colleagues' study were published. In general, the Institute of Medicine report concluded, the quality of guidelines' "development processes and guideline developer adherence to quality standards have remained unsatisfactory and unreliable for decades" [8].
Last year, the Guidelines International Network took a strong position on the need to improve management of conflicts of interest as well [9].
It's hard to know, though, whether we should feel confident that adherence to these policies on conflicts of interest will be better than adherence to other quality standards have been-like those on the evaluation of research [8]. That is a particular concern with increasing pressure to speed up the guideline development process and to reduce its costs [8].

Less Visible Organizational and Personal Financial Interests
Stelfox and colleagues focus particularly on the organizational conflicts of interest of guideline producers and their policies. They examine the financial interests of the organizations, but not of the individuals employed within those organizations. This same blind spot is evident when it comes to policies about committee members; the financial interests of the organizations that individuals represent tend to be disregarded. Yet these can be substantial, including for patients' organizations.
Of organizations responding to the Stelfox survey questions about managing conflicts of interest, most had policies, but their compliance with them often fell short. For example, of those reporting that a majority of guideline committee members must be free of financial conflicts, Stelfox and colleagues found that 61% produced at least one guideline in which a majority of the members disclosed company relationships.
These less visible lines of potential influence could be having more of an impact than we realize. The influence of staff members, of those who assess and manage the data presented to committee members, and the role of the chairperson could be pivotal. Graham and colleagues undertook a qualitative study of the management of conflicts of interest at the UK National Institute for Health and Care Excellence [10]. Their work pointed to the level of invisibility and unawareness of the potential for conflict among those participating in guideline development. Policy is not enough, according to Graham and colleagues. Successful implementation will require more clarity in policy and procedures, as well as training of chairpersons and evaluation of practice.
Moynihan and colleagues opened up another line that has not had the visibility of evaluation of, and recommendations about, biomedical products: expanding the definitions of disease [11]. They studied 16 guidelines by widely recognized US-based organizations on common conditions, identified from a search of MEDLINE, the National Guidelines Clearinghouse, and the National Institutes of Health website. Of those, ten proposed a widening of disease definition, by formulating pre-disease conditions or lowering a diagnostic threshold, for example. There were financial disclosures for all but two of the guidelines, and the average proportion of members with industry connections was 75%, including the chairs of 12 development committees.
Studies are expanding and deepening our understanding of the influences on clinical practice guidelines of interests that run counter to those of patients. This research will no doubt be helpful to the organizations who are already taking conflict of interest management seriously. They will keep improving. But those organizations are not why this problem seems to be intractable.
Guideline processes without adequate financial conflict management have to become unacceptable to a far wider circle. They need to become unacceptable to influential committee members, to the medical journals that lend so many guidelines additional standing and reach, and to the membership of the professional societies that produce them. Until that happens, for guidelines as for clinical research, it's a case of caveat lector: let the reader beware [12].