Influence of Industry on Renal Guideline Development Commentary: Keeping Our Eye on the Ball and Improving Chronic Kidney Disease Patient Outcomes

Clinical practice guidelines (CPG) are “systematically defined statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” (1). CPG and other components of evidence-based medicine have been developed and promoted because of the wide variation in clinical practice throughout medicine. One only needs to review the most recent Annual Data Report of the US Renal Data System or the recently published Centers for Medicare and Medicaid Services clinical performance measure project results to see that such variability is clearly present in nephrology. What should be a welcome tool for the practitioner, however, has been perverted by regulators, payers, and litigators into one that is viewed as setting standards of care and applying these standards to payment policy including the new rush to pay-for-performance.

Because of these realities, it is even more important now to be certain that guideline development is scientifically rigorous and free of inappropriate bias from those who might benefit from particular recommendations, including, but not limited to, members of industry. The Kidney Disease Outcomes Quality Initiative (KDOQI) process, as eloquently described by Van Wyck and colleagues, has followed appropriate, accepted approaches to maintaining scientific rigor throughout the guideline development process (2). It should be noted, however, that there is an enormous evidence gap that pervades much of nephrology and that hampers guideline development panels from making many evidence-based recommendations. In the current KDOQI anemia guideline, there are only three evidence-based statements, whereas the remainder are “clinical practice recommendations” based largely on expert opinion from the guideline development group (3). Although randomized controlled trials are touted as the gold standard of evidence-based medicine, they are far from perfect, and not always feasible or appropriate as pointed out by Smith and Pell in relation to parachute use to prevent major trauma related to gravitational change (4).

Conflicts of interest, particularly financial conflicts, are of concern in the biomedical field at a variety of levels, from pharmaceutical companies providing “freebies” to physicians or students, to researchers being funded by companies in which they have a financial stake (5,6). Some have expressed the need for a national consensus and approach to such issues of financial conflicts in research, and perhaps such an approach related to guideline development and sponsorship would be of value as well (7). Coyne suggests that financial relationships of guideline panel members have corrupted the guideline development process and that strict controls be put in place to eliminate any actual or perceived conflicts as guidelines are developed (8). While I agree with the goal, I would propose that the approach be modified as follows:

1. Selection of guideline topics: It is essential that topic selection follow the structured process recommended by the Institute of Medicine (IOM), rather than be driven by which sponsor is likely to be available to support a guideline (9). This is the approach used by the Renal Physicians Association in its guideline development process.

2. Funding of guidelines: At a minimum, funders should play no role in refining the topic, selecting the expert panel, selecting the technical consultants, writing the guidelines, or unduly influencing the final guideline document. Although the National Institutes of Health (NIH) support for this process, rather than industry support as suggested, would eliminate potential financial conflicts of sponsors, NIH money would be better spent funding studies to fill the gaps in knowledge uncovered during the guideline development process. I would urge the renal community to establish a guideline development consortium, a collaborative of the key nephrology societies, to jointly oversee the guideline development process. Such an organization would solicit funds from a variety of sources and would fund guidelines, selected using the IOM process, from this pool of funds.

3. Conflicts of guideline development panelists: Rather than disqualify guideline panelists with any financial relationship with a funder of a particular guideline, full and complete disclosure of relationships is more appropriate. The need for transparency is essential for credibility and I concur with Coyne that such full disclosure must be made and prominently displayed in any guideline documents.

Winston Churchill once remarked: “It has been said that democracy is the worst form of government except all of the others that have been tried.” Similarly, CPG are imperfect but far preferable to the chaos of clinical practice without them. If we are truly dedicated to improving patient outcomes, then CPG in nephrology, despite their imperfections, have been a real success, as demonstrated recently by Rocco and colleagues (10).

• Copyright © 2007 by the American Society of Nephrology