More than half of the members on panels that produced national guidelines for screening or treating diabetes and hyperlipidemia in the U.S. and Canada had a financial conflict of interest (COI), according to an analysis published Oct. 11 in the British Medical Journal. Among 73 panel members who reported no conflicts, 11 percent were found to have one or more conflicts of interest, the researchers reported.
Concerns over conflicts of interest in the medical arena have been raised by institutions, such as the Institute of Medicine, which in 2009 provided recommendations for managing COIs among panelists participating in the development of clinical practice guidelines. The authors pointed out that publicized incidences of industry-funded payments to physicians and medical thought leaders as well as revelations of research publications ghost-written by drug company employees reflect industry’s influence.
“One area in which the presence of COI may be particularly concerning is the development of clinical practice guidelines,” Jennifer Neuman, MD, instructor of preventive medicine at Mount Sinai School of Medicine in New York City, and colleagues wrote. “Guidelines serve to standardize care, to inform evidence-based practice, and ultimately to protect patients, so their freedom from bias is particularly important.”
Neuman and colleagues selected diabetes and hyperlipidemia for their analysis because of the high prevalence of the diseases, whose treatments account for the highest prescription drug expenditures in the Medicare population. They designed a cross-sectional study using the National Guideline Clearinghouse, MDConsult, UpToDate and organization websites to identify guidelines. They selected guidelines released between 2000 and 2010 by national organizations in the U.S. and Canada, for a total of 14 guidelines.
They defined financial COI as direct compensation by a drug manufacturer through stock, grants, speaker fees, honorariums and pay for a consultancy or similar relationships. To identify COIs, they first checked the guidelines for a COI declaration section; five guidelines did not list COI declarations. They used Medline and Google searches to further look for COIs.
Of the 288 panel members involved in the guidelines, 48 percent reported COIs. The remainder either declared no COIs or did not have the opportunity to declare COIs. Of the 12 guidelines that listed a chair, half of the chairs declared a COI.
The researchers found that 11 percent of those who declared no COI were found through searches to have a COI. After their searches, the researchers found a total of 52 percent of physicians had conflicts.
Panelists involved in government-sponsored guidelines were much less likely to have a COI, and COIs were much more prevalent among panelists producing guidelines sponsored by a specialty society. COIs were more common among Canadian than U.S. specialty panels (83 percent compared to 58 percent).
“Our data illustrate the pervasiveness of COI among members of guideline panels and may raise questions about the independence and objectivity of the guideline development process in the United States and Canada,” Neuman and colleagues wrote. “Furthermore, our study exposes the problem of incomplete disclosure and highlights the important relationship between sponsorship of guidelines and the presence of COI.”
The study applied a conservative approach for determining COI, they wrote. They used only clear documentation of COI. They did not include authorship of a paper on an industry-supported clinical trial or chairing industry-sponsored conferences as a COI, for instance. They said that their conservative approach may have underrepresented the extent of COIs as a consequence.