24% of clinical guideline authors may have undisclosed ties to drug industry

Nearly a quarter of physicians who develop, draft and author clinical guidelines could have potentially relevant undisclosed ties to pharmaceutical companies, a team of Australian researchers reported Feb. 5 in BMJ Open.

Systematic review evidence suggests the majority of guideline writers—anywhere from 56 percent to 87 percent—disclose some sort of industry affiliation in their final publications, first author Ray Moynihan, PhD, and co-authors wrote. But that leaves up to 44 percent of authors either disclosing no ties or choosing to disclose nothing.

“There is global concern about the nature and extent of financial ties between pharmaceutical companies and health professionals, including those who develop influential clinical practice guidelines,” Moynihan, a senior research fellow at the Centre for Research in Evidence-Based Practice at Bond University, and colleagues wrote. “In 2009, a landmark Institute of Medicine report on conflicts of interest acknowledged the importance of collaboration with industry, but warned financial ties to industry were widespread and risked jeopardizing the integrity of medical education, research and practice.”

To investigate the number of potentially relevant undisclosed financial ties between clinical practice guideline writers and pharmaceutical companies, the researchers conducted a cross-sectional study of a randomized sample of 33 Australian guidelines and 402 writers.

Guidelines represented what Moynihan et al. considered “health priority areas”: cancer, asthma, cardiovascular, arthritis/musculoskeletal, diabetes, injury, kidney/urogenital, mental health, neurological and obesity. Four of the guidelines were related to cardiovascular topics, while another four were related to diabetes and one was for obesity.

The researchers reported 86 percent of writers either had no published disclosures (57 percent) or disclosed they had no ties (29 percent) to entities relevant to the guidelines they worked on. In those cases, the team searched for any previous relationships those authors disclosed in medical literature dating back five years.

Of the 344 writers with no disclosed ties, 24 percent had at least one potentially relevant undisclosed tie discovered by Moynihan et al. in recent published literature, and 70 percent of guidelines included at least one writer with a potentially relevant undisclosed tie. The most popular relevant undisclosed ties had to do with pharmaceutical company grants (64 percent) and personal fees (36 percent).

“Undisclosed financial ties of guideline writers appeared to be more common in some therapeutic areas such as diabetes and cardiovascular disease, compared with other areas such as injury and mental health,” Moynihan and co-authors wrote. “Guideline writers working on guidelines developed and funded by government were much less likely to have undisclosed financial ties—8 percent compared with 31 percent.”

The researchers said their findings raise questions about potential biases that might impact public healthcare standards and patient care. In a world they said demands “total transparency,” their results could add weight to calls for reforms like the enforcement of current disclosure policies and the construction of publicly accessible conflict-of-interest research databases.

Moynihan et al. did note one of their incidental findings—that almost 1 in 5 guidelines involved more than 90 percent of writers without any relevant disclosures—suggests it is possible to assemble guideline panels that are almost entirely free of financial conflicts of interest.

“The related reform processes of enhanced transparency and greater independence underway in many nations creates clear opportunities for research comparing the quality of guidelines developed by writers with and without links to industry, a research question beyond the scope of this study and where there are currently limited data,” the researchers wrote.

“Given their potential influence over human health and health system sustainability, such vital research on the independence and trustworthiness of guidelines will be greatly enhanced by complete transparency around the financial conflicts of interest of those developing them.”