AIM: Do conflicts of interests impact clinical practice guidelines?

In the 17 most recently published American College of Cardiology/American Heart Association clinical practice guidelines, conflict of interest reporting was prevalent but varied. However, the report, published in the March 28 issue of the Archives of Internal Medicine, suggests that there may be a large number of potential expert writers and reviewers with guideline writing experience that do not have COIs.

“Clinical practice guidelines serve as standards of care in practice, quality improvement and reimbursement,” the authors wrote. “Although conflicts of interest (COIs) are found in all spheres of medicine, their role in the formation of clinical practice guidelines may be especially significant.”

Because bias within the clinical practice guideline process has the potential to negatively affect patient care compared with individual practitioner COIs, Todd B. Mendelson, MD, MBE, of the University of Pennsylvania in Philadelphia, and colleagues set out to assess 17 ACC/AHA guidelines written between 2004 and 2008 that involved 498 writers/researchers to understand COIs within clinical practice guidelines.

The researchers categorized COIs into four categories: research grants, being on a speaker’s bureau and/or receiving honoraria, owning stock, or being a consultant or a member of an advisory board.

Mendelson et al reported that 651 episodes of participation by 498 individuals were found in the guidelines evaluated, an average of 1.31 episodes per individual. ("Episode" describes one instance of participation in one guideline by one person.) Individuals were most often a member of an advisory board and the percentage of episodes involving a COI varied across guidelines, from 13 percent to 87 percent.

Fifty-six percent of the 498 individuals reported a COI.

Being a guideline committee member was associated with a COI 63 percent of the time, versus 51 percent for peer reviewers. Twenty-one percent of the individuals who reported a COI were involved in two or more guidelines and the percentage of those reporting a COI was higher in people who had more episodes of participation.

Lastly, the researchers reported that 510 companies were involved in the 17 guidelines evaluated; 18 unique noncommercial organizations reported were involved in COIs.

While clinical practice guidelines have uniform practice standards, several recent episodes have spurred questions about the involvement of COIs within guidelines. “Our finding that most episodes of guidelines participation involve COIs, and that most individuals involved in producing guidelines report COIs, is a cause for concern,” the authors wrote. This concern stems from the fact that recent guidelines have been based more on expert opinion than clinical trial data.

In addition to disclosure, the authors offered the following strategies to deal with COIs:

• Agencies that sponsor guidelines could mandate that guideline committee members have no COIs related to the guidelines they are creating. This is reflected in ACC/AHA regulations; and
• Members could be required to abstain from voting on issues related to COIs while participating in the discussion.

However, “While providing more details about COIs may give a reader a better sense of how conflicted a guideline writer or reviewer may be, the actual degree to which any individual may be influenced by any specific type of COI (or even a specific dollar amount) is impossible to assess,” the authors wrote.

Lastly, the authors said that COIs may not be proof of bias and that despite COIs, individuals can still “promote the best interests of clinical care over the interest of industry affiliations.”

“Although restricting participation may prevent some qualified individuals from serving in the guidelines production process, we found that a large percentage of individuals with guidelines experience reported no disclosures, suggesting there is a substantial pool of potential guideline writers and reviewers without COIs,” the authors concluded.

In an accompanying editorial, Steven E. Nissen, MD, of the Cleveland Clinic, wrote that Mendelson et al raised "disturbing questions" and "the depth and breadth of industry relationships reported in this article are extraordinary. Unexpectedly, financial ties between companies and clinical practice guideline authors include relationships extending far beyond scientific collaboration."

Nissen reported that one-third of the writers for the percutaneous intervention guidelines owned stocks in companies affected by the clinical practice guidelines and added that participants in the speaker's bureaus "essentially became temporary employees of industry, whose duty is the promotion of the company's products.

"To allow such individuals to write clinical practice guidelines defies logic," he continued.

In addition, Nissen pointed out, "While sunlight is always a good disinfectant, there is nothing about disclosure that inherently guarantees scientific independence of the clinical practice guideline document.

"Why have professional societies allowed such extraordinary levels of commercial influence to infiltrate clinical practice guideline committees?" asked Nissen. He concluded that the extent to which financial ties can create bias within the guideline writers and chairs is unknown and cause for concern, adding that if the clinical practice guideline policy is not addressed, "the credibility of evidence-based medicine will suffer irreparable harm."