Out of 498 people involved in developing clinical practice guidelines, 56% (277) declared a conflict of interest, according to a study published in the prestigious Archives of Internal Medicine and carried out by researchers from the University of Pennsylvania. A conflict of interest occurs when a person is involved in more than one interest, one of which has the potential to corrupt his/her motivation to act properly in the other.

The authors wrote as background information:

“Clinical practice guidelines (CPGs) have become a fixture in clinical medicine. Though individual clinical trials have meaningful impacts on patient care, CPGs are often adopted as the standard of care and taught as such in training programs at all levels. CPGs also play a prominent role in quality improvement initiatives.

Although conflicts of interest (COIs) are found in all spheres of medicine, their role in the formation of CPGs may be especially significant. Improper bias in the CPG production process can have a potentially more widespread adverse effect on patient care than individual practitioners’ COIs.”

The authors add that there are few studies which examined how extensive conflicts of interest in the creation of cardiology guidelines might be.

Todd B. Mendelson, M.D., M.B.E., and team looked at 17 of the most recent guidelines issued by the American Heart Association and the American College of Cardiology up to the end of 2008. They examined details in the disclosure lists and gathered the data and cataloged conflicts of interests for each individual as being on a speaker’s bureau, receiving paid fees, owning stock, being a consultant, being a member of an advisory board, or receiving a research grant.

They also listed the institutions and companies that were reported in each disclosure. The category “Episode” describes one instance of participation in one guideline by one person. “Individual” describes one person who may be involved in several episodes. “Company” describes an industry or commercial affiliation reported by an individual in a single episode.

In the 17 guidelines the investigators found:

  • 651 episodes of participation by 498 individuals
  • Each individual took part in an average of 1.31 episodes
  • 56% (277) of the individuals reported a conflict of interest
  • Of the 651 episodes, 56% (365) involved a conflict of interest
  • The most common conflict of interests were: 1. Being a consultant or on an advisory board. 2. Receiving a research grant. 3. Being paid a fee to speak. 4. Having stock or some other kind of ownership.
  • The percentage of episodes involving a conflict of interest varied from 13% (2/15 episodes) to 87% (13/15 episodes).

The authors wrote:

“Role as guideline committee member (vs. peer reviewer) was associated with COI (63% vs. 51%), as was role as chair/co-chair/first author (81% vs. 55%). Only 105 of the 498 individuals (21%) were involved in two or more guidelines. The percentage of individuals reporting a COI was higher among individuals with more episodes of participation, and the number of episodes of participation was associated with both presence of COIs and number of COIs.”

In the 17 guidelines a total of 510 commercial companies were involved, with a wide range in the number of companies reported to be involved in various guidelines (average, 38 companies, range 2-242 companies).

On the other hand, just 18 non-commercial organization were reported to be involved in conflicts of interest. The investigators identified the commercial company involved in the greatest number of conflicts of interest in each guideline. One company in particular was reported by more individuals than any other in 7 of the 17 guidelines.

The authors wrote:

“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. These findings are a particular cause for concern given the fact that many of the newest ACC/AHA guideline recommendations are based more on expert opinion than on clinical trial data. However, our findings of the average number of companies (38) and the range of numbers of companies (2-242) reported per guideline are perhaps less salient than the finding that a few companies were most reported in multiple different guidelines, and that one company was most reported in seven of 17 guidelines.

“In conclusion, CPGs play an increasingly influential role in the practice of medicine. COIs are prevalent but vary widely in recent ACC/AHA guidelines. Individuals with greater involvement in CPGs reported more COIs. 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.”

Steven E. Nissen, M.D., of The Cleveland Clinic Foundation, believes that the study’s findings raise disturbing question regarding the reliability and independence of conflicts of interest in cardiovascular medicine.

Dr. Nissen wrote:

“Why have professional societies allowed such extraordinary levels of commercial influence to infiltrate CPG committees? Professional societies and their leadership are often plagued by the same commercial relationships as the CPG-writing committees. Pharmaceutical and medical device companies provide large amounts of the financial support for the education and advocacy efforts of professional societies. Such relationships have created a dependency that is difficult to terminate because the leadership of professional societies is reluctant to antagonize their financial benefactors. The extent to which such financial ties bias the selection of CPG chairs and writers is unknown, but it certainly raises appropriate concerns. The revelations reported in the current article highlight troubling concerns that must be urgently addressed. If we fail as a profession to police our CPG process, the credibility of evidence-based medicine will suffer irreparable harm.”

“Conflicts of Interest in Cardiovascular Clinical Practice Guidelines”
Todd B. Mendelson, MD, MBE; Michele Meltzer, MD, MBE; Eric G. Campbell, PhD; Arthur L. Caplan, PhD; James N. Kirkpatrick, MD
Arch Intern Med. 2011;171(6):577-584. doi:10.1001/archinternmed.2011.96

Written by Christian Nordqvist