March 29th, 2011

Conflicts of Interest in Cardiovascular Guidelines

More than half of authors and reviewers of cardiovascular clinical practice guidelines (CPGs) have at least one conflict of interest (COI), according to a study in the Archives of Internal Medicine. Todd Mendelson and colleagues analyzed the 17 most recent ACC/AHA CPGs through 2008 and found that 56% of the participants reported a COI. The most common COI was being a consultant or a member of an advisory board.

The authors conclude that “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.”

In an accompanying commentary, Steve Nissen writes that the authors “raise disturbing questions about the independence and reliability of CPGs in cardiovascular medicine” and that “the depth and breath of industry relationships… are extraordinary.” Nissen also notes that “professional societies and their leadership are often plagued by the same commercial relationships as the CPG-writing committees.”

In response to the Archives article and an IOM report on CPGs, the AHA and the ACC issued a statement pointing out that the two groups had “refined their policies in 2010 to require even more stringent management of relationships with industry, to align with the Council of Medical Specialty Societies (CMSS). Thus the data within and the conclusions drawn by the article do not reflect the reality of the guidelines development process today.”

3 Responses to “Conflicts of Interest in Cardiovascular Guidelines”

  1. I agree with the core message from both the authors and the editorialist. However, in fairness, the information predates the changes implemented by the ACC/AHA Task Force for Clinical Practice Guideline Committee to minimize the conflicts and relationships with industry which are now more stringent. For example, the chair(s) of the Writing Committee is(are) not allowed to have any conflicts (financial or otherwise), and no more than 50% of the writing committee is allowed to have any COIs.

    What is not known to many is that the Task Force did attempt to implement some of the steps recommended by the authors and the editorialist during the development of the 2007 focused update on unstable angina guidelines. It was an unmitigated disaster and the guidelines had to be redone, thereby delaying their release.

    The ACC/AHA Task Force has a difficult challenge to limit the biases and the conflicts of interest of the guideline writing committee. These are not just limited to financial conflicts but also include intellectual biases and conflicts. In my experience, the best advice often comes from expert “consumers” rather than expert “generators” of information and evidence. One of the recommendations I have for the task Force in this regard is to limit the participation of the principal investigators of guideline-relevant clinical trials in guideline writing process. They should be invited to offer their expert opinion (as part of the peer review), but not allowed to “engineer” the guidelines. Although, the Task Force does a good job in assembling a panel with a broad spectrum of expertise in evidence appraisal, benefit-risk assessment, and clinical decision making, in my opinion, there is room for further improvement.

  2. Robin Motz, M.D., Ph.D. says:

    If the government and public thinks that it would compromise a physicians prescribing integrity if the drug rep gives the physician a ballpoint pen,
    then it must certainly suspect and ask for recusal of any physician/scientist who is paid money by a drug company.

  3. Pietro Vandoni, Medical Doctor, says:

    In the actual era of Evidence Based Medicine, most of evidence generating Randomized Clinical Trials and studies are somewhat sponsorized by drug companies which seems to be the only “institutions” with sufficient financial power to sustain costs of research.
    The core of the problem of COI in guidelines development process is therefore,in my opinion,not only in committes composition but in sponsorship of evidence generating researches.
    I am afraid contemporary medicine could not free itself from economic interest. The only, weak, protection a physicyan can rely upon against excess of Company based Medicine is his clinical experience and judgment and amount of resources he has from heatlh system he works within.

    Competing interests pertaining specifically to this post, comment, or both:
    No COI apart patients health and life