Conflicts of Interest Widespread Among Canadian Guideline Writers
Most of the clinical practice guidelines hailing from Canada have at least one co-author reporting a financial connection to the pharmaceutical industry, a new study reports. For some guideline writers, the disclosure was directly related to the drug being recommended, and in many cases authors were inconsistent in their disclosures when contributing to multiple documents.
The findings were published online earlier this month in BMC Health Services Research.
One thing not clearly spelled out in the paper is “what constitutes a conflict of interest,” said James C. Blankenship, MD (Geisinger Medical Center, Danville, PA), immediate past president of the Society for Cardiovascular Angiography and Interventions, who has helped craft numerous guidelines. “That’s the million dollar question,” he told TCTMD, noting that research has shown that even something as simple as a free lunch may sway prescribing patterns.
Similarly, James N. Kirkpatrick, MD (University of Pennsylvania, Philadelphia, PA), who has studied the phenomenon as it pertains to American of College of Cardiology/American Heart Association (ACC/AHA) guidelines, said it would be hard to make a direct comparison between Canada and the United States based on these data.
What is clear, Kirkpatrick said, is that conflicts matter in this context, both due to their “potential to influence guideline recommendation and also because of how guidelines are perceived and whether they are trusted (see recent controversy over the ACC/AHA guidelines for treatment of high cholesterol).”
The Canadian Experience
Gathering details from the Canadian Medical Association Infobase, Adrienne Shnier, PhD, of York University (Toronto, Canada), and colleagues looked at 28 guideline documents developed by a total of 350 authors. The documents, which spanned various medical specialties and disease categories, were published between January 2012 and November 2013.
Three-quarters of guidelines had at least one author who reported a financial conflict of interest, defined as “including not only financial compensation but also activities that are generally associated with gifting, payment, or reimbursement, even if a monetary value was not disclosed.” Importantly, for six out of the 28 guidelines (21.4%), all authors reported having financial ties to industry.
Not only that, but 54% of documents had at least one author who reported a conflict specific to a drug recommended in the guidelines. In 28.6% of the documents, more than half of the authors met this description.
Moreover, 20 of the 48 authors who contributed to multiple guidelines were inconsistent in reporting their conflicts, and 28.6% of the documents were produced in conjunction with organizations that had financial relationships with manufacturers of recommended drugs.
The US Cardiology Landscape
“In general,” Kirkpatrick said, “the American College of Cardiology/American Heart Association guidelines have been the leaders in disclosure requirements and in instituting limits on the percent of guideline authors and chairs who can have ‘Relationships With Industry,’” or RWI.
He noted that the ACC upholds the recommendations made by the Council of Medical Specialty Societies (CMSS) on this topic. “Many other cardiology subspecialty societies are also very concerned about these issues,” Kirkpatrick said, adding that this is largely due to the Open Payments Program that was implemented as part of the 2010 Affordable Care Act.
These standards “are helpful because they show a commitment to the process of avoiding bias,” he commented. “Whether they do so is an open question and hard to study.”
The ACC/AHA guideline process mandates that each writing committee’s chair, as well as half of its members, be free of relevant RWI. Participants with connections to a drug being considered must recuse themselves from voting on the topic or writing the relevant section of the document.
Under these standards, being principal investigator or co-investigator of an industry-funded, multicenter trial counts as a conflict, Blankenship said. “So essentially anybody that’s involved in any kind of research on the drug [being considered], even at the point of enrolling a patient, has a conflict of interest.”
Transparency and accurate, up-to-date reporting of relationships with industry are both key, he noted, and it’s important to be careful in setting the terms. “If you define it loosely enough, everybody ultimately has some conflict of interest,” making it difficult to find people with the right expertise who can participate in guideline creation, Blankenship said. “It’s hard to find really thoughtful people recognized by their peers as experts who don’t have something that falls into this conflict of interest policy, at least in the United States.”
As for Kirkpatrick, he suggested setting the bar even higher. “I personally think we could find a way to have guidelines committees free of relevant commercial interests while not prohibiting important noncommercial interests, but the CMSS rules about more than 50% [of participants] being nonconflicted are a good start,” he concluded.
- A Ray of Sunshine: CMS Experts Give an Update on 2 Years of Public Disclosure
- Conflicts of Interest Common in ACC-AHA Practice Guidelines
- Patients, Research Participants Prefer Physician Disclosure of Financial Ties
Shnier A, Lexchin J, Romero M, Brown K. Reporting of financial conflicts of interest in clinical practice guidelines: a case study analysis of guidelines from the Canadian Medical Association Infobase. BMC Health Services Research. 2016;Epub ahead of print.
- Shnier, Blankenship, and Kirkpatrick reports no relevant conflicts of interest.