Guideline committee members have conflicts of interest
Organizations have new motivation to improve practices
Of 254 authors of clinical practice guidelines from 14 specialty societies, 53% had conflicts of interest (COIs) and only one of the 45 guidelines disclosed author COI.1
Another 2013 study found that 56% of manufacturers of patented drugs recommended in 13 clinical practice guidelines on glycemic control in type 2 diabetes mellitus, on average, had at least one author with a financial interest in their company.2
COI were reported by 56% of 498 people who helped write 17 guidelines for the American Heart Association and American College of Cardiology from 2003 through 2008, according to a 2011 study.3 Of the people who led those groups, 81% had personal financial interests in companies affected by their guidelines.
Eric G. Campbell, PhD, one of the 2011 study's authors, says the findings were not at all surprising. "From a strategic point of view, if you want to influence a field, it's much easier to influence the content of a guideline that everybody follows, than to go out and try to convince a whole bunch of doctors to do the same thing," he says. Campbell is director of research at Mongan Institute for Health Policy and professor of medicine at Harvard Medical School, both in Boston.
While one primary care physician might see several hundred patients, a guideline can influence the care provided by virtually all physicians in the country. "That is why guidelines should receive the highest level of scrutiny possible," Campbell says.
Pharmaceutical companies want access to the biggest names in the field, so they establish financial relationships with those individuals. "The rank-and-file doctors are not on these committees. These are really the superstars, often, of medicine," says Campbell. "And it is that group that is inherently conflicted, often, because they are the people that industry wants."
The guideline committees are often funded by pharmaceutical companies. "It's about the practice of medicine, but it's also about creating a market," says Campbell. "While no one knows what the balance of the two is, it is impossible to deny that drug companies funding organizations that produce guidelines will further their business interest."
Physicians "can't have it all"
In order for things to change, specialty organizations first need to acknowledge that conflicts are important, emphasizes Campbell. "It is up to the profession of medicine to adequately regulate this," he says. "I have not seen any data, but my suspicion is that this is still very much a largely under-regulated arena."
The profession's failure to self-regulate itself could result in increased outside attention from regulatory forces, he warns.
Providers may need to acknowledge that while they are free to be on a speaker's bureau for a pharmaceutical company, or have an equity interest in a device manufacturer, doing so may prohibit them from participating in other professional activities.
"And one of those activities should be chairing committees that develop guidelines or serving as a member," argues Campbell. "You can't have it all."
The 2011 study showed that 44% of guideline writers had no financial interests in the area they reviewed. This rebuts the argument that there are not enough experienced experts who are independent, says James N. Kirkpatrick, MD, one of the study's authors and assistant professor in the Cardiovascular Division and the Department of Medical Ethics and Health Policy at the Hospital of the University of Pennsylvania in Philadelphia.
"I don't see why it is necessary to include people with COI on the writing committees," says Kirkpatrick. "It is rather common for the presidents of subspecialty societies to divest themselves of COI, so why not require the same of guideline writers?"
Some organizations adhere to the Council of Medical Specialty Societies' guidance regarding relationships with industry, which states that guideline committee chairpersons should not have relevant COI, and more than half of members should be free of COI. (To view the Code for Interactions with Companies, go to www.cmss.org/codeforinteractions.aspx.)
"These recommendations are similar to what has been promoted by the Institute of Medicine," says Kirkpatrick.
Some organizations do require disclosure of COI. "The organizations assume that disclosure of the COI essentially removes the problem, since the reader of the guideline can decide for himself or herself if the COI leads to bias," says Kirkpatrick.
Other organizations go a step further, requiring participants with relevant COI to the topic at hand to abstain from voting on a specific recommendation, or from discussing the recommendation, or both. "Chairs are supposed to enforce these rules," says Kirkpatrick. "I suspect in some cases there is a 'don't ask, don't tell' mentality, which may mean that the organizations don't believe COI is an issue in guideline writing."
Kirkpatrick says the most commonly voiced ethical concern is unrecognized bias compromising the integrity of guidelines. "However, it is hard to draw a direct line between COI and bias, because the degree to which a COI leads to bias is likely very dependent on the individual," he says.
Kirkpatrick is more concerned about the perception of bias that COI brings. "People already have many critiques of guidelines, and studies show that they are often not followed," he says. "I believe there is no faster way to discredit these otherwise useful documents than to have them open to charges of bias because panel members have COI."
Harold C. Sox, MD, MACP, professor of medicine at Geisel School of Medicine at Dartmouth in Hanover, NH, and former guidelines panel chair for the American College of Physicians, says that if guideline panel members have COIs, "regardless of their motives, the seeds of mistrust have been planted."
Recommendations "appropriately tough"
Given the important role that guidelines play in the practice of medicine, the Institute of Medicine (IOM)'s 2009 recommendations are "appropriately tough," says Sox.
"There was a time when the main use of practice guidelines was to serve as a standard of good medical practice, but they had little effect on practice because the movement to improve quality of care was in its infancy," says Sox.
In effect, no one was paying much attention to adherence to standards of practice, says Sox, "but things have changed."
"The most striking example is the U.S. Preventive Services Task Force. The [Affordable Care Act] ACA says that if the Task Force gives a preventive service a strong recommendation, then Medicare will pay for it," says Sox.
More informally, commercial insurers are using guidelines to make coverage decisions. In addition, guidelines are often the starting point for developing practice measures used to assess the quality of care.
"Basically, the stakes are higher with practice guidelines than they used to be," says Sox. "They are influencing policies, rather than simply serving as a standard for physicians to strive to follow."
Sox believes that specialty organizations are likely to take the IOM recommendations seriously. "They are professionals, and in the end, are accountable to the public for their policies," he says. "They also don't want to be identified as non-adherent."
Another factor is the movement toward creating a marketplace for high-quality guidelines. "Guideline developers that want access to the marketplace will have to have strong COI management policies," says Sox.
The Agency for Healthcare Research and Quality, the sponsor of the National Guidelines Clearinghouse, strongly encourages developers of clinical practice guidelines to describe their COI policies, to disclose potential COI, and to describe all funding sources for the development of their guidelines.
According to a newly implemented policy, failure to disclose COI would disqualify a guideline from being posted on the Clearinghouse.5
Organizations will be motivated to improve their practices, including their COI policy, says Sox, "so that their guidelines get a chance to be seen by organizations that use the National Guidelines Clearinghouse as a marketplace for guidelines that they can trust."
- Bindslev JB, Schroll J, Gotzsche PC, et al. Underreporting of conflicts of interest in clinical practice guidelines: Cross sectional study. BMC Med Ethics 2013;14:19.
- Norris SL, Holmer HK, Ogden LA, e al. Conflicts of interest among authors of clinical practice guidelines for glycemic control in type 2 diabetes mellitus. PLoS One 2013;8(10):e75284.
- Mendelson TB, Meltzer M, Campbell EG, et al. Conflicts of interest in cardiovascular clinical practice guidelines. Arch Int Med 2011;171(6):577-584.
- National Research Council. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: The National Academies Press, 2009.
- Hermann RC, Shekelle PG, Balk E, et al. Promoting transparent and actionable clinical practice guidelines: Viewpoint from the National Quality Measures Clearinghouse/National Guideline Clearinghouse (NQMC/NGC) editorial board. December 20, 2010.
- Eric G. Campbell, PhD, Director of Research, Mongan Institute for Health Policy, Boston, MA. Phone: (617) 726-5213. E-mail: email@example.com.
- James N. Kirkpatrick, MD, Assistant Professor, Cardiovascular Division/Department of Medical Ethics and Health Policy, Hospital of the University of Pennsylvania, Philadelphia. Phone: (215) 662-7726. E-mail: James.Kirkpatrick@uphs.upenn.edu.
- Harold C. Sox, MD, MACP, Professor of Medicine, Geisel School of Medicine at Dartmouth, Hanover, NH. E-mail: firstname.lastname@example.org.