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Divisions Faculty Featured General Pharmaceutical Outcomes and Policy Research, Stacie Dusetzina
Grayson Mendenhall
August 26, 2016

It is important to analyze the relationships between the pharmaceutical industry and those who set treatment guidelines for any potential influence they may have on patient-care decisions and the cost of providing patient care, said study co-author Stacie Dusetzina, Ph.D.

Nearly 9 out of 10 physicians and researchers who helped develop a leading set of cancer-care guidelines in the United States reported financial ties to the pharmaceutical and medical device industries, a University of North Carolina at Chapel Hill study found.

Of the 125 panelists who worked on setting the National Comprehensive Cancer Network’s guidelines for lung, breast, prostate and colorectal cancer, 108 received some form of industry funding. The funding could include general payments for food, lodging or speaker fees, as well as research funding, according to the study published in JAMA Oncology. The majority of those payments were within the limits set by the NCCN to prevent financial conflicts of interest, but eight guideline authors exceeded them.

While the study was not designed to explore whether the payments influenced the physician’s clinical practice or the recommendations made in the guidelines, the researchers say the finding of a high prevalence of financial relationships lays the foundation for future studies looking at that question.

“It is not a given that industry funding leads to undue influence, but it is important to analyze these relationships and the potential impact they have on care guidelines because they do influence patient care decisions and the cost of providing patient care,” said study co-author Stacie Dusetzina, Ph.D., an assistant professor in the UNC Eshelman School of Pharmacy and UNC Gillings School of Global Public Health and a member of the UNC Lineberger Comprehensive Cancer Center.

The researchers analyzed payments in 2014 to physicians who helped write the NCCN guidelines, which can influence physician practice. Additionally, the Centers for Medicare and Medicaid Services uses NCCN recommendations to help determine its reimbursement policy for off-label uses for prescription drugs.

The NCCN sets limits for how much physicians can receive in payments from industry and participate in setting the guidelines to reduce the risk of financial conflicts. Guideline authors cannot receive $20,000 or more from a single company or $50,000 or more in total. The researchers found in their analysis that eight physicians, or 6 percent, appeared to exceed the NCCN’s financial conflict of interest limits.

For their study, the UNC researchers reviewed publicly-available data reported through Open Payments, a federal program required by a provision of the Patient Protection and Affordable Care Act that requires U.S. drug and device manufacturers to disclose transfers of financial value greater than $10 to physicians and teaching hospitals. Using this data source, the researchers identified payments to authors who were active on NCCN guideline panels for four major cancer types.

The researchers found that the vast majority – more than 95 percent – of the total financial payments from the pharmaceutical industry were in the form of research funding, as opposed to general payments for meals and travel. Approximately $29 million in research payments were paid to guideline authors in 2014, compared to $1.25 million in general payments.

“The prevalence of financial relationships was fairly high among physicians who authored these cancer treatment guidelines. Knowing this, it will be important to ask whether those relationships influence the recommendations that guideline authors make,” said Aaron Mitchell, M.D., the study’s lead author and a clinical fellow in the UNC School of Medicine Division of Hematology/Oncology, as well as a UNC Lineberger member.

While 84 percent of the physicians received general payments, including fees for consulting, meals or lodging, less than half, 47 percent, received any research payments in 2014.

“Understanding the extent to which guideline authors have financial relationships with the pharmaceutical industry – and the types of financial arrangements that they have – is useful for the NCCN and for the public,” Dusetzina said. “As we learn more about the role of industry payments in shaping prescribing and practice it is best to proceed with caution and continue to encourage transparency.”

The study’s authors point out that industry funding is “all but mandatory” for academic researchers involved in clinical trials testing new drugs or treatment strategies. However, with some of the panelists receiving general payments but not research funding, the researchers raised questions whether this finding could mean some of the guideline authors may be receiving general payments unconnected to research. They cautioned that because they only looked at one year of data, they may not be getting the full story.

“This study demonstrates the value of public reporting to assist organizations like the NCCN to understand the relationships of their contributors with industry,” said study co-author Ethan Basch, M.D., M.Sc., director of UNC Lineberger’s Cancer Outcomes Research Program and a professor in the UNC School of Medicine Division of Hematology/Oncology. “This work lays the groundwork for future research to evaluate whether these relationships meaningfully influence guideline recommendations or not.”

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