August 25, 2016
Researchers at the UNC Lineberger Comprehensive Cancer Center have found a high prevalence of financial relationships among authors who helped develop a leading set of cancer-care guidelines in the United States. They say their findings lay the foundation for future studies of whether drug industry payments influence clinical practice or guideline recommendations.
Ethan Basch, MD, professor of health policy and management at the UNC Gillings School of Global Public Health, and Stacie Dusetzina, PhD, assistant professor of health policy and management at the Gillings School, are co-authors of the study, published online Aug. 25 in JAMA Oncology.
Nearly 90 percent of 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.
Of the 125 panelists who worked on setting the National Comprehensive Cancer Network’s (NCCN) guidelines for lung, breast, prostate and colorectal cancer, 108 received some form of industry funding. This could include general payments for food, lodging or speaker fees, as well as research funding. The majority of those payments were within limits set by the NCCN to prevent financial conflicts of interest, but eight guideline authors exceeded the limits.
While the study was not designed to explore whether the payments influenced the physician’s clinical practice or recommendations s/he 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.
“The prevalence of financial relationships was fairly high among physicians who authored these cancer treatment guidelines, said Aaron Mitchell, MD, clinical fellow in the UNC School of Medicine’s Division of Hematology/Oncology and lead author of the study. “Knowing this, it will be important to ask whether those relationships influence the recommendations that guideline authors make.”
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 participates in setting guidelines to reduce the risk for 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.
“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,” Dusetzina said.
The researchers reviewed publicly available data reported through Open Payments, a federal program required by a provision of the Patient Protection and Affordable Care Act. Open Payments 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.
They 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.
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,” said Dusetzina. “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, as some panelists received general payments but not research funding, the researchers raised questions as to whether the finding could mean that some guideline authors may be receiving general payments unconnected to research. As they examined only one year of data, they cautioned that they may not have the complete story about payments.
“This study demonstrates the value of public reporting to assist organizations like the NCCN to understand the relationships of their contributors with industry,” Basch said. “It lays the groundwork for future research to evaluate whether these relationships meaningfully influenced guideline recommendations or not.”
Basch is also professor of hematology/oncology in the School of Medicine and director of the Cancer Outcomes Research Program at UNC Lineberger. Dusetzina also is assistant professor of pharmaceutical outcomes and policy at the UNC Eshelman School of Pharmacy and a member of UNC’s Cecil G. Sheps Center for Health Services Research.
This news originally was published by UNC Lineberger Comprehensive Cancer Center.