The guideline for cholesterol by the American College of Cardiology and American Heart Association, as well as the guideline for hepatitis C virus treatment by the American Association for the Study of Liver Diseases and Infectious Diseases Society of America did not fully meet the Institute of Medicine standards for commercial conflict of interest management, according to studies published in JAMA Internal Medicine. The authors noted that modest or substantial industry support was common among many patient advocacy organizations, and that such support could influence their positions.
Such findings raise concerns about the trustworthiness of clinical guidelines and independence of patient advocacy organizations (PAOs), warranting more consistent and robust conflict of interest (COI) frameworks, policies and practices, they said.
Seminal hepatitis C virus and cholesterol management guidelines
In the development of recent important clinical guidelines, little is known about whether the Institute of Medicine (IOM) standards for managing COI have been adhered to, Akilah A. Jefferson, MD, MSc, from the department of bioethics at NIH, and Steven D. Pearson, MD, MSc, from the Institute for Clinical and Economic Review, wrote.
The researchers evaluated this issue in the development and publication of two recent guidelines: the 2013 American College of Cardiology and American Heart Association cholesterol management guideline and the 2014 American Association for the Study of Liver Diseases and Infectious Diseases Society of America hepatitis C virus (HCV) management guideline. They evaluated each guideline for adherence to the IOM standards for commercial COI published in the 2011 special report Clinical Practice Guidelines We Can Trust — which call for no commercial COI among guideline committee chairs and cochairs and for less than half of committee members to have commercial COI — and other IOM standards for guideline development and evidence review.
The cholesterol guideline committee consisted of 16 members, of whom seven (44%) reported commercial COI, with all disclosing industry-sponsored research and six (38%) disclosing consultancy in addition. One out of three guideline chairs and cochairs (33%) also disclosed commercial COI.
The HCV guideline committee consisted of 29 members, of whom 21 (72%) disclosed commercial COI, with 18 (62%) reporting industry-sponsored research, 10 (34%) serving on advisory boards, five (17%) serving on data safety monitoring boards, three (10%) acting as consultants and three (10%) reporting other honoraria. In addition, four out of six guideline cochairs (67%) reported commercial COI, with all four reporting additional COI in other publications that were not listed in their guideline disclosures.
Contemporaneous literature reviews for both the cholesterol and HCV guidelines identified additional commercial COIs.
While the HCV guideline met all 9 IOM guideline development and evidence standards, the cholesterol guideline only met 5 (56%).
These results indicate that even 5 years after the publication of the IOM standards, management levels of commercial COI remain an important issue, according to Jefferson and Pearson.
“We believe that our study highlights the need for broader and more explicit adoption of the IOM’s framework for COI management and a commitment from specialty societies to adhere to the IOM standards,” they concluded. “Adoption of consistent COI frameworks will help ensure that the clinical guidelines establishing appropriate care in the United States are developed in a way that can merit the trust of patients, clinicians, and the broader public.”
In a statement, Richard Chazal, MD, FACC, president of ACC, defended the ACC’s approach to developing guidelines.
“The American College of Cardiology is committed to ensuring balance, independence, objectivity, and scientific rigor in all of its activities,” he said. “The policies adopted by the writing panel of the 2013 cholesterol guideline to manage authors’ relations with industry were in effect when this effort began under NHLBI in 2008 until the process was transferred to ACC/AHA in 2013. In the interest of transparency, the ACC/AHA requested that panel authors resubmit RWI disclosures as of July 2013. These policies are outlined in the methods section of the guideline. All relationships relevant to these guidelines are also disclosed in Appendix 1 of the report.”
Patient advocacy organizations
PAOs, such as the American Cancer Society and the American Heart Association, are influential health care stakeholders, according to Susannah L. Rose, PhD, of the department of bioethics at Cleveland Clinic, and colleagues.
“Many PAOs report having financial relationships with for-profit industry, yet little is known about the nature of these relationships,” they wrote.
To address this issue, Rose and colleagues distributed a survey to a nationally representative random sample of 439 PAO leaders, representing 5.6% of 7,865 PAOs in the U.S., from Sept. 1, 2013, to Jun. 30, 2014. The researchers identified PAO leaders from the leadership contact information section on organizational websites, verifying by phone when necessary. They also used GuideStar and LexisNexis if such contact information was not available. The organizational leaders were asked about the nature of their activities, their financial relationships with industry and the perceived effectiveness of their COI policies.
Approximately 66% of PAO leaders (n = 289) returned their survey with at least 80% completion. There was a wide variation in size, funding, activities and disease focus among PAOs.
Results indicated that 67% of PAO leaders (virtually all non-profit) reported receiving funding from for-profit organizations. In addition, 12% reported receiving more than half of their funding from industry. A median of 45% of industry support was from pharmaceutical, device and/or biotechnology sectors. Most respondents (81.8%) reported that COIs were very or moderately relevant to their respective PAO. Slightly more than half (55%) of PAO leaders believed that their organization had very good COI policies in place. Approximately 8% reported feeling pressure to conform their positions to the interest of corporate donors.
“Financial relationships between PAOs and industry demand effective steps to ensure that these groups serve their constituents’ interests while minimizing risks of undue influence and bias,” Rose and colleagues concluded. “Given the growing ability of PAOs to influence health care policy and practice, their financial practices and safeguards demand the same degree of scrutiny applied to other key actors in the health care landscape.” – by Alaina Tedesco
Disclosures: Jefferson and Pearson reported receiving support from the National Institutes of Health. Pearson also reported receiving research grants during the past 2 years from the Blue Shield of California Foundation, the California Health Care Foundation, the Laura and John Arnold Foundation, and the National Pharmaceutical Council and reported membership dues paid to the Institute for Clinical and Economic Review during the past 2 years from Aetna, America’s Health Insurance Plans, Anthem, Blue Shield of California, CVS Caremark, Express Scripts, Harvard Pilgrim Health Care, OmedaRx, United Healthcare, Kaiser Permanente, Premera Blue Cross, Prime Therapeutics, Health Care Service Corporation, AstraZeneca, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck, the National Pharmaceutical Council, Takeda Pharmaceuticals, Pfizer, Novartis, and Eli Lilly and Company. Rose and colleagues reported funding from Edmond J. Safra Center for Ethics at Harvard University.