Caution is advised in the interpretation of Sunshine Act data and accuracy of guideline authors’ relationships with industry.
Background
Industry manufacturers are required by the Sunshine Act to disclose payments to physicians. These data recently became publicly available, but some manufacturers prereleased their data since 2009. We tested the hypotheses that there would be discrepancies between manufacturers’ and physicians’ disclosures.
Methods
The financial disclosures by authors of all 39 American College of Cardiology and American Heart Association guidelines between 2009 and 2012 were matched to the public disclosures of 15 pharmaceutical companies during that same period. Duplicate authors across guidelines were assessed independently. Per the guidelines, payments <$10,000 are modest and ≥$10,000 are significant. Agreement was determined using a κ statistic; Fisher’s exact and Mann-Whitney tests were used to detect statistical significance.
Results
The overall agreement between author and company disclosure was poor (κ = 0.238). There was a significant difference in error rates of disclosure among companies and authors (P = .019). Of disclosures by authors, companies failed to match them with an error rate of 71.6%. Of disclosures by companies, authors failed to match them with an error rate of 54.7%.
Conclusions
Our analysis shows a concerning level of disagreement between guideline authors’ and pharmaceutical companies’ disclosures. Without ability for physicians to challenge reports, it is unclear whether these discrepancies reflect undisclosed relationships with industry or errors in reporting, and caution should be advised in interpretation of data from the Sunshine Act.
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-Hani A. Alhamoud, MBBCh, Ramzi Dudum, BA, Heather A. Young, PhD, Brian G. Choi, MD, MBA
This article originally appeared in the January 2016 issue of The American Journal of Medicine.
