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Comment & Response
April 2016

Relationship of Industry Sponsorship to Results of Cost-Effectiveness Analyses of Drugs Used in Breast Cancer Treatment—Reply

Author Affiliations
  • 1South Carolina College of Pharmacy, University of South Carolina, Columbia, South Carolina
  • 2Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland
JAMA Oncol. 2016;2(4):549. doi:10.1001/jamaoncol.2016.0142

In Reply We read with great interest the letter by Ruan et al commenting on our article. Our study built directly on our 1999 report for oncology drugs that found that industry sponsorship was significantly associated with favorable cost-effectiveness analytic estimates for drugs made by the particular industry sponsor.1 We report that this observation persisted in 2015, when reviewing cost-effectiveness analyses published between 1999 and 2012. Ruan et al hypothesize that our results may reflect increased use of accelerated approval regulations by the US Food and Drug Administration (FDA), bias among investigators, and conflicts of interest as the FDA is responsible for both determining regulatory approvals of new drugs and for postmarketing drug safety assessments. In contrast, we have proposed that factors such as retrospective designs, overt or subvert pharmaceutical company influences on investigators, and conflicts of interest may have been operational in our earlier analysis and continue to be relevant today. We agree with Ruan et al that one should not be surprised that this association has persisted since 1992. However, our policy recommendation derived from our studies focuses on prospective registration of protocols for cost-effectiveness analyses, rather than requiring sponsors to discontinue accelerated approval applications for FDA approval, employing analysts without conflicts of interest who are not familiar with the drugs of interest, or excluding as authors persons who have direct information on the costs, safety, and efficacy of a new oncology product. Just as in clinical trial reporting, prospective registration of economic analyses should be required.

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