Abstract 204: Who Funds “Evidence-Based Medicine” in our Guidelines: Government or Industry? Analysis of the AHA/ACC Class I Secondary Prevention Guidelines in 2011 vs. 2001
Background: Heated debate on the “influence” of the pharmaceutical industry has led some to question whether trials sponsored by industry provide strong evidence for clinical practice. We sought to analyze this issue by looking at what the independent ACC/AHA Guideline committee cited as the evidence base for Class I (strongest) recommendations, and evaluated the funding source, as well as changes over time. Methods: After importing all citations from the AHA/ACC Secondary Prevention 2011 Update into EndNote citation manager, we excluded those that were not primary publications (e.g. consensus statements or summary guidelines). Funding source was determined from the PubMed database (or if not specified, the primary publication itself). Research support was divided by PubMed categories: U.S. governmental (gov’t), non-U.S. gov’t (typically industry), or mixed. (Note that further division of funding source into any (U.S and foreign) governmental source vs. exclusively industry, is ongoing.) All Class I recommendations were reviewed to determine what percentage of the supporting evidence was funded by U.S. gov’t vs. non-U.S. gov’t, weighting those in the mixed category equally between the other two categories. Chi-square tests were used to statistically compare these percentages. Results: Overall, 62% of studies cited to support Class I recommendations in 2011 were sponsored by non-US gov’t (e.g. industry) sources. Nine of 12 categories of Class I recommendations had the majority of the studies supported by non-gov’t/industry rather than from US gov’t funding (Table 1). This was true both for lifestyle interventions and pharmacological therapies, although the percentage of industry-funded trials for pharmacological therapies was significantly higher as compared to studies for lifestyle interventions (83% vs. 46%, p<0.001). Looking at trends over time, in the 2001 guideline, 51% of studies supporting Class I recommendations were funded by the US gov’t, while of the newer additions since 2001, 78% have been funded by non-gov’t/industry sources (p=0.005). Thus, the time trend for the overall % of recommendations that were sponsored by non-US gov’t/industry has risen from 49% in 2001 to 62% in the 2011 guidelines. Conclusion: Based on this initial categorization from PubMed, it appears that the majority of trials providing the evidence for the ACC/AHA Secondary Prevention guideline comes from non-government/industry-sponsored trials, and this percentage has increased over time. This finding suggests that industry-sponsored trials do provide a positive impact on clinical guidelines.