“A delicate diplomatic situation”: tobacco industry efforts to gain control of the Framingham Study

Abstract 

Background

The Framingham Heart Study (henceforth Framingham) is among the gold standards for epidemiological research. Being a prospective cohort study of 5,000+ men and women, it provided early findings about the causes of coronary heart disease (CHD), following a cohort over the course of 24 years. After US government funding ended, the tobacco industry funded Council for Tobacco Research (CTR) provided continued funding for analyses related to smoking.

Objective

This study sought to understand the tobacco industry's motivation and activities in funding Framingham.

Study Design and Setting

We analyzed previously undisclosed tobacco industry documents, conducting iterative searches of the Legacy Tobacco Documents Library (http://legacy.library.ucsf.edu/), and assembled a historical case study.

Results

CTR funded Framingham to obtain full access to Framingham data. CTR planned for long-time industry consultant Carl Seltzer to reanalyze them to suggest that tobacco-related morbidity and mortality primarily resulted from “constitutional” factors, such as age or ethnicity. Once data were obtained, CTR terminated funding for the Framingham principal investigator, who disagreed with Seltzer. Seltzer's critical analyses of subsequently published work by the Framingham team created confusion about the association between CHD and cigarette smoking.

Conclusion

Researchers accepting tobacco industry funding risk losing control of data, analysis, and publication.

Keywords: Tobacco industry, Research ethics, Smoking, Cardiovascular disease, Funding sources, Cohort studies