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

  • Janine K. Cataldo
    Correspondence
    Corresponding author. Department of Physiological Nursing—Gerontology, University of California San Francisco, 2 Koret Way, N611, San Francisco, CA 94143-0610, USA. Tel.: +415-476-4721; fax: +415-476-8899.
    Affiliations
    Department of Physiological Nursing—Gerontology, University of California San Francisco, San Francisco, CA, USA
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  • Lisa A. Bero
    Affiliations
    Department of Clinical Pharmacy and Health Policy, University of California San Francisco, San Francisco, CA, USA
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  • Ruth E. Malone
    Affiliations
    Department of Social and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA
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      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

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      References

        • Framingham Heart Study
        (Available at) (Accessed October 12, 2009)
        • AMA
        The AMA-ERF Committee for Research on Tobacco and Health at its May meeting reviewed your request for continued funding of the Heart Disease Epidemiology Study in Framingham, Massachusetts.
        (RJ Reynolds. Available at)
        • Dawber T.R.
        • BUMC
        Our telephone conversation, March 30, 1970.
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        The Framingham Study: the epidemiology of atherosclerotic disease.
        Harvard University Press, Cambridge, MA1980
        • Hong M.K.
        • Bero L.A.
        How the tobacco industry responded to an influential study of the health effects of secondhand smoke.
        Br Med J. 2002; 325: 1413-1416
        • Bero L.A.
        Tobacco industry manipulation of research.
        Public Health Rep. 2005; 120: 200
        • White J.
        • Bandura P.D.A.
        • Bero L.A.
        Moral disengagement in the corporate world.
        Accountability in Research. 2009; 16: 41-74
        • Malone R.
        • Balbach E.
        Tobacco industry documents: treasure trove or quagmire?.
        Tob Control. 2000; 9: 334-338
        • MacKenzie R.
        • Collin J.
        • Lee K.
        The tobacco industry documents: an introductory handbook and resource guide for researchers.
        London School of Hygiene & Tropical Medicine, London, UK2003
      1. Taylor C. Theories of meaning. Cambridge University Press, Cambridge [Cambridgeshire], UK1985
        • Hill M.
        Archival strategies and techniques.
        Sage Publications, Newbury Park, CA1993
        • Hockett R.C.
        • CTR
        Informal inquiry from Dr. Thomas R. Dawber, now of Boston University Medical Center, concerning possible interest in continuing support of the Framingham, Mass. Heart Disease Epidemiology Study.
        (Council for Tobacco Research. Available at)
        • Hockett R.C.
        (Council for Tobacco Research. Available at)
        • Glantz S.
        • Slade J.
        • Bero L.A.
        • Hanauer P.
        • Barnes D.
        The cigarette papers.
        University of California Press, Berkeley, CA1996
        • Bero L.
        • Barnes D.E.
        • Hanauer P.
        • Slade J.
        • Glantz S.A.
        Lawyer control of the tobacco industry's external research program. The Brown and Williamson documents.
        JAMA. 1995; 274: 241-247
        • Barnes D.E.
        • Bero L.A.
        Industry-funded research and conflict of interest: an analysis of research sponsored by the tobacco industry through the Center for Indoor Air Research.
        J Health Polit Policy Law. 1996; 21: 515-542
        • Ramm H.H.
        • RI
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • BUSOM
        • Seltzer C.C.
        • BUSOM
        • Thomas H.E.
        • BUSOM
        Epidemiology, statistics and psychosomatic application for research grant smoking classes, risk factors and cardiovascular disease.
        (Council for Tobacco Research. Available at)
      2. Special projects approvals, payments, and payables as of December 4, 1968.
        (American Tobacco. Available at)
        • Hockett R.C.
        • CTR
        A new grant application, #826, from Dr. Thomas R. Dawber and Dr. Carl Seltzer.
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • BU
        • Jordan R.N.
        • BUMC
        (Council for Tobacco Research. Available at)
      3. New tobacco-health grants announced; one helps review Framingham.
        (Liggett & Myers. Available at)
        • Sommers S.C.
        • CTR
        No. 826-Dawber.
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • BUSOM
        • Seltzer C.C.
        • BUSOM
        • Thomas H.E.
        • BUSOM
        Epidemiology application for renewal of research grant smoking classes, risk factors and cardiovascular disease.
        (Council for Tobacco Research. Available at)
        • CTR
        • Dawber T.R.
        • et al.
        BUSOM renewal application no. 826r1 smoking classes, risk factors and cardiovascular disease.
        (Council for Tobacco Research. Available at)
        • Hoyt W.T.
        Grant #826r1.
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • BU
        • Jordan R.N.
        • BUMC
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • BUMC
        (Council for Tobacco Research. Available at)
        • Seltzer C.C.
        • HUSPH
        (Council for Tobacco Research. Available at)
        • Kreisher J.H.
        • CTR
        Thomas R. Dawber MD. Grant No. 826r2.
        (Council for Tobacco Research. Available at)
      4. (Council for Tobacco Research. Available at)
        • CTR
        Thomas R. Dawber, MD, Boston University Medical Center, Boston, Massachusetts second renewal no. 826r2 smoking classes, risk factors and cardiovascular disease.
        (Council for Tobacco Research. Available at)
        • Seltzer C.C.
        • HUSPH
        (Council for Tobacco Research. Available at)
        • Hoyt W.T.
        Grant No. 826r2.
        (Council for Tobacco Research. Available at)
      5. Smoking classes, risk factors, and cardiovascular disease.
        (Philip Morris. Available at)
        • Dawber T.R.
        • Jordan R.N.
        Application for research grant epidemiologic study of cigarette smoking and cardiovascular disease.
        (Philip Morris. Available at)
        • Cataldo J.K.
        • Malone R.E.
        False promises: the tobacco industry, “low tar” cigarettes, and older smokers.
        J Am Geriatr Soc. 2008; 56: 1716
      6. Staff February 5, 1974.
        (Council for Tobacco Research. Available at)
        • Seltzer C.C.
        • HUSPH
        (Council for Tobacco Research. Available at)
        • CTR
        Approvals (grants) March 1974.
        (Council for Tobacco Research. Available at)
        • CTR
        Approvals—Sab Meeting of March 13-14-15, 1974.
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • BUMC
        (Council for Tobacco Research. Available at)
        • CTR
        Application 826-a Thomas R. Dawber, MD. Boston University School of Medicine epidemiologic study of cigarette smoking and cardiovascular disease.
        (Council for Tobacco Research. Available at)
        • Hockett R.C.
        Grant application No. 826a.
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • BUMC
        (Council for Tobacco Research. Available at)
        • Seltzer C.C.
        • HUSPH
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • BUMC
        Extension of 826r2.
        (Council for Tobacco Research. Available at)
      7. 19 Sep. Council for Tobacco Research.
        (Available at)
      8. Notes on Seltzer's visit April 10, 1975.
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • BUMC
        • Jordan R.N.
        • BU
        Grant No. 826r2s.
        (Council for Tobacco Research. Available at)
        • Hockett R.C.
        • CTR
        Grant No. 826r2s.
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • BUMC
        Your letter of June 15.
        (Council for Tobacco Research. Available at)
        • Seltzer C.C.
        • HUSPH
        (Council for Tobacco Research. Available at)
      9. (Council for Tobacco Research. Available at)
      10. Seltzer April 6, 1976 visit.
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • BUMC
        (Council for Tobacco Research. Available at)
        • Dawber T.R.
        • Kannel W.B.
        • Revotskie N.
        • Stokes J.
        • Kagan A.
        • Gordon T.
        Some factors associated with the development of coronary heart disease.
        Am J Public Health. 1959; 49: 1349-1356
        • Katz L.N.
        • Allen E.
        • Cherkasky M.
        • Davis F.
        • Dawber T.R.
        Cigarette smoking and cardiovascular diseases: report by the American Heart Association.
        Circulation. 1960; 22: 160-166
        • Doyle J.T.
        • Dawber T.R.
        • Kannel W.B.
        • Heslin A.S.
        • Kahn H.A.
        Cigarette smoking and coronary heart disease. Combined experience of the Albany and Framingham studies.
        N Engl J Med. 1962; 26: 796
        • Kagan A.
        • Dawber T.R.
        • Kannel W.B.
        • Revotskie N.
        The Framingham Study: a prospective study of coronary heart disease.
        Federation Proc. 1962; 21: 52-57
        • Dawber T.R.
        • Kannel W.B.
        • McNamara P.M.
        The prediction of coronary heart disease.
        Transact Assoc Life Insurance Med Directors Am. 1964; 47: 70
        • Doyle J.T.
        • Dawber T.R.
        • Kannel W.B.
        • Kinch S.H.
        • Kahn H.A.
        The relationship of cigarette smoking to coronary heart disease: the second report of the combined experience of the Albany, NY, and Framingham, Mass, studies.
        JAMA. 1964; 190: 886
        • Kannel W.B.
        • Dawber T.R.
        • McNamara P.M.
        Detection of the coronary-prone adult: the Framingham study.
        J Iowa Med Soc. 1966; 56: 26
        • Dawber T.R.
        • Thomas Jr., H.E.
        Prevention of myocardial infarction.
        Prog Cardiovasc Dis. 1971; 13: 343
        • Kannel W.B.
        • Dawber T.R.
        Contributors to coronary risk implications for prevention and public health: the Framingham Study.
        Heart Lung. 1972; 1: 797-809
        • Dawber T.R.
        • Kannel W.B.
        Current status of coronary prevention. Lessons from the Framingham study.
        Prev Med. 1972; 1: 499
        • Gordon T.
        • Kannel W.B.
        • McGee D.
        • Dawber T.R.
        Death and coronary attacks in men after giving up cigarette smoking.
        Lancet. 1974; 2: 1345-1348
        • Gordon T.
        • Kannel W.B.
        • Dawber T.R.
        • McGee D.
        Changes associated with quitting cigarette smoking: the Framingham Study.
        Am Heart J. 1975; 90: 322
        • Gordon T.
        • Kannel W.B.
        • McGee D.
        • Dawber T.R.
        Stopping smoking and CHD.
        Lancet. 1977; 310: 420-421
        • Sparrow D.
        • Dawber R.
        The influence of cigarette smoking on prognosis after a first myocardial infarction: a report from the Framingham study.
        J Chron Dis. 1978; 31: 425-432
        • Wolf P.A.
        • Kannel W.B.
        • Dawber T.R.
        Prospective investigations: the Framingham study and the epidemiology of stroke.
        Adv Neurol. 1978; 19: 107
        • Castelli W.P.
        • Dawber T.R.
        • Feinleib M.
        • Garrison R.J.
        • McNamara P.M.
        • Kannel W.B.
        The filter cigarette and coronary heart disease: the Framingham study.
        Lancet. 1981; 318: 109-113
        • Dawber T.R.
        • Thomas H.E.
        Smoking and heart disease: current thinking.
        Compr Ther. 1979; 5: 15
        • Kannel W.B.
        • Dawber T.R.
        Contributors to coronary risk: ten years later.
        Heart Lung J Crit care. 1982; 11: 60
        • Seltzer C.C.
        Stopping smoking and CHD.
        Lancet. 1977; 1: 420
        • Gordon T.
        • Kannel W.
        • McGee D.
        • Dawber T.
        Letter.
        Lancet. 1977; 310: 420-421
        • Seltzer C.C.
        • LZA
        Smoking and coronary heart disease: what are we to believe?.
        Am Heart J. 1980; 100: 275
        • Zahn L.S.
        • LZA
        (Council for Tobacco Research. Available at)
        • AP
        Researcher disputing tie between smoking and coronary disease.
        (Council for Tobacco Research. Available at)
        • Bero L.A.
        “Experimental” institutional models for corporate funding of academic research: unknown effects on the research enterprise.
        J Clin Epidemiol. 2008; 61: 629-633
        • Krimsky S.
        Science in the private interest.
        Rowan & Littlefield, Lanham, MD2003
      11. Baba A, Cook DM, Bero LA. Tobacco industry efforts to shape the legislative standards of scientific research. The 132nd Annual Meeting of American Public Health Association, Washington, DC; Nov 6–10, 2004.

        • Baba A.
        • Cook D.
        • McGarity T.O.
        • Bero L.
        Legislating “sound science”: the role of the tobacco industry.
        Am J Public Health. 2005; 95: S20-27
        • Seltzer C.C.
        “Conflicts of interest” and “political science”.
        J Clin Epidemiol. 1997; 50: 627-629
        • Seltzer C.C.
        The negative association in women between cigarette smoking and uncomplicated angina pectoris in the Framingham Heart Study data.
        J Clin Epidemiol. 1991; 44: 871
        • Seltzer C.C.
        Framingham study data and “established wisdom” about cigarette smoking and coronary heart disease.
        J Clin Epidemiol. 1989; 42: 743
        • Seltzer C.C.
        Smoking and coronary heart disease in the elderly.
        Am J Med Sci. 1975; 269: 309
      12. Lifetime smokers need not quit after age 65.
        (American tobacco. Available at)
        • Reports R.T.
        Smoking after 65.
        (Council for Tobacco Research. Available at)
        • Reports R.T.
        Smoking after 65.
        (Council for Tobacco Research. Available at)
        • Reports R.T.
        Smoking after 65.
        (Council for Tobacco Research. Available at)
        • Upi
        Quitting smoking “no help after 65”; the Raleigh Times.
        (Council for Tobacco Research. Available at)
      13. Reports RT. “Dr. Seltzer”.
        (Council for Tobacco Research. Available at)
        • Bero L.A.
        • Glantz S.
        • Hong M.K.
        The limits of competing interest disclosures.
        Br Med J. 2005; 14: 118-126
        • PLoS Medicine
        PLoS policy on declaration and evaluation of competing interests.
        (Available at) (Accessed January 5, 2010)
        • Bero L.A.
        Accepting commercial sponsorship.
        Br Med J. 1999; 319: 653
        • Cataldo J.K.
        • Prochaska J.J.
        • Glantz S.A.
        Cigarette smoking is a risk factor for Alzheimer's disease: an analysis controlling for tobacco industry affiliation.
        J Alzheimers Dis. 2010; 19: 465-480