Just a paradigm: evidence-based medicine in epistemological context

  • Miriam Solomon
Original paper in Philosophy of Medicine


Evidence-Based Medicine (EBM) developed from the work of clinical epidemiologists at McMaster University and Oxford University in the 1970s and 1980s and self-consciously presented itself as a "new paradigm" called "evidence-based medicine" in the early 1990s. The techniques of the randomized controlled trial, systematic review and meta-analysis have produced an extensive and powerful body of research. They have also generated a critical literature that raises general concerns about its methods. This paper is a systematic review of the critical literature. It finds the description of EBM as a Kuhnian paradigm helpful and worth taking further. Three kinds of criticism are evaluated in detail: criticisms of procedural aspects of EBM (especially from Cartwright, Worrall and Howick), data showing the greater than expected fallibility of EBM (Ioaanidis and others), and concerns that EBM is incomplete as a philosophy of science (Ashcroft and others). The paper recommends a more instrumental or pragmatic approach to EBM, in which any ranking of evidence is done by reference to the actual, rather than the theoretically expected, reliability of results. Emphasis on EBM has eclipsed other necessary research methods in medicine. With the recent emphasis on translational medicine, we are seeing a restoration of the recognition that clinical research requires an engagement with basic theory (e.g. physiological, genetic, biochemical) and a range of empirical techniques such as bedside observation, laboratory and animal studies. EBM works best when used in this context.


Evidence-based medicine Philosophy of medicine Kuhnian paradigm Nancy Cartwright Randomized controlled trial Translational medicine Evidence hierachy Meta-analysis John Ioannidis John Worrall 


  1. AHRQ. (2002). Systems to rate the strength of scientific evidence. Evidence Report/Technology Assessment 47, Google Scholar
  2. Als-Nielsen, B., Chen, W., Gluud, C., & Kjaergard, L. L. (2003). Association of funding and conclusions in randomized drug trials: A reflection of treatment effect or adverse events? JAMA: The Journal of the American Medical Association, 290(7), 921–928.CrossRefGoogle Scholar
  3. Ashcroft, R. E. (2004). Current epistemological problems in evidence based medicine. Journal of Medical Ethics, 30(2), 131–135.CrossRefGoogle Scholar
  4. Baratz, S. R., Goodman, C., & Council on Health Care Technology. (1990). Improving consensus development for health technology assessment: An international perspective. Washington: National Academy Press.Google Scholar
  5. Bekelman, J. E., Li, Y., & Gross, C. P. (2003). Scope and impact of financial conflicts of interest in biomedical research: A systematic review. JAMA: The Journal of the American Medical Association, 289(4), 454–465.CrossRefGoogle Scholar
  6. Benson, K., & Hartz, A. J. (2000). A comparison of observational studies and randomized, controlled trials. The New England Journal of Medicine, 342(25), 1878–1886.CrossRefGoogle Scholar
  7. Bero, L., Oostvogel, F., Bacchetti, P., & Lee, K. (2007). Factors associated with findings of published trials of drug-drug comparisons: Why some statins appear more efficacious than others. PLoS Medicine, 4(6), e184.CrossRefGoogle Scholar
  8. Berwick, D. M. (2005). Broadening the view of evidence-based medicine. Qual. Saf. Health Care, 14(5), 315–316.CrossRefGoogle Scholar
  9. Bluhm, R. (2005). From hierachy to network: a richer view of evidence for evidence-based medicine. Perspectives in Biology and Medicine, 48(4), 535–547.CrossRefGoogle Scholar
  10. Canadian Task Force on Preventive Health Care. CTFPHC History/Methodology. Retrieved 07/07, 2009, from
  11. Cartwright, N. (1989). Nature's capacities and their measurement. Oxford; New York: Clarendon Press; Oxford University Press.Google Scholar
  12. Cartwright, N. (2007a). Are RCTs the gold standard? Biosocieties, 2(2), 11–20.CrossRefGoogle Scholar
  13. Cartwright, N. (2007b). Evidence-based policy: Where is our theory of evidence? Center for Philosophy of Natural and Social Science, London School of Economics, Technical Report 07/07, Google Scholar
  14. Cartwright, N. (2009). Evidence-based policy: What's to be done about relevance. Philosophical Studies, 143(1), 127–136.CrossRefGoogle Scholar
  15. Cartwright, N. (2010). Will this policy work for you? predicting effectiveness better: How philosophy helps. Unpublished manuscript.Google Scholar
  16. Charlton, B. G., & Miles, A. (1998). The rise and fall of EBM. Quarterly Journal of Medicine, 91(5), 371-371-374.Google Scholar
  17. Cohen, A. M., Stavri, P. S., & Hersh, W. R. (2004). A categorization and analysis of the criticisms of evidence-based medicine. International Journal of Medical Informatics, 73(1), 35-35-43.Google Scholar
  18. Concato, J., Shah, N., & Horwitz, R. I. (2000). Randomized, controlled trials, observational studies, and the hierarchy of research designs. The New England Journal of Medicine, 342(25), 1887–1892.CrossRefGoogle Scholar
  19. Daly, J. (2005). Evidence-based medicine and the search for a science of clinical care. Berkeley; New York: University of California Press; Milbank Memorial Fund.Google Scholar
  20. Davidoff, F., Haynes, B., Sackett, D., & Smith, R. (1995). Evidence based medicine. BMJ (Clinical Research Ed.), 310(6987), 1085–1086.Google Scholar
  21. Denny, K. (1999). Evidence-based medicine and medical authority. Journal of Medical Humanities, 20(4), 247–263.CrossRefGoogle Scholar
  22. Doll, R., Peto, R., & Clarke, M. (1999). First publication of an individually randomized trial. Controlled Clinical Trials, 20(4), 367–368.CrossRefGoogle Scholar
  23. Elstein, A. S. (2004). On the origins and development of evidence-based medicine and medical decision making. Inflammation Research, 53(Supplement 2), S184-S184-S189.Google Scholar
  24. Epstein, S. (1996). Impure science: AIDS, activism, and the politics of knowledge. Berkeley: University of California Press.Google Scholar
  25. Evidence-Based Medicine Working Group. (1992). Evidence-Based Medicine. A new approach to teaching the practice of medicine. JAMA: The Journal of the American Medical Association, 268(17), 2420–2425.CrossRefGoogle Scholar
  26. Feinstein, A. R., & Horwitz, R. I. (1997). Problems in the “evidence” of “evidence-based medicine”. The American Journal of Medicine, 103(6), 529–535.CrossRefGoogle Scholar
  27. Goodman, N. (1955). Fact, fiction and forecast. Cambridge: Harvard University Press.Google Scholar
  28. Goodman, S. N. (2002). The mammography dilemma: A crisis for evidence-based medicine? Annals of Internal Medicine, 137(5 Part 1), 363–365.Google Scholar
  29. Guyatt, G. H., Oxman, A. D., Vist, G. E., Kunz, R., Falck-Ytter, Y., Alonso-Coello, P., et al. (2008). GRADE: An emerging consensus on rating quality of evidence and strength of recommendations. BMJ (Clinical Research Ed.), 336(7650), 924–926.CrossRefGoogle Scholar
  30. Hampton, J. R. (2002). Evidence-based medicine, opinion-based medicine, and real-world medicine. Perspectives in Biology and Medicine, 45(4), 549–568.CrossRefGoogle Scholar
  31. Harari, E. (2001). Whose evidence? lessons from the philosophy of science and the epistemology of medicine. Australian and New Zealand Journal of Psychiatry, 35(6), 724-724-730.Google Scholar
  32. Hopewell, S., Clarke, M. J., Stewart, L., & Tierney, J. (2007). Time to publication for results of clinical trials. Cochrane Database of Systematic Reviews, (1) doi: 10.1002/14651858.MR000011.pub2
  33. Howick, J. (2008). Against a priori judgments of bad methodology: Questioning double-blinding as a universal methodological virtue of clinical trials. PhilSci Archive Google Scholar
  34. Howick, J. (2011). The philosophy of evidence-based medicine Wiley-Backwell.Google Scholar
  35. Ioannidis, J. P. (2005). Contradicted and initially stronger effects in highly cited clinical research. JAMA: The Journal of the American Medical Association, 294(2), 218–228.CrossRefGoogle Scholar
  36. Juni, P., Witschi, A., Bloch, R., & Egger, M. (1999). The hazards of scoring the quality of clinical trials for meta-analysis. JAMA: The Journal of the American Medical Association, 282(11), 1054–1060.CrossRefGoogle Scholar
  37. Kuhn, T. S. (1962). The structure of scientific revolutions. Chicago: University of Chicago Press.Google Scholar
  38. Kuhn, T. S. (1970). The structure of scientific revolutions (2nd ed.). Chicago: University of Chicago Press.Google Scholar
  39. Kuhn, T. S. (1977). The essential tension: Selected studies in scientific tradition and change. Chicago: University of Chicago Press.Google Scholar
  40. Kuhn, T. S., Conant, J., & Haugeland, J. (2000). The road since structure: Philosophical essays, 1970–1993, with an autobiographical interview. Chicago: University of Chicago Press.Google Scholar
  41. Lakatos, I., & Musgrave, A. (1970). Criticism and the growth of knowledge. Cambridge: University Press.Google Scholar
  42. LeLorier, J., Gregoire, G., Benhaddad, A., Lapierre, J., & Derderian, F. (1997). Discrepancies between meta-analyses and subsequent large randomized, controlled trials. The New England Journal of Medicine, 337(8), 536–542.CrossRefGoogle Scholar
  43. Lexchin, J., Bero, L. A., Djulbegovic, B., & Clark, O. (2003). Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ (Clinical Research Ed.), 326(7400), 1167–1170.CrossRefGoogle Scholar
  44. Marks, H. M. (1997). The progress of experiment: Science and therapeutic reform in the united states, 1900–1990. Cambridge: Cambridge University Press.Google Scholar
  45. Meldrum, M. L. (1998). A calculated risk: The salk polio vaccine field trials of 1954. British Medical Journal, 317, 1233-1233-6.Google Scholar
  46. Meldrum, M. L. (2000). A brief history of the randomized controlled trial: From oranges and lemons to the gold standard. Hematology/Oncology Clinics of North America, 14(4), 745-745-760.Google Scholar
  47. Montgomery, K. (2006). How doctors think: Clinical judgment and the practice of medicine. Oxford: Oxford University Press.Google Scholar
  48. Pocock, S. J., & Elbourne, D. R. (2000). Randomized trials or observational tribulations? The New England Journal of Medicine, 342(25), 1907–1909.CrossRefGoogle Scholar
  49. Rawlins, M. (2008). De testimonio: On the evidence for decisions about the use of therapeutic interventions. Lancet, 372(9656), 2152–2161.CrossRefGoogle Scholar
  50. Sackett, D. L., Rosenberg, W. M., Gray, J. A., Haynes, R. B., & Richardson, W. S. (1996). Evidence based medicine: What it is and what it isn't. BMJ (Clinical Research Ed.), 312(7023), 71–72.Google Scholar
  51. Sehon, S. R., & Stanley, D. E. (2003). A philosophical analysis of the evidence-based medicine debate. BMC Health Services Research, 3(14).Google Scholar
  52. Shrier, I., Boivin, J. F., Steele, R. J., Platt, R. W., Furlan, A., Kakuma, R., et al. (2007). Should meta-analyses of interventions include observational studies in addition to randomized controlled trials? A critical examination of underlying principles. American Journal of Epidemiology, 166(10), 1203–1209.CrossRefGoogle Scholar
  53. Solomon, M. (2008). Epistemological reflections on the art of medicine and narrative medicine. Perspectives in Biology and Medicine, 51(3), 406–417.CrossRefGoogle Scholar
  54. Solomon, M. (in progress). Beyond the art and science of medicine. Unpublished manuscript.Google Scholar
  55. Straus, S. E., & McAlister, F. A. (2000). Evidence-based medicine: A commentary on common criticisms. Canadian Medical Association Journal, 163(7), 837–841.Google Scholar
  56. Tonelli, M. R. (1998). The philosophical limits of evidence-based medicine. Academic Medicine, 73(12), 1234–1240.CrossRefGoogle Scholar
  57. Tonelli, M. R. (2006). Integrating evidence into clinical practice: An alternative to evidence-based approaches. Journal of Evaluation in Clinical Practice, 12(3), 248–256.CrossRefGoogle Scholar
  58. Woolf, S. H. (2008). The meaning of translational research and why it matters. JAMA: The Journal of the American Medical Association, 299(2), 211–213.CrossRefGoogle Scholar
  59. Worrall, J. (2002). What evidence in evidence-based medicine? Philosophy of Science, 69(S3), 316–330.CrossRefGoogle Scholar
  60. Worrall, J. (2007a). Evidence in medicine and evidence-based medicine. Philosophy Compass, 2(6), 981–1022.CrossRefGoogle Scholar
  61. Worrall, J. (2007b). Why there's no cause to randomize. The British Journal for the Philosophy of Science, 58(3), 451–488.CrossRefGoogle Scholar
  62. Yank, V., Rennie, D., & Bero, L. A. (2007). Financial ties and concordance between results and conclusions in meta-analyses: Retrospective cohort study. BMJ (Clinical Research Ed.), 335(7631), 1202–1205.CrossRefGoogle Scholar

Copyright information

© Springer Science + Business Media B.V. 2011

Authors and Affiliations

  1. 1.Department of PhilosophyTemple UniversityPhiladelphiaUSA

Personalised recommendations