The Other War on Drugs: The Pharmaceutical Industry, Evidence-Based Medicine, and Clinical Practice

Over the past decade, evidence-based medicine (EBM) has become the standard for medical practice.¹ Evidence-based practices have been established in general medicine and specialized fields; new evidence-based journals have been launched.² Although its roots can be found in mid-nineteenth-century medical philosophy, contemporary EBM was largely developed by the clinical epidemiology program at McMaster University in 1992.³ According to the McMaster manifesto published in JAMA, EBM "de-emphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale as sufficient grounds for clinical decision-making, and stresses the examination of evidence from clinical research."⁴ The most frequently cited definition of EBM is reliance on the "conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients," based on an integration of "individual clinical expertise with the best available external clinical evidence from systematic research."⁵ However, as Stefan Timmermans and Aaron Mauck recently observed, EBM "is loosely used and can refer to anything from conducting a statistical meta-analysis of accumulated research to promoting randomized clinical trials, to supporting uniform reporting styles for research, to a personal orientation toward critical self-evaluation."⁶

Initially, EBM rejected medical practices based on anecdotal and idiosyncratic physician experiences in favor of statistically significant findings from population-based studies. Interventions based on individual cases or small cohorts were portrayed as suspect and quaint. Instead, practitioners were urged to apply findings from population-based studies to their own clinical practice. Not surprisingly, this stance resulted in more than a little resistance and much criticism from a number of practitioners. In response, advocates of EBM increasingly have attempted to portray it as complementary to clinical experience, and there have been calls for a more integrated approach.⁷

At bottom, EBM relies on the elaborate system of publication and peer review of medical research. It requires that health-care providers keep themselves updated on new research findings, become skilled and "efficient" literature researchers/methodologists, and learn how to apply "formal rules of evidence," including statistical analysis to critically evaluate clinical literature.⁸ The challenge is to find time to do so, including the interpretation and translation of the findings as presented.⁹ Although practical concerns have been raised about physicians relying on electronic databases, the validity of the data that constitutes EBM has not been widely questioned.

But what if the research and its findings are flawed or, worse, purposely misleading? What if EBM has been distorted by multinational corporations that are more concerned with profits than scientific evidence? What if pharmaceutical companies have infiltrated the medical research enterprise and have hijacked the peer-review process into a vehicle for drug marketing, including medications of questionable effectiveness and safety? These are, in fact, the claims of increasing numbers of respected members of the academic medical establishment. As a result, the validity and veracity of peer-reviewed research is being challenged, which, in turn, weakens the foundation upon which EBM is built.

The Emergence of a Consensus

Internist John Abramson, author of Overdosed America: The Broken Promise of American Medicine (2004) is deeply troubled by this trajectory.¹⁰ He finds that the pharmaceutical industry has inserted itself into every aspect of medical practice from medical education to basic research and clinical care. Pharmaceutical companies have enticed a number of respectable research physicians into endorsing questionable studies, and through the use of direct advertising to patients and sophisticated marketing they have endangered the integrity of the American health-care delivery system. Abramson, now a clinical professor of medicine at Harvard, asserts that not only has the industry co-opted the mechanisms of evaluation of effective treatment for widely accepted illnesses, but also it has successfully colonized the healthy population by the construction of an array of new illnesses. This has been accomplished through the transformation of risk factors into diseases that putatively require long-term and expensive prophylactic medications.

Like Abramson, Marcia Angell, former editor in chief of the New England Journal of Medicine (NEJM), now professor of social medicine at Harvard, links...