How Big Pharma hijacked Evidence-Based Medicine, Part I

Evidence-Based Medicine (EBM) is a relatively recent phenomenon. The term itself was not coined until 1991. It began with the best of intentions — to give frontline doctors the tools from clinical epidemiology to make science-based decisions that would improve patient outcomes.
But over the last three decades, EBM has been hijacked by the pharmaceutical industry to serve the interests of shareholders rather than patients. Today, EBM gives preference to epistemologies that favor corporate interests while instructing doctors to ignore other valid forms of knowledge and their own professional experience.
This shift disempowers doctors and reduces patients to objects while concentrating power in the hands of pharmaceutical companies. EBM also leaves doctors ill-equipped to respond to the autism epidemic and unable to produce the sorts of paradigm-shifts that would be necessary to address this crisis.
In this article I will:
- provide a brief history of EBM;
- explain how evidence hierarchies work;
- explore ten general and technical criticisms of EBM and evidence hierarchies;
- examine the American Medical Association’s 2002, 2008, and 2015 evidence hierarchies;
- highlight the corporate takeover of EBM; and
- explore the implications of these dynamics for the autism epidemic.
II. History of Evidence-Based Medicine
Medicine faces the same challenges as any other branch of knowledge — deciding what is “true” (or at least “less wrong”). Since its emergence in 1992, EBM has become the dominant paradigm in the philosophy of medicine in the United States and its impact is felt around the world (Upshur, 2003 and 2005; Reilly, 2004; Berwick, 2005; Ioannidis, 2016). Through the use of evidence hierarchies, EBM privileges some forms of evidence over others.
Hanemaayer (2016) provides a helpful genealogy of EBM. Epidemiology — “the branch of medical science that deals with the incidence, distribution, and control of disease in a population” — has been a recognized field for hundreds of years. But clinical epidemiology, defined as “the application of epidemiological principles and methods to problems encountered in clinical medicine” first emerged in the 1960s (Fletcher, Fletcher, and Wagner, 1982). Feinstein (1967) is credited as the catalyst for the emergence and growth of this new discipline. Feinstein, in his book Clinical Judgment (1967) wrote, “Honest, dedicated clinicians today disagree on the treatment for almost every disease from the common cold to the metastatic cancer. Our experiments in treatment were acceptable by the standards of the community, but were not reproducible by the standards of science.” So Feinstein proposed a method for applying scientific criteria to clinical judgements in clinical situations.
According to Hanemaayer (2016), around the same time, David Sackett was leading the first department of clinical epidemiology at McMaster University in Canada. Sackett was influenced by Feinstein and trained an entire generation of future doctors in clinical epidemiology. In the 1970s, Archibald Cochrane expanded the use of randomized controlled trials to a broader range of medical treatments. In 1980, the Rockefeller Foundation funded the International Clinical Epidemiology Network (INCLEN) which took the methods and philosophy of clinical epidemiology worldwide. The efforts of INCLEN would later receive the support of the U.S. Agency for International Development, the World Health Organization, and the International Development Research Centre.
Various terms have been used to describe the methods of clinical epidemiology. Eddy (1990) used the term “evidence-based.” At about the same time the residency coordinator at McMaster University, Dr. Gordon Guyatt, was referring to this growing discipline as “scientific medicine” but apparently this term never caught on with the residents (Sur and Dahm, 2011). Eventually Guyatt settled on the term “evidence-based medicine” in an article in 1991 (Sur and Dahm, 2011).
An Evidence-Based Medicine Working Group (EBMWG) was formed, comprised of 32 medical faculty members mostly from McMaster University but also from universities in the United States. In 1992, the EBMWG planted a flag for their particular approach to the philosophy of medicine with an article in JAMA titled, “Evidence-Based Medicine: A New Approach to Teaching the Practice of Medicine.” The article reads less like a traditional scientific journal article and more like a political manifesto. In the first paragraph they announced their intention to supplant the traditional practices of doctors with the methods and results from clinical epidemiology.
A NEW paradigm for medical practice is emerging. Evidence-based medicine 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. Evidence-based medicine requires new skills of the physician, including efficient literature searching and the application of formal rules of evidence [in] evaluating the clinical literature (EBMWG, 1992).
The article mostly consists of recommendations to consult the epidemiological literature following “certain rules of evidence” which are not defined before making any clinical decision (EBMWG, 1992). The authors also provide an evaluation form for “more rigorous evaluation of attending physicians” based on how consistently they “substantiate decisions” by consulting the medical literature (EBMWG, 1992). But the important point was not the steps per se, but who had ultimate decision-making authority within the medical profession. The EBMWG (1992) article was an announcement that henceforth, clinical epidemiology was at the top of the authority pyramid (what remains to be explained is why doctors fell in line). Over the next ten years the EBMWG published twenty-five articles on EBM in JAMA (Daly, 2005).
Many have questioned the tone and approach of the early EBMWG vanguard (see: Upshur, 2005; Goldenberg, 2005; and Stegenga, 2011 and 2014). But the article, along with extensive organizing within the medical community, had the desired effect. EBMWG (1992) has since been cited over 6,900 times and EBM has become hegemonic throughout medicine — thoroughly reshaping the practices of doctors, clinics, medical schools, hospitals, and governments.
In 1994, Sackett left McMaster University to start the Centre for Evidence-Based Medicine at Oxford University which quickly became a dominant force in the EBM movement (Hanemaayer, 2016). Sackett et al. (1997) systematized EBM to include the following five steps:
- Formulate an answerable question;
- Track down the best evidence of outcomes available;
- Critically appraise the evidence (i.e. find out how good it is);
- Apply the evidence (integrate the results with clinical expertise and patient values); and
- Evaluate the effectiveness and efficiency of the process (to improve next time).
So far so good, but the Devil is always in the details.
III. Evidence Hierarchies
At first glance EBM appears straightforward and helpful. Problems appear once one tries to operationalize it. At the heart of evidence-based medicine are evidence hierarchies (Stegenga, 2014). Evidence hierarchies, as the name suggests, are categorical rankings that give preference to some ways of knowing over others. Rawlins (2008) found that 60 different evidence hierarchies had been developed as of 2006. Some of the best known evidence hierarchies include the Oxford Centre for Evidence-Based Medicine (CEBM), the Scottish Intercollegiate Guidelines Network (SIGN), and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) (Stegenga, 2014).
Read the rest at tobyrogers.substack.com
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Jerry Krause
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Hi PSI Readers,
This article began “Medicine faces the same challenges as any other branch of knowledge — deciding what is “true” (or at least “less wrong”. It seems what we term SCIENCE was begun by Galileo Galilei in 1638. However, the English translation of Galileo’s Italian title was Dialogues Concerning Two New Sciences. New implies there was some ‘older science’.Shortly after Galileo’s book was published Fahrenheit invented the first quantitative thermometer. Now there exists an instrument termed the infrared thermometer; but not often defined is the temperature it measures. It measures the ‘Surface Temperature’ of. the solid or liquid matter it is pointed toward; not necessarily the actual temperature of the solid or liquid matter just beneath the surface. Ponder this information so you know what you are measuring if you use a infrared thermometer.
Have a good day
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