forthcoming in the Fall 2008 Focus newsletter of the Creighton University Center for Health Policy and Ethics:
The Crumbled Building Blocks of Evidence-Based Medicine
The Crumbled Building Blocks of Evidence-Based Medicine
Certainly one of the greatest trends in medicine over the last decade has been the rise of a new mode of medical practice and medical education, that associated with Evidence-Based Medicine, the promulgation of practice guidelines, and other associated developments. Speaking, perhaps, in an overly simplistic way, we might say that there was once a notion of an academic physician as a master of the profession—whose mastery was characterized by experience, judgment, knowledge and clinical know-how, and other more or less “ineffable” aspects of the practice. There was a subjective and ethical aspect to the practice, and schools arose in medicine around the style of their great leaders, something that was passed onto those studying the practice.
That notion of transmission of medical practice has been replaced by a new one, where the frame is no longer defined by experience and judgment, but a new system in which, through a process of isolation and measurement, medicine (and the patient him or herself) is reduced to that which can be broken into bits, quantified, and evaluated in an application that—in adopting a style from science—at least appears to be objective and scientific. In this model, what cannot be quantified and reduced is relegated outside of the field of scientific medicine, making, in such a way, the doctor-patient relationship in clinical practice (transference, as it is known for the psychoanalyst), or the teacher-student relationship in education (another form of transference, for sure) no longer part of the practice or education. In this whole process, physicians give up responsibility and control for the practice to a varied group—payers, insurers, the government, groups of so-called physician experts, all operating now as Committees, who have now assumed (or, been handed over) responsibility for decision-making about practice and education.
While some grumbling about this certainly occurs among older doctors, physicians as a group are remarkably complacent about these developments, accepting them without any significant critical examination. Or, perhaps we ought to say that this reduction and quantification within the realm of medicine has occurred at precisely the same time that we see a developing interest in non-Western or alternative therapies in medicine, as if people are seeking to pick up what is lost in “ordinary” medicine with a different doctor, a complementary doctor, where the physician-patient relationship and the “ineffable” aspects of care are captured with a different relationship.
But, again, while on a whole, mainstream medicine has accepted these developments without question, there is a serious literature within psychoanalysis (at least, psychoanalysis of the Lacanian orientation) that has attempted to carefully scrutinize these developments and examine their influence on clinical practice, especially in Europe, where a small groups of ideologues are attempting to eradicate an entire tradition of clinical practice in mental health care.
It was something of a surprise, then, to come upon the remarkable study done by Erick Turner and colleagues on “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy,” published this spring in the New England Journal of Medicine. In this study, Turner demonstrated that of a total of 75 or so studies completed on newer generation antidepressants, almost all of the 37 studies that demonstrated a positive result were published in the medical literature. Of the studies that demonstrated negative results of the medication, the majority were not published. Of those negative results that were published, the significant majority of those were distorted in such a way that what was originally (per the study design) a negative outcome was reported as a positive outcome. Using a complex statistical tool on effect size, Turner then demonstrated that, as a group, these medications, which have a fairly modest clinical effect as based on the published trials, IN FACT have a far more modest clinical effect when all the data (negative and positive) gathered about their clinical effect is factored into the analysis. The implication of the study is very clear: important information about these medications was withheld from physicians and the public, groups that based their decisions about the use of these medications on a distorted overly positive sample of the data that was selectively released into the literature.
In and of itself, this does not come as too much of a surprise. Any clinician with familiarity with this class of medications is aware that they just are not all that effective. And, in light of all the information that has come out in the last five years about pharmaceutical companies withholding information about medications (such as cardiac mortality in newer anti-inflammatory drugs; suicide risk in antidepressants; and, weight gain in some antipsychotics), only the most naïve person would be surprised by the revelation of a failure of the companies to release these data. And, even for the more scientifically minded physician, the statistical findings should not be too much of a surprise. After all, in all of the selectively released positive studies, the randomly controlled trials show about a 65% efficacy of the medication in comparison to a 50% or so efficacy for the placebo. Seeing that slimmest of margins in the published data will lead the astute reader to hypothesize the existence of studies that do not show the margin (after all, like many phenomena, these studies are distributed along a kind of Gaussian curve: we only got to see one side of the curve).
What I found most remarkable about Turner’s work is the extreme rigor and dispassion with which he approached the subject, using the very tools and techniques of this contemporary development of Evidence-Based Medicine to demolish one of the core foundational building blocks of Evidence-Based Medicine, namely the randomly-controlled trials that form the bedrock on which are built the practice guidelines that physicians are told they must follow to deliver quality care. The published literature, which forms the basis for the whole enterprise of Evidence-Based Medicine, contains a significant misrepresentation. It is not an “objective” source of knowledge about these treatments, but a carefully manipulated presentation of the data gathered by a Medical-Industrial Complex keen on controlling what is promulgated as “science” itself. This is most obvious in the “Supplementary Appendix” to Turner’s article (found on the website of the New England Journal of Medicine) that demonstrates the degree of outright deception in the ways in which some of the negative studies were subsequently reworked and manipulated into positive studies. If these randomized controlled trials are not to be trusted, this whole edifice needs to be re-examined. Physicians, especially in academic medicine, need to reconsider how they think of their practice and transmit that to students and colleagues. And, Evidence-Based Medicine and Practice Guidelines need to be reconsidered, not as the sole legitimate standard for what is scientific in medicine, but as a set of ideas and recommendations promulgated by some, which need to be treated with appropriate skepticism and a critical eye.
In his January 1961 Farewell Speech, President Eisenhower, while recognizing the importance of the military, offered cautionary words about the dangers of a “military-industrial complex,” which would pose a threat for the “disastrous rise of misplaced power” and threaten to “endanger our liberties or democratic processes” and which must be guarded against by “an alert and knowledgeable citizenry.” Within psychiatry and medicine, the work of Turner and his colleagues indicates that we are seeing nothing less than the rise of a similarly dangerous “Medical-Industrial Complex,” at least in the United States today, one which also holds an immense amount of power and poses similar threats to our liberties and to the democratic processes which are the basis of the social bond that is medicine and the work of physicians. Physicians, especially academic physicians, must reconsider the nature of their relations with this Medical-Industrial Complex and the extent to which they want to be complicit in deceptions such as those promulgated in the work that Turner has carefully studied.
 This very common shift from the single Master to the Committee was described in great detail by psychoanalysts Jacques-Alain Miller and Eric Laurent in their 1996-97 Seminar on “The Other who Doesn’t Exist and his Ethical Committees.” A session of the Seminar has been translated into English as “The Other who Doesn’t Exist and His Ethical Committees” in Almanac of Psychoanalysis 1 (1989): 15-35.
 See, for example, Psychoanalytical Notebooks, issue 16 (2007), especially François Sauvagnat’s “The Current State of ‘Evidence-Based Medicine’: Recent Reductionist Trends in Psychiatry and some of their Drawbacks” (85-95) and Eric Laurent’s “Blog-Notes: The Psychopathology of Evaluation” (45-75). These changes are situated within a broad philosophical and historical shift by Jacques-Alain Miller in “The Era of the Man without Qualities” (7-42). The politics of these developments as they have unfolded in France are carefully described in The Pathology of Democracy: A Letter to Bernard Accoyer and to Enlightened Opinion by Jacques-Alain Miller with Contributions from Bernard Burgoyne and Russell Grigg, London: Karnac Books, 2005. For the Francophone reader, the political philosophy of these developments are discussed in Jacques-Alain Miller and Jean-Claude Milner’s Voulez-Vous Être Évalué?: Entretiens sur une machine d’imposture [Do you want to be evaluated? Conversations on a deceptive machine], Paris: Bernard Grasset, 2004.
 “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy.” Turner, E. H., Matthews, A. M., Linardatos, E., Tell, R. A., Rosenthal, R. New England Journal of Medicine. 358 (2008): 252-260.