Bernat, James L. MD
White Coat Black Hat: Adventures on the Dark Side of Medicine. By Carl Elliott. 211 Pages. Beacon Press 2010.
DR. JAMES L. BERNAT ...Image Tools
This is a disturbing book. Carl Elliott, a pediatrician, bioethicist, and philosopher, has written a penetrating exposé showing how the medical profession has lost its way as a consequence of the corrupting effects of money and power. Elliott states his intent: “I do not claim to offer a balanced picture of contemporary medicine. My interest is in how medicine has gone wrong, not in what there is to admire.”
Elliott powerfully illustrates how physicians not only allowed the medical profession to become commercialized and deprofessionalized by money from the pharmaceutical and medical equipment industries but how physicians who personally profited in the process played a necessary role in the transformation.
Elliott begins by exposing the clinical research industry in which a professional class of well-paid human subject “guinea pigs” has evolved to participate in phase I clinical trials. He shows how some of these research subjects migrate from clinical trial to clinical trial, making a living on the surprisingly high stipends but caring not at all about the scientific goal, and even purposely subverting the trial guidelines for fun. Elliott observes that the pharmaceutical sponsors of the clinical trial, and especially the companies who organize them and employ the human guinea pigs, have their own obvious financial incentives. He ponders the ethical question: “What happens when both parties involved in a drug trial see the enterprise primarily as a way of making money?” He answers this question with several disquieting examples of poorly supervised, mishandled, and corrupt studies.
Elliott next turns his attention to pharmaceutical company-sponsored ghostwriting. He explains that pharmaceutical or medical equipment companies consider prepublication planning an essential step in marketing a product. A company identifies a prominent academic physician as a potential author for a publication that had been written in-house. This academic physician usually reviews it, makes minor changes if any, and agrees to serve as its “author” in exchange for a stipend. Elliott distinguishes between the above example, more accurately called ghost-authoring (which everyone now condemns but was quite common in the past) and ghostwriting in which a company-paid writer collaborates with an academic author but whose contribution to the finished product is unacknowledged, making it appear that it originated and was written solely by the academic author. He points out that some scientists see no problem with this arrangement because the serious intellectual work of science resides in the design, execution, and interpretation of an experiment, and writing it up for publication is mostly a technical exercise that could be done by an assistant. He insightfully distinguishes this situation from that of a scholar in the humanities whose intellectual work usually lies in the writing of the paper itself.
Elliott writes an entertaining chapter on pharmaceutical company sales representatives — formerly called detail men and now known as drug reps — who now are mostly attractive, well-dressed, young women. He interviews several former drug reps to understand how they operate, how they are paid, how they succeeded, and what they think of their work. He cites the amazing statistic that, in the United States in 2005, there was one drug rep for every 2.5 physicians. Elliott regards them as highly talented and highly paid con men for whom he professes a combination of admiration and disgust.
Elliott's chapters on thought leaders and flacks are particularly enlightening. He shows how pharmaceutical companies and medical equipment manufacturers have cleverly employed physician thought leaders to help market their products. He cites interesting sociological data showing that contemporary physicians are more likely to be influenced by the opinions and recommendations of respected colleagues than by the sales pitches of drug reps. He then explains how companies, under the guise of education, have employed physician thought leaders on speakers’ bureaus to encourage colleagues to prescribe the products of their sponsors. He points out that these physician thought leaders are indispensable for recommending off-label indications for drugs because it violates FDA regulations for drug reps to mention them.
Elliott describes the evolution of the highly successful program of direct-to-consumer pharmaceutical advertising and mentions the role of the American Medical Association, which in 1992 voted to reverse its opposition to it in the name of patient empowerment. He provides troubling examples of the professional misbehavior of drug company officials and physician thought leaders in the marketing of Neurontin, Vioxx, and selective serotonin reuptake inhibitor antidepressants. He discusses the marketing role of patient advocacy groups that are sponsored and to some degree controlled by the pharmaceutical industry. Rather than serving as a remedy for the conflicts of interest of lecturers in speakers’ bureaus, Elliott opines that mandatory disclosure may exacerbate the conflict if paid speakers conclude that then they are free to say whatever they like.
As a neurologist with an interest in bioethics, I found Elliott's chapter on bioethicists especially painful to read. He points out that not only do bioethics think tanks receive considerable income from medical industry, and that some bioethicists have become entrepreneurs, but that many bioethicists have been hired as paid advisors to pharmaceutical companies, high-tech research companies, and medical equipment manufacturing companies.
After tracing the evolution of the field of bioethics, Elliott shows how some of its practitioners have been gradually transformed by industry money from their former role as disinterested gadflies to that of company advisors, who have “slowly come to resemble the people they are trusted to advise.” He questions whether bioethicists can maintain their impartiality and traditional role of watchdog when they join the team of a company as a trusted advisor. As in all of his questions, Elliott illustrates his points with telling cases, including a fascinating account of a successful commercial institutional review board with an innate conflict of interest because its income is derived solely from companies for whom it reviews clinical research protocols.
Carl Elliott has written an important book that is sure to offend colleagues, many of whom are identified, who he believes have been attracted by money or power into lending their names, reputations, and influence to join “the dark side” of commercial enterprise. Although he will not win any popularity contests with this publication, it is essential for physicians to read his exposé and contemplate their own opinions and positions on the questions that he raises. This courageous book proves that Elliott remains a gadfly — the proper role of a bioethicist.
Neurology Today advisory board member Dr. Bernat is professor of neurology at Dartmouth Medical School and a former chair of the AAN Ethics, Law, and Humanities Committee.