V. Sierpina
Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry. Howard Brody. York: Rowman & Littlefield, 2007, ISBN-13:978-0-7425-5218
I highly acclaim and recommend this book to all physicians, medical students, and those in policy making positions regarding our broken health care system. Costs of care have spiraled out of control as new drugs and technology, however welcome, have made health care increasingly inaccessible to many.
This book by Howard Brody, MD, PhD reveals hidden secrets of the health care industry in relation to the pharmaceutical industry and why such costs and access problems have resulted from their actions, legal maneuvering, lobbying, direct and indirect efforts to influence the public, the medical profession, and politicians and policy makers. With the industriousness of an investigative reporter coupled with the tight focus of an ethical scholar, Brody carefully builds an exquisitely well-documented, logical case. He demonstrates serious problems with the fiduciary responsibilities of pharmaceutical companies to the public, their conduct of shoddy science, and their overly intimate role as educators and ultimately salesmen of their products to physicians.
With billions spent annually on promotion and marketing (roughly double their research and development budgets), Big Pharma dominates medical journal advertising, direct advertising through detail men to physicians, and now increasingly in direct marketing to the public. This creates a heavily weighted view that the pharmaceutical industry is an unalloyed good to the health of the American public and that of the international community. In fact, it has become increasingly difficult to discern the boundary line between the drug industry and their products and the responsible conduct of modern medicine. As a teacher, researcher, and a practitioner of Integrative Medicine, for example, I have come to recognize the safety, efficacy, and cost-effectiveness of many non-pharmacological and preventive approaches such as diet, lifestyle change, mind-body approaches, botanicals, nutritional supplements, hands-on therapies, acupuncture, and the like for a variety of chronic diseases. However, without the billions of dollars of funding for research and marketing, these therapies, with a significant potential to reduce health care costs while increasing public safety, are summarily ejected to the back seat while the Siren call of Big Pharma mesmerizes the medical profession and the public.
Brody’s masterfully written book covers the waterfront of issues that arise in relation to pharmaceutical companies and he even-handedly acknowledges the benefits and positive processes of the industry while likewise pointing out abuses. The book offers an excellent and comprehensive historical perspective throughout of the emergence of various elements in this relationship between the medical profession and the pharmaceutical industry. After laying a firm foundation in ethics, Brody methodically details various legal, political, and scientific abuses. These include abrogation of free market, government protection of profits, unethical and unscientific research practices, and the heavy influence of the drug rep on doctors’ prescribing practices and continuing medical education. He describes the numerous recent incidences of publication of incorrect data derived from industry trials, suppression of data such as the Vioxx case, and the heavy dependence of medical journals for advertising revenue from drug companies which sets up an immediate and inherent conflict of interest. When prestigious journals such as the New England Journal of Medicine or the Journal of the American Medical Association accept drug company adverting, they intentionally or inadvertently provide an imprimatur of approval, safety, efficacy, and value to these products.
He also describes how the federal watchdog agency, the Food and Drug Administration is not immune from Big Pharma influence in their rules, regulations, approval of new drugs, and post-market safety surveillance. As a result, safety warnings about new and already marketed drugs are often slow to reach the profession and the public creating a significant public health safety risk as in the cases of thalidomide, Fen-phen, Rezulin, SSRI’s in children, and of course, Vioxx and related COX-2 inhibitors. I found this ironic in the wake of thousands of injuries or deaths from these drugs and the swift recall by the FDA of ephedrine, a traditional Chinese herbal from the marketplace after just over a hundred patients taking it in excessive doses for weight loss succumbed to arrhythmias. While this recall was to some extent justifiable, it seemed Draconian in view of the sluggish response of the FDA to problems generated by the well-heeled prescription drug industry.
Hearteningly, Dr. Brody concludes his book with three chapters offering solutions to these ethical issues. These include management and divestment strategies, enhanced professionalism in medicine, and regulatory reform. He argues effectively for terminating the free lunches, dinners, promotional gifts, and support of medical journals, societies, and CME by drug companies. Such “gifts” come with ethical, psychological, and financial strings that entangle Caduceus and the medical profession like Gulliver’s Lilliputians. Enough such strings and even the mighty cannot shake them off. Our professional responsibility is first and foremost to the safety of our patients. By accepting samples, gifts, research grants, our professional ethos stands risk of being criticized. Indeed, the appearance of influence by such commonplace practices appears to most citizens as a sign of the unhealthy and often unethical influence of Big Pharma on physicians. Brody offers that we as a profession ought, “Just say no!”
Finally some regulatory reform regarding patent law, the conduct of ethical and scientifically valid research, “me-too” drugs, production of important drugs lacking potential for commercial success, conflicts of interests, safety-monitoring, consumer advertising, CME, reliance on “blockbuster” drugs for profits, and access of drugs in the developing world are all important topics recommended as part of the solution to the problems of the pharmaceutical industry.
This is a deeply thoughtful, academically sound, and disturbing book. It mirrors concerns brought up by earlier works by Abramson (Overdosed America: The Broken Promise of American Medicine, 2004) and Avorn (Powerful Medicines: The Beneftis, Risks, and Costs of Prescription Drugs, 2005). It ought be required reading for the medical profession as a whole and a call to action to help us to regain the public’s trust in our integrity, altruism, and professional ethics.
Victor S. Sierpina, MD
Associate Editor, Explore, Professor, University of Texas Medical Branch