Author: Dr. Jerome P. Kassirer
The profession of medicine encompasses a wide variety of ways in which a physician can dedicate his or her life within the traditional areas of clinical practice, research, education, and administration. In this book, Jerome Kassirer, a former editor-in-chief of the Journal, documents, with well-referenced examples, how conflicts of interest, primarily financial in nature, have infiltrated all areas of the profession. The audience for the book is clearly the U.S. public, who, the author writes, "must become involved if we are to change the greed culture that permeates medicine." I agree, in principle, with the author that there are substantial conflicts of interest within the medical profession. However, I question the potential effectiveness of this book as written for the public. The most obvious reason for a physician of Kassirer's stature as a clinician, academician, and former editor to write a book about conflicts of interest in medicine would be to continue his attempts to eliminate or at least decrease a problem that diminishes the profession. But is this book a good way to accomplish that goal? The book wavers between a scholarly work and a sensational expose. For example, the cover features a man wearing a white coat and a neat shirt and tie, with a stethoscope around his neck and a pricey pen and a few crisp $100 bills tucked in his pocket. I was taken aback by the image, which is clearly meant to depict a "fat cat doc" on the take. However, this jarring image is then tempered by the two opening sentences of the first chapter, which declare that most physicians are hard-working and dedicated to their patients and that perhaps even hundreds of thousands of physicians refuse to take any financial gift that might affect their clinical judgment. Then, aside from a few selected exceptions to that supposed rule, the rest of the book is dedicated to stories about physicians tainted by financial self-interest that altered how they cared for patients, how their research was conducted and reported, what they taught, and how they administered medical institutions, with evidence that all of these conflicts of interest led to the detriment of patient care. The final chapter discusses "what can be done," ending with a "possible roadmap" that includes 10 items for immediate implementation that would be possible primarily by legislation. The reader is asked to take a political stand to force the enactment of such legislation. If the reader were to take such action, the author would deserve a medal. However, if the reader's more likely reaction would be to view with distrust all physicians currently practicing in the United States, it would be unfortunate indeed and would undermine the very reason that the book was written. Catherine D. DeAngelis, M.D., M.P.H.
Dr Jerome Kassirer’s new book published for a general audience, On the Take: How Medicine’s Complicity With Big Business Can Endanger Your Health, chronicles the kind, extent, and consequences of collaborations between the medical profession and industry.1 Adopting the style of an investigative reporter, this highly respected former editor of The New England Journal of Medicine relates, within 213 highly readable pages, a litany of well-referenced examples demonstrating that pernicious financial conflicts of interest are rife in medicine today and threaten to undermine the integrity of the profession. Although many of the incidents recounted in the book are already matters of public record, their inclusion in a single volume provides some sobering and most unsettling food for thought.
Beginning in Chapter 1 with the innocent free gifts, free meals, and free education many doctors receive, Dr Kassirer takes the reader through 8 revealing chapters to demonstrate that "trinkets bloom into meals at fine restaurants, meals grow into speaking fees, speaking fees morph into ongoing consultations and membership on drug company advisory boards, positions that can command up to six figures a year." He raises the question "Has all this money floating around medicine created a pattern of corruption?" By all indications, his answer to this question appears to be a resounding yes, with which we agree. The vis-à-tergo for this perfidy is attributed to the massive expansion of the highly profitable drug, device, biomedical, and commercial educational industries. This dramatic growth began to occur just after increased federal funding enhanced training and research programs in the 1960s, resulting in a flourishing of the academic medical enterprise within the United States. To further profits and remain competitive with the international market, so it reasoned, Congress passed legislation that provided financial incentives for academic medical centers and their investigators to patent their discoveries. As a result, leaders of major medical centers reaped the institutional rewards of licensing agreements, scientists were enriched by royalties, and industry profited from the resulting end product.
Under dramatic headings such as "Money-Warped Behavior," "Your Doctor’s Tainted Information," "Our Obliging Professional Organizations," "Can You Trust Your Doctor," and "Can We Trust Our Researchers," the reader is shown how pervasive conflicts of interest have spread up the professional food chain and have tainted multitudes of physicians and scientists along the way. This pool of professionals includes some who occupy our loftiest ivory towers, some within our federal agencies such as the National Institutes of Health and the Food and Drug Administration, some in our volunteer health agencies, many of our professional organizations and scientific societies, and even some of the panels of experts assembled to promulgate clinical practice guidelines. To be certain, the book also indicts those medical practitioners who are driven by greed. The exposé seems shocking in its extent and as distasteful as the jacket of the book must have been intended when designed, portraying as it does a $100 bill protruding from the breast pocket of an anonymous physician’s white coat.
In the main, Dr Kassirer’s theme strikes at the core of our conscience. There are incontrovertible dictums for the clinical practitioners that most would agree are to be avoided, such as meals at fancy restaurants; industry-sponsored trips, boondoggles that are usually promulgated under the guise of continuing medical education (CME); finder’s fees for enrolling patients in clinical trials; stipends for "pseudoconsulting"; and lavish fees for publishing articles favorable to industry in non–peer-reviewed journals. For the physician-investigator, there is always the possibility that the results of an industry-funded study will be negative or, worse, that the treatment may cause adverse effects. For this reason it must be considered axiomatic that the physician-investigator always remain therapeutically distant from his or her study subjects.
Not one to split hairs, Dr Kassirer stands clearly opposed to allowing editors, associate editors, editorialists, authors of review articles, guidelines developers, and principal investigators of large clinical trials to have any financial entanglements with industry whatsoever. He ingeniously develops such principles as "the fallacy of unique expertise" and "incestuous amplification." He mounts a compelling argument that all gifts from industry, however small (lunch included), are marketing ploys against which we have only limited resistance and that universally arouse a feeling of reciprocity in all of us. He argues that the practice of disclosure of conflicts within the profession is a hollow sanitation device that has failed because of little policing and no sanctions.
Unquestionably, this book is extremely effective at highlighting what is a powerful and well-organized effort by the pharmaceutical and device industries to co-opt vulnerable physicians. These efforts take many forms, but a particularly visible one is the major subsidization of CME programs. As an example, at the annual scientific sessions of both the American Heart Association and the American College of Cardiology, there are as many as 60 to 70 industry-sponsored satellite symposia, each featuring important and well-remunerated academic speakers, and many are accompanied by a free breakfast or dinner. Perhaps the most widespread tactic used to ingratiate the most vulnerable of physicians (overworked and debt-ridden trainees) to industry is the almost-daily practice of the "drug rep" providing meals at teaching conferences at most academic medical centers, community hospitals, and VA hospitals throughout the United States. For the key opinion leaders in a local community or specialty field, the attractions are more substantive, with lucrative appointments to company-funded speaker bureaus, consultantships, and advisory boards, each with its premium honorarium. Increasingly, medical investigators are becoming owners in part or in whole of patents and small companies and are offered stock or stock options in the sponsoring company; some have reaped enormous profits in the process.
In taking this instruction-by-example approach, however, Dr Kassirer does little to inform the reader of the precise magnitude of the problem, perhaps because the magnitude is in fact unknown. Even the informed reader may erroneously conclude that all physicians engage in these relationships and do so with the intent of deceiving their patients. The reader can only be impressed with Dr Kassirer’s unwavering ethic but is likely to be confused by his assertion that the pharmaceutical device–biomedical industry "is not the evil empire," when any remunerated interaction with industry is portrayed as a serious conflict of interest—so serious, in fact, that it should preclude the recipient from participation in any of a variety of professional activities ranging from clinical guidelines development, to writing editorials or review articles, to participating in analyses of many large databases. Such a policy would exclude many of the most qualified and distinguished members of the medical profession from participation in these vital activities. Perhaps it is more direct to state that Dr Kassirer has overlooked or underestimated the power of peer review and consensus development.
Dr Kassirer does acknowledge that his lexicon of egregious professional behavior in medicine did not come about in isolation, but rather that the abuses have paralleled "changes in the culture and the norms of society." We quite agree that practices such as excessively compensating CEOs undermine the nation’s trust in the corporate world and note that the huge salaries of many senior administrators in the healthcare industry are not far behind in this regard. We also hasten to add that, entirely apart from any influence exerted by the pharmaceutical and device industries, hyperbole is the grammar of our day, and sensationalism drives the expanded media coverage we now witness. Throughout all of society there has been an acknowledged decline in traditional morals. Examples of ethical compromises and flagrant greed abound in our culture and have tainted such icons as the New York Stock Exchange and many of its leading corporate members, the Olympic Organizing Committee, the FBI laboratories, government at almost every level, prominent philanthropies, and even organized religion.
Although we do not deny the perils that are associated with excessive interaction with industry that Dr Kassirer so clearly documents, we suggest the case is not presented with adequate balance. Surely one cannot accept the premise that all relationships between physicians and industry are pejorative. To the contrary, there are many physician-scientists who, working with the support of pharmaceutical companies, have identified the mechanism of a disease or devised a therapy that has ultimately demonstrated efficacy and safety and provided significant advances for the care of patients. Some of these individuals have even won Nobel prizes. Similarly, there are many overstretched practicing physicians who find it time-sparing and beneficial to receive early information about new drugs or new technologies from an industry representative, identifiably biased, who visits periodically to provide an incidental, inexpensive but convenient lunch. Physicians are trained to think critically, and they should be able to place the information in appropriate perspective with or without accompanying comestibles. As there are many examples of ethical and mutually beneficial liaisons among medical schools, hospitals, and professional societies, we maintain there is a need to be open-minded about these relationships and to assume that the intent of forming them is not always driven purely by unbridled greed and self-interest.
Fiscal pressures have created and will continue to create tensions among physicians, not-for-profit agencies, academic medical centers, and industry. Eliminating industry relationships is not only impractical but potentially financially detrimental for the organizations involved, particularly the academic medical centers.2 Without fair and appropriate compensation from third-party payers for clinical services to hospitals and physicians, adequate support from the NIH, or sufficient philanthropy or institutional wealth, many are pushed to participate in commercial relationships when the opportunity presents itself. Although the relationships may be thorny, it is a choice that could be made for a greater good if there were "a practical, effective, clearly defined, and evenly applied process in place at each academic medical center to address key questions."3 Unfortunately, uniformly applicable guidelines do not exist for the medical profession, and it is difficult to find comparative guidelines from other professions or even the government that could serve as constructive examples of how to achieve this end. We feel strongly that this should be a primary goal of our profession and that every effort be made to find the solution in some pooling of the combined wisdom of our academic institutions and our many prestigious professional societies.
Before we arrive at how to manage conflicts of interest, however, we must fully disclose these potential conflicts without fear of shame or taint. Rather than being virtually meaningless, as Dr Kassirer claims, we view disclosure as an essential element for helping to mitigate the problem. Whenever a speaker or author reveals the existence of an industry relationship, physicians should be especially critical of the content and decide whether the presentation is unbiased science or a subtle endorsement of a product. Dr Kassirer rightly points out that as currently constituted, disclosures give no indication of the magnitude of physician-industry relationships. Rather than scrapping them, however, the medical profession should strive to make disclosures meaningful, perhaps by developing designations for categories of involvement that would signify whether the degrees of physician-industry relationships are major or minor.4
We applaud the incisive editorial mind and facile pen that bring to our attention the stretching of the moral fiber that threatens the tensile strength of the trust that binds us to our patients. We subscribe to the comments offered by the eminent individuals quoted on the back cover of Dr Kassirer’s book and to many of the commonsense suggestions for improving relationships between medicine and industry he offers in his concluding chapter. The most powerful is the call for an Institute of Medicine study, which would carry enormous weight in providing direction in this murky field. We do not feel the situation calls for draconian measures, although we can envision sending no more emphatic a message to industry, the medical profession, and the public than having the recognized leaders of medicine divest themselves promptly, publicly, and voluntarily of all recognizable conflicts of interest. Medical societies should suggest that their membership do likewise. We would do well to consider taking a page from the book of our students, who, at the 2002 meeting of the American Medical Student Association, approved a policy that urges physicians and trainees alike not to accept gifts from industry and to refuse honoraria for speaking or for token consulting, that opposes giving CME credits for drug company–sponsored events, and that urges hospitals to put an end to pharmaceutical company–funded lectures and lunches on and off site.5
Each physician, hospital, academic medical institution, or professional society must decide individually on the merits of any potential relationship with industry. The pros and cons must be weighed carefully. The pros are largely financial gain; the cons involve ethical risks that can potentially undermine the integrity of the individual, institution, or organization. In forging relationships between medicine and industry, 2 overriding principles seem self-evident. First, the rights and welfare of patients must transcend all other considerations. Second, the integrity of the involved parties must never be compromised. With this in mind, we also must recognize that the complexity of biomedical science, with its sophisticated and costly techniques, coupled with its dependency on academic innovation, is creating an ever-growing interdependence of universities and commercial entities. We strongly endorse those who propose developing new rules of engagement that would be universally applied in an open, informed, and timely manner and would be operative at each academic medical center to translate policy into practice.3 It is our conviction that full disclosure and transparency in medical-industry relationships should ultimately be the rule, not the exception.