We Need to Lead and Not Be Led

Editorials We Need to Lead and Not Be Led he many advances in medical therapies and technologies we have witnessed in recent years have been applauded for the apparent improvements they have brought in treating a variety of urological conditions while maintaining or enhancing quality of life. An undercurrent of skepticism, however, has also emerged as some of these “advances” have been suggested as being the manifestation of artificial markets that have attracted public attention to certain “conditions,” which in turn have led physicians to apply treatments that are costly, may not really be necessary, do not truly fulfill advertised outcomes, and may in certain instances have led to serious side effects and complications. As importantly, the very processes by which some of these new treatment approaches have developed could threaten the ethical underpinnings that we as a medical profession have valued and so jealously guarded through the years. This is because we and our Institutions appear to be at increasing risk of becoming influenced by processes that are economically driven and that have insidiously undermined the manner in which “quality of health care” is perceived and delivered despite our best intentions. An important issue responsible, at least in part, for the evolution of this situation is the reductions in research funding that have prompted our academic institutions to encourage a more active participation in industry sponsored research programs. Understandably, a majority of these are targeted towards the potential economic market a particular type of clinical or translational research might address rather than towards the further understanding of a particular disease process. Clinical studies then undertaken through the stated leadership of investigators from selected institutions but under the direct auspices of Industry sponsorship may produce interesting results. Because of the marketing directive of these studies, however, the results are often presented with an emphasis on the “positive” aspect of their outcomes. This may create early conflicts if initially “promising” results are not fully reproducible by each of the participating institutions, or when individual variations in results are subsumed in the larger mission of presenting “positive” observations. At worst, this can lead to an omission or de-emphasis of negative observations. The fundamental target of such research can further confound this issue. Conditions that may represent quality of life issues have been accentuated increasingly in the collective mind of the public as being significant problems that can now be addressed satisfactorily. However, although a number of these are clearly an issue and of concern for some, they may not be of a magnitude to justify the substantial generalized attention they have drawn. Or, if viewed more skeptically, their emphasis on the population at large may represent an exploitation for baser reasons. Furthermore,

the proposed treatments may not provide realistic and trouble-free solutions for the larger number of individuals, may actually benefit only a small proportion of those who truly have a serious condition, and may create other problems through side effects and/or complications that may not have been emphasized in initial studies or promotional reports. These issues may be compounded when those engaged in these studies are then designated by commercial meeting planners as “thought leaders” and are invited to present their results at Industry sponsored conferences or as invited speakers to selected groups. Although “conflicts of interest” are disclosed and the investigators and speakers are highly knowledgeable in their own right and in the issues they discuss, it becomes difficult to gauge the extent by which they may be influenced by the financial support they have received for these studies or are now receiving for their lectures to colleagues and to the public. Indeed, their complete disengagement from these conflicts of interest may be virtually impossible to achieve in this context. Further adding to this problem is that new medications and technologies are now actively marketed by industry to physicians and directly to the public in what may be more than just an informational sense. The public is inundated with advertisements of new “breakthroughs” in the treatment of a variety of conditions that may in certain instances have been publicized to effectively create a market for a given product. As such, the question arises as to whether a person is actually suffering from a particular condition or, if so, to what degree. Nonetheless, the public is encouraged to consult with their physician about using this latest advance in medical therapy or technology in addressing their presumed condition. Ironically, in many instances they may not have realized they ever had the condition were it not for the publicity that had brought this to their attention. At the risk of being cynical, one can ask whether these advertisements were more likely to have been vetted by psychological experts rather than by objective urological experts to make their message attractive and convincing. Such issues are complex and multi-factorial. Physicians are being increasingly led into situations by economic pressures that society has created in the name of good health care. Priorities regarding quality of life have become confused with health care quality. Information accessible on the Internet is accepted as gospel even if unvetted. Furthermore, the public expects the medical profession to provide access to what they see as “good” health care even if this is largely based on marketing from various quarters or nonscientific interpretation. Incentives for us to participate in these processes are also multi-factorial but are increasingly the result of pressures created by economic considerations which can easily lead to the loss of scientific integrity. Research, now more readily funded through Industry, is increasingly encouraged by our

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0022-5347/06/1763-0861/0 THE JOURNAL OF UROLOGY® Copyright © 2006 by AMERICAN UROLOGICAL ASSOCIATION

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Vol. 176, 861-862, September 2006 Printed in U.S.A. DOI:10.1016/j.juro.2006.06.099

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WE NEED TO LEAD AND NOT BE LED

Institutions which gain from substantive indirect costs, support for educational programs and visibility for marketing such programs to the public. Investigators may obtain financial support for their research programs and support staff not otherwise readily available. When immersed in these studies they become identified as “thought leaders,” a term that substitutes for “expert” or “investigator” but seems Orwellian in its connotation, and become involved through Industry sponsorship in presenting results of studies of these new treatments. Their presentations can then presumably unintentionally produce a subtle but effective argument to use a particular product. Industry representatives visit our offices and departments to provide an “educational” service in the presentation of industry sponsored research results. “Thought leaders” sponsored by the same companies present the same information in a scientific seminar format. As the concept of a condition and its treatment are marketed directly to the public, the public then expects new treatments and technologies for the conditions they now perceive they have, and demands access to approaches they are convinced are “bet-

ter” than previous approaches allowed. The resultant pressures for physicians to comply may then overwhelm their better judgment. We used to be leaders as we honored our commitment to our patients with honesty and integrity. We are increasingly being faced with pressures that may compromise the information we obtain and the decisions we make. This is compounded by the economic exigencies that have taken hold of our medical institutions and systems which may then determine how we are expected to proceed. If we allow this to continue, we risk losing our credibility, compromising our integrity and lessening ourselves as a profession. I believe it is time to take note of what is occurring, recognize what we are doing and then do what we know is right. Only then can we truly honor the commitment that we have to our patients and to each other in preserving our profession in its highest state and maintaining the integrity and credibility we have honored, enjoyed and cherished through the years. It is time again to lead and not be led. Michael J. Droller Associate Editor