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Vigilance, Vigilance, Vigilance
Editorials
Vigilance, Vigilance, Vigilance WE are living in increasingly difficult and uncertain times. The economic downturn has increased the variety of pressures we face in our personal and professional lives. Those pressures can influence what we do and how we relate to the standards to which we would generally aspire. Economic pressures have also affected the institutional context in which we work, undoubtedly compounding behavioral pressures and conceivably undermining certain values that we have developed through our careers. The charge to each of us is to remain vigilant in maintaining the probity and professionalism that are so integral to the fundamental values we share as physicians, investigators, educators, administrative leaders in our profession and role models in representing these ideals for the generations to come. In recent months I have observed or become involved in several examples of the challenges with which we are increasingly confronted. The rapidity of their emergence bespeaks the possibility that such issues are becoming more commonplace. Their common theme may be reflective in part of the economic pressures that have been placed on the processes of investigation, publication and education. Their potential of compromising these processes and their safeguards calls to a heightened level of vigilance to prevent this from happening. Some of these challenges have included 1) a letter from a major drug company acknowledging the inappropriate description in their published supplement of investigational studies and the recommendation of nonapproved potential uses of its product; 2) an article on the failure of investigators to register their clinical trials before enrolling participants, thereby compromising the objective to reduce the risk of selective reporting of outcomes;1 and 3) an article in the New York Times describing the results of an as yet unpublished study by the editors of JAMA on the incidence of industry sponsored ghostwriting and its potential influence in the presentation of research results.2 Publication of industry sponsored supplements in our peer reviewed journals provides revenues to the journals at a time when substantive decreases in 0022-5347/10/1831-0009/0 THE JOURNAL OF UROLOGY® Copyright © 2010 by AMERICAN UROLOGICAL ASSOCIATION
print advertising are having profound economic impact. These supplements generally comprise proceedings from industry sponsored symposia or contributions by those who have participated in studies in an area of interest to the sponsor. Although journal policies generally require that the proposals for these supplements be acceptable to their editorial boards, that the manuscripts be peer reviewed and that full disclosure of conflicts of interest be provided, inherent infrastructural conflicts and consequent biases may intrude in the review of a particular area and the presentation of a specific product. Publication of supplements can serve a valuable purpose in offering comprehensive information from a symposium or of the concepts and interpretations of those who have been active in the area being addressed. That such supplements can serve their sponsors in promoting a particular area should not be viewed as an intrinsic objection provided the review process, disclosures and safeguards are followed. However in fulfilling our responsibilities as investigators, authors, reviewers and editors, it behooves us to maintain strict vigilance in how we participate in presenting information for our colleagues and ultimately its interface with the public. As attested by the broadly distributed letter I received, the economic pressures to publish these supplements and any lapse in vigilance in the review process may result in publication of misleading information, incomplete data, investigator and author bias, and “lack of sufficient transparency.” This well written letter of apology, seemingly a response to regulatory requirements by the Food and Drug Administration but impressive in its openness and perspective, highlighted the importance of these processes in identifying and avoiding errors or the presentation of biased information. Of related concern are results reported in a recent survey which demonstrated that “fewer than half of all clinical trials recently published in high-impact journals were adequately registered . . . and that one-third showed discrepancies between the registered primary outcome and the one that actually was reported.”1 According to this report “As of 2005 the International Committee of Medical Journal EdVol. 183, 9-10, January 2010 Printed in U.S.A. DOI:10.1016/j.juro.2009.10.056
www.jurology.com
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VIGILANCE, VIGILANCE, VIGILANCE
itors decided to require investigators to register their trials before enrolling participants in order to increase transparency in results” and “reduce the risk of selective reporting of outcomes.” This was intended “as a safeguard against publication bias.”1 Mathieu et al concluded that the less than majority adherence to this objective was a concern as this could allow other influences to affect the presentation of study outcomes. Of relevance to this may be the increasing emergence of ghostwriting (broadly defined as undisclosed authorship) as presented in a recent unpublished report by the editors of JAMA who found a “ghostwriting rate of 7.9% in JAMA, 7.6% in The Lancet, and nearly 11% in The New England Journal of Medicine.”2 The editors of JAMA suggest that when financed by industry, ghostwriting may effectively “turn scientific articles into marketing vehicles for their products.” The New York Times article further quotes Dr. Bruce Chabner, editor in chief of The Oncologist: “The problem of incomplete disclosure is particularly worrisome for opinion pieces like review articles, in which an author brings a personal perspective to a wide body of research . . . These articles are likely to influence (clinical sic) practice. It is critical that such articles represent the unbiased views of the authors, and not those of a ghostwriter or a drug’s sponsor.”2 He concludes that “The Oncologist plans to continue publishing clinical trials sponsored by drug companies . . . but (will sic) no longer accept opinion pieces that involve writers
with ties to companies that have a commercial interest in an article’s content.” A representative of the Pharmaceutical Research and Manufacturers of America was alleged to respond that “such measures could be detrimental because they could ‘chill research and chill support for research’.”2 The underlying recurrent theme of these issues seems to be the influence that financial support can have on the work we do in various roles as physicians, investigators, writers, editors, educators and administrative leaders. I do not wish to downplay the importance of such support. It is sorely needed and becomes even more significant in these times of increasing restrictions and decreasing financial resources. Nor is my purpose to criticize those who provide such support but may not understand the intensity with which we prize our integrity, and the ethical foundation and underpinnings of our profession. Rather, I write this note as a caution for all of us to maintain our vigilance in recognizing conflicting issues when meeting our responsibilities as professionals and resisting situations that may compromise our integrity as we seek to continue our contributions in an increasingly difficult time. I believe that such is the only way in which we can continue to have an effective voice in meeting the challenges that will undoubtedly continue to surface, and potentially influence our personal and professional behavior. Michael J. Droller Associate Editor
REFERENCES 1. Mathieu S, Boutron I, Moher D et al: Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009; 302: 977. 2. Singer N and Wilson D: “Medical Editors Push for Ghostwriting Crackdown.” New York Times, September 18, 2009. Available at http://www.nytimes.com/2009/09/ 18/business/18ghost.html?_r⫽1&ref⫽business. Accessed October 8, 2009.
Vigilance, Vigilance, Vigilance WE are living in increasingly difficult and uncertain times. The economic downturn has increased the variety of pressures we face in our personal and professional lives. Those pressures can influence what we do and how we relate to the standards to which we would generally aspire. Economic pressures have also affected the institutional context in which we work, undoubtedly compounding behavioral pressures and conceivably undermining certain values that we have developed through our careers. The charge to each of us is to remain vigilant in maintaining the probity and professionalism that are so integral to the fundamental values we share as physicians, investigators, educators, administrative leaders in our profession and role models in representing these ideals for the generations to come. In recent months I have observed or become involved in several examples of the challenges with which we are increasingly confronted. The rapidity of their emergence bespeaks the possibility that such issues are becoming more commonplace. Their common theme may be reflective in part of the economic pressures that have been placed on the processes of investigation, publication and education. Their potential of compromising these processes and their safeguards calls to a heightened level of vigilance to prevent this from happening. Some of these challenges have included 1) a letter from a major drug company acknowledging the inappropriate description in their published supplement of investigational studies and the recommendation of nonapproved potential uses of its product; 2) an article on the failure of investigators to register their clinical trials before enrolling participants, thereby compromising the objective to reduce the risk of selective reporting of outcomes;1 and 3) an article in the New York Times describing the results of an as yet unpublished study by the editors of JAMA on the incidence of industry sponsored ghostwriting and its potential influence in the presentation of research results.2 Publication of industry sponsored supplements in our peer reviewed journals provides revenues to the journals at a time when substantive decreases in 0022-5347/10/1831-0009/0 THE JOURNAL OF UROLOGY® Copyright © 2010 by AMERICAN UROLOGICAL ASSOCIATION
print advertising are having profound economic impact. These supplements generally comprise proceedings from industry sponsored symposia or contributions by those who have participated in studies in an area of interest to the sponsor. Although journal policies generally require that the proposals for these supplements be acceptable to their editorial boards, that the manuscripts be peer reviewed and that full disclosure of conflicts of interest be provided, inherent infrastructural conflicts and consequent biases may intrude in the review of a particular area and the presentation of a specific product. Publication of supplements can serve a valuable purpose in offering comprehensive information from a symposium or of the concepts and interpretations of those who have been active in the area being addressed. That such supplements can serve their sponsors in promoting a particular area should not be viewed as an intrinsic objection provided the review process, disclosures and safeguards are followed. However in fulfilling our responsibilities as investigators, authors, reviewers and editors, it behooves us to maintain strict vigilance in how we participate in presenting information for our colleagues and ultimately its interface with the public. As attested by the broadly distributed letter I received, the economic pressures to publish these supplements and any lapse in vigilance in the review process may result in publication of misleading information, incomplete data, investigator and author bias, and “lack of sufficient transparency.” This well written letter of apology, seemingly a response to regulatory requirements by the Food and Drug Administration but impressive in its openness and perspective, highlighted the importance of these processes in identifying and avoiding errors or the presentation of biased information. Of related concern are results reported in a recent survey which demonstrated that “fewer than half of all clinical trials recently published in high-impact journals were adequately registered . . . and that one-third showed discrepancies between the registered primary outcome and the one that actually was reported.”1 According to this report “As of 2005 the International Committee of Medical Journal EdVol. 183, 9-10, January 2010 Printed in U.S.A. DOI:10.1016/j.juro.2009.10.056
www.jurology.com
9
10
VIGILANCE, VIGILANCE, VIGILANCE
itors decided to require investigators to register their trials before enrolling participants in order to increase transparency in results” and “reduce the risk of selective reporting of outcomes.” This was intended “as a safeguard against publication bias.”1 Mathieu et al concluded that the less than majority adherence to this objective was a concern as this could allow other influences to affect the presentation of study outcomes. Of relevance to this may be the increasing emergence of ghostwriting (broadly defined as undisclosed authorship) as presented in a recent unpublished report by the editors of JAMA who found a “ghostwriting rate of 7.9% in JAMA, 7.6% in The Lancet, and nearly 11% in The New England Journal of Medicine.”2 The editors of JAMA suggest that when financed by industry, ghostwriting may effectively “turn scientific articles into marketing vehicles for their products.” The New York Times article further quotes Dr. Bruce Chabner, editor in chief of The Oncologist: “The problem of incomplete disclosure is particularly worrisome for opinion pieces like review articles, in which an author brings a personal perspective to a wide body of research . . . These articles are likely to influence (clinical sic) practice. It is critical that such articles represent the unbiased views of the authors, and not those of a ghostwriter or a drug’s sponsor.”2 He concludes that “The Oncologist plans to continue publishing clinical trials sponsored by drug companies . . . but (will sic) no longer accept opinion pieces that involve writers
with ties to companies that have a commercial interest in an article’s content.” A representative of the Pharmaceutical Research and Manufacturers of America was alleged to respond that “such measures could be detrimental because they could ‘chill research and chill support for research’.”2 The underlying recurrent theme of these issues seems to be the influence that financial support can have on the work we do in various roles as physicians, investigators, writers, editors, educators and administrative leaders. I do not wish to downplay the importance of such support. It is sorely needed and becomes even more significant in these times of increasing restrictions and decreasing financial resources. Nor is my purpose to criticize those who provide such support but may not understand the intensity with which we prize our integrity, and the ethical foundation and underpinnings of our profession. Rather, I write this note as a caution for all of us to maintain our vigilance in recognizing conflicting issues when meeting our responsibilities as professionals and resisting situations that may compromise our integrity as we seek to continue our contributions in an increasingly difficult time. I believe that such is the only way in which we can continue to have an effective voice in meeting the challenges that will undoubtedly continue to surface, and potentially influence our personal and professional behavior. Michael J. Droller Associate Editor
REFERENCES 1. Mathieu S, Boutron I, Moher D et al: Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009; 302: 977. 2. Singer N and Wilson D: “Medical Editors Push for Ghostwriting Crackdown.” New York Times, September 18, 2009. Available at http://www.nytimes.com/2009/09/ 18/business/18ghost.html?_r⫽1&ref⫽business. Accessed October 8, 2009.