I was struck by an article in The Wall Street Journal announcing that the Journal of Thoracic and Cardiovascular Surgery had prohibited some authors from publishing in it because they did not fully disclose their affiliations with the companies that produced the products they discussed in their submitted and accepted manuscripts.1 With all the pharmaceutical indiscretions that have made headlines over the past few years—and the liability issues surrounding them—I suppose I have become somewhat numb to the fact that not all published articles about the drugs we prescribe are as forthcoming as we would like to believe they are—and that authors may have certain biases stemming from their association with a particular pharmaceutical company. I work in cardiovascular and thoracic surgery, so two things made this Wall Street Journal article different: the institution where the authors worked is a major force in cardiac surgery, and the authors are well respected within the field. In fact, quoting their statistics and following what they are doing have become part of my practice.
It has not been a blind commitment. As a professional, I have come to understand the implications of having an artificial heart valve identified with the prominent physician who developed it and the company that makes it. I also know that when multiple products are available and each produces reliable results in a given surgeon's hands, the price break is often what allows a particular product to end up on the operating room shelf. These nuances in interpreting research associated with financial support from a manufacturer are integrated into my learning experience, just as understanding P values is incorporated into my professional skills. The difference in this instance was that the financial associations were not revealed when the information was published. Given the institution and surgeons involved, I might assume that the study results were not tainted by the financial association between the product manufacturer and the hospital or surgeons. But had I known of such an association, I also might have confirmed the data by reviewing other sources.
Conflict of interest comes in many forms
Medical professionals assume that authors will disclose financial and consulting relationships that might have a bearing on the conclusions of their research, but the general public does not. As the general media report more and more on the studies appearing in major medical journals, the public is exposed to a good deal of information that most people do not have the background to interpret. In an age when patients are encouraged to take more responsibility for their health, the publication of manuscripts that are not accompanied by adequate disclosures has the potential, eventually, to undermine the relationship between the public and the medical profession. Of course, I am also concerned with the confidence that PAs can have in the information published in JAAPA.
The International Committee of Medical Journal Editors (ICMJE) has devoted much effort to developing procedures for proper disclosure.2 All the medical journals with which I am familiar, including this one, support the ICMJE policy recommendations. These policies, or policies derived from them, are stated in the author guidelines for each journal.
The ICMJE recognizes that conflicts of interest for authors can develop from financial relationships, personal relationships, academic competition, and intellectual passions. Some of these conflicts, obviously, are easier to define than others, and a good deal of responsibility is placed on editors to understand and act responsibly concerning each of them. However, it is not just authors who undergo such ethical scrutiny. Editors themselves must be able to act independently of owner/advertiser interests in order to ensure the uncompromised publication of information. Even with peer-reviewed literature, vigilance is needed concerning potential conflicts between those reviewing the manuscripts and the authors, supporting institutions, and funding sources. The problem is sorting out which conflicts are significant.
The big financial interests are obvious and include funding sources for research, paid speaking engagements, stock options, and the like. Successful researchers and authors often look upon remuneration simply as appropriate compensation for difficult work. Some influences are more insidious, however, such as when the research design is determined by those who are funding it, or when manuscripts are produced by ghostwriters and then noteworthy researchers are asked to lend their names to these ghostwritten manuscripts as authors.3
The funding source cannot always be considered the major conflict. After all, each of us needs to get paid for the work we do. Even nonprofit research organizations rely on their successes to encourage future funding. But trying to be the first or the best does have the potential to produce conflicts of interest for an individual researcher or between researchers. The competition among faculty members to produce research as a means of institutional and personal advancement cannot be dismissed as insignificant. The debacle over stem cell research in South Korea is an unfortunate example.4 And in the past, researchers have clashed in their efforts to advance medicine while possibly being subconsciously aware of the personal future benefits. Consider the proposals for polio vaccines offered by Drs. Salk and Sabin.5 A successful vaccine would no doubt lead to international fame and future research possibilities. Though Dr. Salk did not patent his research to ensure that all could reap the benefits, we need only call the Salk Institute to mind to realize the importance of that original work to future research by him and his colleagues.
Why disclosure is still the best way
These are examples of conflicts of interest that actually exist, and they are related, one way or the other, to financial incentives. Whether each of these conflicts of interest is significant is debatable. Indeed, in a commentary, the editor of The Lancet argued that disclosure policies are based on three fallacies: that scientific writing can be free from common prejudices; that financial conflicts of interest are of greater concern than academic, personal, and political rivalries and beliefs; and that disclosure can “heal the wound inflicted by financial conflict.”6 Most arguments nevertheless favor disclosure—a position adopted by the American Medical Association, which determined that “the best mechanism available to assuage public (and professional) doubts about the propriety of a research arrangement is full disclosure” and that such disclosure “should be made to the journals that publish the results of the research.”7 The rationale for disclosure is that it provides additional information that helps readers evaluate the quality and validity of the research.
I do not believe that physicians or PAs involved in meaningful, peer- reviewed research or authorship purposefully try to mislead others about their results. That would be akin to purposefully doing harm to patients. I do believe that practitioners involved in the development of a new procedure, technique, or treatment are honestly committed to that process and know that it works in their hands. Medicine has a proud heritage of research and innovation. It is one of the few professions that have historically published what went wrong as well as what went right. Medical professionals have always pushed the envelope in seeking cures and treatments. Dr. Salk said, “Risks, I like to say, always pay off. You learn what to do, or what not to do.”5
In today's society, however, winning often seems to be all that matters. No one is rewarded for taking the risk and failing. We often resort to casting our work in a positive light, no matter how false that light might be. Indeed, the prospect of liability and the confusion that often exists over what is a complication and what is malpractice have further compounded the issue.
Sometimes, the procedure or treatment we have developed and studied does not work. When this is the case, we must say so—and we must reestablish the necessity and the value of providing that information. We must be willing to admit to ourselves and to disclose to others any potential conflicts we may have. We must be vigilant in recognizing potential conflicts in the data we review and rely on. Only then can we regain the public's respect and trust.
Note: The author received an honorarium for writing this article (as do all JAAPA authors). He wrote the article himself, after which it was reviewed by colleagues and edited by the Journal staff. The author recognizes that his is not the only opinion on this subject. He also admits that his interest in this subject is strongly associated with his interest in this journal.
REFERENCES
1. Armstrong D. Surgery journal threatens ban for authors' hidden conflicts. The Wall Street Journal, December 28, 2005;B1.
2. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Updated February 2006. Available at: http://www.icmje.org/. Accessed May 25, 2006.
3. Mathews AW. At medical journals, paid writers play big role. December 13, 2005. Postgazette.com, a service of the Pittsburgh Post-Gazette. Available at: http://www.postgazette.com/pg/05347/621668-114.stm. Accessed May 25, 2006.
4. Panel says stem cell work faked. CNN.com. Available at: http://edition.cnn.com/2005/HEALTH/12/23/skorea.stemcell/index.html. Accessed May 25, 2006.
5. Jonas Salk, MD. Academy of Achievement. Available at: http://www.achievement.org/autodoc/page/sal0pro-1. Accessed May 25. 2006.
6. Horton R. Conflicts of interest in clinical research: opprobrium or obsession? [commentary]. Lancet. 1997;349:1112-1113.
7. Council on Scientific Affairs and Council on Ethical and Judicial Affairs. Conflicts of interest in medical center/industry research relationships. JAMA. 1990;263:2790-2793.