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Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA
Correspondence: Beverly Moy, M.D., M.P.H., Massachusetts General Hospital Cancer Center, Gillette Center for Women's Cancers, 55 Fruit Street, Lawrence House, LRH 304, Boston, Massachusetts 02114, USA. Telephone: 617-726-4920; Fax: 617-643-0589; e-mail: bmoy{at}partners.org
Received April 4, 2008; accepted for publication April 17, 2008.
Disclosure: B.M. has received honoraria from Genentech, GlaxoSmithKline, and Wyeth. No potential conflicts of interest were reported by the author.
The recent revelation of big tobacco funding a well-publicized study of computed tomography (CT) screening for lung cancer has stirred fresh controversy over financial conflicts of interest (COIs) in medical research. Dr. Claudia Henschke of Weill Cornell Medical College and colleagues reported in the October 2006 issue of the New England Journal of Medicine that annual spiral CT screening detected curable lung cancer in people at high risk for developing the disease [1]. This work was partly financed by the Foundation for Lung Cancer: Early Detection, Prevention, & Treatment. However, it was recently reported that this foundation was underwritten almost entirely by $3.6 million in grants from the Vector Group, the parent company of the Liggett Group, a major tobacco company. This incident serves as a catalyst to think more critically about financial COIs and why they are so relevant to health care professionals who read and interpret medical research.
The definition, interpretation, and management of financial COIs have become contentious issues in our profession [2, 3]. A financial COI arises when clinicians or researchers might benefit financially by distorting their work, regardless of whether they actually distort that work [4]. The circumstances of the research determine whether there is a COI, not the outcome of the research. This deontological view of COIs recognizes that researchers have a secondary interest that competes with their commitment to their primary interest, that is, the welfare of patients. Therefore, COIs require professional ethical examination.
The proper management of COIs is vital to the medical community because it justifies societal trust, promotes our integrity, and maintains our social contract with patients. Given the recent decline in societal trust of the medical profession and medical research [5, 6], it is especially vital that the medical community deals with these conflicts appropriately. One of the reasons that ethicists and policy makers have struggled with how to deal with COIs is because of the very basic problem of identifying when a conflict exists. To date, management of COIs has been based on rules or policies. The hope is that public trust is engendered by a medical research community that follows such rules. Most major medical journals ask that all "potential" conflicts be disclosed, including any that "could influence (or bias)" the published work [7]. Disclosure of potential conflicts informs the reader that the researchers may be swayed by their competing interests.
While disclosure is an essential element for helping to manage COIs, it is not the only remedy. The effectiveness of disclosure depends upon the public's awareness of the effect and extent of these relationships. Some have argued that disclosures would be made more meaningful to the public by designating levels or categories of involvement to determine if these relationships are major or minor [8].
If COIs are so problematic, why are these relationships not prohibited altogether? The reality is that industry funding is an integral part of the health care system by promoting patient welfare through research and product development. Industry's investments in discovery and research have benefited countless patients. Furthermore, academic researchers deal with shrinking federal grant dollars. Funding dollars for new grants awarded by the National Cancer Institute in 2007 decreased by $74,343,368 compared with 2005 [9]. Given today's funding climate, physicians rely more heavily on industry funding for their research. Major academic medical centers accept significant industry funding to support research and education [10]. Furthermore, academic investigators are expected and are entitled by law to patent their inventions, and thereby receive royalties. The majority of academic department chairs believe that relationships with industry have no effect on their professional activities and do not have a negative impact on a department's ability to conduct independent unbiased research [11].
The CT screening for lung cancer incident has stirred enormous controversy for many reasons. An overarching issue is that this incident represents a failure of full disclosure. The responsibility of full disclosure lies with the individual researchers, the university, and in part, the medical journals. The undisclosed financial relationship of big tobacco funding the lung cancer screening study has failed the "Wall Street Journal Test." In other words, an investigator must determine if he or she fails to disclose a financial relationship, would it be embarrassing if others discover it at a later date?
This incident also reveals the failure of the university to police their faculty members' COIs. In this case, the university not only failed to disclose the financial relationship but it also appears to have participated in the foundation that concealed the relationship. The private foundation established to accept the $3.6 million from big tobacco had the study's principal investigator, Dr. Henschke, as the foundation president and her coinvestigator, Dr. Yankelevitz, as its secretary-treasurer. What appears most inappropriate is that Dr. Antonio Gotto, dean of Weill Cornell, and Arthur J. Mahon, vice chairman of the university's board of overseers, were directors of the foundation. Mr. Mahon has stated that he did not know the original source of the funds before he agreed to serve on the foundation board [12]. However, it would seem not only prudent, but imperative, for university leadership to determine the original funding source of a multimillion dollar foundation prior to endorsing it. In this case, the participation of university leaders on the foundation board implies that the university was complicit in covering up the original tobacco funding, when instead it should have been policing the financial relationship.
Weill Cornell's failures reveal that the current system of voluntary disclosure of COIs is inadequate and that academic universities are currently not up to the task of policing their faculty members' financial relationships. It should be mandated that universities thoroughly analyze the funding sources and financial conflicts of their faculty members. This task includes detailing the major sources of funding to private foundations and recognizing potential conflicts. Previous work has shown that academic universities do not have consistent policies for managing financial COIs and only a few universities have made some minor efforts in reforming their relationships with industry [10, 11]. For example, several universities have started to eliminate gifts or staff lunches sponsored by industry. However, few universities have outlined concrete policies to deal with COIs. Incidents like the CT screening for lung cancer debacle underscore the pressing need for consistent, authoritative national standards spanning all American academic universities for managing COIs in medical research.
Additionally, medical journals need consistent policies for vetting the financial relationships of their studies' authors. Readers should not rely on the personal judgment of a journal's editors to determine the presence of a conflict. In a recent New England Journal of Medicine editorial about the lung cancer screening controversy, the editors expressed their surprise at learning the study's funding source and called for "transparency in reporting if a funding entity has a vested interest in the outcome" [13]. However, the editors did not indicate any policy changes regarding the management of COIs at the Journal. One solution could be the formation of a uniform independent national COI committee that is required to examine the funding of research studies and their authors' financial relationships before they are published in major medical journals. Given that universities and medical journals are currently ill-equipped to police COIs, an independent national COI committee, comprised of members without financial conflicts, could provide the authority and consistency for dealing with these financial relationships.
So how should COIs affect how we, as members of the public and as health care professionals, interpret medical research? Full disclosure is the minimum that we should demand from researchers. Full disclosure allows us to interpret many aspects of research, including the impetus for any given project, the environment in which results were interpreted, and whether the findings could be a subtle endorsement of a product. It is important to note that the mere presence of COIs should neither automatically taint a study's findings nor shame the investigators. However, we, as medical professionals, should demand consistent national policies to deal with COIs. Failure to address and manage financial relationships leads to the societal erosion of public trust and decreased integrity of the medical profession.
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