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Editorials |
1 From the Department of Radiology, University of Arizona College of Medicine, 1501 N Campbell Ave, Room 1363, Tucson, AZ 85718. Received November 4, 2005; final version accepted November 7. Address correspondence to the author (e-mail: Becker{at}rsna.org).
A recent New York Times article by Abelson (1) characterized the relationships between medical device companies across the United States and the nation's physicians who implant such devices as insidious, dangerous to at least some patients, expensive for hospitals and society, and an integral part of a broken system that will soon self-destruct. The author quoted Paul Ginsberg, president of the Washington research group Center for Health System Change, as saying, "We're paying for it, but no one can see it." The article describes how companies carefully nurture relationships with physician-investigators and physician-consultants, build enormous influence over hospital purchasing and pricing, and occupy a privileged place in the health care economy that is "below the radar screen" and not subject to ordinary checks and balances.
Abelson highlighted several cases. One involved a university orthopedic surgeon whose contracts with a device company for consultation ($75 000 per year) and royalties ($100 000 per year) required that he promote the company's products and educate other surgeons about these products. An investigation revealed that the surgeon, whose academic position included teaching trainees and making decisions about specific implants to be used in patients, had completely switched to the company's products after his lucrative contracts were in place. All of this occurred without disclosure by the surgeon of the financial relationship. Not surprisingly, he was fined for violating the state ethics code.
In another example, an Ohio surgeon with close financial ties to a company he cofounded was conducting research on the company's devices as part of his more than 1200 orthopedic implants per year. During a contract negotiation between the device distributor and the hospital, the company issued an ultimatum that the hospital pay 35% more for the devices or agree to a lucrative service contract with the company. The hospital filed suit and the case was settled.
To be clear, the issues raised by Abelson are not unique to orthopedic surgery. In his article, Abelson also points to problems in the cardiovascular device industry. Radiology, too, is not immune, and the issues are the same. Financial interests can and do create biases that affect preclinical and clinical research, graduate medical training, clinical decision making, postgraduate education programs and courses, publications, and the budgets of health care institutions and the nation.
But the matter is not always straightforward. Much good is also derived from research by physician-investigators, including those with a financial interest in the research they perform. The president of the American Academy of Orthopedic Surgeons asserts that much of the innovation that benefits patients can occur only through close relationships between physicians and industry. Though few will doubt the validity of his assertion, we collectively remain uneasy and want safeguards against the potential deleterious effects of financially conflicted clinician-investigators and even nonphysician-researchers. If financial conflict cannot be prevented (and indeed it cannot), then it must at least be managed.
From a purely legal perspective, the physician has a fiduciary responsibility to his or her patients. Likewise, the investigator also has a responsibility to his or her research subjects. But when the physician is also the researcher (clinical investigator), he or she can be conflicted when trying to reconcile the scientific goals and responsibilities of research with those of patient care (2). While we recognize this legal problem, it is not the conflicting legal responsibilities that trouble us the most. Rather, we find the moral, ethical, scientific, and medical issues much more troubling and compelling. Deleterious consequences may result when the investigator succumbs to a form of cognitive dissonance and conflates the language of medical care with that of research (2). Results may include an undermined informed consent process, biased conduct of research, biased interpretation and reporting of results, and unethical or substandard clinical care of patients and subjects.
To avoid such undesirable research outcomes, clinician-investigators must constantly seek a difficult-to-achieve balance that is often referred to as clinical equipoise. All this they must do even in the absence of a real or perceived financial conflict. Clearly, financial interest superimposes yet another layer of complexity on an already difficult situation. Morin and colleagues (2) remind us that fiduciary principles require physicians to always place the interests of their patients above their own. They suggest seven guidelines or preconditions for physicians to perform research: (a) limit research to one's own area of expertise, (b) participate only in research that is ethical, conforms to government regulations, and is approved by an institutional review board, (c) ensure that the informed consent process differentiates between the physician's roles as clinician and investigator, (d) ensure that any financial compensation is commensurate with the efforts of the physician performing the research, does not vary according to enrollment, and conforms to legal requirements, (e) ensure that protocols include provisions for funding the patients' medical care in the event of complications and that uncertainty is clearly communicated, (f) clearly and completely disclose the nature and source of funding and financial incentives, and (g) ensure that research contracts do not impose restrictions or delays on the publication process.
Concern over commercial influence and financial conflict has prompted action by the federal government (3). The U.S. government must ensure that federally funded research is ethical; that it is conducted by investigators who have no financial interest or whose financial interests have been managed satisfactorily, with full disclosure to patients and subjects; and that it is unbiased. The government also must ensure that investigators participating in and reporting on the results of industry-sponsored studies that are used to support applications for U.S. Food and Drug Administration (FDA) approval of medical products and devices are free of financial conflict.
For several years, even when awareness of the potential for financial conflict was high, there were substantial differences between the rules imposed by the National Institutes of Health on its funded investigators and institutions and those imposed by the FDA on companies and their investigators. Finally, in May of 2004, the Office for Human Research Protections published a document titled, "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection" (3). This document provides guidance for both National Institutes of Health–supported research (45 CFR 
46, the Common Rule) and FDA-regulated research (21 CFR 50 and 56) and replaces previous guidance documents. As a point of reference, the Public Health Service threshold for substantial financial interest is $10 000 per year income or equity interests of more than $10 000 and 5% ownership in a company (42 CFR 50.603 and 45 CFR 94.3). The regulations provide examples of methods for managing investigators' financial conflicts of interest (42 CFR 50.605[a] and 54 CFR 94.5[a]) that are beyond the scope of this article.
The Accreditation Council for Continuing Medical Education (ACCME) is responsible for ensuring freedom from commercial influence in postgraduate educational programs for physicians. In late 2004, the ACCME unveiled its new standards for commercial support, which were later implemented in May of 2005 (4). They include existing standards and contain a series of new requirements for continuing medical education (CME) providers that are not included in earlier versions. The preamble makes it clear that commercial support has "enhanced the ability of the CME enterprise to fulfill its purpose." However, it clearly warns of the potential threat of commercial bias to the integrity of the entire enterprise. The new rules (a) require the CME provider to ensure that the selection of all speakers and organizations in a position to control program content is done in a manner completely free of commercial bias, (b) forbid commercial entities from assuming the role of nonaccredited partner in a joint-sponsor relationship, (c) mandate full disclosure of conflicts of interest by all individuals who are in a position to control program content, (d) require individuals who refuse to disclose substantial financial relationships in advance of the program to be disqualified from the program, and (e) require the CME provider to implement a mechanism to identify and resolve all conflicts of interest prior to the CME activity.
With this background on financial interests and financial conflict, we turn now to the thought-provoking study by Brown et al (5) in this issue of Radiology. The article calls our attention to the little known and perhaps even previously unexplored potential effect of financial interests—that is, their association with research paper presentations discussing off-label (non–FDA-approved) use of devices and products. To probe for such an association, the authors retrospectively classified the financial relationships of presenters at the 2003 Radiological Society of North America (RSNA) Annual Meeting and then attempted to correlate these relationships with presentations on non–FDA-approved use of products and/or devices. Overall, financial ties were found in 271 (17%) of 1549 RSNA presentations in 2003. The most common financial ties were employee (39%), corporate grant recipient (34%), consultant (23%), and shareholder (18%). Presenters with financial ties were twice as likely (87 [32%] of 271 abstracts) as those without financial ties (197 [15%] 1278 abstracts) to report on non–FDA-approved uses of products (P < .001).
The authors provide a thorough discussion of the topic, after which they conclude that corporate relationships may influence radiology research. They correctly point out that their study is consistent with the concerns of other authors that financial ties may influence selection of research topics. Still, they are quick to admit that their study design does not permit us to conclude that financial incentives led investigators to perform research involving non–FDA-approved use of devices and products. Indeed, it is possible that the results may be partially explained by a propensity on the part of investigators interested in non–FDA-approved uses of products to seek industry funding. Industry may gravitate to investigators working in such areas. Detailed future surveys about incentives will be needed to ascertain why non–FDA-approved topics were selected for research. In another interpretation of the study findings, industry may be employing deliberate steps to reward individual investigators, to exert influence at and beyond academic and health care institutions, and to knowingly augment product revenues through sales that are aimed directly at off-label use.
One source of uncertainty in the study by Brown et al is the inability to verify the completeness or accuracy of the disclosures by the presenters. A known source of inaccuracy in the study, owing to underreporting, is that the only data source was the 2003 Radiological Society of North America Scientific Assembly and Annual Meeting Program. Therefore, the study does not include any late verbal disclosures that were made at the actual time of presentation. The latter will not be a problem in future studies because, according to the new ACCME standards, full financial disclosure is required for every presenter in advance of the date of presentation. Regardless of the shortcomings of the study, the striking results demand our attention, especially because industry funding is known to compromise objectivity and impartiality of discussion at educational symposia (6).
A suggestion for authors and/or other investigators with an interest in this topic is that they conduct an in-depth probe of the association between financial interest and studies on the off-label use of products and devices. We need to understand cause and effect, and we should examine and report the nature of the study results. Are radiology investigators with financial ties who are conducting studies on off-label uses of devices more likely to report positive results than those whose studies do not involve off-label uses? If positive results prove disproportionately high in the former group, perhaps we will have unearthed new evidence of bias in the planning, conduct, interpretation, and/or reporting of non–FDA-approved radiology research. Blumenthal et al (7) have shown a significant association between the level of industrial research support of academic faculty and the frequency of commercial outcomes.
Medical societies and journal editors must also adhere to strict policies on disclosure of financial interests. The RSNA is updating its annual meeting financial disclosure policies to comply with the new ACCME standards. Radiology (8) and RadioGraphics (9) have financial disclosure policies that are published regularly in each respective journal. The publication information for authors in each journal describes the author's responsibility to disclose financial relationships. The Radiology policy elaborates on this responsibility and provides details of the editor's authority to, at his discretion, share the information with the reviewers and/or readership.
Interestingly, because of their financial disclosure requirements, these journals may provide another data source for study of the association between non–FDA-approved device investigations and financial ties to industry. Brown and colleagues have opened a new avenue of investigation into factors influencing the conduct and outcomes of radiology research that involves investigator financial ties with industry. We should explore it to the fullest.
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