BERNAT, JAMES L. MD
It seems that nearly every month, the popular press reports a new scandal of a physician with an undisclosed financial conflict of interest. Many cases involve leading academic physicians and researchers with undisclosed financial ties to pharmaceutical companies or medical device manufacturing companies, who have published research favorable to the company product or who have been influential peer opinion leaders. The stories usually point out that failure to disclose the conflict violated their own institutional policies and imply that it was a shady relationship. The physicians named have been publicly humiliated and some have been demoted or dismissed. Why is failure to disclose a potential financial conflict a problem and what constitutes adequate disclosure?
A conflict of interest occurs when professional judgment concerning a primary interest, such as patient welfare or research validity, is unduly influenced by a secondary interest such as financial gain. The presence of such a conflict signals unreliability in the professional's competent discharge of responsibility and results in a loss of confidence in the professional by the people served by that authority.
Conflicts of interest exist before there is any actual breach of trust. The appearance of a conflict can be just as damaging as a true conflict if it leads others to conclude that the professional treats the secondary interest above the primary interest. Most serious conflicts of interest result from a financial relationship that inappropriately influences professional decision-making.
AVOIDANCE, DISCLOSURE, AND REGULATION
Figure. DR. JAMES L....Image Tools
Three strategies can remedy conflicts of interest: avoidance, disclosure, and regulation. Relying solely on physicians' judgment to identify and avoid conflicts is inadequate given the complexity and pervasiveness of the financial relationships of contemporary physicians, and the psychological mechanisms that blunt an individual's insight into the conflict.
Disclosure does not eliminate the conflict but mitigates it by producing public awareness and stimulating prevention. By making others aware of the conflict, it allows peers and the public to exercise an appropriate degree of skepticism about the judgments and pronouncements of the conflicted physician. It also discourages the development of serious conflicts that, if they became widely known, would embarrass the physician. US Supreme Court justice Louis Brandeis famously expressed the preventive value of public disclosure of conflicted relationships when he wrote: “Sunlight is the best disinfectant.”
Regulation of conflicts has become necessary because avoidance and disclosure do not adequately solve the problem. Internal regulation is preferable to external regulation. Professional societies, medical centers, and universities should draft regulations that are appropriate to govern their members to prevent governmental agencies from drafting more clumsy or intrusive regulations. Most of these organizations have done so.
In 2008, the AAN revised its policy on member conflicts of interest, which had been first published in 1997. See www.aan.com/globals/axon/assets/3969.pdf. The AAN policy provides definitions, disclosure requirements, the process for administrative review of disclosures, and the disclosure form. The policy applies to members who are serving the AAN as an officer, committee member, teacher, author, consultant, or other position of responsibility or leadership. It does not apply to AAN members who do not serve in any of these roles because their financial relationships do not directly affect the AAN.
In the past few years, the degree and format of conflict disclosure has evolved in the direction of greater specificity and publicity. Many universities and some medical specialty societies now require detailed financial disclosure statements including the dollar amounts of revenue. Some of these rules have been written in response to highly publicized examples of physicians receiving millions of dollars from pharmaceutical and medical equipment manufacturing companies.
In one case recently brought to light by Senator Charles E. Grassley (R- Iowa), Thomas Zdeblick, MD, a spine researcher from the University of Wisconsin, was reported to have received $19 million in royalty and consulting payments from Medtronic Inc. from 2003 to 2007. In his annual financial disclosure forms at the University of Wisconsin, the investigator indicated he received “more than $20,000” in compliance with the university's requirements at the time.
When the matter was publicized by Sen. Grassley, Robert N. Golden, MD, the dean of the University of Wisconsin School of Medicine and Public Health, reportedly stated that their financial disclosure requirement was “indefensible” and “doesn't provide enough information for people to make good sense of it.” In addition to the University of Wisconsin's plans to require greater financial detail in their disclosure forms, the North American Spine Society now requires researchers who present studies at their meetings to disclose the dollar amounts of their ties to medical device companies.
ACCESS TO DISCLOSURE STATEMENTS
Disclosure statements provide effective “sunlight” only when those who need to see them have access to them, a situation that cannot occur if they reside in a file cabinet or a computer hard drive.
Some academic institutions have responded to the need for public access to disclosure statements by creating Web sites that include data of faculty financial relationships. For example, in December 2008, the Cleveland Clinic began disclosing on its Web site, www.clevelandclinic.org, the industry business relationships of its physicians and other researchers. To some extent, this public disclosure was initiated in response to earlier negative publicity about industry financial links of its faculty that had been hidden from public view. The current Web site data do not include payment amounts or industry sponsorship of research but these data may be added later. The Duke Clinical Research Institute has begun a similar public disclosure Web site: www.dcri.org/research/coi.jsp.
In parallel with these local regulatory developments, state and federal governmental agencies are writing disclosure regulations and creating Web sites for online data display. Minnesota and Vermont, for example, now list payments to physicians from pharmaceutical companies on their state Web sites. A federal bill, the Physicians Payment Sunshine Act, is pending in Congress. If enacted, it will create a searchable national database listing gifts and other financial support to physicians from pharmaceutical companies and medical device manufacturers.
The use of online databases to achieve the goal of public transparency is laudable but it introduces a series of technical problems. The data must be current, accurate, and understandable to the public, and they must clearly distinguish industry support for research from payments for consultants, lectures, and marketing. If each institution created its own Web site, the local definitions, categories, and threshold income amounts undoubtedly would differ, further confounding public understanding. If online databases published inaccurate or misleading information, they could create more trouble than they prevent. Some researchers have called for a single searchable national database to address these concerns.
It is ironic that physicians' full disclosure of financial relationships is being driven by bad publicity and resulting increased regulation rather than because it is the ethically correct course of action. Nevertheless, because transparency is necessary for sunlight to disinfect, an online reporting system of physicians' financial ties to industry probably provides the best mechanism to achieve public access. The optimal solution to achieve accurate, clear, accessible, and publicly understandable information is with a carefully designed national searchable database in which data are entered by each physician and researcher, that are reviewed by local administrators, and that can serve medical societies, medical centers, universities, and research institutes.