Leave Your Sidearms Not Your Ethics at the Door

I have recently returned from a series of medical meetings. Some were specialty oriented, whereas others were technology oriented, and one was public policy and socioeconomically oriented. Each of them offered continuing medical education (CME) credits for all or a portion of the meeting. All of them included a commercial exhibit that was, of course, separated from the meeting itself, but in near proximity. The speakers and authors made verbal disclosures at the beginning of each presentation in sessions where CME credits would be granted, and devices and pharmaceuticals were accompanied by labeling. This brings me to the main point of this article, which is the extent to which the current system of disclosures provides for balanced and ethical professional conduct.

Disclosures are a routine part of our daily professional lives. Consider the informed consent process. The physician explains the details of a particular treatment or procedure and explains the risks, benefits, and alternatives. This discussion is supposed to be conducted using clear language at a level that can be understood by the patient. The process is supposed to allow for a dialogue between the clinician and the patient. Its content is supposed to be presented in an unbiased fashion and should be free from undue enticements that would sway someone to take inordinate risks.

Our professional educational system and the scientific literature also routinely incorporate disclosures of perceived or potential conflicts of interest (COI). All CME programs are required to adhere to the guidelines and regulations of the Accreditation Council for Continuing Medical Education (ACCME). ¹ These regulations are comprehensive and include provisions intended to keep industry and commercial support at arm's length from educational content. ¹ All persons who are in a position to control educational content are required to disclose all COI information. This requirement applies to all levels of an educational program from inception to the presentation itself.

A similar process of disclosure exists in the realm of the professional and scientific literature. Authors are asked to disclose sources of funding and equipment and are asked to provide a listing of corporate ties and other relevant affiliations. Editors send the submitted manuscripts to referees and reviewers, who are also asked whether they have any conflict of interest relative to their ability to provide a fair and unbiased review of the submission. Such processes are in place for this Journal (see http://mc.manuscriptcentral.com/photomedicine).

The boardroom of the professional society, insurance provider, and not-for-profit organization must also comply with disclosure rules. These include publication of the potential conflicts for each of the members of the board, active oversight by a designated officer or official charged with assuring that individuals with significant COI are excused or recused from voting, or, in some cases, discussing or voting on issues when a real or perceived conflict exists. Both the government and our legal system are also supposed to function under similar provisions. Some would argue that such provisions are too extensive, whereas others would posit that the rules are too lax, depending upon the particular agency or issue being considered.

There is little doubt that well-intentioned disclosure rules exist in many facets of our professional lives and in society itself. Arguably, they are intended to provide for a more level playing field and to better assure that no one entity or interest has an unfair advantage. They remind me of the scenes in the classic Western movie wherein there's been some deadly barroom brawl or clash between good and evil, juxtaposed with a courtroom or town hall scene where all are asked to leave their weapons on a table outside the door. The purpose is obvious to the viewer. Heated, impassioned, and “more civilized” discussion can take place without the fear for bodily harm. At least in theory, all are equal in the proverbial war of words.

Let us now consider some scenarios inspired by recent meetings and events. Doctors Lemon and Grey have had their abstracts selected for presentation at a major meeting. Dr. Lemon discloses that he is the Chief Medical Officer for Medusa, Inc. and that he will report on a randomized controlled trial (RCT) conducted using the Wonderlux laser system that Medusa manufactures and markets under an FDA 510k clearance. He presents numeric data with statistics that document that the device achieves fantastic cosmetic results. Pre- and post- treatment photographs are shown. However, the astute observer notes that the viewing angles and illumination of the subjects are different, exaggerating the effect. Dr. Grey also presents clinical information and states that he purchased the Wonderlux devices used in his study and therefore he has no conflict of interest. Again, the study extols the virtues of the technology and provides numeric data. Pre- and post-operative photographs are shown. The post-operative images are taken at a greater distance from the lens and the subjects appear to have different positioning in the “before” and “after” images. Both Dr. Lemon and Dr. Grey made disclosures that were appropriate. However, how would you assess their presentations? Was the information presented in an unbiased fashion, or were the presentations designed to unfairly exaggerate the benefits of Wonderlux? Were they ethical in making their presentations as described? Does it matter that Dr. Lemon works for Medusa, Inc. whereas Dr. Grey purchased his own equipment at fair market value for use in his surgicenter? Would your answer be different if you heard 20 other presentations at the same meeting and observed similar image manipulations being used to discuss other clinical topics?

Suppose you are the editor of the Journal of Enlightened Science. Dr. Subtilis submits a manuscript to the journal which is an RCT comparing age-peel to moxibustion and massage for wrinkle reduction. Dr. Subtilis purchased the age-peel device and states this in her disclosures at submission. She doesn't disclose that she is on the medical advisory board of Sensona, Inc. which is a company that markets devices that remove wrinkles with magnetic fields. The paper presents negative results, apparently demonstrating the superiority of moxibustion and massage. You send the manuscript to three reviewers. None indicate that they have a conflict. However, after the paper is accepted you learn that one reviewer owns a Sensona device and another has intellectual property on a device under development that would also remove wrinkles. How would you rate the manuscript and its review? Was the process unbiased? Were there breaches of professional ethics? Should Dr. Subtilis have disclosed the fact that she is on the board of a company that produces a competing technology even though the paper did not include that technology per se? What about the two reviewers? Did they have a significant COI and should they have declined the invitation to review the manuscript? Would you publish an editorial or an erratum once you learned this information?

Thus far, we have considered medical examples. Suppose you are a resident of New Tithe State. The state is facing a major budget shortfall as a result of economic recession, a long history of expensive entitlement programs and an egress of businesses because of the high taxes they would face. Governor Watt proposes sweeping budget change, which cuts some services and would place a cap on malpractice settlements for pain and suffering. The budget passes only after compromise is achieved with the speaker of the house, and the approved budget no longer contains the malpractice reform provisions. The speaker of the house Mr. Plumb is a well-known attorney who is a member of counsel for the personal injury law firm of Black and Cayman. Do you believe that Mr. Plumb should have recused himself from discussions about the malpractice provisions in the budget, or do you think that he could consider all sides of the question in a fair and unbiased manner?

The foregoing are real world examples that I have fictionalized in order to present them to you for your consideration. Each case demonstrates situations in which conflicts of interest existed. Disclosure was provided in some instances, but in others it was either not required or the involved parties skirted the issue. These behaviors should not be condoned. Each attempt to misrepresent or mislead carries real consequences with it. The discovery of such unprofessional behaviors and their resultant negative publicity only serves to discredit the work of countless others who maintain high standards and behave in a professional and ethical manner.

Each time we enter a professional venue or provide material to the peer-reviewed scientific literature, our responsible and thorough disclosure of potential COI are analogous to leaving our sidearms at the door. However, it is our duty not to leave our ethics behind as well.