By next year, the federal government will reinforce regulations that will allow consumers to look up their physicians in a database that will reveal whether they have received pharmaceutical company support and divulge the amounts dispensed. [See Neurology Today, “Industry Set to Disclose All Conflicts: How Will Patients and Their Neurologists React?,” http://bit.ly/GM1sdQ .] The transparency may increase the number of conversations that take place between physicians and patients about relationships with industry. Although disclosure is the most commonly applied solution to the conundrum of conflicts of interest, a Feb. 15 article in the Journal of the American Medical Association, “The Unintended Consequences of Conflict of Interest Disclosure,” suggests that, disclosure can actually have perverse effects, exacerbating bias and, in fact, harming those that it is designed to help.
Neurology Today turned to three AAN Ethics, Law and Humanities Committee (ELHC) chairs to ask about these unintended consequences and how well-meaning neurologists can avoid them in practice: James L. Bernat, MD, who served as ELHC Chair from 1993 to 2003 and is currently chair of the conflict of interest steering committee that oversees the ethics integrity process at Dartmouth-Hitchcock Medical Center where he is the Louis and Ruth Frank professor of neuroscience; Michael A. Williams, MD, chair of the ELHC from 2003 to 2009, who is the medical director of the Sandra and Malcolm Berman Brain & Spine Institute, Sinai Hospital in Baltimore where he serves on the ethics committee; and James A. Russell, DO, current ELHC vice chair who is clinical associate professor at Tufts Medical Center and the vice-chair of the department of neurology at the Lahey Clinic, where he is a member of the ethics section.
WHAT IS THE INTENDED GOAL OF DISCLOSURE AND HOW DOES IT APPLY TO NEUROLOGISTS?
James Bernat (JB): The intent of requiring disclosure is to prevent or mitigate conflicts of interest (COI) by making others aware of them. For example, if audience members at grand rounds are made aware of a speaker's COI, then they can use their discretion when they listen to believe or not believe the speaker. It also applies to academic publications, although the requirements are variable and highly selective, applicable in some cases, but not others. In academics, for example, when we submit an article for publication, we must go through a disclosure process, yet when I recently wrote a chapter for a textbook (Cecil's Textbook of Medicine chapter on coma and vegetative state) no disclosure was required.
IS DISCLOSURE IN AND OF ITSELF ENOUGH?
JB: Disclosure is a mitigating strategy that doesn't eliminate the conflict, but rather serves as a means to an end. It's important for people to understand that disclosure itself is necessary but not sufficient. If there is a conflict, merely to disclose it is inadequate, someone needs to review it to see if it does represent a conflict of interest and if so, to make a judgment. If someone giving a lecture is seriously conflicted, there needs to be oversight to determine if perhaps they should not give the lecture. At Dartmouth we are now requiring a mandated completion of an annual outside interest summary. If you are faculty, your department chairman reviews the conflict because he is best able to judge if an outside interest is a COI. It's unfortunate that we have to worry about these things, but we don't want to lose credibility; institutions need to have integrity and demonstrate that they are taking steps to enhance the responsibility of its members.
Michael Williams (MW): Professional societies are also part of that enforcement, as well as the creation of accountability, which is why it has been built into the ACCME [Accreditation Council for Continuing Medical Education] process and the AAN disclosure policies for educational and scientific presentations.
THE JAMA ARTICLE SUGGESTS THAT DISCLOSURE MAY LEAD TO MORAL LICENSING — THE UNCONSCIOUS FEELING THAT BIASED ADVICE IS JUSTIFIABLE BECAUSE THE PERSON HAS BEEN INFORMED — AND STRATEGIC EXAGGERATION — THE TENDENCY FOR PHYSICIANS TO PROVIDE MORE BIASED ADVICE TO COUNTERACT ANTICIPATED DISCOUNTING. HOW CAN WE AVOID THESE TENDENCIES?
MW: I don't think the mere act of disclosure invariably leads to either moral licensing or strategic exaggeration, but I do believe that we have not adequately asked professionals to match their conduct to the words in the disclosure. As with informed consent — in which there are many people for whom the goal is the signature on the document, rather than what it should be, the related conversation — we need to show with our conduct that we are earnestly trying to avoid bias, which is the goal of COI disclosure. Sadly, I've heard some speakers at CME or scientific events take this issue too lightly, for example, stating, “I have no conflicts of interest, but I wish I did,” or “I have so many conflicts of interest that they end up canceling each other out.”
In the realm of patient care, strategic exaggeration and moral licensing begin with the supposition that the physician is about to make a disclosure to the patient, which occurs infrequently. But let's assume that we tell patients that we have a relationship with industry that makes a device. What we do after the disclosure relates to the concept of a virtuous physician. The virtuous physician would say, “I have to determine if this device (which is the source of my COI) is the right device for this patient, and be willing to use another device if it isn't.” Practically speaking, however, physicians tend to use only one or two devices because it takes experience to use each one well (which can improve safety and outcomes), so the “apparent” bias of using only one or two preferred devices (or drugs) could just as easily be a reflection of a physician's comfort and expertise with the device or drug.
James Russell (JR): The lengths to which a physician goes to level the playing field, whether it is by strategic exaggeration, moral licensing or, say, miscoding, is just plain old deception and lying. Even if it was ethically permissible, I don't know how you can quantify it to maintain the equipoise between what the patient thinks you are doing and what you are actually doing. Historically, there was equilibrium between our fiduciary responsibility to our patients, balanced with the authority to do what's in their best interests. But because some people have been in the pockets of pharma, or have gone to dinner at Morton's on industry's dollar too many times, this authority has been eroded and the government has had to step in. Adhering to strategic exaggeration or moral licensing as a justification will only make matters worse. Joseph B. Martin, MD, PhD, wrote eloquently about this in his 2010 article in Neurology, “The Pervasive Influence of Conflicts of Interest.” The reason that there's so much intervention into the practice of medicine is because we've abdicated our responsibility and the trust that we historically had.
HOW DO YOU HANDLE YOUR OWN DISCLOSURE?
MW: When I teach or lecture, I tell the audience that I'm an ethicist, and that with disclosure I'm trying to minimize the potential for industry-related bias, and I ask for their feedback. In my area of hydrocephalus, I have to work with particular devices (shunts) in situations in which I have to name them by make and model, but I try not to exaggerate their benefits. I also try to point out that all shunts have strengths and weaknesses, and to provide best care, I can select from the array of devices available in the market today.
WHAT ARE SOME OF THE POSITIVE CONSEQUENCES OF DISCLOSURE?
JB: As the authors point out, disclosure may have the greatest benefit on the person doing the disclosing, as publicizing it may exert an inhibitory influence. Louis D. Brandeis, before he became a Supreme Court Justice, said, “Sunlight is said to be the best of disinfectants;” if you bring these relationships out into the open, that very act inhibits people from entering relationships that may cause them embarrassment. If a questionable industry relationship were to appear on the front page of the newspaper, for example, people would be inhibited from engaging in the act in the first place.
ARE THERE ANY ADDITIONAL CONSEQUENCES?
JB: One unintended consequence not mentioned in the JAMA article but which I've observed is that lengthy disclosure can put the audience of informees to sleep, creating “disclosure fatigue” and reducing its impact.
WE TRADITIONALLY THINK OF COI AS IT APPLIES TO INDUSTRY. ARE THERE OTHER SITUATIONS THAT SIMILARLY AFFECT NEUROLOGISTS?
JB: Physicians have to deal with COI on a daily basis because of the manner in which our medical practices are paid. Pre-paid HMOs or the impending accountable care organizations are structured so that physicians may pay more attention to the cost of services and savings rather than to patients, while at the other extreme, the fee-for-service structures create incentives that may lead to over-care and inefficiency.
DO YOU THINK THAT THE NEW SUNSHINE RULES MANDATING INDUSTRY DISCLOSURE IN DATABASES WILL IMPACT RELATIONSHIPS WITH INDUSTRY?
MW: I think that in most physician-patient interactions such a conversation about COI is unlikely to occur. It presupposes, first, that the patient will look me up in the database, second, that the patient will ask me about that information, and third, that what we decide to do will change as a result of this conversation. If the patient is like Diogenes looking for a physician without COI, the reality is that few physicians lack a COI. In 2012 industry makes the drugs and devices we use as physicians, so there is nearly always a third party that benefits from our choices and it's unrealistic to think that we can create a world without COI. Therefore, we must manage COI.
DO YOU DISAGREE WITH ANY OTHER ASPECTS OF THE JAMA ARTICLE?
MW: I thought that insinuation anxiety — the potential for a patient to worry that rejecting a suggested treatment would signal distrust — was a little far-fetched. You have to look at the individual circumstance to understand the true nature of the conflict. There is no way that one can eliminate the power differential between a physician and a patient. One can only try to mitigate it in good faith, for example, by making it comfortable for patients to get a second opinion if they have any concerns about bias or COI. Not all patients view COI as a bad situation for their physicians. I've heard patients talk in a positive manner about physicians with very strong associations with industry and who conduct research. One patient said, “I like that fact because it tells me my physician is trying to advance the science and the product.”
JR: Insinuation anxiety is a subtle form of coercion and erodes the informed consent process. It's hard to know the frequency with which it occurs, but I think it occurs in a lot of different walks in our lives. If you're involved in clinical research, patients may agree to participate in your trial because of fear that you will no longer treat them or continue to care for them if they refuse. What we'd really like to study is to what extent strategic exaggeration, moral licensing,and insinuation anxiety are intuitive to patients and at what frequency they occur in real life. Unfortunately, this is a challenging effort, because once you plant this very seed, your risk entering bias into the survey.