The Patient Was…

Conflicts of Interest, circumstances where one’s judgement or behavior in a particular instance are influenced by one’s personal interests, are virtually ubiquitous. They exist in almost every sphere of life, including business, economics, politics, law, family and personal relationships. They challenge objectivity, negate neutrality, and compromise fairness.

Some perceived Conflicts of Interest seem minor and relatively harmless. As I write this, a television news anchor in a mid-size market is being pilloried for accepting free tickets to a sporting event and concert. Although it is deemed a Conflict of Interest, I frankly don’t see the problem, although it apparently violates a corporate policy which is a separate issue.

Conflicts of Interest certainly exist in medicine and healthcare and can take several forms. They often have a monetary basis, although reputational considerations may also play a role in certain instances. They can lead to misinformation, unnecessary expenses, and even safety issues. Almost always, in my view, they are pernicious.

One example may take place in your doctor’s office and affect you directly. Let us say, as a scenario, that you have come to the office with a symptom or complaint that is not due to an obvious cause, such as a known injury. A careful and thorough medical history by your physician can likely make the correct diagnosis in about 75 percent of cases, according to studies that go back several years. The important words here are “careful and thorough.”  Sir William Osler, a Canadian physician and considered to be the Father of Modern Medicine said, “Listen to your patient, he is telling you the diagnosis.”

A similarly careful and thorough physical examination should be part of the initial encounter with the doctor. It will further improve the accuracy of diagnosis, but to a smaller degree than the initial history. But this process of history and physical examination are time-consuming. And time constraints are prominent in the current medical system. Time spent with a physician is generally not well compensated in today’s climate of healthcare. Current compensation systems favor testing and technology over face-to-face, personal interaction between patient and physician.

So, what often happens in the current environment is either a cursory initial history and physical exam, perhaps not even by the doctor, followed by a series of pre-planned tests, or a series of tests before the patient even sees the doctor. In other words, the testing is planned and set in motion no matter what the particulars of the patient’s complaint or symptoms may be. A colleague once answered my question of how he knew what tests a patient needed before he even met with them, by saying, “They all need every test.”

How is this a Conflict of Interest? Well, the system usually favors the interests of the doctor more than those of the patient. The physician spends less time with each patient, so more patients can be put through the system. Testing is financially compensated much better than time spent in personal interaction. Patients spend more money and time and may be quite inconvenienced by undergoing the prescribed “work-up.” The system is not necessarily patient-centric as it should be.

Another area of medicine where Conflicts of Interest may arise is in research. Here, conflicts can take several forms. One type of conflict can occur in the conduct of clinical trials, where doctors enroll patients in studies of drugs or technologies. Physicians, called Investigators, are paid for identifying and securing the participation of patients, and monitoring their progress in the studies. Sometimes, an investigator may enroll patients who do not meet the strict criteria established for patient participation, thereby jeopardizing the validity of the study results. An investigator may also submit falsified data on a patient who fails to keep up with medical visits necessary to the study, another way of invalidating study conclusions.

Study sponsors, those paying for the conduct of the study and with obvious vested interests in its outcome, have incentives to make the data look as favorable as possible. There are well-known instances in medical research where data and statistical analyses have been manipulated in efforts to make results look better and more robust. These are clearly conflicts of interest and create suspicion and distrust of the whole research industry and community.

Individual scientists, whose positions and reputations depend greatly on innovative research, have incentives to produce new and important findings in their fields. To maintain their status, some prominent individuals have submitted falsified information in published papers, the inaccuracies of which were discovered only years later.

Early in my career, I was involved in novel research in human subjects that was based on exciting data from animal studies. The results in the humans failed to confirm any of the animal results. The lead investigator of our study courageously challenged the researcher who had generated the animal data to redo the animal studies. That individual then confessed to having made up his results in order to establish his reputation.

Medicine, like many other areas in life, has its hierarchy of reputation and influence. At the bottom, perhaps, but to me the most important, are the physicians “in the trenches,” the practicing docs trying every day to care for sick and worried patients and families. Next up the ladder are academics, working in hospitals and medical centers, with academic positions and titles, teaching, maybe caring for some patients, and maybe doing some research. Further up on the scale are chairpersons of divisions and departments, usually full Professors, with academic and administrative responsibilities. Finally, at the top, a smaller but still substantial number of academic leaders at major institutions, usually with endowed Professorships, frequently with worldwide reputations.

These individuals are often encountered as speakers at major medical conferences around the world. They draw large audiences of physicians and others interested in what they have to say, including journalists and investment analysts. Their remarks can have significant influence not only on the science but on the economics of medicine. Almost all of these experts have financial relationships of one sort or another with numerous corporate entities. To avoid even the perception of a potential hidden Conflict of Interest, the universal rule at conferences is full disclosure of these relationships. The idea is not that financial relationships are inherently bad or improper, but rather that disclosure of such relationships allows the audience to figure that into their evaluation of your remarks.

The accepted means of displaying financial relationships with corporate entities, when giving an oral presentation at a medical meeting, is to display a slide listing those relationships at the beginning of the talk. While there is no universal guideline for how long that slide shall be displayed, commenters usually recommend between 10 and 30 seconds, depending upon how much information is listed. In my experience, I have never seen a disclosure slide displayed for more than a fleeting second. I think this is wrong; it trivializes the idea of disclosure and makes it somehow unseemly.

Another area of potential Conflicts of Interest in medicine, and one with enormous implications for public and individual health, relates to so-called Advisory Committees of the FDA (Food and Drug Administration). These are panels of experts chosen and convened by officials of the FDA, to provide independent, unbiased opinions on matters of efficacy and safety of new drugs and technologies. Experts with financial relationships that bear directly on the subjects of discussion should recuse themselves; this does not always happen. And FDA officials may, in some cases, value the relevant expertise over the perceived conflict of interest and recommend participation of an individual in the face of an obvious potential conflict of interest.

It stands to reason that experts in various fields should be the ones that companies engage with to study, support and promote their products. So, it is natural that experts will have financial relationships that represent potential conflicts of interest. Remember, a financial relationship does not necessarily mean that someone will not give a true and unbiased opinion; it simply raises the possibility of an influenced, shaded or nuanced view of a given subject.

One idea that I would like to see implemented, as a test in a few instances, is to run parallel Advisory Committees, one composed of the usual experts, virtually all of whom will have financial relationships, and the other composed of other experts without such relationships. These other experts will likely be younger, less recognized individuals, who have not yet come to the attention of most corporations. But I assure you they exist because I have met, seen, and heard them at major medical institutions. They are extremely knowledgeable and they are uncompromised. If the two Advisory Committees come to similar conclusions, then perceived Conflicts of Interest can be dismissed. If the two Advisory Committees come to different conclusions, then a problem may exist that requires resolution.

Conflicts of Interest exist at many levels of medicine. Some seem unavoidable within the present system of delivering and paying for health care. But some, with major impacts on public and personal health, can be mitigated. These deserve our attention.