Conflicts of Interest are real, and they are tainting our conferences and journals. We need to move beyond the simple declaration of conflicts to an era of critical conflict resolution.
Many medical providers look at conflicts of interest (COI) as murky situations that other, less scrupulous physicians get themselves into. But unless you practice medicine in a cave, you’ve probably experienced some degree of conflict in your professional life. It is unrealistic to think that one aspect of your career will never collide with another. The complexity of our lives makes it nearly inevitable. All too often, serious issues with identifying, disclosing and resolving conflicts arise. The key to beginning to untangle this web is to see that we physicians are actually at the center of the problem. We need to stop pointing fingers at others and start evaluating our own positions and undue influences.
Next, we need to avoid labeling those with potential conflicts as “bad people.” The current culture in medicine is to wear the scarlet COI of shame on your lapel once you have been labeled “conflicted” and tainted. Thus, we are often reluctant to disclose potential conflicts and suggest that others should disclose potential conflicts. This fear-based system promotes silence, rather than disclosure.
Disclosure of COIs are valuable for making certain that expressed opinions are void from financial influence. Whether deliberating an issue at a meeting, conducting research or publishing a clinical guideline, ensuring integrity of the process and final work product is critical to reaching the right conclusions. Despite the best of intentions, even the most ethically-minded person can be unduly influenced by experiences. Jerry Hoffman, someone I greatly respect, once told me that conflicts are not a choice of the morally corrupt, but just part of human nature. I agree. If we can just embrace our collective imperfections as human beings, we should see that we all will eventually run into potential conflicts of interest during our professional careers. Where the rubber meets the road is whether we disclose them or not, and most importantly, how we resolve them.
Personal integrity demands that we recognize our own potential conflicts, as opposed to hiding them or waiting for others to call us out. Just like your mother probably told you, if you have to hide it or don’t want others to know about it, you probably shouldn’t be doing it. We should never feel like we have something to hide. We all make personal and professional decisions that open and close doors, even if we don’t realize it in the moment. For instance, choosing to support specific products in medical industry by research initiatives or speaking on their behalf and getting paid for your work isn’t necessarily wrong or a conflict of interest. However, if you are then asked to serve on a panel to develop clinical guidelines that may or may not include such products, you really are ethically obligated to disclose such potential conflicts.
It’s important to add that not all “potential” conflicts are “actual” conflicts. Why do I keep using the qualifier “potential” in front of “conflicts of interest?” I believe we are in our infancy with respect to dealing with COIs in medicine. Many draw no distinction between “potential” and “actual” conflicts of interest. Once a conflict is disclosed, an actual conflict is presumed all too often. I believe this to be a big mistake and one that leads to the Scarlet Letter labelling mentioned earlier. We need to evolve our thinking and our processes for evaluating COIs. When a conflict is disclosed, we need to take the next step: resolution. In the context of the work at hand, is this an “actual” conflict or not?
Let’s consider a potential conflict in two different contexts. Let’s presume a physician has received compensation from speaking for a pharmaceutical company producing an antibiotic used exclusively for the treatment of community acquired pneumonia. The physician is then asked to speak about stroke management at a specialty society conference. The COI form asks if there are any financial conflicts to disclose. The physician should disclose her relationship with the pharmaceutical company. However, as the lecture has nothing to do with the subject matter she was compensated for by the pharmaceutical company, it may be determined that no “actual” conflict exists for this lecture. Later, the specialty society contacts the physician to ask her to speak about community acquired pneumonia in addition to the stroke talk. This should be recognized as an “actual” conflict. Despite the fact that the physician’s intent is to deliver the information in a fair and balanced manner, the physician has been influenced by industry, which is probably impossible to subtract from the equation. The physician should decline accepting the additional lecture.
This scenario leads to my last and primary concern: Actual conflicts are often ignored and not resolved. This makes me absolutely crazy. Although we have gotten much better about requiring disclosures, we tend to ignore them once disclosed. Let’s revisit the lecture scenario above. When COIs are requested, the resolution process often includes disclosure, review of content and public notice in the syllabus or other conference materials. The same thing happens with publications (i.e. identification and disclosure). However, it seems that the point has been completely lost. The goal of disclusures isn’t simply to inform the public of conflicts of interest. The goal is to resolve the conflicts and avoid undue industry influence!
If a speaker or author has received money from a pharmaceutical company to speak or do research, it is simply not enough for the conference or journal to merely report that fact. These conflicts must be resolved or the information provided by experts can be misleading, biasing the delivery of facts and data.
This is no small issue and not an insignificant phenomena. Resolving the conflicts is critical to the integrity of research and information sharing. If a journal reviews an article about a certain medication or device for the treatment of a specific disease entity (i.e. tPA and stroke, central venous oxygen saturation measuring catheters for sepsis), the review panel must recognize that the conflicts are real and insurmountable. Industry-funded research is an important topic. However, my concerns are focused on the conflicts created when the individual accepts payment from industry. In other words, if the researchers have received dollars from the industry they are studying, their views will be biased. It may very well be unintentional and it certainly doesn’t make them bad people. Despite the fact that the majority of these researchers, authors and speakers are respected in their fields, the bias still exists. When they speak, publish and conduct research within the same industry that is paying their bills, the integrity of their message should be called into question.
We rely on unbiased data and information to serve our patients well, and anything that casts doubt on the integrity of that data should be critically evaluated. If there is even the potential for such bias, why take the chance of it corrupting the information delivered to practitioners? It really is not worth the risk. So, if a speaker has an “actual” conflict, they shouldn’t speak on that topic, and if a peer reviewed publication like the New England Journal of Medicine identifies an “actual” conflict with an investigator, then perhaps the paper should be declined or printed as an opinion paper, as opposed to an unbiased work of clinical research.
If all of this seems overly hypothetical, it’s probably because the practice is so prevalent that we’ve completely accepted it. Despite the fact that there are many current and past examples, I’ll leave you with just one to consider: High dose steroids for spinal cord injuries. Despite the fact that negative data existed for this treatment, industry funded studies were published in the early 1990s showing benefit for this treatment. Even the National Institute of Health participated in a campaign to educate physicians by sending letters advising them of the value of this treatment. Ultimately, conflicts were identified and major flaws in the research were discovered showing no benefit and worsened patient outcomes, which resulted in complete abandonment of this treatment. The concept was “proved.” The researchers truly believed in this treatment and peer reviewed and respected journals published the data. Nonetheless, their bias led them to incorrect, expensive and harmful conclusions.
This one example illustrates how well-intentioned researchers are hard pressed to see their own bias and how those we trust – even respected peer review ed journals – may not address resolution of conflicts in a way that protects our patients and preserves the integrity of published data.
Conflicts are real. So, when asked, critically review your own activities and relationships to make certain you maintain your integrity. If there is an actual conflict, consider withdrawing from participation. If there are only perceived conflicts, it is your responsibility to define how the identified conflict has no actual implications. Present your case. However, in the end, others will need to determine your fate. Collectively, we deserve better from those in authority reviewing potential conflicts. Identification without adequate resolution of conflicts is just going through the motions.
Kevin Klauer, DO, EJD Editor-in-chief of Emergency Physicians Monthly, CMO of Emergency Medicine Physicians, Vice Speaker of the ACEP Council.