The debate over the confirmation of Robert M. Califf, MD, as FDA commissioner illustrates the need to change the way we talk about whether a medical professional has a "conflict of interest" rather than simply an "association of interest."
Maurie Markman, MD
Discussions of conflicts of interest in the healthcare arena are both important and complex. Unfortunately, they can also quickly degenerate from an objective fact-based assessment of genuine conflict into highly biased or politically motivated diatribes where an individual’s personal philosophy and worldview completely dominate the discussion.
Consider, for example the stunningly inane and terribly misdirected rhetoric surrounding the confirmation process for Robert M. Califf, MD, to become the FDA commissioner.1
That he had an association with these companies somehow tainted Dr Califf with an unacceptable “conflict-of-interest” label. Fortunately, despite rather intense grandstanding that lasted many months—delaying the filling of this vital public health post—Dr Califf was finally confirmed.
Dangerous and quite intense rhetoric within the healthcare domain is not unique to assertions about conflicts of interest.
Consider, for example, the loudly voiced claims of some that studying the impact of physician-in-training work hours and existing rules is unethical because these self-declared experts and self-proclaimed defenders of the public good are absolutely certain they know the answers to any questions in this arena.2
The fact that a recently reported randomized trial published in a high-impact medical journal has seriously challenged their basic assumptions will surely not matter to those who have little interest in objective facts, but rather only in their own rigidly held beliefs and opinions.3 When it comes to accusations of a conflict of interest, specifically in the cancer domain, the impact of such strong, perhaps even dogmatic assertions is unfortunately heightened by the connotations of such terminology.
Real Versus Exaggerated Issues
Specifically, the term “conflict of interest” implies to some a rather direct element of assumed wrongdoing or at least the very serious potential for such an outcome.Certainly, the potential for such conflict of interest is realistically relevant and extremely common in everyday oncology practice.
A urologist who recommends a radical prostatectomy rather than radiation for a patient with prostate cancer might be accused of having a conflict of interest, as could a radiation oncologist who recommended radiation rather than surgery.
Similarly, an identical charge could be made against a medical oncologist who makes a decision to employ Drug A rather than Drug B, if Drug A were far more lucrative to the physician’s practice.
But let us be clear here: There is no legitimate claim that a conflict of interest actually exists in any of these situations, and individual physicians must vigorously monitor themselves to ensure their activities are always undertaken based on the benefit to their patients. Yet, there is certainly the potential for conflict of interest in these daily real-world scenarios.
So, why is a physician who participates as an investigator in a pharmaceutical company trial, or accepts a nonexcessive honorarium for participating in a company-sponsored advisory board, or presents FDA-approved data (“on-label”) on behalf of a pharmaceutical company somehow “guilty” and such activities are labeled “conflict of interest”?
Of course, these considerations do not appear to bother those whose mission seems to be to find conflict of interest wherever they believe it might exist.
Consider, for example, a recent report that examined conflict of interest among members of the public, including patients with cancer, who spoke before the FDA on behalf of approval for a new antineoplastic agent.4
As suggested in this analysis, the acceptance of travel assistance by patients with cancer appeared to the authors to warrant the label “conflict of interest.”
These authors presumably feel that by making patients pay their own way to such hearings there would be a more balanced assessment of the clinical utility of the drug in question. Or perhaps there would simply be no patient perspective presented at these meetings, since how many individuals would be able to use their own funds for this purpose?
Clearly, the solution to avoiding the intense political and philosophical bias surrounding the “conflict of interest” question is not to ignore relationships that might have clear relevance. Rather, the goal should be to change the tone of the conversation to reduce the risk, even if only by a limited amount, that certain individuals be able to use this platform for their own possibly quite conflicted purposes.
So, why not simply modify the rather pejorative term “conflict of interest” and replace it with the far more neutral term “associations of interest” or be even more direct and simply state “reported relationships?” These words do not, and should not, imply any inherent or actual “conflict.”
Such a declaration would be followed by a detailed description of the actual relationship in question. This may include an involvement in a company-sponsored clinical trial as a participant or investigator, a member of a medical or scientific advisory board, a speaker at educational/promotional events, or simply travel expenses for an individual to provide the perspective of a patient with cancer to an FDA advisory board meeting.
In many areas of life, the choice of words matters. In this domain, the choice of words appears to matter a great deal.
Maurie Markman, MD, editor-in-chief, is president of Medicine & Science at Cancer Treatment Centers of America, and clinical professor of Medicine, Drexel University College of Medicine.email@example.com.
Widely recognized as an outstanding clinical investigator and truly first-class physician-leader, Dr Califf faced the criticism that he had a conflict of interest essentially based on the sole fact that he had effectively worked with the pharmaceutical and biotech industry for several decades in the development of new drugs designed to benefit patients with heart disease.