For every inclination, it seems, there is an equal and opposite declination. For purposes here, for every colleague I know who thinks that industry funded research is always fine and no different, I know another who thinks it is always tainted. I am in the middle, where I so often find myself as opposing views clash.
Perhaps even more influential than the equal and opposite views disparate members of a group hold at the same time are the equal and opposite views that prevail for all of society over time. We seem indeed much subject to Newton’s third law, much as he never pinned it personally to the collective decision making of humans: all dietary ills may be blamed on fat becomes all dietary ills must be blamed on carbohydrate; nutrient supplements can cure cancer becomes nutrient supplements are worthless; globalism becomes nationalism and then, we may hope, back again.
The swing of a pendulum comes to mind, accounting for the oppositism, and implying an eventual centrist stillness. So again, in my view, may we hope.
I write this not long after the prominent experts involved in drafting blood pressure treatment guidelines for the American College of Cardiology/American Heart Association were excoriated for undisclosed industry ties by an opinion writer in the Baltimore Sun. I sympathize with the writer to some extent; he is a Preventive Medicine resident who seemed to be advocating for more use of lifestyle to manage blood pressure in lieu of drugs. I am board certified in Preventive Medicine, and immediate past president of the American College of Lifestyle Medicine, so predictably- with that perspective, I could not agree more.
But in fact, the guidelines in question clearly situate lifestyle intervention as the primary response in blood pressure control. To date, that tends to be sadly rare in practice, but not for want of emphasis in these guidelines. In addition, the writer was simply wrong about many of his allegations, a victim of righteousness run amok, victimizing others in the process.
This zeal for discerning and exposing potential conflict, at times where none exists, and all too often by those with greater undisclosed conflict of their own, has expansive implications and inevitably invokes the law of unintended consequences. We clearly do not want blood pressure guidelines from doctors peddling some proprietary drug, any more than we want dietary guidelines from those selling coconuts, or donuts. But on the other hand, we do want guidelines from leading experts. The question becomes then: who do we want advising industry, or overseeing the study of their proprietary products?
My answer would be: leading experts. After all, the entire modern pharmacopeia, including the occasional game-changing advance like immunotherapy for lung cancer, reaches us via FDA-regulated research, the vast bulk of it industry funded. I much prefer that research conducted by genuinely qualified colleagues, rather than whomever is left after all the credible candidates decline for fear of being tainted. Let’s be clear that did we not have industry funded research, pharmacy shelves would be empty.
The matter extends beyond research to all manner of consulting and advising. I am aware of many instances where experts declined to consult for some effort in the private sector despite fully supporting its aims to avoid the risk not of actual conflict, but of a conflict allegation. Just consider, though, that innovations in disease and health care, as in almost every other domain, occur overwhelmingly in the private sector. Do we prefer all of this innovation to be guided only by those with lesser expertise, and perhaps lesser scruples, too, as the highly expert and highly scrupulous decline en masse to satisfy the current standard of professional chastity?
I do not. I want the momentum of biomedical advance overseen by the most qualified, conscientious, and sedulous. Sure, I want transparency and disclosure. But if the elite all demur when industry asks for expertise, the less qualified will take their place.
What this all means is that we must more thoughtfully differentiate between conflict, and confluence of interest. Operational definitions of both, and their distinctions, are certainly possible, even if much of the time we simply tend to recognize them when we see them.
At a high level, a conflict is present whenever truth and best efforts to find it are subordinate to any other agenda. A confluence may be present when a professional interaction serves the pursuit of truth and is constrained by both mission and methods from doing otherwise.
In such context, expert interaction with industry is neither reliably innocent, nor preemptively compromising. Quite simply, it depends on who does what and how. Disclosure and transparency are essential, but these, too, have their own requirements. For disclosure of consulting to industry in some capacity to make sense rather than nonsense, we need those at the receiving end to understand that it is not a confession of unsavory motivations or actions. Rather, we want leading experts conducting the research that forms the basis for guidelines, just as we want leading experts generating guidelines, too. Knee-jerk extremism is apt to deny us one if not both, to our collective detriment.
That any involvement with industry implies a compromising bias is, in my view, a naïve charge. All research and consulting involve some variety of bias, because we all tend to direct our time and effort where our perspectives, hopes, and inclinations take us. Those motivations imply bias: we want the things we choose to work on to succeed, or we would have chosen to work on something else. Whatever entity is paying the bills, the defense against bias is robust methods designed to serve truth, and allowing for it to be a truth that disappoints. To make this personal: I have hoped for a specific outcome in every study I have ever run, those funded by the NIH, those funded by the CDC, and those funded by industry. In every instance, I have relied on the same methods to produce the right result, rather than the one I “wanted.”
A homey analogy comes to mind. All researchers tend to put findings into the best possible “light,” to make of our data the most interesting tale for publication. This is not exclusive to any given funding source. In much the same way, parents helping their kids apply to college seek to accentuate the positive. We parents are biased in such matters, clearly; we want our children to succeed, and we want them to see their hopes and dreams fulfilled. But we are duty bound to tell the truth. The result is that most parents help their kids put their applications in the most favorable light, but within the strict bounds of honesty. Some few defy those boundaries. Bias, then, is not the differentiator; integrity is.
True conflicts of interest, and opacity about them, are enemies to truth, and thus to us all. But confluences are salient, too, and neglect to distinguish these may append personal insult to public health injury.
Nobody expects the Spanish Inquisition to recur, but something like it does when sanctimony and the presumption of guilt displace reason and informed judgment. Stated differently, if the current version of conflict precludes expert guidance when it matters most from the most qualified experts, we may all come to rue the consequences. We may find this filed one day under: “tell them what they’ve won, Johnny!”
David L. Katz, MD, MPH, FACPM, FACP, FACLM, is the Founding Director (1998) of Yale University’s Yale-Griffin Prevention Research Center, and former President of the American College of Lifestyle Medicine. He has published roughly 200 scientific articles and textbook chapters, and 15 books to date, including multiple editions of leading textbooks in both preventive medicine, and nutrition. He has made important contributions in the areas of lifestyle interventions for health promotion; nutrient profiling; behavior modification; holistic care; and evidence-based medicine. David earned his BA degree from Dartmouth College (1984); his MD from the Albert Einstein College of Medicine (1988); and his MPH from the Yale University School of Public Health (1993). He completed sequential residency training in Internal Medicine, and Preventive Medicine/Public Health. He is a two-time diplomate of the American Board of Internal Medicine, and a board-certified specialist in Preventive Medicine/Public Health. He has received two Honorary Doctorates.