Over the past several years, “the debate over how to manage or discourage physicians’ financial conflicts of interest with the drug and medical device industries has become more heated” and a number of “critics have questioned or dismissed the concept of “conflict of interest” itself.” To address this issue, Howard Brody, MD, PhD, noted that a definition for conflict of interest must first be established.
Dr. Brody wrote in a recent article in the American Journal of Bioethics that, “a satisfactory definition relates conflict of interest to concerns about maintaining social trust and distinguishes between breaches of ethical duty and temptations to breach duty.”
In the article, entitled “Clarifying Conflict of Interest,” Dr. Brody noted that, “numerous objections to such a definition have been offered,” but “none of which prevails on further analysis.” He asserted that, “those concerned about conflicts of interest have contributed to misunderstandings by failing to demonstrate when social arrangements leading to temptations to breach duties are in themselves morally blameworthy.”
As a result, Dr. Brody wrote his article as an attempt to clarify “conflict of interest” in order to help “develop productive modes of engagement between medicine and for-profit industry that avoid the serious ethical pitfalls now in evidence.”
Consequently, in response to Dr. Brody’s article, Lance K. Stell, PhD, professor of philosophy at Davidson College, and Thomas P. Stossel, professor of medicine at Harvard Medical School and director of translational medicine at Brigham and Women’s Hospital, asserted that Dr. Brody’s article persisted to use “biased, pejorative epithet to frame all of the complex remunerated relationships between the medical profession and the medical products industry.”
In their comment, entitled “Another Dip Into the Muddy Waters of COI,” Drs. Stossel and Stell rightly noted that physician-industry “relationships have been mutually beneficial for the medical profession and for industry.” But most important by far “are the benefits that have accrued to patients who have gained access to more effective, safer, and easier to take medicines; vastly improved monitoring and imaging; faster and more precise diagnostics; programmable insulin pumps, pacemakers, and cardioverters that can report their recorded activity over the phone; and better prosthetics and surgical devices.”
Accordingly, Drs. Stossel and Stell recognized that “anecdotes, “tales from the crypt,” of physician and industry misconduct, which Brody cites, are not even close to compelling data tending to show that, on balance, these relationships produce more patient harm than benefit.” In fact, they recognized that “Brody has no evidence tending to show that a physician afflicted with an industry-related “conflict of interest” will be less trustworthy/more treacherous in his or her relationships with patients, and more likely to harm them.”
Specifically, Drs. Stossel and Stell pointed out that “whether patients trust their physicians less than they used to is a different question.” While Brody may have indicated a loss in trust, Drs. Stossel and Stell cited “repeated surveys, which show consistently that physicians rank at or near the top of “most trust” professionals. Moreover, they discussed how “recent surveys report almost no perception of bias by physicians participating in industry sponsored medical education activities (e.g., Kawczak et al. 2010).”
In addition, Brody himself acknowledges, “that some of his like-minded colleagues have oversold anecdotes and muddled personal preferences as “evidence” of harm.” However, Brody’s article “simply repeats this behavior and cannot provide anything new.”
For example, Brody “resorts to complaining that the evidence we would need is difficult to come by (as if that justified making it up) and that industry remuneration may be gratuitous (“is not necessary”) to justify elevating “conflict of interest” to ethically emergent status.” Drs. Stossel and Stell recognized that judging “whether or what level of industry payments for physician services or time is appropriate is an exercise in subjectivity.”
They pointed to the example of another article Brody wrote, and stated that “contributions from Coca-Cola (which also manufactures sugar-free products) to the American Academy of Family Physicians enable that association to help its members provide better patient care—the larger the contributions, the more social benefit.
While “Brody has the right to wish physicians provided services for free or paid for their own education, imposing his preference in the real world will result in physicians unable or unwilling to comply. Since the paid relationships create value, the unintended consequence of his mandate is lost value.”
The problem with Brody’s approach is that “anyone can quickly bring to mind instances of industry misdeeds: physician greed, arrogance, and avarice, journals peddling flawed studies, industry-sponsored and not, the Food and Drug Administration (FDA) apparently being influenced by politics, etc.” And “anyone can also bring to mind instances where the FDA stood fast against improper pressures, where a patient’s getting on the right medicine was lifesaving, of doctors staying more up-to-date because of sponsored continuing medical education (CME).”
In other words, Drs. Stossel and Stell acknowledge, “myriad heuristics are “available” to help simplify vast complexity and “conflict of interest” (COI) is one of those heuristics.” According to the authors, it’s wrong to use COI and “say that physicians have only recently come to worry about potentially ill effects of outside influence,” because the Hippocratic Oath “makes the physician swear that he will keep himself and his art holy and pure.” So what has prompted the recent prominence given to this heuristic?
Taking a closer look at the use of COI, Drs. Stossel and Stell noted that a literature search for COI found more than 7,300 hits, most published in the last decade (Lanier 2008). “Viewed from 10,000 feet, the outbreak of COI literature has all the characteristics of an “availability cascade” (Kuran and Sunstein 1999).”
For Brody, the COI heuristic is “available” and “biases his reading off of the “police blotter” side of medicine’s relationship with the medical products industry.” As a result, “he grants that having a “conflict” is not equivalent to professional misconduct, but rather is some sort of risk factor for untrustworthiness,” in which an activity “low in value prompts regarding it as risky.”
Accordingly, Drs. Stossel and Stell explain that the COI heuristic is so “available” to pharmascolds like Brody because “affectively, they regard the medical products industry’s relationship with medicine as lacking in value, which prompts their judgment about its riskiness.”
What is problematic about the “risk” approach that pharmascolds take in using the COI heuristic is that “they show so little interest in calculating the rate of professional
misconduct, given the large number of physician exposures to sponsored CME and promotional marketing.” Instead, “what the COI heuristic lacks in analytical precision is more than offset by its pejorative epithet function, which casts an unflattering light on everything distorted by its dim beam.”
In the end, while “Brody and his fellow pharmascolds have been very influential in putting the medical products industry on the defensive” and getting databases for reporting and transparency from industry, Drs. Stossel and Stell note that their efforts have been “a vast waste of money” that “will not improve patient care one bit.”
In fact, they assert that efforts from Brody and pharma critics will only “hurt patient care by diverting scarce resources from research, development, and education to monitoring and “compliance.”
Such consequences have already taken place. For example, “patients will not access the database for the simple reason that they will have no idea what the numbers mean for any practical decision they face. But the pharmascolds will benefit from the database.”
Ultimately, these databases “will provide them with an enormous amount of information to riffle through, subsidized by grants that will help their careers.” While economists would call this “rent seeking,” Drs. Stossel and Stell call it a “conflict of interest.”