NEJM and the pharmascolds

The New England Journal of Medicine (NEJM) called the question: Has criticism of the pharmaceutical industry, and of physician relationships with that industry, gone too far?  Are self-righteous “pharmascolds” blocking the kind of essential collaboration that brought streptomycin and other lifesaving treatments to market?  The editorial by Dr. Jeffrey Drazen and the lengthy three–part piece by Dr. Lisa Rosenbaum push back against a rising skepticism that obviously feels unfair to them, and presumably to many.

Drazen, editor in chief at NEJM, stands in sharp contrast to former editors Drs. Arnold Relman, Jerome Kassirer, and Marcia Angell, all of whom warned of corrosive commercial influence in medicine.  According to Drazen, an unfortunate divide between academic researchers and industry has arisen “largely because of a few widely publicized episodes” of industry wrongdoing.  He underscores the ongoing need for collaboration and guides readers to Rosenbaum’s exposition.

In her first of three articles, Rosenbaum correctly notes that skepticism about financial ties may obscure other biases of arguably greater influence.  For example, industry marketing and promotion, i.e., influence that is not directly financial, also affects physicians.  But what to do about it?  Rosenbaum claims “the answer still largely eludes us,” partly due to the “overwhelming complexity” of the variables:

I think we need to shift the conversation away from one driven by indignation toward one that better accounts for the diversity of interactions, the attendant trade-offs, and our dependence on industry in advancing patient care.

Rosenbaum cites the social psychologist Robert Zajonc, who researched how feelings influence thinking.  According to this account, critics hear “canonical conflict-of-interest stories and pharmaceutical marketing scandals” and this leads to emotional bias: “we worry about ‘corrupt industry’ interacting with ‘corruptible physicians’.”

Our feelings about greed and corruption drive our interpretations of physician–industry interactions…. reasoned approaches to managing financial conflicts are eclipsed by cries of corruption even when none exists.

Of course, indignation runs both ways.  Rosenbaum fails to note that Zajonc’s findings apply equally well to apologists who hear or experience positive relationships, and are thereby reassured that “friendly, helpful industry” interacts with “ethically impervious physicians.”  Perhaps reasoned approaches to managing conflicts of interest and marketing scandals are eclipsed by cries of innocence even when corruption exists.

Rosenbaum’s second installment takes a more adversarial and defensive tone, introducing the derisive “pharmascold” label to describe critics.  Her own criticism of Relman’s seminal 1980 editorial on “The Medical-Industrial Complex” seems misplaced:

Relman wanted to mitigate undue influence by curtailing physicians’ financial associations with companies, but his concern seemed as much about appearance as about reality. Noting the uncertainty about the magnitude of physicians’ financial stake in the medical marketplace, he wrote, “The actual degree of involvement is less important than the fact that it exists at all. As the visibility and importance of the private health care industry grows, public confidence in the medical profession will depend on the public’s perception of the doctor as an honest, disinterested trustee.”

Rosenbaum acknowledged in her first article that the influence of an industry gift or payment may be unrelated to its monetary value.  Relman agrees: the “degree of involvement is less important than the fact that it exists.”  And while public confidence in the medical profession is partly a matter of appearance, Relman was not talking about putting on an act.  He was urging doctors to remain honest, disinterested trustees — a theme to which we shall return.

In holding that we “lack an empirical basis to guide effective conflict management,” Rosenbaum says we don’t know whether commercial bias actually harms patients.  The evidence is only suggestive.  This is particularly weak rhetoric, as there is a great deal of suggestive evidence, some of which she cites herself, and very little, suggestive or otherwise, to oppose it.  Her stance is reminiscent of arguments that staying up all night is good for medical trainees and their patients — because it’s traditional, and because there is no empirical data from those specific groups showing harm.  Never mind that thousands of studies of sleep deprivation exist, and that it is almost uniformly deleterious.  One may likewise point to entire industries, e.g., advertising and public relations, founded on the very influence that is so curiously hard to pin down here.  Is there harm in having medical research and clinical decisions affected by those who stand to gain financially?  Not in every case, but surely the burden of proof lies with those who claim to be an exception.

Rosenbaum correctly notes that disclosure and transparency may not mitigate bias, nor its effect on listeners.  Most consumer advertising is very transparent in its intent; this doesn’t appear to sap its effectiveness in the least.  She ends her second installment by revisiting psychology and the “self-serving bias” which may fuel both pro- and anti-industry positions.  She aptly notes that stereotypes and ad hominem arguments may be unfair.  Why the pharmascold slur then?

The last installment is clearly the best of the three, and could have stood alone as a stronger statement.  Rosenbaum opens with how the culture of medical training has dramatically swung from an unthinking acceptance of industry influence to intense skepticism and peer pressure to avoid it.  She cites yet another psychologist, Philip Tetlock, who focuses on how certain “sacred values” like health prevent us from contemplating inevitable trade-offs.  She also cites psychologist Jonathan Haidt, who found that “people who were offended by social-norm violations worked hard to cling to a sense of wrongdoing, even when they couldn’t find evidence that anyone had been hurt.”  She applies these findings to unbending critics, and to those who either invent harm, or who claim wrongdoing without evidence that anyone has been hurt.  Rosenbaum points out that doctors may be more risk-averse and conflict-avoidant than some patients prefer.  More examples follow of allegedly unfair criticism of industry ties.  “The bad behavior of the few has facilitated impugning of the many.”  Medical progress stops if we scare people away.  We unwittingly replace expertise with conflict-free mediocrity.  And so forth.  She ends with this:

The answer is not a collective industry hug. The answer will have to be found by returning to this question: Are we here to fight one another — or to fight disease? I hope it’s the latter.

Some responses to the NEJM series were quick and biting.  My own reaction is mixed.  Rosenbaum raises several good points.  It isn’t right to stereotype.  Academic collaboration is necessary to move medical science forward.  Witch hunts serve no one.  The appearance of a conflict of interest (COI) isn’t the same as having one, and even that isn’t the same as being biased.  Many psychological blind spots attributed to defenders of industry collaboration may apply as well to its critics.  Perfectionism in avoiding COI may carry costly trade-offs.  Vague indignation is pointless.

However, Rosenbaum goes astray by misconstruing professional ethics and by overlooking its Kantian, deontological nature.  Relman wrote his editorial not for the sake of appearance, but to remind readers of the physician’s ethical duties.  As with other fiduciaries, our standards are higher than usual business ethics; Tetlock is free to call this a “sacred value” if he wishes.  Medical ethics doesn’t wait for “evidence that anyone has been hurt” — just as judges recuse themselves absent such evidence, and bribing public officials is prohibited without waiting for proof of harm.  Haidt’s social-norm violations, e.g., defacing an American flag, may be considered a dereliction of duty and therefore wrong, even if no one is hurt.

As medical fiduciaries, we have a positive duty to avoid COI when we reasonably can.  This is best framed as an attitude, not a pure or absolute set of behavioral rules.  It’s not a crime to talk to a drug rep or to attend an industry sponsored talk.  Under certain circumstances these may be the best way to enhance patient care.  But usually they’re not: expedience is rarely worth the price of having to evaluate commercially biased material.  And make no mistake, commercial bias is the raison d’être of business.  While academic physicians should collaborate with industry when appropriate — and feel proud to do so — they should also recognize it may color their clinical thinking.

As will many other sources of bias.  Rosenbaum is right to point this out, even if it doesn’t exonerate the influence of money.  Her example of sleep deprivation is a good one.  Rather than declaring these influences too complex and myriad to do anything about, let’s try.  If clinical care is adversely affected by the on-call doctor’s need for sleep, maybe the on-call doctor should be well rested.  If clinical care is harmed by draconian regulations and paperwork, let’s work to improve that.  Money can be an obvious, concrete COI, but it’s certainly not the only COI out there.

Rather than focusing on do’s and don’ts, shills and pharmascolds fighting one another, medicine needs to regain its ethical footing.  In the 1940s, Dr. Waksman could collaborate with Merck to produce streptomycin, and later to write a review article on the drug, because his ethics, and probably Merck’s, were above reproach.  This was long before off-label drug promotion, ghostwritten articles, KOL targeting, and all the rest.  If medicine is again to be respected in this way, our best argument can’t be that harm hasn’t been proven yet.  We can’t minimize the mistrust that “a few widely publicized episodes” can bring.  We can’t defend the profession against critics by ridiculing and dismissing the radical fringe.

Will some extreme “pharmascolds” continue to decry all Pharma, without regard to reason or consequences?  Undoubtedly.  Yet we don’t declare pollution a sham because fringe groups of radical environmentalists exist. We don’t abandon our critical faculties when others are excessively critical.  We should accordingly still scrutinize physician COI resulting from commercial influence, and from other sources as well, and seek to minimize it in ourselves and in our profession.  If we can do it without overheated rhetoric and unfair stereotyping, all the better.

Image courtesy of Vichaya Kiatying-Angsulee at FreeDigitalPhotos.net