NEJM and the pharmascolds

medical moneyThe 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 threepart 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

4 comments to NEJM and the pharmascolds

  • A thoughtful review. I’m afraid I saw too much red to be able to find your appropriate distance. Drazen’s roots were showing: New England Journal of Medicine Names Third Editor in a Year, FDA censures NEJM editor, and Medical Journal Editor Vows to Cut Drug Firm Ties.

    • Ignorance is bliss; I hadn’t looked into his past, or anything about him actually. I was more focused on Rosenbaum’s articles. Of course, Drazen solicited the writing in the first place, and it’s fair to speculate on his motivation.

      You remind me that while indignation (or outrage) shouldn’t guide policy, it’s human to feel it in response to outrageous behavior. Striking a balance between studied neutrality and cries of anguish can be tricky sometimes…

      Thanks for visiting. I really admire your dedication to psychiatry as reflected in your blog.

  • I would not see the pharmascold position as being an extreme one. I would currently see it as the mainstream position. What after all is the Sunshine Act database other than a mechanism for public shaming of anyone who is employed or gives a presentation that is sponsored by a pharmaceutical company? It also denies a basic reality of health care across the world and that is that all health care systems depend completely on private industry to discover new drugs and mass-produce the old ones. More specifically it depends on the scientific divisions of these companies and not the advertising and marketing divisions who have been responsible for the publicized wrongdoing. The critics don’t seem to get the difference or the difference between science and advertising. But even Rosenbaum acknowledges that wrongdoing by the company “tarnishes the reputations of everyone associated with it.”

    The pharmascold attitude capitalizes on the public shaming attitude prevalent in social media and like most things it falls heaviest on psychiatry. It is fairly obvious that it results in many of these critics making outrageous claims about psychiatry and psychiatric research by claiming that monolithic Big Pharma and monolithic psychiatry all serve the profit motive of the industry. The combination of this widely accepted conspiracy theory and provocative journalism has created far more heat than light. Rosenbaum’s articles are a meager rebuttal in comparison with what is said on nearly a daily basis in the press and the 5:1 unfavorable rating of psychiatry relative to other specialties.

    There is also the case that the doctor is no longer a “honest disinterested trustee” like Relman wrote in 1980. I doubt he would write the same thing today when 80% or more of the physicians in this country are basically agents of managed care companies or the government. They make decisions on a daily basis that compromise what they consider to be optimal care based on rationed resources and non-physicians telling them what to do. Medical care on the average used to be mediocre at best, today it is subject to whatever a medically uneducated administrator wants to foist on his of her physician employees. This managed care takeover started out with the physicianscolds who maintained that the cost problem in medicine was due to high-priced physicians, fee-for service practice and unnecessary procedures and tests. Nobody seems to have paid any attention to what happened when the new boss took over. The furor of high priced specialists seems to have died down now that they are all employees of managed care companies and the numerous unnecessary “managers” are all being paid like orthopedic surgeons with any productivity requirements. The politics and ethics of the managed care problem are always ignored in the debate about Big Pharma despite the incredible escalation in costs due to the proliferation of those administrators and very similar ethical issues.

    I think that a statement like Rosenbaum’s was overdue. Some of the reaction to it is way overblown considering the fact that she acknowledges the need for transparency, disclosure and regulation as well as the fact that problems clearly exist. I see the whole Big Pharma issue as being way down the list in terms of professionalism and problems facing medicine and psychiatry. If you train physicians to be skeptical and skilled in how to read and evaluate literature they will make decisions in the patients’ interest. Some general idea that everyone is biased or susceptible to advertising does not explain that away.

    • George,

      Thank you for your detailed comment. As you know, we see these things somewhat differently. I don’t equate transparency with shaming, although as mentioned in the post, I also don’t see that it has much effect. I don’t call it a conspiracy theory to assume that any business sector, e.g., Big Pharma, is strongly and often primarily motivated by profit. On the other hand, I differ with critics who assume physicians (especially individual physicians) fall equally into that profit-driven camp. The ones who do are clearly the exception.

      I agree that doctors are no longer Relman’s “honest disinterested trustees.” I believe a major cause is the usurpation of medical ethics by looser business ethics. One way to view this is external pressure, e.g., by managed care, that distorts medical practice. That is largely how I read your blog. Another view that I emphasize is that we physicians have relaxed our own ethical standards in our acceptance of managed care and the like, and that both we and our patients are suffering the consequences. In truth, both perspectives are valid. I also don’t believe that concern about Big Pharma (or MOC, or the many other factors that affect us) blind us to our managed care challenges. It’s “all of the above.”

      Although I disagree in part with Rosenbaum, her articles bring the debate to a better level. I remain hopeful that in a less polarized dialog, industry critics will take a less indignant tone regarding physician “complicity.” And that physicians, including psychiatrists such as yourself, accept that unconscious biases affect all of us — and strive, as a matter of professional ethics, not shaming or arm-twisting, to minimize them.

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