{"id":1030,"date":"2015-05-24T22:16:58","date_gmt":"2015-05-25T05:16:58","guid":{"rendered":"http:\/\/blog.stevenreidbordmd.com\/?p=1030"},"modified":"2015-05-25T14:45:32","modified_gmt":"2015-05-25T21:45:32","slug":"nejm-and-the-pharmascolds","status":"publish","type":"post","link":"http:\/\/blog.stevenreidbordmd.com\/?p=1030","title":{"rendered":"NEJM and the pharmascolds"},"content":{"rendered":"

\"medical<\/a>The New England Journal of Medicine<\/em> (NEJM) called the question: Has criticism of the pharmaceutical industry, and of physician relationships with that industry, gone too far? \u00a0Are self-righteous “pharmascolds” blocking the kind of essential collaboration that brought streptomycin and other lifesaving treatments to market? \u00a0The\u00a0editorial<\/a>\u00a0by Dr. Jeffrey Drazen and the lengthy\u00a0three<\/a>–part<\/a> piece<\/a> by Dr. Lisa Rosenbaum push back against a rising skepticism that obviously feels unfair\u00a0to them, and presumably to many.<\/p>\n

Drazen, editor in chief at NEJM, stands in sharp contrast to former editors Drs. Arnold Relman, Jerome Kassirer, and Marcia Angell, all\u00a0of whom warned of\u00a0corrosive commercial influence in medicine. \u00a0According to Drazen, an unfortunate divide between academic researchers and industry has arisen\u00a0“largely because of a few widely publicized episodes” of industry wrongdoing. \u00a0He underscores the ongoing need for collaboration and guides readers to Rosenbaum’s exposition.<\/p>\n

In her first<\/a> of three articles, Rosenbaum correctly notes that skepticism about financial ties may obscure other biases\u00a0of arguably greater influence. \u00a0For example,\u00a0industry marketing and promotion, i.e., influence that is not directly financial, also affects physicians. \u00a0But what to do about it? \u00a0Rosenbaum claims “the answer still largely eludes us,” partly due to the “overwhelming complexity” of the variables:<\/p>\n

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.<\/p><\/blockquote>\n

Rosenbaum cites the social psychologist Robert Zajonc, who researched how feelings influence thinking. \u00a0According to this account, critics hear “canonical conflict-of-interest stories and pharmaceutical marketing scandals” and this leads to emotional\u00a0bias:\u00a0“we worry about ‘corrupt<\/em>\u00a0industry’ interacting with ‘corruptible<\/em>\u00a0physicians’.\u201d<\/p>\n

Our feelings about greed and corruption drive our interpretations of physician\u2013industry interactions….\u00a0reasoned approaches to managing financial conflicts are eclipsed by cries of corruption even when none exists.<\/p><\/blockquote>\n

Of course, indignation runs both ways. \u00a0Rosenbaum fails to note that Zajonc’s findings apply\u00a0equally\u00a0well to\u00a0apologists\u00a0who hear or experience positive relationships, and are thereby reassured that “friendly, helpful<\/em>\u00a0industry” interacts with “ethically impervious<\/em>\u00a0physicians.” \u00a0Perhaps reasoned approaches to managing conflicts of interest and marketing scandals are eclipsed by cries of innocence even when corruption\u00a0exists.<\/p>\n

Rosenbaum’s\u00a0second<\/a> installment takes a more adversarial and defensive tone, introducing the derisive “pharmascold” label to describe critics. \u00a0Her own criticism of Relman’s seminal 1980 editorial on “The Medical-Industrial Complex” seems misplaced:<\/p>\n

Relman wanted to mitigate undue influence by curtailing physicians\u2019 financial associations with companies, but his concern seemed as much about appearance as about reality. Noting the uncertainty about the magnitude of physicians\u2019 financial stake in the medical marketplace, he wrote, \u201cThe 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\u2019s perception of the doctor as an honest, disinterested trustee.\u201d<\/p><\/blockquote>\n

Rosenbaum acknowledged in her first article that the influence\u00a0of an industry gift or payment may be unrelated to its monetary value. \u00a0Relman\u00a0agrees:\u00a0the “degree of involvement is less important than the fact that it exists.” \u00a0And while public confidence in the medical profession is partly a matter of appearance, Relman was not talking about putting on an act. \u00a0He was urging\u00a0doctors to\u00a0remain\u00a0honest, disinterested trustees\u00a0\u2014\u00a0a theme to which we shall return.<\/p>\n

In holding\u00a0that we “lack an empirical basis to guide effective conflict management,” Rosenbaum says we don’t know whether commercial bias actually harms patients. \u00a0The evidence is only suggestive. \u00a0This 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. \u00a0Her stance is reminiscent of arguments that staying up all night is good for medical trainees and their patients\u00a0\u2014\u00a0because it’s traditional, and because there is no empirical data from\u00a0those specific groups showing harm. \u00a0Never mind that thousands of studies of sleep deprivation exist, and that it is almost uniformly deleterious. \u00a0One may likewise point to entire industries, e.g.,\u00a0advertising and public relations, founded on the very influence that is so curiously hard to pin down here. \u00a0Is there harm in having medical research and clinical decisions affected by those who stand to gain financially? \u00a0Not in every case, but surely the burden of proof lies with those who claim to be an exception.<\/p>\n

Rosenbaum correctly notes that disclosure and transparency may not mitigate bias<\/a>, nor its effect on listeners. \u00a0Most consumer advertising is very transparent in its intent; this doesn’t appear to sap its effectiveness in the least. \u00a0She ends her second installment by revisiting\u00a0psychology and the “self-serving bias” which may fuel both pro- and anti-industry positions. \u00a0She aptly\u00a0notes that stereotypes and ad hominem arguments may be unfair. \u00a0Why the pharmascold slur then?<\/p>\n

The last<\/a>\u00a0installment is clearly the best of the three, and could have stood alone as a stronger statement. \u00a0Rosenbaum\u00a0opens with\u00a0how the culture of medical training has\u00a0dramatically swung from an unthinking acceptance of industry influence to intense skepticism and peer pressure to avoid it. \u00a0She cites yet another psychologist, Philip Tetlock, who focuses on how certain “sacred values” like health prevent us from contemplating inevitable trade-offs. \u00a0She also cites psychologist Jonathan Haidt, who\u00a0found that “people who were offended by social-norm violations worked hard to cling to a sense of wrongdoing, even when they couldn\u2019t find evidence that anyone had been hurt.” \u00a0She applies these findings to unbending critics, and to those who either invent harm, or who claim wrongdoing without evidence that anyone has been hurt. \u00a0Rosenbaum points out that\u00a0doctors may\u00a0be more risk-averse and conflict-avoidant than some patients\u00a0prefer. \u00a0More examples follow of allegedly unfair criticism of industry ties. \u00a0“The bad behavior of the few has facilitated impugning of the many.” \u00a0Medical progress stops if we scare people away. \u00a0We unwittingly replace expertise with conflict-free mediocrity. \u00a0And so forth. \u00a0She ends with this:<\/p>\n

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 \u2014 or to fight disease? I hope it\u2019s the latter.<\/p><\/blockquote>\n

Some responses to the NEJM series were<\/a> quick<\/a> and<\/a> biting<\/a>.\u00a0 My own reaction is mixed. \u00a0Rosenbaum raises several good points. \u00a0It isn’t right to stereotype. \u00a0Academic collaboration is necessary to move medical science forward. \u00a0Witch hunts serve no one. \u00a0The appearance of a conflict of interest (COI) isn’t the same as having one, and even that isn’t the same as being biased. \u00a0Many psychological blind spots attributed to defenders of industry collaboration\u00a0may apply as\u00a0well to its critics. \u00a0Perfectionism in avoiding COI may carry costly trade-offs. \u00a0Vague indignation is pointless.<\/p>\n

However, Rosenbaum goes astray by misconstruing\u00a0professional ethics and by overlooking its Kantian, deontological nature. \u00a0Relman wrote his editorial not for the sake of\u00a0appearance, but to remind readers of\u00a0the physician’s ethical duties. \u00a0As with other fiduciaries, our standards are higher<\/a> than usual\u00a0business ethics; Tetlock is free\u00a0to call this a “sacred value” if he wishes. \u00a0Medical ethics doesn’t wait for “evidence that anyone has been hurt” \u2014 just as judges recuse themselves absent such evidence, and bribing public officials is prohibited<\/a>\u00a0without waiting for proof of harm. \u00a0Haidt’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.<\/p>\n

As medical fiduciaries, we have a positive duty to avoid COI when we reasonably can. \u00a0This is\u00a0best framed as an attitude, not a pure or absolute set of behavioral rules. \u00a0It’s not a crime to talk to a drug\u00a0rep or to attend\u00a0an industry sponsored talk. \u00a0Under certain circumstances these may be the best way to enhance patient care. \u00a0But usually they’re\u00a0not: expedience is rarely worth the price of\u00a0having to evaluate commercially biased material. \u00a0And make no mistake, commercial bias is the raison d’\u00eatre of business. \u00a0While academic physicians should collaborate with industry when appropriate \u2014 and feel proud to do so \u2014 they should also recognize it may color their clinical thinking.<\/p>\n

As will many other sources of bias. \u00a0Rosenbaum is right to point this out, even if it doesn’t exonerate the influence of money. \u00a0Her example of sleep deprivation is a good one. \u00a0Rather than declaring these\u00a0influences too complex and myriad to do anything about, let’s try. \u00a0If clinical care is adversely affected\u00a0by the on-call doctor’s need for sleep, maybe the on-call doctor should be well rested. \u00a0If clinical care is harmed by draconian regulations and paperwork, let’s work to improve that. \u00a0Money can be\u00a0an obvious, concrete COI, but it’s certainly not the only COI out there.<\/p>\n

Rather than focusing on do’s and don’ts, shills and pharmascolds fighting one another, medicine needs to regain its ethical footing. \u00a0In the 1940s, Dr.\u00a0Waksman could collaborate with Merck\u00a0to produce streptomycin, and later to write a review article on the drug, because his ethics,\u00a0and probably Merck’s, were above reproach. \u00a0This was long before off-label drug promotion, ghostwritten articles, KOL targeting, and all the rest. \u00a0If medicine is again to be respected in this way, our best argument can’t be that harm\u00a0hasn’t been proven yet. \u00a0We can’t minimize the mistrust that “a few widely publicized episodes” can bring. \u00a0We can’t defend the profession against critics by ridiculing and dismissing the radical fringe.<\/p>\n

Will some extreme\u00a0“pharmascolds” continue to decry all Pharma, without regard to reason or consequences? \u00a0Undoubtedly. \u00a0Yet we don\u2019t declare pollution a sham because fringe groups of radical environmentalists exist. We don\u2019t abandon our critical faculties\u00a0when others\u00a0are excessively critical. \u00a0We should accordingly\u00a0still scrutinize physician\u00a0COI resulting from commercial influence, and from other sources as well, and seek to minimize it in ourselves and in our profession. \u00a0If we can do it without overheated rhetoric\u00a0and unfair stereotyping, all the better.<\/p>\n

Image courtesy of\u00a0Vichaya Kiatying-Angsulee\u00a0at FreeDigitalPhotos.net<\/span><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

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