MEDICINE OCTOBER 19, 2010
by Carl Elliott
Beacon Press, 224 pp., $24.95
In 1989, a young man named Len began his residency in psychiatry. The year before, while a senior in medical school at Harvard, Len was interviewed for the position by four faculty members. Each judged him to be an “outstanding” candidate. During his first year in training, Len received solid evaluations from his professors. The jig was up, however, when a routine background check by the Board of Medical Examiners revealed that Len had never been to Harvard. It is possible that he never even went to college.
This vignette—a true story—frames Carl Elliott’s sensational and depressing message, which is that most doctors are dupes and the rest are corrupt. We never hear from Len again, it turns out. He was merely a stand-in for the pharmaceutical industry, whose dealings with physicians and medical centers make for many dark adventures.
As any faithful reader of the New York Times knows, the medical profession has suffered some serious self-inflicted wounds: high-profile physicians pocketing enormous “consulting” fees from drug companies or permitting drug companies to commandeer the content of their lectures; others accepting virtual payola from drug salesmen to tout their products. “Without actually intending it,” Elliott writes, “we have constructed a medical system in which deception is often not just tolerated but rewarded.”
At the outset of the book, Elliott, a non-practicing physician and trained philosopher who is a professor at the Center for Bioethics at the University of Minnesota, dispels any promise of even-handedness: “I do not claim to offer a balanced picture of contemporary American medicine. My interest is in how medicine has gone wrong, not in what there is to admire.” White Coat, Black Hat has vivid stories and more: lackey ghostwriters who pen journal articles under the names of cooperating physicians, and arrogant physicians who happily sell their reputations as paid spokesmen for Viagra and Vioxx. Elliot quotes many disgruntled physicians (“I had become a psychiatric callboy”) and former pharmaceutical employees (“Carl, I was almost a criminal”). He is a talented storyteller, and his skewering of pharmaceutical pageantry is particularly amusing. When invited by the Turkish Psychiatric Association to speak on ethics and the pharmaceutical industry, for example, he describes the conference venue—World of Wonders Kremlin Palace on the Aegean Sea—as a Vegas-like extravaganza “that is apparently designed to replicate the experience of a visit to Moscow’s Red Square under the influence of psychedelic drugs.”
My favorite chapter, on ghostwriting medical articles, is the least sensational. With no colorful scam artists to profile, Elliott nonetheless captures the culture of academic publishing very well. The final chapter on drug companies’ use of bioethicists will also be news to most readers, though Elliott’s general disdain for markets shines through: “There is no better way to enlist bioethicists in the cause of consumer capitalism than to convince them they are working for social justice.”
In the end, White Coat, Black Hat succeeds in highlighting the worst side of the physician-industry relationship. In fact, if Elliott’s revelations were fresh, the book would be a blockbuster. But the full truth is that academic medicine has made real progress in addressing conflict of interest. A growing cadre of medical researchers would say that the pendulum of surveillance has swung so far in the direction of zero-tolerance that earnest, young physicians or scientists are ridiculed if they even contemplate a career in private sector drug development. Within the past five years or so, virtually all the major interested bodies—the Food and Drug Administration, the American Academy of Continuing Medical Education, PHRMA, the American Medical Association , the International Committee of Medical Journal Editors—have issued robust standards to protect against conflicts of interest. The Wild West days of free-ranging drug salesmen, lavish gifts, and pharma-scripted talks are largely over. But Elliott’s book unfortunately keeps alive the impression that corruption, both subtle and overt, is rife.
The legitimacy of industry’s presence within academia has become a subject of much soul-searching among physicians over the last decade. Do various financial relationships between doctors and the pharmaceutical industry—promotional marketing, paid speaking and consulting, and research funding—compromise patient care, bias medical research, and diminish the integrity of the profession? The Institute of Medicine defines a conflict of interest (COI, as it is called) as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.” These kinds of circumstances should surely be minimized, but the atmosphere surrounding the COI management has become tense and accusatory. Writing in the Mayo Clinic Proceedings in 2009, a physician captured the spirit of the current discussion: “Today there is a McCarthyesque reaction to the term, conflict of interest, with an unstated presumption of guilt until proven innocent.” The possibility of a confluence of interest between drug makers and academicians in the service of patient care seems to never occur to some. Among the most vocal critics of physician industry relationships—dubbed the “pharmascolds” by a smaller cohort who thinks they have gone too far—are editors of major journals and high-profile medical school deans.
In response to such well-aired concerns, almost all medical schools have banned “detailing,” an activity in which pharmaceutical representatives bring lunch for doctors and trainees, hand out promotional material on new drugs, and offer “gifts” of modest value such as pens, pads, clocks, paperweights, and calendars bearing a company logo. Exorbitant five-star restaurant dinners and luxury golf junkets have now gone the way of the house call. Token items are bad, critics explain, because even a cheap plastic pen or Chinese take-out sets up an expectation of reciprocity, wherein the doctor feels compelled to prescribe the company’s expensive medication instead of a cheaper generic. Or, worse, a physician will prescribe medication when the patient does not even need it.
What we know to date is this: detailing does indeed tend to boost physicians’ prescribing of a given medication. But why assume that this represents a “thank you” for the free lunch? And, worse, why assume that patients were harmed? Rather than having succumbed to the siren song of the Prozac mug, perhaps doctors altered their prescribing patterns in hopes that new products would help patients who are not responding well to the current regime or who suffer unacceptable side-effects. Only prospective data on the prescribing habits and rationales of real physicians in real medical settings will answer the question. In the interim, as a colleague of mine has suggested, trainees and junior physicians should meet with pharmaceutical detailers (better yet, company scientists) only in the presence of supervising faculty, who would lead a probing discussion of the evidence behind the drug-maker’s clinical claims, critically evaluate the methodology, and consider generic alternatives. (It is a well-established fact that doctors are not particularly knowledgeable about the price of drugs. Nor do the vast majority appreciate the enormously complex, lengthy, and often doomed effort behind getting a promising molecule to market.)
It is one thing to scorn emblazoned mouse pads and other tchotchkes, but quite another to denounce academic-industry relationships. These partnerships are vital drivers of medical innovation. The “bench to bedside” process starts with university investigators—among the best and the brightest—who develop and then patent novel molecules and other inventions. The investigators then license those patents to private companies for “translation” into actual therapies. Fruitful public-private collaborations have produced dozens of life-saving therapies, including the vaccine for hepatitis B, beta interferon for multiple sclerosis, and Herceptin for breast cancer. This progression would be impossible without industry’s help, because the process is so hugely expensive, and because there is considerable intellectual capital within pharma needed to transform a promising compound into a safe and effective drug.
Another controversy surrounds industry funding of medical education for physicians, or Continuing Medical Education (CME). Doctors are required to collect educational credit for license renewal. The sponsored lectures, which take place at a medical institution, are given by other doctors and are intended to complement journal reading in disseminating the latest findings in disease physiology and treatment. At issue, of course, is whether company-sponsored lectures are skewed to favor the company’s drug. In major medical centers this is rarely the case given stringent policies whereby the sponsor has no input whatsoever into the content of the lecture or the selection of the expert. To be sure, regional variations exist, and I have heard about disgraceful cases of drug company personnel asking to see the speaker’s slides before his talk or offering to boost the honorarium if the speaker agrees to cover additional topics not in his planned presentation. At the same time, if other medical centers follow the University of Michigan—which decided last spring that it will no longer take any money from drug and device makers to pay for coursework doctors need to renew their medical licenses—training will suffer. Such a move will be especially damaging to non-academic medical centers—which comprise the majority of hospitals– because they will not be able to afford the lectures on their own.
Elliott does not pursue policy options explicitly, but he strongly implies that the only solution is to sever all ties between physicians and the pharmaceutical industry. At what cost? Here the author is resoundingly silent, as promised. Meanwhile, his insistence that pharma is the root of so much trouble distracts from an even bigger problem. If, as Elliott claims, American medicine relies so heavily on commercial interests to be its major source of intelligence about pharmacology and therapeutics, then the failure of the profession to educate itself is alarming indeed.
In White Coat, Black Hat, the pharmaceutical industry is a lightning rod for deeper anxieties surrounding consumer capitalism. “We have gotten so accustomed to the notion of prescription drugs as a commodity, an item to be priced, sold, and advertized,” Elliott laments. But economic gain is not the only potential corrupting influence within academic medicine. The intense quest for tenure, publication, promotion, federal grant money, editorships, and professional fame are famously compelling distractions from the best interests of patients and science.
Perhaps conflict of commercial interest should be treated the way we manage all conflicts of interest. That is, focus on practices (e.g. failure to disclose commercial relationships); police and punish concrete wrongdoing; and tutor trainees in the complex realities of maintaining professional virtue in a world where innovation is so often commercially driven. But in the black-and-white world of the White Coat, Black Hat, no such practical wisdom is to be found.
Sally Satel MD is a resident scholar at the American Enterprise Institute and a lecturer at Yale University School of Medicine.