Annals of Emergency Medicine
Volume 49, Issue 6 , Pages 785-791, June 2007

Docking the Tail That Wags the Dog: Banning Drug Reps from Academic Medical Facilities

Article Outline

 

Last September, Stanford School of Medicine decided its personnel could get along without any more free pens, pizzas, and perks. A task force at Stanford added the school to a small, expanding, and increasingly influential list, alongside Yale, the Universities of Pennsylvania and Michigan, and the University of California at Davis, all of whom have enacted policies regulating the activities of industry reps in academic and clinical facilities.

The national news media—highbrow (Atlantic Monthly1), middle (60 Minutes1), and low (The Daily Show1) alike—have recently focused public attention on drug marketing practices that all physicians recognize and many have decried.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 As Marcia Angell, MD,17 and others have documented, the pharmaceutical industry spends massive sums, far more than it spends on research and development even by its own estimates, for influence in every arena affecting its interests.

In Congress, this effort takes the form of lobbying and post-term hiring; among the general populace, direct-to-consumer advertising; and in the medical community, the industry’s famously expensive and aggressive detailing, as well as assorted activities that essentially amount to marketing under other rubrics, such as continuing medical education (CME), preceptorships, consulting, junkets, and certain types of clinical trials. Largesse from “Big Pharma” inevitably raises questions of conflict of interest (COI), and even physicians whose clinical judgment is unaffected by the reps’ posh treatment—assuming such physicians exist—face concerns about patients’ perception of COI and erosion of the trust essential to doctor-patient communications.

At the heart of the problem is a clash between 2 fiduciary relationships. For pharmaceutical executives and sales personnel, the primary duty is to make money; everything they do is subordinated to that fundamental goal. As Angell has pointed out, “these companies are not charities.”18

No matter how essential some of their products are in medical practice, adds Mildred K. Cho, PhD, Associate Director of the Stanford Center for Biomedical Ethics, “drug companies are like any other company: they have ethical obligations to their shareholders.… In their relationships with doctors, they’re going to have incentives to sell their products, and also to create products that sell well, as opposed to products that people need.” Physicians’ fiduciary responsibility is of course exclusively to patients.

The drug reps controversy reflects what Dr. Cho calls “the age-old tension between education and marketing.” Of the diverse organizational responses to it, complete bans on reps and gifts are relatively recent. Many eyes are on these universities to see not only how effective such measures will be at curtailing COI, but what other consequences might ensue.

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Strings Always Attached 

Developing relationships and brand loyalties early in a physician’s career is a rational investment from the industry’s perspective. Not everyone is comfortable being the target of such attention. Many define their own position by drawing informal lines, saying yes to small items like pens and cheap lunches, but no to larger gifts, expensive meals, and excursions. Such personal negotiations may not involve airtight logical consistency; 1 study19 found that 86% of medical students with ethical qualms over gifts valued below $50 accepted them anyway.

Anecdotally, many commentators describe physicians who understand COI as a general phenomenon but reject the contention that it affects them individually. Gene Carbona, executive director of sales for The Medical Letter and a prominent campaigner against marketing abuses, describes the typical response as a claim of immunity and a form of denial: “Most doctors will say ‘Any gift I take… has no effect on what I write, but it affects my colleagues.’” These disavowals conflict with sociologists’ and ethicists’ observations that any gift, regardless of material value, creates a subtly bias-riddled relationship,20, 21 not to mention the appearance of bias in outside observers’ eyes. Numerous studies have correlated detailing activities with changes in prescription patterns, those of emergency medicine residents not excepted.22

Carbona cites a litany of practices and consequences detrimental to patients: prescriptions for expensive new drugs rather than equally effective generic equivalents, sampling that encourages dependence on unaffordable brand name drugs (generics are almost never sampled),23 disingenuous offers of “patient assistance programs” whose fine print indicates that only the abjectly indigent can qualify, and pervasive dishonesty about the scale of marketing expenses relative to dollars for actual research.

“Nine out of 10 people will not be able to tell you the difference between research and development,” he comments. “Pharmaceutical companies are masters of drug development. Companies are not coming out with any new drugs; most new drugs are the product of university research, out of our pocket. NIH funds that. What [the companies] are masters of… is bringing new ‘me-too’ products to market, the 15th calcium-channel blocker, and they’ll spend a billion in hopes of getting $4 billion in sales. It’s almost organized crime.”

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An Honor System 

In 2000 the American Medical Association (AMA) enacted a set of nonbinding gift guidelines24 in an effort to curb at least some of the increasingly widely reported embarrassments. The American College of Emergency Physicians,25 the Accreditation Council for Graduate Medical Education (ACGME),26 and other professional societies have also developed sets of guidelines.

The Pharmaceutical Research and Manufacturers of America (PhRMA), in the wake of a particularly egregious scandal involving Medicare fraud and outright payments from TAP Pharmaceuticals for physicians to prescribe a controversial drug (leuprolide),27 issued its own marketing code28 in 2002, with provisions modeled on the AMA’s; many greeted this as a positive step. Neither of these 2 codes, however, includes enforcement mechanisms, and loopholes are substantial. Among the more obvious oversights, Angell points out29 that the PhRMA guidelines limit the value of gifts to $100 without also limiting the frequency of gifts.

Troyen Brennan, MD, MPH, and colleagues30 have argued that academic medical centers, where professional habits and values are forged, are the logical leaders in regulating and reducing practices conducive to COI. The backlash against the traffic in perks and prescriptions has spawned activist groups and gained a foothold in certain leading centers.

The No Free Lunch campaign spearheaded by Columbia University internist Bob Goodman, MD, the PharmFree initiative launched by the American Medical Student Association (AMSA) in 2002, and the Australian media-monitoring group Healthy Skepticism (formerly the Medical Lobby for Appropriate Marketing) all aim to dismantle the pervasive culture of entanglement and entitlement. Institutions taking steps in this direction to date have addressed not only gifts but access to clinical personnel and facilities, drug samples, provision of commercially sourced information with ostensible educational purposes, and disclosure of relationships between companies and clinicians or researchers.

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R&D Rhetoric? 

PhRMA responded to inquiries on the subject with a brief official statement defending the expertise of drug reps, calling attention to its marketing code, and reiterating the claim that its companies’ large expenditures, “an estimated $39.4 billion in 2005 in discovering and developing new medicines,” are dedicated “to inventing medicines that allow patients to live longer, healthier, and more productive lives.”31

To critics such as Angell and Carbona, PhRMA’s uplifting rhetoric masks a record of profiteering out of all proportion to its members’ development of beneficial new drugs. The industry group’s contention that reps have “comprehensive technical training” and that “many… are health care professionals themselves” also sits uneasily alongside the observation that college cheerleading squads are prime recruiting grounds for new reps, and that a specialized recruiting firm, Spirited Sales Leaders, was recently formed by a Memphis cheerleading camp entrepreneur specifically to channel former pom-pom artistes into drug marketing careers.32

Carbona spent 12 years as a Merck (later Astra Merck) representative himself, before joining the nonprofit Medical Letter and having what he calls a “retrospective revelation that I [had been] on the side of evil, so to speak.” Knowing the game from inside, he describes his former peers unambiguously as “salespeople with no science background whatsoever. Granted, my argument is weak if the sales rep is a PharmD or an MD; then I don’t have a leg to stand on. But 99.9% of the time, you’re going to enter into a clinical discussion with a sales rep [who] has maybe a business degree.”

His advice to physicians is equally direct: “There’s nothing of value with respect to drug information that comes from a pharmaceutical industry rep. There is absolutely no reason for any physician to enter into a clinical discussion about the care of his or her patients with somebody who’s not a physician.”

Carbona adds that “an emergency room setting is a gold mine” for drug reps, because emergency physicians constantly see new patients, each of whom might end up on 1or more chronic medications. The key values for reps are compliance and persistency, the latter denoting a patient’s need to take a daily dose forever. Primary care physicians control the largest numbers of refills and receive the heaviest detailing attention, but emergency departments are viewed as growth areas: “Most primary care reps don’t get a chance to get new patients. There’s much greater reward in an ER.”

This once respected industry has fallen so far in the public estimation that it ranks below nearly every other American corporate sector, according to a Harris Interactive/Reputation Institute study.33 Only the tobacco and oil industries inspired less confidence, according to that group’s 2005 survey, though the following year’s survey saw Pharma’s reputation rise above those of health insurance and managed care firms. Another 2005 study, the Kaiser Family Foundation’s most recent Pharma-related Public Opinion Spotlight, again placed Pharma below every field except oil and tobacco; 70% of the respondents believed the industry places profits above human needs.34

Nevertheless, even stern critics like Carbona caution that analogies to tobacco, whose product is inherently lethal, have little validity. Big Pharma produces goods that are vital to patients’ well-being. Wholesale, nuance-free demonization of the industry is not a viable option for even the most idealistic student, physician, or commentator.

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The Stanford Experience: Costs, Benefits, and Consistency 

Harry Greenberg, MD, professor of medicine at Stanford, senior associate dean for research, and chair of the 23-member School of Medicine task force that developed the policy, scrupulously acknowledges various beneficial forms of industry contact. To acknowledge the biases inherent in detailers’ influence, he says, “is absolutely not to say that we think there isn’t an incredibly important role for interaction with Pharma in academic medical centers. In fact, we have lots of grants supported by Pharma here at Stanford.” He adds that “many discoveries made at Stanford we try to move out into the community, and that’s frequently through Pharma.”

Research funding and technology transfer do not create the same direct interference with patient care and education, but the existence of longstanding, well-developed procedures dealing with COI in research created useful precedents. Avoiding contractual relations with companies that restrict open research communications, for example, is “a fundamental core principle of Stanford,” Dr. Greenberg asserts. The new policy brings clinical and educational activities into alignment with the policies on research, he says.

The strongest argument in defense of reps’ presence in hospitals and on campus, Greenberg believes, has lost whatever persuasiveness it once had. “The time-honored and useful role of pharmaceutical reps in distributing medical information,” he finds, has been “technologically eliminated” in the digital era. “You no longer have to go to the library and stand in line for a Xerox machine, or look up something in Index Medicus. You go to the computer that is around the corner in the clinic, and in two seconds you have more information than you could ever possibly dream of.” The classic tradeoff—detailed information delivered personally, in return for a certain degree of bias and influence—no longer struck Stanford’s leadership as an acceptable bargain.

Bioethicist Cho, who also served on the task force, points out that the new policy harmonizes not only with the university’s research regulations but with Health Insurance Portability and Accountability Act (HIPAA) privacy rules, which require hospitals to protect patient information from non-health care personnel and thus ban vendor reps from examination rooms and other sites where protected health information is accessible.35 She has heard arguments that the presence of reps on campus helps students develop critical appraisal skills, but since the policy provides for training about marketing strategies, and since students are inevitably exposed to industry interactions off campus anyway, she finds this immunization argument unpersuasive.

The point is not to try to contain students in an “isolated bubble,” she says, or to pretend COI can be fully eradicated—“I think in any endeavor there’s inherent COI”—but to bring consistency in COI management to the clinical and academic setting.

For universities considering a similar move, Greenberg stresses the importance of orderly procedures. “We did it by trying to engage a broad spectrum of people in the medical center: faculty, hospital administrators, and staff, with a fair amount of publicity, articles in the Dean’s newsletter, and meetings of the executive committee that worked on hammering out the policy.”

He credits Yale’s example as an influence but believes Stanford devoted greater effort to the details of rollout than other institutions have done to date. Stanford made the new policy available online, set up a dedicated phone line, and charged an implementation committee with handling questions about interpretation. “It’s gone quite smoothly,” Greenberg reports; “there hasn’t been a great uproar.”

Stanford still allows free drug samples but channels them through the medical center’s pharmacy, which makes decisions about matching available freebies to patients’ needs; donations to individual doctors are banned. Pharmaceutical support of education is also still permitted, but only to departments, with no strings allowed. Device reps are allowed to assist with in-service training of physicians and nurses in hospital or school medical areas on an invitation-only basis. Enforcement has not been a problem to date, and Greenberg attributes the few compliance gaps of which he is aware to “interpretation or lack of knowledge,” not resistance on faculty members’ part. The policy allows for sanctions such as removal of clinical privileges in the event conscious violations occur.

Greenberg acknowledges that it remains unknown whether keeping Pharma from affecting the educational process through gifts and travel will also affect what he calls “the 800-pound gorilla in the room… the influence of Pharma on the individual practice of medicine. That is, does somebody use a device or prescribe a treatment in an ER or anywhere else, that is influenced by their own personal financial relationship?”

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Fighting Information With Information 

Even if every academic medical center in the country adopted a no-reps policy and every student or resident took PharmFree’s pledge to refuse gifts, seek unbiased information, and avoid COI, the commercial influence on American medicine would still be deeply entrenched. Established COI safeguards in other areas of medicine have not eliminated it, merely driven it into different channels. Questions of sheer scale provide useful context as well: Carbona points out that some 100,000 drug reps, each talking to 5 or 10 physicians a day, flood the medical profession with half a million to a million daily targeted messages—far more than any other industry generates, and voluminous enough to make a group of resolute students and deans seem like King Canute commanding the waves.

Cho cites the trend toward private non-academic settings for clinical trials, for example, as one way Pharma finds its way around regulations. Until about the 1980s, she observes, over 80% of clinical research took place at academic centers; this proportion has shifted, in her estimate, to 20% or less. Contract research organizations have taken up much of the slack; away from academic settings (with their COI regulations, human subjects protection, and federal funding entailing research objectivity guidelines), these privatized research management firms pay outright bonuses to community physicians for enrolling certain numbers of patients. The upshot for professional standards and open communications in clinical trials has been troubling.36, 37

Another area where companies generate a tide of nonobjective information is direct-to-consumer (DTC) advertising, which companies might plausibly amplify if their traditional means of reaching physicians are substantially cut off. Carbona points out that the appeals to patients and potential patients are growing increasingly sophisticated. As industry “see[s] that people are starting to steer away from drug reps and pharmaceutical CME,” he notes, it is responding with an insidious new marketing genre called “drugumentaries.”

The recent Home Box Office series Addiction, for example, amounts in his view to “a 90-minute promotional commercial” for pharmaceutical approaches to alcohol and drug detoxification. “What they’re doing now is funding these young budding artsy-fartsy filmmakers, giving them equipment, and asking them to do these drug documentaries. It was shocking to me; it was all promotion.… Every sentence, it sounded just like a detail piece. Whoever’s responsible for this, I’d like to shake that man’s hand.”

If reductions in marketing to physicians results in more DTC ads, product placements, and similar messages, physicians can expect to encounter more patients whose expectations are based on commercial information. Reliance on nonbiased information sources will be critical, if more difficult, in such an environment.

AMSA’s PharmFree endeavors to make academic centers a spin-free zone. Association president Jay Bhatt, a fourth-year student at the Philadelphia College of Osteopathic Medicine, views relationships with Pharma as a steep and slippery slope.

“It only takes one lunch, one, to make a medical student feel entitled,” he says.

Nevertheless, Bhatt speaks optimistically about “health care justice” as a high priority among his peers, and he hopes that his generation of physicians will develop a better-articulated sense of professional ethics than most of their forebears have had. One key to making these ideals practical is to cultivate quantitative analytic skills.

“More and more institutions are developing a curriculum that allows for them to give the students tools to evaluate data and look for bias… and do it quickly, because time is certainly an issue,” he says. “Current practicing physicians didn’t have a lot of that in their medical education.”

Along with pledges, lectures, and events in collaboration with the No Free Lunch group, PharmFree sponsors a Counterdetailing Initiative, which sends medical students to physicians’ offices to distribute materials on evidence-based noncommercial information sources. (Though PharmFree’s position occasionally ruffles faculty feathers, it is consistent with the core principles of medical education: the ACGME’s position paper26 mentions awareness of both marketing practices and ethical guidelines governing them as aspects of 4 of the 6 essential professional competencies mandated for accredited residency programs.)

Bhatt cites drug samples, in some circumstances “a tremendous value to indigent patients,” as the one useful thing a drug rep can provide. The relevant AMSA policy statement,38 while rigorous about other components of university-industry relations (particularly sponsored educational events), does not ban sampling.

Policies on samples, as on other topics, reflect wide differences of opinion. Yale,39 unlike Stanford, allows samples while cautioning against prescribing expensive brand name medications. UCLA’s Geffen School of Medicine adopted gift-ban guidelines in November and discourages, but still allows, direct sampling to physicians when patients cannot afford medication. The policy at UC Davis, which becomes effective July 1, bans samples, gifts, and preceptorships conducted by university personnel for industry reps. Penn40, 41 bans gifts unrelated to patient care and samples for inpatients (allowing sample vouchers for outpatients), confines reps to private offices by appointment (explicitly including the emergency department among off-limits areas), and limits detailing to items in the university’s formulary, with a Center for Evidence-Based Practice overseeing all marketing activities.

Some institutions require elaborate approvals but actually prohibit few of the controversial practices: Duke,42 for example, bans only clinical activity by vendor reps, breaches of HIPAA protected information rules, and payments to house staff, residents, and students, while explicitly encouraging industry-sponsored CME, sampling, and preceptorships for reps.

AMSA has been accumulating data on the various university policies and developing a report card system to indicate the status of each institution’s position. Not all schools have replied to the inquiries, Bhatt reports, but his group has acquired enough information to make its scorecard public; a news release is imminent at this writing.

“You get an A if you have a comprehensive policy that restricts access to both the medical school campus and the academic medical center,” he states. “The ones we’ve given As to are Stanford, Michigan, Penn, Yale, and Davis.”

A grade of B indicates a limited policy that applies to the academic medical center but makes little or no mention of the school or medical students. Other grades may not necessarily mean an institution ignores COI, but that its policy is unformed. A school not even considering a policy gets an F.

Michigan’s policy was among the nation’s earliest, with a sample ban initiated in 2002 and restrictions on reps instituted in 2003. It remains among the more stringent. Along with banning gifts and samples outright (replacing samples with vouchers for starter doses of preferred agents in the formulary), it requires reps to register with the university’s contracts and procurement office, visit individual clinicians only by appointment, give textbooks and other items of educational value only to departments rather than individuals, avoid roaming halls and other areas frequented by clinicians to prevent chance encounters, and wear a red vendor badge while on the premises.

University of Michigan Health System emergency physician Steven L. Kronick, MD, MS, reports that adoption of the hospital-wide policy aroused little controversy. His department had already led the way, banning industry-sponsored meals in the mid-1990s, predating the hospital’s efforts.

“The cleanest way to do it,” Kronick’s group decided, “was just not to accept anything.”

Both the departmental and university policies, he believes, had more noticeable effects on vendors than on physicians. When he encounters reps at meetings, he hears that Michigan’s ban is “making it more difficult for them to get information out; there are venues not available to them that were available before. I’m sure they’re pretty good about coming up with strategies to change that. The direct-to-consumer campaigning is probably in response to some of that limitation.”

In contrast, the transition cost Kronick and his colleagues nothing they really valued. “I think everything we do we try to make evidence-based,” he says. “We just felt that we’ll use the peer-reviewed literature as our source of information, rather than the drug companies.” Samples were not missed either, he recalls: “People felt uncomfortable with the idea that they would give a medicine just because they happened to have it there.”

If medicine is to restore Pharma to a balanced position, controlling information appears necessary; whether it is sufficient is a harder question. Medicine differs from other professions in how it handles COI. The question of disclosure is a salient point. New sunshine laws in Vermont and Minnesota mandating disclosure of industry payments to physicians, as Joseph Ross, MD, MHS, and colleagues43 recently pointed out, neither stemmed the flow of cash (including many payments above PhRMA’s $100 threshold) but what little data were available was startling.

According to the study published in JAMA this year, in Vermont over the 2 years analyzed, 12,227 payments totaling $2.18 million were publicly disclosed. Of these, 2,416 payments to physicians involved $100 or more, totaling $1.01 million with a median payment of $177. In Minnesota over the 3 years studied, 6,946 payments totaling $30.96 million were publicly disclosed. These included 6,238 payments of $100 or more to physicians, totaling $22.39 million with a median payment of $1,000.

Companies used a “trade secrets” classification to withhold most of the Vermont data, the remainder was largely incomplete, and both states failed to develop reasonable access or quality control procedures.

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Disclosure No Panacea 

To Stanford’s Mildred Cho, this finding implies that disclosure per se—sometimes held up as a panacea for COI concerns—fails to constitute useful transparency.

“Just having a law on the books,” she says, “doesn’t mean meaningful facts will be disclosed. The implication is that if disclosure is an important goal, it’s hard to achieve.… One question is whether it’s possible, and the other is whether it’s enough.”

Drawing on Andrew Stark’s analyses of COI in various realms,44 she finds that medicine has developed a peculiar professional culture in which relationships that other fields would designate as unavoidable COI are either denied, rationalized away, diminished in importance, or regarded as a harmless entitlement.

“In law,” she says, “it’s taken for granted that people are subject to conflicts of interest, and that they will be influenced by them, so basically disclosure is almost never used. You recuse yourself from certain situations.”

Elected officials, under different conditions, may use either disclosure or recusal. The critical factor, she holds, and the factor bearing on medical practice, has to do with who has power over whom. Voters are in a position to remove a representative if the information disclosed about that official’s conduct strikes them as intolerable.

Most patients—certainly almost all patients encountered under the pressures of emergency practice—are utterly under their physicians’ power. Without their physician’s interpretation of complex specialized information, including the reliability of the physician’s own information sources (eg, corporate CME), “patients have no idea that you just disclosed something that’s of any relevance,” says Cho. “People that should get the information aren’t getting the information; it’s not clear they’d know what to do with it.”

This fiduciary relationship, Cho believes, requires not just the disclosure of interests conflicting with those of patients but the removal of those other interests. “The historical perspective on disclosure,” she concludes, “is that disclosure was never meant for fiduciary relationships and situations. It was only meant for situations in which there is an agency: the people to whom the disclosures are made have some ability to act.… Somehow the medical profession just hasn’t gotten their heads around that.”

Though much that Pharma provides is invaluable, recognizing that Pharma can never provide the disinterested information physicians need may amount to a constructive, welcome, and long overdue recusal.

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PII: S0196-0644(07)00487-8

doi:10.1016/j.annemergmed.2007.04.010

Annals of Emergency Medicine
Volume 49, Issue 6 , Pages 785-791, June 2007