American Journal of Ophthalmology
Volume 146, Issue 2 , Pages 159-171, August 2008

Debunking Myths in Physician–Industry Conflicts of Interest

  • Paul R. Lichter

      Affiliations

    • Corresponding Author InformationInquiries to Paul R. Lichter, Department of Ophthalmology and Visual Sciences, University of Michigan, W. K. Kellogg Eye Center, 1000 Wall Street, Ann Arbor, Michigan 48105

Department of Ophthalmology and Visual Sciences, University of Michigan, W. K. Kellogg Eye Center, Ann Arbor, Michigan.

Accepted 2 April 2008. published online 07 May 2008.

Article Outline

Purpose

To call attention to the myths that surround physician–industry conflicts of interest, to refute their validity, and to propose ways to address them so as to insure that physicians make medical practice decisions in the best interest of their patients.

Design

Perspective.

Methods

Review, analysis, and discussion of the implications of selected pertinent literature.

Results

Physicians often have voluntary financial relationships with industry based on behaviors and motivations that include entitlement, recognition, belonging, and money. The pharmaceutical and device industry spends billions of dollars annually in marketing to physicians. The sophisticated marketing plan seeks access to physicians through gifting mechanisms to ingratiate them and to influence them to prescribe industry's drugs and to purchase its products. Despite widely accepted studies that demonstrate that industry's marketing activities influence physicians' medical practice behavior to the detriment of patients and the public, physicians persist in voicing myths to justify their partaking of industry's largesse. Many physicians believe that their voluntary financial conflicts of interest with industry can be managed by simply disclosing them and by “being honest.” Yet there is no support from well-conducted studies to support the effectiveness of this approach.

Conclusions

Medical organizations and academic institutions are the ones to take the lead in recognizing that these voluntary financial conflicts of interest are unacceptable and should be stopped. Such conflicts mainly relate to the acceptance of gifts and money that are designed to influence behavior and are a form of financial coercion.

 

Myths abound when it comes to justifying voluntary and avoidable physician–industry relationships: “I was just there to teach,” “Nobody told me what to say,” “I always disclose my conflicts of interest,” “The money won't influence me because I know what they're trying to do,” “I don't even remember who bought me dinner,” “I need to network with industry leaders,” “My department can't get along without industry's money,” “Being on an industry advisory committee lets me see what's going on from the inside,” “Companies need my advice and that's why they pay me,” “Since I consult for many different companies, conflict of interest is a moot point,” or “A company can't influence me to change my prescribing habits.”

These myths and others like them persist despite an extensive and widely accepted body of literature that conclusively shows that industry–physician conflict of interest—including industry's expanding role in continuing medical education1—is driving up the cost of healthcare to the detriment of the public, the medical profession, and our patients.2 Perhaps the overriding myth is the one implying that the prescribing of medicines and the ordering of tests and treatments is no different than advice we receive on TV to buy a particular kind of soap. Yet no one has the power to make us buy the soap. However, physicians have professional status that gives them power over their patients such that prescriptions for drugs will be filled and orders for tests will be completed. Thus, if industry can influence—even just a little bit—our attitude toward drugs and devices so that we write more prescriptions and write them for more expensive and sometimes unneeded drugs, or that we order tests or treatments that may not be necessary on devices that may not have proven value, then the gain to industry's bottom line can be enormous. Why do physicians, medical organizations, and academic departments support and defend—often vehemently—these myths and these conflicts of interest? There are practical issues like the gifts and money those conflicts generate and there are psychological issues like the good feelings generated by being recognized and by belonging to a perceived select group of peers. Then, too, there is the rationalized belief that these conflicts can be managed by disclosure or that one really is not conflicted by taking the gifts or the money. Physicians, be they community practitioners or academic department chairs, commonly deny that interactions with industry can influence their behavior.3, 4 Finally, there are philosophical issues wherein physicians, organizations, and institutions believe that education is good no matter who controls the content or who pays for it.

Changes are taking place in the way that physician–industry relationships are being viewed. Interactions that may have been acceptable or tolerated in the past are under serious scrutiny. Much of this scrutiny relates to industry conflict of interest with individual physicians, with continuing medical education (CME), with academic medical centers (AMCs), and with medical organizations. Safeguarding the public's interest is the critical issue.5 Thus, medical organizations and academic institutions are paying increasing attention to the conflicts these industry ties create.6, 7, 8 Like individual physicians, these entities must continue to ask themselves what the purpose is in having close financial and programmatic ties with industry.

The relationship that physicians, medical organizations, and academic departments have with industry is complex in that industry makes its living from the prescriptions that physicians write and from the devices and services they purchase. Yet physicians, medical organizations, and academic departments commonly receive money and other benefits from industry. “Money or favor given or promised in order to influence the judgment or conduct of a person in a position of trust” is Merriam-Webster's definition of bribe.9, 10, 11

This perspective presents background on the physician–industry conflict of interest issue. It examines the motivations, attitudes, and practices of the parties involved and discusses measures that have sought and are seeking to change the attitudes of individual physicians, academic departments, and medical organizations toward the effects of these conflicts of interest on the practice of medicine. Readers will recognize that industry weaves its marketing web through individual physicians, medical organizations, and academia at the same time—intertwined with the goal of the broadest influence possible on the practice of medicine.

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Background 

Congressional hearings,12, 13 the Office of the Inspector General,14 the press,15, 16, 17, 18, 19, 20, 21, 22, 23 books,24, 25, 26 the peer-reviewed literature,3, 5, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36 a bioethics research institute,37, 38 and topic-driven websites39, 40 continue to raise serious questions about the appropriateness of most types of physician–industry relationships and to propose ways to eliminate them. Yet, as noted above, physicians perpetually and staunchly defend their partaking of industry largesse for reasons that boil down to this: physicians believe that they are too smart to have their medical judgment influenced by industry's marketing tactics.41 This attitude has survived despite the lack of evidence to support it and an abundance of evidence to refute it. A truism that is difficult to grasp when dealing with health-related industries is that all industries have one goal: to make money.42 There is no professional ethic to hinder this goal. There are classic business school cases about Philip Morris'43 and Starbucks'44 marketing success—aided by their products' addictiveness—that should cause us to pause when we face sophisticated marketers. Can there be ethics in businesses whose bottom line depends on marketing products that are clearly detrimental to the public's health? Yet, there seems to be a disconnect for physicians when the same marketing approach is aimed at them to prescribe more expensive drugs and to purchase more costly instruments that may not be in their patients' best interest. The public—and physicians—are heavily overmatched when it comes to Madison Avenue marketing.

Physicians even help industry's efforts to keep the money flowing by claiming that they cannot do without industry subsidies to reduce their meeting costs or that academic departments need industry's money so that their trainees can go to conferences.45 Arguments defending the gamut of physician–industry conflicts of interest can be carried to extremes. Thomas Stossel, while protesting the increasing efforts to identify and limit inappropriate physician–industry relationships, makes a telling statement: “I do not deny that industry is profitable, occasionally venal, or sometimes even criminal, but to imply that doctors lack these characteristics is blatantly unfair.”46 He implies that as long as profit motives, venality, and criminality are balanced between industry and physicians, it is just an expected part of our market economy. Others seem to think that the more gifts physicians take, the greater their certainty of strength of moral character. One physician proudly conveyed how he earned more than $100,000 in one year giving talks on behalf of a number of drug companies.47 He was comfortable in doing so because he said he only talked about drugs he thought were “best.” He, like many other physicians on industry's payroll, loses sight of the negative impact on healthcare costs that emanates from the collective actions of the medical profession in their industry conflicts of interest.38 To address and, perhaps, to deflect concerns about physician–industry relationships, guidelines have been written by the American Medical Association (AMA), by the pharmaceutical industry, and by medical organizations to deal with them.48, 49, 50 However a careful read of these guidelines reveals wide discretion in how they may be interpreted. Notably, the AMA conducted a campaign to educate physicians about its guidelines, and much of the campaign was funded by pharmaceutical companies.51

To be sure, conflict of interest has always been a part of medicine. We physicians deal with conflicts of interest with every patient we see.52 Our advice to the patient determines the frequency of return visits or the decision to perform in-office testing or to undertake a surgical procedure. Yet, we have an ethical obligation to provide advice and treatment that is in the best interest of the patient. If we have received a gift from industry that encourages us to prescribe an unneeded medication or one that costs more than an equally effective alternative,2 are we acting in the patient's best interest? The term interest is one that deserves greater scrutiny.

In a thoughtful discourse on the ethical nuances of conflict of interest, Brody26 discusses how the word interest is a weak term when it comes to a physician's obligations to her patients and that duty is a more appropriate term. As a real-world example, physicians may have an interest in making money. However, in their dealings with industry, it is not sufficient to compare this interest with another interest of providing the best care for patients. The issue of conflict of interest is not valid in this situation. Rather, a physician's obligation to her patients is far more than an interest for the physician; it is her duty. So, although physicians have an interest in making more money, there is not a duty to do so. This is contrasted with the duty to place their patients' interests above their own practice-related financial interests. Sieghart also spoke about a professional's duty: “Within a professional relationship, altruism is paramount and self-interest has no place. The professional has a duty, regardless of his own interests, to put the skills at the service of those who need them. It is striking how profoundly this ethos differs from the rule of conduct applicable to every other market in the supply of goods or services. No merchant or shopkeeper is under any comparable obligation; nor are the suppliers of other services, however skilled.”53

A particularly enlightening article by Mather54 reviews the culture of gift-giving and the literature documenting how industry benefits, in every sphere imaginable, from its marketing tactics with the medical profession. He speaks of “capital conversion” whereby clinicians and scientists reciprocate with industry by exchanging their own cultural capital for industry's economic capital. Mather points out that “the target of industry marketing is not so much the individual agent as it is medical practice.” He goes on to explain that industry recognizes the need to understand its relationship with physicians and the health profession from a “macro-structural” scale rather than from the “micro-structural” viewpoint taken by the profession. Mather conducted extensive interviews with numerous healthcare personnel in an academic institution to formulate and support his concepts.

The literature is replete with evidence that industry goes to great lengths to steer physicians away from their duty to serve the best interests of their patients. After all, it is physicians who, as gatekeepers, control industry's success through the prescriptions they write and the devices they purchase. Physicians are the gatekeepers that industry covets. It is no wonder, then, that industry uses enormous amounts of money to influence physicians, but in a way that makes physicians believe that they are not being influenced.55 A 2006 report by Steinman and associates deals with the specific issue of Parke-Davis's illegal marketing of its drug Neurontin for off-label uses.56 Some $40 million was spent on marketing the off-label use of the drug to physicians. This activity was illegal. Prescriptions for off-label use soared. Much of the marketing campaign involved activities with hidden marketing intent such as funding for speakers bureaus and key opinion leaders.

It is no surprise that this industry—pharmaceutical and device—behaves like any other for-profit entity. It seeks profits through investments. What is interesting, though, is how well industry blurs the distinction between marketing and education56 and how naïvely physicians help those industry efforts. How is this accomplished?

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Physician Motivation and Rationalization 

As individual physicians, our motivations in relation to industry are several. It is unfair to generalize and say that each of us has the same motivations when dealing with industry, but I review a few compelling ones, one or more of which may apply to a particular individual. Although written in different terms than Maslow used in describing his hierarchy of needs,57 the concepts are similar in that physicians deal with industry in part to help fulfill human motivations. In turn, industry plays on those human motivations to initiate and perpetuate its relationships with physicians, with the organizations that represent them, and with academic institutions that train them.

Entitlement 

As a first motivation, we may see ourselves as being entitled to whatever industry offers us.58 There can be a number of reasons for this sense of entitlement. For many in my generation, recollection of our first days in medical school are associated with receiving our first doctor's bag—black leatherette with two handles and fasteners on the top—and the pride we had and the gratitude we felt toward the company that gave it to us. Thus began our gifting relationship with industry. As more gifts came, we felt more entitled to them. We received “stuff” from companies and, later, snacks and meals, free samples, maybe a book, and whatnot. We believed that we worked very hard and that these freebies were simply part of the reflection of the companies' recognition of our hard work. The gifts continued and increased during residency and practice—lunches brought in by drug representatives during a briefing about a new drug, or simply as a chance for us and our staff to eat conveniently. There were and are dinner meetings where an out of town expert may be flown in to talk about a topic that is sure to include drugs, devices, or both. If we are accused of having a conflict of interest by taking the free meals and “stuff,” we bridle even at the hint that we can be bought, and in fact, we proclaim that we know what industry is trying to do and we would never fall for it.46 Of course, we also believe that while we are not influenced, our colleagues are.55 This is true of medical students59 as well as residents60 and practicing physicians.41 Invariably, industry spokespersons support physician prescribing behavior by stating that it is an insult to physicians' intelligence even to suggest that their integrity can be bought for a dinner or a pen.

If our prescribing patterns—available to industry through subscription to an AMA-sponsored service with an interesting history61—and, perhaps, our personal attributes are promising to a company, we may be invited to a resort for an “advisors” meeting or the like—some way to raise the ante toward further eliciting our thanks in the form of more prescriptions for the company's products and, perhaps, becoming a company speaker to help convince others to prescribe more of those drugs. We may be targeted by the company to become a key opinion leader who may be the one who helps train the speakers for the local talks. We may well believe that we are entitled to every bit of money a company is willing to pay us or gifts that they direct our way.

Recognition 

A second potential motive for physician–industry relationships is recognition. Many of us like to be recognized as an expert, and when industry turns us into an expert by choosing us to be on the circuit, our name and sometimes our photograph are printed in programs. When we speak at a meeting, our fellow physicians come to hear us. They applaud for us and then ask us questions—sometimes hanging on every word we say. This can be a heady feeling. We sometimes are tapped as a key opinion leader and think that this makes us special, even though this recognition makes it clear that we have been converted into salespeople for industry.62 Yet, whatever role we take on industry's behalf, when we are challenged with the conflict-of-interest phrase, we bristle at any inference that the honoraria and recognition we receive may bias us to favor a company's interest over that of our patients. We claim that the company does not tell us what to say and that we are “only there to teach.” We believe that our teaching is so valuable that the chance the company gives us to do it trumps any possible conflict that may arise for us or for the dinner attendees who have been convinced to attend. We can not imagine that any of this is wrong.38 By responding to the recognition industry arranges for us, we are helping industry to mask sophisticated marketing techniques under the guise of education. What is more, our attitude in defending ourselves and industry against any questions of conflict of interest are even more to industry's liking.

Some of us may be so good at what industry gets us to do that we are invited to be on a company's scientific advisory board. This recognition makes us believe that we are even more entitled to payments from industry because, after all, the word advise implies that we are using our expertise and brain power to assist the company. In fact, we may believe that we are entitled to large payments for being on this advisory board. Although companies do have physicians who provide them with important advice regarding drug development and marketing, many industry scientific advisory boards are simply vehicles to establish gratitude and enhanced loyalty among recognized physicians. Industry's business strategy is to convert its “advisors” into salespeople. Even cleverer are the companies that gather their advisory board members from around the world and then have board meetings in far-flung and seductive venues. The international recognition for advisory board members is even puffier. We may believe that we are entitled to the money and the fancy trips, yet not consider that our acceptance of the money and trappings establishes conflict, drives the writing of more prescriptions for expensive drugs, the purchase of unproven devices, and the ordering of non–evidence-based tests—all of which increases patient burden and drives up the cost of healthcare. Members of company scientific advisory boards likely cannot imagine that they or their esteemed colleagues are doing anything improper. After all, they believe that they are offering valuable advice to the company and deserve proper consideration in return. It is unlikely that they would think for a minute that they are being duped by highly sophisticated and well-disguised marketing schemes. Yet the obvious glows so brightly that we can not see it. Why would industry spend millions of dollars on our honoraria, our travel, and on the steak dinners for the attendees if industry did not know that these expenditures lead to more prescriptions for its drugs or to more purchases of its devices?38

Belonging 

A third motivation for our relationships with industry is the sense of belonging that those relationships create. For the individual practitioner, an invitation to a fine steakhouse for dinner provides the chance to mingle with colleagues whom the company believe are worthy of such an invitation. The sense of being special is created by the company. Added to that is the chance to mingle with the out-of-town speaker. Physicians who do not care to partake of industry's largesse face a particularly difficult problem because attendance at meetings and interacting with colleagues is part of physicians' professional responsibilities and often is necessary simply for them to do their jobs. One is reminded of the smoke-filled conference rooms of bygone days where physicians who wanted to take part in professional meetings, but were opposed to being subjected to second-hand smoke, had no options. Either forsake one's professional interactions or endure the smoke. Today, with industry sponsorship of CME activities, the smoke-filled room that was difficult to avoid is replaced with the room of free hors d'oeuvres and drinks and the course with reduced registration fees. Avoiding industry largesse can compromise one's opportunity to interact with colleagues. Our colleagues who welcome industry's intrusions and who organize and run the meetings with industry sponsorship are imposing their will on those who disapprove of those industry conflicts of interest. Even when one recognizes that CME is being used as a subterfuge for industry marketing, one may feel forced to partake of it simply to do one's job.54

Money 

A fourth motivation of physicians to enter into and maintain relationships with industry, and the one that most effectively establishes that relationship, is, in fact, money. Industry pays us for being a speaker, for participating on an advisory board, and for giving advice. We are enticed by the money. Perhaps we believe that the inexorable reduction in reimbursement for our medical services is a good reason to accept some money from industry to offset what we believe is unfair loss of practice income. Or, in the case of CME, we may believe that what we are doing for industry is a service to our profession and to the colleagues who come to hear us speak. In any event, we like the money. We even like the indirect benefits of money that we do not receive as cash: receptions and dinners paid for by industry, or CME courses with no or a reduced registration fee are money we do not have to spend. We like that, too.

Thus, entitlement, recognition, a sense of belonging, and money are among the motivations many physicians have in accepting industry largesse that creates conflict of interest—or, more accurately, perhaps, conflict of interest above our professional duty. Again, as Brody points out, we have no duty to earn more money, but we have a duty to our patients and to the public.26

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Industry's Motives 

Companies are in business. Their bottom-line obligation is to increase value to their stockholders: to make money.42 Whether the company sells soap, refrigerators, drugs, or medical devices, the stockholders want to see profit. If a company makes what seems to be a charitable contribution, it is done with business intent. The gift may do some good in a community or in other ways, but the company's stockholders do not want the company to act like a charity and spend money that has no business purpose. What, then, is industry buying with some of the $57.5 billion it spends annually on marketing to physicians—$61,000 per physician—or nearly twice as much as expenditures for research and development?63

Industry buys access, influence, and gratitude. These are intertwined. When a company sets up a steakhouse dinner meeting, it needs a speaker to make the meal simply incidental to an educational activity and, therefore, acceptable under various physician–industry gifting guidelines. As stated above, often the speaker is an out-of-towner whom the company promotes as an expert even if the individual is a newcomer to the circuit. The company may be testing him or her out to see how well she or he performs. Doing well means that more invitations will follow. The company then invites that speaker to regional, national, and, for the best performers, international meetings, for this is how their products are marketed. Whether it is a local steak dinner meeting, a regional meeting where registration fees are nominal or complimentary, or a national or international meeting, the object is to attract attendees, to give them something, and to have the company's representatives mingle with the crowd: the chance for access and the chance to influence.

The representatives work to solidify their relationships with existing good prescribers and seek out new prescribing recruits. In the end, the free meals, reduced registration fees, and whatever else may be a part of the company's “generosity” are designed to create a sense of gratitude on the part of the recipient. In our culture, gratitude leads to reciprocity.54 That comes with good feelings toward the giver. When a physician has good feelings toward a company, she or he will reciprocate by writing prescriptions for the company's drugs or by buying its devices, regardless of whether the company provided an expensive gift such as a free resort trip64 or simply a free cup of gourmet coffee from a coffee cart in the hospital.65 Best of all for the companies, the physician does not believe she was influenced by the gifts to write these prescriptions. All of these efforts are part of business strategies and tactics that have proven over and over again to be effective.

Industry does much of its marketing to physicians through its ever-increasing influence on CME and through payments or gifts to both physician teachers and meeting attendees. In 2006, industry covered the cost of 61% of CME, spending nearly $1.45 billion, or more than three times what it spent in 1998.66 In the context of advancing its shareholders' collective interests, this activity is simply business driven. Yet the partners in this dance should realize that the dance itself is problematic. Each physician, professional organization, and academic institution is complicit in endorsing industry's behavior and, with that endorsement, of perpetuating the belief among many practitioners and others that industry's duty is the same as the profession's—namely, to act in the best interest of patients. Difficult as it may be to accept, industry has no such duty. Industry's responsibility is to act in the shareholder's best interest. Industry wants us to believe otherwise, of course, and we naïvely help to make that happen. An important part of what industry is buying with its money is professional recognition and the endorsement it implies from leaders in the field.

Industry targets leaders because of their name recognition and the respect in which their colleagues hold them. In academia, there are decisions on pharmaceutical formularies and on research projects and policies that industry has an interest in influencing and that academic institutions should have an interest in keeping free from industry influence.67, 68 In professional organizations, the clinical care guidelines they produce are desirable prey for industry; having grateful committee members on these guideline panels can yield results favorable to industry's products.69 The influence wielded by industry's grateful panelists is not necessarily blatant. In fact, the less blatant, the better it is for industry.

The “fallacy of unique expertise” is a helpful phrase coined by Kassirer to debunk the commonly stated justification for having conflicted physicians on guideline and policy panels—namely, that those are the physicians “in the know” and that physicians without conflicts cannot be the best experts.70 These beliefs are promulgated despite strong evidence that conflicted panelists are influencing guidelines and policy to the detriment of patients and the public.71

Industry has an interest in supporting medical organizations to gain favor from their executives and board members. These are the people who decide on broad programmatic issues for the organization from which industry can benefit. The recent partial funding by industry of 10 new dermatology residency positions speaks to the value to industry of its established relationships with physician leaders of professional organizations.72 Apparently, the American Academy of Dermatology Board of Directors devised the plan to increase the supply of dermatologists. Just saying “yes” to an organizational leader's request for funds curries favor from that leader in whatever discussions or votes may occur later that may affect industry's interests. In fact, giving gifts to the charities of physician leaders is an industry ploy to engender gratitude chits.17 Industry does not care whether its payments go into the pockets of physicians or to their charities. As long as the physician has a reason to be grateful to industry, that is what counts most.

Expressing gratitude to industry seems to be a natural for physician organizations as much as it is for individual physicians. When organization leaders speak or publish glowing words of thanks to industry for “contributions” to the organization, the influence on the rank-and-file members is bound to be significant. Any of us who has attended national medical meetings or has read the meeting program booklets can not help but recall how well organizations thank their donor companies. Sometimes industry officers are called to the stage to accept handshakes and hugs of thanks along with a plaque or trophy—all to the applause of the audience. Faces of executives are splashed on large screen televisions. This imprimatur that these industry relationships are not only acceptable, but are warmly encouraged, shows how well it pays for industry to curry the favor of medical organization leaders. The web of relationships is intricately woven by industry—all in the name of goodness to support education, charities, or whatever is needed to generate those feelings of reciprocity.

Thus, access, influence, and gratitude are the three outcomes that motivate industry, and it has many well-practiced strategies and tactics to use them to raise profits—sometimes with unjustified burdens on patients and the public.

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Medical Organization Motives 

The motivation for medical organizations to have financial conflicts of interest with industry reflect, in part, the same motivations as their members—namely, entitlement, recognition, belonging, and money—but on a much grander scale. Generally, these relationships begin with the organization's leadership, some of whom have may have achieved at least some of their credentials for a leadership position through their own personal relationships with industry. The organization has programs to run—meetings, publications, courses, a web site. All of this costs money and the need for money seems to be never ending. If the organization wants to maintain and expand its programs, one source of funding is through membership dues. But members themselves are used to paying bargain rates or even nothing for much of their CME and other medical programs because of their own accustomed receipt of industry largesse. Thus, it is natural for organizational leadership to approach industry for funding. Many leaders themselves have established strong relationships with executives of major companies through personal arrangements or through their academic departments and institutions. Industry uses the gratitude generated by those relationships then to ingratiate itself with a medical organization whose members write many prescriptions and purchase expensive instruments and devices.

The organization's leaders enjoy hobnobbing with industry executives at receptions and dinners or even in committees where industry and the organization do business together. Industry is able to fulfill, for those around the medical organization's boardroom table, the motivations of recognition and belonging that help create individual relationships. Leadership believes that its members are well served by not having to pay the increased dues to the organization that may be required were industry not a funding source.

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Academic Medical Centers Motives 

Conflict of interest with industry is perpetuated in a major way by AMCs and their faculty.73 Academic physicians are writing many of the papers that appear in journals and they are involved in research that may be of interest to industry. Thus, academic departments are high-value targets of industry and are lured by the same motivations as their faculty and community physicians—entitlement, recognition, belonging, and money—to become cozy with industry representatives.

It may be a visiting professor program that industry is eager to sponsor. To the department chair, this is a wonderful gesture by industry. The company seems simply to want residents to have a good education and to be exposed to experts from out of town. Why not take this money? After all, the department has to struggle to meet its budget and industry's money is simply money that the department will not have to spend. Then there are dinners with a speaker to which faculty and residents are invited. Or industry invites the department chair or a faculty member to serve on the company's speakers bureau or to participate as a key opinion leader or to join an advisory board. Perhaps the company offers money for the department to test a new device or to participate in a clinical trial. These examples are ways in which industry can gain influence with the chair and faculty of the department and with its house staff. Gratitude for gifts will yield something in return for the giver. That is our culture.54

Drug and device representatives mingle with academic physicians to exert influence at every opportunity. These personable individuals make friends easily. They are recruited for that ability. We like the money and the free meals, and we are happy to try out a new drug in return, or to submit a request to add that drug to the hospital formulary. We do not see anything wrong with that. Subtlety is the name of the game for these industry relationships. The less we think there is anything wrong, the better for industry. All of these examples lead to the writing of more prescriptions and to the use of more expensive drugs and devices. Departments very likely, when push comes to shove, can manage without the money, but they become addicted to it. It is no different for industry speakers or for many of our professional organizations. As soon as the money is flowing, it becomes difficult to imagine life without it.

Another interesting twist on industry's dealings with academia relates to its funding of so-called fellowships to students, trainees, and junior faculty. Only the companies can tell us why they do this, but it is reasonable to speculate. Because companies are not in the business of giving charity, there has to be a business reason for these grants. Let's start with the process of offering the grant. The company wants to be perceived as supporting education and research, of supporting young people, of simply wanting to see careers furthered. The company announces through mailings, through organizations, and through speakers the availability of the grants. They request nominations—quite detailed at times—describing why the nominee is deserving of the grant. A curriculum vitae and bibliography are requested, too. It may be that the company has put together an advisory committee to recommend the winners. All of this still sounds noble and harmless. The winner receives the money and uses it for research and to further her career.

So where is the business gain for the company other than to seem to be charitable and interested in young people? Actually, these grants can provide the company with the names of future leaders in their field as determined by chairs of departments or by other faculty. The company does not have to cull leaders from long lists of students, residents, and junior faculty. Imagine the value to the company of being told whom to target as a future key opinion leader. And these grantees will be indebted to the company that gave the grant. It may be that the grant came at a critical time for the grantee, a time when money was needed to undertake a new project or to hire a technician. Even small amounts of money can serve the same purpose to the company, but the larger awards are likely to insure that the best of the future leaders are identified. Beyond this, the company receives indebtedness points from the department chair or from an organization and its members for awarding a grant to their student, resident, fellow, or junior faculty member. Publicity in many forms often is lavished on the company for its “generosity.”

The company expects those grants to pay off handsomely down the road. Recall the rather bizarre arrangement mentioned earlier to demonstrate how industry influences medical organizations: 10 new dermatology resident positions were established with funding from the pharmaceutical industry.72 Imagine the influence on the academic dermatology department chairs who received these residency positions—and on their faculty and the residents themselves.

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What To Do? 

Disclosure is often the first word out of the mouths of many physicians when posed with the challenge of what to do about their conflicts of interest with industry. Disclosure heretofore has been one way to manage—sanitize?—the conflicts instead of eliminating them. By requiring sometimes elaborate disclosure by physicians of their relationships with industry, organizations have, perhaps, come to believe that they are cleansed of any possible disservice to their membership by allowing conflicted physicians to play important roles in the organization's policy making and programs. The plethora of professional society meeting programs shows the lengths to which a medical organization will go to publicize these disclosures. Other disclosures may include the monetary amounts received by physicians from industry, the implication being that large amounts of money are more influential in creating bias than are smaller amounts. However, Dana and Loewenstein, in a well-researched social science perspective of gifts, refute the value of allowing the conflicts to exist at all, regardless of disclosure.36 These authors point out that people are not aware of their biases even when they are taught about them. Human behavior, therefore, is unsuited to having mandatory disclosure, limits on gift size, or even educational programs as a means to control bias. Dana and Loewenstein found that the misunderstanding about conflict of interest is so widespread that disclosure is meaningless in trying to control it. This suggests that the recommendation by Blumenthal that individual physicians will have to lead their professional organizations in opting to change the culture of physician–industry relations is not workable and that prohibition in some form may be the best option.74

Cain and associates studied conflict of interest using jars of coins of differing total values.75 They used estimators who guessed at the value of the coins in the jars and advisors to help them. The advisors had a conflict of interest in dealing with the estimators because the incentives of each group often were not aligned. In the end, the authors showed that awareness of conflict of interest is not sufficient to protect those susceptible to it and that it gives conflicted individuals “strategic reason and moral license to further exaggerate their advice.” The authors also found that those susceptible to the conflicted advice, despite knowing it was biased, failed to discount it sufficiently to control the conflict.

A common fallacy in discussions of conflict of interest can be seen in the Mayo Clinic's approach to dealing with them. One might assume from the lengths to which the Clinic has gone to manage its institutional and individual conflicts that their monetary benefit is collectively great and worth preserving. Camilleri and Cortese state that the Clinic's policies are a work in progress and that they may undergo evolution.76 However, the authors make the risky leap that “there must be an ‘honor system’ whereby individuals with conflict of interest make honest and informed selections of treatments for individual patients in their practice.” Yet the literature has shown time and again—honor systems notwithstanding—that industry gift-giving works. That is why industry spends billions of dollars each year on marketing to physicians. It is simply naïve to believe otherwise. The companies are happy to have conflicted physicians and their conflict managers believe these physicians to be “pure.” In fact, however, when Mayo faculty have these conflicts, it tells their house staff that conflicts are okay as long as they are “managed” when, in fact, house staff should be taught that there is no place for voluntary financial conflicts of interest with industry because whether physicians are honest is not the issue. Upstanding physicians always believe that they are doing what is in their patients' best interests. Recall that they do not believe that industry marketing affects their clinical decisions, although they believe it affects those of their colleagues.55 It takes the collective industry marketing machine and our falling prey to it to make the entire system work. One person's vote does not make an election, but rather the collective votes of everyone. The same principle holds true for the way industry influences the medical profession and why, as noted earlier, Mather states that “the target of industry marketing is not so much the individual agent as it is medical practice.”54

Simply having financial conflicts of interest with industry sets the stage for doubting any statements or advice given by the conflicted individuals or entities, even when the advice may be reasonable. A New York Times article recently reported that tobacco money was behind a study that concluded that aggressive imaging screening can detect lung cancers earlier and save lives. The broadly expressed outrage that this industry funding was not made clear to the journal to which the paper was submitted and published shows that the public and others are on high alert to conflict-of-interest issues.77

In another instance, the New York Times78 reported on the results of a clinical trial showing that Vytorin, a drug that combines two separate cholesterol-lowering drugs, Zocor and Zetia, was no more and, perhaps, even less effective than Zocor alone in reducing plaque in arteries. Vytorin is the result of a joint venture between Merck and Schering-Plough. The Times article commented on the fact that Merck/Schering Plough had the results of the clinical trial two years before releasing them. Zocor is available in a generic form that costs approximately $6.00 per month for treatment. Vytorin, however, can cost more than $100 per month. What raised the conflict of interest issue, as also reported in the New York Times,79 is that the American Heart Association, in a statement the day after the Vytorin study results were released, cautioned that the study was not conclusive and that patients taking Vytorin should consult their physicians before considering stopping the drug. Although there may be nothing wrong with the statement, soon it was discovered that the American Heart Association as well as the American College of Cardiology, which issued a similar statement, receive significant funding from Merck/Schering Plough and that neither organization disclosed the financial conflict of interest when issuing their respective statements. Thus, although disclosure is not effective in managing the physician–industry conflict issue, failure to disclose such conflicts when they exist raises the specter of concealment—whether intended or not—and can lead to a harsh response from parties with clout such as congressional legislators and the public.

In a letter dated January 24, 2008, to the President of the American College of Cardiology, the Chairman of the U.S. Senate Committee on Finance, Senator Charles E. Grassley, requested records of all funding received by the College or its foundation from pharmaceutical companies or their foundations. On the same date, the Chairman of the U.S. House of Representative's Committee on Energy and Commerce, Representative John D. Dingell, sent a strongly worded letter to the American College of Cardiology specifically addressing the Vytorin study and asking for all records relating to funding from Merck/Schering-Plough since 2002 including, among a detailed list, money given by Merck to fund a joint Adult Cardiology Fellowship for six physicians annually as well as all funds provided to leaders of the organization.

All medical organizations have good reason to recognize that having a conflict of interest is enough to cast doubt on anything the organization says or does relating to companies with which the conflicts exist. Further, the lung cancer and Vytorin episodes77, 78 should help medical organizations, academic departments, and individual physicians understand that what published studies have shown over and over again is true in practical terms—namely, that physician–industry conflicts of interest raise red flags regardless of whether anything wrong has taken place.

Legislation is a second approach to stanch the physician–industry gift culture. Five states and the District of Columbia require pharmaceutical companies to report gifts to physicians. In two of the states, Minnesota and Vermont, the resulting databases are accessible to the public. Ross and associates found that the databases were difficult to access and were not user friendly and that companies avoided reporting much of their gift-giving by calling the data a “trade secret.”80 However, the authors also found that many physicians received payments of $100 or more and that the highest payment exceeded $1 million. Although it is too soon to tell what effect such legislation may have, so far few believe that these laws, as constituted, will have much effect on curbing industry's influence on physicians.

Meanwhile, Senate bill S.2029, the Physician Payment Sunshine Act, has been introduced to require companies with more than $100 million in yearly revenues to report to the federal government all gifts to physicians that exceed $25. Penalties for each instance of failure to report would range from $10 to $100,000.81

Federal guidelines from the federal Office of the Inspector General regarding physician–industry relationship are in effect.14 Although these guidelines were watered down by lobbying efforts,82 they have helped to focus attention on how physician–industry relationships, under certain circumstances, can be prosecuted under fraud and abuse statues.

Public efforts provide a third set of initiatives to deal with physician–industry conflict of interest. The Pew Charitable Trusts have funded the Prescription Project,83, 84 led by Community Catalyst in partnership with the Institute on Medicine as a Profession. Its purposes are several as noted on the Project's web site: “to conduct research and issue reports that document the scope of the problem and examine its impact on healthcare quality and cost; to collaborate with leading speakers, physician organizations, public and private health plans, consumer organizations, and policy makers to promote policy solutions and best practices; to assist AMCs and professional medical societies in adopting policy change initiatives; to develop state and national initiatives to maximize the use of evidence-based systems and reduce conflicts of interest; and to launch a national communications effort to raise awareness among physicians, payers, consumers, policy makers, media and the public about the need for reform.”83, 85

In addition, the Massachusetts Prescription Reform Coalition recently was announced. It has three objectives: banning gifts from industry to physicians; preventing mining by industry of individual physician prescription data to use in marketing efforts; and developing a program to provide unbiased drug information to physicians.86

The Josiah Macy Jr. Foundation conducted a conference last November on “Continuing Education in the Health Professions,” and the Chairman's summary of the Conference has been published in advance of more extensive coverage.87 The conference participants emphasized the incompatibility between industry's profit motives and physicians and noted that physicians have a “moral responsibility to provide safe, high quality care for their patients.” The participants came down hard, on moral and ethical grounds, against any support from industry for CME.

Still a fourth means of dealing with this issue is to have AMCs take a leadership position. For the past several years, many medical students have taken a strong stand through the American Medical Student Association's PharmFree program, and last fall, they sponsored National PharmFree Week to bring attention to and to prohibit having industry marketing on medical campuses.88

A bold proposal has been promulgated that challenges AMCs to eliminate conflicts of interest relating to gifts, CME support, and other clearly marketing-related industry largesse.33 Although many AMCs have instituted policies to restrict industry conflicts,6, 7, 8 many still leave room for those conflicts to exist.89, 90 Campbell and associates surveyed department chairs at medical schools and at the country's 15 largest teaching hospitals.4 Sixty per cent of chairs had some form of personal relationship with industry such as being a paid consultant or a scientific advisory board member or participating in a speakers bureau. In addition, some 80% of clinical departments had one or more relationships with industry, including funding for food and for CME. Most chairs did not see anything wrong with these personal or departmental relationships. The Pew-funded Prescription Project hopes to change that behavior through informational and educational conferences.85

It is easy to take a righteous stand against physician–industry relationships. Yet, if we accept the fact that we have a duty to our patients to act always in their best interests above our own, then we cannot in good conscience be shills for industry. Voluntary relationships that simply puff our egos and give us money and freebies—the trinkets, the steak dinner, the high-end reception at our meetings, the speakers bureaus, the advisory boards, the reduced meeting registration fees and reduced organizational dues, for example—that may seem like harmless activities are, in fact, a violation of the public trust and a collective embarrassment to medicine.91 As Katz and associates stated, “[F]rom a moral and regulatory perspective, policies that determine the acceptability of a gift according to its size are unsound. The power of gift-giving, both large and small, must be acknowledged if appropriate regulatory policies are to be created and enforced.”92 These authors recognize that gift-giving is a necessary and practical part of our social fabric; however, they rightfully point out that “medicine … is different.” Although physicians and industry must, at times, interact financially, those interactions only seem appropriate where the physician's motivation is to assist industry with drug or device development, not with their promotion and sales. Clear deliverables must be a part of any financial arrangements between physicians and industry.33 Knowing in advance what we are being paid to do will go a long way toward distinguishing legitimate physician–industry relationships from those aimed solely at more prescriptions for drugs and more purchases of devices. Finally, there do not seem to be deliverables that meet the ethical and moral test for justifying industry involvement in legitimate CME.

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Conclusions 

Although industry has brought to market many of the products that have helped to revolutionize medicine, there is great concern and strong evidence that the successful marketing tactics by industry have driven up the cost of healthcare unnecessarily. Those tactics would not be nearly as successful were it not for the complicity of physicians. When a company wants to give us money—for whatever reason—it is being given to promote the company's business interests. If the money is to teach, we must ask, “To teach what and why?” If the money is for research, the same question applies. If the money is for grants, again, what are the motives? Remember that industry does its best to conceal the purpose of the money it spends on physicians, on research, in organizational support, on grants, and, in the broadest sense, on anything related to the professional marketing of its products. The more we believe we are not doing anything wrong by taking gifts from industry, the better industry likes it. The more we think that industry does not want us to do anything wrong and that their own guidelines help us to be ethical, the more industry can do to further its marketing plan. Physicians do not want to be duped by industry, but they believe it when industry tells them that physicians are too savvy to be influenced by a free dinner. Although there is no peer-reviewed study that supports such a claim, physicians want it to be true. Significant sums of money paid to key opinion leaders and advisory board physicians—many from academic medicine—promote the status quo. Breaking the cycle of misinformation on conflict of interest requires the leadership of AMCs, professional medical organizations, private foundations, and government. Individual physicians have shown themselves to be easy prey for the pharmaceutical and device industry, and there is little likelihood that individual behavior will change unless bold steps are taken to encourage and even enforce those changes.

Finally, it is important to reiterate that this perspective is not written to suggest that all interactions between physicians and industry must cease. However, it is hoped that physicians will recognize their physician–industry voluntary financial relationships for what they are: a conflict of interest over their duty to patients and to the public. The distinction needs to be made, though, between interactions that have very specific goals, goals that stand to benefit our patients and the public and those that simply drive up the cost of care through promotion of unnecessary drugs and tests or the writing of prescriptions for expensive drugs when a less expensive one is just as good. Perhaps the first question that a physician should ask when industry money or in-kind gifts are offered—no matter how noble-sounding the reasons—is: “Could this really be a bribe?”

As John F. Kennedy said, “For the great enemy of truth is very often not the lie—deliberate, contrived and dishonest—but the myth—persistent, persuasive, and unrealistic. Too often we hold fast to the clichés of our forebears. We subject all facts to a prefabricated set of interpretations. We enjoy the comfort of opinion without the discomfort of thought.”93

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The author indicates no financial support or financial conflict of interest. The author was involved in design and conduct of study; collection and management of the data; analysis and interpretation of data; and preparation of the manuscript.

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PII: S0002-9394(08)00276-6

doi:10.1016/j.ajo.2008.04.007

American Journal of Ophthalmology
Volume 146, Issue 2 , Pages 159-171, August 2008

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