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Dean Thomas J. Lawley

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Professionalism and Conflict of Interest: Heightened Challenges for Academic Medicine
Adapted from the Dean's State of the School Address, October 10, 2006

elcome to everybody, and thank you for taking time out of your busy day to join us. It has been another good year for the School of Medicine. Our research dollars continue to increase, and our rate of growth continues to be the fastest of all of the Top 20 institutions, actually tied with Vanderbilt but tied for first in terms of fastest growing. Our new curriculum continues under development by Dr. William Eley and his colleagues, and our medical education building is nearing completion. So all in all, this has been a very good year. The subjects of my talk this afternoon are professionalism and conflict of interest. About two weeks ago, the School of Medicine had its White Coat Ceremony. This is an annual event for first-year medical students, who have been with us for about eight weeks and who formally receive their first white coat. We had Dr. Wright Caughman as the keynote speaker, and he spoke about what it means to be a doctor and the concept of professionalism. For the first time, students see themselves as emerging physicians, as future repositories of knowledge and trust and deserving of respect. But the real reason for the ceremony is to convey a very important message about professionalism. It is for students to understand that the white coat worn by a physician is different from the white coats of other individuals, because we believe when the physician wears the white coat it symbolizes knowledge, competency, altruism, and honor. It symbolizes the fact that in doctor-patient relationships, the patient always comes first. At the close of the ceremony, we recite the Hippocratic oath to emphasize again the altruistic core values of medicine.
     These students have no conflicts of interest. They have no experience with pharmaceutical device or equipment firms or their representatives, and they have not learned the mechanisms with which to deal with them. Even earlier, on the first day of medical school, we have a session with our first-year students in which we talk about the concept of medical professionalism. We ask the students what it means to them. We ask them to try to define the term, and they always become very engaged in the exercise because they understand—as does the public—that physicians hold themselves to high standards. The students always use terms such as: honesty, integrity, altruism, caring and compassion, respect, leadership, responsibility, accountability, excellence, scholarship, competency, special skills, expert knowledge, and specialized training.
     Our students enter medical school with feelings of great respect and admiration for their professors, and they expect to see and be taught these hallmarks of professionalism. Our graduate students and our allied health students also come to us with the same trust. Trainees expect their physician scientist teachers to be role models to teach them through formal education and indirectly by how we behave and conduct ourselves so they can do the right thing, make their professional choices, and see how to live their lives. Sometimes, as we all know, this is referred to as the "hidden curriculum." All of our students trust us to teach them to be the very best they can be as academic or private physicians or scientists. They imitate us by observing how we interact with each other, with patients, the public in general, and with industry. Then they go out and behave just like we do.
The public believes our academic institutions are the source of education and new discoveries and information that they trust will benefit them. They hold us to a higher standard because we are privileged to be a public trust for the advancement, preservation, and dissemination of knowledge. They accord us multiple privileges not given to other professions. Therefore, the public expects physicians to provide information and education that is unbiased, to treat patients with unbiased competence, to contribute to health care policy, and to practice medicine in ways that do not inappropriately increase the cost of health care.
     In addition to receiving compassionate and state-of-the-art medical care, our patients expect us to be competent, altruistic, and ethical, to use the most up-to-date diagnostic and therapeutic techniques, to conduct biomedical research they support uncontaminated by even the perception of bias, to see that discoveries with potential to improve health are rapidly translated into practice through clinical trials, and to know and inform them about any potential adverse effects that might influence their consent to participate in research.
      Physicians in our institutions are accorded special privileges by society because we have a social contract to carry out the missions of clinical care, education, and research with the highest standards of professionalism. Essential tenants of professionalism are that patient care and education of our trainees always take first priority. We enjoy our privileges because we have and adhere to strict codes of conduct embodied in professionalism in our daily lives, and this in turn has created and sustained public trust in our positions. If this trust were to become eroded significantly, it would have widespread negative consequences both for the medical profession and for our patients.




The Changing Relationship Between Academia and the For-Profit Medical Industry

here are clouds on the horizon and in some cases directly overhead. The problems centers on the changing relationship between academic physicians and scientists and industry and on the development of conflicts of interest involving pharmaceutical, device, and equipment companies who are our partners, as well as our vendors. The threat is that the profession of medicine and our institutions will lose the respect and trust of our patients and the public, and we also will lose the respect and trust that we have for each other.
     What is a conflict of interest? There are lots of definitions. One is that a conflict of interest exists in any clinical, educational, research, or administrative duty when an individual or an institution has an outside interest—usually financial—that affects or appears to affect the individual's or institution's professional judgment in carrying out responsibilities.
     In research, especially research involving human subjects, the issue of conflict of interest has been increasingly in the limelight. For the past decade academic medicine surely has not been exempted. Although conflicts in education, in patient care, and administration are extremely important, conflicts of interest in research have garnered most of the attention to date, especially those involving relationships that individual investigators have with pharmaceutical, device, or equipment companies that sponsor their research. Research conflicts have the potential to bias not only the outcome of the research but also the delivery of patient care. We as an institution and as individual faculty investigators must be extremely careful to prevent even the appearance that these conflicts might affect our judgment.
     Some of the most common potential conflicts occur when an investigator's financial interest—usually in the company that is funding the research—compromises or appears to compromise the investigator's conduct in selecting and informing patients, data analysis, use of statistics, interpretation or reporting of research, use of staff, purchasing materials, sharing results, protocol design, and finally, the training of students and fellows, such as using trainees to perform services or do research for the company and then requiring confidentiality.
     Our faculty have many relationships with industry. Many of them are beneficial to the public as well as to the faculty member, the institution, and the company. Some examples of fiduciary and financial relationships that might be conflicts of interest in research—again depending on the circumstances—are compensated consulting to help the company develop a drug or device, write research protocols, or write the paper about the company's or investigator's research; serving on company speakers bureaus to help the company market and sell its products; holding a position, particularly in start-up companies, as a board of directors member or scientific advisory board member; or holding significant equity in the company.
     In the area of conflicts of interest and research, the federal government has issued regulations that require institutions to curtail, manage, or eliminate conflicts of interest. The Association of American Medical Colleges (AAMC) and the Association of American Universities have weighed in heavily with guidelines to assist schools in appropriately implementing these regulations, particularly in the area of human subject research. Emory and its School of Medicine and academic medical center adhere to these regulations and guidelines and monitor and enforce them through our Conflict of Interest Committee. This is a very hard-working, thoughtful group of scientists and physicians, many of whom have personal experience with real or potential conflicts of interest in their academic lives. I want to take this opportunity to thank the members of our Conflict of Interest Committee and my staff who support them in this challenging job. In particular, I would like to thank Dr. R. Wayne Alexander, who has chaired the committee since its formation in 1996, Dr. Tristram Parslow, who became the new chair in September, and Assistant Dean Brenda Seiton, who oversees the Conflict of Interest Office and assists the faculty directly in managing their conflicts and external consulting activities.
     In fact, you need to know that Emory is viewed as a national leader in this area. We are frequently cited by the AAMC and other medical schools as a best-practice example in identifying and trying very hard to reasonably manage complex conflicts of interest and research, rather than outright prohibiting the activities or, on the other hand, allowing them to get out of control.
Changing Times, Unwaivering Principles

here are important common principles about conflicts of interest regardless of whether they involve research, education, clinical practice, or administration. Conflicts are inevitable for faculty and institutions engaged in technology transfer. Conflicts rarely arise from a bad person doing the wrong thing, whether it would be illegal, immoral, or unethical. Rather, they usually arise when a good person has two worthy objectives, and the objectives conflict with one another. The faculty member, by the way, is seldom consciously aware of having the conflict until educated.
     On a regular basis over the past few years and in ways that have not been favorable to our profession and institutions, the leading newspapers and magazines in the country, our scientific and medical journals, and our professional societies have been engaged in dealing with and discussing problems in research, publication, education, and patient care that have occurred at the conflicting interface between academia and industry. And the debate is increasing. A quarter century ago, the idea that a university or scientist would market intellectual property based on laboratory discoveries funded by NIH was unheard of, and our academic culture included a squeamishness about academic industry interactions which I can very well remember.
     But times have changed. Business has become a bigger part of academic culture. The Bayh-Dole Act required universities to try to transfer government-funded research to the commercial sector for the benefit of the public, and it allowed universities and investigators to reap benefits as the number of patents and licenses increased. Our academic culture has changed to include acceptance that we should partner with industry to get new drugs, therapies, devices, and equipment on the market to improve health care and conduct science. These changes, although in most ways beneficial to the public, also have created fertile ground for conflicts of interest and conflicts of commitment to develop.
     In today's world, it is clear that for academic medicine to thrive and fulfill our dreams, we must interact productively with pharmaceutical, device, and equipment companies, but at the same time we must maintain the trust and admiration of the public, our patients, students, and residents. The issues that have arisen around real or perceived conflicts of interest between physicians' commitment to patient care and industries' desire to sell their products create challenges to our principles of medical professionalism. They cut across all three of our missions: research, education, and clinical care. We have made good progress in managing our conflicts of interest in research, but we need to address our conflicts of interest in these other two areas as well.
      Pharmaceutical firms and device companies are in business to make money for their investors through inventing and perfecting drugs and devices that will improve human health and cure disease. But naturally they have no access or very limited access to patients, and in hospitals that use their products, they expect physicians will prescribe and purchase or request the products. The nub of the problem is that our commitments to altruism, scientific integrity, and absence of bias in medical decision-making sometimes bump up against financial conflicts of interest. Let me be clear that the good the pharmaceutical firms and device manufacturers have brought to humanity through their discoveries and distribution of their products is enormous, and just like physicians and scientists, no pharmaceutical or device company wants a product on the market that would harm patients.
     What we have in common with industry is that pharmaceutical, device, and equipment companies do want to create and develop products that benefit patients and do need and want the expertise and advice of academic physicians and scientists to help them. The problem is that academia and industry have fundamental differences in their motives that can never be fully reconciled. Pharmaceutical, device, and equipment companies have a fiduciary responsibility to their shareholders to make money. Physicians have a moral and ethical obligation to their patients, their peers, and their trainees, a social obligation to the public, a professional obligation to their profession and societies, and a fiduciary duty to their universities. Physicians have an obligation to put patient care and the education of their trainees and peers first.
    The Influence of the Pharmaceutical Industry

want to present some data to give a better feeling for the reality of what is going on. The good side from our point of view is that the Pharmaceutical Research and Manufacturing Association reported their member companies spent $33 billion on research and development for new drugs in 2003, much of it devoted to either internal research or awarded externally in the form of research grants to academic physicians. But the top nine pharmaceutical companies spent about $58 billion on marketing alone in 2004—a figure that is twice the size of the NIH annual budget then. The money was spent on free samples, drug representatives and direct-to-physician promotions, direct-to-consumer advertising, and physician education, including funding of medical meetings, journal advertising, company educational events, CME, GME, travel and expenses for faculty, and my personal favorite, speakers bureaus.
     These spending categories raise issues for academic medicine. Free samples from pharmaceutical companies are beneficial in the care of indigent patients, but they raise the cost of drugs. Should they be provided directly to and dispensed by individual physicians or provided to pharmacy for distribution? All of us support better education as part of improved health care for our patients, but is health care well served by direct-to-consumer advertising? Often, funding for physician education comes in the form of unrestricted gifts, but are they unrestricted when it is understood that the company's name will be directly associated with the gift to the individuals who receive it? Speakers bureaus raise concerns because the purpose is for industry to use the names of prestigious faculty, as well as the linked names of their institutions, to support, endorse, or sell the product. Just think of what all of these activities do to our health care costs.
     Let's look further at how industry marketing funds are spent. About 90,000 sales representatives are employed by pharmaceutical companies, the majority of them for direct-to-physician marketing. Eighty to 90% of physicians meet regularly with sales representatives. Sales representatives provide education about the latest products from their companies, but their purpose is to convince physicians to prescribe or use their drugs or devices in the treatment of patients. Some data indicate prescription rates for these products increase after such visits. Physicians meet with pharmaceutical sales representatives four times per month on average. In a study in 2001, Kaiser Permanente found that 92% of physicians accepted free drug samples, 61% of physicians received free meals, entertainment tickets, or travel; 13% of physicians got financial incentives or in-kind benefits; and 12% of physicians got financial incentives to do clinical trials.
     GME support from industry also is growing. Residents get six gifts on average from Pharma annually. In a study of emergency medicine departments, 41% of residents were taught by drug reps, 35% of the residents received free samples at work, and 29% of residents received pay from companies for their travel to professional meetings. In one study of Canadian psychiatry departments, one department had 70 lunches sponsored by drug companies during the year and 75 promotional items provided to the residents.
     The number of company-named fellowships to individuals is growing. It is not uncommon for departments or faculty to receive offers from companies to pay the salaries of specialty fellows, who then become potential customers by way of company-named fellowships.
     Companies are paying residents' travel to professional meetings and memberships in professional organizations, some unsolicited. These gifts may often carry an obligation to attend certain kinds of company dinners or marketing lectures. Companies come on campuses to provide food, pens, and promotions at in-house seminars, and company representatives are present sometimes at grand rounds.
     Industry's support of continuing medical education also is growing. Pharma provides approximately $900 million of the $1 billion spent annually on CME, according to the Accreditation Counsel for Continuing Medical Education (ACCME). The ACCME has established rules about industry support for CME, but the rules are permeable sometimes, and their implementation in some institutions may have only cursory oversight.
  Managing Conflict of Interest in Medicine

edicine has entered precarious waters in the past decade. The influences of industry and the marketplace are pervasive in our system and touch many faculty positions and investigators. The pressures are intense, and they are not going to go away. The School of Medicine through our Conflict of Interest Committee and my office does work to manage conflicts of interest in research. We require at a minimum disclosure to the public, the committee itself, trainees, staff, and human subjects; reduction, management or elimination of financial interests that could affect research, teaching or administration; protection of trainees from any negative effects of a faculty adviser's conflicts of interests; and special precautions for human subjects in clinical research.
     It is not uncommon for physicians and scientists to receive gifts or to have conflicting financial relationships with companies and to say that they understand the motives of the companies, and they are not going to be biased. Indeed, academic physicians and scientists are good people. They are sometimes indignant at the suggestion that small or large gifts or their paid consulting relationships with industry might influence their decisions about treating patients or generating or reporting data. But a variety of studies have shown that the individual physician or scientist is certain he or she is not influenced but in turn believes that others are. Self-perception may not be the best test.
     Sometimes faculty physicians and scientists feel if they have disclosed that they have a financial relationship with a company, they have done all that is required to manage their conflict of interest. But disclosure alone isn't enough. Listing the companies in small print on the face page of a paper or in the back of a journal tells nothing about the nature of the relationship and the conflict or how it might influence the research. Disclosures like the one I found in small print in the back of a national meeting program are becoming more common and are most likely ignored. The speaker, someone in my specialty, was involved with 38 pharmaceutical firms and had six kinds of relationships with these firms. Worse, I fear that a long list is becoming a kind of perverse status symbol. Sometimes an activity simply shouldn't be done unless the investigator gives up the financial interests.
     Our profession is responding also at the national level to perceived threats to professionalism. The accrediting and licensing organization, national professional societies, subspecialty societies, AAMC, Counsel of Deans, Counsel of Teaching Hospitals, Counsel of Academic Specialties, National Board of Medical Examiners, and others all have endorsed principles of professionalism. The medical professionalism project initiated by leaders of the American Board of Internal Medicine and the European Federation of Internal Medicine has created the charter on medical professionalism. It has been widely published and adopted by nearly all medical professional societies and groups. It acknowledges that medicine is in the midst of a technological revolution, of changing market forces, and of problems in health care delivery, and it reaffirms the fundamental and universal principles and values of medical professionalism. It provides three fundamental principles and 10 professional responsibilities. The principles are the primacy of patient welfare, patient autonomy, and social justice. The principles provide the framework for the set of professional responsibilities, which include professional competence, honesty with patients, patient confidentiality, maintaining appropriate relations with patients, improving the quality of accessed care, just distribution of finite resources, scientific knowledge, and maintaining trust by managing conflicts of interest and professional responsibilities.
     I believe academic health centers have a special responsibility to take a leading role in assuring the maintenance of public trust by addressing their own conflicts of interest head on in developing policies that are fair, thoughtful, and effective to assure our patients and our students that they do indeed come first. Several of our colleagues at the AAMC and representatives in the pharmaceutical and device industries have begun this process. Dr. Roy Vagelos, the former CEO of Merck, is heading up the AAMC task force that will begin to address these issues.
     Several medical schools now have implemented new conflict-of-interest policies. Stanford, Yale, Penn, Penn State, and NYU, among others, have adopted and published new conflict of interest policies in the past year, and more medical schools will follow. Stanford's policy, created by a faculty committee, for example, addresses six kinds of interactions with industry: gifts and compensation; site access by sales and marketing representatives; provision of scholarship or education funds to students and trainees; support for educational or other professional activities; disclosure of relationships with industry; and education of students, trainees, and staff regarding potential conflict of interest in industry interactions. Now, most of the new policies provide for the following: no personal gifts from industry anywhere at the school or the affiliates; no sales or marketing representatives on campus or in any patient care areas except by appointment; educational funds from industry go to the department or the school, not individuals; industry support of trainees must be free of conflict of interest and must be specifically for education; all industry support for educational programs must follow CME guidelines at a minimum; no ghost-written articles; individual disclosure of related financial interests must be made according to the international committee of medical journal editors; no food provided directly from industry on campus; new rules about faculty participation in industry-sponsored meetings; and no participation in speakers bureaus.
     I recall vividly when I attended my first American Academy of Dermatology meeting in 1974 at the Palmer House in Chicago. This was a chance to be exposed to the luminaries in my specialty and to learn about the new products that were coming on the market. When I entered this vast exhibit hall, I was overwhelmed by the number of pharmaceutical booths manned by friendly sales reps who were eager to give residents and faculty information about their latest products as well as free samples of soap, shampoo, moisturizers, makeup, on and on and on. I saw other residents and senior academics and practitioners standing in line for samples, and so naturally, I did the same. Boarding the plane after the meeting, I recall that I saw a dermatologist get on. I didn't know him. He had trouble fitting all of his newly acquired pharmaceutical samples in the overhead compartment.
     A year or two later I am at the same national meeting, and I asked my mentor if he wanted to go over to the exhibit hall and pick up a few samples. He said, "Tom, I don't do that, and you shouldn't either." I asked him why, and he said first, it didn't feel good to him because free samples are never free—the patients pay for them through increased drug costs—and second, he said it doesn't look good. He thought it was embarrassing to see so many of our colleagues carrying around big sacks of samples and that it was a bad example because all of those people made more than enough money to afford the product. And last, he didn't want to feel as though he was in some company's pocket or that he owed any drug reps any favors. I went over to the exhibit hall, not to seek anything, but instead as an observer. I watched, and I realized that he was right, and I was cured of that activity.
     I use this example to point out how we as mentors influence the behaviors of others, particularly of our trainees, that professionalism encompasses activities both large and small, and that we need to pay attention to what we are doing. How should we react when pharmaceutical device firms offer unrestricted educational grants for grand rounds? What exactly do they mean by unrestricted? How about when a device company offers to pay a clinical fellow's stipend for a year but with the expectation that its name will be associated with the gift and identified to the fellow? Does that influence the future behavior of that fellow? Should we be accepting pens and bagels and pizzas from pharmaceutical reps? What does it signal to our residents and students if we do? What should we do when a pharmaceutical or device company wants to fund an endowed chair with no apparent quid pro quo when the company is a large-scale vendor of supplies used by that department? These are but a few questions that you and I ask ourselves and then attempt to answer, in my opinion, with too little guidance.


A New Policy Takes Shape

hat can and should we do at Emory? I believe all physicians, but especially those of us in academic health centers, bear a special responsibility to address these issues. I believe the time has come for us to re-examine who we are as academic physicians and scientists and to reassert the way we want to present ourselves to our students, residents, our patients, and the public. We must develop internally consistent, fair, transparent policies that address all manner of interactions between us as faculty and pharmaceutical and device companies and their representatives, and we will do so this academic year. It's time, and it is in our best interest.
     We will appoint a task force on conflict of interest to advise us how we ought to interact with pharmaceutical, device, and equipment companies. They will conclude their deliberations and provide their advice in spring 2007. The task force will include representatives of the School of Medicine, Emory Clinic, Emory hospitals, our affiliated hospitals, the Executive Vice President's office, the Ethics Center, the Dean's staff, and others. We must develop guidelines and refine others that already exist. We need to define and to understand perceived and real barriers to professionalism and how they can be overcome by personal and institutional actions and initiatives guided by a coherent policy. I will expect the final policy to address certain basic elements and principles representing the highest standards. Underlying all will be how we present ourselves to the community, our peers, our patients, and trainees. I want the final policy to be a living and breathing document that can be amended and adapted as new situations arise in our changing world.
     I recognize that no policy will cover every situation. We must depend on the integrity of all of us to put the patient, the trainee, and the public first. In broad strokes, the task force and the Dean's office will implement a process that will include broad representation, with the extensive use of information from literature, organizations, and other schools. We will bring in experts from other institutions and organizations for the task force's use and to present or be available to the faculty in general for discussion; develop a draft policy and guidelines from the task force recommendations; communicate that draft policy for input from all of you through emails and a town hall meeting; and then finalize a comprehensive policy and guidelines on conflict of interest.
     I also will seek recommendations from the task force on how best to educate our faculty and staff and incorporate the concepts into our training of students, residents, and fellows so that they form lifelong habits. I am not seeking a standard based on what's on the front page, although I do think the end product will reduce any risk we might have. This initiative is not just about compliance, although compliance and playing by the rules are important. Rather, this initiative is about enhancing our culture of ethics and professionalism and then giving all of us guidelines and policies that make decisions based on personal integrity, ethics, and professionalism easier. You are highly ethical and embody the highest standards of medical professionalism and personal integrity, and I want the final policy and guidelines to reflect that.
     Let me conclude with the following thoughts. Industry and academic medicine have had a spectacular partnership over the past century. We have helped each other immensely in our overlapping missions and shared goals. We have wiped out diseases in individual countries and globally, using interventions ranging from vaccines and antibiotics, antihypertensives, antidepressants and antineoplastics, to devices that open our clogged arteries, control our cardiac rhythm, and replace our worn out joints. The accomplishments that are possible in the future are wonderful: stem cells and the promise they hold for the emerging field of regenerative medicine; gene therapy to advance personalized treatment for cancer; alteration of metabolic and self-signaling pathways; and ultimately, predictive medicine, where we intervene in an individual before he becomes ill using biomarkers yet to be discovered. The whole face of medicine will change, and individuals will take more and better care of themselves. The number of face-to-face visits with health care providers will decrease. We in academic medicine and our colleagues in biotech and pharmaceutical industries will lead the way. The future is remarkable and within reach. Thank you very much for your attention.

   Thomas J. Lawley, MD
    Following the State-of-the-School address, Dean Lawley took questions from audience members.

Q: If Emory were to adopt a policy similar to Stanford's and prohibit industry support for academic meetings, is the School of Medicine or the University prepared to provide ongoing support for those activities, which are in many respects key to our academic mission?

Lawley: It's an excellent question. It would depend on the extent to which we were able to readjust where resources are applied. I think I'd like to back up, though. The notion would be, perhaps, that industry wouldn't be prevented from helping sponsor activities, they would just have guidelines so there was not an indication that any content was being altered. This is exactly the kind of thing that I would suggest this task force will spend weeks and months grappling with—trying to come to the proper way of threading that difficult needle.

Q: Could you tell us a little bit about the process the committee will have to go through in trying to place itself in the position of those that we help educate? Drug companies, whether we like it or not, are sometimes a major vehicle for continuing education of those individuals.

Lawley: First, one of the things that we need to do is to make sure that we have populated this committee correctly. This has to be a committee of people who have conflicts, people who deal with the device industry, people who deal with the pharmaceutical industry on a regular basis. It can't be a group who just never have any contact with industry. That doesn't make any sense. But people also need to leave their hats at the door when they come in and try to think institutionally about what is best for the school, what is best for their department, what is best for the University. In terms of who else might populate that committee, I have thought and haven't come to any conclusions about whether we want to have trainees or individuals outside of Emory altogether, the public, on that committee. I do think it is absolutely clear that we need to reach beyond the School of Medicine. We need to reach into the Health Sciences Center, and so I would presume that we would have individuals from the School of Nursing, the School of Public Health, and so on. But beyond that, we haven't come to any conclusion, and we haven't appointed this committee yet. We are holding off, trying to do some serious thinking about it. I am not sure if that fully answered your question but maybe a little bit.

Q: I am still worried about whether there is not influence. What if from every lunch, every seminar they receive some benefit? There simply is compelling data that [these items] influence. How can we say to our trainees on one hand we do this, but it doesn't influence that, but on the other hand go ahead [and participate] and be influenced?

Lawley: Well said.

Q: This same address perhaps will be beneficial to all four years of the medical school, and the residents, fellows, and interns could hear again some iteration of this, as well.

Lawley: I would be glad to deliver it to all four years of the medical school. But I do think it is important we understand that we need to begin to get our act together, and I don't think the conclusions of the task force are predestined or predetermined. I do think there are both large and small issues that end up having a large impact and large effects. Physicians didn't start accepting all sorts of things from pharmaceutical firms when they became private physicians or attending physicians. They started when they were in medical school or when they were first year residents. We have all done it. We have all gotten pens. I was in clinic today, and I needed to write down a phone number, and I was groping around for a piece of paper, and sure enough, there it was, the pharmaceutical company pad. I wrote the phone number down because it was either that or using my hand, but the point of this is that you can over to any Emory clinic or hospital or to Grady Hospital and find those things. Is there something inherently bad about it? There's nothing inherently bad about a pad of paper, but it is the symbolic nature of it that we worry about, or at least I do.

Q: How do we enforce good behavior when people are not just on campus but away at all these meetings? Are there any points at which rules and regulations are almost unenforceable?

Lawley: I think in the end we depend on the ethics and the good will of the individual. It is really about developing a culture, not so much prescribing rules. Yes, we can come up with a rule that says no pizza and no lunch, but the truth of the matter is that if we have to be going around attempting to enforce that, we have lost already. I would say this is more of an awakening or a reawakening of the realization that it isn't right, or at least it needs to be modulated in some way so there are some control levers around us.

Q: I am sure you are aware that multiple editorials have appeared recently advocating for partnerships with industries and pharmacy to promote research, especially in light of dwindling resources of the NIH. What constitutes appropriate relationships?

Lawley: My feeling about industry-sponsored research is that it is a very good thing. There is no question about that-—it just needs to be handled correctly. A conflict of interest issue arises when an individual already has another sort of fiduciary or financial relationship with that particular company and then is accepting research dollars to fund human subject research. But there is nothing inherently wrong with accepting legitimate dollars to do legitimate research from a pharmaceutical firm. We bring in millions of dollars a year in nonfederal pharmaceutical-based or foundation-based research. It is just when we get into the conflicts, particularly the financial conflicts, that we run into difficulties. I must say we do a very good job in managing those. One person that I didn't recognize earlier, who is a national expert on all of this, is Dr. Claudia Adkison. She has just come back from speaking in Los Angeles about this very subject.

Q: The issue of research really is a concern, beyond just the funding of the research itself. I think we have to look also at what gets published, and based on the published data, is there a conflict if only a bit of the data is able to get into print?

Lawley: I would like to think that those days are gone, although perhaps only recently dead, but the idea that data would not be made available by pharmaceutical companies has received huge amounts of press coverage, and court cases have evolved over this. I think there is great sensitization to that now. I am not saying it doesn't go on, but I do think that is something that has become much more obvious in the past couple of years than it was five or 10 years ago.

Q: I think it is important that we avoid bias, that we avoid adherence to bias when doing our research. We do it with our trainees when we present both sides, so I think it is going to be important for the task force to look at everything.

Lawley: You are exactly right, and you touch on something that has to do with institutional conflicts of interest. That is something that is, in some ways, even more difficult, but we do manage those institutional conflicts here at Emory, and most big universities have found ways in which to do it. Thank you. President Wagner?

President Wagner: I would first like to say thank you and congratulations to the School of Medicine for leading in this critically important area of conflict of interest and conflict of commitment. I want to echo a few of your points. First, fundamental principles that are important to the broad university have to do with academic autonomy, something we need to fight to preserve. We must figure out ways to manage research and thought processes that are supported by industry, but we must not risk enslaving ourselves, burdening ourselves, if you will, to commercial interests. We must be free to practice academic autonomy. Second, we do serve a public good, and it is very important to realize that we serve a public good, and we have a public trust to uphold. It is a unique position of universities and, sadly, it has become increasingly unique, as the public no longer feels a sense of trust of its own government, of large industry, of just about any large organization that you can think of, including religious institutions. Universities are somewhere in that public trust, and we risk compromising that trust when we compromise our capacity for disinterested research. We risk violating the public good. There is a cost, however, to serving the public good. It is an opportunity cost at the very least, and it is presumably for that reason we get the tax breaks that we get. Society gives us certain opportunities to benefit in ways that others cannot, but the cost of doing our research in an institution that exists for the public good is that we may not be able to profit as we might otherwise like to do. I serve, as Dean Lawley knows, on an ad hoc committee advising one of our competitors on their own efforts to develop an institutional conflict-of-interest policy. It was very difficult in the early days. In fact, I considered excusing myself from the committee because it started out by saying how much money can this institution make on its name and still stay above board and legal. They had put the cart in front of the horse. The question is how do we do our tasks—what we have been asked to do and entrusted by the public to do—and if we can make a little money on the side and in a very clean way, that would be fine. Our responsibility is to manage conflict; it is not always to eliminate conflict.

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