Welcome to the the Office of the President

Sigma Chi Address

April 18, 2001

Thank you for that kind introduction. Let me begin by telling you what a privilege it is for me to be with you this evening. In fact, the timing of this talk has a great deal of personal significance for me. Believe it or not, it is 25 years, almost to the day, since I was inducted as a member of Sigma Xi. In many respects, that election is a distant memory – much has transpired in the interim. Nevertheless, it occurred at a pivotal point in my life, and therefore, I will always think of it as an important rite of passage.

In all honesty, I did not know much about Sigma Xi at the time of my election. Twenty-five years ago, I was a graduating senior at the University of North Carolina. As it was fairly uncommon to elect undergraduates at that time, I felt doubly honored just to have been considered for membership.

Whether I warranted election into this society is an entirely different question. Reflecting back a quarter century later, my election seems a bit premature at best. Nevertheless, I am grateful to have been given the benefit of the doubt and hope that the following couple of decades have not given those who elected me too much reason to regret their decision.

Of course, had the members known that I would end up in administration, the decision might have gone the other way. In many circles, assuming a university presidency is tantamount to a charge of moral turpitude. Even so, to the best of my knowledge, membership in Sigma Xi is irrevocable. As far as I can tell, the principal criterion for sustaining your membership is to continue to pay your annual dues. Having done so successfully for a quarter century, including through the lean years of medical school, residency and graduate school, my honor is intact. So, while there is adequate reason to question the sanity of anyone pursuing a career in academic administration, you are stuck with me as a fellow chapter member.

It is a special pleasure for me to welcome the new members of Sigma Xi. Your initiation into this society is an acknowledgement of what you have already accomplished and an indication of your future promise. While it is a proud moment for each of you, please know that we share in your pride. We are delighted to welcome you into membership and look forward to your involvement with the Charleston Chapter. Together, we will work to advance the future of science and engineering in our community.

For those who are new to Sigma Xi, let me share with you one of the principal pleasures that I derive from my membership. Every couple of months, a copy of the society’s magazine, American Scientist, arrives in the mail. This is a truly fascinating publication, in which articles appear across the full spectrum of scientific and engineering inquiry. These articles are written for a general scientific audience, which is to say that the more technical aspects are thankfully eliminated. It is possible, therefore, for a lowly epidemiologist like myself to learn something about a topic far-removed from my own research. For example, thermoelectric clathrates were featured in the most recent issue of the journal.

Now, if you are like me, this may have been your first exposure to clathrates, thermoelectric or otherwise. As astounding as it may be to the chemists and chemical engineers among us, I suspect that most in this room are clathrate virgins. Shocking isn’t it that so many of us could have gone through life without experiencing the thrill and excitement of clathrates?

Now, in this instance, as with most articles in American Scientist, a successful presentation may be judged by whether the key points might be adequately summarized over drinks at a cocktail party. Why anyone would want to discuss thermoelectric clathrates in polite company is a completely separate question. I suspect that few of you were engaged in discussing them before dinner tonight, for example. Of course, in some circles, this crowd would not be considered polite company, but that is an entirely separate matter. If, by some chance, you were discussing clathrates earlier this evening, I suspect that others quietly drifted away from you. Do not be concerned, however. Surely, there is a 12-step program that can help you with this problem.

For those of you who were not engaged in discussing thermoelectric clathrates before dinner, I apologize for bringing them up now. As the subject has been raised, however, it would be unkind of me to leave you hanging at this point. As they say about the National Enquirer, "inquiring minds want to know." For those of you who have not read the March-April issue of American Scientist cover to cover, let me provide a little background. Thermoelectric clathrates are solids with cage-like atomic arrangements that are efficient at converting heat to electricity. If that has not fully captivated you, let me tell you that groundbreaking work in this field is taking place virtually in our backyard. One of the authors of the article in question collaborated with colleagues at Clemson University to synthesize, and I am quoting here, "an ytterbium-bearing skudderudite that boasts a figure of merit that exceeds 1 above about 600 kelvins."

Personally, I have had an abiding interest in 'figures of merit’ ever since puberty. In my experience, however, it is far more conventional for males of our species to evaluate 'figures of merit’ on a ten-point scale. Unlike most of science, this rating system is widely recognized, is easily validated and is highly reproducible. Using that benchmark, exceeding 1 would not be judged particularly noteworthy. Certainly, it would not be consistent with 600 kelvins of heat.

At this point, no doubt I have offended all of the thermoelectric chemists in the room. In addition, those of you who simply subscribe to common standards of decency probably are not too pleased. My colleagues from the Medical University probably are trying to hide in total embarrassment as well. Still, you have to admit that it would make great press coverage. If a reporter from The Post and Courier were here, the headline in tomorrow’s paper would probably read something like: "MUSC Leader Generates Static on Thermoelectricity." Think about the possibilities for a creative reporter. They could run a sub-headline like: "Audience is Shocked!" or "Charged Comments Sent Scientists to Opposite Poles." One can only dream of press coverage like that!

On that note, perhaps I should turn to the focus of my remarks this evening. After considering a number of possible topics to discuss, I settled on the issue of scientific integrity. We can all wonder at the irony of a university president talking about anything related to integrity. If you’ll forgive the analogy, a university president talking about integrity is a bit like having Al Gore come to talk on the topic of personal charisma. Well, recognizing that I may be on less than entirely firm ground here let me plough ahead. The particular aspect of scientific integrity that I wish to address tonight is managing conflicts of interest. Now, conflicts of interest have been around for a very long time. One of the earlier commentators on this topic was Samuel Johnson. In the mid-eighteenth century, he wrote that: "Integrity without knowledge is weak and useless, and knowledge without integrity is dangerous and dreadful."

Almost two and one-half centuries later, a great deal of attention has been devoted in biomedical research circles to the issue of financial conflicts of interest. Not following the literature in other disciplines, I do not know the extent to which this topic has been discussed elsewhere. In principle, however, this issue is relevant to all areas of science that have the potential for commercial application. For our purposes tonight, therefore, let us assume that these comments are germane to a wide range of scientific endeavors, even though my point of reference will be biomedicine.

At the outset, it seems useful to reflect on why this topic has received so much attention recently. First and foremost, we are living through a modern day industrial revolution. Just as the steam engine powered the industrial revolution of the nineteenth century, information technology and molecular biology have powered the recent economic expansion. At the moment, of course, the equity markets are in a retreat from almost a decade of sustained growth. Nevertheless, the current downturn is likely to be fairly short-lived. After an adjustment period, we will witness renewed growth, and again, it will be technology that leads the way.

The fuel for this engine is intellectual property. Those who possess intellectual property are the warlords of the new economy. Not surprisingly, faculty members at our research universities often are the developers of this intellectual property. Licenses, patents and royalties on these properties can produce substantial revenues, far in excess of normal faculty compensation.

A second factor was the passage of the Bayh-Dole Act of 1980. This federal legislation was designed to reward translational research, foster the development of new products, and diversify the funding sources for academic research. Under this law, universities that received federal research funding were obligated to develop intellectual property policies.

Most responded by developing policies for sharing revenues between the investigator, the investigator’s department, and the university. This division of funds served its intended purpose of creating an incentive for faculty to pursue the commercial spin-offs of their research. Prior to that time, investigators rarely had a personal financial stake in the application of their research. Now the situation is different, however, and a faculty member can literally become an overnight millionaire on the basis of equity ownership in a start-up venture that is well capitalized. At the Medical University, we have not yet seen instant millionaires, but the potential is there, as demonstrated at a number of other universities. Our intellectual property policy, modeled after the one at Harvard, allows the faculty member to retain a one-third interest in the financial returns of their invention. To date, we have had eight start-up companies created. Although none are yet at the point of commercial application, success rates elsewhere would suggest that one or two of these might be commercial successes.

The third factor that has arisen is the extraordinary growth in the pool of available funds to support technology transfer. It is estimated that the annual expenditure on research and development by private industry is $55 - 60 billion per year. Of this total, probably a fifth is devoted to research that is conducted at universities. In addition, venture capital to support start-up companies continues to accumulate at an astounding rate. Even in a state like South Carolina that has been slow to the venture capital table, there are now multiple funds, plus a growing number of angel investors. The bottom line is that there is a lot of money out there to help bring innovative ideas to market.

We thus have a technology-driven marketplace, linked to incentives for faculty to transfer their technology, combined with an abundance of capital. This unholy trinity has created an environment in which there are ample opportunities for conflicts of interest. Now, let me be clear that a conflict of interest is a state of affairs, it is not an indictment of inappropriate behavior. By conflict of interest, I mean a circumstance in which a primary responsibility might be compromised by some secondary interest. Here the primary responsibility of the investigator is to adhere to sound scientific procedures in an unbiased search for truth. The secondary interest is a personal advantage, such as a financial reward, that might compromise the investigator’s objectivity.

It is easy to miss the distinction between a conflict of interest as a state of affairs rather than as an indictment of inappropriate behavior. Just this past week, I spent considerable time reviewing a case with the MUSC Board of Trustees in which there was a potential for a conflict of interest. In my opinion, and the opinion of the University’s Conflict of Interest Committee, there was no evidence of any impropriety. Still, for some individuals on the Board, the mere fact that there was the potential for a problem served as a call to action. There are those who want us to avoid even the appearance of conflict of interest. They will want us to rush in to intervene at the earliest opportunity, under the premise that the worst possible outcome will occur in the absence of intervention. Certainly, assuming that someone is guilty until proven innocent is expedient, but it comes at a heavy cost.

As you might imagine, I do not believe that course of action is the best way to proceed. Conflicts of interest are inherent in scientific work, as they are in virtually every human enterprise. It is impossible to eliminate such conflicts. If we establish as our goal the eradication of conflicts of interest, surely we will be disappointed. A far better approach is to recognize the complicated nature of the research environment and to try to manage the enterprise in such a way as to minimize the likelihood of an actual problem arising.

First and foremost, those of us within the scientific community have a responsibility to assure that high standards of personal conduct are part of our culture. The burden of that obligation falls particularly firmly upon those of us who work within educational institutions. Here, the process must begin with the selection of persons with high integrity into our educational programs. When we rank students for entry into our degree programs, are we focused primarily on grade point averages and GRE scores? Without question, intellectual ability is an important indicator for success in a scientific career. On the other hand, brain power alone is not, and should not be, sufficient. We must be equally concerned with the moral character of those who enter into scientific careers. We should try to understand what motivates our prospective students and try to anticipate the extent to which they will adhere to accepted standards of personal conduct.

As educators, our supervisory role begins following admission of a student into a graduate program. Regardless of discipline, our learners must be educated on ethical principles in the conduct of research. All graduate students at the Medical University, for example, must complete a course in scientific ethics. Even more important, however, these principles must be reinforced in the laboratories and clinics where these students undertake their research. The faculty must lead by example not just when it comes to scientific methodology, but also when it comes to standards of responsible conduct.

We are fortunate that the scientific method itself offers some additional safeguards. Basic principles of research design have been developed to minimize the possibility of investigator bias. For example, in randomized clinical trials, we routinely blind the investigator to the treatment assignments of individual patients. We often rely upon separate individuals to perform the intervention from those who evaluate the outcomes. We utilize data safety monitoring boards to assure an independent assessment of the outcomes under study. All of these approaches and many other measures help to assure the integrity of the research conducted.

Beyond the scientific method itself, we must develop principles of managing the research enterprise, which address the potential for conflicts of interest. These principles should begin with the basic principle of disclosure. For example, in a university environment, when a faculty member has a potential conflict of interest, this should be revealed to the appropriate officials.

In most institutions, this requirement is formalized through a policy on conflicts of interest. The individual or group to whom these matters should be reported will vary from institution to institution. In most research universities, for instance, a committee exists to review these potential conflicts of interest. The committee approach has many advantages, principal among them being the use of a peer-review process. The committee approach also relies upon the collective wisdom of a group, rather than upon the individual judgment of a single administrator. As these situations often lend themselves to a range of opinion, it is prudent to have a process that can incorporate more than one opinion.

A committee structure also can provide for the inclusion of representatives from outside of the institution. This is particularly important in instances where the conflict of interest is present at the institutional rather than the individual level. In such situations, a financial gain would accrue to the institution as a whole, rather than to a particular scientist. A recent case is worth mentioning. Beth Israel Deaconess Medical Center in Boston is a Harvard University affiliated teaching hospital. As with many academic medical Centers, Beth Israel Deaconess has experienced significant financial pressures over the past few years. In response, Beth Israel Deaconess is considering entering into an exclusive technology transfer agreement. Under the proposed agreement, a single company would be given a first right of refusal to pursue commercialization of all the discoveries arising from research at Beth Israel Deaconess.

Other academic health centers have already entered into exclusive agreements for technology transfer. Massachusetts General Hospital, for example, another Harvard teaching affiliate, has a deal with Shiseido, a Japanese cosmetic company. Over the past decade, this agreement has brought in about $180 million to Massachusetts General. So you can see that we are talking about some serious money here, even though this agreement is limited to intellectual property in the field of dermatology alone. What makes the Beth Israel Deaconess deal even more expansive is that it cuts across a broad range of research, from cancer, to heart disease, to diabetes, to obesity, to infectious diseases, to neuroscience, to women’s health. While such a broad agreement would offer huge financial benefits for the struggling health system, one has to wonder whether it comes at too great a price. Can the leadership of Beth Israel Deaconess evaluate the costs and benefits objectively? In fact, can anyone within that medical center be objective in evaluating the proposed agreement? Certainly, the presence of representatives of the community-at-large would increase the credibility of any review that took place.

Of course, not all potential conflicts of interest are financial in nature. The focus on economic conflicts of interest probably relates to some aspects that make them distinctive. Financial interests can be easily quantified, they are intuitive for the public to understand, and they are seen as strong motivators of personal conduct. For all of these reasons, fiscal interests warrant particular scrutiny. This is not to say, however, that the work of a Conflict of Interest Committee should be limited to financial issues alone. Let me cite a recent example from the Medical University. One of our leading investigators won a large federal grant funded as the result of an extremely intense national competition recently. For obvious reasons, we were proud of this faculty member and her accomplishment. This study required a large amount of fieldwork in multiple locations which the principal investigator determined would be best handled by a contract to an outside research firm. The company selected was a non-profit entity, with an outstanding national reputation for the quality of their work. A perfect match, right? Well, I have omitted one detail from my description. The principal investigator of the grant is the daughter of the chairman of the board of the outside contract organization.

Now, the board chair of this research organization is not compensated for his work with them. He is a faculty member at a prestigious research university and a nationally prominent investigator in his own right. He will receive no personal financial gain from this project, nor will his daughter, the principal investigator. Nevertheless, in the eyes of some people, there is the potential for a conflict of interest in the choice of this firm to do the fieldwork. Whether one agrees that this example represents a potential conflict of interest or not, it probably is prudent for the Conflict of Interest Committee to review it. When first presented to our Committee, however, they were reluctant to hear the case, as they felt that their purview was limited to potential financial conflicts. With some gentle arm-twisting the Committee agreed to hear the case. Nevertheless, we can all appreciate the "mission creep" that can occur as conflicts of interest are defined more broadly.

Once the Conflict of Interest Committee has reviewed a particular case, they will make a recommendation for action. In some instances, they will recommend that the potential conflict should be eliminated, especially if it is believed to compromise the integrity of the individual, the institution, or science in general. This type of remedy obviously is drastic and most likely to be invoked only for the most extreme kinds of conflicts. For better or worse, the world is not so black-and-white. Conflict of Interest Committees are more likely to be engaged in sorting out various shades of gray. Accordingly, their typical recommendation is likely to be to develop a plan to monitor and manage the potential conflict.

This is perhaps as good a place as any to wrap up my remarks. Certainly, we have not exhausted the topic of conflicts of interest, although you may well feel exhausted. I am content to conclude that a life in science has grown increasingly complex. The fruits of our labors have enormous economic potential and scientists increasingly find themselves conflicted by these forces. How quaint it now seems to reflect back on what Max Planck wrote almost 70 years ago in a publication entitled Where is Science Going. Planck wrote that: "Scientific discovery and scientific knowledge have been achieved only by those who have gone in pursuit of them without any practical purpose whatsoever in view." If Planck were alive today, would he think that we have gone astray? Indeed, have we gone astray?

Thank you very much.