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.
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