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Ethical Leadership for the 21st Century

Shirley Ann Jackson, Ph.D.
President, Rensselaer Polytechnic Institute

Coca Cola Lecture
The Sale Hall Chapel, Morehouse College
Atlanta, Georgia

Thursday, April 21, 2005

Thank you very much for inviting me. I am honored to be counted among the distinguished scholars who have lectured at Morehouse College as the Coca-Cola Leadership Lecturers.

I think this may be one of the more inspiring assignments I have received — to select a topic which speaks to "issues of integrity, empathy, and hope as moral indices for ethical leadership", as prescribed by the lecture guidelines.

I have selected issues to speak about which encompass some of the things I have encountered within my own experience in science, technology, and in public policy; and the ethical questions — which present when "knife-edge" issues come up against human society. The thread which runs through these elements, tying them together, is leadership.

Taken on their own, science and technology are, essentially, neutral commodities. They choose no sides. They offer no judgments. They render no opinions — except with respect to the science, itself. But, science is no stranger to controversy — there are always debates about scientific results and discoveries themselves, such as their veracity, or their replicability.

The results of research, in other words, remain neutral, until application, when they are ascribed meaning or significance. The truly controversial issues lie at the juncture of science and humankind, when new knowledge is applied in ways which may have unanticipated moral or ethical implications, where safety or security risks are introduced, which must be balanced against the benefits achieved, where we find public understanding of science — or not; where we find fears about its use — or not.

These make up some of the "knife-edge" issues inherent in the advancement of scientific discovery and technological innovation.

Let me begin my discussion of these issues in the realm of biotechnology and medical science, given that ethical leadership is a tradition of Morehouse College, and that the biotechnology and medical science arenas are a key focus of the Morehouse School of Medicine, whose commitment to the healthcare needs of the underserved is well recognized.

And, it is always instructive begin with a look at specific examples.

About 90 percent of the world's diseases affect the populations of developing nations. But, only about 3 percent of research and development is directed toward those diseases. The bulk of drug development investment is made in treatments for diseases which affect people in developed countries, where costs can be more readily recovered.

Consider HIV/AIDS

One of the greatest challenges in treating HIV infection is that the HIV virus continually replicates and mutates, leading to drug resistance. Fuzeon, a groundbreaking HIV/AIDS drug which received U.S. Food and Drug Administration (FDA) approval in March 2003, shows promise in helping patients to overcome this resistance to many of the more commonly used anti-retroviral drugs. Fuzeon interferes with the action of GP41, a protein on the surface of the HIV, which allows it to gain entry to CD4 cells. This drug inhibits the ability of the HIV virus to fuse to immune system host cells, inhibiting viral replication, and helping to restore the patientís natural defenses.

Fuzeon was the first HIV/AIDS drug approved in seven years. It was developed by a team at Trimeris, a biotechnology company, which developed the drug in partnership with Roche Pharmaceuticals — a team which included several alumni of the university I lead — Rensselaer Polytechnic Institute.

But, HIV/AIDS patients, and their advocates, point out that Fuzeon costs between $30,000 and $40,000 per patient per year, putting it out of reach of HIV/AIDS patients without health care coverage. Conventional treatments cost about half that amount.

The prohibitive costs of funding and exploiting pharmaceutical research and development are a key aspect here. The average development cost of a new drug in the year 2000 was approximately $800 million. Does patent protection yield the best way to help fund research and development? Or, to get the best drugs? Should government policy regulate the cost of pharmaceuticals, and if so, how? And, to what extent?

A more critical question is who benefits from a drug? And, what are the drug developerís responsibilities to see that patients in need of the drug get it?

Consider a disease such as Leishmaniasis — a parasitic infection transmitted through the bite of an infected sand fly. A deadly version of this infection — visceral Leishmaniasis (VL) (also known as kala-azar) — affects 1.5 million people around the world, killing 200,000 every year, primarily in India, Bangladesh, Sudan, Brazil, and Nepal.

One solution to the global ethical issue of who pays for drug development was devised by Victoria Hale, a scientist in the pharmaceutical and biotechnology industries who had served as an official at the FDA. Dr. Hale knew from her FDA work that many promising drug-development projects — especially for diseases of the poor — do not go through to development completion and clinical trials because of a lack of funding.

Dr. Hale organized the Institute for OneWorld Health, the first not-for-profit pharmaceutical company in the United States. The company identifies these "orphan drugs" negotiates for intellectual property rights, raises development funding, and talks researchers into contributing their expertise to the development process.

Last year, OneWorld Health completed the largest-ever Phase III clinical trial of paromomycin, an off-patent, broad-spectrum aminoglycoside antibiotic with anti-parasitic activity known to be effective in treating Leishmaniasis, but which had not gone through clinical trials for approval. Another antibiotic, Amphotericin B, effectively treats Leismaniasis, but a course of the drug costs $120. Clinical trials by OneWorld Health showed that a course of paromomycin was as effective as Amphotericin B, but costs only about $10.

OneWorld Health is seeking regulatory approval in India for injectable paromomycin, a once-a-day, 21-day cure for visceral Leishmaniasis, which provides lifetime immunity. When approved, paromomycin will be the most affordable, safe therapy to treat visceral Leishmaniasis in the world.

Sometimes it takes thinking beyond the usual, and action to resolve an ethical issue.

Researchers conducting clinical trials in developing countries for new drugs to treat of HIV/AIDS, tuberculosis, or malaria — diseases which disproportionately affect those countries — are coming under criticism for not providing participants with treatment when the trials conclude. The World Medical Association Declaration of Helsinki, which lays out guidelines for global medical ethics, states that patients in a study should be assured of access to the best proven prophylactic, diagnostic, and therapeutic treatments.

The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) do not adhere to the Declaration of Helsinki principles. Instead, the FDA has proposed alternative guidelines. However, critics say that the proposed guidelines are not transparent and do not address researcher conflict of interest. In addition, they do not require the publishing of study results, or require providing clinical trial subjects with post-trial treatment.

Should U.S. government agencies adopt global standards? Or, are they both so expensive and so restrictive that they would inhibit drug research and development?

In yet another example — in areas of high biodiversity, organisms which cannot flee their predators — plants or coral, for instance — are evolutionarily predisposed to develop high toxicity. Biologists are learning that such substances may become drugs — useful in treating human disease. Testing the harvested material, called "cyanobacteria", however, requires equipment which relies on radioactivity, which is difficult to import to developing countries.

Eduardo Ortega, a parasitologist at Panama's Institute for Advanced Scientific Investigations developed a new testing method by tagging a parasite's DNA with fluorescent stain. Then the parasite is incubated with cyanobacteria. If the cyanobacteria under study have no effect, the fluorescence will increase as the parasite reproduces. If the fluorescence does not increase, researchers know that they have found bacteria with potential for development as a pharmaceutical.

This method is being used to "prospect" for organisms which have activity against malaria, dengue fever, and, also, Leishmaniasis.

The issue raises interesting questions about who should profit from patents based on biodiversity found in developing countries. If the extracted material were a mineral, there would be little question that the country of origin would receive compensation. U.S. patent law protects the individuals who do the intellectual work needed to turn raw biological discoveries into marketable products. International law does not yet address such issues. What is the right ethical position?

My final biomedical example concerns the issue of balancing potentially life-saving, but experimental treatment with regulatory oversight.

In 2003, a teen-age boy was brought to the emergency room at Beaumont Hospital in Royal Oak, Michigan, having been accidentally punctured in the heart with a nail gun. Although physicians repaired the puncture, the boy suffered a massive heart attack, and imaging showed he had suffered heart muscle damage. Physicians then transplanted stem cells from his bone marrow into his heart in the hope that his heart muscle tissue would regenerate. He improved with this treatment. When the treatment was revealed, the FDA forbade further transplantation — pending additional nonhuman studies. The ability to do this procedure at all resulted from breakthroughs in basic bioscience and tissue engineering. However, it had not gone through requisite trials and FDA approvals, and was, therefore, extremely risky. What would you have done?

To illustrate "knife-edge" issues personally, let me tell you about one which I encountered as Chairman of the U.S. Nuclear Regulatory Commission (NRC), and a related derivative issue.

At Millstone Nuclear Power Plant in Waterford, Connecticut, questions had arisen over serious safety issues, especially during full nuclear reactor core off-loads, during refueling. An NRC investigation found numerous instances of non-adherence to safety requirements — some quite serious. The agency gave the utility 30 days to show that its plants had corrected safety problems, had dealt with design basis issues, and had an adequate corrective action program — or have the plants shut down, an unusual step for the NRC.

In March of 1996, just eight months into my tenure as Chairman, a Time Magazine cover story took the issue public, raising concerns over serious safety issues and regulatory practices at Millstone, and, by extension, around the country.

Ultimately, I ordered the shut down of the Millstone Nuclear Power Station. It remained closed for two-and-a-half years. One of its reactors was never restarted — for economic reasons. A related nuclear power plant, Connecticut Yankee, also shut down during this period, never re-opened.

As you may imagine, the event caused a crisis of confidence for the NRC. I decided that this event was an important learning moment for the agency, and I immediately requested an in-depth, lessons-learned assessment. The day the Time Magazine article broke, I addressed all agency employees, and, the day after, I held a press conference.

I did this because the media, the public, the Congress — as well as every other constituency — needed to know that I accepted responsibility for the agency; that I would explain and account for the agency's performance; that the agency would improve its performance in the future; and that operational safety in nuclear activities remained our overarching mission and focus.

One does not lightly close down a nuclear power plant. It is a hugely complex undertaking with vast repercussions. It involves millions of dollars in costs to the industry owners — costs which eventually are passed along to customers. It affects the ability to supply electricity to critical care facilities, such as hospitals, and the ability to provide needed cooling in the heat of the summer. It affects the salaries of hundreds of workers and, therefore, their families. It affects public confidence levels in nuclear power generation. It affects the reputations of the Congressional representatives from the area, and more broadly, the confidence the Congress and the public have in the regulatory agency.

During the time the plant was closed, there was enormous pressure:

  • from the public — to keep the plan shut down — perhaps permanently;
  • from plant employees — to restart the plant as quickly as possible, because they were worried about a permanent shutdown and the loss of jobs; ultimately the CEO resigned;
  • from the media — who questioned the performance and the credibility of the NRC;
  • from the Congress — whose members were split between those who thought the NRC was being too hard on the nuclear industry, and those who thought the agency was not being tough enough. (There were a number of hearings before the Congress and meetings with its members — on all sides of the issue);
  • from the Connecticut Congressional delegation, specifically — whose members had to balance their own views on safety with the need for nuclear-produced electrical power in Connecticut during two very hot summers;
  • from the NRC staff — some of whom felt unfairly maligned by the media and others; and
  • also from the Commission itself (the five Presidential appointees at the top of the NRC) — not all of whom completely agreed with the tough stance I had taken with the licensee (the utility) and with some members of the NRC staff, although ultimately, we all came together on what must be done.

This multifaceted sequence of events encompassed multiple lessons: There was some reassignment of some staff, the resignation of others, a re-organization of the NRC, and significant changes in the agency's approach to the regulation of nuclear reactors — all of which I initiated. These changes occurred as the agency was developing a new strategic plan, improving its planning, budgeting, and performance management systems, creating a review process for license renewal (the 20-year extension of the license term of a nuclear reactor), creating regulatory documents for risk-informed, performance-based regulation, and creating the International Nuclear Regulators Association, all of which, and more, I initiated and accomplished during a four-year tenure as Chairman of the NRC. It was a hugely complex situation at a time of great change, and great stress, at the NRC. And yet, each constituency ultimately had its concerns addressed, and we were able to move on in a positive framework.

A derivative issue, related to the safety of U.S. nuclear power plants, is the safe and secure disposition of spent nuclear reactor fuel and high level radioactive waste. So let me tell you about Nevada's Yucca Mountain, which is proposed as the nation's high level nuclear waste depository. Currently, the spent nuclear fuel for the nation's nuclear power plants is stored at 74 sites around the country. Finding a safe repository for nuclear waste is a sensitive and complex challenge.

The U.S. Geological Survey (USGS) has been using computer modeling of water infiltration and climate to determine whether the site, located 100 miles northwest of Las Vegas, could safely isolate radioactive waste, and prevent ground water contamination.

Last month, improprieties in the quality assurance process being studied by USGS scientists came to light. Emails between some USGS scientists seemed to indicate that data had been compromised. Ultimately, it will be the responsibility of the U.S. Nuclear Regulatory Commission to adjudicate the issue. Congressional hearings have been held, and federal agencies are investigating.

Whether or not the issue will impact the viability of the project, is yet to be determined. The incident highlights the criticality of objective and credible science. Is the data flawed? Are pressures influencing what should be objective science? What are the pressures on the project and on the scientists? From whom do they come, and what are the motivations? How can the scientific process best be protected? How do we come to a reasonable resolution?

Looking at all these examples, which represent a mere snapshot of decisions faced by scientists, engineers, business leaders, and public officials every day. What would you do in these instances? How would you resolve these issues, were you in a position of leadership? What resources would you draw upon for guidance? How do "integrity, empathy, and hope" apply in resolving the complex issues which will surface in our increasingly complex world?

Basically, most of these questions encompass change — change in technology, change in capacity, change in orientation, change from the norm. And, change usually is difficult.

The principles which have guided me in various positions of leadership could well be adapted to be useful in this regard.

There are six.

The first is Integrity, which, as you know, is the state of being of sound moral principle, upright, honest, sincere. Integrity means holding to the highest standards and setting an ethical example — on a continuous basis. It is something everyone must examine his or her conscience to determine and to follow. I also like the definition provided by former Congressman J.C. Watts (R-OK) who said, that integrity ìis doing the right thing when nobody's looking. There are too many people who think that the only thing that's right is to get by, and the only thing that's wrong is to get caught."

The second is Vision. There are two kinds — vision which sets the tone and the direction, and which must be rooted in a clear-eyed view of the big picture, and vision to delineate the complex, intertwined ethical questions, amid their larger context and their implications for society at large.

The third is Courage. To lead requires the courage to make, and to stand by, difficult choices — to be willing to face the "knife-edge" issues, which, in the scientific context, discovery and innovation often pose. And, once having made a decision, courage is needed to stay the course.

The fourth is Engagement of others in coming to a principled stand on a difficult issue, and in getting others to join you in staying the course. In addition, engaging constituencies and enlisting participation enable the decision-making to profit from multiple insights and creative energies.

A fifth element is Language. The language we choose when we talk about issues, and engage in discussion, exchange, and debate is very important. Language helps set the tone and can include — or exclude. Language has the capacity to elevate the discussion, drawing the best from participants.

A sixth and last element involves Action. One must be willing to act, not merely to believe. Action is needed to fashion practical approaches to address "knife-edge" issues. Such approaches are inherent in the examples, which I have delineated.

Much is written about leadership, but today's leadership must adapt to the changing environment. Today's global economy, geopolitics, instantaneous news, and high-speed interactive communications technologies make for an interconnectedness between and among people which requires new leadership skills and qualities.

In the past, leadership relied on strength and determination in a single individual. This still holds, but leadership, today, also must address greater complexities at multiple levels. By that same token, past leadership ultimately was answerable to a relatively small, contained homogeneous community, making ethical leadership easier and clearer.

In today's wi-fi, hot-wired, hyper-linked, 24-7-365 on-line world, however, leadership challenges are no longer single, or simple. They intertwine and reach beyond a single community to touch communities across the entire planet. Ethical leadership in this environment ultimately is answerable to a global community. Leadership which is effective must take into account a vast array of needs, capacities, skills, backgrounds, perspectives, cultures, languages — and, yes, hopes. For it is hope which ultimately lifts the human spirit, and motivates people to take ethical stands and to act on them.

And so, how do we contend with the ethical leadership challenges of the third millennium?

Let me leave you with some suggestions.

First of all, be curious, ask questions, and be as informed as you can be. Allow differing ideas and perspectives to stretch your thinking. Creativity, innovation, discovery, and ethical decision-making derive from the sensitivities developed from such juxtapositions.

Gather around you people from a diversity of backgrounds, perspective, experience, and viewpoint — seek commonalities and new approaches. Let the differences freshen and inform your thinking.

All along the way, in everything you do, you encounter choices and decisions, most of them small, many seemingly unimportant. Yet, each requires a special clarity — the ability to see beyond the immediate issue, to contemplate the broader one, to weigh the benefits, to be aware of consequences, to be informed and knowledgeable, and a leadership which is strong and inclusive.

Finally, be strong. Nothing is ever gained if we are unwilling to take a stand, to be unafraid, to lead by example, to engage others.

The specific examples I have shared with you today relate, primarily, to public policy. You ßmay think you are not directly involved, but in reality, everyone is. The small decisions and judgments one makes every day coalesce, within every community to create the larger mind-set. The bottom line is — what you think and what you do matter. They reinforce each other.

In the end, I believe that each of us has the power — and the obligation to confront the ethical issues — whether one is an actual leader of others or is leading others by example. The issues are too important to leave to others to decide.

I will close by quoting the Rev. Dr. Martin Luther King, Jr., that great leader of moral integrity and courage, with the vision to see the ethical path, who called for action with language which engaged a community and, ultimately, a nation. He once said:

"Cowardice asks the question — is it safe?
Expediency asks the question — is it politic?
Vanity asks the question — is it popular?
But, conscience asks the question — is it right?
And, there comes a time, when one must take a position that is neither safe, nor politic, nor popular;
But, one must take it because it is right."

Thank you.

Source citations are available from the division of Strategic Communications and External Relations, Rensselaer Polytechnic Institute. Statistical data contained herein were factually accurate at the time it was delivered. Rensselaer Polytechnic Institute assumes no duty to change it to reflect new developments.

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