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Leonard Heaton Oration: The United States Military Cancer Institute–realities and potentialities
GARY P. WRATTEN SURGICAL SYMPOSIUM
Leonard Heaton Oration: The United States Military Cancer Institute–Realities and Potentialities John F. Potter, MD Director, United States Military Cancer Institute, Uniformed Services University of the Health Sciences, Bethesda, Maryland, and the Walter Reed Army Medical Center, Washington, District of Columbia It is a great honor for me to have been asked to deliver the annual Heaton Oration. General Heaton is remembered by all of us not only for his superb surgical judgment and operative skills, which were demonstrated in the care of his patient, President Dwight D. Eisenhower, but also for his farsighted and compassionate leadership as the Surgeon General of the United States Army. A renaissance man in uniform, he is a role model for all of us today. Col Shriver suggested that I take as a theme for the oration the establishment of a cancer research institute, based on my experience with the founding of the Lombardi Center and the United States Military Cancer Institute (USMCI). I would like to begin by telling you about the history of the USMCI. As a Regent of the Uniformed Services University of the Health Sciences, I had the opportunity to conduct a survey of cancer research in the military institutions in the National Capital Area. I began this process on July 10, 2000, with an interview with the Dean of the Medical School, Dr. Val Hemming, a retired Army Colonel with a distinguished career in infectious disease research. Dr. Hemming told me that there was a good deal of cancer research here, but that there was little collaboration between investigators. The Dean welcomed the initiation of a process, which, in his words, “would bring people together.” Dr. Robert Goldstein, Chairman of Medicine, was the first of many to point out that the existent Institutional Review Board (IRB) situation was a very major impediment to research, because an investigator in 1 institution had to secure IRB approval, not only from his own hospital, but also from all the other military institutions where he sought to do research. In the worst-case scenario, this necessitated as many as 5 separate IRB approvals: Walter Reed, the Navy, Malcolm Grow, Uni-
Correspondence: Inquiries to John F. Potter, MD, Walter Reed Army Medical Center, Building 1, Room A108, 6900 Georgia Avenue NW, Washington, DC 20307-5001; fax: (202) 782-6794; e-mail: [email protected] The opinions and assertions contained herein are the private views of the author and are not to be construed as official or as reflecting the views of the United States Government, the Department of Defense, or the Department of the Army.
CURRENT SURGERY • Published by Elsevier Inc. on behalf of the Association of Program Directors in Surgery
formed Services University, and the Jackson Foundation. The negative impact of this system on research productivity is readily apparent. It is a testimony to the commitment of military investigators that they were willing to enter this bureaucratic quagmire. Capt Glenn Wagner, the Director of the Armed Forces Institute of Pathology, saw a great need for a cancer institute because funding from the Department of Defense for cancer was essentially limited to patient care. Great research resources could not be tapped due to the lack of a relatively few research dollars. As a specific example, he sited the Automated Central Tumor Registry (ACTUR), which is located in the AFIP. In the last 14 years, more than 270,000 cases of cancer in the military have been accessioned on this system. However, there has been little analysis of this data primarily due to the lack of professional research personnel. A relatively small expenditure for a research epidemiology program might pay enormous dividends. The Commanding Officers, General Timboe at Walter Reed, Admiral Martin at the National Naval Medical Center in Bethesda, and General Brannon at Malcolm Grow, were enthusiastic about this endeavor. The kind offer of General Timboe for office space led to the establishment of the headquarters of the USMCI at Walter Reed. The results of this cancer survey of more than 60 scientists were reported on August 29, 2000. The frame of reference for these evaluations was based on my experience as a site-visitor for the NCI to the leading universities in this country, including Harvard, UCLA, Duke, and Yale. This survey showed that there were superb basic and clinical scientists here. In addition, there were enormous resources in technology, epidemiological data, DNA, serum, and pathology specimens, and there was a large, idealistic population willing to entering clinical trials. On the negative side, there was little or no communication across specialty and service lines. The IRB process was a catastrophe and was impeding research efforts. Other negative findings of the survey were that military in0149-7944/03/$30.00 doi:10.1016/S0149-7944(03)00105-3
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vestigators have a tendency to rely primarily on military funding for research support. In many cases, Department of Defense (DoD) grants are critically peer reviewed by highly competent military and civilian scientists. However, the award of such grants does not carry the panache of the R0-1⬘s and P0-1⬘s, which are awarded by the National Institutes of Health (NIH). Correctly or incorrectly, it is NIH grants that are regarded by the national scientific community as the bell weather for scientific excellence. Another disquieting finding of the survey was that military beneficiaries were being treated more often in the civilian sector than in the military health system. In the year 2000 alone, there were 706,395 visits to civilian oncologists and only 479,092 to military cancer specialists. This situation has many negative implications. First, it reduces the number of patients being cared for in Military Treatment Facilities (MTFs), thereby lessening clinical experience for residents and medical staff. Fiscally, care is more costly to DoD in the civilian sector. An argument could also be made that the cancer beneficiary will receive better care in the military health system than in the average civilian setting. Finally, declining numbers of patients reduce the number of patients available for clinical trials. It is my belief that vigorous efforts must be made to increase the flow of patients to the MTFs in the future. The awareness by the beneficiary that an MTF is a collaborator with the USMCI should increase the desire of that beneficiary to come to that MTF for treatment. The survey also suggested that a cancer institute would have positive effects not only on research, but also on patient care and education, producing further enhancement of the academic luster of military medicine. The next noteworthy event in our history was the ribboncutting ceremony here at Walter Reed to dedicate the newly renovated headquarters of the USMCI. These offices were a major step forward in establishing the identity of the cancer institute. A meeting was held on July 17, 2001, with Col Robert Eng, the Director of the Armed Forces Radiobiology Research Institute (AFRRI), and with representatives of the basic science and radiation medicine communities to discuss the feasibility of employing the nuclear reactor at AFRRI for cancer research. A new porphyrin compound had been discovered that increased significantly the deposition of boron in neoplastic cells, thus increasing their sensitivity to neutron irradiation. This development warranted investigation, especially as several of the few nuclear reactors in this country have cancelled research activities. This boron capture neutron therapy initiated a new collaboration among the physicists at AFRRI, basic scientists at USU, and the radiation therapists at Walter Reed and the National Naval Medical Center. On September 18, 2001, the Charter for the USMCI was signed. This document declared that, because of the impact of cancer on the military, and because of the importance of research in lessening this affliction, the signatories establish the USMCI with the goal of achieving designation as a Compre-
hensive Cancer Center. This document was signed by MG Harold Timboe, Commander of WRAMC; James A. Zimble, MD, President USU; Adm Kathleen Martin, Commander NNMC; BG Barbara Brannon, Commander MGMC; and Col Michael Dunn, Commander Walter Reed Health Care System. On October 31, 2001, the first meeting of the extramural Committee of Scientific Advisors for the Institute was held. This day-long session included an introductory overview of the Institute and the presentation of the science of each of its programs. This Committee is a panel of distinguished scientists who meet here to review our progress. It offers critique and counsel on both short- and long-term goals. The Committee is chaired by Charles M. Balch, MD, a national leader in surgical oncology who has played a key role in the development of a number of comprehensive cancer centers in this country. He is at present the Executive Vice President of the American Society of Clinical Oncology and a Professor of Surgery at John Hopkins University. Other members of the committee include Larry Norton, MD, who is the Chief of Medical Oncology at Sloan-Kettering Memorial and the immediate past president of ASCO; Ralph Weichselbaum, MD, Daniel K Ludwig Professor and Chair, Department of Radiation and Cellular Oncology at the University of Chicago; George Vande Woude, PhD, the Director of the Van Andel Cancer Institute in Michigan; Esther H. Chang, PhD, Professor of Oncology at Georgetown; Laurel W. Rice, MD, Director of the Division of Gynecologic Oncology at the University of Virginia; and Michael J. Weber, PhD, Director of the Cancer Center at the University of Virginia. During this critique, the Institute presented to the visitors its own analysis of its strengths and weaknesses. We had determined that strong programs existed here in both basic and clinical science, but that our greatest potential to contribute significantly to the national cancer endeavor would lie in the field of Phase III clinical trials with a special emphasis on epidemiology and prevention. Our beneficiary population offers a unique and extraordinary opportunity for clinical research in these areas. The Committee subsequently forwarded a very favorable report on the progress of the Institute, endorsing the epidemiology and prevention theme. Another, nonscientific, group that counsels the Institute especially on the human dimensions of cancer is the Committee for the USMCI. This committee, which is being formed, will be limited to 25 distinguished Americans and is chaired by Gen. H. Norman Schwarzkopf. Other members include the First Lady, Mrs. Laura Bush; the Honorable Frank Carlucci, the Chairman of the Carlyle Group and a former Secretary of Defense; and Mr. Gerald S.J. Cassidy, Chairman of the Cassidy Companies. Organizationally, the USMCI is an academic and scientific entity of the matrix type, functioning in the military. It is characterized by the voluntary participation of its members. There is no line authority in its structure. The Institute is academically
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positioned in USU where the Director occupies a position analogous to the Dean and reports directly to the President. The Director allocates, with the advise of the Executive Committee of the Institute, budgetary and space resources and appoints members to the Institute who have received the approval of its Executive Committee. The Executive Committee is the prime advisory and policymaking committee of the Institute. It is composed of the Associate Directors for clinical science, basic science, administration, epidemiology, protocol review, informatics, and cancer prevention. In addition, 2 members-at-large are voting members. The USMCI IRB Committee, chaired by Cdr Brian Monahan, a medical oncologist, is composed of representatives from Walter Reed, NNMC, Malcolm Grow, and USU. Its goal was to create an IRB for the USMCI that would permit the investigator to obtain protocol approval for all military institutions in this area in a single step. Members of this committee were drawn from all areas of science, specialty, and military service. The challenges to the committee were substantial. There were valid legal issues originating from differences in regulations of the 3 services. These legal problems were resolved by the adaptation of compatible regulatory language by the 4 local commands. Administrative and “turf” problems were similarly resolved. As a result, a “Memorandum of Understanding” (MOU) establishing a single cancer IRB was drawn up. This specifies that approval or nonapproval of any protocol remains the perrogative of the local commander. This commander acts on the recommendations of the IRB, but maintains the authority to reject its recommendation for approval. The MOU was signed by the President and the 3 hospital commanders in a ceremony at the TRICARE meeting on February 4, 2002. Now, this single-step IRB approval will save 6 to 12 months for multi-institutional research. It will also expedite the utilization of the latest treatment discoveries for the patient. The quality of the ethical and scientific review by this committee composed exclusively of cancer scientists should be excellent. Also, the IRB is a strong cementing force between investigators in different specialties and services. In regard to application for membership in the Institute, a formal process has been established. Candidates are persons where activities are primarily devoted to cancer research, treatment, education, or service. In practice, clinical researchers are individuals who are board eligible or certified in one of the oncologic specialties. As regards surgeons, those who meet the criteria for admission to the Society of Surgical Oncology are eligible. At present, all members are drawn from the National Capital Area. However, it is hoped that, in the future, military oncologists from about the country will wish to join our organization. This will increase our strength and will promote our goal of establishing a nationwide military cancer cooperative group. In my opinion, the high quality of science in the military is not widely appreciated in civilian academia. One possible cause for this situation is that military investigators do not apply
frequently for NIH grants. There is a tendency to rely on DoD funding. In many cases, the peer-review process of DoD grants is just as rigorous, if not more rigorous, than that in the civilian community. With that being said, however, the reality is that quality of science is evaluated by the number of R0-1s, P0-1s, and similar grants that an institution possesses. That is why I have been encouraging our Institute members to apply for such grants. We must end the scientific apartheid that exists between civilian and military scientists. The Institute will offer important benefits and services to its members. One of these will be the establishment of a biostatistical core facility to offer consultation on protocol design. Such a service should improve the quality of grant applications and manuscript preparation. An epidemiology team will also be developed that will function to support our investigators in detecting etiologic factors in the tumor systems that they are studying. An emphasis on molecular epidemiology will be stressed. Our members have told us that a major problem, caused by their demanding clinical schedules, is the lack of time for grant and manuscript preparation. The Institute will employ a professional scientific writer who will assist the investigator in manuscript and grant preparation and submission. This writer would be fully aware of the regulations and idiosyncrasies of the organizations to which the document might be submitted. Also, this professional would assist the scientist by performing literature searches, validating data, prodding recalcitrant coinvestigators into productivity, and, in general, simplifying the task of the scientist. Word-processing services would, of course, be offered. In the future, as more funds become available, the Institute will support its members by paying for ancillary personnel such as research nurses, data managers, and similar professionals. I wish to acknowledge today the contributions of those of you who have made the Institute a reality. First of all, my sincere thanks to our host today Major General Harold Timboe, who kindly offered the office space for the Institute in historic building 1, here at Walter Reed. He has also been the source of wise counsel and support for me during our initial startup vagaries. President James A Zimble has strongly backed our endeavors and has shown exemplary vision in the initiation and development of the Institute. COL Michael Dunn has also been a strong supporter and has appreciated fully the academic possibilities of this endeavor. Colonels David McLeod and Judd Moul have established a world-class prostate research team here that we are trying to replicate in other areas. COL Craig Shriver has supported our efforts from the first. His Clinical Breast Care Project combines basic, clinical, and translational research. In a few years, his program will have national recognition. Capt Glenn Wagner has facilitated the collaboration of the AFIP in our activities.
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Colonels Jay Carlson and Scott Rose are leaders of an excellent Gynecological Oncology research program. Last in terms of rank, but not in scientific ability, is Capt Joseph Flynn, who has contributed importantly as the Special Assistant to the Director. I am deeply indebted to all of these people. Not only are they excellent scientists and physicians, but they have also become my good friends. In our vision for the future, the United States Military Cancer Institute has unique resources for cancer research because it is a component of the Department of Defense, which operates a vast medical expertise. Department of Defense military beneficiaries number 9 million and offer a unique opportunity for clinical research. In the last 14 years alone, more than 270,000 cancers were accessioned on the Automated Central Tumor Registry (ACTUR) system. The military population is characterized by the racial, ethnic, and social diversity, which is essential for the protocol studies, that will benefit all Americans. Other exceptional resources include the AFIP, whose scientists are at the cutting edge of medical discovery. Armed Forces Radiobiology Research Institute with its nuclear reactor is a unique asset where the benefits of neutron beam therapy can be rigorously assessed by a scientific team that has been assembled by the USMCI. The 30-million serum specimens in DoD could be, with administrative approval and informed patient consent, an extraordinary resource for cancer genomic and proteomic discovery. The military is an idealistic group; they are imbued with the spirit of self-sacrifice for the good of the whole. This is the probable reason why the accession rate of patients on cancer protocols at Walter Reed runs about 30%, in comparison to the 1% to 2% rate in the civilian sector. The application of discovery in cancer prevention, detection, and treatment could be made expeditiously in the military. Such studies would decrease the occurrence of cancer or would allow its detection at the earliest moment when effective treatment could be initiated. From the military viewpoint, such successes will preserve the wellness of the military force. Most importantly, the Institute will further enhance the academic luster of military medicine, and it will call to the attention of the scientific and lay communities in this country of its vital contribution to medical investigation. Also, the opportunity to belong to an elite intellectual entity will enhance the retention of the best and the brightest in the military, and it will promote the recruitment of similar quality people to its ranks. The prime function of the Department of Defense is not cancer research, but it is funding an enormous medical enterprise. Some of these resources can be employed for research purposes with the expenditure of relatively negligible amounts of additional dollars, most, if not all of which, would be obtained from outside DoD. Moreover, our extraordinary potential and the large scope of our activities will contribute importantly to the national war against cancer. Given the clarity of
these concepts, it is surprising that this initiative was not undertaken long ago. Vincent T. Lombardi was born in 1913, the son of an immigrant Italian butcher who lived in a lower middle class neighborhood in the Sheepshead Bay area of New York City. In high school, Lombardi tried out for the football team. He was small in size, but his emotional commitment overcame this handicap and he made the team, becoming an outstanding guard. He was offered a scholarship to Fordham University, where he became a member of the legendary Seven Blocks of Granite—a line that played 60 minutes on both offense and defense. After graduation, he became an instructor in physics and the basketball coach for a small private high school in New Jersey. Lombardi knew nothing about basketball, but within a year, his team was the state champion of their division. He subsequently obtained a position as a high school football coach and was quite successful in this endeavor. He was then recommended to the legendary football coach at West Point, COL Earl (Red) Blake for an assistant coach position. Blake had played football at the Academy when Gen. Douglas MacArthur was its commandant. When Lombardi was interviewed by Blake, a disciplinarian of great repute, he was grilled for hours on the minutiae of offensive line play. It was only after a second interview some weeks later that Blake agreed to take on Lombardi as an assistant coach with a salary of $7,000 a year and free housing. Lombardi jumped at this opportunity. Red Blake was totally committed to the concept of winning. His organization, discipline, and attention to detail were extraordinary. In the future, Lombardi was the first to admit that, as for his success, “It all came from Red Blake.” Nevertheless, Lombardi, an assistant coach at age 47, had lived a life of total obscurity until he was appointed head coach of the Green Bay Packers. This was his first head-coaching position. His success with the Packers over the next 9 years was unprecedented. Possibly exhausted by the intensity required in these successes, he dropped out of coaching for a year, but when offered the position as coach of the Redskins, he quickly accepted. In 1969, he led Washington to its first winning season in many years. In 1970, the Redskins trained on the athletic field at Georgetown, immediately behind the University Hospital. During a practice, Lombardi developed abdominal pain and he was admitted to the surgical service of Dr. Robert J. Coffey, Chairman of the Department. He was operated on 3 days later and a colectomy was performed for cancer of the recto-sigmoid. There was no evidence of metastasis, and it was believed that a curative resection had been performed. Being Lombardi, he was back on the practice field as soon as he was ambulatory. There, 1 month later, on July 27, 1970, the abdominal pain recurred and he was readmitted. A laporotomy revealed carcinomatosis throughout the entire abdomen. No one involved in his care had ever seen a solid tumor whose progression was so violent. Despite chemotherapy and irradiation, his course was rapidly downhill, and he died on September 7, 1970, at the age of 57.
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Lombardi has been characterized in the literature of our culture as being consumed only by the goal of winning. Such, however, is not the case. A more subtle characterization must be drawn. Lombardi was, of course, committed to winning, but the main thrust of his entire life was the commitment to excellence, which required the expenditure of every bit of intellectual, physical, and psychological energy that he possessed. The actual winning of a contest was important, but was of secondary concern to him. As Lombardi put it, “The difference between men is in energy, in the strong will, in the settled purpose, and in invincible determination.” Lombardi also epitomized a commitment to honor, integrity, and patriotism. During the Vietnam War, these virtues were not uniformly displayed in our country. As Lombardi lay dying, he faced his death with his characteristic courage. He said to a chaplain, “I am not scared to die. I’m not afraid to meet my God right now. But what I do regret is that there is so damn much left to do here on earth.” Maj Gary P. Wratten, Medical Corps, United States Army, was born in upper New York State on June 25, 1933. He received his medical degree from the University of Buffalo in 1958 and completed his internship at Brooke Army Medical Center in 1959, and his surgical residency here at Walter Reed in 1963. After his residency, he did a fellowship in head and neck surgery with Dr. Robert Chambers in Baltimore and then returned to Walter Reed as Chief of the Head and Neck Surgi-
cal Service. Here, he established the Army’s first Head and Neck surgery training program. In June 1966, he assumed command of the 45th Surgical (MUST) Hospital, a 60-bed division hospital in the 67 Medical Group. Later that same year, the 45th was ordered to Viet Nam. Four days after he arrived in country, on November 4, 1966, Maj Wratten and his unit were setting up MUST equipment in Tay Ninh province when they were attacked by the Viet Cong. Maj Wratten was hit in the chest by mortar fire. He died at the scene. He was survived by his wife, Shirley, and 5 young children. He is buried at the Arlington National Cemetery. There are striking similarities between the lives of Vince Lombardi and Gary Wratten. They were both idealists and were dedicated to outstanding performance in their respective professions. They were team players and were committed to excellence, honor, and integrity. Their lives were cut short, one by cancer and the other by violence. Vince Lombardi left memorable sayings that still inspire us today. Maj Gary Wratten left no such remarks, but there was no need for them. His life, and death, spoke for him. The virtues of these great men should inspire all of us to total commitment to our goals. It is in this spirit that we seek the establishment of a Cancer Institute, which will contribute to the conquest of this grim disease and which will reflect glory upon military medicine.
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Leonard Heaton Oration: The United States Military Cancer Institute–Realities and Potentialities John F. Potter, MD Director, United States Military Cancer Institute, Uniformed Services University of the Health Sciences, Bethesda, Maryland, and the Walter Reed Army Medical Center, Washington, District of Columbia It is a great honor for me to have been asked to deliver the annual Heaton Oration. General Heaton is remembered by all of us not only for his superb surgical judgment and operative skills, which were demonstrated in the care of his patient, President Dwight D. Eisenhower, but also for his farsighted and compassionate leadership as the Surgeon General of the United States Army. A renaissance man in uniform, he is a role model for all of us today. Col Shriver suggested that I take as a theme for the oration the establishment of a cancer research institute, based on my experience with the founding of the Lombardi Center and the United States Military Cancer Institute (USMCI). I would like to begin by telling you about the history of the USMCI. As a Regent of the Uniformed Services University of the Health Sciences, I had the opportunity to conduct a survey of cancer research in the military institutions in the National Capital Area. I began this process on July 10, 2000, with an interview with the Dean of the Medical School, Dr. Val Hemming, a retired Army Colonel with a distinguished career in infectious disease research. Dr. Hemming told me that there was a good deal of cancer research here, but that there was little collaboration between investigators. The Dean welcomed the initiation of a process, which, in his words, “would bring people together.” Dr. Robert Goldstein, Chairman of Medicine, was the first of many to point out that the existent Institutional Review Board (IRB) situation was a very major impediment to research, because an investigator in 1 institution had to secure IRB approval, not only from his own hospital, but also from all the other military institutions where he sought to do research. In the worst-case scenario, this necessitated as many as 5 separate IRB approvals: Walter Reed, the Navy, Malcolm Grow, Uni-
Correspondence: Inquiries to John F. Potter, MD, Walter Reed Army Medical Center, Building 1, Room A108, 6900 Georgia Avenue NW, Washington, DC 20307-5001; fax: (202) 782-6794; e-mail: [email protected] The opinions and assertions contained herein are the private views of the author and are not to be construed as official or as reflecting the views of the United States Government, the Department of Defense, or the Department of the Army.
CURRENT SURGERY • Published by Elsevier Inc. on behalf of the Association of Program Directors in Surgery
formed Services University, and the Jackson Foundation. The negative impact of this system on research productivity is readily apparent. It is a testimony to the commitment of military investigators that they were willing to enter this bureaucratic quagmire. Capt Glenn Wagner, the Director of the Armed Forces Institute of Pathology, saw a great need for a cancer institute because funding from the Department of Defense for cancer was essentially limited to patient care. Great research resources could not be tapped due to the lack of a relatively few research dollars. As a specific example, he sited the Automated Central Tumor Registry (ACTUR), which is located in the AFIP. In the last 14 years, more than 270,000 cases of cancer in the military have been accessioned on this system. However, there has been little analysis of this data primarily due to the lack of professional research personnel. A relatively small expenditure for a research epidemiology program might pay enormous dividends. The Commanding Officers, General Timboe at Walter Reed, Admiral Martin at the National Naval Medical Center in Bethesda, and General Brannon at Malcolm Grow, were enthusiastic about this endeavor. The kind offer of General Timboe for office space led to the establishment of the headquarters of the USMCI at Walter Reed. The results of this cancer survey of more than 60 scientists were reported on August 29, 2000. The frame of reference for these evaluations was based on my experience as a site-visitor for the NCI to the leading universities in this country, including Harvard, UCLA, Duke, and Yale. This survey showed that there were superb basic and clinical scientists here. In addition, there were enormous resources in technology, epidemiological data, DNA, serum, and pathology specimens, and there was a large, idealistic population willing to entering clinical trials. On the negative side, there was little or no communication across specialty and service lines. The IRB process was a catastrophe and was impeding research efforts. Other negative findings of the survey were that military in0149-7944/03/$30.00 doi:10.1016/S0149-7944(03)00105-3
391
vestigators have a tendency to rely primarily on military funding for research support. In many cases, Department of Defense (DoD) grants are critically peer reviewed by highly competent military and civilian scientists. However, the award of such grants does not carry the panache of the R0-1⬘s and P0-1⬘s, which are awarded by the National Institutes of Health (NIH). Correctly or incorrectly, it is NIH grants that are regarded by the national scientific community as the bell weather for scientific excellence. Another disquieting finding of the survey was that military beneficiaries were being treated more often in the civilian sector than in the military health system. In the year 2000 alone, there were 706,395 visits to civilian oncologists and only 479,092 to military cancer specialists. This situation has many negative implications. First, it reduces the number of patients being cared for in Military Treatment Facilities (MTFs), thereby lessening clinical experience for residents and medical staff. Fiscally, care is more costly to DoD in the civilian sector. An argument could also be made that the cancer beneficiary will receive better care in the military health system than in the average civilian setting. Finally, declining numbers of patients reduce the number of patients available for clinical trials. It is my belief that vigorous efforts must be made to increase the flow of patients to the MTFs in the future. The awareness by the beneficiary that an MTF is a collaborator with the USMCI should increase the desire of that beneficiary to come to that MTF for treatment. The survey also suggested that a cancer institute would have positive effects not only on research, but also on patient care and education, producing further enhancement of the academic luster of military medicine. The next noteworthy event in our history was the ribboncutting ceremony here at Walter Reed to dedicate the newly renovated headquarters of the USMCI. These offices were a major step forward in establishing the identity of the cancer institute. A meeting was held on July 17, 2001, with Col Robert Eng, the Director of the Armed Forces Radiobiology Research Institute (AFRRI), and with representatives of the basic science and radiation medicine communities to discuss the feasibility of employing the nuclear reactor at AFRRI for cancer research. A new porphyrin compound had been discovered that increased significantly the deposition of boron in neoplastic cells, thus increasing their sensitivity to neutron irradiation. This development warranted investigation, especially as several of the few nuclear reactors in this country have cancelled research activities. This boron capture neutron therapy initiated a new collaboration among the physicists at AFRRI, basic scientists at USU, and the radiation therapists at Walter Reed and the National Naval Medical Center. On September 18, 2001, the Charter for the USMCI was signed. This document declared that, because of the impact of cancer on the military, and because of the importance of research in lessening this affliction, the signatories establish the USMCI with the goal of achieving designation as a Compre-
hensive Cancer Center. This document was signed by MG Harold Timboe, Commander of WRAMC; James A. Zimble, MD, President USU; Adm Kathleen Martin, Commander NNMC; BG Barbara Brannon, Commander MGMC; and Col Michael Dunn, Commander Walter Reed Health Care System. On October 31, 2001, the first meeting of the extramural Committee of Scientific Advisors for the Institute was held. This day-long session included an introductory overview of the Institute and the presentation of the science of each of its programs. This Committee is a panel of distinguished scientists who meet here to review our progress. It offers critique and counsel on both short- and long-term goals. The Committee is chaired by Charles M. Balch, MD, a national leader in surgical oncology who has played a key role in the development of a number of comprehensive cancer centers in this country. He is at present the Executive Vice President of the American Society of Clinical Oncology and a Professor of Surgery at John Hopkins University. Other members of the committee include Larry Norton, MD, who is the Chief of Medical Oncology at Sloan-Kettering Memorial and the immediate past president of ASCO; Ralph Weichselbaum, MD, Daniel K Ludwig Professor and Chair, Department of Radiation and Cellular Oncology at the University of Chicago; George Vande Woude, PhD, the Director of the Van Andel Cancer Institute in Michigan; Esther H. Chang, PhD, Professor of Oncology at Georgetown; Laurel W. Rice, MD, Director of the Division of Gynecologic Oncology at the University of Virginia; and Michael J. Weber, PhD, Director of the Cancer Center at the University of Virginia. During this critique, the Institute presented to the visitors its own analysis of its strengths and weaknesses. We had determined that strong programs existed here in both basic and clinical science, but that our greatest potential to contribute significantly to the national cancer endeavor would lie in the field of Phase III clinical trials with a special emphasis on epidemiology and prevention. Our beneficiary population offers a unique and extraordinary opportunity for clinical research in these areas. The Committee subsequently forwarded a very favorable report on the progress of the Institute, endorsing the epidemiology and prevention theme. Another, nonscientific, group that counsels the Institute especially on the human dimensions of cancer is the Committee for the USMCI. This committee, which is being formed, will be limited to 25 distinguished Americans and is chaired by Gen. H. Norman Schwarzkopf. Other members include the First Lady, Mrs. Laura Bush; the Honorable Frank Carlucci, the Chairman of the Carlyle Group and a former Secretary of Defense; and Mr. Gerald S.J. Cassidy, Chairman of the Cassidy Companies. Organizationally, the USMCI is an academic and scientific entity of the matrix type, functioning in the military. It is characterized by the voluntary participation of its members. There is no line authority in its structure. The Institute is academically
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positioned in USU where the Director occupies a position analogous to the Dean and reports directly to the President. The Director allocates, with the advise of the Executive Committee of the Institute, budgetary and space resources and appoints members to the Institute who have received the approval of its Executive Committee. The Executive Committee is the prime advisory and policymaking committee of the Institute. It is composed of the Associate Directors for clinical science, basic science, administration, epidemiology, protocol review, informatics, and cancer prevention. In addition, 2 members-at-large are voting members. The USMCI IRB Committee, chaired by Cdr Brian Monahan, a medical oncologist, is composed of representatives from Walter Reed, NNMC, Malcolm Grow, and USU. Its goal was to create an IRB for the USMCI that would permit the investigator to obtain protocol approval for all military institutions in this area in a single step. Members of this committee were drawn from all areas of science, specialty, and military service. The challenges to the committee were substantial. There were valid legal issues originating from differences in regulations of the 3 services. These legal problems were resolved by the adaptation of compatible regulatory language by the 4 local commands. Administrative and “turf” problems were similarly resolved. As a result, a “Memorandum of Understanding” (MOU) establishing a single cancer IRB was drawn up. This specifies that approval or nonapproval of any protocol remains the perrogative of the local commander. This commander acts on the recommendations of the IRB, but maintains the authority to reject its recommendation for approval. The MOU was signed by the President and the 3 hospital commanders in a ceremony at the TRICARE meeting on February 4, 2002. Now, this single-step IRB approval will save 6 to 12 months for multi-institutional research. It will also expedite the utilization of the latest treatment discoveries for the patient. The quality of the ethical and scientific review by this committee composed exclusively of cancer scientists should be excellent. Also, the IRB is a strong cementing force between investigators in different specialties and services. In regard to application for membership in the Institute, a formal process has been established. Candidates are persons where activities are primarily devoted to cancer research, treatment, education, or service. In practice, clinical researchers are individuals who are board eligible or certified in one of the oncologic specialties. As regards surgeons, those who meet the criteria for admission to the Society of Surgical Oncology are eligible. At present, all members are drawn from the National Capital Area. However, it is hoped that, in the future, military oncologists from about the country will wish to join our organization. This will increase our strength and will promote our goal of establishing a nationwide military cancer cooperative group. In my opinion, the high quality of science in the military is not widely appreciated in civilian academia. One possible cause for this situation is that military investigators do not apply
frequently for NIH grants. There is a tendency to rely on DoD funding. In many cases, the peer-review process of DoD grants is just as rigorous, if not more rigorous, than that in the civilian community. With that being said, however, the reality is that quality of science is evaluated by the number of R0-1s, P0-1s, and similar grants that an institution possesses. That is why I have been encouraging our Institute members to apply for such grants. We must end the scientific apartheid that exists between civilian and military scientists. The Institute will offer important benefits and services to its members. One of these will be the establishment of a biostatistical core facility to offer consultation on protocol design. Such a service should improve the quality of grant applications and manuscript preparation. An epidemiology team will also be developed that will function to support our investigators in detecting etiologic factors in the tumor systems that they are studying. An emphasis on molecular epidemiology will be stressed. Our members have told us that a major problem, caused by their demanding clinical schedules, is the lack of time for grant and manuscript preparation. The Institute will employ a professional scientific writer who will assist the investigator in manuscript and grant preparation and submission. This writer would be fully aware of the regulations and idiosyncrasies of the organizations to which the document might be submitted. Also, this professional would assist the scientist by performing literature searches, validating data, prodding recalcitrant coinvestigators into productivity, and, in general, simplifying the task of the scientist. Word-processing services would, of course, be offered. In the future, as more funds become available, the Institute will support its members by paying for ancillary personnel such as research nurses, data managers, and similar professionals. I wish to acknowledge today the contributions of those of you who have made the Institute a reality. First of all, my sincere thanks to our host today Major General Harold Timboe, who kindly offered the office space for the Institute in historic building 1, here at Walter Reed. He has also been the source of wise counsel and support for me during our initial startup vagaries. President James A Zimble has strongly backed our endeavors and has shown exemplary vision in the initiation and development of the Institute. COL Michael Dunn has also been a strong supporter and has appreciated fully the academic possibilities of this endeavor. Colonels David McLeod and Judd Moul have established a world-class prostate research team here that we are trying to replicate in other areas. COL Craig Shriver has supported our efforts from the first. His Clinical Breast Care Project combines basic, clinical, and translational research. In a few years, his program will have national recognition. Capt Glenn Wagner has facilitated the collaboration of the AFIP in our activities.
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Colonels Jay Carlson and Scott Rose are leaders of an excellent Gynecological Oncology research program. Last in terms of rank, but not in scientific ability, is Capt Joseph Flynn, who has contributed importantly as the Special Assistant to the Director. I am deeply indebted to all of these people. Not only are they excellent scientists and physicians, but they have also become my good friends. In our vision for the future, the United States Military Cancer Institute has unique resources for cancer research because it is a component of the Department of Defense, which operates a vast medical expertise. Department of Defense military beneficiaries number 9 million and offer a unique opportunity for clinical research. In the last 14 years alone, more than 270,000 cancers were accessioned on the Automated Central Tumor Registry (ACTUR) system. The military population is characterized by the racial, ethnic, and social diversity, which is essential for the protocol studies, that will benefit all Americans. Other exceptional resources include the AFIP, whose scientists are at the cutting edge of medical discovery. Armed Forces Radiobiology Research Institute with its nuclear reactor is a unique asset where the benefits of neutron beam therapy can be rigorously assessed by a scientific team that has been assembled by the USMCI. The 30-million serum specimens in DoD could be, with administrative approval and informed patient consent, an extraordinary resource for cancer genomic and proteomic discovery. The military is an idealistic group; they are imbued with the spirit of self-sacrifice for the good of the whole. This is the probable reason why the accession rate of patients on cancer protocols at Walter Reed runs about 30%, in comparison to the 1% to 2% rate in the civilian sector. The application of discovery in cancer prevention, detection, and treatment could be made expeditiously in the military. Such studies would decrease the occurrence of cancer or would allow its detection at the earliest moment when effective treatment could be initiated. From the military viewpoint, such successes will preserve the wellness of the military force. Most importantly, the Institute will further enhance the academic luster of military medicine, and it will call to the attention of the scientific and lay communities in this country of its vital contribution to medical investigation. Also, the opportunity to belong to an elite intellectual entity will enhance the retention of the best and the brightest in the military, and it will promote the recruitment of similar quality people to its ranks. The prime function of the Department of Defense is not cancer research, but it is funding an enormous medical enterprise. Some of these resources can be employed for research purposes with the expenditure of relatively negligible amounts of additional dollars, most, if not all of which, would be obtained from outside DoD. Moreover, our extraordinary potential and the large scope of our activities will contribute importantly to the national war against cancer. Given the clarity of
these concepts, it is surprising that this initiative was not undertaken long ago. Vincent T. Lombardi was born in 1913, the son of an immigrant Italian butcher who lived in a lower middle class neighborhood in the Sheepshead Bay area of New York City. In high school, Lombardi tried out for the football team. He was small in size, but his emotional commitment overcame this handicap and he made the team, becoming an outstanding guard. He was offered a scholarship to Fordham University, where he became a member of the legendary Seven Blocks of Granite—a line that played 60 minutes on both offense and defense. After graduation, he became an instructor in physics and the basketball coach for a small private high school in New Jersey. Lombardi knew nothing about basketball, but within a year, his team was the state champion of their division. He subsequently obtained a position as a high school football coach and was quite successful in this endeavor. He was then recommended to the legendary football coach at West Point, COL Earl (Red) Blake for an assistant coach position. Blake had played football at the Academy when Gen. Douglas MacArthur was its commandant. When Lombardi was interviewed by Blake, a disciplinarian of great repute, he was grilled for hours on the minutiae of offensive line play. It was only after a second interview some weeks later that Blake agreed to take on Lombardi as an assistant coach with a salary of $7,000 a year and free housing. Lombardi jumped at this opportunity. Red Blake was totally committed to the concept of winning. His organization, discipline, and attention to detail were extraordinary. In the future, Lombardi was the first to admit that, as for his success, “It all came from Red Blake.” Nevertheless, Lombardi, an assistant coach at age 47, had lived a life of total obscurity until he was appointed head coach of the Green Bay Packers. This was his first head-coaching position. His success with the Packers over the next 9 years was unprecedented. Possibly exhausted by the intensity required in these successes, he dropped out of coaching for a year, but when offered the position as coach of the Redskins, he quickly accepted. In 1969, he led Washington to its first winning season in many years. In 1970, the Redskins trained on the athletic field at Georgetown, immediately behind the University Hospital. During a practice, Lombardi developed abdominal pain and he was admitted to the surgical service of Dr. Robert J. Coffey, Chairman of the Department. He was operated on 3 days later and a colectomy was performed for cancer of the recto-sigmoid. There was no evidence of metastasis, and it was believed that a curative resection had been performed. Being Lombardi, he was back on the practice field as soon as he was ambulatory. There, 1 month later, on July 27, 1970, the abdominal pain recurred and he was readmitted. A laporotomy revealed carcinomatosis throughout the entire abdomen. No one involved in his care had ever seen a solid tumor whose progression was so violent. Despite chemotherapy and irradiation, his course was rapidly downhill, and he died on September 7, 1970, at the age of 57.
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Lombardi has been characterized in the literature of our culture as being consumed only by the goal of winning. Such, however, is not the case. A more subtle characterization must be drawn. Lombardi was, of course, committed to winning, but the main thrust of his entire life was the commitment to excellence, which required the expenditure of every bit of intellectual, physical, and psychological energy that he possessed. The actual winning of a contest was important, but was of secondary concern to him. As Lombardi put it, “The difference between men is in energy, in the strong will, in the settled purpose, and in invincible determination.” Lombardi also epitomized a commitment to honor, integrity, and patriotism. During the Vietnam War, these virtues were not uniformly displayed in our country. As Lombardi lay dying, he faced his death with his characteristic courage. He said to a chaplain, “I am not scared to die. I’m not afraid to meet my God right now. But what I do regret is that there is so damn much left to do here on earth.” Maj Gary P. Wratten, Medical Corps, United States Army, was born in upper New York State on June 25, 1933. He received his medical degree from the University of Buffalo in 1958 and completed his internship at Brooke Army Medical Center in 1959, and his surgical residency here at Walter Reed in 1963. After his residency, he did a fellowship in head and neck surgery with Dr. Robert Chambers in Baltimore and then returned to Walter Reed as Chief of the Head and Neck Surgi-
cal Service. Here, he established the Army’s first Head and Neck surgery training program. In June 1966, he assumed command of the 45th Surgical (MUST) Hospital, a 60-bed division hospital in the 67 Medical Group. Later that same year, the 45th was ordered to Viet Nam. Four days after he arrived in country, on November 4, 1966, Maj Wratten and his unit were setting up MUST equipment in Tay Ninh province when they were attacked by the Viet Cong. Maj Wratten was hit in the chest by mortar fire. He died at the scene. He was survived by his wife, Shirley, and 5 young children. He is buried at the Arlington National Cemetery. There are striking similarities between the lives of Vince Lombardi and Gary Wratten. They were both idealists and were dedicated to outstanding performance in their respective professions. They were team players and were committed to excellence, honor, and integrity. Their lives were cut short, one by cancer and the other by violence. Vince Lombardi left memorable sayings that still inspire us today. Maj Gary Wratten left no such remarks, but there was no need for them. His life, and death, spoke for him. The virtues of these great men should inspire all of us to total commitment to our goals. It is in this spirit that we seek the establishment of a Cancer Institute, which will contribute to the conquest of this grim disease and which will reflect glory upon military medicine.
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