2
The Early Committee Years

With the report in hand, the National Academy of Sciences (NAS) and the Veterans Administration (VA) entered into serious contract negotiations. By the end of summer 1946, the Academy had received promises of $850,000 from the VA for fiscal year 1946–1947. The money would establish a permanent Committee on Veterans Medical Problems (CVMP), maintain a central office in the National Research Council (NRC) devoted to medical follow-up activities, and subsidize research at veterans hospitals.15

The Academy set the enterprise in motion. In August, NRC and NAS officials agreed on a list of members for the permanent Committee on Veterans Medical Problems. The committee mostly consisted of faculty and researchers from prominent medical schools who had played key roles in the wartime medical effort and had been involved in the project's formulation. Although Dr. Edward Churchill was a committee member, he was no longer the chair. This responsibility fell to Dr. O.H. Perry Pepper of the University of Pennsylvania Medical School. Lewis Weed of the NRC told him that his duties would be light, involving only occasional meetings. Nonetheless, he and the committee faced a tremendous opportunity to "aid ... the Veterans Administration in the betterment of the care of patients and in the conduct of follow-up studies on clinical cases which are the direct result of the World Wars."16 On September 20, 1946, Dr. Pepper convened the permanent committee's first meeting.

By this time, the National Research Council had hired two staff members to direct the committee's work. Gilbert Beebe and John Ransmeir, M.D., became, in effect, the first Medical Follow-up Agency staff. Beebe handled matters related to statistics; Ransmeir supplied medical advice. Both were present at the first meeting.



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--> 2 The Early Committee Years With the report in hand, the National Academy of Sciences (NAS) and the Veterans Administration (VA) entered into serious contract negotiations. By the end of summer 1946, the Academy had received promises of $850,000 from the VA for fiscal year 1946–1947. The money would establish a permanent Committee on Veterans Medical Problems (CVMP), maintain a central office in the National Research Council (NRC) devoted to medical follow-up activities, and subsidize research at veterans hospitals.15 The Academy set the enterprise in motion. In August, NRC and NAS officials agreed on a list of members for the permanent Committee on Veterans Medical Problems. The committee mostly consisted of faculty and researchers from prominent medical schools who had played key roles in the wartime medical effort and had been involved in the project's formulation. Although Dr. Edward Churchill was a committee member, he was no longer the chair. This responsibility fell to Dr. O.H. Perry Pepper of the University of Pennsylvania Medical School. Lewis Weed of the NRC told him that his duties would be light, involving only occasional meetings. Nonetheless, he and the committee faced a tremendous opportunity to "aid ... the Veterans Administration in the betterment of the care of patients and in the conduct of follow-up studies on clinical cases which are the direct result of the World Wars."16 On September 20, 1946, Dr. Pepper convened the permanent committee's first meeting. By this time, the National Research Council had hired two staff members to direct the committee's work. Gilbert Beebe and John Ransmeir, M.D., became, in effect, the first Medical Follow-up Agency staff. Beebe handled matters related to statistics; Ransmeir supplied medical advice. Both were present at the first meeting.

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--> From the beginning, a duality of purpose attended the committee's work. On the one hand, the committee was to advise the Veterans Administration on its medical programs. This advice involved matters related to clinical medical practice, such as whether radioactive isotopes should be used in VA hospitals. The VA also expected advice related to its research program. According to Paul Hawley, the VA was not equipped to undertake major clinical or biological studies. Instead of doing the work itself, it sought to fund extramural work that would be done in places with better facilities and superior personnel. Nor did VA officials feel competent to evaluate research proposals. The expectation was that the committee, along with other advisory committees of the NRC, such as those pertaining to medicine and neuropsychiatry, would handle this task. The committee was also to serve as a focal point for follow-up studies that were not directly related to the VA's medical care. Hawley justified this by noting that the VA's greatest research contribution "would be the follow-up of disease conditions throughout a life-time or even throughout several generations." Dr. Francis Braceland also stressed that the committee should not allow its broad mission to cause it to lose sight of follow-up studies "as its major method of attack." The committee passed a motion that ''in allocating support for research problems, emphasis be given to projects of major importance for long-term study." Follow-up Studies One study received consideration and approval at the committee's first meeting. The idea involved the study of soldiers from different geographic regions who had developed rheumatic fever during military service. A greater incidence of rheumatic fever among those in military service would suggest the importance of environment, rather than heredity. Control groups were formed by using adjacent serial numbers to choose from men with non-rheumatic fever hospital diagnoses in the same year or men who took out National Service Life Insurance, depending on the needs of the particular study. Affected soldiers were also to be compared with family members who had remained at home. This study indicated just how useful the data gathered by the military could be in understanding the course of disease.17 It also showed that follow-up could take many different forms. Michael DeBakey had tended to emphasize clinical follow-up: the reexamination of a patient to observe the course of a disease or the long-run efficacy of a particular treatment. Beebe, among others, had an interest in what he called "mass statistical studies," done entirely from records and not requiring a doctor to observe a patient. The most obvious sort of mass statistical study involved determining the death rates over time from individual diseases, injuries, or psychiatric conditions that had arisen during the war. Death records were widely available because an estimated 98 percent of all World War II veterans had taken out the National Service Life Insurance policies offered them during their service.18

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--> Whether clinical or statistical, follow-up studies required the creation of rosters of people with particular diseases and demographic characteristics. Facilitating the creation of these rosters became a priority for Beebe and Ransmeir. If the rheumatic fever study was to be done, for example, it would require the creation of rosters that combined both medical and nonmedical characteristics of individuals. People in the rheumatic fever sample would have to be matched with controls with identical dates and places of induction, and identical training environments. The contemplated study would involve the medical records of up to 9,000 people. These records would have to be culled from the 18 million Army records housed in a federal records center in St. Louis, Missouri, which covered 1.5 million feet of floor space and employed 5,000 people. The Army eventually stationed teams of people working on follow-up studies approved by the NRC in the St. Louis center. Similar logistics had to be worked out with the Navy and the Veterans Administration. Eager to show that they could master their daunting task, Beebe and Ransmeir wanted to launch a pilot study that would locate and resolve the problems in the system of gathering records.19 Traumatic epilepsy and arterial injuries were early candidates for such a study. All in all, the work of the Committee on Veterans Medical Problems (CVMP) got under way in what the NRC described as a "deliberate and sensible fashion."20 The committee began to receive and pass judgment on research proposals from other NRC advisory committees. Not all of the projects approved were follow-up studies. Some, including a study of group therapy in VA hospitals and clinics, merely happened to be conducted in VA facilities. Often, the follow-up studies that the committee approved came from investigators who had been involved in the committee's creation, as was the case with Barnes Woodhall's work on peripheral nerve injuries or DeBakey's follow-up of arterial injuries in veterans. After the first few years, the proposals came less often from other NRC committees and more often from outside sources such as university medical researchers.21 A project's approval meant little if funds were not available to support it. Almost immediately, the committee encountered problems caused by the uncertainties of federal funding. Although money was available to pay the salaries of Dr. Ransmeir and Dr. Beebe, who carried the respective titles of medical executive and medical statistician, funding for the studies proved more elusive to obtain. At the start of the 1948 fiscal year, the committee learned that extramural research money for the year had already been exhausted and the VA could not guarantee that funds would be available in fiscal year 1949.22 In fact, the NRC had been given only two days to make a request for fiscal year 1948. The VA appealed to the Bureau of the Budget, but the bureau denied the request because of a lack of convincing documentation. Hence, the 1948 federal budget made no specific mention of the CVMP program and contained no provisions for contracts with universities or the NRC. The little money spent on CVMP projects came from a budget item designated for research by VA personnel in VA hospitals.23

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--> The NRC blamed this situation on "current legislative uncertainties" concerning VA appropriations. Even with these difficulties, 20 projects approved by the CVMP were receiving VA funds in November 1947.24 In the absence of funds for more projects, Beebe and Ransmeir worked on perfecting administrative routines, such as grant application procedures and the mechanics of preparing rosters from Army and Navy files. Beebe, in particular, collaborated with project directors on improving the statistical design of the projects.25 Throughout this early period, confusion persisted about the committee's mission. How much time and effort were to go to medical follow-up, and how much to other activities? Dr. Paul Magnuson of the VA noted that his agency already had a Board of Professional Consultants; presumably, the CVMP should serve a different function. Placing heavy emphasis on medical follow-up, he thought that the committee should concern itself primarily with the "salvage of medical information from our experience in the war and overall guidance and advice in the medical research program." Committee member Francis Braceland admitted that this aspect of the committee's work had developed slowly and should be "more actively pursued." DeBakey agreed but noted that funding was problematic. Because VA rules allowed contracts to be let for only a year at a time, an investigator had no assurance of continuing support. This was an important consideration in studies involving lengthy efforts to locate records, find the participants, perform clinical procedures, collect data, and assess the results. Dr. E.H. Cushing of the VA chastised the committee for routinely approving the suggestions of other committees and not coming up with ideas of its own. Cushing and others felt that the committee had not done enough to push the idea of medical follow-up.26 A curious duality in the committee's work emerged. In March 1948, the committee announced a significant "reorientation" in its "program and outlook"—from follow-up studies to what it described as "the entire medical research program of the Veterans Administration, of which the follow-up studies constitute merely one significant part." At the same time, however, the entity now known as the Medical Follow-up Agency began to take shape. At the end of 1947, for the first time, an entity distinct from the Committee on Veterans Medical Problems appeared on an NRC organizational chart. The committee had made a real start toward assembling the staff and facilities needed for the follow-up projects. A change in personnel had occurred already. On March 20, 1948, Dr. Ransmeir resigned, and was replaced by Dr. Theodore Moise, a Johns Hopkins medical school graduate and surgeon with a background in bacteriology and pathology. Bernard M. Cohen, a Ph.D. statistician, also joined the organization, initially on a six-month loan from the Department of Commerce.27 At the end of the year he was joined by Seymour Jablon, another applied mathematician. Both men, especially Jablon, would play major roles in the agency's history.

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--> Starting the Follow-up Agency On April 30, 1948, Gilbert Beebe reported for the first time to the Committee on Veterans Medical Problems on the operations of the Follow-up Agency. Although Beebe was sometimes described as director of the committee's statistical division, he had also become the agency's informal director. Its work included the statistical evaluation of all projects submitted by the committee, doing detailed statistical planning on clinical follow-up and mass statistical studies, assisting investigators in devising and testing record forms and schedules, drawing samples for studies, and providing investigators with data from service medical and personnel records. In little more than a year, the staff had done statistical planning for 16 follow-up studies. By this time the agency had three people working in the Records Center at St. Louis, and the VA had set aside space for the committee's operations in Washington, D.C. All in all, the agency payroll covered 24 full-time and 4 part-time employees, including 7 people engaged in statistical analysis and 16 people who worked with the federal records. Beebe said that there was a need for more trained statisticians who could help investigators with the statistical design of their projects. He worried about the possibility of introducing bias into the experiments because of inadequate or inappropriate sampling techniques. Hearing the report, the committee voted its "strong support of the activities and functions of the follow-up agency."28 By the fall of 1948, the committee had received the first tentative results from its projects. One such project, which concerned the long-term effects of hepatitis, illustrated the difficulty of undertaking such studies. The study examined the incidence of infectious and postvaccinal hepatitis in the armed forces during World War II. More than 200,000 such cases were estimated to have occurred during this time period. Investigators sought to determine long-term residuals of viral hepatitis infection (e.g., cirrhosis and other forms of liver disease). In the course of this research, doctors had a difficult time getting study participants to come in for examination. Such impediments reduced the statistical validity of the study's findings. 29 The question of getting people to appear for examinations became a point of contention between the committee and the Veterans Administration. In April 1949, the committee identified this as its greatest problem. Most of the research in the 17 active follow-up projects took place in university clinics and hospitals. Nothing compelled a person to appear for an examination. Gilbert Beebe complained that the VA's prestige and resources were not being used to encourage veterans to submit to these examinations. Without help from the VA, Beebe believed that no more than 60 to 80 percent of the men chosen for study would be examined. The committee pushed the Veterans Administration to help by linking the Follow-up Agency's work with the physical examinations that the VA performed for other purposes (e.g., to rate a veteran's disability). The VA, for its part, felt that such action would be a misuse of a sensitive aspect of social policy.

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--> Veterans needed to be reassured that their disability pensions were based on objective medical evidence; the necessary medical examinations were not to become tools of social experimentation. As a result, although the committee lauded the Army and the Navy for their extensive help in locating records, it found the VA somewhat recalcitrant in supporting follow-up work. "Over the past two years repeated efforts to obtain more cooperation from the VA have not been successful," Dr. Perry Pepper lamented.30 The VA had its own grievances with the committee. At a time of rapid expansion of the National Institutes of Health (NIH), the leaders of the VA felt that they were losing influence in the medical research establishment. They believed that the NRC, which received support from the VA, should be a stronger advocate for its patron. The VA also believed that the committee made decisions too slowly and, in the process, encouraged researchers to seek funds from the NIH and other parts of the Public Health Service. Cushing, the VA's assistant medical director for research and education, asserted that if the NRC did not provide better service, the VA would set up its own advisory committees.31 Beebe, Cohen, and others in the agency turned their attention toward studies that substituted paper records for the direct medical observation of individuals. As a test of this method, they attempted to see how many cases in a given roster of veterans could be located through Veterans Administration records, or other means, and discovered that they were able to trace a high percentage of people in the various groups. Of a group of 403 World War II veterans with Hodgkin's disease, for example, they were able to trace 384, or 88.5 percent. They concluded that "if the test of feasibility of these studies is a demonstration that every man on a roster can be accounted for until he dies, ... the results so far indicate that it is possible to come very close to such an accounting."32 With such information, many studies of mortality, morbidity, and disability became possible. One could, for example, compare survival rates for different diseases over time.33 For this reason, the committee endorsed a program of mass statistical studies, hoping that certain diseases could be followed routinely for mortality, morbidity, and rates of hospitalization.34 By the end of the 1940s, the Committee on Veterans Medical Problems and the Follow-up Agency had acquired a new degree of sophistication. The committee rarely accepted an application for a study unless its staff had explored the study's administrative and statistical feasibility. Adding mathematical statistician Jablon to the staff removed some of the burden from Beebe in the performance of such work. Record follow-up studies, those that did not involve a clinical examination, were made easier by the appointment of Bernard Cohen on a permanent basis. Ms. Nona Murray Lucke, an experienced record executive, helped in gathering data from the various archives in which it was stored. Regina Loewenstein supervised statistical coding, tabulation, and analysis. These staffers made it possible for clinical work on various projects to take place in 30 different centers around the nation. 35

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--> The First Round of Studies By the spring of 1950, five of the seven projects approved in 1947 were nearing completion. These included studies of psychoneurosis, peripheral nerve injuries, vascular injuries (see photo), and infectious hepatitis. Of the 19 clinical follow-up studies being conducted during fiscal year 1950, observations had been completed in 8 of them. The initial round of studies had taken longer to complete and was more expensive than investigators had originally contemplated. Most of the investigators had budgeted for only the clinical phase of the project and would need additional funds for the data analysis to follow. Despite these financial issues, the work of the Committee on Veterans Medical Problems had already generated 59 published papers related to the various studies.36 As the first round of studies neared completion attention turned toward the next steps. Neither Gilbert Beebe nor any of his staff had envisioned such a large program. Each project turned out to be time-consuming, and 20 active projects put a severe strain on staff resources. Still, they needed to recruit new projects to Investigators working on follow-up study of vascular injuries in World War II. Photo taken at Emory University in Atlanta, circa 1950. Dr. Gilbert Beebe, second from left, back row; Dr. Michael DeBakey, far right, front row. Photo courtesy of Dr. Gilbert Beebe.

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--> replace the old ones. This process had to take place with full regard for both scientific rigor and the usual vagaries of the budget process. In fiscal year 1950, for example, the Bureau of the Budget reduced the VA's budget for research contracts from the requested $2.9 million to $1.8 million. Another problem that the committee faced concerned reporting the results of the first studies. Beebe hoped that there would be "careful analysis" of the statistical data, not simply a reporting of results. For projects that were spread among several medical centers, care would have to be taken to ensure that the publication of results was coordinated across centers. The committee hoped it would have the chance to examine each manuscript "for statistical review" before publication.37 Among the projects that the Committee on Veterans Medical Problems considered during this period was one devoted to capturing the long-term outcomes of people who had sustained trench foot, immersion foot, or frostbite in World War II. To facilitate this project, Beebe obtained rosters from the Veterans Administration and the Army. Five centers would examine about 100 patients from the 115 patients' files that they would be given. The sampling plan allowed each center to see a disproportionate number of severe cases. Although the study would not yield exact information on the effect of individual forms of treatment, "residuals of cold injury" would be obtained and related to the severity of the original injury. To minimize variance in the clinical examinations, doctors in New Orleans examined ten cases in advance of the study and obtained satisfactory agreement on their observations. DeBakey, still an active member of the CVMP, observed that although expensive, the study would provide "much needed information on the natural history of this condition." The committee recommended that $67,187 be given to the principal investigators for this study. 38 Dr. F.A. Simeone, an investigator in the cold injury study, had already participated in a study of veterans who had incurred arterial wounds. In this latter study, he continued work that he had done during the war. For example, he had treated one patient by means of "non-suture anastomosis," reencountered the patient during the follow-up study, and found the patient to be symptom-free. The project also enabled him to follow up other patients who had received similar treatment to determine how many of them complained of intermittent claudication (irregular gait) or pain in walking. His preliminary observation was that sympathectomy, defined as the transection, resection, or other interruption of some portion of the sympathetic nervous pathways, decreased the incidence of claudication. Although the technical terms made the discussion difficult for non-doctors to follow, the process demonstrated that the agency's initial work followed directly from clinical interests that doctors had developed during the war.39 Impact of the Korean War Beginning in 1950, the Korean War changed the tone of the follow-up program. What had been a leisurely excursion into the medical records from the

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--> Second World War now acquired a new sense of urgency as administrators tried to determine what lessons from the previous war they could apply to the present one. The outbreak of war added new funding pressures to the program. In particular, Dr. E.H. Cushing of the Veterans Administration wanted to know whether the follow-up program was cost-effective. Accordingly, the Committee on Veterans Medical Problems, now headed by Dr. Wilbert C. Davison, a professor of pediatrics and dean of the medical school at Duke, created an ad hoc committee to investigate the follow-up program's cost and value. The committee included himself, Michael DeBakey (at the time chairman of the department of surgery at Baylor), Dr. Allen O. Whipple of New York's Memorial Hospital, and Herbert Marks of the Metropolitan Life Insurance Company.40 On January 22, 1951, the ad hoc committee reported to Cushing and Dr. Milton C. Winternitz, chairman of the NRC's Division of Medical Sciences. "All of us have expected concrete, tangible, and useful results from the VA follow-up projects but none of us realized, until the meeting today, how excellent the progress has been and how important the reports are even in their preliminary stage," Davison wrote. He predicted that the VA, the military, and the taxpayers would "all profit enormously" if the program was continued.41 Many findings presented at the meeting illustrated the wide reach of the program; two of the most important concerned hepatitis and schizophrenia. In the hepatitis study, a follow-up of approximately 1,000 survivors of infectious hepatitis revealed no residual or severe liver damage. In the schizophrenia study, the average length of service prior to breakdown was two and a half years. Investigators concluded that the majority of cases could have been detected by adequate study at time of induction.42 In the short run, the findings that mattered most were those that appeared to have relevance to the Korean War situation. Herbert Marks noted that the tuberculosis studies would help the armed forces weed out men who were likely to come down with this disease, reducing the loss of manpower in the field and the costs of pensions and medical care. The studies of peripheral nerve and arterial injuries led to more effective management of these types of casualties in Korea. As DeBakey noted, the finding that there were no long-term consequences of infectious hepatitis once a patient recovered from the disease would affect the determination of disability pensions for both wars. DeBakey admitted that the work was "costly and time-consuming" but noted that "the preliminary reports of some of the studies already provide knowledge that should permit great savings in the operational activities of the Veterans Administration."43 The review of follow-up activities that took place at the beginning of the Korean War enabled the Committee on Veterans Medical Problems and the Follow-up Agency to gain a comprehensive view of the work being undertaken. Each investigator submitted a report that summarized a study's findings and outlined preliminary conclusions. From a study of posttraumatic epilepsy came

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--> the finding that 20.9 percent of a sample of men who had suffered head wounds had epileptic seizures. Most of the epilepsy developed within the first two years of the injury. A large study of 2,700 men with peripheral nerve injuries (see summary of study in Box 1), conducted at five university hospitals, reinforced the necessity for specialized neurologic treatment of such injuries, including early diagnosis, prompt evacuation, and the use of special neurophysiological techniques as an adjunct to surgery. A follow-up study of schistosomiasis acquired during military service revealed that a majority of patients still complained of such symptoms as diarrhea, abdominal cramps, right-upper-quadrant pain, and fatigue. A study of rheumatic fever, in contrast, demonstrated no progression of the disease for at least five to seven years after the attack that occurred during service. 44 In the spring of 1951, the CVMP reported that investigations of psychoneurosis, tuberculosis, hepatitis, sarcoidosis, and testicular tumors were ending. Follow-up studies of peripheral nerve injuries, vascular injuries, schistosomiasis. and schizophrenia were close to completion. In order to do the statistical analysis for these studies, the follow-up staff decreased the amount of time it spent locating records, thus restricting its ability to start new studies. The intent was to produce information that would be useful to the military in the Korean effort (e.g., management of particular types of wounds, induction policy) as quickly as Box 1 Study of Peripheral Nerve Injury In 1957, the Medical Follow-up Agency (MFUA) and its collaborators published a study of peripheral nerve regeneration based on the follow-up of 3,656 World War II injuries. Clinical follow-up data for this study, one of the first proposed to the Committee on Veterans Medical Problems, were gathered at five clinical centers (in Chicago, Boston, New York, Philadelphia, and San Francisco), all of which followed a standardized data-gathering protocol. Three-quarters of the men in the study eventually reported for examination and participated in the study. The study determined the optimal time for nerve suture and established the value of physical therapy during the time of nerve regeneration. For nerve injury with total loss of function, the study suggested that a radical approach should be used, whereas for cases in which the continuity of a nerve has not been interrupted, treatment should be conservative, with end-to-end suture substituted for neurolysis. In addition, functional recovery was shown to be reasonably predictable on the basis of the distance from the lesion to its area of principal innervation. Selected Reference Woodhall, B., Beebe, G.W. Peripheral Nerve Regeneration, a Follow-up Study of 3,656 World War II Injuries. VA Medical Monograph. Washington, D.C.: U.S.Government Printing Office, 1957.

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--> possible. Only the cold injury study was added to the clinical follow-up program during fiscal year 1951, and the agency sacrificed the expansion of ''record follow-up studies" (those that did not involve clinical observations) in order to complete the clinical studies. The military emergency in Korea also made it more difficult for the agency to obtain the equipment necessary for its work, such as the IBM machines "best suited to the kind of work performed."45 During this period, Gilbert Beebe began giving speeches in which he described the Follow-up Agency's mission to military and medical audiences. In these talks, he put forth questions that the agency sought to answer, such as: Do men with severe frostbite and trench foot recover completely? or What is the chance of survival for men with Hodgkin's disease? He emphasized the value of military records for scientific investigation. "If you want a thousand cases of schistosomiasis, there is a specific place to go and you can physically put your hands on a thousand punchcards which represent a thousand admissions for this disease," he said. He claimed that "everyone has felt much better ... knowing that a single group has been entrusted with the responsibility of organizing access to this material and of evaluating the specific research proposals made in connection with it." As for the investigators who worked with this material, Beebe cited a group of committed doctors who had become interested in a particular problem during the war and who were willing "to put up with a considerable amount of necessary administrative and organizational work" in order to use the records. However, even the most committed clinical investigators required the help of agency staff in acquiring rosters, locating individuals, and examining sample records, and even then, considerable problems remained in getting people to report for examinations. Still, concluded Beebe, the rewards of such an enterprise were immense.46 Despite Beebe's optimism, the future of the follow-up program was far from ensured. Between 1952 and 1955, the agency faced a painful transition from total dependence on the Veterans Administration to more diverse sources of financial support. This period coincided with expansion of the VA's own intramural activities, which decreased its reliance on external contracts, and with the arrival of the first Republican administration in Washington since 1932. In a statement prepared in April 1952, Gilbert Beebe wrote that until final reports were prepared for some of the larger and more expensive studies, it would be difficult to "know whether the program should be brought to an end as a postwar episode of temporary interest and value." At the end of fiscal year 1952, total costs for the effort were expected to reach $2.2 million, with about 38 percent going to the Follow-up Agency itself. The most expensive of the 25 projects cost $600,000. Beebe admitted that the conduct of cooperative, multicenter projects had proved to be a challenge. Even within single centers, the staff noted that well-qualified examiners differed greatly in their reports "as to specific signs, symptoms, and laboratory values." These diagnostic differences, coupled with the agency's inability to compel individuals to submit to examination, revealed ten-

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--> sions between the exacting world of the statistician and the pragmatic concerns of the clinician.47 Responding to the financial problems and the mounting concerns of the Veterans Administration, the Committee on Veterans Medical Problems decided that each follow-up project would be studied by experts on the particular subject, with the objective of assessing the report's ''value."48 Five years of effort had, according to Dr. Wintemitz, brought "relatively little harvest to date." The NRC wanted to evaluate the follow-up program through the final reports of the various studies, but "unfortunately,'' noted Winternitz, none of the major studies had been completed. Beebe said that the slow pace of the work reflected the many stages of a project. Even after the clinical examinations had been performed, agency staff still needed to perform the tabulations, conduct the statistical analysis, work with the investigator on a final manuscript, and make a final check of the statistics and tables used in the manuscript. Beebe hoped that the bulk of the statistical work on approved projects would be completed by the end of June 1953. 49 In the meantime, the majority of the committee's work shifted from the follow-up studies to advising the Veterans Administration on its intramural research program.50 Reviewing the Agency's Progress By early 1953, the follow-up studies program was officially under "review and reassessment" by the NRC. The reasons were both internal and external. The Agency staff was overloaded with statistical work. Some of the investigators were late with their final reports. With the arrival of President Dwight D. Eisenhower and a Republican Congress, the external environment was also changing. The Veterans Administration faced a stringent review of its budget requests. President Eisenhower proposed the creation of a cabinet-level Department of Health, Education, and Welfare (HEW) that would include the Public Health Service and possibly other medical programs of the federal government, including those of the VA as well. Beebe and others feared the impact that the new HEW would have on the agency's funding relationships with the federal government.51 Although the work of the Follow-up Agency appeared to be stalled, the staff enjoyed a period of considerable creativity and productivity. Bernard Cohen continued his work on the studies in which he made use of existing medical records to illuminate larger epidemiological and policy concerns. His pilot study, begun in 1948 and designated R-1 or record study one, led to a detailed draft final report in 1951 (draft because it had to be put aside in the crush of other work) and to a summary of the methodology, which was published in the American Journal of Public Health, the first of a long series of staff publications that became the agency's hallmark. The success of this project encouraged the agency to undertake other record studies, each involving Cohen and one of his colleagues, on

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--> subjects such as Hodgkin's disease, tuberculosis, prisoners or war, and Buerger's disease (thromboangiitis obliterans). The prisoner of war study (see Box 2), designated R-4, which was to focus a great deal of attention on the agency, involved examining an environmental situation rather than a disease entity, for which the record approach was better suited than the clinical approach. The study itself focused on the mortality expe- BOX 2 Mortality Studies of Former Prisoners of War Almost as old as the Medical Follow-up Agency (MFUA) is the series of follow-up studies, now seven in number, of former prisoners of war (POW) from World War II and the Korean War. Some of the studies have focused on mortality and others on morbidity (see Box 8). Work began with a study, published in 1955, which presented findings on mortality, morbidity, and disability after liberation, as well the recollections of prison experience. The study showed, for example, that former POWs of the Japanese suffered markedly higher mortality, due primarily to tuberculosis and accidents, following their repatriation than did a group of comparison veterans; this was not the case for prisoners of the Germans. In the second study of the series, the original sample was augmented through the addition of POWs from the Korean War and combat comparison individuals, as well as a group of malnourished World War II POWs. This brought the mortality sample to more than 19,000 men and the morbidity sample, which was smaller because morbidity follow-up was more expensive, to more than 5,000. By the time of the study, which was published in 1970, the excess mortality among World War II Pacific prisoners, relative to the U.S. general population, had practically disappeared, whereas the mortality rate of POWs of the Korean War remained significantly higher than that of the U.S. population for more than a decade. The results of the next mortality study, the fourth overall, were published in 1975. It was clear by this time that the early increased risk of dying among former POWs had waned, although excess deaths due to cirrhosis of the liver appeared as a late effect. As the MFUA entered its sixth decade, a seventh study of former POWs was begun. This mortality study will provide 50 years of follow-up data, capping the literally decades-long MFUA efforts. Selected References Cohen, B.M., Cooper, M.Z. A Follow-up Study of World War II Prisoners of War. VA Medical Monograph. Washington, D.C.: U.S. Government Printing Office, 1955. Keehn, R.J. Follow-up studies of World War II and Korean Conflict prisoners. III. Mortality to 1 January 1976. American Journal of Epidemiology 111:194–211, 1980. Nefzger, M.D. Follow-up studies of World War II and Korean War prisoners. I. Study plan and mortality findings. American Journal of Epidemiology 91:123–138, 1970.

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--> rience of the prisoners. Preliminary computations indicated that those who had been prisoners of war in Japan experienced an excess of mortality compared to the U.S. white male population in the period between 1945 and 1951; prisoners in Europe had a significantly lower mortality rate than U.S. white males for this period. Excited by this finding, the staff believed that record follow-up projects deserved a more important place in the committee program than they had received. As Bernard Cohen put it, "the medical records of the armed forces and the Veterans Administration provide unparalleled materials and opportunities for follow-up studies."52 Donald Mainland, a professor of medical statistics at New York University, produced a more sober evaluation of the Follow-up Agency in a report for the NRC that appeared in March 1953. He lauded the work of Gilbert Beebe and his staff. Still, he found much to criticize. In the excitement at the beginning of the program, studies had begun without sufficient planning. Few people understood that clinical competence did not imply statistical competence. The agency did not do enough small pilot studies. Instead, it undertook too many large projects, too quickly. The clinical investigators failed to appreciate the importance of statistical expertise. All in all, the relative value of the program would have been greater "if those responsible (investigators and committee members) had been better acquainted with the principles and limitations of statistical surveys." Mainland argued that if the program continued, it should do so on a diminished scale. In the meantime, the NRC might consider establishing a statistical advisory unit to serve a wide variety of purposes.53 With Mainland's report in hand, the Committee on Veterans Medical Problems discussed the future of the follow-up program in April 1953. The committee decided that applications for new follow-up studies should have an adequate experimental plan, an estimate of the "feasibility of the proposal from a statistical viewpoint," and investigators "with enthusiasm, competence, and dependability in regard to completion of the study." In other words, they proposed to interpret existing standards in a rigorous manner. The committee looked with particular skepticism on projects that involved multiple research locations. 54