1
Creating the Agency

Although the Second World War caused mass destruction, it also served as a source of much scientific progress. The field of medicine was one discipline that was able to benefit from this wartime progress. National mobilization led to the provision of medical care on a scale unknown in American history. Not only were many of the nation's young adults pressed into wartime service, so too were its doctors. The nation's leading medical schools assembled units of doctors who treated wartime casualties and provided routine medical care to members of the armed forces. As a result, millions of people who previously had seen a doctor sporadically, if at all, began to receive comprehensive care. These medical encounters produced a large set of medical records that constituted a potential resource for clinicians and statisticians. The Medical Follow-up Agency grew out of a desire to use these records to improve medical care and learn more about the course of disease.

The Idea

After the surrender of Japan in August 1945, the nation's attention shifted to the process of demobilization. During the war, the National Academy of Sciences (NAS), acting through the Division of Medical Sciences of its National Research Council, had provided advice to the surgeons general of the Army and Navy on medical research and other matters related to wartime care. Between 1940 and 1946, advisory committees on war services held more than 700 meetings and 243 conferences and played an important role in shaping the nation's wartime medical policy.1 In 1946, however, the National Research Council (NRC) contem-



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--> 1 Creating the Agency Although the Second World War caused mass destruction, it also served as a source of much scientific progress. The field of medicine was one discipline that was able to benefit from this wartime progress. National mobilization led to the provision of medical care on a scale unknown in American history. Not only were many of the nation's young adults pressed into wartime service, so too were its doctors. The nation's leading medical schools assembled units of doctors who treated wartime casualties and provided routine medical care to members of the armed forces. As a result, millions of people who previously had seen a doctor sporadically, if at all, began to receive comprehensive care. These medical encounters produced a large set of medical records that constituted a potential resource for clinicians and statisticians. The Medical Follow-up Agency grew out of a desire to use these records to improve medical care and learn more about the course of disease. The Idea After the surrender of Japan in August 1945, the nation's attention shifted to the process of demobilization. During the war, the National Academy of Sciences (NAS), acting through the Division of Medical Sciences of its National Research Council, had provided advice to the surgeons general of the Army and Navy on medical research and other matters related to wartime care. Between 1940 and 1946, advisory committees on war services held more than 700 meetings and 243 conferences and played an important role in shaping the nation's wartime medical policy.1 In 1946, however, the National Research Council (NRC) contem-

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--> plated an end to these emergency activities. At the beginning of the year, Dr. Lewis H. Weed, the chairman of the Division of Medical Services, reported that all of the committees would be discharged by the end of June. At the same time, negotiations were under way to forge a new relationship with the surgeons general of the Army, Navy, Public Health Service, and Veterans Administration. Weed expected the division ''to be intimately concerned with research problems undertaken by the principal federal agencies concerned with medicine.'' 2 On March 12, 1946, Major General Norman T. Kirk, the surgeon general of the United States Army, wrote to Frank B. Jewett, the president of the National Academy of Sciences, and suggested that conferences be held to discuss a new advisory relationship between the Academy and the federal medical agencies. Within three weeks, a preliminary conference took place in which the participants agreed that "strong efforts" should be made to continue the services of the National Research Council. An ensuing conference on postwar research held on April 18 at the National Academy of Sciences attracted 43 people, among them some of the nation's leaders in medical administration and medical research. Dr. Edward Churchill, a professor of surgery at the Harvard Medical School, chaired the meeting. Those in attendance included Louis Dublin, who had done pioneering work in health statistics with the Metropolitan Life Insurance Company; William Menninger of the famous psychiatric family; Barnes Woodhall, a distinguished clinician and medical researcher from Duke; and John Whitehorn, the chief of the psychiatry department at Johns Hopkins.3 Faculty members from the medical schools at Northwestern, Western Reserve, Columbia, Vanderbilt, Pennsylvania, and Yale also attended. Even in the presence of so much senior medical talent, Colonel Michael E. DeBakey of the Army's Office of the Surgeon General, a surgeon who subsequently came to international fame in his field, played the key role at the meeting. A memo that he had sent to General Kirk on March 5, 1946, served as the basis for the discussion. In this memo, DeBakey pointed out that "an enormous amount of material" had accumulated in the medical records kept by the armed services. "It can fairly be said," he wrote, "that no similar amount of material has ever been accumulated, and it is doubtful whether a similar amount will ever again be available." DeBakey proposed to turn this material to "practical use by the establishment of a clinical research program, including a follow-up system to determine the natural and post-treatment history" of the diseases and conditions treated during the war. DeBakey offered the example of peptic ulcer as a condition that might be studied. A follow-up of cases identified during the war would establish the conditions under which the ulcers led to perforation, hemorrhage, and other complications. Such an exercise could enable clinicians to settle such questions as whether "benign peptic ulcers undergo malignant changes." Investigators would also be able to ascertain the long-term effects of various forms of treatment. "These and other data, departing from a given base line and followed up over long periods of time, dispassionately and in the absence of special pleading,

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--> Dr. Michael DeBakey. Photograph courtesy of Dr. Lois DeBakey. have never been available," DeBakey noted. Among other conditions that might benefit from such an approach were head injuries, bone defects, and peripheral nerve injuries. In DeBakey's memo lay the origins of the Medical Follow-up Agency. He envisioned the project as a joint undertaking between the Army and the Veterans Administration (VA). He also saw a role for the National Research Council, which would appoint a committee to initiate and implement the project and, in DeBakey's words, "exercise a general supervisory function." This method of operation would continue the successful partnership between the NAS and the federal government that had been established during the war. To finance the enterprise, DeBakey thought funds might be obtained through a National

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--> Research Foundation, should Congress choose to establish one (this notion later evolved into the National Science Foundation), or through a direct federal subsidy.4 At the April conference on postwar medical research, DeBakey's idea received a favorable response, both from key government officials and from private practitioners. General Menninger, who, like DeBakey himself, would soon return to civilian practice, pointed to the need for such follow-up activities in psychiatry. He noted that little was known about the long-term effects of such conditions as battle fatigue. Barnes Woodhall mentioned that studies had already begun regarding soldiers who had received operations for peripheral nerve injuries. Others cited the value of the work that could be done in such fields as the treatment of epilepsy and cancer. Dr. Paul Magnuson, assistant medical director of the Veterans Administration medical program, endorsed the proposal and noted that the VA was prepared to supply funds to carry it out. Dr. Robert Dyer, director of the National Institutes of Health—which were just beginning their period of tremendous postwar growth—became enthusiastic over the chance "to follow a whole generation of men and trace their life history." He called it an "unparalleled" opportunity. Louis Dublin agreed that "there was nothing comparable to this opportunity in the entire world." To miss it would be "utterly tragic.'' Indeed, a similar discussion had taken place after the First World War, but the opportunity had been lost.5 Dublin's comments underscored the desire not to repeat the mistakes that had been made after the World War I. Rather than simply return to the status quo ante as it had done then, American medicine would now put to use the clinical experience of the Second World War. Most of the attendees realized that a new type of relationship between the government and the medical profession would govern medical research in the postwar era. Dublin, a vice-president of the Metropolitan Life Insurance Company, noted that there were projects, such as the one DeBakey was proposing, that were simply beyond the scope of private companies. What his company could do was small compared to what could be done with the military records that, as one doctor noted, covered 10 to 12 percent of the population. Dublin also warned that the work would have to be carried out by "highly skilled personnel" and not by the "ordinary physician." He implied that this effort would require the assistance of statisticians and would fall into the domain of academic medical centers. Dr. Churchill selected three participants to draft a resolution that would express the sense of the conference. With unanimity and with the Veterans Administration eager to have the National Research Council assume an advisory role in its postwar research program, the group passed the resolution immediately. Urging the nation to seize an "unparalleled opportunity," the group recommended that the NRC appoint a committee "to explore the most effective means by which a medical research program ... can be carried out, to the end that the

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--> care of patients, the investigation of disease, and the improvement of medical practice and education be advanced."6 Organizing a Plan of Action This first meeting led to another when, on May 7, 1946, a temporary Committee on Veterans' Medical Problems met at the National Academy of Sciences to formulate a plan of action. Once again, Dr. Churchill chaired the meeting. Eight others joined him on the committee, six of whom worked in leading medical centers. Churchill explained the group's mission as preparing a report to the National Research Council that would serve as "a basis for action."7 To research and write the report, the committee relied on DeBakey and Gilbert W. Beebe, who had been detailed to the NRC from the Army's Office of the Surgeon General. DeBakey, who had directed the Surgeon General's Surgical Consultants Division, held the civilian job of assistant professor of surgery at Dr. Gilbert Beebe—1996. Photo by Bill Branson, courtesy of Dr. Gilbert Beebe.

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--> Tulane. A persuasive writer, he brought a clinician's perspective to the task. Beebe, who had headed the Analysis and Reporting Branch of the Control Division in the Surgeon General's Office, held a Ph.D. in sociology and statistics. In civilian life, Beebe had worked at the Milbank Memorial Fund, an important institution in epidemiology and in what a later generation would call health services research. 8 Much of the discussion centered on the structure of the organization that would perform follow-up work. DeBakey envisioned a committee of prominent physicians volunteering their time in the traditional NAS manner that would select appropriate projects and oversee the agency. An operating body, composed of full-time employees of the National Research Council with expertise in statistics and research design, would complement this directing body. One important task of this body would be to prepare the rosters of individuals to be used in particular studies, using information provided by the Army and the Navy. The studies themselves, once they had been approved by the directing committee and designed in conjunction with the operating body, could be carried out by qualified individuals in the Veterans Administration, medical colleges, or other appropriate institutions. 9 On June 13, 1946, DeBakey and Beebe finished a draft of the report on the feasibility of a research program devoted to medical follow-up. Along with DeBakey's original memo, this report became one of the two founding documents of the Medical Follow-up Agency. A program of clinical research that focused on the follow-up of veterans would, the report said, make "a priceless contribution to clinical medicine," "stimulate research in clinical and scientific medicine," and "improve the level of medical practice in both federal and other hospitals." The National Research Council was the ideal place from which to run such an effort. As a quasi-government agency, it provided "the logical mechanism by which the resources of scientific and clinical medicine [could] be marshaled for the coordination and direction of so broad a program." Indeed, the program had to be broad enough to encompass clinical studies testing new therapies as well as statistical studies of mortality and morbidity. The report indicated ''no insuperable barrier'' to prevent the creation of rosters of people for studies, the use of wartime clinical records, or the location of people who would participate in follow-up activities. Bey ond these parameters, the report argued that the program could not be "visualized in definitive detail in advance of actual trial."10 Finding the Funding One area of concern was funding for the new endeavor. The draft report recommended that no single agency provide all the funds, even though DeBakey and Beebe knew that the Veterans Administration was prepared to make a large contribution to the program. Even before the draft's completion, Paul R. Hawley, chief medical director of the Veterans Administration, announced his agency's

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--> intention to contract with the NRC for two types of services. At one level, the Veterans Administration desired help from the National Research Council with the direction of its extramural research, expecting the NRC to convene a supervisory committee for the research program and to issue contracts to the institutions carrying out the resulting research. The Veterans Administration also sought a follow-up program for which the NRC would provide "a statistical service to investigate military records and help in the development of research problems." Pleased with this interest, DeBakey, Beebe, and the committee still saw the need for "broad financial participation" on the part of "all the interested federal medical agencies." They hoped that, at the least, the new entity would be headed by a "first-class medical executive'' and would attract "medical analysts of the highest caliber.'' They wanted the new agency to be assured of five years of funding. Writing at a time when federal support for medical research through the National Institutes of Health had not yet become routine, they believed that this required access to nonfederal funds either as grants or "as guarantees against the failure of federal funds."11 The bottom-line recommendation was that the surgeons general and the VA's chief medical director should take steps that would enable the NRC's Division of Medical Sciences to establish "a continuing committee on clinical research and follow-up, with provision for administrative officers, professional and secretarial assistance ... as well as funds for the support of a broadly conceived research program."12 Beebe and DeBakey estimated that it would cost at least $200,000 to start the effort. As studies began, the annual amount needed would rise to $500,000. The report concluded with examples of the studies the new entity might undertake. These ranged from studies of infectious hepatitis to examinations of the personalities of military heroes.13 DeBakey and Beebe's draft report gained quick approval from the Committee on Veterans Medical Problems. Dr. Roy McClure of the Henry Ford Hospital in Detroit expressed positive "delight" with the proposed program, which he called "very sound." Advising the group not to change a word of the report, Dr. Paul Magnuson of the Veterans Administration said that "experience would indicate the necessary changes in due time." The priority was to get the program up and running. Toward this end, the committee endorsed the report with only minor modifications. 14