Another large part of our program is the work going on in collaboration with States and 3 cities where 2 or more cases occurred in the same family. These will have the same kind of examinations including the 60-day muscle evaluation that I have mentioned. We have chosen those particular families because they will be the ones in which many have had gamma globulin as part of the contact-prophylaxis program which is going on throughout the country. We will compare the severity of the disease in cases which get gamma globulin a few days before they become ill with cases that develop before they have a chance to get gamma globulin. We estimate that we will have 1,000 records of families with multiple cases which will provide more information regarding modification. The third aspect deals with the collection of descriptive data on the administrative aspects of the problem Dr. Norton has already presented for the areas such as in his State. We will record and analyze the methods of distribution and the problems which have been met and will digest this information into usable form which will be available for the States for easing the administrative aspects of the problem next year. Mr. HESELTON. What happened in the other States besides those mentioned? Dr. LANGMUIR. They are mostly the smaller States where the amount of polio may be expected to lead to one or no multiple cases in households, such as in Nevada and the Western States where the facilities are few and the distances of travel are great. However, if an epidemic had occurred in Nevada, I am sure we would have been called in and would have gone. Mr. HESELTON. This morning we had a very interesting session with the people from the Sister Kenny Foundation. Are any of your physical therapists persons who were trained at the Kenny Institute? Dr. LANGMUIR. I am sorry that I cannot tell you where they have been trained. The physical therapists have been provided by the American Physical Therapy Association. We then attempt, as far as possible, to utilize them in the States of their residence. Á number of the State health departments employ them, and in certain areas like Kansas City and Atlanta, physical therapists were assigned to us to cover several States. (Dr. Langmuir's prepared statement follows:) THE NATIONAL PROGRAM FOR THE EVALUATION OF GAMMA GLOBULIN (By Alexander D. Langmuir, M. D., Chief. Epidemiology Branch, Communicable Disease Center, Public Health Service, Department of Health, Education, and Welfare; prepared for hearing of the House Committee on Interstate and Foreign Commerce) The discovery of the value of gamma globulin in the prophylaxis of poliomyelitis, announced by Dr. W. McD. Hammon of the University of Pittsburgh, in October 1952, is one of those rare events when a single well-controlled scientificstudy lays the basis for a new program of national scope that offers a hopeful approach to a previously insoluble major disease problem. In view of the scope and cost to the Nation of producing and distributing gamma globulin, the Communicable Disease Center of the Public Health Service felt a great responsibility to sponsor a major program to collect on a national scale the maximum amount of useful information about this new agent. The objective is to learn well before the 1954 poliomyelitis season how the limited supplies can best be utilized. A national evaluation program was established in collaboration with the Association of State and Territorial Health Officers, the American Physical Therapy Association, and the D. T. Watson School of Physiatrics, affiliated with the University of Pittsburgh School of Medicine. An advisory committee, composed of 17 authorities on poliomyelitis, planned the program and reviews its progress. A National Evaluation Center was organized in the CDC in Atlanta to direct the activities. A group of 20 epidemic intelligence service officers, 8 nurse epidemiologists, and 6 statisticians were detailed to the program. Prior to their field assignments, these officers received an intensive orientation course including 1 week of training in muscle evaluation at the D. T. Watson School of Physiatrics. Health departments in 41 States and 3 cities are actively collaborating. Physical therapists who perform the crucially important muscle evaluations to determine the severity of paralysis have been mobilized, trained, and assigned to all study areas by the American Physical Therapy Association with the aid of a grant from the National Foundation for Infantile Paralysis. A standardized muscle-evaluation procedure was developed to provide consistency of data in all study areas. Two methods of use of gamma globulin have been recommended this year: (1) Mass prophylaxis of selected age groups in epidemic areas. (2) Contact prophylaxis of household and possible other contacts of clinically diagnosed cases. The first method is the only one for which the value has been established by direct scientific observations. It is applicable, however, only to specialized situations of intense epidemics. The second method, contact prophylaxis, has not been established by direct controlled study, but it is generally applicable throughout the Nation. A determination of the relative value of this method, compared with mass prophylaxis, should help in deciding the criteria for utilization of gamma globulin in 1954. Three general approaches are being employed: (1) The detailed epidemiologic study of each epidemic area where mass prophylaxis has been used. (2) The careful appraisal of multiple-case households in all study areas. (3) The critical evaluation of administrative methods employed in the various States for distributing gamma globulin. In mass prophylaxis areas, the duration and severity of the epidemic will be compared to previous epidemics in the same or comparable areas to determine whether or not characteristic differences occur that can be attributed to gamma globulin. The extent to which cases occurring after mass prophylaxis appear in older age groups not receiving the immunization will be measured. The severity of paralysis in cases occurring immediately before mass prophylaxis will be compared with the severity of cases which develop in spite of immunization to determine whether or not modification of paralysis has been achieved. Multiple-case households have been chosen for the evaluation of contact prophylaxis. Household contacts of poliomyelitis cases generally receive gamma globulin immediately following the diagnosis of the first case in the family. This is usually 3 to 5 days after onset. Subsequent cases developing in the household may or may not have received gamma globulin. Thus, by studying multiple-case households, the severity of paralysis among contact cases receiving gamma globulin may be compared with that among contact cases which did not. This evaluation will be based on careful muscle testing performed by physicaltherapists, approximately 60 days after onset. It is planned to collect detailed records on more than 1.000 multiple-case households. This aspect of the program will not show the extent to which gamma globulin prevents paralysis, but it is expected to measure the degree to which gamma globulin may modify the severity of paralysis. The administrative aspects will be studied with the view to learning which of the various methods of distributing, accounting for, and controlling the limited and valuable supplies of gamma globulin that are developed by the States are most practical, acceptable, and effective in actual use. The program is now in full operation, and proceeding according to schedule. The cooperative relationships of the National Evaluation Center with the participating State and local health authorities are universally enthusiastic. The results of the program are not yet available, because the crucial evaluation depends upon the 60-day muscle tests which are only now being performed in large numbers. The schedule calls for a complete analysis of the records and studies by December 31, with the preparation of a fully documented report for review, approval, and release by the Advisory Committee before January 31, 1954. The members of the National Advisory Committee are: Dr. Alexander D. Langmuir, chairman Miss Lucy Blair, consultant, professional services, American Physical Therapy Dr. John M. Chapman, epidemiologist, Los Angeles City Health Department Dr. Thomas Francis, Jr., professor of epidemiology, University of Michigan Dr. D. G. Gill, State health officer, Alabama State Department of Health, Montgomery Dr. A. L. Gray, director of preventable disease control, Mississippi State Board of Health, Jackson Dr. Morris Greenberg, epidemiologist, New York City Health Department Dr. William McD. Hammon, professor of epidemiology, University of Pittsburgh School of Public Health Dr. Arthur C. Hollister, Jr., chief, Bureau of Acute Communicable Disease Control, California State Department of Public Health, Berkeley Dr. Robert F. Korns, director, Bureau of Epidemiology and Communicable Disease Control, New York State Department of Health, Albany Dr. John R. Paul, professor of preventive medicine, Yale University School of Medicine, New Haven Dr. John D. Porterfield, director of health, Ohio Department of Health, Columbus Dr. Albert B. Sabin, director, Children's Hospital Research Foundation, Cincinnati Dr. Leonard M. Schuman, deputy director for division of preventive medicine, Illinois Department of Public Health, Springfield Dr. Thomas F. Sellers, State health officer, Georgia Department of Public Health, Atlanta Dr. Jessie Wright, medical director, D. T. Watson School of Physiatrics, affiliated with the University of Pittsburgh School of Medicine Mr. DOLLIVER. Are there any further questions? Mr. CARLYLE. Has it been stated how much it costs to manufacture gamma globulin? Dr. LANGMUIR. The cost of one dose of gamma globulin? Dr. LANGMUIR. Could Dr. Grant answer that question? Dr. GRANT. It is made from fresh blood, and you have to consider that the cost includes the cost of collecting the blood. It costs, I would say, about $9.50, between $9 and $10 for 1 injection, and that is the rockbottom price. Mr. DOLLIVER. Are there any other questions? Do you have any other witnesses, Doctor? Dr. ANDREWs. I have no further witnesses, Mr. Chairman. Mr. DOLLIVER. I am sure every member of the committee, and especially our chairman, would wish me to express our very deep gratitude to Dr. Andrews and the other members of the panel. I know that you have come here at considerable sacifice of time, energy, and perhaps convenience. These hearings we hope, and certainly believe, will be of advantage to the people of the United States and to all concerned. We are very deeply grateful to you for your assistance to us. The committee will stand adjourned until 10 o'clock tomorrow when I believe we take up arteriosclerosis. (Thereupon, at 5: 12 p. m., the committee adjourned until tomorrow, Wednesday, October 7, 1953, at 10 a. m.) HEALTH INQUIRY (Poliomyelitis) MONDAY, OCTOBER 12, 1953 HOUSE OF REPRESENTATIVES, COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE, Washington, D. C. The committee met, pursuant to adjournment, at 10 a. m., in the committee room of the House Committee on Interstate and Foreign Commerce, Hon. Charles A. Wolverton (chairman) presiding. The CHAIRMAN. The committee will come to order. The hearings today will be directed to a continuation of discussions begun before this committee on October 6 in connection with poliomyelitis. We welcome to this hearing the representatives of the National Foundation for Infantile Paralysis, the Public Health Service officers, and other interested scientists and laymen who have so generously given of their time in order that the facts about polio may be made known to the American people and to the members of this committee. I would like to restate the purposes of this series of hearings having to do with the diseases of greatest importance in America today. This committee has legislative responsibilities in the field of health. In order to discharge these responsibilities, the committee feels it necessary and appropriate to inquire into the current status of a number of diseases-what things are known about them, what is being done to control them, what research is in process and what is needed, what private and public agencies are engaged in prevention and control programs, what, if anything, needs to be done that is not being done to protect the American people. In previous hearings, the committee has been tremendously impressed by the testimony that has been given by a number of distinguished witnesses. It has been an encouraging demonstration of sincerity, integrity, and coordinated effort. But the committee has also been concerned about the great gaps in our research knowledge, about the economic loss and human suffering caused by long-term illness, about the failure in some instances to apply the knowledge that is now available, and about the widespread lack of adequate measures to protect the rank and file of the American people from the economic burdens of catastrophic illness. It is our hope that in today's discussion of poliomyelitis we may get a clear picture of what you gentlemen think we and the American people should know about this dread disease-we, because this committee is keenly aware of its legislative responsibilities and intends to continue to discharge them well, and the American people because they 39087-53-pt. 3-11 763 |