Document OzLQvr6X30NJV16869vkkRkXQ

Saint Lukes Hospital JtL VhLJ.j Ck~.l 11311 Shakir Boulevard Cleveland. Ohio 44104 April 8, 1969 Mr. Frank Zimmerman National Gypsum Company 325 Delaware Avenue Buffalo, New York 14202 Dear Frank, Enclosed is a copy of the proposal that ha*s been submitted to our Scientific Committee by Doctors, Weill and Ziskind of New Orleans. Our Committee has not looked at this officially as yet, and will not do so until sometime in May. It has been circulated. As I indicated to you on the telephone today, I hope that 70U will look at this, especially from the point of view of whether or not there is anything there that might be troublesome for National Gypsum Company, and which we could avoid-by making the necessary adjustments at the outset. I can only repeat that these are two very high-caliber people, and they are as anxious as I am to do the work properly and without causing disturbance where it is at all avoidable. I will be in town on Monday, the 14th, and if there blems will appreciate knowing about it on that day. seeing Bill Duncan on the 18 and 19th and will talk it. are any pro I will fc2 to him about With best wishes. GWW:vk Enclosure George Wp Wright, M.D. Director of Medical Research PLAINTIFF'S EXHIBIT 36G35 A STUDY OF THE HEALTH EFFECTS RELATED TO ASBESTOS EXPOSURE IN WORKERS OF THE INDUSTRY AND OTHER RESIDENTS OF NEW ORLEANS Introductory State ment New Orleans is well represented in the manufacture of asbestos cement products, an industry which accounts for the major use cf asbestos liber in the United States. There has been increasing interest in the role of long term asbestos fiber inhalation in the production of pulmonary and pleural neoplasms. This interest extends not only to the workers in the manufacturing plants using asbestos materials but also to the community at large, particular: y those individuals living in areas adjacent to the industrial installations where the fiber is used. Carcinogenic or co-carcinogenic properties of asbestos have become apparent since improved industrial hygiene techniques have led to dust suppression with the result that workers incur a smaller risk of early development of diffuse pulmonary fibrosis and cor pulmonale. In addition, the better control of infectious diseases has also resulted in greater longevity for the workers and larger numbers are surviving to develop malignancies. Since pleural mesotheliomas have been adequately associated with prolonged exposures to asbestos dust, these tumors in addition to the pulmonary and gastrointestinal carcinomas and peritoneal mesotheliomas must be sought for in populations thought to be at increased risk due to their occupational or geographic proximity to the asbestos industry. 3GG3G * .' 2 Although the clinical, radiographic, and pulmonary physiologic abnormalities encountered in classical cases of asbestosis have been recognized for many years, several patterns of dlff-is** .H.i tea pe have emerged in local plant worker Those different radiographic and physiologic patterns are un doubtedly related to varying mixed dust exposures, although all of these workers who develop diffuse pulmonary infiltrations with or without respiratory functional impairment are labelled as having Masbestosi6The investigators have evidence that a significant number of these workers may actually have simple silicosis or silico-asbestosis as a result of exposure to silica dust ir t the plants which produce asbestos cement products. There is an obvious need for identifying these individuals with abnormal deposits in their lungs, correlatin the x-ray, clinical and physiologic changes with the exact nature of their work exposures and properly identify their pulmonary disease. It is of interest to note that inhalation of asbestos dust has been thought to foster the retention of quartz dust with a resultant pulmonary disease which followed sooner and attained a more serious grade than could have been expected on the basis of mere additive action. Whether this experimental finding has clinical application in the production of disease in workers of this industry should be investigated. The importance of correlating radiologic changes with pulmonary functional impairment is further demonstrated by the finding that where this mixed dust a exposure produced widespread nodulation (as seen in workers from the local manufacturing installation) it was associated with little or no clinical symptoms and normal pulmonary function. 3C637 Research Plan: 3 It is proposed that this investigation be conducted in two phases, one involving the workers of the Johns Manville and National Gypsum Plants in New Orleans, and the other dealing with selected portions of the New Orleans population outside the plant. During the first year, the Phase I investigation will be actively started as outlined below. The community study, or Phase II, will undergo intensive planning during the first year with full employment of consultative resources so that a meaningful active program can be started at the beginning of the second year, aimed at assessing the risk of the develop- ment of pulmonary or pleural neoplasia outside the plant but as the result.jaf., .Jprolonged environmental exposure to asbestos dust Marked stability of residence in the New Orleans population will significantly aid the follow-up of the study groups. I. Phase I The aim of this portion of the investigation is to determine the frequency, functional effect, and extent of abnormal diffuse pulmonary infil trations secondary to occupational dust exposures in the Johns Manville and National Gypsum plants which in New Orleans produce a variety of asbestos cement products. Current chest x-ray films, including the PA, right anterior % oblique and left anterior oblique projections, will be carefully examined in all workers for the presence of abnormal parenchymal infiltrations. Ir.divi- duals with abnormal lung fields will be further studied in the Pulmonary Function Laboratory, Department of Medicine, Tulane University School of Medicine. 3CG38 4 At this time, complete clinical information will be gathered with particular emphasis on the detailed occupational history, the presence of respiratory or cardiovascular symptoms, and the physical examination. These individuals will then have complete studies of pulmonary function including the measurements of lung volume; ventilatory capacity, including the parameters of air flow rates; pulmonary mechanics, including compliance and airway resistance, arterial blood gas measurements at rest and during exercise; and determination of the pulmonary diffusing capacity, using the carbon monoxide single breath method. Clinical, radiographic, and physiologic data obtained will be correlated with the length and type of work exposure. Plant records and previous medical history will be fully utilised for this purpose. The incidence of pleural fibrosis and/or calcification will be determined in this group of workers. Pulmonary function studies will also be completed in those individuals with pleural changes but no detectible infiltrations in the lungs. ^^^th^j^rk^r^ will have a brief questionnaire administered ;n order to survey the presence of respiratory symptoms and, in addition, simple ventilatory tests performed in order to detect the presence and severity of diffuse airways obstruction so that this process will not be confuse f with the potential effect of prolonged dust exposure. . An important part of this investigation will be its prosp?ctive aspects, which will include the careful clinical, physiologic, and radiograrhic follow-v.p of all of these workers in future years, whether they continue employment in . 36G39 another type of work. ^ the plant, retire, or change to The late development 5 of pleural or pulmonary changes will thus be detected even though asbestos exposure has not been continuous. It is suggested that all future employees at these two plants be included in this study and have pre -cmployment radio- graphic and ventilatory examination. In this way changes related to the development of chronic obstructive pulmonary disease can be separated from dust effects on the lungs. The identification of pulmonary, pleural, or abdominal malignancies in these workers will, of course, result from the stfcdy as outlined above. In raddition, individuals who have worked in these plants in the past will be carefully traced and their current health surveyed.! In those workers who have expired, an energetic attempt will be made to ascertain the cause of death and, when possible, autopsy data will be reviewed and the worker's physician contacted. Because of the imperfections known to be associated with the collection of this type of retrospective data, the prospective aspect of the search for malignant change in asbestos workers will be strongly emphasized. During the long term period of this study, every effort will be expended to obtain autopsy or other pathologic documentation of the cause of death ir. workers who have been employed in these plants. Information gained from the plant work records will lead to correlation of the onset of the malignant disease with the onset of occupational exposure, the years of exposure, any latent period during which 3GC40 p 6 the occupational exposure had ceased, and the residential history. Parti cular attention will be directed toward individuals who develop thoracic or abdominal malignancies and who had very short exposures to asbestos fiber v--____________ ___________ ___ twenty ot more years ago. Another aim of this investigation will be to characterize the present and past plant conditions in regard to dust exposure and measures undertaken for its control and to detect any consequent change in incidence or type of disease. Workers and executive personnel who have been employed in these plants for long periods of time will be carefully questioned in this regard and attempts will be made to quantitate impressions of changing dust_concer.trations with actual particle counts obtained in the past. Jobs resulting in high dust exposures will be identified in order to correlate disease patterns with various jobs which are associated with different degrees of dust exposure. It is anticipated that particle and fiber counts will be made in these two plants periodically in the future and that the resulting data will be made available to the investigators. II. Phase II The aim of the community investigation will be to provide data which will help to assess the risk of individuals outside the plant developing malignancies related to asbestos fiber exposure. The complexity of this problem requires a detailed planning stage which is projected for the first year of this overall program. During this period discussions will be conducted by the investigators and consultative advice will be sought both in New Orleans 3GC31 7 and from workers in other areas. It is expected that a workable and productive epidemiologic design will result from this planning phase and that the active part of the community investigation will begin in the second year. 0 The advisability of implementing a citywide "ferrugenous body" survey will be considered and this, together with a system for reporting pleural meso theliomas, will be discussed with local pathologists. Case detection of t mesotheliomas can be increased by a systematic search of the hospital records. An attempt will also be made to gain information regarding the incidence of this tumor and geographic location of these patients from past and present cancer surveys which are being conducted in this city. In future,,years other occupational exposures to asbestos materials may also be considered and a more definitive plan of investigation involving insulation workers will be discussed during Phase II of this proposal. Early in this investigation the application of modern statistical and computer techniques will be planned for the collection, retrieval and analysis of data relating to the plant and community study groups. b. Data colle :ted from a careful prospective study of the asbestos cement industry will be highly significant if it helps to answer some of the difficult questions poseci by the incomplete information on human health effects resulting from this exposure. Can the early diffuse changes of asbestosis be detected by x-ray or modern pulmonary function testing so that further deterioration of function as a result of advancing disease will be prevented? 3GG42 8 Will the acknowledged rei'.-ction of dust concentrations in the industry over the past several years ha\ *.n effect on the incidence of fibrotic and neoplastic disease? Is bronchogenic dnoma of asbestos workers seen only in those individuals who are also c` ; ette smokers, as has been suggested, and does this increased incidence o' bronchogenic carcinoma in exposed subjects, also include individuals without the parenchymal changes of asbestosis ? We hope that this investigation will provide useful information on these problems to industry and^Dthers interested]in occupational health. This study will help to evaluate the usefulness of new tools for the stud^ of this environmental exposu such as ferru'genous body counts, atmospheric fiber counts, and^selected pul monary physiologic parameters. Certainly, recent studies have provided conflicting opinions concerning many of these vital points. It has been evident that an integrated approach has usually been lacking and often information regarding environmental occupational conditions is available but not correlated with human health effects, or the reverse is true. It is this common pitfall which we hope to avoid in our proposed investigation. c^ The Human Righhts Committee of the Tular.e Medical School will review tills proposed study. Only standard and accepted methods for the collection of clinical, radiographic, and physiologic data will be used. d. The facilities of the Tulane Pulmonary Diseases Section and 0 Pulmonary Functior. Laboratory will be fully utilized for this investigation. The we.l equipped and modern Pulmonary Function Laboratory contains the following pieces of major equipment: Several spirometers and gas analyzers 36G13 9 for the measurement of lung volumes and ventilation; blood gas analyzers with Pc>2 PcO2 ant^ electrodes, Scholander gas analyzers for analysis of expired air; appropriate pneumotachygraph screens; electrical transducers; pre-amplifie'rs, integrators, and oscilloscope for the measurement of pul monary compliance; body piethysmograph and appropriate attachments for the measurement of airway resistance and thoracic gas volume; gas chromatograph .and carbon monoxide infrared analyzer for alveolar gas analysis in measure ment of pulmonary diffusing capacity. A second system for the collection of alveolar gas samples in diffusing capacity measurements is being requested in the budget, in addition to two portable waterless spirometers far use in the plants. III. Previous work done on this project a. The investigators have conducted a number of studies in the field of occupational and environmental respiratory disease. A bibliography and selected reprints are included with this application. Additionally, a number of cases from the local asbestos cement industry demonstrating varying patterns of diffuse respiratory disease has come to the attention of our group. Cases of P1 eural mesotheliomas from within and outside the plant have also been IV. Perscnal Publications Weill. H., Ziskind, M. M. , Dickerson, R.C. and Dcrbes, V.J. * Allergenic air pollutants in New Orleans. J. Air Pol. Control Assn. 15:467, Oct., 1965 36614 10 Weill, H. , Ducchner, II. A., Gonzalez, E., Herbert, S.J., Aucoin, E. , Ziskind, M.M.: Bogassosis: A study of pulmonary function in 20 cases. Ann. Int. Med. 64:737, 1966 For cman, Spencer, Weill, Hans, Duke, Roy, George, Ronald and Ziskind, Morton: Bullous disense of the lung: Physiologic improvement following surgery. As;n. Int. Med., 69:757, 1969 Weill, Hans, George. Ronald, Munsokul, Narong, Ziskind, Morton, and Buechner, Howard: Management of acute respiratory failure in chronic obstructive pulmonary disease. Submitted for publication Weill, Hans, George, Schwarz, Marvin, Ziskind, Morton: Evaluation of pulmonary function after acute exposure to chlorine gas. Am. Rev. Resp. Dis., March, 1969 V. Results obtained by Others 1. Selikoff has found a very high incidence of asbestosis in insulation workers after twenty years of exposure. Additionally, he found pleural calcification in one-fourth of these workers exposed for more than twenty years. These investi gators also found a significantly increased incidence of bronchogenic carcinoma and mesotheliomas in these workers. 2. Thomson and Bader in separate studies confirmed that asbestosis results in reduction in lung volume, disturbance of gas transfer and increased stiffness of the lungs (reduced pulmonary compliance). Evidence of airways obstruction was only rarely encountered. 3. McVittie showed that intra-thoracic malignancy accounted for 40% of the deaths in a group of asbestos workers. 4. Thomson found that 30% of urban males living in Cape Town, South Africa, or Miami, Florida, had asbestos bodies demonstrated in the lungs at autopsy, an indication of the wide exposure to asbestos fiber among the general population. Attention has recently also been directed to the possible role of talc ancl other 36G15 %, / n fibers in the production of ferrugcnous bodies by Cralley. 5. Knox and Doll have found that with the decreasing dust concentrations in an asbestos textile plant the current risk of developing bronchogenic carcinoma is ^considerably less and may perhaps hot be above the expected general incidence. These are brief illustrations of recently reported studies. The current literature indicates an increasing public concern regarding the association of asbestos exposure and neoplasia. There is also the strong indication that diffuse pulmonary fibrosis is now occurring later in the life of an asbestos worker and its incidence may be decreasing. VI. Biographical Sketches are attached. 1 3CC16 > PROPOSED BUDGET * 12 Personnel Hans Weill, M. D. , Principal Investigator ' Morton Ziskind, M. D., Co-Investigator Research Associates (3) Carmel Wagenspack, Field Coordinator Pulmonary function technician Clerk TIAA FICA 25% 25% 30% 100% 100% 100% $ 4,500 5, 000 - 11, 000 7, 000 4, 000 2,460 1,091 Consumable Supplies Analyzed gases Parts for gas chromatograph Electrodes for blood gas analysis Esophogeal balloons (at $8.00 each) Chemicals, buffers, etc. Glassware and tubing Maintenance of equipment Clerical and secretarial supplies, telephone Photographic and reproduction expense 1,500 500 500 -soo 500 500 1, 500 2, 000 1,000 8, 500 Other Expense Biostatistical and computer consultations Travel and other expenses for Field Coordinator and study subjects Travel for investigators, meetings and conferences Radiologic expenses ($20 for each complete chest survey) Sub-total 1,000 3, 000 2, 000 2,000 ___________ 8, 000 51,551 Overhead Rate (45. 2% of S&W . 14, 23S Permanent Equipment Box balloon-spirometer collecting system for pulmonary diffusion measurements Jones Pulmonar Spirometers, 2 at $300 each 2,500 600 3, 100 Total $ 68,889 * The first year budget is largely devoted to the initiation of the plant study and planning for the non-industrial phase of the investigation. Future budget requirements will in addition include the cost of carrying out the community stud