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UNION CARBIDE CORPORATION old riogebury roao. oanbury. ct obbit Corporate Health, Safety and Environmental Affairs Department August 9, 1982 HCL-13 Mr. John H. Marsh Raymark Corporation 100 Oakview Drive Trumbull, Connecticut 06611 Subject: Medical Surveillance of Stratford Employees Dear John: You recently sent me a document entitled "Medical/Scientific Decision Making in Occupational Disease Compensation" by Dr. Ronald E. Gotz and asked me for some guidance concerning the type of pulmonary function tests presently carried out at Stratford. It would appear that Dr. Gotz' reference to "primitive (1940's) pulmonary function studies" and "more sophisticated studies" gives you cause to wonder whether the pulmonary function tests conducted at Stratford are adequate. Dr. Gotz* thesis deals with assessment of disability for compensation purposes and he espouses the use of a battery of lung function tests to distinguish between the diseases of smoking and those of occupational origin. The use of radiography is referred to disparagingly by Dr. Gotz indicating a lack of understanding on his part of the role which this important diagnostic technique plays in the attribution of disease to exposure. I will not dwell on this aspect of his theories but will merely point out the comments on this aspect in the recently published document "Criteria for the Diagnosis of Asbestosis and Considerations in the Attribution of Lung Cancer and Mesothelioma to Asbestos Exposure" (M.A.P. of the A.I.A. - Int. Arch. Occup Environ Health (1982) 49:357-361). You may also wish to consult the attached articles on the subject of radiographs. The presenting features of an occupational lung disease will vary with the type of dust, the length and severity of exposure and the susceptibility of the individual and may also be influenced by other factors. According to the "Report and Related Papers of a Meeting of Experts" entitled "Respiratory Function Tests in Pneumoconioses" published by the International Labor Office, Geneva (Occ. Safety and Health Series No. 6) in 1966, the following statement characterizes the diagnostic features of occupational lung disease: A 0818 1 2 "In a subject who gives a history of occupational exposure the presenting feature may be an abnormal chest radiograph, a characteristic symptomatology which usually includes a history of breathlessness, the onset of respiratory or cardiac failure or positive findings on assessment of lung function or application of clinical pathological tests. The experts also noted that pneumoconiosis may arise as a result of proximity to a source of industrial dust in subjects who have not themselves worked in the industry." The requirements for medical surveillance of a working population potentially at risk from asbestos are different from those needed to make a diagnosis incorporating an assessment of disability for purposes of compensation. As you well know from my testimony to the Congress of the United States' House of Representatives' Committee on Education and Labor, Subcommittee on Labor Standards in May 1979, I think that the British definitions of loss of faculty, disability and disablement should be adopted when deciding on compensation issues. I am attaching the relevant section of the testimony to this letter for your information (Appendix 1). The purpose of medical surveillance is to observe individuals from the earliest possible time of exposure, after establishing base-line values for certain selected parameters, and to evaluate, in the light of exposure measurements or estimates, the likelihood of an observed effect being due to the offending dust. In the evaluation many confounding variables have to be allowed for including age, sex, physique, life-style and smoking habits. If an effect is observed which is attributable to exposure, having eliminated all other causes as thoroughly as possible, then removal from exposure may be indicated even though no disability has been demonstrated in terms of loss of function. Disablement exists resulting from the presence of the observed effect even though actual loss of lung function is not yet demonstrable -- the mere knowledge of the presence on an x-ray of pleural plaques will from thence forth affect the individual's ordinary activities of life and influence mental functions (eg. depression, anxiety, etc.). In selecting the lung function tests for use in industry as opposed to those for use in a special pulmonary function laboratory, certain criteria need to be considered. Once again let me draw upon the ILO Report referred to above by attaching pages 4, 5 and 6 for your information. (Appendix 11) Severe forms of asbestosis are seldom seen these days because of steadily improving conditions in industry, and the major concerns with regard to asbestos exposure center on the uncertainties surrounding the dose-response effects at low levels of exposure for varying periods of time. I doubt whether lung function tests are of much importance in this regard. Since asbestosis and lung cancer often occur together in the same person, the appearance of lung function changes in a person under surveillance, in conjunction with other criteria already mentioned, obviously help .to identify a case with a potentially greater risk of lung cancer or mesothelioma attached to it. 3 I believe that W. Raymond Parkes in his magnificent book "Occupational Lung Disorders" (Butterworths, 1982) adequately summarizes the "Influence of Smoking on Lung Function". I am unaware of any specific tests which will distinguish smokers from non-smokers, asbestos workers from smokers, etc. The only value of lung function tests in diagnosis is to confirm other findings. It is essential to obtain a detailed occupational exposure history, an accurate smoking history and adequately physically examine each and every case. When the x-ray has been assessed and the other features reviewed, then diagnosis can be aided by interpretation of the lung function tests. Where symptoms are few or physical findings are minimal, a battery of tests such as those suggested by Dr. Gotz may have to be employed to detect an effect of either asbestos exposure or smoking. Even the use of the most sophisticated techniques will not enable the physician to decide in the absence of a history of exposure to asbestos or tobacco smoke. The tests done at Stratford are by no means primitive. They may be simple and relatively mundane in comparison with the capabilities of a modern hospital laboratory, but they measure the essential criteria needed to keep a population exposed to ever decreasing levels of asbestos under surveillance. It is some time since I visited the plant and since leaving Raybestos (sorry Raymark) I have not been kept informed of the tests in use. I seem to recollect that shortly before I left the tests were being done by ETRA in the mobile van with computerized equipment capable of measuring not only FEV, and FVC but also producing a flow-volume curve and a print-out interpreting the findings. Provided the physicians examining the employees are capable of interpreting the tracing produced and do not rely entirely on the print-out (which has no knowledge of exposure of smoking history), then I can see no reason to question the present set-up. The only improvement I can suggest is for each and every test to be evaluated by a pulmonary physiologist taking into account the occupational history, smoking habits and findings on examination of the employee, such as is done at Manheim. I hope I have answered your question. I think Dr. Gotz has prepared an excellent document, although he obviously still needs more experience of the real world in occupational medicine. Please don't confuse medical surveillance of workers with medical diagnosis of compensation claimants; the needs are different. "In particular, care should be taken before drawing conclusions from subjects applying for compensation since such a group inevitably includes .an unduly large proportion of those with respiratory impairment. A working population may also be misleading in some circumstances since it will not include those subjects who have left on account of illness." (ILO Report 1966). The latter is known as the "healthy worker effect." The final attachment to this letter is a paper which has been accepted for publication by "Connecticut Medicine" and will appear in the Fall. It is for your information only and not to be quoted from until after publication when I will send you a reprint. Kind regards. Yours sincerely, HCL:jsh cc: Mr. Robert B. Sims Hilton C. Lewinsohn 45/6t uO Enclosure Appendix I and II attached Criteria for the Diagnosis of Asbestosis and Considerations in the Attribution of Lung Cancer and Mesothelioma to Asbestos Exposure Prepared by the Medical Advisory Panel to the Asbestos International Association Int. Arch. Occup Environ Health (1982) 49:357-361) Development of radiological and clinical evidence of parenchymal fibrosis in men with non-malignant asbestos-related pleural lesions From the Medical Research Unit, HM Naval Base, Devonport PLI4RU, UK British Journal of Industrial Medicine 1982;39:54-59 Comparison of independent randomised reading of radiographs with direct progression scoring for assessing change in asbestos-related pulmonary and pleural lesions From the Medical Research Unit, HM Naval Base, Devonport PLI4RU.UK British Journal of Industrial Medicine 1982:39:60-61 The Medical Surveillance of Persons Exposed to Asbestos Publications-Pending File Hilton C. Lewinsohn, M.B. A. C. Assessment of Disability and Bill H. R. 2740 1. As a result of my experience as a Pneumoconiosis Medical Office in the United Kingdom, I have come to abide by certain defin itions of loss of faculty, disability and disablement which are as follows: Loss of faculty means the total or partial loss of the normal use of organs or parts of the body, or the distruction or im pairment of physical or mental functions, (e.g. the power to grip, to walk, to remember, to digest, to hear or to ventilate the lungs). Disability denotes the specific loss of capacity for any of the ordinary activities of life imposed by the loss of faculty (thus the loss or impairment of the power to grip may involve the inability to hold a tool or operate a machine or play base ball) . m Disablement is used to denote the total of the disabilities, that is, the aggregate loss of health, strength and power to enjoy life, and it is on the assessment of this disablement tha the level of compensation will be determined. Thus, exposure to asbestos results in asbestosis which may lead to loss of faculty (e.g. breathlessness on effort) and this imposes various disabilities for work or play (e.g. inability to walk distances or run) which together make up the disablemen resulting from the dust exposure. With regard to the Bill itself, I believe that the cause is just, but certain aspects are overstated and vlll liberalize the dispensation of compensation to include possibly non-occupational illnesses. Should industry or the state compensate persons for the life-style they choose and for their life-habits, such as cigarette smoking? Should not such individuals vho multiply the risks involved be asked to ontribute towards the costs of the Insurance with which this Bill proposes to provide them? 'Affected person' is too broadly defined in Sec. 102(b) and should only include the reference to occupational exposure. Panels of medical experts should be established to examine claimants or death claims, similar to the British Pneumoconiosis Medical Panels. Although a physician may be Board Certified or Board eligible in the fields stated, such a physician may have no special Imowledge of occupational lung disease in general or asbestos-related diseases in particular. Unless an expert panel of medical experts is established for the purpose of administration of this act, many unwarranted claims will be incorrectly decided, and, perhaps, some justified claims may even be dismissed. I would recommend that the Secretary be empowered to appoint physicians competent to decide on the medical facts presented to them and to aportion the percentage of disablement assessed. Only reports on radiographs prepared by a panel of three NIOSH "B" readers should be accepted in evidence and strict criteria should be adeopted for interpretation of radiographic findings based upon internationally accepted standards. Each and every claim should be decided by the physicians who should reach agreement before recommending compensation or rejecting the claim. If it is not possible for them to agree, the claim should be referred to a referee appointed by the Secretary vfaose decision vill be final. This concludes my statement. Thank you for inviting me to attend these hearings. I trust that my contribution vill be of value to this Subcommittee in its further deliberations. -u- lung expansion (restrictive syndrome). The latter change may be due to the presence of a space occupying lesion, for example progressive fibrosis or a diffuse infiltrative lesion or diffuse fibrosis. 12. Impairment of the process of gas exchange when it occurs may be the result of abnormal distribution of pulmonary ventilation and perfusion or to loss of alveolar surface and pulmonary vessels for the transfer of gases in the lung. These changes may be the result of diffuse tissue destruction in emphysema, diffuse infiltration in pulmonary fibrosis or a space occupying lesion. The conditions ere usually associated with characteristic changes in lung function including the occurrence of increased ventilation and arterial blood gas abnormalities on standard exercise. SECTION II Review of Respiratory Function Tests Brief Description of Lung Function 13. The lungs are the organs of gas exchange where the body absorbs oxygen from the air and gives off excess carbon dioxide. Through the latter function, the lungs contribute to the maintenance of the acid base balance of the body; they also supply air for phonation and other purposes. The function of the lungs depends on their structure, on the integrity of the chest wall and on the mechanisms which regulate movement of the respiratory muscles and distribution of blood and gas at the level of the alveoli and alveolar capillaries. 14. For convenience of assessment the function of the lungs may be divided into the ventilatory function, the gas exchange function and lung perfusion. These in turn may be subdivided into a number of components. The components which Influence the ventilatory function Include the size of the lungs (lung volumes), their distensibility (compliance) and the calibre of the airways (airway resist ance) ; these components together with the properties of the chest wall largely determine the ventilatory capacity. 13* Under the heading of gas exchange the major components of function Include the distribution of gas and blood to the different parts of the lungs (mixing indices and ventilation perfusion relationships) and the capacity to transfer gas across the alveolar capillary membrane (transfer factor or diffusing capacity). These components contribute to the gaseous composition of the arterial blood (blood gases) and hence to the drive to respiration from the respiratory centres in the brain. Disturbances of any aspect of lung function may give rise to breathlessness on exertion through an effect on the ventilatory capacity or the processes of gas exchange or the regulation of respiration. The ways in which these factors are inter-related are illustrated schematically in fig. 1. Lung function tests may be used to assess the integrity of any of the components or of the over-all function. Criteria for the Choice of Tests of Lung Function 16. The following considerations need to be borne in mind: 17. Acceptability. The test should be safe and simple for the subject; the latter criterion may require extensive instrumentation. Where the procedure is to some extent unpleasant the operator should be satisfied that it is really necessary and explain this in detail to the subject. 18. Objectivity. So far as possible the Information which is obtained should be independent of the instruments used to make the measurement, the motiva tion of the subject and the personality of the operator. 19. Reproducibility. The measurement should have, on the same subject, a variability within and between days which is small in relation to its absolute magnitude (the coefficient of variation in normal subjects preferably below 10 per cent.). 20. Discrimination. The test should nrovide useful Information. To this cc . *he course of a particular disease. The variability of the test should nt be so large as to interfere with the interpretation of the result. For this be possible the index should be reproducible and its variability from one ormal ub3ect t0 another should be small in relation to the differences between omal a^ grossly abnormal subjects. Fig. 1 Lung Functions 6 21. Technical Considerations Reliability the equipment should preferably be rugged, portable and easy to maintain and operate. Ease of calibration this should be based on some physical or chemical property which is described in absolute units and is not influenced by interaction with the subject. The procedure should be simple and preferably use materials which are available in most laboratories. Output of data this should preferably be in the form in which the data are to be used. For some applications an instrument providing a chart record is to be recommended and for others a direct reading instru ment. In either case the operator should introduce appropriate correction factors before reporting the results. Luna Volumes 22. The volume of gas in the lungs at different stages of lung expansion aiay be described in terms of a number of indices of which the following are recommended for routine use (see fig. 2 and, in Appendix, the nomenclatures used in various countries). Total lung capacity (T.L.C.): the volume of gas contained in the lungs at the end of a full inspiration. Residual volume (R.V.): the volume of gas remaining in the lungs at the end of a sustained maximal expiration. Fig. 2 Spirogram Labelled to Show the Subdivisions of the Total Capacity lOO OAKVIEW DRIVE. TRUMBULL CONNECTICUT 06611 (203) 371-0101 July 28, 1982 Hilton C. Lewinsohn, M.B., B.Ch., D.I.H. Union Carbide Corporation Old Ridgebury Rd. Danbury, CT 06817 Dear Hilton: I am enclosing a document titled "Medical/Scientific Decision Making in Occupational Disease Compensation" by Dr. Ronald E. Gots. I met Dr. Gots earlier this year when he testified at hearings on the proposed Miller Bill for asbestos-related disease. We've had a number of meetings since and he has visited Trumbull to discusss Stratford workers' compensation claims with Bob Sims, Don Brodasky, Bill Ambrose, A1 Moquet and myself. I thought you would find the enclosed paper interesting and might also be able to provide me with some guidance concerning the type of pulmonary function tests presently carried out at Stratford. Please note the first paragraph on page 16 which refers to "primative (1940's) preliminary function studies" and three, lines below, "more sophisticated studies...". I would appreciate it if you could tell me if the tests conducted at Stratford are of the more sophisticated variety which can accurately distinguish between the diseases of smoking and those of occupational ori gin. Best of luck in your new position. Sincerely am Enclosures cc: Mr. Donald Brodasky Mr. W. W. Cloyd R. B. Sims, Esq. John H. Marsh Director Environmental & Government Affairs National WA^NGlONOffCE RonodE Gots.MD.PUD Bartxra A.Gois,MD Arttvr Kaufman, MB BtCKwoaMSPK oorsjtant MONTEREY OFRCE EartJ.Kob.MD. 7315 Wisconsin Avenue Washington. DC 20014 (301) 656-8030 MEDICAL/SCIENTIFIC DECISION-MAKING IN OCCUPATIONAL DISEASE COMPENSATION ANALYTICAL SYSTEM OPERATIONAL APPROACH PRESENTED TO CRUM & FORSTER CORP. NOVEMBER 1,1981 RONALD E. GOTS M.D.,Ph.D. NATIONAL MEDICAL ADVISORY SERVICE BETHESDA, MARYLAND An v/'V6 JQ~> (301) 656-8030 r r MEDICAL/SCIENTIFIC EECIS ION-MAKING IN OCCUPATIONAL DISEASE COMPENSATION Contents , I. Introduction............................................................................... 1 II. Current Decision-Making: Inherent Flaws.,...................... 4 1 III. A New Approach to Decision-Making in Occupational Disease Ccmpensaticn................................................................. 7 p IV. Organizational Approach............................................................23 V. Sunmary.......................................... 34 Appendixes Appendix A: A Model For Diagnostic Decision-Making in Occupational Pulmonary Diseases............................... 36 Tables and Figures Figure I: Analytical Considerations in Causation Analysis... 22 Figure II: Organizational Approach to Occupational Disease Decis4on-Making............................................................... 30 Table 1: Interstitial Lung Diseases of Known Etiology............37 Table 2: Representative pulmonary function studies used 'to: 1) assess extent of disease; and 2) differentiate between snoking-related and inorganic dust diseases (occupational)..................... 40 J National 0 /VtedicaMdvisory Service me WASHNGTON OFRCE Rondd E Gols. MD. PhD Bartxxa A.Gols.MD Artixr Kaijfmar\MD B. K. KwOh MiPrt consJtant MONIBSYOFRCE EarlJ Kofc.MD. 7315 Wisconsin Avenue Washington. DC 20014 r I. Introduction (301) 656-8030 r Americans believe, that occupational exposures are a more important cause of lung cancers than is smoking cigarettes. The man cn the street knows that "stress" is a significant cause of illness of all types, witness the recent coverage of the air traffic controllers' allegations of job-related stress. Toxic shock syndrcme? A deadly disease caused fcy tampons. Love Caned? A chemical' dunp'site that has sickened nearby residents. Agent orange? A toxic defoliant which contaminated American soldiers in Vietnam causing everything from sterility to cancer. What do these popular notions have in ocrron? First, they are either untrue or unproven. We know far more about lung cancer and smoking cigarettes than we do abcut lung cancer due to occupational exposures. Stress and disease is a popular notion with weak scientific documentation, except in -die case of certain psychiatric illnesses. Toxic shock syndrome, while associated with tampons, has been with us for years and was first identified and named in children. Despite numerous epidemiological surveys, no adverse health effects have been uncovered in the Love Canal evacuees. Few, if any, ailments have been linked to agent orange exposure despite exhaustive epidemiological studies. These examples are not all occupational diseases, but they are illustrative of a phenomenon which pervades the occupational disease compensation system--the power of the media and other sources of false or poorly-documented information to create public mispercep tions about causes of ill health. < *1 National /VledicaMdvisory Service re___ Page 2 Ask the man cn the street to define an occupational disease and he'll reply, "Sinple. It's when you get sick fran sanething at work.'' Ask the industrial board cciuuissioner (as I have). He'll tell you that nobody knows; otherwise he wouldn't have differing opinions fran two doctors as he always does. Ask two physicians about many oaition diseases: you'll get two different answers; rarely with ary substan tive support. What about compensation? Employees vho "know" that they are sick fran their jobs carplain that the companies fight their claims: this supposedly non-adversarial process is too costly, too slow, unjust and adversarial. Employers and insurers offer the same complaints, but their orientation is reversed: too many of the claims are not workrelated they say. Industrial board ccmnissioners fret over conflicting testimony. Awards are made in aie case; vhile an identical claim is denied. Why? Because, in one case, the claimant's evidence was better presented; in the other, the defendant's. These observations point out the complexities and inequities of the occupational disease compensation system. The reasons for those inequities are the lack of guidelines upon vhich to make fair and uniform decisions and the narked disparity between public and cornon medical perceptions of what constitute occupational diseases and the medical /scientific data bases Which are available to provide the most rational answers. Occupational disease can no longer be left to case-by-case decisicn-making. The issues are too carplex; scientific data, vhile often available, is rarely^brought into the decisicn-making process; the perceptions of both petitioners and arbiters are frequently far removed from state-of-the-art knowledge. National /MedicaMdvisory Service nc___ Page 3 If changes are not made now, the future is even bleaker. The explosion of popular health information--correct or erroneous--will move asynchronously with expanding scientific knowledge about the true health effects of the. workplace. Good data will be mixed with bad. Industrial boards will be influenced by media exposes. The dearth of interested, knowledgeable scientists will leave the industrial boards with gut feelings and conflicting testimony from practitioners who are not conversant with modem occupational medicine data. We can anticipate, therefore, that the rtmtoer of occupational disease claims will grew; while the discriminatory resources of the decision-makers fails to keep pace. Decisions will be more arbitrary, less factually based, more inequitable (either to enplcyer or erployee, depending upon the case) and less uniform. Adoption by the states of the so-called "disability evaluation units" is a partied answer. Therein lies the final pathway for ajudication of occupational disease claims. But sinply recommending a new component of the bureaucracy without providing relevant guidelines for its decision-rreking is passing the buck. It can only lead to such interstate variability that the hue and cry far federal intervention will once again be heard. Medical determinations in occupational disease oerpensation are, admittedly, no - simple matter. The morass of cumulative illnesses, latency and an expanding data base, both lay and scientific, inter twines hazards, organ systems and specific diseases in a seemingly unentanglable web. It is little wonder that most authorities in this field would rather leave specific cause and effect decision-making to someone else. As a physician and scientist concerned, not so nuch with the legal and policy components of the occupational disease carpensaticn system, as with the incorporation of rational scientific data into /WedicaMdvisory Service re___ Page 4 decision-making, I shall take a different approach. My goal is to propose a system whereby occupational diseases can be catalogued and categorized and universally-applicable determinations of ocmpensability can be made. The prime coordinators of this system nust (we shall see why later) be a scientific .advisory ccrmittee, whose recaimendations and criteria can be disseminated to die states. The specific criteria for compensability will, a&nittedly, be of variable arbitrariness depending upon the strength of the scientific data balanced against agreed upon public policy considerations. But sane arbitrariness to maintain overall equity, to minimzie litigation, to expedite rulings seems to be a fair trade-off, as long as employers end enplyees share equally in the fruits or the consequences of those policies. Compromise for the overall good is, after all, the nature of the ccnpensaticn system and of our democratic society. II. Current Decision-Making; Inherent Flaws A. A Need for Uniformity We need cnly survey the various states' approaches to occupational diseases`to' recognize the confusion that exists in the very definition Of that which they are compensating and the urgent need for rational change. Exclusionary schedules in sane states? varying decisions about "cumulative illness"; apportionment versus presumption; statutes of limitations following exposure; and the carmen ill-defined test of "arising out of and in the aourse of employment," demonstrate the lack of consensus or systematic approaches to this problem. Medical decision-making rust be overhauled with rules and systems that are sufficiently data-based, reasonable and fair to all, that all states can eperate under their untorella. After all, an occupational National /VIedicaMdvisory Service nc.__________________________________________________________________ Page 5 lung disease is no different in Colorado than in Louisiana; latencies of cancers axe the same in New York and California. The canpositicn of various constituencies and politics will, of course, require negotia tion and modification of initial models, but models can be developed and the necessity of adopting standarized models can be convincingly argued. Decision-making currently takes the form of sane admixture of statutory mandates and industrial coimissicn discreticn in most states. Statutes of limitations may be an exclusion to recovery, but when the exposure began may be arguable. Exclusionary schedules may be highly restrictive, but in sane cases they have been circumvented by successfully arguing that an illness actually arose fran a series of accidents, rather than fran a chronic exposure. lb any physician/scientist who has a knowledge of both the occupational disease literature and the pragmatic world of compensation, the irrationality of the state systems is striking. Ihat irrationality pervades both the statutory provisions and the compensation board decisions. B. Unreasonable Statutory Provisions Statutes barring recovery following a defined period after exposure are archaic`and unfair. Too many long-latency occupational diseases are wfell-established. Fixed schedules are irrational. Schedules, as guides, may be reasonable, but they cannot be exclusion ary. The knowledge base is too fluid and rapidly changing to justify rigid schedules. Gy the same token, heart disease schedules for certain occupational groups, such as policemen and firemen, are political, not medical decisions. For the most part they make little sense medically. National /VIedicaMdvisory Service re___ Page 6 r C. Medical Opinions and Industrial Boards: Poor Guidance; Poor Decisions r Decision-making by the industrial boards is similarly r fraught with imprecision and inequity. Contested occupational disease cases farexceed in percentage the contested occupational injury cases. Understandably so. Occupational diseases are more mysterious and the links to the workplace rore uncertain. Cases are adjudicated by non medical individuals. Ib make their decisions they utilize testimony, \ written or live, of physicians. Most often the claimant's treating physician supports the claimant's position: a'defense witness opines the opposing view. The problems with this process are numerous. First of all, an adversarial approach is introduced into a supposedly non-adversarial system. Secondly, the vast majority of clinicians are unqualified to effectively assist the industrial boards in data-based decision-raking. Fhysicians have become arbiters of medical and legal causation, not out of choice, training or expertise, but by default. In sane cases vhen they have a special interest, specialized expertise, knowledge and the time to delve into occupational causes of disease, they can be effec tive arbiters. In nost cases, however, those necessary characteristics are missing. And, as more occupational diseases are alleged, the qualified physician pool won't begin to keep pace. Unfortunately, the industrial boards, having little independent medical knowledge, have no way of distinguishing strongly fact-based opinions from pure guesses. I have reviewed numerous occupational disease claims in vhich the treating physician made diagnoses or drew connections to workplace exposures Which were unequivocally erroneous. CP S O OP 1 National /MedicaMdvisory Service nc___ Page 7 Here are a few examples. An award was given to a plumber, who had a peripheral neuropathy, for the diagnosis of occupationallycontracted lead poisoning. His clinical evalution was ocrrpleted and demonstrated that this man did not have lead poisoning. His carpensation (later rescinded) was predicated upcn a false diagnosis by the treating physician. When a patient complained of difficulty breathing following exposure to fumes at work, the patient's attribution became the diagnosis. "Obstructive lung disease fran exposure to industrial chemicals" wrote her internist who, incidentally, was a specialist in pulmonary medicine. In fact, this chemical cannot and did not produce her problem, which was actually childhood asthma complicated by cigarette smoking. When questioned by a well-prepared defense attorney, the physician admitted that he didn't know what chemical she had breathed or anything about its physical, chemical or toxicological properties. His attribution was a direct restatement of the claimant's opinion. Unfortunately, these situations are exceedingly cannon. More often than not, testifying physicians know little about the exposure-disease relationships which they make. Ergo, we have lay decision-makers basing their decisions upcn unsubstantiated opinions. n How can this possibly result in equity? III. A New Approach to Decision-making in Occupational Disease Compensation A. Introduction A uniform approach to decision-Treking regarding medical causaticn and disability involves two components. Fli'fet, we must determine what considerations imst underlie any guidelines for a National /WedicaMdvisory Service me________________________________________________________________________ Page 8 uniform system. Second, we most establish an organizational construct to create and administer those guidelines. I shall, in this and the next section, present an approach to both of these tasks. I will not attempt to catalogue all occupational illnesses or to formulate a complete program. That requires both time and a wide range of medical and scientific disciplines. goal is to present a conceptual approach vhich can serve as an organizational model. B. Causation Analysis: An Overview First, how do we decide whom to compensate? All occupa tional diseases may be considered under vhat I will call the "candoes-did" triad. Can the alleged offender* cause the claimed disorder? Does the claimant have vhat he car she claims he or she does? Did the alleged offender cause this claimant's illness? This reductionist approach may, at first, seem an oversamplification. In feet, this kind of overview is necessary to bring sane order into the chaos vhich now plagues the system. By breaking our decision tree into these three components we accomplish several things. First, whether normally articulated car not, each of these components is an"essential element. Together they complete the entire medical causation decision nexus in any occupational disease claim. Once those questions are answered, we know whether or not the claimant *1 shall case the term "offender" to refer to any alleged cause of an occupational disease. This is more general than the usual term "exposure" for it includes such factors as stress and others that are yet to be suggested. ^ to National vVIedicaMdvisory Service nc___ f Page 9 has a medically-justified ocnpensable illness. Those elements are used row, but often without the adjudicators realizing it and without a r cohesive framework. r Secondly, each element of this decision triad is satisfied using different criteria. Thus, each has its unique scientific requirements and strategy. r Third, within each group (can, does, did) certain operational rules can be established vhich will be applicable to most existing occupational diseases and adaptable to any newoaners. In a ircmerrt, I shall discuss each of these elements. First,'as a preface, the reader mast understand vhy data-bases (particularly those fran regulatory agencies) are not directly applicable to workers' compensa tion. Ttoo frequently they do guide compensation decisions, although they were never designed to do so. C. Regulatory and Safety Data versus Compensation Data L A great deal of argument about cause and effect relation Li ships canes, rot from the perspective of compensation, but from the perspective of prevention. There, eminent scientists regularly, I vigorously and reasonably .disagree about vhat data should be accepted L as indicative of a potential human health hazard. There the arguments are quite valid, for even a potential carcinogen should be, in sane L way, controlled. How rtuch and at vhat cost, are the questions. Scientists erbroiled in these debates have not, however, been brought into any discussion of compensability. Yet, their arguments and their data oonceming prevention have been taken out of context and injected by plaintiff counsel and seme physicians into ccrpensaticn decision making. 1 T* O CP to c? TO National /Medical Advisory Service nc___ Page 10 The fact is that decisions about compensability--the Can's--are sanewhat easier and more restrictive than are decisions about risk management, both of vhich utilize the same data. Risk management demands that even circumstantial evidence be considered for, the argument goes, we cannot afford to wait or to take chances with human life. Canpensability, cn the other hand, askss "Is our knowledge about a cause and effect relationship sufficiently strong to assume that an offender can cause the harm alleged in this individual?" Even the most ardent of regulators--from the past ten years of NIOSH, far example--must see the difference. Protection and carpensation ask different questions and expect different degrees of proof. A caitnai expression among Washington regulators vhich illustrates this dichotomy is, "Just because science doesn't have all the answers, the safety of Americans can't wait." The validity of that statsnent and the extremes of protection vhich should follow can be argued. What cannot be argued is that such a statement is a risk prevention statement not a compensation statement. Paraphrased, it says, "Protect if an agent is possibly harmful." It does not say, "Pay if an agent is possibly harmful." Most science is directed towards prevention, as it should be. But it has been drastically distorted and misutilized as the "science" of canpensability. That nust be changed. D. Causation Analysis - Can? What we are asking with this question is Whether we have sufficient data of sufficient quality to link an occupational offender or a particular occupation (the specific offender may be unknown) to a particular disease? Here popular perceptions are separated fran scientific realities. It is also the question vhich separates good science frar. bad? conclusive data fran inconclusive? bacterial and animal studies fran human studies. q 00 ro National AledicaMdvisory Service inc___ Page 11 Whether or not an occupational offender can produce a given disorder cannot invariably be answered conclusively. What can be determined, however, is the quality of our information and, therefore, the weight of the evidence. A panel of respected scientists fran the appropriate disciplines, such as epidemiology, toxicology, chemical carcinogenesis (for cancer issues), pulmonary medicine (for lung diseases), and others (the precise composition of the group will be discussed in more detail later) can reach a concensus. The first question encompasses vhat type of data, vhat amount of data and vhat quality of data is necessary in order to develop cause and effect inferences. The strength of the data would then determine far us a probability factor--the degree to which a probable cause and effect las been established by current weight of evidence. This could be expressed in a number of ways. A scale of one to cne hundred is cne possibility, but this nay be suggesting scmewhat greater precision than actually exists. Another, perhaps more practical, delineation is by several cause and effect categories: a) clearly established in human beings; b) probable in human beings; c) 50-50; d) possible; e) unidentified. It is even possible to assign weights, in terms of quality, to given scientific articles and, thereby, canputerize this decision tree. What needs be decided by the panel of experts is vhat type of articles, in vhat journals, of vhat quality will be given vhat weight. Once that is done, most of the weighing could be carried out by a team of masters-degree level literature reviewers. This could be done cxi an ongoing basis with regular ipdates as new data develops. The model would have to be tested far several dozen diseases and exposures of various types--malignancies, pulmonary diseases, stress-related diseases, etc. ' I> C CD ro o -p- National /VledicaMdvisory Service nc___ Page 12 This process ray sound unrealistic and inpossible, but it is a workable approach. Moreover, a concensus and guidelines could be concluded relatively promptly with substantially fewer professional hours and debate than would accrue fran the aggragate of 50 individual state carmittees; and time, expenses and headaches orders of magnitude less than individual case-by-case decision-making. Finally, it is, ultimately, bound to be .fairer and more uniform than the current flipping of coins or arbitrary statutes. There will clearly be sane arguing over fine points, but there are certain fundamental truths in science vhich serve as the foundation. Inferences about the relationship between causal factors and human disease are the result of a composite of laboratory and human data. Animal (and in sane cases bacteriological) data provides preliminary inferences. Human epidemiological data, particularly high quality studies, such as randomized, controlled, prospective studies or observational cohort studies and, last, and least effective (caimonly used studies today), the case controlled studies are essential. When statistical correlations are very strong and compounding variables well-controlled, we lave the best human evidence. While statisticians and epidemiologists ray disagree about the believability of a given study, most will acknowledge vhich types of studies are best and What kinds of statistical correlations provide the best assurance of a cause and effect relationship. Let us consider a few examples of our "can" decision-making. At the "clearly-established" extreme, we have most acute poisonings associated with toxic chemicals. Heavy exposures to many organic compounds, metals, gaseous fumes, irritating chemicals can, unequivocally, produce a variety of ailments specific to each of the offenders. Organ systems affected may include the skin, central nervous system, liver, cardiovascular system, respiratory, kidney and others. Thus, one can develcp a long list of acute effects of various National /VledicaMdvisory Service nc_____________________________________________________ _______ Page 13 occupational exposures. This can be done simply and inexpensively using widely available occupational medicine guidelines. If a worker claims such an injury, the "can" is affirmatives this offender can cause acute poisonings. Che must then answer, far that individual, the "does" and "did" questions, to be discussed shortly. Certain chronic-diseases, including sane malignancies, have equally strong scientific ties to industrial exposures. The pneumocconioses such as asbestosis and silicosis are examples. Hemangiosarcomas in vinyl chloride workers, mesothelianas in asbestos workers, bladder cancers related to a variety of organic chemicals, and leukemias following benzene exposure are sane examples of malignancies which have been strongly associated by well-controlled human studies to the workplace. Importantly, the strength of those associations has cane, not primarily from animal data, but from human.studies. In fact, seme known hunan carcinogens have no corresponding animal model. At the other extreme are those diseases vhich have been linked to the workplace more by a aarbination of popular media science, union pressures, the plaintiff bar and an admixture of input by social scientists, psychologists and others whose training in disease mechanisms and controlled research techniques is, at best, variable. Notable in this category are many of the relationships between "stress" and a host of organ system malfunctions; heart disease and the working environment; and certain other cumulative breakdowns of the human machine. Far the most part, with certain individual exceptions (predi cated upon quality experimental data), these are not of sufficient "can" status to even consider carpensability; yet, catpensaticn for many of those ills is and has been awarded. The same is true (for reasons enumerated in Section III. C.) of many wrongly accepted occupational cancers. The NIOSH list of potential carcinogens is not and cannot be accepted as the guidepost for caipensability. For many of those agents the evidence is too weaj^ /9C. non-existent in human National AledicaMdvisory Service he_______________________________________________ ____________________ Page 14 beings. The "can" question is answered: "unknown based vpon current data;" therefore, a malignancy in a worker exposed to that agent is not oairpensable. Somewhere in the middle are illnesses in vhich the weight of evidence leaves us with uncertainties. Whether an animal carcinogen vhich has, in cne epidemiological study, produced a twofold increased risk of a specific human cancer can cause cancer in humans falls in the area of scientific judgment. There, the pre-established criteria for acceptance or denied of the relative probability of a relationship will be critical. As mentioned earlier, that decision-making'process could be computerized by assigning relative weights to the various data followed by a probability analysis. Finally, whether or not those diseases are potentially compensable will be a function of the input from scientists acmbined with public policy decisions. Scientists can tell the decision-makers hew strong our understanding of a cause and effect relationship is today. Ftolicyirekers, insurers, union represen tatives and others must agree upon the cut-off points for compen sability. In sunmary, the can question involves two categories of determinations. In the first, the answer is unequivocally "yes": no debate is required. Acute -poisonings, chronic poisonings, occupational pulmonary diseases, etc., are examples. The second are more challenging: the data is uncertain, equivocal, variable in quantity cr quality, subject to differing interpretation. Mary of the "occupa tional" cancers, aplastic anemias, chronic liver diseases, psychiatric disorders, and stress and its effect on multiple organ systems exemplify this group. Cur initial approach to these problems does not plunge us into the specific literature of any given ailment or cause. Instead, the initial approach should be to reach a concensus about how various kinds of data (regardless of the specific issue) will be weighted. Although 9cme modification will be nneecceessitated by specific AQ8207 National /MedicaMdvisory Service nc______ ------------------------------------------------------------------------------------------------ Page 15 exigencies, this approach will provide a broadly applicable groundwork for decision-making. Furthermore, it will reduce markedly the time and disputes which vrould accrue if each condition were attacked fran the outset. It sets the stage for manageable decision-making. E. Causation Analysis: Does Once we have answered the first question affirmatively and determined that an offender can produce a claimed disorder, the second question asked is "does." Does the claimant have vhat he/she claims? This is not a trivial question, for misdiagnoses and rash assumptions that the claimant has an occupational disease are extremely cannon. A pathologist may misinterpret biopsy or autopsy specimens calling a benign bladder tumor a ralignancy. A clinician ray diagnose nultiple sclerosis as manganese toxicity. An internist ray call an idiopathic neuropathy, lead poisoning; or a viral hepatitis, carbon tetrachloride poisoning; or glanerulosclerosis, pesticide poisoning of the kidneys; or chronic_asthra and bronchitis, asbestosis. All of these and many more represent actual cases vhich we have reviewed. Thus, we must recognize, for reasons described earlier, that occupational diseases are fraught with the potential for diagnostic error. S This said, t is. apparent that the "does" question requires establishing diagnostic criteria. This is probably the easiest job of the scientific advisory ccrmittee, since diagnostic criteria for most of these diseases are available and are widely accepted, even if, in practice, physicians foil to consult them. The final adjudicators of compensability must be made aware of this gap in general medical knowledge and nust demand that certain diagnostic tests be performed and that specific abnormalities must be identified before compen sability can be determined. A8208 National /Vledical Advisory Service me___ Page 16 In the cases mentioned previously, diagnostic criteria were often not relied upon. Diseases were ccrrpensated despite anple evidence that the claimant did not meet the criteria for the claimed disorder. In one class of ailments--the occupational lung diseases, particularly asbestosis and silicosis--highly_ variable diagnostic criteria have been put forth and accepted by courts and industrial boards. In many cases, chest x-rays and primitive (1940's) pulmonary functicn studies are used to establish the existence of interstitial fibrotic lung diseases (those frem inorganic dusts, such as silicosis, asbestosis, and many others) in exposed workers. More sophisticated studies vhich can accurately distinguish diseases of smoking (chronic bronchitis and emphysema) fron those occupational lung diseases are either ignored or explained away. The result is that the number of workers claiming asbestosis, etc., far exceeds the number with measurable disease. It happens that pulmonary diseases are strikingly amenable to objective, numerical measurenents to determine impairment, diagnosis and apportionment of relative contributing factors--particularly smoking versus inorganic dusts. Thus, they offer an opportunity to establish a computerized test model. A computer program can be developed by entering normal data and varient data with appropriate descriptors indicating vhich patho logical processes give rise to vhich numerically-rated pulmonary function abnormalities. Once programming is completed, one can introduce the data of any claimant and get an instantaneous response. This would tell us: 1) the degree of impairment? and 2) vhether this was predominantly a fibrotic or obstructive lung disease--i.e., related to an inorganic dust exposure or smoking cigarettes. A *20 d /VledicaMdvisory Service nc___ Page 17 At the farthest extremes, we could tell whether the claimant's ailments were almost exclusively smoking-related or f occupationally related. In between, there would be mixed pictures (a combination of causes), but the relative contributors would be quantified. This would permit the application of compensation, based upon either apportionment or full compensation, beyond a given threshold--a policy decision. But now, instead of being arbitrary and contested from case-to-case, determination of compensability would be immediate. The claimant ^s_ computer readout matched with the apportionment or threshold schedule and the impairment schedule would determine compensability and the disability rating. Apportionment is an inevitable outgrowth of the "does" question. In certain situations, i.e., the lung diseases described above, one can reasonably and rationally apportion relative^contribu tions of various etiologic factors--sane occupational, seme not--to a claimant's disorder. The scientific advisory panel can provide that input when it is determinable and applicable. Whether compensation should be apportioned, predetermined or whether a threshold of fractional contribution should trigger full compensation is a policy decision rather than a medical one. A model for"cne such decision system--occupational pulmonary diseases--is presented in Appendix A. F. Causation Analysis: Did? Once we have determined that an occupational offender can cause a claimed disorder and that the claimant does, indeed, have the disorder, we are faced with a final medical/scientific decision. Was it the cause in this case? In many instances, the answer will be clear-cut. An asbestos worker who has asbestosis got it from his job. National /VledicaMdvisory Service nc Page 18 A solderer vho has lead poisoning has an occupational disease. A heavily exposed Naphthylamine worker with bladder cancer has an occupational disease. Note in the last exanple I add, "heavily exposed," for now we get into a new area of decision-making. Many occupational diseases have multiple possible etiologies. The "can" and "does" questions may be answered affirmatively, but the "did" in this particular individual may be uncertain. Take, for exanple, asbestos and lung cancer. Most authorities report a tenfold increase in bronchogenic carcinoma in asbestos workers vho ad so stroke cigarettes. At one extreme, we nay have a heavy smoker vho worked in a shipyard far fifteen years. Twenty years later, he develops bronchogenic carcinoma. Because of the known additive risk factor, one could hardly argue that the asbestos exposure was not a probable significant contributor in his case. On the other hand, vhat about the same disease in an individual with the same smoking history vho worked for two weeks in a shipyard. Was his errployment a probable risk factor, or, more specifically, a probable significant contributor in his case? Probably not. Another exanple is hesnangiosarcciTB of the liver and vinyl chloride exposure. Vinyl chloride is a known cause of this disease. So, too, are thoracotrast (a radiological contrast media used in the 1940's), arsenic, and asbestos. Furthermore', large groups have no known exposure etiology. Thus, a trivial exposure to vinyl chloride (widely and falsely touted as the sole cause of this malignancy) cannot automatically be assigned an etiologic relationship. Other causes must be ruled out and the minimal exposure necessary must be defined by the scientific advisory committee. In between we have a broad spectrum of aggragate canbinaticns of various risk factors. Currently, these cases are the source of vigorous debate and active litigation. National /VledicaMdvisory Service me___ Page 19 Any effective occupational disease program most deal in 9cne systematic way with this problem of multiple causative factors and their relative contributions to a claimant's disease. On the cne hand, j it isn't fair for an injured worker to be denied compensation simply because he smoked. On the ether, it isn't fair for an aiployer to be forced to compensate every disease vhich nay or nay not have been contributed to by the employment. Asbestos and lung cancer is cnly cne example. Others include chronic obstructive lung disease in smbker/aotton workers (is it byssinosis car smoking-caused disease?); leukemias in uranium miners; lung cancers in arsenic workers; aplastic J anemias in benzene workers; and many more. The standard terminology widely used and accepted in the 1972 Report of the National Camussion cn State Workmen's Compensation Laws is: "arising out of and in the course of employment." This criterion, simple cn its face, is cbviously the source of controversy and litigation. It cries out far refinement. Many groups, including the American Industrial Health Ccrmissicn (AIHC) are currently evaluating these issues of relative causal relationships. The ocimonly used term for this is "risk assessment." In the past, records of exposure data were poorly kept. Hence, industrial oanrCLssions have adopted the erroneous premise that increased production of or use of a chemical equalled increased exposure to a worker. This premise is flawed since it failed to consider changes in production methods, worker protection, etc. Organizations, such as the AIHC and virtually all large manufacturing carparu.es, are actively catpiling current exposure data as well as retrospective estimates of past exposures. Developing criteria to answer our did question requires the analytical expertise of well-qualified industrial hygienists and industrial toxicologists. We can, for marry risks and many exposures. National /VledicaMdvisory Service nc__________________________________________________________________ Page 20 establish numerical risk assessments. Many have already been carried cut. Tb help us there is a newly-developed general model, vhich recognizes the validity of threshold exposures and safe limits. It was tested for lcw-level exposure to presumed carcinogens and the risk of exposed workers developing malignancies was exceedingly low. This model is being considered far adoption by our new EPA. It would replace the former "no safe exposure level" theory of earlier regulatory policy. Fran the standpoint of occupational disease com pensation, the implications of this model, vhen combined with exposure data being carpiled, are extraordinary. No longer can minimal exposure to a presumed, or even accepted, injurious agent be automatically proffered as the cause of a given disease. The relative- caused rela tionship, in seme cases high, but in many, very small, can be quantitated. The "did" question in those controversial cases requires several types of scientific data: epidemiological data regarding relative risk factors; and, exposure data for each of those factors. Unlike the "can" question for vhich universal guidelines can be established, guidelines here are more disease- and exposure-specific. Whether the "did," can or should be addressed in a systems approach depends upon two factors: 1) whether sufficiently refined epidemio logical data will permit assignments of probable causes and, 2) whether the offender-disease in question involves a large enough population to make a centralized approach cost effective. Asbestosis and lung cancer, cotton dust and byssinosis, radiation and leukemia, noise and hearing loss are sane example of occupational diseases which meet the two criteria above and should be considered by a scientific task force. Ch the other hand, more unusual illnesses, or oies vhich have not been studied as exhaustively, will have to be reviewed case by case. Guidance in those cases will be National /VledicaMdvisory Service re___ Page 21 provided by our scientific advisory caindttees for the "can" and "does" guidelines, but pfot the "did" will have to be determined by the state medical panels. Figure I illustrates the three analytical considerations in causation analysis. G. Disability Analysis The second component of a revamped occupational disease program (after causation analysis) is disability analysis and assess ment of rehabilitative potential. Because this is more far-reaching, and extends to occupational injuries--currently far more expensive than diseases--I shall devote only a snail discussion to this issue. The facts are these: 1) Currently, disability ratings are generally judgmental and arbitrary--pulled ait of the hat by treating physicians and defense medical experts. 2) A rating system, codified, adopted by Congress and used as the "Bible" of disability rating by the Veterans Adninistraticn or the Department of Defense is available to bring order to a randan process. The Veterans . Administration "Schedule for Rating Disabilities" is ~comprehensive, covering every possible organ system, muscle group, etc. First, it recognizes the difference between impairment (a bodily dysfunction and, hence, medical definition) and disability (the translation of that impairment into its affect cn performance of a job). The Veterans Administration schedule takes verbal descriptions of impairments and assigns to those a numerical disability rating. It was established, primarily, for manual, blue-collar labor. Even so, the disability ratings provided in the Veterans Administration schedule are far more conservative than the Page 22 CAN ? 1. NECESSARY CRITERIA (QUALITY.QUANTITY AND TYPES OF STUDIES)TO ACCEPT A CAUSAL RELATIONSHIP. 2. APPLICATION OF CRITERIA. OFFENDER ORGAN SYSTEM DISEASE I\ PROBABILITY DOES ? 1. DIAGNOSTIC CRITERIA NECESSARY FOR EACH OCCUPATIONAL DISEASE OR GROUPS OF DISEASES: CLINICAL.LABORATORY. DID ? OFFENDER DISEASE \ CRITERIA f. REQUIRED EXPOSURE. 2. OTHER CAUSES. 3. EPIDEMIOLOGICAL CONSIDERATIONS. 4. PROBABILITY ANALYSIS. DISEASE OFFENDER OTHER CAUSES EPIDEMIOLOGY < ........ I PROBABILITY ANALYTICAL CONSIDERATIONS IN CAUSATION ANALYSIS Figure I National /HedicaMdvisory Service inc__________________________________________________ _ Page 23 ratings accepted by irony state canpensation boards in individual cases. Far exarrple, emphysema described as "moderate; with moderate dyspnea occurring after climbing cne flight of steps or walking more than cne block an level surface; pulmonary function tests consistent with findings of moderate erphysema" is given a 30% disability rating. Ihat description would, in many jurisdictions, lead to a ruling of permanent total or permanent partial-disability. Ihe Veterans Mministration schedule is an excellent starting point for a comprehensive codification of a disability rating system for the states. It vrould have to be modified by job classification, recognizing, for exanple, that a 30% pulmonary disability in a laborer may be 0% disability in an office worker; or, aonversely, a 0% hearing disability in a laborer, may be a 60% disability in a telephone operator. However, for the most cannon impairments that project is surely manageable. Moreover, the impairment and disability ratings are also measurable, quantifiable and, hence, amenable to computerization. IV. Organizational Approach A. Introduction How are these' systems to be developed and managed and vho should be the scientific decision-makers? Before discussing the specifics of the scientific advisory ccrmittee (the term I have used throughout this proposal) or state level disability evaluation units (a designation used in the 1972 report, but a label vhich, for reasons to be set forth, I will recaimend changing), I shall introduce certain guiding principles. The need to establish uniform guidelines for state statutes* is predicated upcn three factors: National /WedicaMdvisoty Service nc______________________________ ____________________________________ Page 24 1. Occupational diseases are the same wherever they occur. Only incidences vary as a function of intrastate industry. 2. Federal control of the definitions described above cannot work. There is simply too much special interest pressure and politicization of governmental science; the results of vhich are amply illustrated by. the black lung program. Although politcal exigencies must ultimately play a role in the final decision making, the scientific guidelines must be drawn by independent blue ribbon scientists who have no ideological ties. That, I submit, cannot be done under the aegis of the federal government. 3. Cnly a limited number of physicians and scientists have the time, expertise and interest to participate in this project. This means that the knowledge of the few giants in their fields must be brought together quickly in a well-focused fashion and then broadly disseminated to the states. I shall elaborate cn this latter point. B. The Scientific Advisory Ctrmittees Policymakers must be made to recognize a critical fact: the usual practicing jhysi'cian. has little more knowledge of occupational diseases_than do lay industrial referees. The field is obscure, rarely part of their everyday practice amid filled with a scientific literature with which most practitioners are totally unfamiliar. Busy practi tioners are often reluctant participants in the occupational disease Merely guidelines subject to modification by each state i1 ? National /VIedicaMdvisory Service nc___ Page 25 field, brought into the picture by cue of their patients or by an erployer ccr insurer; yet, it is their "expertise" which guides modem decisions. A system vhich utilizes as its arbiters experts without expertise, time or interest is seriously flawed. V A properly organized program, aognizant of this fetal flaw, must utilize efficiently those few who do have the time, interest and expertise. A concentrated knowledge base trust be developed and finetuned by those few and then widely disseminated to the ultimate users: the states via their ocmpensaticn systems. Identifying the proper experts far the task requires an under standing of the very disparate worlds of science and worker's canpensatian adjudication. Mary of the individuals vhose knowledge is required to develop an effective system--experts in the relevant medical and scientific subspecialties--rarely interact with the world of ocmpensation. They can provide necessary answers, but they have to be asked the right questions. The world's leading authorities in toxic liver disorders, in pulmonary pathology, in coronary artery disease may never have reviewed a claim and ray have no idea how their contribu tions to our understanding of these disease processes can be applied to the practical world of canpensaticn dollar awards. Similarly, an occupational disease Specialist ray not be familiar with the subtle, rapidly-evolving' literature, in the subspecialties of cardiology, hepatology, endocrinology and other fields vhich have enormous irrpact in the occupational disease field. Although he ray have a good general command of the occupational disease field (the "cans"), how to translate this into award decision-making (the "does" and "dids") ray be foreign territory. Finally, subspecialty experts, although highly knowledgeable in those fields relevant to occupational disease compensation, may have limited time and/or interest in this social/political/scientific multispecialty area. '<9 National /MedicaMdvisory Service re___ Page 26 What this says is that appropriate expertise in the relevant fields of occupational medicine, epidemiology, biostatistics, toxi cology and the various medical and scientific subspecialty disciplines is available, but marshelling those talents into action requires: 1. Identifying and securing the proper individuals. 2. Targeting their consultative activities in the precise directions necessary for compensation decision-making. 3. Utilizing their time efficiently. Ibis kind of coordination might best be coordinated by a non-profit foundation (section D) and controlled by a ccrrmittee conposed of physicians and scientists vho have an operational knowledge of occupa tional disease carpensaticn, the necessary scientific data sources (medical/scientific literature) and vho have the resources and abilities to bring a blue ribbon team of relevant specialists into advisory oerrmittees. The coordinating ccrrmittee Trust be able to formulate targeted questions and to supply data sources so that the scientific advisory committee can function smoothly, quickly and towards a specific, well-directed goal. I suggest that the coordinating oarrmittee and the chosen experts form the scientific advisory ccmnittee convened under the auspices of a non-profit foundation. The charge of the scientific advisory ccmnittee is to answer, as well as modem knowledge permits, the "can," "does" and "did" questions discussed earlier. The carpositicn of the coordinating ccmnittee may renain constant and should include individuals vho are knowledgeable in both disease canpensaticn and scientific resources. It should also include National /MedicaMdvisory Service nc___ Page 27 individuals whose expertise is required in all phases of decision making, including (at a minimum) a statistician, an epidemiologist, an expert in occupational medicine and a toxicologist. Those individuals must be open-minded, fair and have the time and interest in this problem to devote sufficient energy, particularly during the initial phase when guidelines are being developed. Ad hoc members of the camdttee would include those subspecialists, highly regarded in their fields, whose expertise would be required to answer specific questions or to deal with specific organ systems, specific occupations or specific toxic agents. Their input would be limited to their specific areas of special scientific investigation. For example, a pulmonary specialist is needed to consider the "can," "does" and "did" questions for occupational pulmonary diseases, but occupational cancers are out of his field and, instead, necessitate the involvement of experts in carcinogenesis. C. A Clearinghouse for Eata Acquisition The smooth functioning of the camdttee and most efficient use of high-level professional time requires a supporting infrastructure. The lifeblood of the scientific advisory ccrmittee is a data base of relevant medical/scientific literature. This should probably be collected by a central' clearinghouse which is continually operative to assure up-to-date resource rraterial and the ability to respond to a dynamic field. Data abstractors--masters and Eh.D. level individuals with the appropriate expertise--could be utilized to abstract and prioritize the literature. Carputerizaticn would surely expedite retrieval. There is no purpose here in discussing the precise data acquisition systems. Many clearinghouses far accumulating scientific data directed towards a specific goal are in force. There are many effective, usable models of varying degrees of sophistication. c National /MedicaMdvisory Service rc___ Page 28 D. The Governing Body: A Non-Profit Foundation I suggest that the governing and managing body for these scientific advisory aarriittees be an independent non-profit foundation. This might be called The American Occupational Disease Institute. There are several compelling reasons to establish such an organization: 1. It improves credibility, independence (and hence acceptance) of recannendations of the scientific advisory aamdttees. 2. It provides an organizational structure under vhich the occupa tional disease questions discussed earlier can be coordinated for study. 3. It could be available, through petition, to consider the study of specific problems and questions raised by industry, insurers, labor car the industrial ocrrmissions. 4. Its Board of Directors, physicians and scientists from academia, labor, industry and private medical practice, would provide balanae and credibility. 5. The time is ripe for each an organization to begin to develop wide recognition as the problem solver in occupational disease compen sation, before the chaos worsens. 6. Many similar organizations, hence precedents, exist in other fields. The reccrrmendations of our scientific advisory aarmittees have the best opportunity far political acceptance if they are promulgated under the aegis of such a foundation. Precedents for this kind of National /WedicaMdvisory Service rc___ Page 29 organizational guidance deal with electrical and mechanical standards and, in some instances, standards for occupational exposure to chemicals. The National Fire Protection Association (NFPA) puts forth electrical standards vhich have been adopted into state and municipal electrical codes. The ASTM sets standards for almost every mechanical item used in industry. ANSI has developed occupational health standards for chemical exposures, many of vhich have been adopted by OSHA and various states. All of these are independent, non governmental foundations. All are supported heavily by industry but have the imprimaturs of labor and/or consumer organizations. Their Boards of Directors are sufficiently representative to satisfay the concerns of all interested segnents of society. There is no need here to discuss the precise composition of such a foundation. Suffice it to say that its Board must be represen tative of all interested groups and scholarly resources. Since its thrust is purely medical and scientific, the Board should be composed of physicians and scientists. It must have sufficient autonomy to be permitted to search for objective scientifically-based answers to the questions posed earlier. The organizational approach to occupational decision-making is illustrated in Figure II. E. Transfer and Use of Information by the States The function of the foundation and its scientific advisory carmirtees is to develop guidelines--specific and general--for use by the state adjudicators. The guidelines would bear the imprimaturs of leaders in the relevant scientific fields, individuals beycnd reproach vho are not subject to attacks of preconceived biases. Tb insure their objectivity, their guidelines and criteria nust be based purely upon Page 30 } ( MEDICAL/SCIENTIFIC BOARD OF DIRECTORS ACADEMIA INDUSTRY LABOR STATE HEALTH COMMISSIONER MEDICAL ESTABLISHMENT (i.e. AMA APPOINTEE) SCIENTIFIC COORDINATING. COMMITTEE (SCC) OCCUPATIONAL PHYSICIAN STATISTICIAN EPIDEMIOLOGIST TOXICOLOGIST SCC & AD HOC MEMBERS SCIENTIFIC ADVISORY COMMITTEES 'i INDUSTRIAL HYGIENE PULMONARY HEPATOLOGY RENAL CARCINOCENESIS ETC. STANDARDS \ GUIDELINES SCHEDULES ORGANIZATIONAL APPROACH TO OCCUPATIONAL DISEASE DECISION-MAKING^ ~ Ficrurp TT National /VledicaMdvisory Service nc_________ :-------------------------------------------------------------------------------------- Page 31 scientific probabilities with no concern, vhatsoever, about vhether their findings would potentially increase or decrease the population eligible for compensation. Hew that data is translated into state statutes and/or guide lines for industrial commissions must be decided at the state levels. Many of the criteria and guidelines will be irrefutable and absolute in accordance with moderan scientific knowledge. We can reach precise guidelines regarding the diagnosis and vrark-relatedness of many acute toxic illnesses and a good number of chronic diseases. Others will be less precise and will be presented as probabilities: i.e., a particu lar cancer is poorly or moderately-well linked to a particular exposure (can?); recommended criteria for establishing a cause and effect link in a multiple etiology disease like obstructive lung disease in cotton workers, perhaps a computerized analysis for apportionment or threshold determination (does?). In seme cases, global recommendations, like elimination of carpensaticn far so-called "stress-related" heart disease, nay be made accompanied fcy the best scientific justifications for such a recarmendaticn. Ultimately, the states should be well-served by this approach. Strong recarmendations can serve as the data base for immediate change. Probability assessments will have to be agreed upen and policy decided by a coalition of industry, labor and policymakers and the disability evaluation units of each state's carpensaticn system. Obviously, this leaves roam for debate, but that, after all, is vhat distinguishes state-run programs from centralized federal mandates. At least the states will have sophisticated guidance under the proposed system. A < National /Medical Advisory Service inc___ Page 32 F. State Medical/Scientific Panels A medical/scientific panel at the state level has been recom` mended and dubbed the "disability evaluation unit." I suggest that the states do need radical advice, both to decide how to implement the scientific advisory ccitmittees' inputs for global changes, and to adjudicate those cases vhich cannot be dealt with via an umbrella system, but must be decided individually. I would suggest, however, that these panels, or individuals, not be called disability evaluation units, a clear misncmer. This may seem trivial, but I believe that a / different name is rare than pro forma: it is essential to denote the true function of that panel. The intrastate ^physician and/or scientific panel mentoers ray help determine disability, but their more critical function is to determine compensability--the causal relation ships between the workplaces and the illnesses. The state medical panel may be called: "Medical Evaluation Panel," "Occupational Illness Medical Advisory Group" or any other name vhich connotes a broader responsibility than disability evaluation. For the nonent, I shall use the term "Medical/Scientific Panel." The burdens of the medical/scientific panels will be markedly reduced by input fran the scientific advisory caimittees. Ihvsician members must be apolitical and must have sufficient scientific grounding to understand and interpret recommendations set forth by the scientific advisory cxxmdttees. This suggests that several panels with | specific functions and, hence, specific expertise, be utilized. They would be the state counterparts of the scientific advisory oamdttees. The full scope of epidemiologists, toxicologists, statisticians, etc, would neither be required nor practical at the state level. Input from those specialties would be required only once, at the central level. The state medical/scientific advisory ccrmittee might be composed of a chairperson and tvo ad hoc members in relevant specialties. Ideally, National /Vledical Advisory Service nc__________________________________________________________________ Page 33 the chairperson should be knowledgeable in occupational medicine and/cxr public health. He car she could cane fran an academic institution or be a full time state employee under the auspices of the Department of Health. Ad hoc members should be subspecialists in the medical discipline being adjudicated--pulmonary medicine, hepatology, oncology, etc. Ideally, they should be chosen fran academic centers to provide the best assurance that scientific principals will be followed in their decision-making. Jfy suggestion is that their determinations of causa tion and disability be binding after criteria for their decision-making have been accepted by the legislatures and the industrial caimissions. G. Product Liability We are all well aware of the erosion of workers' ocrnpensation as the sole remedy far occupationally-injured workers. The majority of asbestosis actions today are not workers' compensation, but third party liability actions. I wall not discuss proposed tort remedies, many of which have been put forth. I should like to mention, however, the potential additional value of the medical/scientific decision-making tools in this expanding frontier of tort liability. The same perversions of science (i.e., the use of NIOSH's list of potential carcinogens to, prove that a worker's exposure caused his cancer) is used by plaintiffs and their counsel even more effectively before a lay jury. Our guidelines, while not necessarily binding in court actions, will provide powerful tools for adjudicating compen sability. If they are put forth by an independent foundation, they wall have the imprimatur of fairness and scientific accuracy. If they are adopted by the states, they will have the force of accepted standards. Thus, although our primary focus must remain modernization and objectification of occupational disease decision-making by industrial boards, a secondary benefit, perhaps even more financially National /MedicaMdvisoiy Service rc__________________________________________________________________ Page 34 beneficial, will result. These criteria will provide fairer guidelines for the adjudication of tort actions arising fran alleged workplace illnesses. V. Surtmary 1. State statutory provisions and compensation board decisions in occupational disease matters are variable, inequitable and frequently irrational. 2. Popular misconceptions generated by the media and other sources, unicn pressures, and an aggressive plaintiff -bar have distorted the medical/scientific infrastructure which rust guide a rational and fair system. 3. The gap between "common wisdom," the guider of industrial ccrtnissicn decision-making and scientific realities widens daily. More and more poorly-documented "occupational ailments" are regularly added to the list of claimed occupational illnesses. 4. Most physicians, die "referees' referee," have little under standing of the specialized field of occupational diseases and causation analysis. Therefore, the industrial boards are guided by unsupported opposing "opinions" (not facts), put forth by treating physicians cn one side and defense medical witnesses cn the other. 5. A barrier to a progressive new system is the tendency to plunge into debates about individual diseases, cumulative illnesses, latencies, apportionment versus presurption, etc. Innovation requires identifying carmen decision points vhich characterize all occupational diseases. National /MecJicaMdvisory Service me___________________________________________________________ Page 35 6. A system is suggested vhich asks three questions: Can a given occupational offender produce the claimed disorder? Does the claimant indeed have it? Did the alleged occupational offender produce the disorder in that individual? 7. The system is workable, in many cases computerized, and broadly inclusive. Most occupational diseases will be covered under these guiding principles. Those principles will provide uniformity and input of the best-available modem scientific evidence. 8. The guidelines should be established by scientific advisory caimittees and then disseminated to the states. This provides: 1) utilization of the most respected experts in the requisite fields; 2) a centralized data base; 3) economy of time and effort; and 4) uniformity. 9. A non-profit foundation (perhaps named The American Occupational Disease Institute) should be established to provide the organiza tional oversight and support for these scientific advisory ccrrmittees. It would provide the credibility and independence necessary to convince the states to adopt the committees' reccrmendations. 10. The state medical/scientific panel is the final pathway for acceptance or modification of reccnnvendations by the scientific advisory comuttee. It is also the adjudicator of individual case problems not specifically covered by the scientific advisory ccrrmittees' reccnmended guidelines. National /Medical Advisory Service re___ Page 36 Appendix A A Model For Diagnostic Decision-Making in Occupational Pulmonary Diseases Pulnonary Diseases; Causes, Disabilities, Prognoses Many "occupational diseases" are ripe targets for a centralized, scientifically-grounded systems approach. Ito begin tackling this vast sea of confusion, we recommend a prototype program directed at one or more of the 90-called pneumocconioses, or interstitial fibrotic lung disorders. These disorders, most of vhich are amenable to this systems approach are shown cn Table 1. There is no question that cigarette smoking is the major cause of chronic non-infectious pulmonary disease in Americans. A significant fraction of lung dysfunction purportedly due to occupational exposures, are probably caused, in large part, by smoking cigarettes. Of critical relevance to the claims professional is that tools are available to distinguish the contributions of smoking versus occupational inhalants to a claimant's pulmonary dysfunction. In feet, this can be done using a ccmbinaticn of well-established epidemiological data and modem, but proven, accepted and readily available physiological testing methods. The biological fact vhich permits this differentiation is that smoking and inorganic dust particles cause different diseases. Sicking causes wo pulmonary problems: chronic bronchitis and emphysema. Both are characterized functionally by reduction in expiratory airflow. Chronic bronchitis is a process of inflammation and narrowing of the air passageways (bronchi) vhich transmit air to and from the air sacs (alveoli). Emphysema is a process in vhich there is destruction of the Page 37 INTERSTITIAL DISEASE-CRYSTAL ET AL TABLE I Interstitial Lung Diseases oI Known Etiology* Oco^iUorul EntksnrwnUI Mutants Inorganic duals Silica (variants of silicon dioxide) SilicatM Asbestos (hyckxted sodium. Iron. calcium and magnesium silicates) Talc (hytkated magnesium silicates) Kaolin ("China clay," hyukated aluminum silicate) Slllimanite (anhydrous aluminum silicate) Diatomaceous earth ("Fuller's earth, alum inum silicate with Iron and magnesium) Nepheiine (hard rock containing mixed silicates) Mica (potasskm and magnesium aluminum silicates) Aluminum Powdered aluminum Bauxite ("Shaver's disease.** aluminum oxide) Antimony (oxides and alloys) Carbon (with or without silica) Coal dust (kaphite Beryllium Mixed dusts (predominancy oxides of Iron with silica, silicates, and otbar Inorganic compounds) Hard metal dusts Titanium oxide Tungsten. titanium, hafnium, and nlobkm cart)idee Cedmkan Organic i Living < Farmer's lung Bogaisosls kkishroom worker's ling Kmidiner lung. air conditioner kng Maple berk stripper's kng Cheese worker's lung Malt worker's kng Sequoiosls Paprika sputter's kng Wheel weevil disease Suberosie .*'. Bird breeder's kng Chicken handler's disease Aspergillosie Pituitary snutt kng Turkey banker's kng Duck fever Wood-pulp worker's < Same-taker's disease Detergent worker's kng Lyeoperdonosle Wood-dust worker's idieiae Coffee worker's kng Furrier's kng New Qulnaa Kng Coptic disease -type" Organic dusts cent'd Chemical sources Synthetic-fiber lung Bakelite worker's kng Oases, fumes, vapors, asraxots Oxygen Sulfur dioxide Chlorine gas Fumes Oxides of tine, copper, manganese, cadmium. Iron, magnesium, nickel, brass, selenium, tin and antimony Vapors Mercury Thermosetting resins Toluene diiaoeyanate Aerosols Fats Pyrethrum Copper sulfate neutralized with hydrated lima ("Bordeaux mixture'*) Drugs Chemotherapeutic agents Busuifan Bleomycin Cyclophosphamide Mothofroxate Nitrosoureas (BCNU) Procarbazine Mitomycin Antibiotics Nitrofurantoin Sulfonamides Penicillin Others Qipheny tuydentoln Drugs inducing lupus-liks syrxkome Oold salts Hexamabtonkm Macamytamlns Mathysarglda Penlolinkm Propranolol Carbamaxina Paroquet Reditta* External Inhaled Wectloua agents Residuie ol active Infection of any type kderstWal disease caused by dteerders of organa ether then lung Chronic pulmonary edema Chronic uremia * Sea [1] lor detail; new eddbonatobw fat of Interstitial krg(Fieeiei of known eOotagy Induk "summer type" organic duet Jieese [17], mitomycin [IS] and carbamaxina [IS], March lit) The American Journal of Medicine Volume 71 *0*. 2 3C National /Medical Advisory Service re---------------------------------------------------------------------------------------------------- Page 38 alveoli. Like chronic bronchitis, erphysema causes airflow obstruction because lung elasticity is lost, the alveoli become floppy and dis tended and the air cannot be pushed cut. The inorganic particulate diseases are entirely different. These diseases affect the interstitium ("inside" of the tissue), compromising the air sacs and causing than to fibrose ("scar"). This scarring causes reduction in size and stiffening of the air sacs (as opposed to emphysema which makes than floppy) and has little, if any, affect on the air passageways (in contrast to chronic bronchitis). Sinple, non-invasive pulmonary function tests can quantify the degree of pulmonary impairment. Moreover, they can readily distinguish between chronic bronchitis, emphysema, and the interstitial fibrotic lung diseases. These tests are not esoteric, but they are more sophisticated than the chest x-ray and the simple spirometry of 20 years ago: the types of pulmonary evaluations still used by mo6t internists who are not subspecialists in pulmonary medicine. FEV^ (forced expiratory volume in cne second) and VC (vital capacity), the most commonly reported pulmonary function studies, do not permit an accurate assessment of pulmonary pathology. Seme of the more precise determinants are: FEV^/RO and diffusing capacities. There are, in addition, even more sophisticated tools available at select centers such as: volume pressure relationships, vhich include lung compliance, pulmonary compliance of functional residual capacity, the maximal transpulmonary pressures, the coefficient of retraction; and specific techniques to determine the degree and nature of active alveolar inflanmaticn such as: bronchioalveolar washing studies and scintigraphic scanning with gallium-67 citrate. The latter two are the most sophisticated, modem methods of determining vhether an inflam matory disease is active and progressive or stable and quiescent. Seme National /Vledical Advisory Service nc___ Page 39 of the unique pulmonary function changes which help distinguish between sucking-related and occupational pulmonary diseases are shown in Table 2. In any given disease by using a predetermined combination of the above tests, it is possible to: 1) quantify the degree of functional impairment; 2) assess vhat fraction of impairment is smoking related; 3) determine how much pulmonary pathology (as opposed to functional impairment in (2)) is smoking versus dust related; and 4) rake some predictions about prognosis. Several patterns may emerge. In nany cases, most, or all, of the diseases will be chronic bronchitis and/or emphysema--diseases due to smoking. In a relatively small fraction of cases, most of the lung pathology will be interstitial fibrosis--due to inorganic dust expo sure. In seme cases, the pattern will be mixed. Because of the quantitative nature of these measurements this decision-making systen is readily ccmputerizable. In cases of combined etiologies, further distinctions can be rade. The above tests can tell us, with seme precision, vhat proportion of the disorder is smoking-related and vhat proportion is due to dust inhalation. We can rake this fractional apportionment even more accurate by incorporating epidemiological data regarding the effects of cigarette smoking. Pulmonary physiologists and epidemiologists have, through combined efforts, plotted the effects of varying pack-years of smoking on lung function. These effects are predictable, reproducible aid relatively constant among individuals. Using this data, we can demon strate, for example, that a 40 year old ran who smoked 1-1/2 packs per day for 20 years and has a specific reduction in various pulmonary function tests has this imrairment purely because of cigarette smoking. Page 40 Smoking Chronic Bronchitis Emphys ema Lung Volumes 1 VC 1 TLC 1 Airflow Studies 1 FEV, I FEVt/FVCX 1 01 ffusing Capacity I Lung Compliance I 1 ! 1 t 4 or nl * Occupational Fibrotlc Lung Diseases nl Representative pulmonary function studies used to: 1) assess extent of disease; and 2) differentiate between smoking-related and Inorganic dust diseases (occupational). f Reduced 4 * Increased nl Normal VC "Vital Capacity TLC Total Lung Capacity FEV^/FYCX Forced Expiratory Volume in one second/Forced Vital Capacity (t) Table 2 A 33 National /MedicaMdvisory Service nc ---------------------------------------- ------------------------------------------------------- Page 41 A stark contrast to the availability of accurate, objective testing in pulmonary disorders are the simplistic criteria often used to settle or adjudicate claims. False perceptions about "occupational" lung diseases among the lay public, the plaintiff bar, the defense bar and even the medical ocuinunity lead to diagnoses and payments in the absence of true evidence of disease. Trial magazine recently printed -- -- -- an article entitled "Medical Causation in Products' Liability Disease Litigation." Thomas W. Henderson, a plaintiff's attorney, made the following fallacious statement which was highlighted in a separate box: Very likely the single most important piece of medical information in the proof of an occupational and environmental disease case is the chest x-ray (1). The feet is that chest x-rays are not indicators of either impair ment or disease: they merely suggest exposure. Leading authorities in interstitial lung diseases, note that there is no correlation between roerrtgenographic patterns and the overall histologic estimates of disease (2-4). Well-aontrolled studies have validated that statement (5-9). Furthermore, there is so much interobservor variability in radiographic interpretation of these lung disorders that even the staging of visible abnormalities is highly subjective. Thus, chest x-rays, "the most important piece of medical information," according to Mr. Henderson, are subject to variable interpretation and, even when significant abnormalities do exist, they are poor indicators of the extent of lung damage. The plaintiff bar has touted chest x-rays and simple spiranetric measurements (i.e., FEV^) as the prime determinants of asbestosis. They have been aided in this effort by seme physician witnesses. Unfortunately, the medical consultants working with the defense have National /VIedicaMdvisory Service he___ Page 42 nor uniformly countered these propositions effectively, either because they lack state-of-the-art knowledge of pulmonary diseases, or because they lack time or in-depth interest in claims analysis. The plaintiff bar has a strong stake in x-ray diagnosis. Chest x-rays are graphic, simple and subject to biased interpretations. Moreover, most claimant's whose chest x-rays are read as "abnormal" have no functional irrpairment; thus, the positive chest x-ray popula tion exceeds the sick population. Insurers should not be compensating chest x-rays: they should be compensating disability. The cnly true indicators of disability and disease are sophisticated pulmonary function testing. Such tests (actively ignored by the claimants' bar) will markedly reduce the population of impaired claimants; separate relative causes of impairment such as cigarette smoking; and provide prognostic data which shew whether the disease is quiescent or progressive. National /Medical Advisory Service nc___ Page 43 References 1. Henderson, T. W. s Medical Causation in Products Liability Disease Litigation. Trial 17: 53-57, 1981. 2. Crystal, R. G., Gadek, J. E., Ferrans, V. J., Fulmer, J. D., Line, B. R., Hunninghake, G. W.: Interstitial Lung Disease: Current Concepts of Pathogenesis, Staging and Therapy. Am. J. Med. 70: 542-568, 1981. 3. Keogh, B. A., Crystal, R. G.: Pulmonary Function Testing in Interstitial Pulmonary Disease. What Does It Tell Us? Chest 78: 856-865, 1980. 4. Keogh, B. A., Crystal R. G.: Chronic Interstitial Lung Disease. In: Simmons, D. H., ed. Current Pulmonology (Vol. 3). New York, John Wiley & Sens, 237-340, 1981. 5. Carringtcn, C. B., Gaensler, E. A., Milsus, J. P., Schachter, A. W., Bruke, G.W., Goff, A. M.: Structure and Function in Sarcoidosis. Ann. N. Y. Acad. Sci. 278: 265-282, 1976. 6. Carrington, C. B., Gaensler, E. A.: Clinical-Pathologic Approach to Diffuse Infiltrative Lung Disease. In: Thurlbeck, W. M., Abell, M. R., eds. The Lung Structure, Function and Disease. Baltimore, Williams & Wilkins, 58-87, 1978. 7. Scadding, J. G., Hinson, K. F. W.: Diffuse Fibrosing Alveolitis (Diffuse Interstitial Fibrosis of the Lungs). Thorax 22: 291-304, 1967. 8. Naeye, R. L.: Types of Fibrosis in Coal Wbrkers' Pneumoconiosis. Ann. N. Y. Acad. Sci. 200: 381-400, 1972. 9. Theros, E. G.: The Value of Radiologic-Pathologic Correlation in the Education of the Radiologist. Am. J. Roentgenol. 107: 235-257, 1969. PERKIN-ELMER The Perkin-Elmer Corporation Main Avenue Norwalk, Connecticut 06856 (203) 762-1000 Telex 965-954 HCL 150 December 17, 1981 Geoffrey Berry MRC Pneumoconiosis Unit Llandough Hospital Penarth, UK Dear Geoffrey: I hope you are well and that the Pneumoconiosis Unit has managed to weather the storm of Margaret Thatcher's economic policies.' The Rochdale publications are still of great importance and of value in many ways to many different disciplines studying the problems peculiar to asbestos and health in the U.S.A. I was recently approached by Peter Wilson who is working as a consultant to Professor McAvoy (Frederick William Beinecke Professor of Economics, Yale University). They are attempting to predict the impact of asbestos-exposure in the U. S. A. in terms of disease yet to come to light. I believe that their work is sponsored by a large insurance company. Wilson is relying heavily on a paper of Nicholson's which will be published in the "Banbury Report 9". I have not seen the text and Nicholson has not yet responded to my request for a copy. I wonder if you would be kind enough to study the enclosed letter and draft outline of Wilson's reasoning and let him have your comments. You will note that he is using the figure relating crepitations, possible exposure and certification to cummulative dose and attempting to predict the numbers of cases in the U.S.A. from it, using crude data on exposure provided by Nicholson. Please let him know what you think of this approach it doesn't seem reasonable to me! I will be in England for the Christmas holidays and will be in Branston, Lincolnshire from December 23 - until December 28. If this letter reaches you in time it would be nice to hear from you again. My address will be: c/o K. R. Cook 48 Lincoln Road Branston, Near Lincoln Lincolnshire Phone: 0522-791-363 A08237 Please give my kind regards to Chris Wagner, Margaret Wagner, Peter Elmes and your wife and family. Tell Chris to expect a note from me in the new year asking for advice on a study of mesothelioma which we want to continue with in Connecticut. With kindest regards and wishing you all the compliments of the season, Sincerely HCL:dr attach. Hilton C. Lewinsohn MB.,BCh.,MFOM.,DIH *08238 industrial economics, inc. 250 church street suite 22 . new haven, Connecticut 06511 (203) 789-1937 Dr. Hilton C. Lewinsohn Director, Occupational Safety and Health Programs Perkin - Elmer Main Ave. Norwalk, CT 06856 December, 4, 1981 Dear Dr. Lewinsohn: Thank-you very much for an enjoyable lunch and afternoon of conversation. Your suggestions and materials have been a great help. I am enclosing my preliminary work. I have several questions I would like to discuss with you over the phone if possible. They are as follows: -How are the asbestosis incidence and prevalence data related in the Rochdale study? -Would it be possible for me to obtain the data underlying the curve relating asbestosis prevalence to exposure (or can the figures be derived from the incidence rates)? -Could you suggest a source for data on the extent of disablement over the course of a person's life following certification? -Do you have any material defining the different levels of disablement- in terms of capacity to work? I have read your congressional testimony with great interest. It appears that the US could avoid some costly mistakes in any asbestos compensation scheme by borrowing some of the UK's practises, such as the Pneumoconiosis Medical Panels. Thanks again for all of your help. Sincerely, 408233 Peter M. Wilson Estimating Asbestos Morbidity Light exposures to asbestos can bring on pleural and parenchymal abnormalities in workers reflected in abnormal x-rays. In more heavily exposed persons nearly all eventually register abnormal x-rays (see table). However, the prevalence of asbestosis severe enough to cause significant disability is only found in more heavily exposed persons, and many people at risk of asbestos-related lung cancer because of light exposure are not at risk of asbestosis disability or death. In a study of a Belgian asbestos cement factory, Lacquet et al diagnosed no asbestos cases among persons with exposures less than 100 fiber-years per milliliter(1), and they found an incidence of only 0.02 percent at 100-199 fiber years. Similarly, Berry et al in their study of a Rochdale asbestos factory found little or no certified asbestos cases (by a Pneumonocibuisus Medical Panel) among persons exposed to less than 50 fiber years (2). Based on a figure from the Berry paper (attached),an equation relating asbestosis prevalence to cumulative exposure can be estimated as follows: Y= -6 + 0.12 X , X greater than 50 Y= 0, X less than 50 Where Y is the percentage of a cohort with asbestosis as diagnosed by UK Pneumoconiosis Medical Panels, and X is cumulative exposure in fiber-years/ml. For each person diagnosed by the medical panels as having asbestosis, compensation is awarded on a percentage disablement basis. Thus the individual records of asbestosis cases contain an indicator of the extent of disability since certification. However the information does not appear available for a sample of cases except for at initial certification. (l)L.M Lacquet et al,"Roentgenographic Lung Changes, Asbestosis and Mortality in a Belgian Asbestos-Cement Factory," Bio logical Effects of Mineral Fibers, IARC Scientific Publi cation 30, p.783, 1980 (2) G. Berry et al, "Asbestosis: a study of dose-response rela tionships in an asbestos textile factory," British Journal of Industrial Medicine, 1979, 36:98-112. A0824C To estimate the prevalence of asbestosis as defined by UK medical panels among the population of US asbestos-exposed persons, I relied on the average exposure histories underlying Nicholson's cancer projections.3 Where average fiber concentrations were not shown, I assumed they were proportional to relative cancer risks for a 25 year period of employment. A weighted average was taken for groups exposed to lower concentrations after 1972 than before. The average period of exposure was estimated by dividing estimated annual workforce by annual new entrants for each decade. For all groups with cumulative exposures less than 50. fiber years on average, no asbestosis was assumed. For those with average exposures greater than 50 fiber years, the Rochdale asbestosis curve was used to estimate prevalence. The results are shown on the attached tab!e. That asbestos manufacturing and inulation occupations produce nearly all cases is consistent with UK experience, in which 40-50 percent of asbestosis cases have been insulators, and all but 10-15 percent of the others have been in asbestos manufacturing. However, the estimates may be too low because they are based on average exposures. Within each group is a subgroup representing the'tail'of the frequency distribution around the average exposure. Those within the 'tail' received relatively heavy exposures and are at risk of having asbestosis. If exposures are tightly clustered around the means then this would not lead to serious error, but if they are widely dispersed some correction should be made to account for them. Another question still to be answered is how the predicted 46,100 asbestosis cases would be distributed over the next 30 years. (3) W.J. Nicholson et al, "Cancer from Occupational Asbestos Exposure: Projections: 1980-2000," Banbury Report 9: Quan tification of Occupational Cancer, Cold Spring Laboratory, I98T: 40824l Cumulative exposure (fibre--years/MI) Fig 19 The relationship between the percentage developing crepitations, possible asbestosis and certified asbestosis, and cumulative exposure to asbestos, for men tint employed after 1950. Taken from Berry, C (1977).J 83 A Projected Prevalence of Asbestosis among US Asbestos-Exposed Workers, 1980-2000 Industry (F-yrs./ml) (F/ml.) Average Cumulative Predicted Avg. Fiber Years Exposure Asbestosis Concentration Exposed Prevalence Cases < Number of Primary/secondary asbestos manuf. 12.6 18 227 21.2% 26,200 Insulation 11.6 14 162 13.4% 18,600 Shipbuilding 7.3 2.3 17 0 Construction 3 15 45 0 Railrd. Engine repair 3 7 21 0 Utility Services 4 15 57 0.84% 1,300 Stationary Engineers 2 16 35 0 Chem.Plant & Re finery Maintenance 2 14 31 0 Auto Maintenance 0.3 16 5 0 Marine Engine Rm. 1.5 14 21 0 Total----- -- 46,100 1 Dose- response' relationship assumed: Y= -6 + .12X, X greater than 50 Y- 0, X less than 50 where Y is the percentage of a cohort with asbestosis as defined by UK Pneumoconiosis Medial Panels, and X is cumulative asbestos exposure in fiber-years per mililiter. A O82 <3 Number of New Cases of Asbestosis Diagnosed by UK Pneumoconiosis Medical Panels, 1950-1976 Number Avg.per year Est.Incidence, 20,000 population 1950-52 1953-57 1958-62 1963-67 1968-72 1973-76 49 189 175 470 610 690 .> 16 38 35 94 122 138 1 0.5% 0.6% 0.7% Source: JC McVittie,"Asbestosis in Great Briton," Annals New York Academy of Science, 132:128, 1965 G.Berry,"Mortality of Workers Certified by Pneumoconiosis Medical Panels as Having Asbestosis," British Journal of Industrial Medicine, 38:130,1981. < INTERNAL CORRESPONDENCE UNION CARBIDE CORPORATION old RlDGEBURY ROAD. DANBURY. CT QSB17 To Loeoton Araa Copy co Medical Directors Contract Physicians Data OfTQ.natinfl Deot. Araa suoiacc August 8, 1983 Corporate Medical/HS&EA Danbury, P2594 Asbestos Related Diseases Because asbestos related diseases both with and without asbestosis are a cause of considerable concern and confusion, I have attached an execellent article written by D. Davies that appeared in the July 16, 1983 issue of the BRITISH MEDICAL JOURNAL. Davies has distilled a great deal of information into a succinct description of when compensability may be indicated. His comments on lung cancer are especially interesting. The fact that only a small percentage of pleural plaques (15% reported by Hourihane) are detectable during a lifetime by usual chest radiographs gives one concern. If our chest x-ray examin ations are of poor quality and are poorly interpreted, we could be accused of exercising inadequate "reasonable" care in our detection efforts. Hilton has been working with you to try to up grade our chest x-ray examinations and interpretations. I appreciate that Dr. Hilton Lewinsohn called this article to my attention. Hilton is our resident expert on asbestosis and asbestos related diseases so if you have any questions or problems give him a call on extension 8-421-5214. Thomas A. Lincoln, M.D. Corporate Medical Director TAL:cms enclosure F /7V\ 5: F\ /" lOOOAKVIEW DRIVE. TRUMBULL CONNECTICUT 06611 (203) 371-0101 itCEIVED January 7, 1983 JAN 1 1 1983 r. LEWINSOHN, M.D. H. C. Lewinsohn, M.D. Union Carbide Corporation Old Ridgebury Rd. Danbury, CT 06817 Dear Hilton: A report dated 8 October 1982 by the Industrial Injuries Advisory Council, "Asbestos-Related Diseases Without Asbestosis," is enclosed with my cover letter to Clyde Szuch. Please let me know if there's anything wrong with my brief summary. Also enclosed are three memoranda concerning Dr. Gilson's proposal for a "Prevalence Study of Asbestosis": 23 December 1982, Sir Neville Stack to various associations 11 October 1982, Albert Van Rosse to various associations 3 October 1982, note by J. C. Gilson re Prevalence of Asbestosis in the Asbestos Industry. I am puzzled by a seeming, to me, contradiction in the Advisory Council's report "that occupational exposure to asbestos may cause lung cancer in the absence of overt asbestos" (paragraph 33) and John Gilson's comment in his "note" of 30 October 1982 (third paragraph, page 2): "There is some evidence that the slope of the dose response curve is such that Asbestosis may well be detectable at a level where there is still little or no detectable excess Lung Cancer. At least the evidence does not suggest the reverse, i.e. that even when Asbestosis is no longer produced, an excess of Lung Cancer will persist." The two statements do not seem to be in agreement even though Dr. Gilson contributed to the work of the Advisory Council. I'd appreciate your comments. 408248 am Encs. cc: Mr. W. W. Cloyd John H. Marsh Director Environmental & Government Affairs l^rf January 6, 1983 Clyde A. Szuch, Esq. Pitney. Hardin, Kipp & Szuch 163 Madison Ave. Morristown, NJ 07960 Oear Clyde: The enclosed report, "Asbestos-Related Diseases without Asbestosls" prepared for Parliament (UK) by Committee II of the Industrial Injuries Advisory Council, broadens the definitions of asbestos-related diseases for benefit purposes. Specifically, the report recommends two conditions not previously prescribed be covered by the Industrial injuries scheme. 1. "Bilateral diffuse pleural thickening more than 5m thick and extending over more than one-quarter of the chest wall. 2. "Primary carcinoma of the lung where there Is accompanying evidence of one or more of the following: (a) asbestosls fb) bilateral diffuse pleural thickening (c) bilateral pleural plaques. Sincerely, am Enc. cc: Mr. Wade W. Cloyd George Kalapos, Esq. John H. Marsh Director Environmental & Government Affairs A 082 4 9 January 15, 1980 . *' 'r 1 Mr. Ralph Capecelatro First Selectman Town of Orange Connecticut 06477 ^ 181 Hitchcock Court " ' Orange, Connecticut 06477 ' ; '; * - * '. ' ``' ! / Dear Mr. Capecelatro: Thank you for giving me the opportunity to inspect the basement area of the former Mary L. Tracy Elementary Sohool which was the subject of a report by Lisa A. Bull in "The New Haven Register", Saturday, January 12, 1980. This report indicated that an asbestos health problem might exist in the building as a result of damage to pipe insulation containing some asbestos. My inspection revealed that the hot water pipes in the basement area are mainly suspended at ceiling level and are insulated by means of that appears to be an asbestos-containing pipe covering which has been wrapped with cloth and painted. In the section of the basement where a suspended ceiling has been installed, the pipes below the ceiling appear to have been insulated with a non-asbestos material. No inspection was made of the area above the ceiling as it is completely isolated from the room. The damage I saw was confined to insulation on one pipe in the hallway and another at floor level in the kitchen area. In another instance pipe covering had been removed, apparently when performing maintenance on valves, and had not been replaced, leaving the cut ends exposed. The concern with regard to exposure to asbestos of the general public and school children in particular has arisen because of the known health hazards associated with it in industry. According to various reports published in the world literature, no known health effects in the public at large have been determined as a result of the use of asbestos. It is important to realize that asbestos-related diseases are the result of exposure to conditions producing relatively high concentrations of dust in occupational settings, in the neighborhood of dusty operations and in some instances affecting household contacts of workers in those dusty trades. At the present time there is insufficient epidemiological evidence available to allow a safe exposure limit to be set, but experience in industry where dust conditions have vastly improved in the past 10 to 20 years suggests that a level may exist below which no effect will be observed during the normal life span of exposed workers. The present level permitted in industry by the OSHA Asbestos Standard is 2 fibers per c.e. of air, greater than 5 At in length, averaged over an 8-hour wrk-day as measured by phase-contrast mioroseopy. (continued) '^0825C 2. Levels of airborne asbestos fibers measured in the ambient air in buildings containing asbestos and in other situations are usually thousands of times less than this, and no proof is as yet available that such low levels can produce any of the known asbestos-related diseases. It is therefore my opinion that no hazard existed at the time the school was in use, and that even though damage may subsequently have occurred to some insulated pipes, no hazard exists at present because friable asbestos material is not present in the area affected. The EPA Office of Toxic Substances publication "Asbestos-containing materials in School Buildings: A Guidance Document, Part 1" (March 16, 1979) states: "When should school officials be concerned about asbestos material? If friable asbestos material is present in the school building, an exposure problem may exist. Chapter 3 outlines the recommended steps to identify friable asbestos material and to undertake a control program . . to reduce exposure. ;- Is pipe covering and boiler lagging of concern? Friable asbestos material was used for many years in pipe covering and boiler lagging until EPA prohibited its application in 1975. Pipe covering and boiler lagging do not create an exposure hazard unless the friable insulation material is exposed and damaged. Pipe covering and boiler lagging should be routinely inspected. If the insulation material is exposed, retaping or oovering the damaged area will prevent asbestos fiber release. Is ceiling tile of concern? Ceiling tiles are not friable and should be of no concern." ...Page <i. In view of the above statements, the extent of the damage observed and the concern expressed about it, it is my considered opinion that simple repair work to the damaged pipe covering is all that is required to prevent any un necessary generation of free asbestos fibers into the air of the basement. It is ray understanding that for various reasons unraiated to the presence (continued) '*08251 3. of asbestos, the basement area Is not to be used for any public gatherings at the present time. The presence of insulation material containing some asbestos cannot therefore be considered a health hazard to the remainder of the building, particularly after restoration of the damaged sections to normal condition. The risks associated with removal of the asbestos insulation material are many times greater than repairing the damage and maintaining it in good repair, in this particular instance* i. I trust that these few observations and remarks will be of value to you in restoring a sense of perspeojtive to a problem which has been grossly exaggerated. My son attended the Mary L. Tracey School and I have no fear whatever concerning his health as a result of being educated in that stimulating environment and pleasant building. Yours sincerely, /sh attachment: curriculum vitae Hilton C. Lewlnsohn, M3., 3Ch., DIH, MFOM bxposed asbestos discovered 2> i O 0 fL V 'i in Orange Community Center \ , By USA A. BULL ' . ; Department confirmed. Responding to ance with fire and safety codes played a - Staff Report*..' - - ; information gathered in a 1977 Depart- part in the decision to close the area. ORANGE -- Municipal officials Lave . ment of Education survey on schools' banned the use 0/ the Mary L. Tracy ' asbestos problems, Curry said be asked Community Center basement where the local school 'office last June for asbestos is exposed in some sections of samples of "ceiling material" where But aside, from banning use of the basement, it is unclear wbat restrictions local health officials will impose. heating pipe insulation. .asbestos was detected. White said he will not order suspended Although asbestos in insulation is pot The samples were never sent. Cibbar ceilings removed to see if the situation unusual or normally dangerous, an offi elli said "the problem was corrected" by exists elsewhere as long as the asbest,as cial from the state Department of Health painting the tiles. -is "covered by tape or a ceiling." -- as Services said Friday a health hazard may First Selectman Ralph Capecelatro, long as the ceiling is intact exist for the entire building -- used for who also denied knowing of the condition, r At Wallingford's Sheehan High School. Dearly 60 years as an elementary school Friday called for a full.investigation to "where the presence and removal of -- if insulation is damaged. : * . determine whether similar asbestos insu- asbestos caused a major controversy, A carcinogen when tiny fibers are lation exposures exist in the town's three ` beams which were hidden by suspended inhaled the asbestos appears exposed as other elementary schools. - - ---ceilings were sprayed, it was discovered. a paper-like material in at least three He noted that other prohibitive costs with fireproofing insulation containing places where the ^basement .pipe insula ^f bringing the basement into conform- ath*tnc tion was -either cut or broken. In at least one place, several feet of damaged insulation already were wrap ped with - sealing tape ' to prevent exposure or flaking, the most hazardous condition. Most of the pipe insulation, however,'is intact _ Director of Health Robert White said, "As long as we don't use the area, we really don't have to do anything. Mainte nance people are the only ones who go through there, and not very often." He claims the condition is not dangerous. But according to George Curry, a spokesman for the health department chief's office, 1 percent asbestos content is viewed as '`'potentially hazardous." The exposed material at the community cen ter was found to contain 32.5 percent asbestos in tests made last month by an independent laboratory. The area is not locked or sealed off, and warning signs are not posted. White said be will leave the imposition of safe ty measures to the selectmen's office. ,* . V A routine inspection by sanitarian Ar- t thur Castellazzo uncovered the potential ly dangerous exposure. State health au-. thorities have not been asked 4fr take air. samples to determine what, if any, asbes tos is present in the area.t - <- The area includes a cafeteria, full kitchen, two classrooms and restrooms, .and was being prepared for use as a youth drop-in center, offices and the site of an expanded elderly nutrition pro gram. , ' ;; -V . , Above the basement in the split level building are a senior center, the Park and Recreation Department offices. Human Services Agency offices and Pub lic Health Department offices. ' Daily meals for the school, when It was in session, were prepared in the ` basement kitchen, according to Superin- 1 tendent Vincent Cibbarelli. He denied knowing of the condition when the school was turned over to the town in October. Asbestos also was detected in ceiling tiles in the basement, the slate Health