Document k9kYaX7dX1ng6dMgKzQxXO3RE

1 626 South Staunton Drive Tucson, Arizona 85710 September 9 1974 Richard A. Lemen Chief, Biometry Branch, DPSCl HI OSH U.S. Post Office Building. !*' 5th and Walnut Streets >t\/: Cincinnati, Ohio 45202 :' ,, V Dear Diet: " ;1 . .- - -j Enclosed is my report of our recent trip* to the Texas Asbestos Workers program in Tyler. " * ii f DID `U FILES Please let me know whali happens'with the findings and recommendations. If you have any questions, please call me. Thank you. Sincerely yours. O* dy William M. J ohjMrtw;,' ' __ LEL2213115 1 TEXAS ASBESTOS WORKERS PROGRAM TYLER, TEXAS AUGUST 26-27, 1974 TRIP REPORT: WILLIAM w ' .Tnwwsnw M. n Purpose: liw I wv. .i Ilv'lfi i i V, On August 26 and.27, 1974, Richard lemen of KIOSK and I reviewed cany of the nodical, epidemiological, and procedural aspects of xhe Tyler Asbestos Workers program. This review was considered a function of NIOSK's responsibility to assist the Rational Cancer Institute in the monitoring of the contract with the Texas Chest Foundation in view of HIOSH's experience and expertise in asbestos epidemiology and field- programs. Findings: A former asbestos worker of the Pittsburgh Corning Corporation plant was first seen on June 24, 1974. A total of 133 patients have been examined as of August 26, 1974, an average of three to four patients per working day. Reports on 64 patients have been sent to the patients and their private physicians as of August 26, 1974. The 64th patient was examined on July 18, 1974. This represents a delay in reporting of approximately five weeks; however, we were told most of the remaining patient reports would be completed during the week of August 26, 1974. The acting program Director and chief physician is Dr. John Miller, former Clinical Director of the East Texas Chest Hospital. This is a part time Job for Dr. Miller, who recently left his full-time position with the East Texas Chest Hospital to enter tne private practice of Internal medicine and chest diseases in Tyler. Dr. Killer reportedly srends his largest block of continuous time at the Program on Wednesday afternoons, although he is available for a limited time on most other days. Dr. Hurst expressed concern about the need for a full time nodical director and emphasized that Lr. Killer has extraordinary time demands in Just establishing his pri*.'2te practice. Ir. -J.p. Lu has been recently assigned to tt:e Program as a full time physitian and has been seeing all the patents since August 15, 1974. Dr. Miller is reviewing chest X-rays and reviewing ana signing patient summaries, after the clinical data has-been assembled by the nurse. Clinical .data sheets including respiratory symptoms, smoking historiest partlnent physical findings, pulmonary function data, chest X-ray features . and sputum cytology findings are sent to each patientprivate physician. Following a brief review of a limited number of medical records, it is apparent that the diagnosis of asbestosis or "findings consist ent with asbestosis" are not entered in the patient charts and | BB 0013116 | % Oil* 1 'V ? ^ *"MT Page 2 ' lA. letters. Two out of tv:o Individuals who were diagnosed' as as'oestosis in the 1IT0SK survey of October., 1971, by multiple criteria are not currently diagnosed as having asbestosis, despite the fact that these individuals meet multiple criteria for tne diagnosis and have essentially the same findlngs_as in 1971* The reluctance to include asbe3tosis in the charts^.is interpreted as a way to avoid involvement in compensation and legal actions. Consequently, the patient's private physician doe3 not even receive benefit of the interpretation of whether his patient has asbestosis or "findings consistent with asbestosis". Only a small fraction of the total number of chest X-rays have been interpreted by a radiologist and have a.dictated report for the patient record, Examples were noted where the examining physician made handwritte'u interpretations on small sheets of paper,.which did not even Include the name of the patient, 4iso, the chest X-rays have not been interpreted according to either the U.I.C.C./Cincinnati or ILO-U/O Classification of Radiographs of Pneumoconiosis, Also, the few charts-we reviewed did not Include a mounted 12-lead EKG with an interpretation by a cardiologist. The sputum cytology laboratory is staffed by three technicians. The senior technician indicated she was pleased with the quality of specimens. Aerosol induction hy an ultrasonic nebulizer is used for the collection of one specimen at the hospital. In addition, . three first morning specimens are examined, for the presence or absence of asbestos or ferruginous bodies using papanicalou stain. Iron stain has not been used. The presence or absence of asbestos bodies or ferruginous particles is then reported to the patient and his physician without Interpretation of their significance. ,, The senior technician said she counts and records the number of particles in some specimens but not in relation to any specific unit area or volume. Rorced expirograms are obtained with an Ohio 342 spirometer with a graph recording. We did not observe an actual patient situation anti the recording and calculation of spirometrie values. Also, a twelve lead EKG is obtained in addition to blood samples for = hematocrit, hemoglobin, and careinoembryonic antigen (\)0Jhe ZZl test is provided by b5f Koffman-la Roche. A urinalysis is performed without an apparent microscopic exam. Three technicians are budgeted for the pulmonary function, and blood and urine specimen; Also, a nuestionair oatieat.by the nurse or social was submitted with the coorrnntract Institute and was never submittc Sr$*nt questionnaire the national Cancer Q-'fS^ap'roval. It has not I ] BB 0013117 1 % NOTE. vr , -1 ST OiO r r'lLES Page 3 been formatted for keypunch coding purposes. It has been' assumed that the 'Jgovernaent" will provide the final questionnaire and obtain 0MB approval. Consequently, the Program has been limit ing the number of patients, awaiting a final nuestionnaira. MuOSH and NCI have been confused about their specific roles and responsib ilities in developing a final questionaire. According to Dr. Michael Sporn, the MCI Project Officer, NCI is waiting for KIOSK and Dr. Irving Selikoff to develop a final questionnaire.' Also,, according to Dr. Sporn, NCI has responsibility for obtaining CM3 approval. In addition, Dr. Sporn says that NOI exnccts KIOSK and Dr. ^elikoff,vith their experience in asbestos field invesk-akcions, to provide ppiiip"T-naLd<",'"2lf'ai and data control guidance to the PrsrgramT ~Br. Selikoff apparently h.^s a contract with KOI to follow up the Patterson workers and provide guidance to the Tyler Program. No meaningful provisions appear to have been made at this time for data handling including coding and reduction of medical Information, Also, it appears that no decision has been cade regarding where and who will do the computer storage and analysis of the data. Patients are entered into a master log book and assigned a Program number as they are 3een. When summary letters ar.d data are sent to individual patients, the date of correspondence and a check mark are Inserted in the patient name column in the log ' book. Richard Lemen and X learned that in November 1973, chest X-rays and pulmonary function studies were obtained by the East Texas Chest Hospital, at the expense of the Pittsburgh Corning Company,on many workers included In the August 1971 medical studies. According to Herman Yandle, the former local union chairman, the workers ar.d their physicians have never received the results of the November 1973 medical studies. ichard Leman and I visited Dr. Haskell Muntz in his office in Tyl er. Dr. Muntz is in the practice of general internal medicine and ha s referred approximately 70 former Tyler asbestos workers to a Tyle r thoracic surglon for closed lung biopsy at the Mother Frances Hostit l. Dr. Muntz said that as many as two to three men have beer, i iopsied on some days and that no biopsies have been done in recs:.* weeks. A local pathologist has read the biopsies and n i c r : code evidence of asbestosis reportedly has been found inuiV, nuals with nd uLhur uNjeuuive clinical evidence 6f and in individuals with very brief " plant, Individuals reporteuiy are ital : cr ohe day, and the closed 1 local iancathutic in the operating room, :C$xg^ased to the on,inion that the procedure entails that a tissue diagnosis of asbestosis is ess^J' of lltiga- tion a; d compensation, partlculaw^^ J iSSPith a negative ches t X-ray. I expressed my resei^fc ^ , Kuntz about using * ! r*- t r Hy. h; >. Ml DID i. Page 4 an invasive procedure with a low but definite risk to make the diagnosis of asbestosis. I expressed m,y opinion that one must look at the entire clinical picture and the exposure history. Dr. Muntz said that he personally had delivered frozen lung tissue to Dr. Selikoff in Dew York and that he had not received any interpretations from Dr. Selikoff. Dr. Muntz expressed concern about the psychological health of the former asbestosl .- workers in his practice and said that they were as a group bitter and depressed about their prognosis. Dr. Muntz said many of the former workers have shown marked improve ment in the forced expiro'grams over the past several months follow ing symptomatic treatment in addition to allery shots for pollenosis. Kichard Lemon and I talked briefly by telephone with Mr. Fred Baron, a Dallas attorney who is representing many of the former workers; i again expressed my reservations about doing closed lung .biopsies for litigation and compensation purposes. . During a two week period ending June 3, 1974, a total of eleven educational neetings were held within a 50 mile radius of Tyler. -A total of 639 letters were mailed inviting former workers to attend, and a total of 198 individuals attended these evening meetings. In addition, 60 individuals contacted the Program-for an appointment.. Summaries of the educational meetings were sent to those unable to attend,including approximately 180 Individuals out of state and in the Dallas and Houston metropolitan areas. Approximately 130 individuals are lost to follow up as confirmed by returned Program correspondence. Four sessions were held at the tast Texas Chest Hospital (three for former workers and one for hospital staff). In addition, uei.tir.gs wer held in Athens, Longview, Kilgore, Hawkins, Jacksonville Liniaie. and Gilmer, `exas. The meetings consisted of a slide presentation followed by a question and answer period. . These meetings wore largely th responsibility of Mrs. Fielding, the Program nurse, and Mrs. Klein, a social worker. nieharb Lemer. and I paid a visit to the Imperial American Company, the current owner of the building in the Owentov^ Industrial Park formerly occupied by the Pittsburgh Cpr&in*SCorpora tion asbestos operations. We discussed the asbestoAOprO^La^>-with Mr. -er.nis M. Mclnnis, the Plant Manager of ImperLat"<^m&u*Jtcan.. Jor the past year the building formerly housing thao'V&h.eiAjfe''operations has o = en leas_a to International Metals for^tSxh^gg^wr electrical apt-lances such as evaporative coolers. and I toured the building with permission ar.d could.^iVidJr^qQvisual evidence of residual asbestos dust. Tne NI0i^TfiAS?6n^'T oj^rice in Dallas reportedly did an industrial hygie^W^^^&tAjwi'for residual asbestos dust several months ago, and the Imperial American Company nor the Dlvlsxa^o&JS'l^fif Studies and Clinical Investigations received a repor "bb 0022222. 4 ^Tr. TM; i/** ' ' J J j w. ,. Page 5 Conclusions, Recommendations, and Questions; .1. ) A medical director is needed who can devote all or a significant proportion of his professional time to the Program. Dr. Miller has the pressing demands of a private practice. The problem of recruiting a qualified and experienced chest physician for the position has no easy solution. 2.) All chest X-rays should be read by a radiologist, hopefully with some training, interest, and experience in occupationl lung disease. All chest X-rays should be read with a comprehensive radiological Interpretation and according to the U,I.C.C./Cincinnati or ILO-U/C Classification of pneumoconiosis. a dictated report by a radiologist should become a part of each patient's medical record, a copy of the report should be placed, in the X-ray envelope, and an additional copy should be sent to the patient's private physician. 3.} Each sheet of paper in the medical record should- include the patient's name for medical-legal reasons and for good record keeping. Aso, an identification number should be on each sheet. Perhaps each patient should have an identification plate for stamping of medical record sheets, as used in. a hospital or clinic setting. a.) The master log book user1 to enter patient names end- identification numbers is not adequately organized. For example,there are no separate columns for recording only disposition data and when summary medical data has been forwarded to the private physicians. Consequently, the log does not fulfill any control or scheduling function. Also, the secretary has made data entries in the patient name column which only she or a limited number of people can understand. 5.? *11 s.diresres on envelopes are indiv'dually typed. Mailing address labels should be made up in advance using modern data processing or computer methods. Many of these addresses already have bee.': key punched by KIOSK. ?. A 2 eaicai records consultant should review the entire meth: : :f rec erd keeping and data flow in view of the current. inaf ^ :cacies. -ij.se, no provisions have yet been made for fojapatting the i i.-'-S.] j ~ * ^ for computer storage and eventual analysiUK, deei: .c-nsnor conOcTr'eott.e-'' npllnannas. hhsavveo hboeenn mirnardioe abboouutt, who wil3JJrSpf\ijM _ data :rocessi ng and control. ever a fJ1*in; . , has :c Sinai of th Also, a D r. o i gover e National Cancer Institute apparer.tljfW'.api'iqit' yot for preliminary OMB clears non on aYSv'aj&^ipdrnadia* Also tionnalre has: not been drafted- clearance 0013120 4 _ ' -f h.-xh, DID 'vj FiLES ; ;"."l r.j i' J` Page 6 8.) A final questionnaire:should .be. put into .'finished-fora quickly, and OMB approval should.be requested without delay. Meanwhile, at least 10 patients should be scheduled daily in view of the number of professional and technical staff and the availabil ity of sputum cytology and radiological services. The present questionaire should continue to De used until a final fora is available. 9.)' Asbestosis or `"f ladings consistent with asbestosis" should be .used in the medical record. The patient may request that his data be released to his legal representatives for purposes of litigation or compensation, ``he medical record should includ an accurate clinical assessment including the;diagnosis- of asbestosis based on sound criteria; moreover, an interpretation regarding the presence of asbestosis or "findings consistent with asbestosis" should be forwarded to the patient's private physician, not just fragments of clinical data which the average physician has no way of interpreting as asbestosis, 10.) Carcinoembryonic antigen (CEA) testing is being provided by a major pharmaceutical company. This is a controversial test Is view of the problems of false-positive and false-negative results. Who will provide sigmoidoscoplc and barium enema procedures? Has this phase of the program, which is essentially clinical research, been reviewed by a.human subjects research committee. There is already some epidemiological data pointing toward an increased risk of colon cancer in asbestos workers according to Dr. Selikoff. Ahe current questionaire does not assess change in bowel habits which may be the first hint of colon cancer.. Also, the physical exam does not include apparently a rectal examination and test for occult blood, particularly in those individuals who are over age 50r 11.) Have the research and clinical aspects of the Program been reviewed in total by an NCI human subjects review committee. It is n.v understanding that at this time not one full time U.S. Public Health Service physician has made a site visit to the Program, despit= the fact that the program exists .basically for the medical surveillance and the early clinical detection of lung cancer in a htga risk group. .) Altkougn I have serious reservations about the closed lung bicrci= s reportedly performed on 70 former asbestos workers, the slides should be reviewed Dy a pathologist experienced in occupational lung si senses and asbestosis. For example, the confirmation of ^ astirto sis in a number of workers with short exposures ujonid ^ O' h av: sc ientl.flo and medical value, particularly in those with no radiological or other clinical evidesnncCeR ooif' 13 -) Why were the results of the NovembDeo.r 1. bja^und^atit^tudles perform cd at the Bast Texas tlfteat Hospital not<'to the' former workers and ti.eir physicians? 1* . ) Most of the education meoti^V^^ru^jeaAjiSh a two week period beginning in late May. Arpc.-S^riiJXtis been minimal :. . ^ ------------- --- 1 BB 0013121~7 4'\`- *1 Page 7 initial publicity and no continuing publicity of the Program in local newspapers, radio, and television,,- Should the Program, maintain a low profile with the local media? 15.) No educational meetings reportedly have been held with local physician groups. The clinical and procedural aspects and Program goals should be explained at clinical conferences at local hospitals*'- 16.) Many of the workers reportedly are very depressed and anxious about the projected increased incidence of cancer and disabling lung disease. Should not a social psychiatrist or behavioral . scientist be consulted about the problem in order to maximize the total health benefit of the Program? 17.) Two social workers p_re currently employed, and a third social worker is budgeted. Comprehensive social and economic information apparently is not being vigorously obtained from those patients and their families with employment, financial, and health complications associated with past'-occupational.exposures, to asbestos, Working relationships apparently have not been established with local social agencies to assure maximization of benefits and public services. Also, the number of home visits have been minimal? 18.) Many workers reportedly are V*T of the Program objectives and integrity. If these attitudes appear to endanger the success of the Program, perhaps the staff should undergo sensitivity training directed toward the warranted confidence and needs of their patient3. Many of the former asbestos'mrorkers seeJ'the Eat~Texas-Chest Hospital as an agent of the Pittsburgh Corning Corporation, because the workers were initially told there, were no cases of asbestosis in the medical survey of August 1971 performed by the hospital / at ths expense of the company? 19.) The identification and reporting of asbestos or `/ ferruginous bodies in the sputum of fofner asbestos workers-'appears / x to zs a meaningless endeavor with no diagnostic or prognostic signifisance.- ?/hat is the research objective of thi3 procedure? .. 21,'; Apparently part time workers including collegevfstudeats and individuals obtained from Manpower were employee tish gh Corning Corporation plant in such activltifS'g <$%fe<P :. unloading bags of asbestos from railroads cars.' labials shcwli be identified and offerred the services gram* 21 o) Some Program staff members expi^6x?Qi^c>iiem and niusion about the selection of a control, giun,vt'How would control groun be utilized at the or control screening of the highest risk former asbestos workers r > Page 8 ./ 22.) The NI03H Regional Office in Dallas should send a report of their Industrial hygiene findings about the building formerly occupied by the asbestos operations to all concerned parties.- 23.) The roles and expectations of HIOSK, MCI, and Ht. Sinai in the Program need further discussion and possibly fornal agreement. Perhaps, the time has come for a meeting of all concerned parties to evaluate the current status and progress of the Progrdm and their respective roles. Prior to such a meeting, the Program personnel should prepare a progress report and activities summary*' NOTE: TH!2 DOCUMENT DID NOT COME FROM PPG FILES Respectfully, submitted. William M. Johnson 626 South St-iunton Drive Tucson, hrizena 85710 Phone: 6:2/635-8363 A'^' .OO' 'iV**' vtV-** *: w6* * I BB 0013123 J I l%