Document aJvE98o1NV1EpK4YKNpqMdLJM

rwmgjn i PLAINTIFF'S i EXHIBIT 1 626 South Staunton Drive Tucson, Arizona 85710 September 9, 1974 Richard A. Lemen Chief, Biometry Branch, DPS Cl HIOSH U*5, Post Office Building 5th and Walnut Streets Cincinnati, Ohio 45202 . * . . Dear Dick: .. . Enclosed is my report of our recent trip to the Texas Asbestos Workers Program in Tyler. Please let me know what happens with the findings and recommendations. If you have any questions, please call me* Thanl: you* Sincerely yours. William M. Johnson, K*D* TEXAS ASBESTOS WORKERS PROGRAM TILER, TEXAS AUGUST 26-27, 1974 TRI? R2?OST: YJILLIAM M. JOHNSON, K, D, Purpose: 0^1 August 26 and .27, 1974, Richard Lcmen of KIOSK and I reviewed cany of the medical, epidemiological, and procedural aspects of the Tylor Asbestos workers Program. This review was considered a function of KIOSK's responsibility to assist the National Cancer Institute in the monitoring of the contract with the Texas Chest Foundation in view of KIOSH's experience and expertise in asbestos epidemiology and field- pro.grans. 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 2o, 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 64tnpatient 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, for.tur Clinical director of the East Texas Chest Hospital. This is a part tine job for Dr. Miller, who recently left his full-time position with the last Texas Chest Hospital to enter tne private practice of internal medicine and cheat diseases in Tyler, Dr, Killer reoorteuly ssends his largest block of continuous time at the Program on Wednesday afternoons, although he is available for 1 its-:i time on most otner ciays. Dr, Hurst expressed concern about t.-.c need for a full time medical director and emphasized that r.r. Killer has extraordinary time demands in just establishing his private irsctiec. Ir. -7..'. lu has been recently assigned to ten Program as a full :ur. :- ph;-r i*.:i.t arid has seen seeing all the patents since Auau.'a to, 1774, Dr. Miller is reviewing chest X-rays and reviewing a n: sirring potUst rirmi'i?.; , after the clinical data has been asssxc.'.cJ by nurse. Clinical Mixta sheets including respiratory symptoms, smoking histories , -par bln-wit physical findings , pulmonary function data, chess X-ray features , and s -:utuu cytology findings are sent to each t,a t i. o r. t; C private ph y r; i c ian. Following a brief review of a limited number of medical records, it is apparent that the diagnosis of auoestosis or "findings consist ent with asbestosis" are not entered in the patient charts and * Page 2 i letters* Two out of two individuals who were diagnosed'as I asoestosls in the NT03K survey of October., 1971, by multiple 1 criteria arc not curx*cntiv diagnosed as having asbestcsis, despite the fact that these individuals meet multiple criteria for the diagnosis and have essentially the same findings ..as in 1971* The i reluctance to include asbestosis in the charts--is interpreted as 1 a way to avoid involvement in compensation and legal actions* Conseouently> the patient's private physician does not even receive f benefit of the interpretation of whether his patient has asbestosis or "findings consistent with asbectosis"* Only a small fraction of the total number cf chest X-rays have been interpreted by a radiologist and have a.dictated report for the patient record* Examples wore noted where the examining physician made handwritten interpretations on small sheets of paper,.which did not even include the name of the patient. Also, the chest X-rays have not been interpreted according to either the U*J.C*C*/Cincinnati or liO-U/G 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 throe technicians. The senior technician indicated she was pleased with the quality of specimens. Aerosol induction by 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. forced :spirograms are obtained with an Ohio 342 spirometer with a rray-h recording. We did not observe an actual patient sit-.at ion ?.r.d the rceorv.i/w-; and calculation of spiroactric values* Alee. - twelve, lean RKG is obtained in addition to blood samples for 2 hematocrit, hemoglobin, and carcinoeabryaaic antigen {C'-liA)o Th-- ---t test xc provided by by Hoffman-La Roche. A urinalysis is porfrruvi without m apparent microscopic exam. Three technicians 'xt: tud^etnu for the pulmonary function, and blood and urine specimens. Each patient has four chest radiographs in the Radiology Her-.rcr-int including a P-A and lateral with grid and a P-A and ietfrai without ::ril. A two u invite processor is used, and the timr: in tin: Ra-i.io.lcny iWon.rttent is considered less than thirty minutes.per patient* Also, a nuestionaire anp-'rontly is administered to the patient.by the nurse or social worker* The present Questionnaire was submitted with the contract .ipoiication to the I!ational Gu.'ieer Institute and was never submitted for CM8 ap*roval. It has not * Page 3 been formatted for keypunch coding; purposes. It has been assumed that the 'Igovernmcnt" will provide the final cuestionnairs and obtain OMB approval. Consequently, the program has been Halt ing the number of patients, awaiting a final questionnaire* N.7QSH and NCI have been confused about their specific roles and responsib ilities in developing a final quentionaire. According to Or. Michael Sporn, the NCI Project Officer, NCI is waiting for NJOSH and Or. Irving Selikoff to deveioo a final questionnaire' Also according to Or. Sporn, NCI has responsibility for obtaining 0M3 approval* In addition. Or. Sporn says that NOT expects NIOSH and Or. ^eiikoff,with their experience in asbestos field laves gabions, to provide <-.<,1 and data control guidance to the Program.- Or- SnJ igoff apparently has a ;s40.i)ou contract .with NCI to follow up ^he Patterson workers and provide guidance to the Tyler Program. No mep.nir.gful provisions appear to have been made at this time for data handling including coding and reduction of medical information. Also, it appears tnat no decision has been made 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 seen. When summary letters and-data are sem to individual patients, the date of correspondence and a chech mark are inserted in the patient name column in the log book ' Richard Lenen and I learned that in November 1973, chest X-rays and pulmonary function studies were obtained by the Sast Texas Chest hospital, at the expense of the Pittsburgh Corning Company, on many worker:: included in the August 1971 medical studies. According to Merman i'andic, the former local union chairman, the workers erd their physio tana have never received the results of the November 3971 medical studies. Pit hard '.oraen and I visited Dr. Haskell Muntz in his office in "yl-:r. Dr. Muntz is in the practice of general internal medicine and r.as referred approximately 70 former Tyler asbestos workers to a Tylvr thoracic surginn for closed lung biopsy at the Mother -Frances Hostlhr.'.. Dr. Muntz said tnat as many as two to three men have beer. :: epsio-u. on some any:; and that no biopsies have been done in rece;.- vj!ezs. A local pathologist has read the biopsies and tier: :_ro~lc ov 1 u c-rice of as bos toy is reportedly has been found in inelv_rials with m1) Ctrloctire clinical evidence of asbestosis and it individuals wits verv brief employment at the asbestos plai-z. Individuals repor louiy are aom.it ted to Mother Prances Hosp ital for one day, and the closed lu:u; biopsies are done under a local anccthutic in the one ratin'} room. Dr. Muntz expressed to us the opinion that the procedure entails a low risk and that a tissue diagnosis of asbestosis is essential for purposes of litiga tion and compensation, pnrticuiartly in patients with a negative chest X-ray. I expressed my reservations to Dr. Muntz about using * Page 4 - an invasive procedure with a low but definite rick, to make the diagnosis of asbcstos.U. I expressed ray 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. Selikofi in Hew York and that he had not received any interpretations fro:.' Dr. Selikoff. Dr. Muuts expressed concern about the psychological health of the former asbestos: .-workers in his practice and said that they were as a group bitter and depressed about their prognosis. Dr. Kuntz said many of the former workers have shown narked improve ment in the forced expiro'grams over the past several months foilov/ing symptomatic treatment in addition to allery shots for poller.osic. Richard 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 ny 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 meetings wore held within a 30 mile radius of Tyler. *A total of 639 letters were mailed inviting former workers to attend, and a total of 196 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 130 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 cessions were held at the Last Texas Chest Hospital (three for former workers and onv for hospital staff). In addition, ues.tir.gs wer held in Athens, Longview, Kilgore, Hawkins, Jacksonville, Lindtie, and Gilmer, *ex;:a. The meetings consisted of a slide presentation foilowea by o question and answer period. .These raactiiicz :u:n largely th responsibility of Mrs. Fielding, the Program nurse, and Mrs. Klein, a social worker. Lizkarc I-o.-Dn and I raid a visit to the Imperial American Conrany, th-: current owner of the building in the Owentown Industrial lurk formerly occupied by the Pittsburgh Corning Corpora tion i.zcentr-j operation::. c discussed the asbestos problem with Mr. -fcnnis K. Mciniis, tin: Plant Manager of Imperial American. xor the past year the building formerly housing the asbestos operations has seen loas-i to In torn itional Metals for storage of electrical apt.Liincftd such as evaporative coolers. Richard Lemen and I toured the building with permission and could find no visual evidence of residual asbestos dust. Tnn NIOHH regional office in Dallas reportedly did nr: industrial hygiene evaluation for residual asbestos dust several months ago, and reportedly neither the Imperio.l American Ccuiu.any nor cue Division of Field Studios and Clinical Investigations received a report. Page 5 Conclusions. Recommendations, and Questions: K) A medical director is needed who can devote all or a significant proportion of his professional tiae 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.) ^11 chest X-rays should be read by a radiologist, hopefully with some training, interest, and experience in occupationl lung disease. 11 chest X-rays should be read with a comprehensive radiological interpretation and according to the U. I.C.C./^incirnati or ILO-U/c ''lassification of Pneumoconiosis. 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. Also, 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. The master log book used to enter patient names and 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.d'.'rssre? on envelopes are individually typed. Mailing address labels should be made up in advance using modern data processing or computer methods. Many of these addresses already have oss.- key punched by NI03K* 5. a medical records consultant should review the entire raethri :: record keeping and data flow in view of the current inafe::::ies. no provisions have yet been made for formatting the miol.aJ j.-ita :hr computer storage and eventual analysis. Jio deei.*.-onsUor ooncrc t:? plans have been, made about who will oversee data prooessinr and control. ~. ` fhe i'atioral Cancer Institute apparently has not yet ever v.ppiiofi xor pre.lininHrv 0X3 clearnor'H or. ~"csticnnad-ra* Also a final questionnaire has: not been draf ted- and final' clearance has r.ct beer, requested. Tro exact roles ..i HIOSH, ana ,-it. Sinai in the development, approval, and final authorization of the questionnaire - ha3 not .been defined adoouately . . . ,, . Also, tr.e Program in Texas has limited the number of scheduled ap:;ointmc.:t3, while awaiting a final questionnaire from the "government*'. t Page 6 8.) A final questionnalrecshould. be.put into,'finished fora quickly, and 0MB 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 oe used until a final form is available. . 9.)* Asbestosis or "findings consistent with asbestosis" should be.used in the medical record. ?hu patient may request that his data be released to his legal representatives for .purposes of litigation or compensation. x`he medical record should include 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 sigcoidoscopic and barium enema procedures? Has this phase of the program, which is essentially clinical research, been reviewed by a human subjects research committee. here already some epidemiological data pointing toward an increased risk of colon cancer in asbestos workers according to Dr. Selikoff. Ahc 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 exaain?.tion and test . for occult blood, particularly in those individual's who are over age 50* . 11.) Have the research and clinical aspects of the program beer, reviewed in total by an FCI human subjects review committee. It is r_v understanding that at this time not one full time U.S. Public Health Service physician has made a site visit to the Program, despitf the fact that hit-.: Program exists .basically for the medical . surveillance and the early clinical detection of lung cancer in ?. hi.tr. risk group. . . ' *i.) Althouyr. I have serious reservations about the closed lung bioycisS reportedly performed on 70 former asbestos workers, the slidvs shoula bi reviewed oy a pathologist o.xxvirior.ccd in occupational lung diseases and asbestosis* For example, the confirmation of astirtesis in a 'lumber of vor'-rers with, short exposures on 1d hav --s?i^ ^ qnA mad.Leal value, particularly in those iruTividuals with no radiological or other clinical evidence of disease. 13.) Why were the results of the November 1973 medical studies performed at the Bast Texas i*;hest Hospital not forwarded' to the former workers and t:.eir physicians? ' 1A.) Most of the education mootings were held in a two week period beginning in late May. Apparentlythere has been minimal i 7 . Page 7 initial publicity and no continuing publicity of the Progran 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 vrith local physician groups. The clinical and procedural aspects and Program goals should be explained at clinical conferences at local hospitals1 . 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 are 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. Wor2<ing 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 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 patients. Many of n/ the former asbestos**workers see'the ISa&fTexas-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 the expense of the company.* 19,} The identification and reporting of asbestos or '/ ferruginous bodies in the sputum of former asbestos workers-"appears / s to me u r.ear.i:igl2ss endeavor with no diagnostic or prognostic significance.- Tffcat is the research objective of this procedure? . i:.; Apparently part time workers including college students and individuals e:.vained from Manpower were employee at the Piter burgh Corning Corporation plane in such activities as unloading bags of asbestos from railroads cars*1 These individuals should be identified and offerred the services of the Program- 21.) Some Program staff members expressed concern and confusion about the selection of a control group. How would a control group be utilised at the present time* Would a control group be important in interpreting the prevalence and incidence of sputum cytology findings of atypia.- 'perhaps, NI03H and NCI . should reach an agreement on the indications for and selection methods of a control group A control group seems academic at this time, because top program priority should be devoted to health screening of the highest risk former asbestoa workers* t % Page 8 22*) The &I03H 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 NIOSK, NCI, and tff. Sinai in the program need further discussion and possibly formal agreement- Perhaps, the tine has cone for a meeting of all concerned parties to evaluate the currant status and progress- of the Progrda and their respective roles. Prior to such a neeting, the Program personnel should prepare o progress report and activities summary* Respectfully, submitted* / 625 South * tauntor. Drive Tucson, sena 55710 Phone; 6ii/ 535-8363