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FES 0T? '97 11:23 FR GEQN-ENV-SflFE-fflLTH 216 930 3034 TO 87037416091
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THE GEON COMPANY
One Geon Center, Avon Lake, Ohio 44012
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John Gressler
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One Geon Center
Avon Lake, Ohio 44012 216-930-1000
FAX MESSAGE (Page 1 ofl)
To; Mr, Richard Ehrenberg CDC/NIOSH
From; Dennis Cocco
Date; February 7, 1997
As per my phone conversation with you earlier today, f would like to inform you that we believe there were some serious errors written in the 1997 editorial portion of your February 7, 1997 MMWR on "Angiosarcoma of the Liver among Polyvinyl Chloride Workers - Kentucky". These concerns center on;
a) Your presentation that VCM is now universally considered a highly potent chemical carcinogen is not exactly correct.
B) Your description that a manufacturer received "substantial profits" as a result of the development of a patented system is simply not true. Also, the inference that someone profited from the problem is certainly misleading
Please consider that we believe you should reconsider releasing the document as it is currently written or at least be prepared to issue a retraction at the earliest opportunity. We will be sending you shortly a formal letter to follow up with this FAX to further clarify our position.
Please do not hesitate to contact me should you have any questions. My telephone number is (216) 930-1S38 and my FAX is (216) 920-1428.*****
*****
V
CMA 114864
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HFGoodrich
4020 Kfnrott Lakes Parkway Richfield, Ohio 44286-9368
Tdphon 216-659-7998 Fax; 216-659-799G
FAX COVER SHEET
The BFGoodrich Company
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DATE: to:
CDOMOSH Office of Extramural Coordination and Special Projects
1600 Clifton Road, NE, (IMU); Atlanta, GA 30333 FACSIMILE (404) 639-0035
*? / & / 9/COVER A ^ PAGES
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FROM: (404)539-3525
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Bemit Xuchinjld
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___ Melvin Myers .... Victoria Thomas ____ Price Connor , ____ Richie Dickerson
COMMENTS:
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Ifyou have any questions regarding this fax, please call. Thank you.
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February 1.1937 / Vol. 40 / No, S
97 Angloiareema of the Uvgr Among Polyvinyl Chloride Workers
101 Botes of Homicide, Suicide, end FlreemoRelsted Death Among Children -- 26 Industrialized Countries
10S Adult Blood Load Epidemiology and Surveillance -- U.S. Third Quartet, 1396
107 FDA Approve! of COMVAX1" 110 FDA Approval ofACEL4MUNE* 112 Notice to Reeder*
As pan of its commemoration of CDCs SOth anniversary. MMWR la reprinting se lected MMWR articles of historical Interest to public health, accompanied by current editorial notas.
Reprinted below is a report published February 9. 1974. which described the inves tigation of a duster of cases of angiosarcoma of the liver among polyvinyl chloride workers in Kentucky, followed by a contamporary editorial note. The report illustrates die public health process in occupational safety and health--progressing from the in itial observation of a new problem by informed clinicians through follow-up epidemiologic end toxicologic investigations to a targeted regulatory response, which virtually eliminated the newly recognizedproblem.
EPIDEMIOLOGIC NOTES AND REPORTS ANGIOSARCOMA OF THE UVEA AMONG POLYVINYL CHLORIDE WORKERS -- Kentucky
Between September 1967 and December 1973.4 cases of angioasreoma of the liver wore diagnosed among men employed in tho polyvinyl chloride polymerization sec tion of a B.R Goodrich plant near Louisville, Kentucky. This section of the plant began operations in 1930. ft employs about 270 parsons and produces polyvinyl chloride as well as a variety of copolymers by polymerization of vinyl chloride monomer. Ail 4 men had worked continuously in the section for at least 14 years prior to onset of illness (Table 1); sit 4 had worked directly in verious phases oftha polymerization pro cess.
Cut 1 presented in August 1967 with an epigastric mass and thrombocytopenia. An exploratory laparotomy was performed in September 1967; liver biopsy revealed angiosarcoma. Case 2 presented in January 1970 with gastroimoatinal (Gi) bleeding. RacurrenQBBkAng In May 1970 led to an exploratory laparotomy at which time a di~ agnosia dBBHfnaercoma was made on liver biopsy. Casa 3 presented In January 1964 with Qf ojpcpihg which recurred in May 1905 with signs of portal hypertension. A porticovaTshunt was performed, and liver biopsy yielded a diagnosis of cirrhosis. Repeat biopsies in October 1970 and September 1372* confirmed this diagnosis. Autopsy in March 1973 revealed angiosarcoma. Case 4 presented in July 1973 with
U.S. DEPARTMENT OR HtALTH AND HUMAN SERVICES / Public Health Service
I
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MMWR
February 7,1997
Tabl*l
Cuu of Angiosarcoma of the Liver among Polyvinyl Chloride Workers
ft Goodrich Plant
L6*ji>vill<. KatUucky
Case
Age at
illness onset
1 43
2U 3 41 r 4 ~M ~
Illness onaet
Aufl. 1967 Jan. 1970 Jan. 1904
JvW T973
Date of
Diagnosis
Sepf. 1967 May 1970 Mar. 1973 Dae. 1973
Death
Jan. 7, I960 Sept. 37,1971 Mar. 3,1973 0e, 19.1373
Years worked With PVC before illness
17
14
14
27
hepatosplenomeQaly, weight Ions, and jaundice. Two livtr biopsies were interpreted as showing severe Cirrhosis. Autopsy in December 1073 revealed angiotsreoma.
in each ease, pathologic material revealed the pretence of extensive cirrhosis of a non-alcoholic type in eddition to angiosarcoma. In 2 cases, the diegnosis of angio sarcoma was made only at autopsy, cirrhosis having been diagnosed 7 years before In Case 3 and 6 months before in Case 4. None of the patients gave histories of pro longed alcohol use or exposure to hepetotoxin outside their work place. In particular, none had ever had exposure to thorium dioxide or to arsenic, two materials known specifically to induce hepatic angiosarcoma In man (1,2).
Reported by John Creech, M.O,, Plant Phyaidan, 6.R OeoJrioh Chemical Company. Louisville, Kentucky; Maurice N. Johnson, M.O>, Director of Environmental Health, B.F. Goodrich Chemical Company, Akron, Ohio; Bmtfom Block. MJX, Medical Consultant Kmntudty Occupational Safety and Health Administration, Kontudcy state department of Labor; National Institute for Occupa tional Safety and Health, and the Cancer and Birth Detects Division, Bureau of Epidemiology, CDC.)
Editorial Note
Angiosarcoma of the liver la an exceedingly rare tumor, it it estimated that only about 25 such cases occur each yoor in the United States. Four ceecs, therefore, among e email number of workers at a single plant is a moat unusual event, and one which rsisea the possibility of soma work-relaiad carcinogen, conceivably vinyl chlo
ride itself. Although no data are yet available concerning The occurrence of angio
sarcoma among workers at other vinyl chloride plants in the United States, It seems
distinctly possible thatthe problem may be industry-wide. Epidemiologic studies have started to deieriplne the extent of tha problem in the United Ststes, with respect both to engioaMjjjfrre Qfthe liver and to its possible relationship to post-toxic cirrhosis.
concerning the potential hepafo-TOxtcliy and oncogenicity or vinyl chloride d^Rmttsd. Studies in Germany have suggested a link between hepatio dam age and ^KpWenai exposure to vinyl chloride <J), while Italian workers have sug gested tftwvMyt chloride may cause a wide varieiy of tumors In animals (4), The chemical concentrations used in these latter experiments, however, far exceed levels
likely to be encountered in Industrie! environments. Efforts to confirm such observa
tions and to measure effects at lower dose levels are now in progress.
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1. da Silva fftrca J. Abbatt JD, Cayglla da Motw L Rorij ML Malignancy and other lata affects following administration of thoretrasti uncat 2:201-206.1868
2. Rogation W, Kim (j. Ospina J, Holland JF: Hemanglcandothelial sarcoma of liver from chronic
arsanic intoxication by Fowlary aoiurlon. Cancer 2U14-622.1S6S
3. Maratailar KJ, Laibach WK, Mfillar R. at ai: Chroniach-toxiseha labarschidan bai Arbaitam In dar PVC-Prodyttlon, Dtsch Mad Wochentehr 98:2311*2314,1973
4. viola PL. Slgonl A. Caputo A; Oncogenic responto of rat akin, lungs, and bona to vinyl chloride. Cancer Research 31 16-522,1971
Editorial Not*--1*97: Workari constitute the segment of the U.S. population most
heavily exposed to chemical toxins and physical agents. Because of their intense and prolonged exposures compared with the general public's, workers generally develop illnesses of toxic etiology more frequently, more quickly after the introduction of new chemical compounds, and in more sevara forma.
Work-related diseases encompass a broad range of human illnass (7), For exam*
pie, chronic bronchitis frequently occurs in coal miners; skin cancer in farmers; btad* der cancer in dye workers exposed to aniline compounds; leukemia and lymphoma in chemical workers exposed 10 benzene; kidney failure in lead workers; impaired repro ductive function in workers exposed to lead end certain pesticides; and chronic disor ders of the musculoskeletal system in workers who sustain repetitive trauma.
The diagnosis of occupationally associated disease often is difficult (2), For most
diseases, a case of occupational origin it not clinically distinguishable from illness resulting from other etiologies. Informed suspicion is therefore essentia! to recognize occupational disease, and a careful history of occupational exposure ia the critical diagnostic instrument. In the Initial diagnostic interview of each new patient the phy sician must obtain at lean a brief history of occupational exposures. Modification of the concept of the sentinel health event (SHE) lit has further assisted physicians in establishing linkages between occupational exposures and disease (4).
A SHE has been defined as 'an unnecessary disease, disability, or untimely death whose occurrence signals a failure of prevention* (3). Examples in general madicine
include maternal deaths during childbirth, outbreaks of cholera, or a single case of poliomyelitis. To extend the concept of the SHE to the workplace, a "sentinel health event (occupational)* (SHE(Ol) ia analogously defined (4) aa "an unnecessary dis ease. disability or untimaly death which is occupationally related." Recognition of e SHE(O) requires clinical astutanass and attention to the exposure history. Typically, the occurrence of a SHE(O) stimulates further investigation or research end may trig ger regulatory or other targeted preventive action.
This MMWR report on angiosarcoma of tha liver in vinyl chloride polymerization workers rearesenla a splendid description of a $H6(0). This report marked tha first recognMi|u(ttfie carcinogenicity to humans of vinyl chloride monomer (VCM), the hlghhftft^HS[g*s to which workers were exposed in the B.F. Goodrich plant near Louisvfl^^EKUcfcy. The initial observation was made by John Cratch, M.D., the plant phyawqHHo,ftfaurice Johnson, M.D. the corporate medical director. These physi cian* Heitfeviduated three man with angiosarcoma of tha liver during a 2-year period
(5). They realized, through cartful history-taking, that all of the men with this rare malignancy war* employed in the same department of the plant
Publication of this report and a related journal article (5) stimulated a series of clinical investigation*, epidemiologic studies, and toxicologic analyses. Henry Falk,
A
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Anglo
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M.D., an Spidsmlc Intelligence Service (SIS) officer in lh Cancar and Birth Defects
DMalort Jh CDC% Bureau of Epidemiology, was assigned by his Division Director, Clark W. Heath, Jr., M.O., to investigate this outbreak. Working with Richard Waxweilar,
PH.D,, of the National Institute for Occupational Safety and Health, Hans Popper, M.D,, of the Mount Sinai School of Medicine, and Louie Thomas, MD, of the National Can cer Institute. Dr. Falk confirmed the existence of the outbreak and also dtseovered a prwnslignant lesion--(dlopathJc hepstlc fibrosis--in additional mambers of the popu lation heavily exposed to VCM (6). This work stimulated a major international confer ence thet wee convened at the New York Academy of Sciences by Irving Selikoff. M.D. 17}, at which the carcinogenicity ofVCM waa confirmed. VCM Is now universally con sidered to be a highly potent chemical carcinogen (7).
This recognition of the carcinogenicity of VCM also stimulated intense regulatory activity [8). To prevent future esses of VCM-essociated angiosarcoma, the Occupa tional Safety and Health Administration In 1974 proposed a 500-fold reduction in the occupational exposure standard for VCM gee--from 500 parts per million (ppm) in air to 1 ppm. The plssties-manufaeturfng industry immediately objected that such reduc tion was not possible and would drive the vinyl chloride polymerisation industry over seas. An industry-sponsored study estimated that the cost* to comply with the proposed new standard would exceed $25 billion (.8}. Within the year, however, a ma jor plasties manufacturer announced development of a novel closed-loop polymeriza tion process that greatly reduced atmospheric releases of VCM and almost completely eliminated worker exposures.^The manufacturer patented this system and sub
sequently licensed Itto other manufacturers at substantial profOto VCM standard of 1 ppm remains In force today (9) and is readily achieved In the workplace. New cases of hepatic angiosarcoma in vinyl chloride polymerization workers have been virtually eliminated (fd).
This eplsods. one of the earliest reports of an occupational disease outbreak pub lished in the MMWff, underscores the importance of informed clinical observation in the recognition of work-related illness. Furthermore, the regulatory actions precipi tated by this report and the ensuing investigation of this episode Illustrate that a safe working environment and economic progress are not mutually exclusive. When wellconceived protective standards are accepted with good will and Ingenuity is used to encourage compliance with those standards, then job safety, economic advances, and
a healthy environment can comfortably co-exist.
1-90? editorial Note by PhUip J Landrigan, MO, MSc, Coalman, Daportmont of Community Madidno, Mount Sinai SeAool of Muuidnv, Nowlbtk, and former Director, Division or Surveil lance. Hazard gvlvarfona, and Raid Studios, National institute tor Occupational Safety and HaaitK COG.
teefc L eda. Textbook of clinical occupational and environmental medicine,
jhia, Pennsylvania: W.B. Saunders Company, 1994. taker DB. The recognition and control of eceupotional disease. JAMA
inbarg W, Chalmers TC. Child CQ 111, Fishman Afi Petn'n 8. Measuring the
quality of medical care: S clinical method. N Engl J Med l97S.-294:M2-a. 4. Mullen RJ. Murthy LL Occupational sentinel health events an updated iist for physician rec
ognition and public health aurvelllanca. Am J Ind Med 1091;19.*77&-89.
5. Creech JLJ&Johnson MN> Angiosarcoma of the liver in ih* manufacture of polyvinyl chloride.
J Oeewp Med 1974:18:150-1.
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8. Folk H. Creech JL Jr, Heath CW Jr, Johnson MN, Key MM, Hepatic disease among workers
M a vinyl ehloride polymeriration plant JAMA 1974;230:50-03. 7. SaMtofTU. Hammond EC. eda. Toxicity of vinyl ohlorida-polyvfnyl chloride. Ann NY Acad Sci
1975248:1-337.
6. International-Apency for Research on Caneer. Overall evaluations of carcinogenicity: an up dating of IARC monographs, volumes 1-43 tlARC monographs suppl 71. Genovs, Switzerland:
International Agency for Research on Caneer, 1997.
9, Office of Technology Aasoaament, Gauging control Technology and Us regulatory impacts in occupational safety end health. Washington, DC US Congress. Office of Technology Assess ment '>395; publication no, OTA-ENV-636.
10, PaIk H, Baxter PJ. Hepatic angiosarcoma registries: implications for rare tumor studies. In:
Pete ft. Sohneiderman M, ed*. Banbury report no, 9: quantification of occupational cancer. New Yoriq Cold Spring Harbor Laboratory, 1981.
fes of Homicide, Suicide, end Firearm-Related 1 bath kmong Children -- 26 Industrialized Cot
During 1950-199S^h* overall annuel death rate for U.3. chtelren aged d5 years
declined substantiaUyV), primarily reflecting decrease* in dews associated with un
intentional injuries, pneWnonia, influenza, cancer, and conOTnital anomalies. How*
aver, during the same pe^od. childhood homicide rates tripled, and suicide rates
quadrupled (2). In 1994, anWng children aged 1-4 yeartehomlcide was the fourth
leading eause of death; amon^^Udren aged 9-14 years,/omlclde wasthe third lead
ing causa of death, and suicide v\s the sixth iJ). To codpare panama and the Impact
of violent deaths among children%th* United Statearntd ether industrialized coun
tries, CDC analyzed data on childhomthomicide, suiejpe. and firearm-related death in
the United States and 36 other Indusnjsllzed counviee for the most recent year for
which data were available in each counted). ThisApart presents the findings ofthis
analysis, which indicate that the United atacas Jraa the highest rates of childhood
homicide, suicide/ and firearm-related death
industrialized countries.
In the 1094 World Development Report ( :08 nations were classified by gross
national product; from that list, the United St and all 26 of the other countries in
the high-income group and with population: f ^million were selected because of
thair economic comparability and the likellhj thaMhosa countries maintained vital
records most accurately. In January and F< ruary 199& the ministry of health or the
national statistics Institute in eseh of the countries v\fe asked to provide denomi
nator data and counts by sax and by 6-yofir age group* fdethe most recent year data
were available for the number of auleffas {InTernsilonal Otissiflcerian of Diseases,
Ninth Revision [ICD-9J*. codes E9$0.0*959), homicides (E9tK9jO-E969), suicides by
fireaflnJStfbp-95S4). homicides by firearm (6969.0-E965.4flUinlMentIonal deaths
ceused^Hvpimi (E922jQ-922-9), aA firearm-related deaths fonvhich intention wu
undetd^^Hfaf (SBE5.0-E885.4); 26 dk%\ countries, including the Stilted States, prg-
vided'^HHte^daia*. 7Wenry U1K) countries provided dan for 19^3 or 1994; the
remaimR&jpbumriee provided date for isso, ii. 1992, or 1995. Causrcpecific rates
* Complete date wore provided by Australia, Austria, Belgium. Canada. Denmark. Sfoland end Wales. Finland, Freftne, GermanyJHang Kong, Ireland, Isresi, Italy. Japan, Kuwait, NifcerLaneta. New Zealand. Northern Ireland/Norway, Scotland. Sincepore. Sweden, Spain, Switzerland. Taiwan, end the United StatesAn this analysis, Hong Knng, Northern Ireland, and Taiwan are
considered ss countrie*. '
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