Document X8y8bQ1xqLp1j4x9NJ13VbDOd

< in * t '' ^ / / li i CDC February 7, 1997 / Vol. 46 / No MIWNR MORBIDITY AND MORTALITY WEEKLY REPORT 97 Angiosarcoma ot the Liver Among Poiyvinvt Chloride Workers 101 Rates of Homicide, Sutcide, and Firearm-Related Death Among Children -- 26 Industrialized Countries 105 Adult Blood Lead Epidemiology ana Surveillance -- u,S,, Third Quarter. 1996 107 FDA Approval of COMVAXTM 110 FDA Approval of ACEL-IMUNE 112 Notice to Readers As part of its commemoration ofCDC's 50th anniversary, MMWR is reprinting se lected MMWR articles of historical interest to public health, accompanied bycurrer editorial notes. Reprinted below is a report published February 9, 1974, which described the inves tigation of a cluster of cases of angiosarcoma of the liver among polyvinyl chlorid workers in Kentucky, followed by a contemporary editorial note. The report illustrate the public health process in occupational safety and health--progressing from the in itial observation of a new problem by informed clinicians through follow-ui epidemiologic and toxicologic investigations to a targeted regulatory response, whict virtually eliminated the newly recognized problem. EPIDEMIOLOGIC NOTES AND REPORTS ANGIOSARCOMA OF THE LIVER AMONG POLYVINYL CHLORIDE WORKERS -- Kentucky Between September 1967 and December 1973,4 cases of angiosarcoma of thelivei were diagnosed among men employed in the polyvinyl chloride polymerization sec tion of a B.F. Goodrich plant near Louisville, Kentucky. This section of the plant begar operations in 1938. It employs about 270 persons and produces polyvinyl chloride as well as a variety of copolymers by polymerization of vinyl chloride monomer. Al. 4 men had worked continuously in the section for at least 14 years prior to onset ol illness (Table 1); all 4 had worked directly in various phases of the polymerization pro cess. Case 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 gastrointestinal (Gl) bleeding. Recurrent bleeding in May 1970 led to an exploratory laparotomy at which time a di agnosis of angiosarcoma was made on liver biopsy. Case 3 presented in January 1964 with Gl bleeding which recurred in May 1965 with signs of portal hypertension. A portacaval shunt was performed, and liver biopsy yielded a diagnosis of cirrhosis. Repeat biopsies in October 1970 and September 1972 confirmed this diagnosis. Autopsy in March 1973 revealed angiosarcoma. Case 4 presented m July 1973 with U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES / Public Health Service t UCC 105818 98 MMWR February 7,19: Angiosarcoma -- Continued Table 1 Cases of Angiosarcoma of the Liver among Polyvinyl Chloride Workers B.F. Goodrich Plant Louisville, Kentucky Case Age at illness onset Illness onset ate of Diagnosis Death 1 43 2 36 3 41 4 58 Aug. 1967 Jan.1970 Jan.1964 July 1973 Sept. 1967 May 1970 Mar. 1973 Dec. 1973 Jan, 7, 1968 Sept. 27, 1971 Mar. 3, 1973 Dec. 19, 1973 Years worked with PVC before illness 17 14 14 27 hepatosplenomegaly, weight loss, and jaundice. Two liver biopsies were interprets as showing severe cirrhosis. Autopsy in December 1973 revealed angiosarcoma. In each case, pathologic material revealed the presence of extensive cirrhosis of non-alcoholic type in addition to angiosarcoma. In 2 cases, the diagnosis of angic sarcoma was made only at autopsy, cirrhosis having been diagnosed 7 years before i Case 3 and 5 months before in Case 4. None of the patients gave histories of prc longed alcohol use or exposure to hepatotoxin outside their work place. In particula none had ever had exposure to thorium dioxide or to arsenic, two materials know specifically to induce hepatic angiosarcoma in man (1,2). (Reported by John Creech, M.D., Plant Physician, B.F. Goodrich Chemical Company, Louisvilh Kentucky; Maurice N. Johnson, M.D., Director of Environmental Health, B.F. Goodrich Chemic, Company, Akron, Ohio; Bradford Block, M.D., Medical Consultant, Kentucky Occupational Safei and Health Administration, Kentucky State Department of Labor; National Institute for Occupt tional Safety and Health, and the Cancer and Birth Defects Division, Bureau of Epidemiolog' CDC.) Editorial Note Angiosarcoma of the liver is an exceedingly rare tumor. It is estimated that onl about 25 such cases occur each year in the United States. Four cases, therefore among a small number of workers at a single plant is a most unusual event, and on. which raises the possibility of some work-related carcinogen, conceivably vinyl chic 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 seem distinctly possible that the problem may be industry-wide. Epidemiologic studies hav< started to determine the extent of the problem in the United States, with respect bott to angiosarcoma of the liver and to its possible relationship to post-toxic cirrhosis. Published data concerning the potential hepato-toxicity and oncogenicity of viny chloride are limited. Studies in Germany have suggested a link between hepatic dam age and occupational exposure to vinyl chloride (3), while Italian workers have sug gested that vinyl chloride may cause a wide variety of tumors in animals (4). Th< chemical concentrations used in these latter experiments, however, far exceed level: likely to be encountered in industrial environments. Efforts to confirm such observa tions and to measure effects at lower dose levels are now in progress. UCC 105819 Vol. 46 / No. 5 MMWR 9 Angiosarcoma -- Continued References 1. da Silva Horta J, Abbatt JD, Cayolla da Mona L. Ronz ML: Malignancy and other late effect; following administration of thorotrast. Lancet 2:201-205, 1965 2. Regalson W, Kim U, Ospina J, Holland JF: Hemangioendothelial sarcoma of liver from chronn arsenic intoxication by Fowler's solution. Cancer 21:514-522, 1968 3. Marsteller HJ, Lelbach WK, Muller R, et al: Chronisch-toxische leberschaden bei Arbeitern ir der PVC-Produktion. Dtsch Med Wochenschr 98:2311-2314, 1973 4. Viola PL, Bigoni A, Caputo A: Oncogenic response of rat skin, lungs, and bone to vinyl chloride Cancer Research 31:516-522, 1971 Editorial Note--1997: Workers constitute the segment of the U.S. population mos, heavily exposed to chemical toxins and physical agents. Because of their intense anc prolonged exposures compared with the general public's, workers generally develof illnesses of toxic etiology more frequently, more quickly after the introduction of nev chemical compounds, and in more severe forms. Work-related diseases encompass a broad range of human illness (7). For exam pie, chronic bronchitis frequently occurs in coal miners; skin cancer in farmers; blad der cancer in dye workers exposed to aniline compounds; leukemia and lymphoma ir chemical workers exposed to benzene; kidney failure in lead workers; impaired repro ductive function in workers exposed to lead and 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 mos diseases, a case of occupational origin is not clinically distinguishable from illness resulting from other etiologies. Informed suspicion is therefore essential to recognize occupational disease, and a careful history of occupational exposure is the critica diagnostic instrument. In the initial diagnostic interview of each new patient, the phy sician must obtain at least a brief history of occupational exposures. Modification o the concept of the sentinel health event (SHE) (3) has further assisted physicians ir establishing linkages between occupational exposures and disease (4). A SHE has been defined as "an unnecessary disease, disability, or untimely deatf whose occurrence signals a failure of prevention" (3). Examples in general medicine include maternal deaths during childbirth, outbreaks of cholera, or a single case o poliomyelitis. To extend the concept of the SHE to the workplace, a "sentinel healtf event (occupational)" (SHE(OJ) is analogously defined (4) as "an unnecessary dis ease, disability or untimely death which is occupationally related." Recognition of t SHE(O) requires clinical astuteness and attention to the exposure history. Typically the occurrence of a SHE(O) stimulates further investigation or research and may trig ger regulatory or other targeted preventive action. This MMWR report on angiosarcoma of the liver in vinyl chloride polymerizatior workers represents a splendid description of a SHE(O). This report marked the firs' recognition of the carcinogenicity to humans of vinyl chloride monomer (VCM), the highly reactive gas to which workers were exposed in the B.F. Goodrich plant near Louisville, Kentucky. The initial observation was made by John Creech, M.D., the plan, physician, and Maurice Johnson, M.D., the corporate medical director. These physi cians had evaluated three men with angiosarcoma of the liver during a 2-year perioc (5). They realized, through careful history-taking, that all of the men with this rare malignancy were employed in the same department of the plant. Publication of this report and a related journal article (5) stimulated a series o' clinical investigations, epidemiologic studies, and toxicologic analyses. Henry Falk UCC 105820 100 MMWR February 7,199: Angiosarcoma -- Continued M.D., an Epidemic Intelligence Service (EIS) officer in the Cancer and Birth Defect: Division in CDC's Bureau of Epidemiology, was assigned by his Division Director, Clad W. Heath, Jr., M.D., to investigate this outbreak. Working with Richard Waxweiler Ph.D., of the National Institute for Occupational Safety and Health, Hans Popper, M.D. of the Mount Sinai School of Medicine, and Louis Thomas, M.D., of the National Can cer Institute, Dr. Falk confirmed the existence of the outbreak and also discovered e premalignant lesion--idiopathic hepatic fibrosis--in additional members of the popu lation heavily exposed to VCM (6). This work stimulated a major international confer ence that was convened at the New York Academy of Sciences by Irving Selikoff, M.D (7), at which the carcinogenicity of VCM was 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 regulator* activity (8). To prevent future cases of VCM-associated angiosarcoma, the Occupa tional Safety and Health Administration in 1974 proposed a 500-fold reduction m the occupational exposure standard for VCM gas--from 500 parts per million (ppm) in aii to 1 ppm. The plastics-manufacturing industry immediately objected that such reduc tion was not possible and would drive the vinyl chloride polymerization industry over seas. An industry-sponsored study estimated that the costs to comply with the proposed new standard would exceed $25 billion (8). Within the year, however, a ma jor plastics manufacturer announced development of a novel closed-loop polymeriza tion process that greatly reduced atmospheric releases of VCM and almost completeh eliminated worker exposures. The manufacturer patented this system and sub sequently licensed it to other manufacturers at substantial profit. The VCM standard o' 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 (10). This episode, one of the earliest reports of an occupational disease outbreak pub lished in the MMWR, underscores the importance of informed clinical observation ir 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 tc encourage compliance with those standards, then job safety, economic advances, anc a healthy environment can comfortably co-exist. 1997 Editorial Note by Philip J Landrigan, MD. MSc, Chairman, Department of Community Medicine, Mount Sinai School of Medicine, New York, and former Director, Division of Surveil lance. Hazard Evaluations, and Field Studies, National Institute for Occupational Safety anc Health. CDC. References 1. Cullen M, Rosenstock L, eds. Textbook of clinical occupational and environmental medicine 2nd ed. Philadelphia, Pennsylvania: W.B. Saunders Company, 1994. 2. Landrigan PJ, Baker DB. The recognition and control of occupational disease. JAMA 1991;266:676-80. 3. Rutstein DD, Berenberg W, Chalmers TC, Child CG III, Fishman AR Perrin EB. Measuring the quality of medical care: a clinical method. N Engl J Med 1976:294:582-8. 4. Mullan RJ, Murthy LI. Occupational sentinel health events: an updated list for physician rec ognition and public health surveillance. Am J Ind Med 1991;19:775-99. 5. Creech JL Jr, Johnson MN. Angiosarcoma of the liver in the manufacture of polyvinyl chloride. J Occup Med 1974;16:150-1. UCC 105821 1 W' t No. 5 MMWR 101 Angiosarcoma -- Continued 6, Falk H, Creecn JL Jr. Heath CW Jr, Johnson MN, Key MM Hepatic disease among workers at a vinyl chloride polymerization plant. JAMA 1974:230.59-63. 7 Selikoff IJ. Hammona EC. eds. Toxicity of vinyl chloride-poiyvinyl chloride. Ann NY Acad Sci 1975:246'1-337. 8. International Agency for Research on Cancer. Overall evaluations of carcinogenicity: an up dating or IARC monograpns, volumes 1^12 [IARC monograpns suppl 7], Geneva, Switzerland, International Agency for Research on Cancer. 1987. 9. Office of Technology Assessment. Gauging control technology and its regulatory impacts in occupational safety and health. Washington, DC: US Congress, Office of Technology Assess ment, 1995: publication no. OTA-ENV-635. 10. Falk H, Baxter PJ, Hepatic angiosarcoma registries: implications for rare tumor studies. In Peto R. Schneiderman M, eds. Banbury report no. 9: quantification of occupational cancer. New York: Cold Spring Harbor Laboratory, 1981. Rates of Homicide, Suicide, and Firearm-Related Death Among Children -- 26 Industrialized Countries During 1950-1993, the overall annual death rate for U.S, children aged <15 years declined substantially (1), primarily reflecting decreases in deaths associated with un intentional injuries, pneumonia, influenza, cancer, and congenital anomalies. How ever, during the same period, childhood homicide rates tripled, and suicide rates quadrupled 12). In 1994, among children aged 1-4 years, homicide was the fourth leading cause of death; among children aged 5-14 years, homicide was the third lead ing cause of death, and suicide was the sixth (3). To compare patterns and the impact of violent deaths among children in the United States and other industrialized coun tries, CDC analyzed data on childhood homicide, suicide, and firearm-related death in the United States and 25 other industrialized countries for the most recent year for i which data were available in each country (4). This report presents the findings of this analysis, which indicate that the United States has the highest rates of childhood homicide, suicide, and firearm-related death among industrialized countries. iI In the 1994 World Development Report (5), 208 nations were classified by gross national product; from that list, the United States and all 26 of the other countries in the high-income group and with populations of >1 million were selected because of their economic comparability and the likelihood that those countries maintained vital records most accurately. In January and February 1996, the ministry of health or the national statistics institute in each of the 26 countries were asked to provide denomi i nator data and counts by sex and by 5-year age groups for the most recent year data were available for the number of suicides (International Classification of Diseases, Ninth Revision [ICD-9], codes E950.0-E959), homicides (E960.0-E969), suicides by firearm (E955.0-E955.4), homicides by firearm (E965.0-E965.4), unintentional deaths caused by firearm (E922.0-E922.9), and firearm-related deaths for which intention was undetermined (E985.0-E985.4); 26 (96%) countries, including the United States, pro vided complete data*. Twenty (77%) countries provided data for 1993 or 1994; the remaining countries provided data for 1990, 1991, 1992, or 1995. Cause-specific rates *Complete data were provided by Australia, Austria, Belgium. Canada, Denmark. England and Wales. Finland, France, Germany, Hong Kong, Ireland. Israel. Italy, Japan, Kuwait, Netherlands. New Zealand, Northern Ireland, Norway, Scotland, Singapore, Sweden, Spain. Switzerland, Taiwan, and the United States. In this analysis. Hong Kong, Northern Ireland, and Taiwan are considered as countries. UCC 105822