Document zBZaXnLZG97wqZ0xVVyrvRr6
APPLIED EPIDEMIOLOGY
INC.
February 27, 1998
Ms. Wendy K. Sherman Manager, Vinyl Chloride Health Committee Chemical Manufacturers Association 1300 Wilson Blvd. Arlington, VA 22209
Dear Ms. Sherman:
Enclosed please find our "baseline" results for the CMA Vinyl Chloride Study cohort. Specifically, these results reflect our re-calculation ofall causes ofdeath reported by Dr. Wong through 1982, as well as several additional causes of death not previously analyzed or reported (due to limitations of the available analytical packages ofthe time) and with at least two observed or two expected deaths. Our cohort differs from that analyzed by Dr. Wong in that we have identified and corrected numerous errors, restored several hundred cohort members not included in Dr. Wong's analyses and discovered some additional deaths. The details of these differences have been presented in earlier progress reports, and the final description will be detailed in our final report to CMA.
Three columns ofresults are presented in the accompanying table: the first column contains results based on our cleaned and expanded cohort using the United States mortality rates as the reference (methodologically most comparable to Dr. Wong's results); the second set contains results using rates for the states in which each plant was/is located; and the third reflects Dr. Wong's results.
Almost universally, our results mirror those of Dr. Wong. Most exceptions are due to some re arrangement of specific causes of death within broader disease categories, often reflecting the way deaths are coded over different time periods and in different states (e.g., liver cancers and cardiovascular disease deaths).
The one result which might be considered a "new" finding is the elevated SMR for "connective and soft tissue" cancers (three-fourths of the way down on page two), with SMR=381 using the United States reference rates (95% confidence interval 153 to 785) and SMR=367 using state referent rates (95% confidence interval 147 to 755), based on seven observed deaths due to these cancers.
(continued)
P.O. BOX 2424 AMHERST, MA 01004
it
256-3556 FAX (413) 256-3503
CMA 171054
(Ms. Sherman, page 2)
Biologically, this observed excess might be related to the well-known association between vinyl chloride exposure and angiosarcoma of the liver, as angiosarcomas (tumors of the blood vessels) occurring outside of the liver are classified as soft tissue sarcomas. On the other hand, deaths due to angiosarcoma of the liver but erroneously recorded on a death certificate simply as "angiosarcoma" without specifying "ofthe liver" will be classified as a soft tissue sarcoma as well. Unfortunately, it is not possible to determine from the death certificate whether this has occurred. Nevertheless, this association has not been reported elsewhere to date; therefore, we believe that you may have some obligation to report this finding to EPA under the Toxic Substances Control Act. Please feel free to call if you have any questions about these baseline results. Thank you. Sincerely yours,
Kenneth A. Mundt, Ph.D. enclosure
CMA 171055
Applied Epidemiology, Inc. baseline study results and Wong et al., 1992 results: Observed (Obs) and expected (Exp) deaths, standardized mortality ratios (SMR's) and ninety-five percent confidence intervals (95% Cl's) using U.S. white male mortality rates, plant state-specific white male mortality rates, for follow-up through December 31,1982
Cause of death All causes
Applied Epidemiology, Inc. baseline analysis
U.S. reference rates
State reference rates
Obs Exp SMR 95% Cl
1569 1734.92 90
86-95
Exp SMR 1876.87 84
95% Cl 80-88
Obs 1536
WongetaJ., 1992
U.S. reference rates
Exp SMR 95% Cl
1705.27 90
86-95
All malignant neoplasms Cancer of:
Buccal cavity & pharynx Tongue Other parts buccal cavity Pharynx
Digestive organs & peritoneum Esophagus Stomach Intestine, except rectum Rectum Liver & biliary tract Pancreas
389 363.09 107 97-118 380.46 102 92-113 359 341.73 105
94-17
13
11.81
110 59-188
11.61
112 60-192
12
4 2.74 146 40-374 2.56 156 43-400 4
3
3.15
95 20-278
2.98
101 21-294
3
5
5.66
88 29-206
5.79
86 28-202
4
106 94.82 112 92-135 91.43 116 95-140 99
7
8.59
81 33-168 8.37
84 34-172
7
11 16.10 68 34-122 14.78 74 37-133 10
21 31.44 67 41-102 29.57 71 44-109 20
5 9.71 51 17-120 8.89 56 18-131 5
39 8.11 481 342-657 9.11 428 304-585 37
18 19.21 94 55-148 18.89 95 56-151 16
11.55 nr nr nr
89.21 8.07 16.01 28.79 9.91 5.77 18.40
104 54-181 --Ill 90-135 87 35-179 63 30-115 70 42-107 50 16-118 641 450-884 87 50-141
C M A 171056
Page I of6
4
Cause of death Peritoneum & other digestive organs
Respiratory system Larynx Trachea, bronchus & lung Other respiratory system
Prostate Kidney Bladder Skin Eye Brain & other nervous system Thyroid Bone Connective & soft tissue Lymphatic & hematopoietic
Lymphosarcoma/reticulosarcoma Hodgkin's disease Leukemia & aleukemia
Obs 5
128 3 122 3 15 11 6 7 2 22 2 2 7 37 10 3 12
Applied Epidemiology, Inc. baseline analysis
Wonget al., 1992
U.S. reference rates
State reference rates
U.S. reference rates
Exp SMR 95% Cl
Exp SMR 95% Cl Obs
Exp SMR 95% Cl
1.65 302 98-706
1.82 274 89-640
4
nr
-
132.71 5.44 125.56 1.71 16.55 9.53 8.58 8.28 0.32 13.61 0.74 1.66 1.84 36.91 7.77 5.16 14.73
96 80-115 151.35
55 11-161
5.94
97 81-116 143.58
176 36-513
1.83
91 51-149 15.59
115 58-207
9.73
70 26-152
8.34
85 34-174
8.34
628 76-2269 0.42
162 101-245 13.05
269 33-972
0.73
120 15-434
2.19
381 153-785
1.91
100 71-138 37.29
129 62-237
7.72
58 12-170 5.31
81 42-142 15.03
85 71-101 115
50 10-148
3
85 71-101 111
164 34-480
1
96 54-159 15
113 56-202
11
72 26-157
5
83 33-171
6
475 58-1717
0
169 106-255 23
274 33-989
2
91 11-330 2
367 147-755
6
99 70-137 37
130 62-238
11
57 12-165
3
80 41-139
13
122.25 5.24 115.87 nr 15.20 9.06 8.46 7.36 0.31 12.76 0.68 1.81
nr 36.28 7.98 5.45 13.94
94 78-113 57 12-168 96 79-116 99 55-163 121 61-217 59 19-138 82 30-178 0 180 114-271 293 36-1059 111 13-399 -102 72-141 138 69-247 55 11-161 93 50-159
Page 2 of6
C M A 171057
*
Cause of death
Other lymphatic & hematopoietic
Unspecified
Benign & unspecified nature neoplasms
Unspecified nature of eye, brain & other nervous system
Other
Obs 12 29 7
4
3
Applied Epidemiology, Inc. baseline analysis
Wonget al., 1992
U.S. reference rates
State reference rates
U.S. reference rates
Exp SMR 95% Cl
Exp SMR 95% Cl Obs
Exp SMR 95% Cl
9.25
130 67-227
9.23
130 67-227
10
8.37
119 57-220
22.37
130 87-186
25.13
115 77-166
23
nr
-
5.70 123 49-253 5.54 126 51-260 4
5.08 79 21-201
2.68
149 41-382
2.80
143 39-365
1
nr --
2.07 145 30-424 2.01
149 31-436
3
nr -
Diabetes mellitus
23
23.89
96 61-144 25.38
91
57-136
22
23.52
94
59-142
Diseases of the blood & blood forming
2
4.17 48 6-173 4.37 46 6-165
2
3.76 53 6-192
organs
Mental, psychoneurotic & personality disorders
Alcoholism
Other mental disorders
7
12.74
55 22-113 13.15
53 21-110
4
11.80
34
9-87
4 8.86 45 12-116 9.20 43 12-111 3 nr --
3 3.87 77 16-226 3.94 76 16-222 1
nr
C M A 171058
Page 3 of6
Cause of death
Diseases of the nervous system & sense organs
Multiple sclerosis
Other diseases of nervous system & sense organs
Obs 14
3 11
Applied Epidemiology, Inc. baseline analysis
Wongetal., 1992
U.S. reference rates
State reference rates
U.S. reference rates
Exp SMR 95% Cl
Exp SMR 95% Cl Obs
Exp SMR 95% Cl
17.29
81
44-136
17.40
80 44-135
15
nr
--
2.31
130 27-380
1.87
161 33-470
3
nr -
14.98 73 37-131 15.53 71 35-127 12
nr
Diseases of the heart Rheumatic heart disease Ischemic heart disease Chronic disease of endocardium Other myocardial degeneration Hypertension with heart disease Other heart diseases
642 680.17 94
87-102 735.95 87
81-94
601
nr
--
12 18.71 64 33-112 16.46 73 38-127 14 19.33 72 40-122
535 583.71 92 84-100 630.80 85
78-92
488 597.73
82
75-89
5 3.55 141 46-329 3.17 158 51-368 3
nr -
3
7.89 38 8-111
5.84
51
11-150
31
nr
--
23
15.20
151 96-227
14.50
159 101-238 23
nr
-
64
51.12
125 96-160
65.17
98
76-125
42
nr
--
Other diseases or the circulatory system
109 129.73 84 69-101 143.51 76
62-92
103
nr
--
Hypertension without heart disease 3 4.53 66 14-193 5.06 59 12-173 8 nr -
Cerebrovascular disease
78
86.64
90 71-112 96.46
81
64-101
70
91.93
76
60-96
Diseases of arteries, veins & pulmonary circulation
28 38.55 73 48-105 41.99 67 44-96 25 nr -
Page 4 of6
C M A 171059
Cause of death Diseases of the respiratory system
Pneumonia Chronic & unspecified bronchitis Emphysema* Asthma Pneumoconioses & other respiratory diseases (includes COPD) Emphysema & COPD* Diseases of the digestive system Diseases of stomach & duodenum Hemia & intestinal obstruction Cirrhosis of the liver Other digestive system diseases
Obs 70 16 2 17 1 33
63 9 2 38 14
Applied Epidemiology, Inc. baseline analysis
Wonget al., 1992
U.S. reference rates
State reference rates
U.S. reference rates
Exp SMR 95% Cl
Exp SMR 95% Cl Obs
Exp SMR 95% Cl
91.93
76
59-96
111.60
63
49-79
70 87.61
80 62-101
31.54
51
29-82
34.41
47
27-76
15 31.94 47
26-78
4.38 46 6-165 5.44 37 4-133 2 nr -
20.12 84 49-135 23.45 72 42-116 17 nr -
3.00 33 1-185 3.76 27 1-148 1 2.89 35 1-192
30.30
109 75-153
41.21
80 55-112 35
nr
-
41 22,83 180 129-244
97.55
65
50-83
93.36
67
52-86
60 95.58 63
48-81
12.11
74 34-141
12.02
75 34-142
8
11.15 72 31-414
3.81 53 6-190 3.83 52 6-189 2 nr --
56.70
67
47-92
50.91
75 53-102 35
56.06
62
43-87
24.93
56
31-94
26.60
53
29-88
14
nr
-
Diseases of the genitourinary system Chronic/unspecified nephritis Other genitourinary diseases
8 4 3
19.80
40
17-80
21.55
37
16-73
9
9.41
43
12-109
10.11
40 11-101
4
3.77 79 16-232 4.33 69 14-203
20.41 8.29 nr
44 20-84 48 13-123 --
C M A 171060
Page 5 of6
Cause of death
Diseases of musculoskeletal system & connective tissue
Obs 1
Applied Epidemiology, Inc. baseline analysis
'
U.S. reference rates
State reference rates
Exp SMR 95% Cl
Exp SMR 95% Cl Obs
3.15 32 1-177 3.28 30 1-170
Wongetal., 1992 U.S. reference rates
Exp SMR 95% Cl
Symptoms & ill-defined conditions
7
21.51
33
13-67
26.68
26
11-54
10 21.79 46
22-84
All external causes Accidents Violence Suicide Homicide
Other causes
183 226.58 8)
69-93
256.67
71
61-82
168 225.97 74
64-87
117 153.26 76
63-91
175.92 67
55-80
108 150.16 72
59-87
66
73.32
90 70-114 81.75
81
62-103
60
nr
-
49 53.89
91 67-120 55.51
88 65-117 46
52.78 87 64-116
17 19,43 87 51-140 26.24 65 38-104 14 nr -
15 25.00 60 34-99 25.49 59 33-97
?
nr -
Unknown
28
97
nr=no rates available for category of death * In the NIOSH categories of death (used in AEI baseline analysis), deaths from emphysema (1CD-7 527.1; ICD8 492; ICD9 492) are included in Emphysema and deaths from COPD (1CD-7 527.2; ICD-8 519.2; ICD-9 496) are included in Pneumoconioses & other respiratory diseases. In the Monson categories of death (used in Wong et al. analysis), Emphysema & COPD includes deaths from any of the following: Pulmonary collapse (ICD-7 527.0); Emphysema without
mention of bronchitis (ICD-7 527.1); Other diseases of the lung (includes COPD) (ICD-7 527.2).
C M A 171061
Page 6 of6