Document yr1RbqmjyY7M1QOoqXq0D0MQn
Chemical Manufacturers Association
URGENT
February 27,1998
Dear Vinyl Chloride Health Committee Members:
Attached is a letter and data table from Dr. Ken Mundt. Please review the information with your appropriate company representative as soon as possible. In addition, I have enclosed a calendar for setting up a VCHC conference call to discuss the information. Fill out the calendar and fax it back to me at 703/741-6091.
If you have any questions, I can be reached at 703/741-5639.
Sincerely,
Attachments(2)
Wendy K. Sherman Manager, Vinyl Chloride Health Committee
Innovation. Technology and Responsible Care At Work 1300 Wii'ON Blvd., Arlington, VA 22209 Telephonf /03-741-5000 Fax 703-741-6000
BFG 01231
Responsible Care'
A PublicCommitment
FEB 27 '98 12:56 TO 17037416091
FROM Applied epidemiology T-781 P.02
APPLIE! EPIDEMIOLOG>
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 of all causes of death 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 of the time) and with at least two observ ed 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 of results arc 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^ (413) 256-3556 FAX (413) 256-3503
BFG 01232
FEB 27 '90 12:57 TO 17037416091
FROM Applied Epidemiology T-781 P.03
(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
c
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'TEB 27 98 12:57 TO 17037416091
Applied Epidemiology, Inc. baseline study results and Wong et al., 1902 results: Observed (Obs) and expected (Exp) deaths, standardized mortality ratios (SMR's) and ninety-live percent confidence intervals (95% Cl's) using U.S. white male mortality rates, plant state-specific white male n^ortality rates, for follow-up through December 31,1982
Cause of death Al causes
Obs 1569
Applied Epidemiology, Inc. baseline analysts
U.S. reference rates
Stale reference rales
Exp SMR 95% Cl
Exp SMR 95% Cl
1734.92 90
86-95 1876.87 84
80-88
Obs 1536
Wong el aL, 1992
U.S. reference rates
Exp SMR 95% Cl
1705.27 90
86 95
Al maligiuit neoplasms Cancer of:
Buccal cavity & pbarytu Tongue Other parts buccal cavity Pharynx
Digestive organs A 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
1J.S1
] 10 59-188
11.61
112 60-192
12
11.55
104 54-181
4
2.74
146 40-374
2.56
156 43 400
4
nr
-
3
3.15
95 20-278
2.98
101 21-294
3
nr -
5
5.66
88 29-206
579
86 28-202
4
nr
--
106 94 82
112 92-135
91.43
116 95-140
99
89.21
11 1 90-135
7
8.59
SI 33-168 8.37
84 34-172
7
8.07 87 35-179
11 1610 68 34-122 14.78 74 37-133 10 1601 63 30-I IS
71 31.44 67 41-102 29.57 71 44-109 20 28.79 70 42 -107
5
9.71
51
17-120
8.89
56 IS 131
5
9.91
50 16-118
39
8.1)
481 342-657
9.11
428 304-585
37
5.77 641 450 884
18 1921 94 55-148 18.89 95 56 151 16 18.40 87 50-141
FROM A p p lie d EpidemioloBy T-781 P. 04
B F G 01234
<2 j
k. a . ? r 1 'A
Page I of6
*>< v0 ^
Ir
w *3 o St Ul
Applied Eptd emiology, Inc. baseline analysis
Wong cl al., 1992
U.S reference rates
State reference rates
K.S. reference rates
Cause of death
Ohs Exp SMR 95% Cl Exp SMR 95% Cl Obs Exp SMR 95% Cl
) Peritoneum & other digestive / organs *\ "1 Respiratory system
5 1.65 302 98-706 1.82 274 89-640 4 nr -
12S 132.71
96
80-115
151.35
85
71-101
115 122.25 94
78-113
Larynx
3 5.44 55 11-161 5.94 50 10-148 3 5.24 57 12-163
Trachea, bronchus & lung
122 125.56 97
81-116
143.58
85
71-101
111 115.87 96
79-1 16
Other respiratory system
3 1.71 176 36-513 1.83 164 34-480 1
nr -
Prostate
IS 16.55 91 51-149 15.59 96 54-159 15 15.20 99 55-163
Kidney
11
9.53
115 58-207
9.73
113 56-202
11
9.06
121 61-217
Bladder
6
8 58
70 26-152
8.34
72 26 157
5
8.46 59 19 138
Skin
7
828
85 34-174
8.34
83 33-171
6
7.36
82 30-178
Eye
2
032
628 76-2269
0.42
475 58-1717
0
0 3I
0
Brain & other nervous system
22
1361
162 101-245
13 05
169 106-255 23
12.76
180 114 271
Thyroid
2 0.74 269 33-972 0.73 274 33-989 2 0.68 293 36-1059
Bcine
2
1.66
120 J5-434
2.19
91 11-330 2
LSI 1(1 13-399
Connective A soft tissue
7
1.84
381 153-7*5
1-H
367 147-755
6
nr
-
Lymphatic & hematopoietic
37
36.91
100 71 138
37.29
99 70-137 37
36.28
102 72-141
Lymptrosarcoma/reticulosarcocna
10
7.77
129 62-237
7.72
130 62-238
H
7.98 138 69-247
Hodgkin's disease
3 5.16 58 12-170 5.31 57 12-165 3 5.45 55 11-161
Leukemia & aleukemia
12 14.73 81 42-142 15.03 80 41-139 13 13 94 93 50-159
Page 2 0/6
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'FEB 2? 93 12*50 TO 17037416091
B F G 01236
Applied Epidemiology, Inc. baseline analysis
Wong el al., 1992
U.S. reference rales
Slate reference rates
U.S. reference rales
Cause ofdeath
Obs Exp SMR 95% Cl
Exp SMR 95% Cl Obs
Exp SMR 95% Cl
Other lymphatic & hematopoietic
12
9.25
130 67-227
9,23
130 67-227
10
8.37 119 57-220
Unspecified
29
22.37
130 87-186
25.13
115 77-166
23
nr
-
Benign & uospeeUied nature neoplasms
7 5.70 123 49 -253 5.54 126 51-260 4 5.08 79 21-201
Unspecified nature of eye, brain & other nervous system
Other
4
2.68
149 41-382
2.80
143 39-365
1
3 2.07 145 30-424 201 149 31-436 A
ur nr -
Diabetes rnellitus
23 23.89 96 61-144 25.38 91 57-136 22 23.52 94 59-[42
Diseases of Itie blood &. blood forming
2
4.17 48 6 173
437 46 6-165
2
3.76 53 6-192
organs
Mental, psyctoonenrotic & personality disorders
Alcoholism
Otlier 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 3 3.87 77 16-226 3.94 76 16-222
nr nr
Page 3 of 6
D
rOTmJ
Q. r 3
o <oo
-IJ CO TJ o
cr>
'FEB 27 98 12:58 TO 17037416091
Cause of death
Diseases of the nervous system & sense organs
Multiple sclerosis
Other diseases of nervous system & sense organs
Ohs 14
3 II
Applied Epidemiology, Inc. baseline analysis
Wong et al., 1992
US reference rates
State reference rates
US. reference rates
Exp SMR 95% Cl
Exp SMR 95% Cl Obs
Exp SMR 95% Cl
17.29
81
44-136
1740
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
FROM A p p lie d E p id e m io lo g y T-731 P.07
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 1646 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
I2S 96-160
65.17
98
76-125
42
nr
-
BFG 01237
Other diseases of the circulatory system
109 129.73 84 69-101 143.51 76
62-92
103
nr
-
Hypertension wititout 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 ofarteries, veins &. pulmonary circulation
28 38.55 73 48-105 41.99 67 44-96 25 nr -
Page 4 of6
FB 27 '9 8 1 2 :5 9 TO 17037416091
Cause of death Diseases of the respiratory system
Pneumonia Clironic & unspecified bronchitis Emphysema* Asthma Pneumoconioses & other respiratory diseases (includes COPD) Emphysema & COPD* Diseases of the digestive system Diseases of stomach & duodenum Hernia & intestinal obstruction Cirrhosis of the liver Other digestive system diseases
Obs 70 16 2 17
33
63 9 2 38 14
Applied Epidemiology, Inc. baseline analysis
U.S. reference rates
Slate reference rales
Exp SMR 95% Cl
Exp SMR 95% Cf
91.93
76
59-96
111.60
63
49-79
31.54
51
29-82
34.41
47
27-76
4.38 46 6-165 5.44 37 4-133
20.12 84 49-135 23.45 72 42-116
3.00 33 1--185 3.76 27 1-148
30.30
109 75-153
41-21
80 55-112
97.55
65
50-83
93.36
67
52-86
12.11 74 34-MI 12.02 75 34-142
3.81 S3 6-190 3.83 52 6-189
56.70
67
47-92
50.91
75
53-102
24.93
56
31-94
26.60
53
29-88
WongetaL, 1992
U.S. reference rates
Obs Exp SMR 95% Cl
70 87.61
80 62-101
15 31.94 47
26-78
2 nr -
17 nr
1 2 89 35 1 192
35 nr
-
41 22.83 380 129-244
60 95.58 63 48-81
8 11.15 72 31 414
2 nr -
35 56.06 62
43 87
14 nr
-
Diseases of the genitourinary system Chronic/unspecified nephritis Other genitourinary diseases
3 4 3
19.80
40
17-80
21.55
37
16-73
9 20.41 44 20-84
9.41
43
12-109
10.11
40
11-101
4
8.29 48 13-123
3.77 79 16-232 4.33 69 14-203
nr --
FROM A p p lie d E p id e m io lo g y T-791 P .06
B F G 01238
Page 5 of6
'FC3 27 98 12:59 TO 17037416091
Cause of death
Diseases of musculoskeletal system & connective tissue
Obs l
Applied Epidemiology, Inc. baseline analysis
Woog ct 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
3.15 32 1-177 3.28 30 1-170
-
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
I0S 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=oo rales available for category ofdeath In the NIOSH categories of death (used in AEI baseline analysis), deaths from emphysema (1CI>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 A other respiratory diseases. In die Monson categories of death (used in Wong et al. analysis), Emphysema A COPD includes deaths from any of the following: Pulmonary collapse (1CD-7 527.0); Emphysema without mention of bronchitis (ICD-7 527.1); Other diseases ofthe lung (includes COPD) (ICD-7 527.2).
FROM A p p lie d E p id e m io lo g y T-781 P .09
B F G 01239
Page 6 of6