Document weBa3VzqGNN416gmREN9KD0Q
B.F. Goodrich Chemical Company
A DIVISION OF THE B.f. GOODRICH COMPANY 6100 OAK TREE BOUIEVARD CtEVElAND. OHIO <4131 PHONE 2T6-524-O2O0
April 19, 1974
Dr. Charles Kupchella University of Louisville Cancer Center Health Science Center Walnut and Preston Streets Louisville, Kentucky 40201
Dear Doctor Kupchella:
Enclosed is a draft of the medical and personal history questions that we plan to use in the health records study and of the liver test data that we plan to analyze as part of that study. Please feel free to critique both. Of course, the question format is not yet finalized. It is our intention to obtain the medical and per sonal history information using an interview technique.
This study will be undertaken at our PVC plants in Pedricktown, New Jersey, Avon Lake, Ohio, Louisville, Kentucky, Henry, Illinois, Long Beach, California, the monomer plant in Calvert City, Kentucky, and the Technical Center at Avon Lake, Ohio. Approximately 3500 employees will be included in the study. As we discussed, a complete work history will also be compiled for each employee, and will be coupled with an analysis of chemicals used at each location by years with estimates of exposure to each chemical by job classification. Admittedly, this latter data will be subjective, as objective data is not available in sufficient quantity to be useful.
These data, once collected, will be stored and analyzed by various statistical techniques. Of course, we plan to discuss this subject with you in much more detail in our meeting on Friday, April 26th.
If I don't talk to you before that meeting, we will plan on being in your office at 9:00 a.m. on Friday morning.
Sincerely yours,
B. F. GOODRICH CHEMICAL COMPANY
tt-tfr& ts e :
W. J. Wilcox WJW/cls
bcc:
John Creech, M.D. - Louisville
0. F. Beckmeyer
M. N. Johnson
B. M. G. Zwicker
R* W. Strassburg
A. M. Fairlie
R. L. Bowles
T. E. Stevens G. Pow
BFG65179
MEDICAL HISTORY QUESTIONS
I.D
1. Sex M_F__
Year of Birth _______ Height_________ Weight
2. Milatary Service
Branch No. of Months ______________________
3. Race Black White Oriental Other (State)
4. Ethnic Backgroung (eg English, German, Polish)
(if more than 2 say "Mix")
5. Past Medical History
(Have you ever had or been treated for)
a. Allergy
b. Asthma, hay fever
c. Skin rash
d. Arthritis
e. Bursitis
f. Rheumatic fever
g. Anemia
h. Cancer
i. Diabetes
j. Epilepsy
k. Meningitis
l. Measles
m. Mumps
n. Scintica
o. Stomach Ulcers
p. Tropical diseases q. Tuberculosis r. Typhoid fever
S3 CJ
s. chest pain t. frequent cough
13
BFG65180
2
5. Fast Medical History, contd. u. Spitting of blood v. Pneumonia w. Heart trouble x. High blood pressure y. Gall bladder trouble z. Jaundice aa. Kidney stones bb. Liver problems cc. Been in auto accidents dd. Had to change jobs for health reasons ee. frequent or recurring headaches ff. Varicose veins gg. Hepatitis
6. Present Health Status (Have you had any of the following conditions in the past year or do you have any of them now) a. Weakness, chills or fever b. Headaches c. Swelling of hands or feet d. Painful joints e. Sore or bleeding gums f. Hoarseness g. Nervousness or insomnia h. Chest pain i. Pain in side j. Cough k. Loss of appetite
BFG65181
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6. Present Health Status, contd. l. Heartburn or indigestion m. Constipation, diarrhea or blood iit the stools n. Frequent or painful urination o. Bleeding from any part of the body
7. Have you ever had surgery 8. Mention any other diseases of injuries you have had. 9. Conditions requiring medical attention in past two years. 10. Have you ever been hospitalized?
11. Where have you lived?
Heavy Industrial Area
Moderate Industrial Area
Little Industry
Rural
age 0-10
__________ ____________ ___________ ________
age 10-20 age 20-30
______ ______
' _____
______ _______ _______ _____
age 30-40
______ _______ ______ ______
age 40-50
______ ________ _______ _____
12. Causes of Death of Relatives
living
cause of death
Father
Mother
Paternal Grandfather Paternal Grandmother Maternal Grandfather Maternal Grandmother Brother or Sister
It
II
II BFG65182
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13. Have you had acroosteolyses (Hand problem)? No Slight Considerable Problem
14. Have you ever kept food or liquids to drink in the Cold Room?
Never Once or Occasion- Often, for
Twice
ally
Many Months
15. Have you ever been affected by vinyl chloride
Never 1-3 times Several times
Dizzy or "high"
Sick
Passed out
16. Have any other chemicals affected you strongly? (BF6, previous employment, home, or elsewhere)
Where Occurred
Which Chemicals
How Many In What
Times
Manner
17. Have you been exposed to any chemicals outside of
your work at BFG.(Previous employment, home, or elsewhere)
Which Chemicals
No. of Months Exposed
Intimate Contact (Yes or No)
18. Have you ever had a blood transfusion? Never One
More than one
19. How much alcohol do you consume? Average weekly consumption (1 beer equals 1 cocktail)
None 1-2 drinks 3-7 drinks 8-20
20+
per week per week drinks drinks
per week per wk
19. Use of tobacco Cigarettes
Pipe or Cigar
No Less than 1-2 packs 2 or more
1 pack
per day packs per day
No 1-5 daily 5-10 daily
*3
Chew or dip snuff No a little frequently BFG65183
20. Do you regularly take any No Patent Prescription What kind medication?
LIVER FUNCTION TEST RESULTS
A. The following data are to be acquired as available for each employee and
entered into the computer:
1. SMA 12 results, numerical values for each test.
2. Fractionated bilirubin, LDH, and alkaline phosphatase liver function tests.
3. GGTP results (gamma glutamyl trans peptipase)
4. SGPT (Syrum glutamye pyruvic transaminase)
5. Quantified results of liver scans - break into appropriate categories
and establish numerical ratings depicting severity of abnormalities
observed.
6. Quantified liver biopsy results
7. Quantified liver and spleen X-rays
8. Blood and platelet count
9. Quantified physical exam results
B. Additional information we would like to obtain for purposes of contrasting
with existing information.
1. "Control" SMA 12 test results run by Metropolitan Life on their
employees.
2. Fractionated bilirubin, LDH, and alkaline phosphatase liver function
test data on about 10 people having normal or low SMA 12 results.
3. Liver scans - need scans on people with normal or low SMA 12 results.
Vould like scans on 10 BFG people in this category. If impossible
because of radiation hazzard, can we obtain the desired information
from a registry?
4. Liver biopsy - Is there a registry available, frcm which contrasting in- jq
formation on liver scans and SMA 12 tests could be obtained?
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5 In general, if unbiased registry data are available for points 2,3,and 4,
the distributions of these data would be useful to contrast with BFG
a
results.
BFG65184
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2C. Follow up test series on certain individuals - Methods will be devised
to analyze these data when they become available.
SO M O
BFG65185
May 3, 197A
STATUS - HEALTH RECORDS STUDY
The first priority has been to structure the format of the data as it must go into the computer and organize the method by which it must be assembled.
1. Medical and personal history questions were put together by Wilcox and Fairlie as a "starter" and submitted to U of L team for critique and improvement. Must still establish final form and mechanism for aquisition of information. Now being developed by U of L and Doctor Hammond.
2. Coding Mechanism -- established and procedure written up. Ready to put into action.
3. Job Classification Procedure -- developed by J. R. Kute -- write-up prepared -- classification needs to be completed by plants other than Louisville.
4. Work History -- a procedure was developed by J. R. Kute and A. M. Fairlie. Procedure written up and data form designed. Ready for plant implementation.
5. Chemical Exposure History -- a procedure was developed by R. L. Bowles, A. M. Fairlie, and J. R. Kute. Procedure written up and data form designed. PVC chemicals list submitted to BFG toxicologist and G. D. Schaaf for editing. Temporary list should be ready for plant implementation May 7th.
A. Need complete list using advice of U of L, NIOSH, CDC, or con sulting industrial toxicologist (By 5/25/74).
B. Need to develop computer program to develop indices (By 7/1/74).
C. Need interplant critique on temporary chemical exposure ratings (Week of 5/25 - 6/1).
6. Blood and Liver Function Tests
A. The general set of tests to be included and special needs for "control" type data were discussed with U of L team. We found excellent agreement as to needs and we have excellent coopera tion in getting the desired information.
B- Must firm up commitments and set timetables for aquisition of perlfial data.
BFG65186
Status - Health Records Study
-2-
C. Have not developed structure of data for entry Into the computer -- need to do with Creech and Makk (et.al.). High priority -- have to design data forms.
t
D. Must acquire and enter quantified data into the data forms.
When these things are done, the mechanism for the Work, Chemical, and Medical history is complete and assembly of the complete history is pri marily dependent on how rapidly the plants acquire the necessary informa tion.
AMF/cls 5/3/74
A. M. Fairlie
CA ih*
BFG65187
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WORK HISTORY TABLE. For each worker, develop a work history for the
computer according to the format below. . fer to
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9 mos. as Relief Operator in Bill starting 1946 63 mos. as Recovery Oper. in Bill starting 1947 121 mos. as Charge Oper. in B121 starting 1952 144 mos. as Supervisor in B121 starting 1962
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RATING BASIS
0 No exposure
1 Minimal exposure to low levels (Chemical in building -- not handled, low vapor pressure and dust level, probably works on different floor.)
2 Moderate exposure (Works around the chemical, but ex posure is minimal.)
3 Works in area subject to occasional high excursions (Normally exposure is minimal but occasional spills, leaks, or dust exposure can happen.)
4 Works in areas where level is high (Exnosure levels in the area are frequently high. Might consider that some risk is involved if chemical is very toxic.)
5 Intimate contact -- skin or high inhalation (Such as poly cleaners in the old days -- handling slurry and such.)
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BFG65200
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BFG65202
WORK AND MEDICAL HISTORY
ANALYSIS OF DATA 1. Compare following distributions of SMA 12 results:
a. BFG versus Metropolitan Life. b. Different BFG plants. c. For a given plant, PVC versus Non-PVC. 2. Run Multiple Regression Analysis where: a. Each SMA result is a dependent variable and all Medical History
and Work History (including chemical exposure) information are the Independent variables. b. Same as (a) except only each Liver Function SMA result will be a dependent variable and the remaining SMA results will be in cluded as independent variables. c. The four Liver Function SMA results will be combined into one dependent variable (this can be done in a variety of ways accord ing to different medical theories or suppositions). Each of these will be correlated against all other independent variables listed in (a) and (b). 3. Run Correlations (either simple or multiple) among: a. SMA b. Fractionated Liver Function Tests c. Expanded Battery d. GGTP
e. SGPT
f. Quantified Results of Liver Scan g. Quantified Liver Biopsy Results h. Incidence of Angiosarcoma
AMF/cls 4/24/74
'
CvT 3 m
BFG65203
WORK HISTORY
The Louisville plant has made a study of types of jobs and broken them down into 63 types of job classification. This same type of breakdown should be done by the rest of the Chemical Company plants. WORK HISTORY TABLE. For each worker, develop a work history for the computer according to the format below.
Job Months On Year Type This Job Started
Example Employee 0129
TRANSLATION
35 mos as Helper in Bill starting 1942 9 mos as Relief Operator in Bill starting 1946
63 mos as Recovery Oper. in Bill starting 1947 121 mos as Charge Oper. in B121 starting 1952 144 mos as Supervisor in B121 starting 1962
9 9 T IE T S 2 !
This work history will be used with chemical exposure ratings for different job classifications to develop chemical exposure information per employee per chemical. Also, with this format correlations with SMA can be run versus building numbers and time.
AMF/cls 4/24/74
BFG65204
CHEMICALS PROCEDURE
1
1. Request complete lists from plants -- group by building, including history.
2. Submit lists to medical or toxicological experts who should recommend those chemicals for study.
a. Submit existing lists now.
b. Submit others when available.
c. Types of chemical selected for study should be less than 50-70, maximum.
3. Establish ratings from all plants on as equitable a basis as possible -- take into account material handling differences from plant to plant.
a. Consult with manufacturing group experts as to plant differences and perhaps bring in knowledgeable representatives from different plants to define exposure differences for different plants versus time. Like groups work together, eg. PVC with PVC'ers.
b. Working with panels of experienced people in each plant, develop the exposure table for each worker classification, per chemical, across time.
RATING BASIS 0 1
2 3
4
5
No exposure
Minimal exposure to low levels (Chemical in building -- not handled, low vapor pressure and dust level, probably works on different floor.)
Moderate exposure (Works around the chemical, but ex posure is minimal.)
Works in area subject to occasional high excursions (Normally exposure is minimal but occasional spills, leaks, or dust exposure can happen.)
Works in areas where level is high (Exposure levels in the area are frequently high. Might consider that some risk is involved if chemical is very toxic.)
Intimate contact -- skin or high inhalation (Such as poly cleaners in the old days -- handling slurry and such.)
.cn
3
BFG65205
CHEMICALS PROCEDURE 3. c. A typical rating
VC1 Monomer -- Louisville
2
4. Combining exposure level with length of exposure. Develop three pieces of information per worker per chemical.
a. Years since initial exposure.
b. Total months exposure. c. Various ways of determining degree of exposure will then be calcu
lated and correlated with SMA results:
1) EnE En
2) EnE2 \H"
3) EenE Een
Where n = No. of months at exposure level, E
BFG65206
tv l CO
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AMF/ds 4/24/74
LIVER FUNCTION TEST RESULTS
A. The following data are to be acquired as available for each employee and
entered into the computer:
1. SMA 12 results, numerical values for each test.
2. Fractionated bilirubin, LDH, and alkaline phosphatase liver function tests.
3. GGTP results (gamma glutamyl trans peptipase)
4. SGPT (Syrum glutamye pyruvic transaminase)
5. Quantified results of liver scans - break into appropriate categories
and establish numerical ratings depicting severity of abnormalities
observed.
6. Quantified liver biopsy results
7. Quantified liver and spleen X-rays
8. Blood and platelet count
9. Quantified physical exam results
B. Additional information we would like to obtain for purposes of contrasting
with existing information.
1. "Control" SMA 12 test results run by Metropoliten Life on their
employees.
2. Fractionated bilirubin, LDH, and alkaline phosphatase liver function
test data on about 10 people having normal or low SMA 12 results.
3. Liver scans - need scans on people with normal or low SMA 12 results.
Would like scans on 10 bfg people in this category. If impossible
BFG65207
because of radiation hazzard, can we obtain the desired information
from a registry?
*5
js
4 Liver biopsy - Is there a registry available, frcm which contrasting in cj
formation on liver scans and SMA 12 tests could be obtained?
&
%
5 In general, if unbiased registry data are available for points 2,3,and 4,
the distributions of these data would be useful to contrast with BFG
results.
2 C. Follow up test series on certain individuals - Methods will be devised
to analyze these data when they become available.
BFG65208
0 ,'T fm g
Mr. Robert Bowles Dr. Andrew Falrlle Mrr James Hi Kute Mr. William Wilcox
ST^AS^r^J
MEETING
April 26, 1974
Senior Statistician, B. F. Goodrich Product Development, Avon Lake, Ohio Senior Statistician, B. F. Goodrich, Cleveland
giattatlilau, LuulumlUe Dlnnti fr. F. Goodrich
Supervisor, Employee Relations, B. F. Goodrich, Cleveland
fYV^<vy>
C^AvC. PtOCK
M^rv^/v PhO
Nablh R. Asal, Ph.D.
' William Chrlstopherson, M. I John Creech, M. D.
E. Cuyler Hammond, Sc.D. Charles E. Kupchella, Ph. D. Laszlo Makk, M. D. Condlct Moore, M. D.
LA Of' L C f4/v , EhsC*.
UMIA LOMISOU C* C/4C/HC4 C
Associate Professor, Department of Biostatistics and Epidemiology, College of Health, University of Oklahoma Health Sciences Center
Professor and Chairman, Department of Pathology, University of Louisville
Clinical Instructor, University of Louisville Department of Surgery, B. F. Goodrich (Louisville) Plant Physician
Vice-President, American Cancer Society New York
Administrative and Scientific Coordinator Cancer Center, University of Louisville
St. Anthony's Hospital; University of Louisville, Assistant Clinical Professor of Pathology
fO to
Director, Cancer Center, University of Louisville
BFG65209
B.F Goodrich
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BFG65210
PRINTED IN U.S.A.
LIVER FUNCTION TEST RESULTS
A. The following data are to be acquired as available for each employee and
entered Into the computer:
1. SMA 12 results, numerical values for each test. ~k
2. Fractionated bilirubin, LDH, and alkaline phosphatase liver function tests.
t43. GGTP results (gamma glutamyl trans peptipase)
firk, SGPT (Syrum glutamye pyruvic transaminase)
5. Quantified results of liver scans - break into appropriate categories
and establish numerical ratings depicting severity of abnormalities
observed.
CX-+-^
6. Quantified liver biopsy results
7. Quantified liver and spleen X-rays
8. Blood and platelet count
9. Quantified physical exam results
B. Additional information we would like to obtain for purposes of contrasting
with existing information.
7^1. "Control" SMA 12 test results run by Metropolitan Life on their
employees. --
V\
2. Fractionated bilirubin, LDH, and alkaline phosphatase liver function
test data on about 10 people having normal or low SMA 12 results.
3. Liver scans - need scans on people with normal or low SMA 12 results.
Would like scans on 10 BFG people in this category. If impossible
because of radiation hazzard, can we obtain the desired information
from a registry?
CA
4. Liver biopsy - Is there a registry available, frcm which contrasting in4**
Q
formation on liver scans and SMA 12 tests could be obtained?
tj
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the distributions of these data would be useful to contrast with BFG
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BFG65211
-2C. Follow up test series on certain Individuals - Methods will be devised
to analyze these data when they become available.
BFG65212
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PRINTED IN U S A.
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FKIN TED IN U.S.A.
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