The above four persons
in the toxicology department were involved
assembling data for
clinical chemistry and hematology determinations
April 1973 to Feb.
Joyce Schulmann -
performed urinalysis and hematology determinations
April l973 to Feb.
Philip Muellner -
Technician in Path-Tox Dept. July l970
till end of
Janet Praal - Technician,
prepared individual work sheets for urinalysis.
No longer employed
C. The following
employees were interviewed regarding clinical
procedures, and methods
for recording clinical lab. data.
1) Bart Tangonan
on 6/1/77 regarding the recording of data.
2) Judith Beauchamp,
on 6/2/77 regarding hematology and urinalysis.
3) Judith Schmal,
on 6/2/77, 6/7/77, and 7/29/77 regarding
4) Tony Martinez,
on 6/3/77 regarding urine and blood collection,
and recording of
5) Jane Drury, on
6/7/77 regarding electrophoresis.
Accounts of these
interviews are attached as exhibits #47-54.
D. Other Documents
and Procedures Used to Authenticate Clinical
Laboratory Data values
in Submission were as follows:
1) One loose leaf
volume entitled "SC-19192: 104 Week
Toxicity Study In
The Rat. PT - 988573 Protocols, Organ
Hematology, Urinalysis, Blood Chemistry,
The volume was subdivided into
to the above parameters. The individual
pages (See Exhibit
#77, Section IX for example) are composed
of forms containing
the appropriate measurements and units
printed on the left
side of the page onto which data on
sheets" corresponding to each of
pasted in columns representing the various
time periods. These
pages, in addition to other information,
were headed by the
identifying number of the rat for which
were made. The information on the sticky
back sheets (see
Exhibit #77, Sec. IX) was copied (hand
written) from laboratory
notebooks, sheets, Auto-
teletype sheets (on line data generated
or computer printouts (containing
raw and calculated
data resulting from on line or off line
input data from instruments)
by individuals of General
(see interview with Bart Tangonan).
Many of the pages
were initialed "BRT" (apparently
R. Tangonan). Most
of the final values transcribed into
the sticky back sheets
resulted apparently from calculations
made directly by
the analytical instruments or by external
computer using the
appropriate stored equations and data
the reference standards.
(2) Since the values
appearing in the volume referred to in
above section were
copied from other sources, an attempt
made to verify these
values by examining the information in
these sources. No
attempt was made to recover the teletype
sheets, or computer
printouts which we were told were no
or could not be recovered (see interview
with Judith R. Schmal,
Exhibit #54). All laboratory notebooks
that might contain
the original data were requested. Notebooks
dated prior to the
dates of the DKP study were excluded.
notebooks were then identified by BA
numbers which were
listed on the top sections of the sticky
back sheets included
in the volume referred to above.
Examination of these
few laboratory notebooks revealed only
very small amount
of data would could be used for additional
verification of the
values in the submission. It was necessary
to obtain the consultation
of Judith Schmal to clarify the
system used to relate
the values in these books with the
and period of time of bleeding. The following
notebooks, as designated
by information on the front covers,
1) Lab. notebook
#N-26375 (hematology), 25 June 71 to 1/21/72.
2) Lab notebook #127133
(phenylalanine), 10/8/71 to 4/21/72.
3) *Lab notebook
#113239 (cholesterol), dated 5/1/72.
4) *Lab notebook
#17, BA #0007118926 (SGOT), 12/27/71 to
5) Lab notebook #126472
(phenylalanine), 4/21/72 to 6/8/72.
6) Blue Book #1591,
identified "JF VON - 70" (hematology).
7) Columnar book
#21, identified "JF VON 27"
8) Spiral notebook
identified "JABEA-" (coagulation/prothrombin)
9) *Spiral notebook
#16, (SGOT), 8/27/71 to 12/16/71.
*Those books (3,4,
& 9 above) marked with an asterisk
provided us with no
useable data, because
a formula or standard curve (no longer
was necessary to
convert the data.
Copies of the applicable
pages from all of the above notebooks
obtained, and are
included in exhibit #77.
The following data
were cross checked against available data
entries (in addition
to being checked against transcribed data
in bound volume):
1. Hematology - Erythrocytes:
Treatment days 42,91,364
& 546 Males and Females.
2. Hematology - Leucocytes,
Treatment Days 42,
91, 364, & 546 Males and Females.
3. Hematology - Leucocytes,
Treatment Days 42,91,189,364,
& 546, Males and Females.
4. Hematology - Coagulogram,
Treatment Days 42
& 91, Males and Females.
Treatment Days 42,189
Males and Females, Day 91 Males.
were found between the clinical laboratory
on pages 5-7 of submission Volume 1
(referenced on page
120) and those actually carried out.
were documented by the interviews
described in Section
C and in a document (Exhibit #77,
Section II) voluntarily
submitted by Jutidy Schmal, June
7, 1977 in response
to requests for clarification of the
procedures as they were actually conducted
in regard to analytical
methology instrumentation, and
processing and recording
1) Glutamic Pyruvic
C.D. and Cotlove, E. (1971)/
Clin. Chem. 17; 1114
The reference describes
a coupled reaction U.V. assay for
serum glutamic oxaloacetic
transaminase in which malic
As described by Judith
R. Schmal (June 7,1977) glutamic
was assayed by a method adopted from
Sigma Kit Technical
bulletin #410 - U. V. using Lactic acid
2) Glutamic Oxaloacetic
Reference: Same as
in (1) above.
As described by Judith
R. Schmal (June 7, 1977), from Novem-
ber 1971 to March
15, 1972 a manual colorimetric method
(Fermco Kit) was
used (employing dinitrophenylhydrazine).
From March 15, 1972
the method used was adapted from Sigma
Kit, Technical bulletin
#410 - U. V. using Lactic acid
3) Blood (serum)
(Marsh in Submission) W.H., Fingerhut,
B. and Miller, H.
(1965). Clin Chem 11, 624.
The referenced method
calls for reaction of urea with diacetyl
monoxime in the presence
of thiosemicarbazide and ferric
ions in a relatively
weak acid solution.