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SURVIVAL
An attempt was made to construct a Survival Table using data from the "Tissue Masses and Deaths" book.
We were unable to determine the exact method used in constructing the table in the FDA submission. There was some survival data in the "Tissue Masses and Deaths" book (Exhibit 65), but this only extended through week 109 and consisted solely of running totals. According to Tony Martinez deaths purportedly were initially recorded in any one of the following documents:
(1) Body/Feeder Weight Sheets
(2) Autopsy/Pathology Sheets
(3) Observation Sheets
(4) Palpable Mass Sheet
He said that animals found dead at feeding/observation intervals were usually recorded on the observation, or Body/Feeder Weight Sheets. At other times, the death was recorded on a "scrap" of paper and then later transcribed to one of the documents. The term "scrap of paper" was used by Searle personnel both during the Task Force and current investigations. No notebooks containing observations or deaths ever surfaced during either investigation. Animals killed "in extremis" were recorded on Autopsy sheets. The least likely source for original death recording would be the Body/Feeder Weight Sheets.
Dates of death sometimes differed on the various records, making it impossible to determine which one was correct. A survival table was finally constructed for weeks 40-115, using the Body/Feeder weight teletype (hard copy) sheets and dates on which animals no longer appeared as a base (Exhibit 68). In this manner, the number of days on study was calculated for each animal (Exhibit 66). Using starting dates for each group, a calendar was made to encompass the entire duration of this study (Exhibit 67). Toward the end of the study, some feedings/observations were made at intervals such as 109 3/7, 110 6/7 and 111 6/7 weeks, so some differences are anticipated between this table and the one in the FDA submission. However, the final number of animals in each dosage group and sex do coincide. The table constructed for this report was on a weekly basis; that in the submission covering only weeks 40, 46, 52, 60, 68, 76, 84, 88, 92, 96, 100, 104, 108 and 115.
A Life Table Analysis was performed from the Survival Table by Dennis Wilson, Department of Mathematics, Bureau of Foods (Exhibit #73). The female control population differed from the high level population p < 0.05. The male control population differed from both the medium and high dose levels (p. 0.05 in both cases). In all cases, the differences are due to the higher mortality level of controls. |
