FDA report on Searle's submission for NutraSweet approval 1977 - Part 22

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#38. Memo dated August 29, l974 from Dr. G. L. Schoenhard to Dr. K.S.


#39. Table 1 - Summary of Average Body Weights and Weight gain (%change/

week) from the FDA Statistical Analysis.

#40. Table 2 - Summary of food intake (g/day and g/kg./day and dosage

(mg./kg./day) from the FDA STatistical Analysis

#41. Table 3 - Summary of Food Efficiency (g. gained/100g. actual food

consumed) calculated in the FDA STatistical Analysis.

#42. Computer printout of FDA Statistical Analysis of food intake and

body weight data.

#43. Pathology report from Division of Pathology, Bureau of Foods, con-

cerning uterine polyps, along with correspondence, and memo from

Janet Springer.

#44. Pathology report from Armed Forces Institute of Pathology, concerning

uterine polyps.

#45. Pathology report from Massachusetts Institute of Technology, concern-

ing uterine polyps.

#46. Written account of interviews with Dr. Jean Taylor on 6/2/77, 6/3/77,

and 6/7/77.

#47. Written account of interview with Judy Beauchamp on 6/2/77.

#48. Written account of interview with Barbara Bickford on 6/1/77.

#49. Written account of interview with Clifford J. Seul on 6/2/77.

#50. Written account of interview with Bartolome R. Tangonan on 6/1/77.

#51. Written account of interviews with Tony Martinez on 5/19/77,6/3/77,

7/7/77, and 8/2/77.

#52. Written account of interview with Ted Reichert on 5/24/77.

#53. Written account of interview with Barbara Bickford and Clif Seul

on 6/2/77.

#54. Written account of interview with Judith Schmal on 6/2/77 and


#55. List of animals bled at 104 and 114 weeks.

#56. Written account of interview with Alan Mitchell on 7/20/77.

#57. Written account of interview with Raymond G. Schroeder on 7/18/77.

#58. Injection records showing administration of penicillin, dates of

administration, rat numbers, and units injected.

#59. Methodology for "Phenistix" determination of phenylketones in urine.




#60. Dr. Frith's report of examination of slides for DKP study


#61. Key for animal identification card numbers used on the body/feeder

weight teletype sheets.

#62. Chart correlating animal cage numbers with pathology numbers,

arranged by dose group.

#63. Chronological list of pathology numbers and corresponding animal

cage numbers.

#64. Organizational charts showing responsibility during the time that

study E-77/78 was conducted.

#65. Volume entitled "tissue masses & deaths". Chronological list

of all animals that died, during study, and dates that masses were

first observed.

#66. Charts of days on study for each animal.

#67. Calendar for duration of study showing starting dates, days and weeks

for each group.

#68. Survival table.

#69. Charts of Housing/Dosage Groups.

#70. "Observations for Drug Effects" records for housing groups A through


#71. "Observations for Drug Effects" records for housing groups G through


#72. Ophthalmoscopic records and copies of pathology sheets that have

ophthalmoscopic findings.

#73. Life table analysis and statistics on body weight and food

consumption data by Dennis Wilson, Div. of Mathematics, Bureau of


#74. Evaluation of feeding study on DKP, a conversion product of

Aspartame, by Janet Springer/Ann Ducca, FDA Division on Mathematics.

#75. Volume A - teletype sheets for body and feeder weight data, housing


Volume B - "

Volume C - "

#76. Copy of Searle Computer Program.

#77. Volume of protocols, organ weights, dosage, hematology, urinalysis,

blood chemistry, and protein electrophoresis.

#78. Complete gross pathology sheets, males.

#79. Complete gross pathology sheets, females.

#80. Key to slide tissue identification numbers and abbreviations.

#81. Key to stain abbreviations.




#82. Copies of submission appendix tables relating to hematology,

clinical chemistry, urinalysis, and electrophoresis, along with

check marks showing errors, and attached copies of raw data

sheets documenting the errors.

#83. Copies of submission appendix tables for organ weights, with

errors indicated, and copies of pathology sheets documenting

the errors.

#84. Data sheets showing the phenylketones test erroneously labeled



Signed by:


John S. Arnold



David M. Eerspamer



Dr. Jean Taylor



Dr. Leonard Friedman







Exhibit #85 - Copy of Volume 1 of the submission to FDA.


Exhibit #86 - Copy of Volume 2 of the submission to FDA, consisting

of the individual pathology summaries, both gross and



Exhibit #87 - Statistical analysis of Blood and Clinical Chemistry

Data by Dennis Wilson, Division of Mathematics, HFF-



Exhibit #88 - Copies of pages from Histology accession book #770C,

and Histology inventory sheets.


Exhibit #89 - Documents from Searle's Math-Stat. Dept. concerning

statistical analysis of study 988S73.




Jerome Bressler

Team Leader


Continue to Part 23


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