FDA report on Searle's submission for NutraSweet approval 1977 - Part 4

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Robert A. Moe, PhD. - Executive Vice-President

George Clay, PhD. - Group Leader, CNS Pharmacology

Robert Bost, PhD. - Director of Food Products,

Regulatory Affairs

Holly Ru Probst - Director, Corporation Information

Management Group.

Dave Britton - Director Corporation Information

Department

William Merino, PhD. - Director, Domestic Pharmaceutical

Products

Richard Viktora - Attorney

James Phelps - Vice-President, General Counsel

Elwood H. Ensor, PhD. - Vice-President

Paul Klimstra, PhD. - Vice-President Pre-Clinical

Research and Development

Roger Thies - Attorney

 

During the course of our investigation one or more of the

following Searle personnel were present in the Conference Room

which we used for our data review.

 

Richard Viktora - Attorney

Roger Thies - Attorney

George Clay, PhD. - Group Leader, CNS Pharmacology

Robert Bost, PhD. - Director of Food Products

Regulatory affairs

Don Cook, PhD. - Associate Director, Department of

Bio Research

Dick Aspinol, PhD. - I. I. D. Group Leader

Bill Jenkins, PhD. - Director, Product Affairs

Fred McIlreath, PhD. - Director, Regulatory Affairs

Paul Landefeld, - Attorney

 

Most of the time one attorney (R. Viktora or R. Thies) and

one scientist were present. During our initial meeting with

Searle personnel, James Phelps stated that a Searle monitor

must be with us at all times during our data review in order

to "protect the data".

 

During the course of our investigation, various individuals

were interviewed in an attempt to obtain all available raw

data and reconstruct the manner in which the study was con-

ducted, as accurately as possible. Since many employees

involved in the study or support areas are no longer employed

at Searle, others were interviewed who had general knowledge

of such parameters as statistics and chemistry.

 

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Significant interviews are attached as Exhibits, as referenced.

Individuals interviewed were as follows:

 

1. Donna Helms - Administrative Assistant to Dr. McConnell on 5-18-77,

6-30-77 and 7/1/77 (Exh. #46).

2. Judith Beauchamp - Hematology Lab Supervisor on 6-2-77 (Exh. #47).

3. Barbara Bickford (Nee Ross) - Technician, Department of Analytical

Research on 6-1-77 and 6-2-77 (Exh. #48).

4. Clifford J. Suel - Supervisor, Department of Analytical Research and

Development on 6-2-77 (Exh. #49).

5. Bartolome R. Tangonan - Research Technician, Pathology Toxicology

Department on 6-1-77 (Exh. #50).

6. Tony Martinez - Research Assistant and Toxicology Lab Supervisor on

5-19-77, 6-3-77, 7-7-77, 7-20-77 and

8-2-77 (Exh. #51).

7. Ted Reichert - Supervisory Systems Analyst on 5-24-77 (Exh. #52).

8. Phil Polli - Systems Analyst on 5-24-77 (Exh. #53).

9. Judith Schmal - Clinical Chemistry Section Supervisor on 6-2-77 and

6-7-77 (Exh. #54).

10. Jane Drury - Analytical Chemist, Bioanalytical Dept. 6-7-77.

11. Alan Mitchell - Teratologist on 7-20-77 (Exh. #56).

12. Raymond G. Schroeder - Former Searle Teratologist on 7-18-77 (Exh.

#57).

13. Dr. Rudolph Stejskal - Pathologist on 6-23-77.

14. Patricia Erdenberger - Research Assistant and Histopathology Lab

Supervisor on various dates (Exh. #58).

 

Dr. Robert McConnell, Pathology-Toxicology Advisor at the time of this

study, was not directly involved with daily procedures. He is no longer

employed at Searle.

 

An attempt was made to interview Dr. K. S. Rao, Monitor of Study P. T.

#988S73 on 7-25-77. We were referred to Dr. Rao's attorney, who refused

permission for an interview (see Jerome Bressler's memo dated 7-27-77,

Exh. #33).

 

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PURPOSE OF STUDY PT 988S73 (E-77/78)

 

SC-19192: 115 Week Oral Tumorigenicity Study in the Rat

 

According to the submission to FDA, this study was intended to evaluate

the safety and tumorigenic potential of SC-19192, diketopiperazine

(5-benzyl-3, 6-dioxo-2-piperazine-acetic acid), which is a conversion

product of aspartame, and to induce and define such adverse effects as

might occur only at prodigious multiples of the estimated daily human

intake. The commercial grade of aspartame (SC-18862) may contain up to 2

percent of the conversion product (DKP), according to Searle's

specifications.

 

DATES

 

Study e-77/78 (PT #988S73) was initiated on November 8, l971. The study

was to be terminated at 104 weeks, but was extended to 115 weeks. The

reason for extending the study was stated as follows in protocol amendment

#3 dated September 6, l973: "it was decided to extend or continue the

study until the mortality of either sex reduced the control group to 20

animals per sex, provided the survival in the treated groups is not less

than 10 animals/sex/treated group prior to that period. This approach is

consistent with current FDA desires." A copy of the study protocol is

attached as exhibit #11.

 

Initiation of treatment was staggered over a two week period as follows:

 

HOUSING DATE PLACED SCHEDULED DAYS ON

GROUP ON STUDY SACRIFICE STUDY

 

A - Male 11/8/71 1/21/74 805

B - Female 11/9/71 1/22/74 805

C - Male 11/9/71 1/22/74 805

D - Female 11/10/71 1/23/74 805

E - Male 11/11/71 1/24/74 805

F - Female 11/12/71 1/25/74 805

G - Male 11/15/71 1/28/74 805

H - Female 11/16/71 1/29/74 805

J - Male 11/17/71 1/30/74 805

K - Female 11/17/71 1/30/74 805

L - Male 11/18/71 1/31/74 805

M - Female 11/19/71 2/1/74 805

 

Continue to Part 5

 

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