The investigation began on 4/25/77, and encompassed the authentication of all data, both raw and summary, relating to the studies jointly chosen for review by Bureau of Foods and EDRO. Two studies actually done at G.D. Searle were selected for initial coverage, and a decision to expand the investigation to a third study was made at a later date.

Following are the titles of the three studies selected for review:

1.)  E-5 (P.T. #851S70), Evaluation of the Embryotoxic and Teatogenic Potential in the Rat, conducted with SC-18862 (aspartame).

2.)  E-89 (PT #1218S75), An evaluation of the Embryotosic and Tetatogenic Potential in the Mouse, conducted with SC-18862 (aspartame).

3.)  E-77/78 (PT #988S73), 115 Week Oral Tumorigenicity Study in the Rat, conducted with SC-19192 (diketopiperazine).

This report is concerned only with study E-77/78.  The report of E-5 and E-89 was submitted separately.

HISTORY OF BUSINESS

G. D. Searle & Co. provides a wide range of health care products and services on a worldwide basis.  Its business is divided among three principal areas:  pharmaceuticals, medical instruments and optical products, and hospital and laboratory products. The firm's corporate offices are located in Skokie, Illinois, with various branches and facilities throughout the world.

Effective June 1, 1977, Donald H. Rumsfeld assumed duties as President and Chief Executive Officer.  Mr. Daniel C. Searle, formerly Chief Executive Officer is now Chairman of the Board, while William L. Searle and Wesley M. Dixon, former Chairman and President respectively, are now Vice-Chairmen.

Effective March 1, 1977, the firm underwent a major realignment, shifting to a managerial system based on product lines.  This resulted in the establishment of four main product-line groups, which are:  Pharmaceutical/Consumer Products, Diagnostics, Hospital Supplies and Optical Products.  Each group is headed by a President who will report to Searle's Executive Vice-President for Operations, Dr. James A. Buzard.  A copy of the G. D. Searle & Co. annual report for 1976 which is attached as Exhibit #1 further expands on the firm's operations and lists Corporate Officers.

Mr. O. B. Parrish is President of the Pharmaceutical/Consumer Products Group and also a Corporate Vice-President.  An organizational chart for this group is attached as Exhibit #2.  Mr. Guy Labrosse is now Group Executive Vice-President for U. S. Commercial Pharmaceutical Operations.  In the U. S., this is known as Searle Laboratories.  The facility at 4901 Searle Parkway, Skokie, Illinois is a part of the U. S. Operations, e. g. Searle Laboratories, yet houses the majority of the Research and Development Group.

Worldwide Pharmaceutical Research and Development is also a part of the Pharmaceutical/Consumer Products Group, but not of Searle Laboratories.  The Research and Development OF aspartame is a function of this group.  Copies of organizational charts for this group are attached as Exhibit #3.  Dr. Robert A. Moe recently resigned and his position is temporarily being filled by George V. O'Bleness, Corporate Vice-President for Compliance and Administration.