The submission to FDA (Vol. 1, P. 10) reported that an unidentified infectious disease spread among the animals between 12 and 14 weeks of treatment, and that a second unidentified infectious disease occurred in high incidence between 48 and 52 weeks of treatment.  In both cases, the control and treated rats were reportedly affected with equal frequency and severity.  The same page of the submission also stated that over a period of two weeks, a total of 17 animals (8 control, 3 low dose, 4 medium dose, and 2 high dose) died.  A memorandum dated October 13, 1972, and that more animals were morbid.  Dr. Rao reported that this primary antemortem symptom observed was inappetance and labored respiration.  Postmortem examination of dead animals revealed primary lesions in the lungs, and lungs exhibited patchy pneumonia, according to Dr. Rao.  The memo indicates that Dr. Rao intended to administer 10,000 units of penicillin G, intramuscularly, to all the animals 2 to 3 times per day beginning 10/30/72.  A copy of Dr. Rao's memo is attached to the protocol (See Exhibit #77, Section 1).

The submission to FDA (Vol. 1, P. 10) stated that, "to prevent further loss of animals, all morbid rats were injected IN with 20,000 units of potassium penicillin G daily for 4-8 days."

A review of the injection records (attached to Vol. A of Exhibit #75) showed that some animals were treated between approximately 51 and 60 weeks, and in one instance, a high dose animal, kB3HF, received at least 10 injections.  In addition, some animals received 30,000 units per day (10,000 units 3 times per day) rather than the 20,000 units reported in the submission.