Dr. Engel declared the meeting open for discussion.
JOHN MACISCO: This is largely a question in regard to experimental design. I was wondering, with respect to the table for pregnancies according to pills missed, what the data would have looked like if controlled by frequency of coitus and age.
DR. GARCIA: All the women in the field trials fall within the reproductive age group and are under age 40. They have proven fertility and their stated coital frequency is continuously recorded. No statistically significant difference has been elicited when comparing the stated coital activity before and during medicated cycles. If anything, in the Haitian trials, there is a suggestion that there might be a slight increase in the coital frequency during the medically protected cycles.
Might I digress for a moment to make a comment concerning a point that was discussed earlier concerning method of administration of the medication. Reference was made to John Cobb of Lahore, West Pakistan, who administered medication according to the lunar cycle. I should like to refer to Charles Flowers of Chapel Hill, N.C., who has been carrying on a study for a little less than a year in which he likewise is dealing with a population that norreally does not know how to count. He wished to determine whether it might be feasible to dispense with the close supervision. Usually such organizational provision is necessary with these patients to insure that they take the tablets according to the cyclic schedule. Accordingly, he gave these patients the medication and simply asked them to take a tablet daily ad infinitum or until they had a menstrual flow. Apparently, to date, he has not observed any adverse effects and no pregnancies have occurred.
EDWARD LAUMANN: I wonder if you could expand a little on the symptoms table, particularly the subjective. I was wondering how you characterized or identified subjective symptoms. Also, among the control people who were to be given the placebos, might this percentage of symptoms perhaps be expected to occur in people