§ Mr. Ashleyasked the Secretary of State for Social Services (1) pursuant to his reply of 15 April to the right hon. Member for Stoke-on-Trent, South, if the studies of Debendox by the Committee on Safety of Medicines were on a sufficient scale to have provided a reliable indication of whether or not Debendox could be a teratogenic agent carrying the following degrees of danger to the foetus (a) one in five (b) one in 10 and (c) one in 50;
(2) pursuant to his reply of 15 April to the right hon. Member for Stoke-on-Trent, South, which of the studies considered by the Committee on Safety of Medicines contained the largest number of women who had taken Debendox; and to what level of risk of danger to the foetus he estimates that a sample of this size would be statistically meaningful.
§ Dr. Vaughan[pursuant to his reply, 22 April 1980, c. 119–20]: I can add little to my earlier replies to the right hon. Member's questions on this subject. The studies containing the largest number of women who had been prescribed Debendox were those by Smithells and Sheppard and Shapiro et al. Taken together the studies contained sufficient patients to reveal any clinically significant increase in 525W malformations in the children born to mothers who had been prescribed Debendox over the background incidence of such events.