§ Mr. Ashleyasked the Secretary of State for Social Services whether the Committee on Safety of Medicines has considered or whether it intends to consider the following research reports related to the drug Debendox (a) the study by Drs. Roll and Matthiaschk for the German health authorities, (b) the study by Dr. Hendrickx of the University of California, and (c) the research report of Dr. Barbara Manard; if the reports had been considered; and if he will make a statement regarding the conclusions reached.
§ Mr. Geoffrey FinsbergAt my hon. Friend's request, the Committee on Safety of Medicines (CSM) has considered the studies by Roll and Matthiaschk and by Hendrickx. The committee concluded that neither study gave cause for concern and found no reason to alter its previous advice—that there is no scientifically-acceptable evidence that Debendox causes harm to the foetus. It is understood that both studies are to be repeated and the CSM will keep the matter under review.
Dr. Manard's paper "Bendectin and Birth Defects: a Review of the Evidence" has not been considered by the CSM but it has considered all the papers to which it refers, together with other scientific evidence relating to the safety of Debendox.
331W
§ Mr. Ashleyasked the Secretary of State for Social Services whether consultations have taken place between his Department and Hewell Pharmaceuticals Ltd. regarding the company's proposal to reformulate the drug Debendox by the removal of the dicyclamine element; and when the reformulated drug will be available on the British market.
§ Mr. Geoffrey FinsbergMatters relating to the licensing of drugs must remain confidential for commercial reasons.