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Dept of Health

Answer

Tim Loughton: To ask the Secretary of State for Health (1) what assessment he has made of the European Medicines Evaluation Agency's call for more clinical trials on analogues used in diabetes treatment; [210222] (2) what assessment he has made of the possible carcinogenic effect of analogues prescribed for diabetes; [210223] (3 what his policy is on the mitogenic potency of insulin analogues. [210225] Ms Rosie Winterton: Insulins are known to have a weak mitogenic effect on some cells in cell culture. Before any licence is granted, a full and thorough review of all the available data takes place to ensure that the product is of appropriate standards of safety, quality and efficacy. The European regulatory guidelines "Points to Consider", a document on the non-clinical assessment of the carcinogenic potential of insulin analogues provides guidance to industry on the general approach to the assessment of new insulin analogues, and these points need to be addressed before a licence would be granted. For any application, the documentation, including clinical trial details and results, accompanying the formal application for the product licence should be consistent with current European and national legal requirements and guidelines relating to applications for marketing authorisations. As with all new medicines, several insulin analogues are currently under intensive monitoring by the Medicines and Healthcare products Regulatory Agency and the committee on safety of medicines. We are not aware of any clinical evidence to suggest that diabetic patients who receive either human insulins, insulin analogues or animal insulins are at an increased risk of developing cancer. Any further clinical trial data would always be considered to be of benefit and welcomed.

Secondary information

Type

Written question

Reference

430 c1470W; 210222;210223;210225

Session

2004-05

Subjects

Diabetes Medical treatments Research

Link

View this Written question on www.publications.parliament.uk