§ Mr. Simon HughesTo ask the Secretary of State for Health (1) when the Licensing Authority expects to receive further data on myocardial infarction and third generation oral contraceptives; [19189]
(2) whether data on myocardial infarction risk from third generation oral contraceptives were made available to members of the Committee on Safety of Medicines on 13 October 1995; and from which studies that data were derived; [19186]
(3) if he will publish the odds ratios relating to myocardial infarction and third generation oral contraceptives which were made available from the World Health Organisation and Spitzer studies to the Medicines Control Agency prior to the meeting of the Committee on Safety of Medicines on 13 October 1995. [19187]
§ Mr. MalonePreliminary data on myocardial infarction from the World Health Organisation case control study were made available to the Committee on Safety on Medicines on 13 October 1995. These data remain unpublished and were provided to the Medicines Control Agency in confidence. Limited data on myocardial infarction from the general practice research database were also available to the committee. Further data from the GPRD study and the findings of the transnational study have since become available, and have been published in the medical literature. Further epidemiological data on myocardial infarction are expected, but the time frame for their availability is currently unclear.
§ Mr. HughesTo ask the Secretary of State for Health what financial contribution the Licensing Authority made to the costs of distributing the letter dated 26 October 1995 from the Family Planning Association which contained advice on the prescribing of combined oral contraceptives. [19188]
§ Mr. MaloneThe Medicines Control Agency covered the costs of printing and distribution of the letter to relevant health professionals.
§ Mr. HughesTo ask the Secretary of State for Health what legal proceedings have been instituted against(a) the Licensing Authority, (b) the Medicines Control Agency, (c) Medicines Control Agency staff and (d) the 322W Committee on Safety of Medicines in connection with the recent advice from the Committee on Safety of Medicines on third generation oral contraceptives. [19192]
§ Mr. MaloneNone.
§ Mr. HughesTo ask the Secretary of State for Health on what date Ministers in his Department were informed of potential safety concerns regarding third generation oral contraceptives. [19183]
§ Mr. MaloneMinisters were informed of the preliminary findings of the World Health Organisation's case control study on 14 July 1995.
§ Mr. HughesTo ask the Secretary of State for Health what steps he is taking to monitor the effects on public health of the dissemination of the advice from the Committee on Safety of Medicines relating to third generation oral contraceptives. [19185]
§ Mr. MaloneInformation from a variety of sources is being monitored, including data on the occurrence of cardiovascular diseases, pregnancy and abortion.