§ Mr. Simon HughesTo ask the Secretary of State for Health, pursuant to his answers of 11 December 1995,Official Report, column 521, and 19 December 1995, Official Report, columns 1149 and 1153, when the final manuscript from Professor Jick relating to third generation oral contraceptives was received by the Medicines Control Agency; and if it was included in the papers dispatched by courier at 16:00 on 11 October 1995. [22259]
§ Mr. MaloneThe final manuscript of Professor Jick's study was received on 11 October 1995, after the papers were dispatched by courier. A near final version of the manuscript was included with the papers dispatched to committee members. There was no substantive change to the analysis in the final version.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to his answer of 19 December 1995,Official Report, column 1150, what new data, and from which studies, were presented to the Committee for Proprietary Medicinal Products at its meeting on 17 and 18 October 1995. [22260]
§ Mr. MaloneThe committee was presented with findings from the three new epidemiological studies relating to the cardiovascular risks of second and third generation oral contraceptives; these were the World Health Organisation's study, the transnational study and the general practice research database study conducted by Professor Jick.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to his answer of 19 December 1995,Official Report, column 1153, on which Minister's authority the "Dear Doctor" letter of 18 October 1995 relating to safety concerns regarding desogestrel and gestodene was issued. [22261]
§ Mr. MaloneThe then Under-Secretary of State, my hon. Friend the Member for Bolton, West (Mr. Sackville).
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to the answer on 19 December 1995,Official Report, column 1149, when the Licensing Authority received a manuscript relating to the transnational study, and if the Licensing Authority received a final manuscript for that study. [22262]
§ Mr. MaloneI refer the hon. Member to the replies I gave the hon. Member for Gordon (Mr. Bruce) on 19 December,Official Report, columns 1149 and 1153. The Licensing Authority has not received a manuscript relating to the transnational study from the investigators. The Licensing Authority has seen the report of the study published in the British Medical Journal on 13 January 1996.
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§ Mr. HughesTo ask the Secretary of State for Health if a referral of the matters relating to combined oral contraceptives containing desogestrel or gestodene was made to the Law Officers in terms of paragraph 22 (i) or 22 (ii)(c) of "Questions of Procedure for Ministers" of May 1992, prior to the referral to the Committee for Proprietary Medicinal Products made on 11 October 1995. [23268]
§ Mr. MaloneIt is not normal practice to disclose whether the advice of Law Officers has been sought in any particular case.
§ Mr. HughesTo ask the Secretary of State for Health (1) what meetings have been held between the Licensing Authority and the pharmaceutical companies holding product licences for combined oral contraceptives containing desogestrel or gestodene since 7 November 1995; [23269]
(2) pursuant to the answer of 8 February, Official Report, columns 344-45, with which companies and on what dates the discussions regarding supply took place. [23278]
§ Mr. MaloneInformation about discussions held between the s Licensing Authority and pharmaceutical companies is treated on confidence under the Medicines Act 1968.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to the answer of 8 February,Official Report, columns 232–44, relating to the letter of 11 October 1995 from the Medicines Control Agency, for what reasons it is not normal practice to publish such documentation. [23270]
§ Mr. MaloneThe relevant documentation is considered to be a confidential communication between regulatory bodies. Such communications are not normally published because they may contain information which is sensitive for commercial reasons or relates to the formulation of policy.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to the answer of 19 December 1995,Official Report, column 1149, if regulatory action with respect to clinical trials of combined oral contraceptives has now been completed; and if he will make a statement. [23273]
§ Mr. MaloneI refer the hon. Member to the reply I gave him on 8 February,Official Report, column 386. In the case of clinical trials, the Licensing Authority would not normally make a public announcement.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to the answer of 8 February,Official Report, column 344, whether those who made arrangements on 11 October 1995 for the meeting of the Committee on Safety of Medicines on 13 October 1995 were made aware of the formal referral regarding safety concerns relating to desogestrel and gestodene to be considered by the Committee for Proprietary Medicinal Products on 17 to 18 October 1995. [23275]
§ Mr. MaloneThose making the arrangements were aware of the requests that this issue be placed on the agenda of the Committee for Proprietary Medicinal Products on 17 and 18 October 1995.
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§ Mr. HughesTo ask the Secretary of State for Health, pursuant to the answer of 8 February,Official Report, columns 343–44 what was the legal basis for the referral of 11 October 1995 to the Committee for Proprietary Medicinal Products. [23277]
§ Mr. MaloneI refer the hon. Member to the replies I gave him on 8 February,Official Report, columns 343–44, and the hon. Member for Gordon (Mr. Bruce) on 19 December 1995, Official Report, column 1150.
§ Mr. MaddenTo ask the Secretary of State for Health (1) what representations he has received about the safe use of Femodene ED; if he will list the names of those who have made such representations; and what action he has taken in response to such representations; [24297]
(2) what research he has (a) commissioned and (b) evaluated into the contraceptive pill Femodene ED; what medical side-effects, if any, the pill produces; what advice he has received from the manufacturer about the medical conditions where use of this pill would be inappropriate; and if he will make a statement. [24296]
§ Mr. MaloneFemodene ED is a combined oral contraceptive preparation containing ethinyloestradiol and gestodene. It is one of the seven brands of oral contraceptive which was subject of advice from the Committee on Safety of Medicines in October 1995 in relation to the risk of venous thromboembolism. The advice of the CSM was based on research studies which indicated that oral contraceptives containing gestodene or desogestrel are associated with an increased risk of venous thromboembolism, compared with other oral contraceptives. The chairman of the CSM wrote to doctors and pharmacists on 18 October 1995 and a copy of his letter is available in the Library.
The contra-indications to use and side-effects of Femodene ED are documented in the product data sheet issued by the manufacturer and in the British National Formulary.
I refer the hon. Member to the statement to the House made by my right hon. Friend the Secretary of State for Health on 23 October 1995, Official Report, column 701–11, and also, in respect of the matter of representations, to the replies I gave to the hon. Member for Southwark and Bermondsey (Mr. Hughes) on 8 February, Official Report, column 345.