§ Mr. Simon HughesTo ask the Secretary of State for Health, pursuant to his answer of 7 March,Official Report, columns 321–22, (1) if the data on myocardial infarction from the Spitzer and Jick studies was made available to the Committee on Safety of Medicines on 13 October 1995; [27751]
(2) if the interim data from the transnational study was made available to the Committee on Safety of Medicines at its meeting on 13 October 1995. [27752]
§ Mr. MaloneLimited data on myocardial infarction from the Jick study were made available to the committee. The committee considered the data on venous thromboembolism from the transnational study at its meeting on 13 October 1995, but no data on myocardial infarction from this study were available to the Medicines Control Agency or the Committee on Safety of Medicines at that time.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to his answer of 25 March,Official Report, column 428, if his officials assisted the chairman of the Committee on Safety of Medicines in drafting the letter of 18 October relating to oral contraceptives containing desogestrel and gestodene. [27753]
§ Mr. MaloneThe letter was drafted by the chairman of the Committee on Safety of Medicines on the basis of the committee's recommendations. Officials were involved in making minor amendments to the letter. The final version was agreed by the chairman.
§ Mr. HughesTo ask the Secretary of State for Health for what reasons he is unable to make available the advice from the Committee on Safety of Medicines of 13 October 1995 on oral contraceptives. [27756]
§ Mr. MaloneThe advice of the Committee on Safety of Medicines is considered to be a confidential communication between the committee and the licensing authority. Such communications are not normally published because they may contain information which is sensitive for commercial reasons or because their disclosure would undermine the policy-making process.
However, on this occasion, in the interests of public health, the advice given by the CSM at the meeting on 13 October 1995 was sent out in a letter from the 244W chairman dated 18 October 1995 to all doctors and pharmacists. Copies of this letter are available in the Library.
§ Mr. HughesTo ask the Secretary of State for Health if he will list those members of the transnational study team which his officials met on the afternoon of 9 October 1995. [27759]
§ Mr. MaloneProfessor W. Spitzer and Dr. K. MacRae.
§ Mr. HughesTo ask the Secretary of State for Health if the Committee on Safety of Medicines has made an assessment of the safety of desogestrel and gestodene since the publication of January 1996. [27760]
§ Mr. MaloneI refer the hon. Member to the reply that I gave him on 25 April at column281.