HC Deb 05 June 1996 vol 278 cc447-9W
Mr. Simon Hughes

To ask the Secretary of State for Health, pursuant to his answer of 11 December 1995,Official Report column 521, which advisers were given the elements of the data on desogestrel and gestodene; and on which dates. [31289]

Mr. Malone

Communications between the Licensing Authority and its independent safety advisers are confidential.

Mr. Hughes

To ask the Secretary of State for Health, pursuant to his answer of 11 December 1995,Official Report, column 521, on what dates in 1989, 1991 and 1995 the Committee on Safety of Medicines reviewed the safety of oral contraceptives containing desogestrel and gestodene. [31286]

Mr. Malone

The safety of oral contraceptives containing gestodene or desogestrel was reviewed in March 1989, February 1991, May 1995 and October 1995.

Mr. Hughes

To ask the Secretary of State for Health if he will list the estimates made by the Medicines Control Agency of the incidence of venous thromboembolism associated with,(a) desogestrel, (b) gestodene and (c) levonorgestrel both in June 1995 and on 13 October 1995. [31276]

Mr. Malone

In June 1995, information on the incidence of venous thromboembolism with specific combined oral contraceptives preparations was not available. By 13 October 1995 new information had become available which provided the following estimates of the incidence of venous thromboembolism: for oral contraceptives containing levonorgestrel approximately 15 cases per 100,000 women each year, for oral contraceptives containing gestodene or desogestrel approximately 30 cases per 100,000 women each year.

Mr. Hughes

To ask the Secretary of State for Health from what location the 190,000 letters relating to oral contraceptives containing desogestrel or gestodene were dispatched. [31277]

Mr. Malone

Horndean, Hampshire.

Mr. Hughes

To ask the Secretary of State for Health what estimate his officials made prior to despatch of the "Dear Doctor" letter of 18 October 1995 relating to oral contraceptives of the proportion of letters that would be received by doctors prior to the public announcement scheduled for the afternoon of Thursday 19 October 1995. [31278]

Mr. Malone

I refer the hon. Member to the statement my right hon. Friend the Secretary of State made on 23 October 1995 at columns 701–2. The letters were posted by first class post on Wednesday 18 October 1995. Officials expected that most doctors would receive a copy of the letter, by means of at least one of the three mechanisms of communication used, prior to the public announcement scheduled for Thursday 19 October 1995.

Mr. Hughes

To ask the Secretary of State for Health if he will list the dates on which Ministers received updates regarding the analysis of the World Health Organisation study; and whether Ministers asked the Medicines Control Agency to seek the advice from the Committee on Safety of Medicines on 13 October 1995. [31279]

Mr. Malone

I refer the hon. Member to the reply that I gave him on 7 March at column321. Ministers were not updated regarding the analysis of the World Health Organisation's study between July and October since there was no material change in the findings of the study.

It is normal practice for the Medicines Control Agency to seek the committee's advice on all safety issues with medicines which have important public health implications. Ministers did not ask the MCA to seek the advice of the Committee on Safety of Medicines on this issue.

Mr. Hughes

To ask the Secretary of State for Health on what date, and at what time, the press conference as originally scheduled was made known to the media; and on what date and at what time the revised timing of the public announcement was made available to the media. [31280]

Mr. Malone

The public announcement last year about the safety of certain oral contraceptives was originally planned as a press notice, to be issued in the afternoon of 19 October, having allowed time for doctors and pharmacists to receive the information already sent to them. As a result of inquiries from the electronic media, which were received from 9 am that day, it was decided to bring the announcement forward to 12 noon so that it could inform lunchtime news coverage on radio and television. The Department does not keep records showing the precise times at which the media are informed of forthcoming press conferences.

Mr. Hughes

To ask the Secretary of State for Health, pursuant to his answer to the hon. Member for Gordon (Mr. Bruce) of 19 December 1995,Official Report, column 1153, what steps his officials took to establish that data collection for the transnational study had been completed and if the stage in the recruitment process was communicated to the Committee on Safety of Medicines prior to or during its meeting on 13 October 1995.[31281]

Mr. Malone

Officials from the Medicines Control Agency asked the investigators of the transnational study what stage had been reached in recruitment for their study. They were informed that the data on venous thromboembolism were complete but identification of cases of myocardial infarction was still in progress and it was understood that substantive data would not be available for one to two years. The Committee on Safety of Medicines were informed of this at the meeting on 13 October 1995.

Mr. Hughes

To ask the Secretary of State for Health if his officials contributed to the drafting of a letter attributed to the chairman of the Committee on Safety of Medicines which was published in theBritish Medical Journal of 4 November 1995. [31282]

Mr. Malone

The letter was written by the chairman of the Committee on Safety of Medicines, who discussed its contents with officials before finalising it.

Mr. Hughes

To ask the Secretary of State for Health, pursuant to his answer to the hon. Member for Gordon (Mr. Bruce) of 19 December 1955,Official Report, column 1149, if he will list the United Kingdom representatives on the Committee for Proprietary Medicinal Products in October 1995. [31283]

Mr. Malone

The two members of the Committee representing the United Kingdom competent authority are Dr. Susan Wood and Dr. David Jefferys.

Mr. Hughes

To ask the Secretary of State for Health, pursuant to his answer to the hon. Member for Gordon (Mr. Bruce) of 19 December 1995,Official Report, column 1149, which of the United Kingdom representatives on the Committee for Proprietary Medicinal Products made the formal request that the safety of oral contraceptives containing desogestrel and gestodene be placed on the agenda for the meeting of the Committee for Proprietary Medicinal Products on 17 and 18 October 1995. [31284]

Mr. Malone

Dr. Susan Wood, representing the United Kingdom competent authority.

Mr. Hughes

To ask the Secretary of State for Health, pursuant to his answer of 11 December 1995,Official Report, column 522, if Professor John Guillebaud attended the meeting on 10 October 1995 relating to desogestrel and gestodene. [31285]

Mr. Malone

I refer the hon. Member to the reply that I gave to the hon. Member for Gordon (Mr. Bruce) on19 December 1995 at column1151.