§ Mr. Malcolm BruceTo ask the Secretary of State for Health (1) if the Committee on Safety of Medicines considered the manuscript produced by Professor Jick and what supplementary written material was made available from that study at its meeting on 13 October; [6085]
(2) pursuant to his oral statement to the House on 23 October, Official Report, column 701, on what date the Medicines Control Agency commissioned Professor Jick to conduct a study to examine safety questions regarding third generation oral contraceptives; and what was the cost of that study to the Medicines Control Agency. [5968]
§ Mr. Malone[holding answer 14 December 1995]: The Medicines Control Agency did not commission Professor Jick to conduct a study of the safety of oral contraceptives and did not provide him with funding. During June and July 1995 the MCA discussed with him the feasibility of his conducting a study which would help to evaluate further concerns regarding venous thromboembolism arising from a study conducted by the World Health Organisation. The findings of Professor Jick's study were considered by the Committee on Safety of Medicines at its meeting on 13 October. The committee also considered the findings of a study by Professor Jick of fatal cardiovascular events in users of oral contraceptives.
§ Mr. BruceTo ask the Secretary of State for Health (1) what was the publication date of the report produced by Professor Spitzer and colleagues and considered by the Committee on Safety of Medicines at its meeting on 13 October; [6084]
1147W(2) on what date (a) the Medicines Control Agency requested expedited analysis of the trinational study on oral contraceptives, (b) the Medicines Control Agency first received data from the study and (c) the Medicines Control Agency received a written report of the study. [5970]
(3) what discussions his officials held on 9 October regarding safety concerns relating to third generation contraceptives. [5969]
§ Mr. Malone[holding answer 14 December 1995]: Official of the Medicines Control Agency first saw preliminary data from the transnational study on 10 July 1995. It made a written request for an expedited analysis of the study on 13 July 1995. Such an analysis was presented by the investigators to officials from the MCA at a meeting held on 9 October 1995, and to a meeting of a working group which included members of the Committee on Safety of Medicines and invited experts on 10 October 1995. The MCA has not received a final report of the study but it has reviewed the published protocol and received written documentation of the findings including an abstract which was understood to have been submitted to a scientific meeting.
§ Mr. BruceTo ask the Secretary of State for Health (1) what action has been taken with respect to third generation oral contraceptives by(a) the licensing authority and (b) the Medicines Control Agency under powers conferred by the Medicines Act 1968 and subsiduary legislation; [6086]
(2) from what date he proposes to (a) suspend, (b) revoke and (c) vary the licences of the third generation oral contraceptives which were recently the subject of advice from the Committee on Safety of Medicines; [5916]
(3) what regulatory action has been taken in respect of the third generation oral contraceptives referred to in the "Dear Doctor" letter of 18 October; and if he will make a statement. [5919]
§ Mr. Malone[holding answer 14 December 1995]: Any consideration of possible regulatory action is treated in confidence between the licensing authority and the company or companies concerned. The licensing authority makes a public announcement only after any regulatory action has been completed.
§ Mr. BruceTo ask the Secretary of State for Health (1) at whose request, and when, the issue of the third generation oral contraceptives was placed on the agenda of the meeting of the Committee on Proprietary Medicinal Products held on 17 and 18 October; [5914]
(2) if the United Kingdom representatives at the meeting of the Committee on Proprietary Medicinal Products on 18 October told that committee of the intention to issue later that day the "Dear Doctor" letter relating to third generation oral contraceptives; [5910]
(3) what assessment he has made of the licensing authority's compliance with its obligations to its European partners in relation to those matters relating to the safety of third generation oral contraceptives considered at the meetings of the Committee on Proprietary Medicinal Products held on 17 and 18 October and on 26 and 27 October. [5913]
1148W
§ Mr. Malone[holding answer 14 December 1995]: The Medicines Control Agency has an obligation to keep other European Community member states informed of issues on the efficacy, quality and safety of medicines and it has taken extensive action in this respect for oral contraceptives. When information from the World Health Organisation study was first provided to the MCA in confidence, it sought to ensure its release to other member states, although its request was not granted. The safety of third generation oral contraceptives was placed on the agenda of the Committee on Proprietary Medicinal Products—CPMP—pharmacovigilance working party in August 1995 and other member states were informed that important new evidence was about to emerge. The United Kingdom made it clear that the issue would need urgent consideration and that steps were being taken to obtain further information.
The safety of third generation oral contraceptives was placed on the agenda of the CPMP meeting of 17 and 18 October at the formal request of the UK representatives of the committee on 11 October, after further information on the issue became available. At the meeting on 17 and 18 October, UK representatives presented the new data to the committee and made it clear that the UK considered that there was an urgent need to communicate the findings with appropriate recommendations to doctors and women in the UK without delay.
The CPMP was unable to reach a position at the meeting of 17 and 18 October and a further meeting was convened for 26 and 27 October. UK representatives participated in this meeting and arranged for Professor Rawlins and Professor Langman of the Committee on Safety of Medicines to attend as additional UK experts. The CPMP assessment which was issued following the meeting of 26 and 27 October makes it clear that, on the basis of three studies, oral contraceptives containing desogestrel or gestodene are associated with an increased risk of venous thromboembolism. Its position statement recommends that preparations containing desogestrel and gestodene should not be withdrawn but does not make specific recommendations for action. This and the fact that the CPMP's position statement is not a binding opinion indicate that the matter of informing and advising doctors and users is for individual member states to deal with based on their particular prevailing circumstances.
§ Mr. BruceTo ask the Secretary of State for Health (1) what information relating to third generation oral contraceptives was considered by the sub-committee on pharmacovigilance before the meeting of the Committee on Safety of Medicines on 13 October; [5921]
(2) which members of the Committee on Safety of Medicines and what other persons were present at the special meeting of the committee held on 13 October; [5925]
(3) what arrangements were made for the chairman of the Committee on Safety of Medicines to attend the special meeting of the Committee on Safety of Medicines held on 13 October; [5966]
(4) at what date and time the special meeting of the Committee on Safety of Medicines held on 13 October was called; [5931]
1149W(5) if he will list the names and appointments of all persons present at the ad hoc sub-committee of the Committee on Safety of Medicines which met on 11 October, to consider issues relating to the third generation oral contraceptives; [5907]
(6) if he will publish the full text of the recommendations of the Committee on Safety of Medicines on third generation oral contraceptives; [5930]
(7) what factors led the sub-committee on pharmacovigilance not to consider safety concerns relating to third generation oral contraceptives prior to the meeting of the Committee on Safety of Medicines on 13 October; [5911]
(8) when he will publish the full documentation which was made available to the Committee on Safety of Medicines before its meeting on 13 October. [5917]
§ Mr. Malone[holding answer 14 December 1995]: No ad hoc meeting of a sub-committee of the Committee on Safety of Medicines was held on 11 October. A working group which included members of the CSM and invited experts was convened on 10 October to consider new information relating to the safety of third generation oral contraceptives. This issue was not considered by the sub-committee on pharmacovigilance before the meeting of the CSM on 13 October due to the urgency of the matter. It is normal practice for urgent safety issues to be considered by CSM without prior consideration by the sub-committee on pharmacovigilance when there are time constraints. In these circumstances ad-hoc working groups are convened as necessary.
Arrangements for the meeting of the CSM of 13 October were made during the morning of 11 October and by agreement with the chairman of the committee.
The papers and proceedings of meetings of the CSM, its sub-committees and ad hoc working groups which advise the CSM are confidential. The recommendations made by the CSM at the meeting on 13 October are embodied in the letter from the chairman dated 18 October.
§ Mr. BruceTo ask the Secretary of State for Health what estimate he has made of the number of deaths which would be prevented annually if the prescribing advice from the Committee on Safety of Medicines on third generation oral contraceptives were acted on by all United Kingdom general practitioners. [5929]
§ Mr. Malone[holding answer 14 December 1995]: It is estimated that about two deaths and 100 to 150 cases of venous thromboembolism would be prevented annually in the United Kingdom if the Committee on Safety of Medicines' recent advice on third generation oral contraceptives was acted upon.
§ Mr. BruceTo ask the Secretary of State for Health (1) what information relating to the potential beneficial effects of third general oral contraceptives was made available to the Committee on Safety of Medicines before its meeting on 13 October; what steps the Medicines Control Agency took to establish that all currently available information was presented to the committee; and what steps the Medicines Control Agency took to establish when further information might be available; [5918]
1150W(2) what assessment he has made of the adequacy of the information made available to the Committee on Safety of Medicines before its meeting on 13 October. [5967]
§ Mr. Malone[holding answer 14 December 1995]: The Medicines Control Agency sought to obtain data on all information relevant to the cardiovascular risks of oral contraceptives. This included whether the third generation oral contraceptives might be associated with a lesser risk of arterial disease than other oral contraceptives that might offset the increased risk of venous thromboembolism. The data examined related to large populations of women in the United Kingdom with careful and exhaustive analyses to assess factors which could influence the findings. Two of the studies provided to the committee prior to the meeting included data on the risk of stroke and myocardial infarction and one study provided data on mortality. In October 1995, the MCA discussed with the investigators of the studies the availability of further information on the relative risks of myocardial infarction and stroke with different oral contraceptives and understood that substantive data would not be available for one to two years.
§ Mr. BruceTo ask the Secretary of State for Health what information was made available by the Medicines Control Agency to Wyeth, Schering and Organon, relating to safety concerns regarding third generation oral contraceptives before the meetings held between the Medicines Control Agency and those companies on 12 October. [5908]
§ Mr. Malone[holding answer 14 December 1995]: These companies were already aware of the preliminary findings of the World Health Organisation's study through their attendance at a meeting held in Geneva in July 1995 to discuss the data. After a review of the findings of the three studies on third generation oral contraceptives that were provided to the Medicines Control Agency in confidence by the investigators, the MCA arranged meetings with companies to present the findings to them. The MCA provided the companies with Professor Jick's data with his agreement and requested and received assurances from the investigators of the other studies that the companies were being provided with the data from these studies.
§ Mr. BruceTo ask the Secretary of State for Health (1) when the despatch of the "Dear Doctor" letters relating to safety concerns about third generation oral contraceptives was begun; [5923]
(2) when the Government's Chief Medical Officer was informed of the decision to issue the "Dear Doctor" letter to general practitioners dated 18 October; [5912]
(3) when the order was placed for the printing of the "Dear Doctor" letters which were dated 18 October; [5927]
(4) on whose authority the "Dear Doctor" letters relating to safety concerns on third generation oral contraceptives dated 18 October were issued. [5909]
§ Mr. Malone[holding answer 14 December 1995]: The decision to issue the letter to all United Kingdom doctors and pharmacists from the chairman of the Committee on Safety of Medicines was taken by Ministers following advice from the Committee that there was an urgent need to inform doctors and users about new information relating to the safety of third generation oral 1151W contraceptives. The Chief Medical Officer was made aware of the CSM's advice on 13 October and was made aware of the CSM's advice on 13 October and was informed of the decision to issue the letter on 16 October. The order for the printing of the letters was placed on 16 October and dispatch began at 4.30 pm on the 18 October.
§ Mr. BruceTo ask the Secretary of State for Health (1) what steps the Medicines Control Agency and the Committee on Safety of Medicines have taken to establish that the information which they considered on 13 October in relation to third generation oral contraceptives was final; [6087]
(2) when the Medicines Control Agency received the final version of the reports for each of the three studies on third generation oral contraceptives which were considered by the Committee on Safety of Medicines on 13 October. [5928]
§ Mr. Malone[holding answer 14 December 1995]: The Medicines Control Agency investigated the safety of oral contraceptives in the light of the new evidence emerging from three studies during the period July to October 1995. During this time it received several manuscripts from the World Health Organisation and Professor Jick providing the findings of their respective studies. The final reports of the studies conducted by the WHO and Professor Jick were received by MCA on 6 and 11 October respectively. Near-final drafts of both papers were provided by the end of September 1995 and, in each case, the MCA was assured by the investigators that there would be no substantive change to the analysis. In the case of the transnational study, MCA was presented with an analysis of the data on 9 and 10 October. During these meetings assurances were given by the investigators that these analyses were final.
§ Mr. BruceTo ask the Secretary of State for Health (1) if he will publish the advice which he received during the period 9 to 18 October from the Medicines Control Agency with respect to safety concerns relating to third generation oral contraceptives; [5915]
(2) what advice the licensing authority received from the Medicines Control Agency following the special meeting of the Committee on Safety of Medicines on 13 October. [5920]
§ Mr. Malone[holding answer 14 December 1995]: Following the meeting of the Committee on Safety of Medicines on 13 October, Ministers received from the Medicines Control Agency a submission containing the CSM's advice. It is not normal practice to publish such internal documentation.