§ Mr. Ashleyasked the Secretary of State for Social Services when the report of the British Reye's syndrome surveillance was completed; when it was received by the Committee on Safety of Medicines; when it was discussed; and what was the conclusions of the report and the views of the committee.
§ Mr. HayhoeI refer the right hon. Member to the reply from my hon. Friend the Parliamentary Under-Secretary of State to him on 13 May at column448 and to my reply to my hon. Friend the Member for Salisbury (Mr. Key) on 10 June at columns 145–46.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) when the Committee on Safety of Medicines met to discuss the relation between Reye's syndrome and the taking of aspirin; what new evidence it discussed; if he will list the occasions, since the meeting in 1982, when 367W Reye's syndrome was discussed; when the committee was informed that the United States authorities intended to require warning labels on aspirin; if the committee had been informed of the decline in the incidence in Reye's syndrome in the United States of America that followed; and if he will make a statement;
(2) which manufacturers of aspirin, or organisations representing them, made representations to the Committee on Safety of Medicines regarding the taking of aspirin by children and its possible link with Reye's syndrome; and when they did so.
§ Mr. HayhoeThe Committee on Safety of Medicines, which has since 1982 been keeping under review the possibility of a link between Reye's syndrome and aspirin, began in March 1985 to re-examine all the available evidence. In April 1985 the Committee gave further consideration to this issue and advised that the available evidence had not established a causal link between aspirin use and Reye's syndrome. In March 1986 the Committee again reviewed all available evidence on Reye's syndrome and aspirin including: the report of the pilot phase of the United States of America public health services study on Reye's syndrome and medications, published in theNew England Journal of Medicine on 3 October 1985; "United States of America Morbidity and Mortality Weekly Reports on Reye's Syndrome for 1985", published on 7 February 1986; a proposed rule by the United States Food and Drug Administration on labelling for oral aspirin-containing drug products published in the Federal Register on 17 December 1985; and a preliminary communication from the authors of the uncompleted Reye's syndrome risk factor study based on the British Reye's syndrome surveillance scheme. In April and May 1986 the committee gave further consideration to the possible link between aspirin and Reye's syndrome and possible steps to reduce the use 'of aspirin by children, including consideration of papers provided by the Aspirin Foundation and the Proprietary Association of Great Britain and a summary of the views of some Companies.
On 29 May the Committee concluded that while the causes of Reye's syndrome are not clearly defined, and its epidemiology in the United Kingdom differs from that in the United States of America, aspirin may be a contributory factor to the causation of Reye's syndrome in some children in the United Kingdom. It accordingly recommended that aspirin should no longer be given to children aged under 12 years unless specifically indicated and endorsed the programme of action to be carried through by the pharmaceutical industry and the Health Departments as set out in my reply to my hon. Friend the Member for Salisbury (Mr. Key) on 10 June at columns 145–46.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will publish in full the recommendations of the Committee on Safety of Medicines on the taking of aspirin by children; and if he will make a statement.
§ Mr. HayhoeI refer the right hon. Member to my reply to my hon. Friend the Member for Salisbury (Mr. Key) on 10 June at columns145–46 and to the letter from the chairman of the Committee on Safety of Medicines of the same date, a copy of which is in the Library, in which the committee set out in full its advice to doctors, dentists and pharmacists. The committee has also prepared a more 368W detailed scientific statement on Reye's syndrome and aspirin which I understand will be published this week in the CSM Update series in the British Medical Journal.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will detail the action taken by his Department to explore the possibility of a link between the taking of aspirin and Reye's syndrome; and if he will estimate its cost.
§ Mr. HayhoeThe Department has kept in close touch with studies by the Committee on Safety of Medicines of all the available evidence, from this country and overseas, of possible links between aspirin and Reye's syndrome. This evidence includes the preliminary results of the Reye's syndrome risk factor study, run jointly in the United Kingdom by the British Paediatric Association and the communicable disease surveillance centre of the public health laboratory service. The study is conducted by members of the CDSC but it is difficult to separate out the cost of this work from the total cost of CDSC to public funds.