§ Mr. Ashleyasked the Secretary of State for Social Services whether the figures of 9 per cent. of overseas patients and 3.6 per cent. of British patients reported, in evidence submitted to the Committee on Safety of Medicines before the product licence for Opren was issued, as suffering from photosensitivity as a result of taking Opren, is in line with the incidence found in later research and conforms with the incidence indicated by the level of photosensitivity adverse reaction reports; and to what any difference is attributed.
§ Mr. Kenneth ClarkeStudies of benoxaprofen — Opren submitted by Lilly Industries Ltd. in support of its products licence application, and subsequent studies, have shown a wide variation in the reported incidence of photosensitivity as an adverse reaction associated with the drug. Reports to the Committee on Safety of Medicines of suspected adverse effects are not used to calculate the incidence of side effects, because it is known that not all adverse reactions are recognised or reported.
§ Mr. Ashleyasked the Secretary of State for Social Services if there were any elderly people amongst the 291 United Kingdom and 200 United States of America patients in the clinical trials submitted by Lilly Industries 134W to the Committee on Safety of Medicines when, it applied for a product licence for Opren; whether elderly people were included in later clinical trials; where and when; and how many.
§ Mr. Kenneth ClarkeSuch information would normally be confidential for commercial reasons, as I explained in the House on 27 January.—[Vol. 35, c. 1121.] But in the special circumstances of this case I have decided with the agreement of the company that this information may be made available.
About 52 of the patients included in the United Kingdom trials were 65 years old or over. It is only possible to give an approximate figure because in the reports of some trials the exact ages of patients are not given. No age breakdown is available for the 209 patients who completed trials in the United States, but, of the 277 patients who took part in trials there, 86 were 65 years old or over. The additional clinical data submitted in support of the product licence application was, at the request of the CSM, only an analysis of the adverse reactions of the skin and nails in about 2,000 patients and gave no details of the ages of patients.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) pursuant to the reply of 9 February, Official Report, c. 412, in what way the evidence from Basingstoke and Indianapolis about the drug Opren was conflicting; and if he will give details of the further evidence received by the Committee on Safety of Medicines in August 1982 which led to the suspension of the licence;
(2) whether the Committee on Safety of Medicines received before October 1981 any information, either written or oral, from Dista Products regarding the accumulation of Opren in elderly people; when Dista Products gave the first warning that the dosage should be reduced for elderly people; and when and how the Committee responded.
§ Mr. Kenneth ClarkeThe possibility of accumulation of Opren in elderly people was discussed at a meeting in August 1981 between the company and members of the CSM secretariat. In the documents presented in October 1981, the company suggested that accumulation of the drug might be a cause of the gastro-intestinal bleeding associated with the drug in some elderly people, and that the dosage for patients over 75 should therefore be reduced. The committee decided at its meeting in November 1981 that it would wish to see further evidence before deciding if any dosage change was necessary for elderly patients. The conflicting evidence presented in the preliminary report of a study in Indianapolis and Basingstoke was that the drug appeared to be retained much longer in the bodies of the patients in Basingstoke than in the patients in Indianapolis. The further evidence of August 1982 was received after the licence had been suspended, and the licensing authority has therefore not asked for the CSM's advice on it. This evidence included a pharmacokinetic study on patients aged between 65 and 75 years, a review of information on renal and liver function in patients on long term treatment with the drug, and information on the metabolism of the drug and the properties of the R and S enantiomers.