§ Mr. Ashleyasked the Secretary of State for Social Services, whether the Committee on Safety of Medicines requested information from Eli Lilly about the severity and incidence of the photo-sensitivity adverse reactions from Opren; and whether the committee was aware that the Food and Drugs Administration in the United States of America considered the company to have withheld information about adverse reactions.
§ Mr. Kenneth ClarkeInformation about the severity and incidence of photosensitivity adverse reactions formed part of the product licence application for Opren considered by the Committee on Safety of Medicines before the drug was marketed in 1980. At that time, the committee was not aware of any concern on the part of the United States Food and Drugs Administration about allegations that Eli Lilly had withheld information about adverse reactions.
§ Mr. Ashleyasked the Secretary of State for Social Services whether the Committee on Safety of Medicines accepted the claim of Eli Lilly in its advertising that the drug Opren might modify the disease arthritis; whether it made any attempt to verify the claim; and whether the committee had consultations with the United States Food and Drugs Administration about the acceptability of the advertisements for Opren.
§ Mr. Kenneth ClarkeThe Committee on Safety of Medicines has no responsibility for the regulation of advertisements for medicinal products and has therefore not considered the matter.
§ Mr. Ashleyasked the Secretary of State for Social Services whether, pursuant to his answer, 23 December 1982, Official Report, c. 682, he considers that Opren was the cause of at least 10 of the deaths that were reputed to be associated with it.
§ Mr. Kenneth ClarkeThe data available on yellow cards can only be used to establish a working hypothesis. They cannot be used to establish scientifically a causal link 389W between a drug and a reported reaction either generally or in any specific case. On the basis of the information available, however, the Committee on Safety of Medicines is of the view that of the 76 deaths reported to them as possibly associated with benoxaprofen and later assessed as having probably been due to the clinical events referred to in those reports, it was reasonable to work, for purposes of the Medicines Act, on the basis that rather under half of those events were probably caused by benoxaprofen.
§ Mr. Ashleyasked the Secretary of State for Social Services for what reasons he stated in a letter to the right hon. Member for Stoke-on-Trent, South that it was impracticable and undesirable for contra-indications for the elderly to be included in the data sheet for the drug Opren.
§ Mr. Kenneth ClarkeThe right hon. Member has, with respect, taken this phrase out of context. In my letter to the right hon. Member I was referring to the consideration of options for licensing action in July 1982 other than immediate suspension of Opren. It was decided that it would be impracticable and undesirable at that stage to contra-indicate the drug in the elderly firstly because most people using the drug were elderly, and a contra-indication might not have sufficient impact to ensure that the drug was quickly withdrawn from all of them. Secondly, although the evidence of hazard related mainly to the elderly, it was difficult to assess the relative risk to younger patients, because of the limited use of the drug by those patients.