§ Mr. Ashleyasked the Secretary of State for Social Services (1) whether the research studies submitted by Eli Lilly when it applied for a product licence for Opren conformed with the guidelines laid down by the Committee on Safety of Medicines;
(2) if he will estimate the total number of adverse reactions and deaths associated with Opren in view of the fact that the yellow card system reports only a small percentage of adverse reactions and deaths associated with any drug;
(3) if the clinical trials on Opren included any old people; and, if so, what proportion they were of the total number taking part in the trials;
(4) for how long he intends to maintain the suspension of the licence for Opren;
(5) whether the Committee on Safety of Medicines has had discussions with the United States Food and Drug Administration about the licensing of the drug Opren;
(6) if he will give details of the efforts his Department or the Committee on Safety of Medicines has made to establish the extent and seriousness of side effects associated with drug Opren; and in what proportion of cases these were associated with elderly people;
(7) whether, in its application for a product licence for Opren, the manufacturers gave any indication that the drug might have adverse effects on the kidneys, liver or other vital organs;
(8) if he will publish in the Official Report the latest estimate of the Committee on Safety of Medicines of the number of people whose death is thought may be associated with Opren, and of the number who may have had side effects from the drug; and if he will categorise the side effects giving the numbers for each category.
§ Mr. Geoffrey FinsbergData submitted to the licensing authority by applicants for product licences are confidential. I can confirm, however, that data submitted684W in support of the applications for product licences for Opren conformed to the licensing authority's guidelines, and included information on its administration to elderly patients. The manufacturers also included data relating to possible adverse effects on the kidneys, liver and other vital organs.
The product licences for Opren suspended by the licensing authority were surrendered voluntarily by the company concerned in September and are therefore no longer extant.
The Committee on Safety of Medicines is aware that not all adverse reactions to drugs are recognised or reported, but it is not possible to estimate the extent of this either in general or in relation to a particular drug. Consequently, it is not possible for the Department or the committee to estimate the incidence of deaths or other serious adverse reactions associated with Opren in the whole or any part of the patient population.
The Department has kept in close touch with the United States Food and Drugs Administration on this subject and there has been a mutual exchange of data on adverse reactions, of which the Committee on the Safety of Medicines has also been kept in touch.
§ Mr. Ashleyasked the Secretary of State for Social Services whether he has had discussions with Eli Lilly regarding voluntary compensation for those damaged by Opren.