asked the Secretary of State for Social Services (1) what is the estimate of the Committee on Safety of Medicines of the number of people who took Opren who had photo sensitivity reaction;
(2) when the Committee on Safety of Medicines requested further evidence about the two side effects of Opren photo sensitivity and onycholysis; and whether it was given any evidence or papers prepared by people not employed by the manufacturing company Eli Lilley;
(3) how many clinical trials were examined by the Committee on Safety of Medicines before it gave a product licence to Opren; how many patients were involved; how many received the drug at a sub-therapeutic dose; how many of the trials lasted longer than three weeks: how many involved more than 40 people; how many were double blind trials;
(4) what experimental studies were reported to the Committee on Safety of Medicines by the manufacturers of the drug Opren as evidence of the drug's freedom from carcinogenicity;
(5) whether the Committee on Safety of Medicines decided that the study of the side effects of Opren by Walter M. Mikulaschek provided by the manufacturing company after a request for further information was of a scientific standard acceptable to them;
(6)if the Committee on Safety of Medicines requested evidence of the safety of Opren on old people before it issued a product licence;
(7) whether any of the clinical trials on Opren carried out in the United States of America or in the United Kingdom and available to his Department, showed that older patients were more likely to suffer adverse reactions;
(8) whether the Committee on Safety of Medicines before it gave a product licence to the drug Opren, requested evidence of freedom from carcinogenicity from the manufacturing company.
These questions concern matters contained in statements of claim in current legal actions against the Department of Health and Social Security and the Committee on Safety of Medicines. I am advised that they are therefore sub judice.
asked the Secretary of State for Social Services (1) whether Professor Sir Abraham Goldberg, the chairman of the Committee on Safety of Medicines, was ever employed by Eli Lilley to do research into Opren; if members of the Committee on Safety of Medicines were made aware of Professor Sir Abraham Goldberg's past involvement with the company; and if Professor Sir Abraham Goldberg took part in the committee's deliberations on Opren;(2) if Eli Lilly and its British subsidiary disclosed immediately to the Committee on Safety of Medicines all the evidence it had of adverse reactions to Opren.
The matters raised in these questions fall within the issues contained in statements of
claim in legal actions against our Department and the Committee on Safety of Medicines and are sub judice. We and the committee intend to defend those actions.
I feel, however, that because of the personal nature of some of the innuendos, it is right to put the following facts on the record. Professor Sir Abraham Goldberg has never been employed by Eli Lilly. In 1978–80 staff of his university department carried out a study on gastric bleeding with benoxaprofen (Opren) and fiurbiprofen, financed by the company. Such financing is normal practice where university departments carry out studies on behalf of the pharmaceutical industry. Sir Abraham gave advice on the planning of the study but was not involved in the conduct of the study. This role was set out on the record when the report of the study by Dr. Yeung Laiwah and others, was published in 1981 in the Annals of Rheumatic Diseases. In January 1980, staff of his department began planning a further study at the request of Eli Lilley into gastric bleeding with benoxaprofen and piroxicam. This study continued into 1982 but was never completed. He gave no advice on that study and took no part in it.
Sir Abraham was not a member of the Committee on Safety of Medicines when it gave its advice to licence Opren in February 1980. He was appointed to the committee from March 1980 and was fully involved in all the committee's discussions leading up to the withdrawal of the product from the United Kingdom market in August 1982.
I must make it clear that I have complete confidence in the integrity and judgment of Professor Sir Abraham Goldberg. I regret that the right hon. Member should use parliamentary questions to make thinly veiled attacks on named individuals and to embark on a search for information in support of legal claims.