§ Mr. AshleyTo ask the Secretary of State for Health what scientific evidence was considered by the Committee on Safety of Medicines before it gave its approval for a licence to the drug AZT for the treatment of AIDS.
§ Mr. MellorThe Committee on Safety of Medicines considered a range of scientific matters relating to the safety, quality and efficacy of this drug. The information supplied by a pharmaceutical company to support a licensing application is commercially confidential.
§ Mr. AshleyTo ask the Secretary of State for Health (1) what evidence there is on the reversibility of the side effects of the drug AZT and on the effect on the AIDS virus if the drug is discontinued;
379W(2) what are the known side effects on AIDS patients of the drug AZT.
§ Mr. MellorZidovudine (AZT) has been associated with a range of side effects as set out in the ABPI Data Sheet Compendium 1988–89 (pages 1634–6). A copy is in the Library. Many patients do develop side effects due to the potency of this drug and the seriousness of their illness. Doctors are advised to monitor patients very carefully and adjust the dosage or even stop the drug altogether should side effects occur. Reversibility of side effects depends upon their nature and severity and upon the clinical state of the patient. Little information is available about the effects of discontinuing treatment on the AIDS virus, however there have been reports of a rise in the blood levels of the viral antigen.
§ Mr. AshleyTo ask the Secretary of State for Health how many deaths are known to have resulted from the use of the drug AZT.
§ Mr. MellorNone that we are aware of. The Committee on Safety of Medicines has received three adverse reaction reports where patients being treated with Zidovudine (AZT) have died. Unfortunately all of these patients had a limited life expectancy due to the nature of their illnesses, and it is not possible to establish that any of these deaths resulted from the use of this drug.
§ Mr. AshleyTo ask the Secretary of State for Health what evidence there is of the efficacy of the drug AZT(a) in prolonging the lives and (b) in improving the quality of life, of British AIDS patients who have been treated with it; and if he will make a statement.
§ Mr. MellorI am advised that evidence for the efficacy of the drug Zidovudine (AZT) when used in the treatment of patients in the United Kingdom was published in January 1989 in volume 18, supplement 1 of theJournal of Infection.
§ Mr. AshleyTo ask the Secretary of State for Health how many AIDS patients have been treated with the drug AZT; and how many are currently receiving it.
§ Mr. MellorWe do not hold this information centrally.