§ Mr. GallowayTo ask the Secretary of State for Health how many yellow card reports of adverse reactions to AZT have been made by doctors dispensing and prescribing the drug.
§ Dr. MawhinneyEighty-three. A report of a suspected reaction in association with a drug does not necessarily mean that the drug caused the effect reported.
§ Mr. GallowayTo ask the Secretary of State for Health if she will place in the Library all the research data and 385W compiled statistics on adverse reactions and side effects of AZT; if she will list these adverse reactions and side effects; and if she will make a statement.
§ Dr. MawhinneyResearch data on the adverse effects of AZT submitted to the Medicines Control Agency in support of the product licence applications is confidential under section 118 of the Medicines Act, 1968. Information on the adverse effects of AZT is available in standard reference books and medical and scientific publications in the public domain. Information is also given in the data sheet for the product, produced by the manufacturer and authorised by the licensing authority, a copy of which will be placed in the Library.
The most serious adverse reactions associated with AZT are disorders affecting the blood including anaemia and neutropenia. Other adverse effects reported include nausea, anorexia, abdominal pain, headache, rash, fever, muscle pain, insomnia and malaise.
§ Mr. GallowayTo ask the Secretary of State for Health what was the cost to the national health service, including the salaries of doctors, the use of other ancillary drug treatments, beds and administration, of the Concorde trials.
§ Dr. MawhinneyThe costs of the Concorde trial were met by the Medical Research Council, which receives its grant-in-aid from the office of my right hon. Friend the Chancellor of the Duchy of Lancaster.
§ Mr. GallowayTo ask the Secretary of State for Health (1) if she will place in the Library the research data which compares mortality rates between those AIDS patients given AZT and those AIDS patients not given AZT; and if she will publish full details of mortality rates for both the AZT group and the placebo control group during the Concorde trials;
(2) what assessment she has made of the development of cancers in the trial subjects who took AZT for the duration of the Concorde trial;
(3) what assessment her Department has made of the numbers and characteristics of patients who (a) suffered adverse reactions to AZT during the Concorde trial and (b) had to cease taking the drug because of the severity of the adverse reactions.
§ Dr. MawhinneyPreliminary results of the Concorde trial involving AZT were published in a letter in theLancet on 3 April. We are still awaiting the full report of the trial which has not yet been analysed by the investigators. As soon as the full report and raw data are received, these will be carefully analysed by the Department and the Medicines Control Agency. Advice on the licensing implications will be sought from the Committee on Safety of Medicines.
§ Mr. GallowayTo ask the Secretary of State for Health how much time was spent in deliberations by the Committee on the Safety of Medicines to decide whether to license AZT; if she will list the names of members of the particular committee who were to present at specific hearings on the licensing of AZT; and if she will place in the Library the minutes of these meetings.
§ Dr. MawhinneyAZT was licensed in 1987 by the Licensing Authority following full consideration by the Committee on Safety of Medicines and its sub-committees.386W The advice of the CSM has also been sought for subsequent variations to the original licence. The deliberations of the CSM are confidential and records are not kept of how much time the CSM or its sub-committees spend on any particular item on their agendas.
A list of members of the CSM and its sub-committees for 1987 is published in the CSM's annual report, copies of which are available in the Library.
§ Mr. GallowayTo ask the Secretary of State for Health if she will publish details of the ongoing studies in Britain using AZT on asymptomatic subjects, and of research studies into AZT conducted since 1988, which have been notified to her Department.
§ Dr. MawhinneyThree trials organised by the Medical Research Council, which receives its grant-in-aid from the office of my right hon. Friend the Chancellor of the Duchy of Lancaster, have involved asymptomatic patients using AZT
Concorde—comparing immediate treatment with AZT to deferred treatment once symptoms have developed.Delta—comparing AZT monotherapy with combination therapy using AZT and dideoxyinosine (ddl) or dideoxycytidine (ddC) in patients with CD4 counts between 350 and 50 per cumm. A minority of the patients in this trial will be asymptomatic. This trial is ongoing.Pental—evaluating the early use of AZT in asymptomatic children with HIV infection born to HIV antibody-positive mothers. This trial is ongoing.All three are international multicentre trials.
There is no requirement to notify the Department centrally of ongoing clinical trials funded from other sources.
§ Mr. GallowayTo ask the Secretary of State for Health how many prescriptions of AZT were issued to asymptomatic individuals in each month since April 1988.
§ Dr. MawhinneyThis information is not available centrally.
§ Mr. GallowayTo ask the Secretary of State for Health (1) if she will review the complaint made in 1992 by the film company Meditel to the Medicines Control Agency, relating to advertising claims by the Wellcome Foundation in relation to AZT;
(2) what action was taken by the Medicines Control Agency and her Department in respect of the complaint made by Meditel in 1992 against the Wellcome Foundation; and if she will make a statement.
§ Dr. MawhinneyThe Medicines Control Agency examined the complaint and reviewed promotional material for AZT at the time. Action was not taken against the Wellcome Foundation. There is no reason to review the complaint now.