§ Mr. GallowayTo ask the Secretary of State for Health what are the present clinical criteria for having AIDS; what were the clinical criteria for having AIDS in 1987; how those criteria have changed; and what effect the criteria have on eligibility of patients to be prescribed AZT.
§ Dr. MawhinneyIn the United Kingdom, the current clinical criteria for AIDS are those set out by the US Centers for Disease Control in 1987. Copies will be placed in the Library. The 1987 AIDS case definition revised the 1985 definition by addition of non-infectious, non-cancerous HIV-associated conditions and by widening the diagnostic critieria for certain AIDS indicator diseases.
Zidovudine, or, AZT, is currently licensed in the United Kingdom for the following indications:
- asymptomatic disease in adult patients showing signs of immune suppression, i.e., CD4 counts repeatedly below 200 per cumm or between 500 and 200 and falling rapidly
- early symptomatic HIV disease in adults with CD4 counts below 500 per cumm
- advanced disease, i.e., AIDS and AIDS Related Complex, in adults and children
- HIV related symptons or asymptomatic disease with markers indicating significant HIV-related immune suppression in children over the age of three months.
§ Mr. GallowayTo ask the Secretary of State for Health how many(a) civil servants within her Department, (b) consultants sitting upon any of the advisory committees since 1977 or (c) other individuals involved organisationally in the Concorde trials have received money in royalties or grants, or had career positions, or directorships or consultancies, with the Wellcome Foundation, the Wellcome Trust or any of the Wellcome Foundation's subsidiary companies.
§ Dr MawhinneyNo civil servants within the Department have received money in any form from the Wellcome Foundation or the Wellcome Trust. Membership of the Committee on Safety of Medicines is published in the Medicines Commission annual report, which includes a comprehensive list of members' interests in the pharmaceutical industry. Information is not available for outside experts who sit on other Departmental advisory committees. The Concorde trial480W was 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.
§ Mr. GallowayTo ask the Secretary of State for Health if she will place in the Library the full results of the Concorde trials; and if she will make a statement on the results.
Mr. JacksonI have been asked to reply.
The full report of the trial is still in preparation and is due to be published within the next few months. A copy of the letter to The Lancet summarising the preliminary results is available in the Library.
§ Mr. GallowayTo ask the Secretary of State for Health is she will place in the Library all the relevant research data prior to the start of the Concorde trials in 1988, which showed that AZT was of benefit to HIV antibody positive asymptomatic individuals.
§ Mr. Robert JacksonI have been asked to reply.
Prior to the start of the Concorde trial one paper had been published which indicated a potential benefit of AZT treatment in asymptomatic HIV-infected individuals, and this reported data on a very small number of subjects. A copy is available in the Library. (Lancet (i) 1988: pages 373–376).
§ Mr. GallowayTo ask the Secretary of State for Health what arrangements are being made for those Concorde trial subjects who were given the drug AZT: how many are still being prescribed the drug; and who is bearing the cost.
§ Mr. Robert JacksonI have been asked to reply.
All patients in the Concorde trial will have the opportunity to discuss their future treatment with their doctors in the light of the results of the trial and their own clinical status and will be told whether they received AZT or placebo during the blinded phase of the trial, if they wish to know. For those deciding to continue treatment with AZT and who fall within the currently licensed indications, the cost of the drug will be met by the national health service. There is no information available on the number of patients still being prescribed the drug.
§ Mr. GallowayTo ask the Secretary of State for Health when the Concorde trials relating to AZT were completed; when the results were announced; and if she will make a statement about the way in which the preliminary results were announced.
§ Mr. Robert JacksonI have been asked to reply.
Analysis of the data from the Concorde trial collected up to 31 December 1992 was completed in March 1993; limited follow-up information will continue to be collected on the patients, in an unblinded fashion, so the trial is not completely finished. Preliminary results were published in a letter to The Lancet on 2 April 1993, having been announced to doctors and other staff involved with the trials at participating clinical centres at a meeting on 1 April 1993. The trial co-ordinating committee considered it important for the key data to be made available to an international readership in a preliminary report through the scientific press as soon as possible, to avoid the spread of inaccurate rumours among patients and their doctors.