§ Mr. DuncanTo ask the Secretary of State for Health (1) what meetings his Department has had with(a) members of the Spongiform Encephalopathy Advisory Committee, (b) members of the Advisory Committee on Dangerous Pathogens, (c) the Ministry of Agriculture, Fisheries and Food, (d) the Environment Agency and (e) the Health and Safety Executive, following the finding of abnormal prion protein in the appendix of a patient in Torbay; and if he will make a statement; [57151]
(2) what recommendations have been made to his Department by (a) the Spongiform Encephalopathy Advisory Committee and (b) the Advisory Committee on Dangerous Pathogens following the finding of abnormal prion protein in the appendix of a patient in Torbay; what steps he has taken to implement the recommendations in each case; and if he will make a statement; [57152]
(3) what discussions he has had with (a) SEAC, (b) ACDP, (c) HSE, (d) MAFF and (e) the Environment Agency on the destruction of surgical instruments in the context of new variant Creutzfeldt-Jakob Disease in the context of any further findings over new variant CJD; [56994]
(4) what checks have been made of patients subsequently operated upon in hospitals where individuals infected with new variant Creutzfeldt-Jakob Disease have undergone operations; [56996]
(5) what research his Department has commissioned following the finding of abnormal prion protein in the appendix of a patient in Torbay; [57021]
(6) what assessment his Department has made of the risk to patients of contracting new variant Creutzfeldt-Jakob Disease from surgical instruments; and if he will make a statement; [56947]
(7) what contingency plans his Department has made should he be advised that there is a risk that patients could be infected with new variant Creutzfeldt-Jakob Disease by surgical instruments; [57005]
(8) what action has been taken following the finding of abnormal prion protein in the appendix of a patient in Torbay; what meetings it has held with other bodies on this matter; and if he will make a statement. [57004]
§ Ms JowellIn early July we learnt that abnormal prion protein had been found in the appendix removed from a patient in Torbay who, although he did not show any symptoms of disease at the time, some 2½ years later died of nvCJD.
533WThe matter was immediately referred to the joint Advisory Committee on Dangerous Pathogens/Spongiform Encephalopathy Advisory Committee Working Group (ACDP/SEAC WG) on Transmissible Spongiform Encephalopathies which considered it at a meeting on 8 July. The advice of this group, as stated by the then Chief Medical Officer in his Press Release of 27 August 1998, is that the overall risk of transmission of nvCJD to other patients is minimal.
On 21 September SEAC considered the implications of this incident for the risks from surgical instruments and a summary of their discussion was made available to a sub-group of the ACDP/SEAC WG specially convened to look at decontamination advice on 24 September. Following the sub-group meeting on 24 September discussions are underway with the HSE, the Medical Devices Agency, and a number of independent experts about changes to instrument design and decontamination procedures aimed at reducing any remaining risk still further. Proposals for further work are also being finalised and these groups will consider their final advice once these discussions are completed.
The existing guidance from ACDP/SEAC "Transmissible Spongiform Encephalopathy Agents: safe working and the prevention of infection" (published in March 1998) aims to minimise the risk to patients and staff from nvCJD and already specified that all instruments used on known or suspect cases of CJD must be destroyed as must those used on procedures involving the brain, spinal cord or eyes of patients thought to be at risk of CJD, for instance recipients of human growth hormone. This guidance also specifies that disposable instruments should be used whenever reasonably practicable for other procedures on at risk patients.
We are considering with the CJD Surveillance Unit in the light of expert advice what follow up studies should be undertaken in respect of patients who had operations in hospitals where nvCJD patients had undergone surgery before they showed any sign of this disease.
The Department, MAFF, the Environment Agency and the Health and Safety Executive have jointly issued a call for further research into the inactivation of TSEs. The call closed on 23 October. The thirteen outline proposals received are now being considered and an announcement will be made as soon as possible about those that will be pursued further.
The aim of all this work is to ensure that any risk of transmission of nvCJD through surgical procedures is reduced as far as it is possible to do so. We shall review the procedures currently in force as more information becomes available about the characteristics of the disease, and about the effects of changes in decontamination procedures or in instrument design, and will take further action if that seems necessary.
As announced on 27 August by the previous Chief Medical Officer the Department, in conjunction with the Medical Research Council, was already considering anonymised pilot surveys to assess whether the abnormal prion protein associated with the disease might be in appendixes and tonsils removed during routine surgery. The proposals received are now the subject of expert scientific review and we expect to make a decision on funding shortly.
534W
§ Mr. DuncanTo ask the Secretary of State for Health (1) if his Department records the(a) hospital admissions, (b) operations and (c) dates of any operations undergone by individuals who have been diagnosed with new variant Creutzfeldt-Jakob Disease; and if he will take steps to make public such information; [56995]
(2) if his Department records the names of those individuals who have been diagnosed with new variant Creutzfeldt-Jakob Disease. [57002]
§ Ms JowellNo. The Department does not hold clinical information on individual patients with new variant Creutzfeldt-Jakob Disease (nvCJD). Personal information of this nature is confidential to the patient, their family, and the clinicians responsible for their care and is not made public. Clinical information is held by the CJD Surveillance Unit (CJDSU) which advises clinicians on the care and treatment of patients. The CJDSU is bound by the same requirements for confidentiality as other clinicians and passes information to the Department only in an anonymous and aggregated form.
§ Mr. DuncanTo ask the Secretary of State for Health how many cases of new variant Creutzfeldt-Jakob Disease have been recorded in the UK. [56992]
§ Ms JowellSince new variant Creutzfeldt-Jakob Disease (nvCJD) appeared in late 1995 there have been 30 definite and probable cases. All of these patients have died.
Statistical information about Creutzfeldt-Jakob disease is published by the Department on a monthly basis. The latest table was published on 2 November.
§ Mr. DuncanTo ask the Secretary of State for Health (1) if he will publish the evidence his Department has evaluated on the effectiveness of routine autoclave sterilisation in the destruction of prion proteins; [56993]
(2) at what temperature his Department has been advised that prion proteins are destroyed. [56946]
§ Ms JowellThe unconventional agents that cause Transmissible Spongiform Encephalopathies (TSEs) are extraordinarily resistant to physical and chemical treatments that destroy even the most resistant bacteria, spores, fungi and viruses. The current advice on inactivation and decontamination is contained in the Advisory Committee on Dangerous Pathogens/ Spongiform Encephalopathy Advisory Committees' guidance on"Transmissible Spongiform Encephalopathy Agents: Safe working and the prevention of infection" which was published in March 1998. Copies have been placed in the Library. Additionally, since publication, the guidance has been available on the Stationery Office website (www.official-documents.co.uk/documents/doh/ spongifm.contents.htm). It contains information on the effectiveness of routine autoclaving in the destruction of the agents of TSEs. The guidance is based upon the best available scientific data on inactivation. It does not itself provide evidence of the temperature required to ensure complete inactivation of prion proteins. The two Committees are keeping this subject under review as part of their continuing work in this field and on 12 September 1998 the Department, jointly with the Ministry of Agriculture, Fisheries and Food, the Environment Agency and the Health and Safety Executive, issued a call for further research into the inactivation of TSEs. The call 535W closed on 23 October 1998. The thirteen outline proposals that were received are now being considered and a further announcement will be made as soon as possible about those that will be pursued further.
§ Mr. DuncanTo ask the Secretary of State for Health if he will publish the full findings of the Spongiform Encephalopathy Advisory Committee's research. [57022]
§ Ms JowellThe Spongiform Encephalopathy Advisory Committee (SEAC) does not fund or carry out research. If it considers that new or further research is needed it makes recommendations to that effect. Any recommendations on research would be included in the public summary published after each SEAC meeting.
Recommendations for research are considered by the relevant department and other funders such as the Medical Research Council (MRC) and the Biotechnology and Biological Sciences Research Council (BBSRC) and by the Transmissible Spongiform Encephalopathy (TSE) Funders Co-ordination Group and the TSE Research Advisory Group.
A "Strategy for Research and Development Relating to the Human health Aspects of Transmissible Spongiform Encephalopathies" was published in November 1996 and has been available in the Library since December 1996. In July 1998 a comparable "Strategy for Research and Development Relating to the Animal Aspects of TSEs" was published and placed in the Library.
These strategies are kept under review and calls for research proposals issued as necessary by the appropriate funding bodies. The findings of individual research projects are published in peer-review scientific journals as they become available.
§ Mr. DuncanTo ask the Secretary of State for Health (1) what plans his Department has to inform those patients found to be infected with new variant Creutzfeldt-Jakob Disease as a result of screening; and if he will make a statement; [56997]
(2) what plans his Department has to screen tissue specimens for signs of new variant Creutzfeldt-Jakob Disease; and if he will make a statement; [56998]
(3) what plans his Department has to screen individuals for signs of new variant Creutzfeldt-Jakob Disease; and if he will make a statement. [56999]
§ Ms JowellThe report of the detection of the agent associated with new variant Creutzfeldt-Jakob Disease (nvCJD) in the appendix of a patient who was not showing any clinical symptoms of the disease when the tissue was removed but who died of nvCJD two and a half years later, was published on 27 August. On the same day the former Chief Medical Officer announced that the Department, in conjunction with the Medical Research Council, was discussing with the relevant scientists proposals for anonymised pilot surveys to assess whether the abnormal prion protein associated with the disease might be in appendices and tonsils removed during routine surgery. The proposals received following these discussions are now the subject of expert scientific peer review, and we expect to make a final decision on funding shortly.
536WThese studies are designed to improve understanding of the epidemiology of nvCJD. It must be emphasised that they are research studies on pathological specimens and are not diagnostic screening tests. The research proposals will be governed by ethical committee approval, as is normal, to safeguard patient interests.
§ Mr. DuncanTo ask the Secretary of State for Health if he will publish the full findings of the Advisory Committee on Dangerous Pathogens research. [57023]
§ Ms JowellThe Advisory Committee on Dangerous Pathogens is an independent committee which advises Government, but which does not undertake or commission research in its own right. However, if the Committee considers that research is needed it can make recommendations to Government to that effect. These recommendations would be considered in the context of the Department's overall research strategy.
§ Mr. DuncanTo ask the Secretary of State for Health what is his Department's current estimate of the number of cases of new variant Creutzfeldt-Jakob Disease likely to be diagnosed in(a) 1999 and (b) 2000. [56945]
§ Ms JowellNo reliable estimates can yet be made about the future numbers of new variant Creutzfeldt-Jakob disease cases. To make reliable estimates of the future number of cases we need to have more information about the incubation period, the level of exposure to the agent that can cause the Disease, the route of infection and the role of genetic susceptibility. The Spongiform Encephalopathy Advisory Committee sub-group which advises the Chief Medical Officer on the epidemiology of the disease considers that it is likely to be at least three to four years before we are in a position to make a reliable estimate.