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27 Mar 2006 : Column 807W—continued
Stem Cells
Mrs. Moon: To ask the Secretary of State for Health how many hospitals in each region provide stem cell collection via blood sampling of the umbilical cord at the request of a parent. [60036]
Caroline Flint: Cord blood units are collected and registered by the NHS cord blood bank, which is part of the National Blood Service. These collections are donated voluntarily and are used for bone marrow and stem cell transplantation. The NHS cord blood bank currently collects cord blood stem cells from three collection sites, Barnet General (under North Central London strategic health authority (SHA)), Northwick Park (under North West London SHA) and Luton and Dunstable hospitals (under Bedfordshire and Hertfordshire SHA). There are a number of commercial cord blood banks that offer mothers the opportunity to store their own baby's cord stem cells. However, we do not hold information on the number of hospitals that assist with these collections.
Stoma Appliances
Mr. Laurence Robertson: To ask the Secretary of State for Health pursuant to the answer of 13 February 2006 to the hon. Member for South Derbyshire, Official Report, column 1795W, on stoma appliances, if she will summarise the views expressed during the consultation on the provision of stoma appliances and other services; what policy decision she has made on the basis of that consultation; and if she will make a statement. [61229]
Jane Kennedy:
It is our intention to publish a summary of responses and to respond to the consultation in due course.
27 Mar 2006 : Column 808W
Strep-EURO Research Project
Mr. Andy Reed: To ask the Secretary of State for Health what evaluation her Department has made of the findings of the Strep-EURO research project. [59736]
Jane Kennedy: The project has yet to conclude its findings, but preliminary results suggest that it will provide improved and comparable estimates of the incidence of severe group A streptococcal diseases for some European countries.
Suspended Doctors
Mr. Lansley: To ask the Secretary of State for Health how many doctors have been suspended in each quarter since April 2001. [60399]
Jane Kennedy: The number of doctors on suspension in each quarter since April 2001 is as follows:
| Quarter | Number of doctors | |
|---|---|---|
| 01 | 2001 | 32 |
| 02 | 2001 | 33 |
| 03 | 2001 | 33 |
| 04 | 2001 | 29 |
| 01 | 2002 | 30 |
| 02 | 2002 | 33 |
| 03 | 2002 | 38 |
| 04 | 2002 | 29 |
| 01 | 2003 | 27 |
| 02 | 2003 | 26 |
| 03 | 2003 | 32 |
| 04 | 2003 | 24 |
| 01 | 2004 | 21 |
| 02 | 2004 | 21 |
| 03 | 2004 | 20 |
| 04 | 2004 | 19 |
| 01 | 2005 | 19 |
This is the most up to date information available.
From April 2005, the national clinical assessment service (NCAS) formally took over responsibility for collecting the data. From this date NCAS has collected not only long-term (over six months) suspensions but all suspensions of whatever length now called exclusions for employed doctors and dentists but still suspensions for general practitioners.
From 1 April, 2005 the practice of placing employed doctors and dentists on gardening leave as an alternative to suspension ceased. Therefore the figures from this date will include for the first time figures for what would have been employees on gardening leave as well as those on formal suspensions—all are now termed exclusions. We intend to report the full year's figures this spring, and then to report figures on a quarterly basis.
Telephone Numbers
Anne Milton: To ask the Secretary of State for Health if she will list the (a) 0800, (b) 0845 and (c) 0870 telephone numbers for the public administered by (i) her Department and (ii) agencies which report to her. [56539]
Mr. Byrne:
The Department runs or supports the following helplines, using the 0800, 0845 telephone numbers for the public.
27 Mar 2006 : Column 809W
The Department is currently not using any 0870 telephone numbers for the public.
It is not possible to list the 0800, 0845 and 0870 telephone numbers for the public administered by agencies which report to the Department. This information can be provided only at disproportionate costs.
TGN 1412
Mr. Lansley: To ask the Secretary of State for Health what discussions she has had with the Medicines and Healthcare Products Regulatory Agency on the suspension of the phase 1 clinical trial authorisation of the drug TGN 1412; and if she will make a statement. [61262]
Jane Kennedy: The Medicines and Healthcare products Regulatory Agency (MHRA) immediately notified Ministers of the suspension of the authorisation of the drug TGN 1412 clinical trial on 14 March 2006. I refer to the reply I gave on Thursday 16 March 2006, Official Report, columns 105–106WS. An investigation into the circumstances of the case is currently under way as a matter of urgency. Ministers are regularly informed of developments and will make further statements when investigations are concluded.
I have had two discussions with the MHRA on this issue. One was a telephone call with the Chief Executive, Professor Kent Woods, on Tuesday 14 March 2006.
27 Mar 2006 : Column 810W
Ialso had a brief meeting with members of the MHRA executive board during a pre-planned visit to the MHRA on Thursday 16 March2006.
Mr. Lansley: To ask the Secretary of State for Health (1) whether the Medicines and Healthcare Products Regulatory Agency (MHRA) was aware of (a) the inflammatory effect on the lymph nodes of two monkeys of the drug TGN 1412 in pre-clinical testing and (b) the adverse drug reaction seen in early human trials of the drug anti-CLTA4 antibody prior to TGN1412 receiving its authorisation for a phase 1 clinical trial; [61263]
(2) what the trial protocol approved by the Medicines and Healthcare Products Regulatory Agency stipulated in respect of the length of time between which the doses of the drug TGN 1412 should be administered to the different participants in the phase 1 clinical trial; and whether this protocol was followed. [61266]
Jane Kennedy: All data submitted by the applicant in support of the clinical trials authorisation (CTA) application, including primate toxicology studies, was reviewed by experienced Medicines and Healthcare products Regulatory Agency assessors and was considered in reaching their decision to approve the trial.
The CTLA4 trial refers to a different monoclonal antibody directed at a different T cell receptor acting via a different mechanism. The adverse events which occurred in 12/41 patients appeared to be milder and somewhat different from the TGN 1412 reactions. It is not clear how the findings from this trial might relate to the events that occurred in the trial of TGN 1412.
The protocol required that dosing of all trial participants occurred during a two-hour period.
An investigation is ongoing into the cause of the events associated with this trial.
Mr. Lansley: To ask the Secretary of State for Health (1) whether the Medicines and Healthcare Products Regulatory Agency (MRHA) considered the possibility that the drug TGN 1412 might give rise to a cytokine storm in humans prior to granting its approval to the phase 1 clinical trial authorisation; [61264]
(2) whether the Medicines and Healthcare Products Regulatory Agency (MRHA) has submitted (a) the data supporting the phase 1 clinical trial of the drug TGN 1412 and (b) the trial protocol to an independent assessor for a second opinion on the safety of the MHRA's original clinical trial authorisation. [61265]
Jane Kennedy: All data submitted by the company in support of the clinical trial authorisation (CTA) application was reviewed by experienced medicines and healthcare products regulatory agency assessors.
Based on the review of this data they concluded that it was appropriate to proceed to a clinical trial in man. In addition, the starting dose for this first into man trial was one five hundredth of the dose showing no adverse effect in animal studies and it was expected, at the proposed doses, that TGN 1412 would be well tolerated in humans.
27 Mar 2006 : Column 811W
The same conclusions were reached independently by assessors at the German regulatory agency, the Paul Ehrlich Institute, who reviewed the same application and approved it.
An investigation into the cause of the events following the administration of TGN 1412 is ongoing.
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