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Note of the 26th Meeting of the Gene Therapy Advisory Committee (GTAC) held on 9 February
2000.
Present:
Professor Norman C Nevin (Chair), Canon Dr Keith Denison, Professor Anthony Pinching, Professor James Neil, Professor
Anthony Dayan, Professor Patrick Johnson, Mrs Irene Train, Dr Brenda Gibson, Professor Elizabeth Anionwu, Professor
John Burn, Dr Sohaila Rastan, Mr Michael Harrison, Ms Caroline Benjamin, Mrs Ann Hunt
Secretariat:
Mrs Margaret Straughan, Dr Mark Bale, Dr Jayne Spink
Also present:
Mrs Marcia Fry (Department of Health), Dr Elaine Gadd (DH), Dr Elaine Godfrey (Medicines Control Agency)
The Chairman welcomed two new members to the Committee: Dr Sohaila Rastan from industry and Ms Caroline Benjamin,
a genetic associate nurse.
The meeting discussed the following issues:
Proposal from the Northern General Hospital & Western Royal Infirmary, Sheffield for the treatment of ovarian
cancer.
The Chairman and the Secretariat had met with the proposers to resolve the outstanding issues related to this proposal.
The proposers have agreed actions to address the issues of concern to the Committee and will rewrite the Patient
Information Leaflet. It was agreed that approval to proceed would be given by Chairman's action if the amended
Patient Information Leaflet is satisfactory.
Protocol amendment to Phase I trial of immunotherapy in malignant melanoma. St George's Hospital, London.
The proposers wish to widen the inclusion criteria to include tumours which are subcutaneous or lymph node metastases.
The Committee advised that the proposers would need to submit a new protocol for each category of patients with
appropriate justification and information for patients.
Protocol amendment to the gene therapy trial in follicular lymphoma using a DNA vaccine. Royal Bournemouth Hospital
& Royal South Hampshire Hospital.
The original proposal had been approved by the Committee in May 1999. The proposer had then approached GTAC with
a view to immunising bone marrow donors. The Committee felt that this was an exciting scientific and novel concept
but raised new ethical concerns.
It was agreed that the Secretariat should meet the proposers with a view to aiding in the preparation of a revised
protocol addressing all the Committee's concerns. It was further agreed that the proposers should be asked to
attend the next meeting to present the new protocol.
Survey of Adenoviral Studies in the UK.
An initial review of all UK adenoviral trials is taking place. It was agreed to establish a working group to analyse
the data derived from the audit with a view to establishing a code of practice. This working group would consist
of members of GTAC, investigators currently involved in adenoviral studies and experts. It was agreed that MCA/CSM
should be invited to participate.
Report on NHS Inquiry into certain Gene Therapy work at Hammersmith Hospital.
The Chairman informed the Members of the report of an NHS Executive Inquiry. A discussion ensued regarding a number
of recommendations made in the report.
Reports to the Committee.
GTAC heard reports from the Chairman and Secretariat on the following matters:
- Wellcome Trust Public Understanding of Gene Therapy.
- GTAC Workshop 2000.
- CPMP Guidelines for gene transfer products.
- NETS Subgroup.
- Definition of gene therapy.
- Review of DNA vaccine trials by GTAC.
- Flagging study.
- Publication of the GTAC Fifth Annual Report.
IMPORTANT NOTE.
All gene therapy is research and recruitment of patients into research trials takes place under strict rules set
out by GTAC, under principles elaborated by professional bodies and only after review of clinical protocols by
GTAC.
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