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Note of the 25th Meeting of the Gene Therapy Advisory Committee (GTAC) held on 15 December
1999.
Present:
Professor Norman C Nevin (Chair), Canon Dr Keith Denison, Professor Anthony Pinching, Professor James Neil, Professor
Michael Steel, Professor Anthony Dayan, Mrs Rosie Barnes, Mr Michael Harrison, Professor Ian Hart, Dr Brenda Gibson
Secretariat:
Dr Jayne Spink, Dr Kerry Knight, Mrs Margaret Straughan, Mr Anthony Taylor
Also present:
Dr Brian Davis (Medicines Control Agency), Mrs Beryl Keeley (Department of Health)
The Chairman welcomed a new member to the Committee: Mr Michael Harrison, a medical lawyer specialising in injury
and medical negligence.
The meeting discussed the following issues:
Flagging of gene therapy patients on the NHS register.
This proposal is under consideration by the South Thames Research Ethics Committee and the Office of National Statistics.
Subject to approval, the process for flagging would be introduced in 2000. The UK is the first country in the
world to put in place a mechanism for long-term monitoring of patients.
Gene Therapy Proposal from St George's Hospital, London. Gene Therapy product for peripheral arterial occlusive
disease (PAOD).
It was agreed to defer decision on these protocols pending receipt of additional pre-clinical data and satisfactory
responses to the concerns raised by members.
Safety of Adenoviral Vectors/Reporting of Adverse Events.
The Committee heard a report on the 3 day Recombinant DNA Advisory Committee (RAC) meeting in Bethesda, USA, outlining
the background of the death in USA and the current position regarding compliance with adverse event reporting and
the implications for RAC. It was agreed that the Secretariat would contact all investigators using adenoviral
vectors to seek information on serious adverse events in UK studies.
Proposal from the Northern General Hospital & Western Royal Infirmary, Sheffield for the treatment of ovarian
cancer.
Conditional approval had previously been granted for this study. A revised document had been received but was
felt not to have fully addressed the concerns of members. It was agreed that the Chairman and Secretariat would
meet the investigators to help address GTAC's concerns.
Reports to the Committee.
GTAC heard reports from the Chairman and Secretariat on the following matters:
- Plans for the Third GTAC Workshop.
- The NETS subgroup meeting on the scope of gene therapy.
- A Wellcome Trust initiative on public understanding of gene therapy.
- Ethics Committee approval for non-NHS studies.
- Outcome of NHS Inquiry at Hammersmith Hospital.
- A published UK DNA vaccinia study.
Dates of Meetings in 2000.
9 February 2000
10 May 2000
19 July 2000
11 October 2000
12 December 2000
IMPORTANT NOTE.
GTAC considers that gene therapy has not yet developed to the stage where it can be considered as treatment. 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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