From CECIL CLOTHIER
I write in response to the article ‘Britain dithers over gene therapy’
(This Week, 12 December) and the further observations in Comment.
When the Report of the Committee on the Ethics on Gene Therapy was published
in January this year, ministers asked the committee to remain in being while
extensive and necessary consultations about its conclusions took place.
Ministers did so in order to handle any proposals for gene therapy that
might be made before substantive arrangements were in place.
In the event, research in this field moved forward more quickly than
had been envisaged by the committee, the government and, most significantly,
by the researchers themselves. Steps have therefore been taken to ensure
that the committee is fully prepared to deal with any applications which
might be forthcoming in advance of final decisions on our report. The sources
of expertise available to the committee have been greatly expanded and strengthened.
The committee met in November to consider two such applications. Approval
will be given when the committee is satisfied that they are scientifically
sound and ethically proper. The decision to approve any application will
be made public.
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Before any protocol for gene therapy is approved, those responsible
must demonstrate that the techniques they wish to use on patients have been
subjected to adequate preclinical studies to assess their safety and effectiveness.
This process has not been hampered in any way by the fact that ministerial
decisions on our report have yet to be made.
Our advice to ministers remains that an expert supervisory body should
be set up to deal with these applications. In the meantime, the mechanisms
described above will enable the committee to deal efficiently, thoroughly
and swiftly with any applications it receives to apply gene therapy to patients.
Cecil Clothier Committee on the Ethics of Gene Therapy London
