From: Kerry-Ann.Stanley@bauer.co.uk
Sent: Thursday, March 01, 2001 9:27 AM
To: fdadockets@oc.fda.gov
Subject: Xenotransplantation

Docket No. 00N-0989
Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane
Room 10-61 HFA-305
Rockville, MD 20852
fdadockets@oc.fda.gov (oc.fda.gov)




Re: Docket No. 00N-0989


To whom it may concern,

I am writing in support of a proposed rule that would
provide public access to study design and safety
information on all new or ongoing clinical trials
involving either gene therapy or xenotransplantation.
Both are potentially dangerous areas that the public
should know about. This proposed rule only brings gene
therapy and xenotransplantation in compliance with the
same types of information already released to the
public by other government agencies.

Because of the grave public health risks, disclosure
should include additional information such as names of
physicians conducting the trials and names of
participating medical centers. All information should
be made public except trade secrets and patient
identification. The FDA must assume the sole
responsibility for summarizing and distributing
information submitted by the research sponsors, rather
than leave it to the sponsors' discretion.

I strongly believe that because of the public health
risks, legal and ethical issues, enormous cost,
serious animal welfare concerns, and the failure to
adequately assess other alternatives, all
xenotransplantation clinical trials should stop.
Moreover, the U.S. government should stop funding
xenotransplantation research.

Sincerely,

Kerry-Ann Stanley LL.B(hons)



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