From: Stefania Pes [stefania.pes@tin.it]
Sent: Thursday, March 01, 2001 1:51 PM
To: fdadockets@oc.fda.gov
Subject: 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,
> Stefania Pes  Alessandria Via Don Giovine 30 Italy

Sergio Pes Alessandria Via Don Giovine 30 Italy
Donata Pes Cascinagrossa (AL) Via Giacchero 8 Italy
Paolo Facco Cascinagrossa (AL) Via giacchero8 Italy
Paolo Todarello Novi Ligure (AL) Via Villalvernia 16 Italy
Nadia Tindiglia Alessandria Via Don Giovine 30 Italy