From: Linda Gentille [linda@pianoprincess.com]
Sent: Saturday, March 10, 2001 12:24 PM
To: oc.fda.gov
Subject: Re: Docket No. 00N-0989

Importance: High
March 9,2001 
  
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, 

We are 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. 

We understand that 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, 
  

Linda Gentille and Jan Knepper 
88 Route 610 
Petersburg, Nj, 08270 
  
  

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Linda Gentille 
Cape May, NJ 
U.S.A. 

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