Court Rules USFDA Withheld Xenotransplant Info From Public

[Guest guest]

From Bob Phelps <info

Date 15:36 Sep 20

Subject Court Rules USFDA Withheld Xenotransplant Info From Public

 

CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION PRESS RELEASE SEPTEMBER 4, 2002

CONTACT: ALIX FANO TEL: (212) 579-3477 <banxeno

 

USFDA Failed to Justify Withholding Xenotransplantation Information From

Public, Court Rules

 

Court Gives FDA Until November 10, 2002 to Prove Secrecy Concerning

Xenotransplantation is Legal

 

(Washington) - The United States District Court for the District of

Columbia, Judge Ricardo M. Urbina, ruled Tuesday that the Food and Drug

Administration (FDA) failed to prove that it could withhold approximately

27,000 records concerning xenotransplantation clinical trials from the

Campaign for Responsible Transplantation (CRT).

 

CRT, a New York-based coalition of 90 public interest groups, believes

that cross-species or xeno-transplants should be banned because of the

risk of infecting patients and the general public with

viruses [1] from " genetically altered pigs " , biotechnology companies source

animals

of choice.

 

The Court held that the FDA failed to justify its decision to withhold the

records in question under the Freedom of Information Act (FOIA) because

the agency did not describe them in sufficient detail, or prove that they

could lawfully be withheld.

 

'We are very pleased with the judge s decision, says CRT s Director

Alix Fano. " It proves, in this phase of litigation, that the FDA has

failed to meet its obligation for public disclosure under FOIA. We look

forward to discovering why the FDA is being so protective of the documents

in its possession " , she says.

 

The FDA claimed that thousands of records could lawfully be withheld as

" trade secret " and/or " confidential commercial information; " but the Court

concluded that the FDA needed to make an either/or distinction, rather than

use a blanket rationale for withholding the information, leaving CRT to

guess which claim applied. The Court called the distinction " crucial. "

 

In addition, the Court determined that the agency's contention that

thousands of records could be withheld because they would reveal internal

FDA discussions about the regulation of xenotransplantation were " vague "

and " conclusory. "

 

The Court has given the FDA until November 10, 2002, to make a final

attempt to prove its justification for withholding the records at issue.

The FDA was ordered to supply additional documents and affidavits in its

defense, and both parties were ordered to resume settlement talks.

 

CRT originally filed a FOIA request in March 2000 to obtain information on

clinical xenotransplantation trials, with the aim of gathering data on

side-effects, possible human infections, and deaths in such trials. After

the FDA repeatedly ignored its requests for information, CRT filed suit in

November 2000 charging that the agency violated the FOIA. The law

requires federal agencies to release documents to the public upon request,

barring specific statutory exemptions. In its lawsuit, CRT explained that

the records it requested should not be exempt from disclosure since trial

sponsors have themselves divulged details about their human experiments to

the media and the public through press releases, the Internet, and

presentations at FDA-sponsored public meetings.

 

But in March 2001, six biotechnology companies (Diacrin, Genzyme,

Diacrin/Genzyme, Circe Biomedical, Nextran, and Novartis) intervened in

the litigation between CRT and the FDA, to limit or prevent disclosure of

documents to CRT.

 

We know, through articles in scientific journals and magazines, that

since the early 1990s, over a dozen patients have died in xenotransplant

experiments, says Fano. Some 232 adverse events occurred during the

testing of one product, Diacrin s NeuroCell, which used pig cells in

Parkinson s treatments. This is not the rosy picture of

xenotransplantation portrayed by its proponents.

 

Companies and government health officials are promoting

xenotransplantation as a panacea for the human organ and tissue shortage

despite mounting concerns about risk and the availability of safer

options. The FDA, which has approved over a dozen clinical xenotransplant

trials, has admitted that the technology is dangerous. Given a growing

catalogue of new killer pig viruses, AIDS, mad cow disease, and recent

gene therapy fiascos in which patients died and side-effects were covered

up, CRT finds the U.S. s enthusiasm for xenotransplantation disturbing.

 

CRT is represented by the Washington, DC public interest law firm, Meyer

& Glitzenstein.

 

http://www.crt-online.org

 

[1] Viruses infecting pigs that cannot be

guaranteed to be absent from a xenograft include porcine retrovirus,

porcine polyomavirus, porcine parvovirus, porcine circovirus, porcine

cytomegalovirus, porcine reproductive and respiratory syndrome virus,

influenza virus, porcine hepatitis E virus, and porcine herpesvirus.

 

 

 

PLEASE NOTE: GeneEthics Network email address has changed

geneethics

info

 

mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm

 

Bob Phelps

GeneEthics Network

340 Gore St, Fitzroy 3065 Australia

Tel: 03 9416.2222 {Int Code 613} or 1300 133868

email: info (Bob Phelps)

WWW: http://www.geneethics.org

 

The problem with the gene pool is, there is no lifeguard.

 

Knowing is not enough, you must also act.

 

" If the people will lead, the leaders will follow. " David Suzuki

 

mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm

 

APPEAL FOR YOUR CONTRIBUTIONS

 

The GeneEthics Network is totally dependent on your financial contributions.

 

We work hard to empower and activate all citizens and groups concerned over

the fast tracking of gene technology and its products into all aspects of

our lives, without public knowledge or consent.

 

To help us continue this important work, please donate (over $2 is

deductible). Please send us an email for advice on how you can support

GeneEthics.

 

mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm

 

Please don't send unsolicited attachments

 

mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm

 

NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is

distributed without profit to those who expressed a prior interest in

receiving the included information for research and educational purposes.

 

mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm