CRT computer dies after xenotranspantation secrecy court case

[Guest guest]

Shortly after the court's decision was announced, Alix's computer

was attacked by a virus so virulent that it appears computer cannot

be restored to use. -

 

Wednesday,

September 04,

2002 3:34 AM

 

PRESS RELEASE - FDA Failed to Justify Withholding

Xenotransplantation Information From Public, Court Rules

CAMPAIGN FOR RESPONSIBLE TRANSPLANTATIONPRESS RELEASESEPTEMBER 4, 2002

 

CONTACT: ALIX FANO

TEL: (212) 579-3477

FDA 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