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From: TSS (216-119-144-71.ipset24.wt.net)
Subject: BLOOD PRODUCTS TSE RECALLS OCT 13, 2004 USA
Date: October 18, 2004 at 9:35 am PST

-------- Original Message --------
Subject: BLOOD PRODUCTS TSE RECALLS OCT 13, 2004 USA
Date: Mon, 18 Oct 2004 11:32:00 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE


##################### Bovine Spongiform Encephalopathy #####################

PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall B-0008-5.
CODE
Unit number 6684748 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL, by telephone on October
28, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of
residing in an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.

_______________________________

PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0025-5;
b) Cryoprecipitated AHF, Recall # B-0026-5;
c) Plasma Cryoprecipitate Reduced, Recall # B-0027-5.
CODE
a), b), and c) Unit 20GM75704.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise, ID, by telephone on April 4,
2003 and by letter dated August 6, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for
Creuztfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MT.
_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0036-5;
b) Fresh Frozen Plasma. Recall # B-0037-5.
CODE
a) and b) Unit number 2383755.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
February 4, 2003, and August 13, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of
residing in an area considered at increased risk of exposure to variant
Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.


RECALLS AND FIELD CORRECTIONS: BIOLOGICS ‚ CLASS III

_______________________________

PRODUCT
Recovered Plasma. Recall # B-0012-5.
CODE
Unit numbers D03-02509 and D04-00404.
RECALLING FIRM/MANUFACTURER
Metrowest Medical Center, Farmingham, MA, by letter on August 10, 2004.
Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of
residing in an area considered at increased risk of exposure to variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
_______________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00869.html

TSS

################# BSE-L-subscribe-request@uni-karlsruhe.de #################

-------- Original Message --------
Subject: Transmissible Spongiform Encephalopathies Advisory Committee; [FR Doc. 04-21282 Filed 9-21-04; 8:45 am] (TSS SUB. short version 10/4/04)
Date: Fri, 08 Oct 2004 08:13:58 -0500
From: "Terry S. Singeltary Sr."
To: fdadockets@oc.fda.gov

Transmissible Spongiform Encephalopathies Advisory Committee;
[FR Doc. 04-21282 Filed 9-21-04; 8:45 am] (TSS SUB. short version 10/4/04)

Greetings Dr. Freas, Dr. Langford, Dr. Smallwood and all FDA,

I WISH to make the following submission and comments about all
topics of this meeting about human/animal TSEs. My comments and
submissions as follows please;


>>USDA-licensed tests for the diagnosis of bovine
>>spongiform encephalopathy (BSE) and other transmissible spongiform
>>encephalopathies (TSE),


IN the past all we have heard is the fact that the present BSEs test
do not guarantee public health safety. I request that the USA implement a
BSE/TSE test that DOES guarantee public health safety, one approved for consumer
protection, a test for live cattle, one that would detect all TSEs in the
bovine, one that would detect sub clinical TSEs; EFSA Scientific Report
on the Design of a Field Trial Protocol for the Evaluation of BSE Tests for
Live Cattle Publication date: 17 September 2004 Adopted on 1 July 2004
(Question N° EFSA-Q-2003-084) * 146 kB Report

http://www.efsa.eu.int/science/efsa_scientific_reports/bse_tse/612/report09_bse02_tests_livecattle_en1.pdf

http://www.efsa.eu.int/science/efsa_scientific_reports/bse_tse/612/bse02_sr09_tests_livecattle_summary_en1.pdf


>> review of the worldwide BSE situation,


THE most disturbing factor of this topic are the new atypical TSEs
showing up in not only cattle, but also sheep, and no one knows yet
about how many different strains of cwdTSE in deer/elk. WITH evidence of
sporadic CJD being very similar to these atypical TSEs in cattle and sheep,
and the findings from Asante, Collinge et al that BSE prions propagate
as either nvCJD or sporadic CJD, the ramifications of these findings are
very very worrisome and should not go ignored any further. WITH
the fact that there are over 20 documented strains of scrapie, and the
most logical hypothesis is scrapie to BSE, why would one believe in
only one phenotype of TSE in the bovine. IN fact, we have a new study
of two distinct prion strains derived from BSE in mice. YOU must not
continue to ignore these studies;

BSE prions propagate as either variant CJD-like or sporadic CJD-like
prion strains in transgenic mice expressing human prion protein

http://embojournal.npgjournals.com/cgi/content/full/21/23/6358

THE new findings of BASE in cattle in Italy of Identification of a
second bovine amyloidotic spongiform encephalopathy: Molecular
similarities with sporadic Creutzfeldt-Jakob disease

http://www.pnas.org/cgi/content/abstract/0305777101v1

Characterization of two distinct prion strains
derived from bovine spongiform encephalopathy
transmissions to inbred mice

http://vir.sgmjournals.org/cgi/content/abstract/85/8/2471

Adaptation of the bovine spongiform encephalopathy agent to primates
and comparison with Creutzfeldt-Jakob disease: Implications for
human health

http://www.pnas.org/cgi/content/full/041490898v1

In an experimental study of the transmissibility of BSE to the pig,
seven of 10 pigs, infected at 1-2 weeks of age by multiple-route
parenteral inoculation with a homogenate of bovine brain from
natural BSE cases developed lesions typical of spongiform
encephalopathy...

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=npg&cmd=Retrieve&db=PubMed&list_uids=10684682&dopt=Abstract

THE recent discoveries of previously unidentified strains of
Scrapie such as 221C44 and the Nor9845;

FULL TEXT APPRX. 91 PAGES

UK Strategy for Research and
Development on Human and Animal
Health Aspects of Transmissible
Spongiform Encephalopathies

2004-2007

http://www.mrc.ac.uk/pdf-uk_strategy_v5.2.pdf

WHEN in fact, the findings from Marsh and the findings at
MISSION, TEXAS support even further evidence that there
are further strains of TSE in the USA besides that one
accidentally documented BSE case in Washington on
Dec. 23, 2003;

In Confidence - Perceptions of unconventional slow virus diseases of
animals in the USA - Report of a visit to the USA - April-May 1989 - G A H
Wells [head of England's main veterinary lab]

http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf

Evidence That Transmissible Mink Encephalopathy
Results from Feeding Infected Cattle

http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf

>
>>labeling claims for TSE clearance studies for plasma derivative
>>products.
>>
>
>
>>The committee will then discuss and make recommendations
>>regarding presumptive transfusion transmissions of variant Creutzfeldt
>>Jakob Disease (vCJD) and current FDA-recommended safeguards.
>>
>
>
ONE of the things i have been most worried about and will continue to
bring to the attention of the TSE advisory committee is the continued
denial of the potential of transmission of sporadic CJD via blood and
blood products. THERE are studies showing infectivity in the blood of
sporadic CJD, and just how many phenotypes there are of sporadic CJD is
anyone's guess at this point in time. WE have already documented
transmission of sporadic CJD via tissues and organs. TO continue the
BSE/nvCJD only theory will only continue to spread this agent. WE must
move away from this mentality and move on with all TSEs and treat all
TSEs as one, until proven otherwise, not the other way around. with
6,000 'DEAR nvCJD LETTERS' due to blood and blood products so far, i can
only imagine the number, once sporadic CJD is documented to have
transmitted via blood, what that number will be when those 'DEAR
SPORADIC CJD LETTERS' go out and how many will become clinical once
exposed, a frightening thought. OR, has infection by sporadic CJD
already happened, i don't think they are too sure if the 2nd
_infection_ of CJD was sporadic or variant;

Summary of SEACs discussion on the second presumed case of blood
transfusion-associated infection with vCJD

> 7. SEAC agreed that the western blot results and glycotype profile
> suggested it was unlikely that the infection was preclinical sporadic
> CJD (sCJD). The committee noted that a single study by Glatzel et al
> (2003) had reported PrPres in the spleen of sCJD clinical cases.
> However, the levels of PrPres present in sCJD cases were low and
> detected in patients with a lengthy clinical illness from sporadic CJD.


http://www.seac.gov.uk/statements/state070804.htm

vCJD: Blood Transfusion Incident

http://www.publications.parliament.uk/pa/ld199697/ldhansrd/pdvn/lds03/text/31217-09.htm

MOST importantly, the 1968 MEDICINES ACT where it states 'NO SAF' was
blatantly ignored,
for animals and humans.

http://www.bseinquiry.gov.uk/files/yb/1983/06/00001001.pdf

8. The Secretary of State has a number of licences. We understand that
the inactivated polio vaccine is no longer being used. There is a stock
of smallpox vaccine. We have not been able to determine the source
material. (Made in sheep very unlikely to contain bovine ingredients).

http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf

http://www.bseinquiry.gov.uk/report/volume7/chapted2.htm

http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf

although 176 products do _not_ conform to the CSM/VPC
guidelines.

http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf

IMPORTS OF POTENTIALLY TAINTED BIOLOGICAL PRODUCTS TO USA

3002.20.0000: VACCINES FOR HUMAN MEDICINE

U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)

<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
=================================================================
WORLD TOTAL . . . . . . . 25,702 26,150 550,258 378,735
Austria . . . . . . . . . --- --- 45 225
Belgium . . . . . . . . . 14,311 12,029 248,041 199,036
Canada . . . . . . . . . 1,109 1,527 15,798 16,305
Denmark . . . . . . . . . 80 234 246 682
Federal Rep. of Germany 1,064 4,073 12,001 6,329
France . . . . . . . . . 3,902 4,859 87,879 92,845
Ireland . . . . . . . . . --- --- 120 478
Italy . . . . . . . . . . --- --- 2,359 81
Japan . . . . . . . . . . 445 1,903 11,350 11,298
Netherlands . . . . . . . --- --- 94 6
Republic Of South Africa --- --- 2 1
Spain . . . . . . . . . . --- --- 60 30
Switzerland . . . . . . . 716 353 9,303 4,271
United Kingdom . . . . . 4,075 1,172 162,960 47,148

http://www.ita.doc.gov/industry/otea/Trade-Detail/Latest-December/Imports/30/300230.html

FULL TEXT PARTIAL LISTING

http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh

Transmissible encephalopathies and biopharmaceutical production.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9119144&dopt=Abstract

Blood donated after vaccination with rabies vaccine derived from sheep brain cells might transmit CJD

http://bmj.bmjjournals.com/cgi/content/full/313/7069/1405/a

Blood to be screened for CJD

http://bmj.bmjjournals.com/cgi/content/full/313/7055/441

***Similar levels of infectivity in the blood of mice infected with
human-derived vCJD and GSS strains of transmissible spongiform
encephalopathy***

http://www.blackwell-synergy.com/openurl?genre=article&sid=nlm:pubmed&issn=0041-1132&date=2003&volume=43&issue=12&spage=1687

Spongiform encephalopathy transmitted experimentally from
Creutzfeldt-Jakob and familial Gerstmann-Straussler-Scheinker diseases.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=2276050

Lancet 2000; 356: 955 - 956

snip...

Blood from four of 37 human beings with clinically evident sporadic CJD has been
reported to transmit the disease after intracerebral inoculation into guineapigs,
mice, or hamsters. But each success has been questioned on technical grounds
and has not been reproducible;

http://www.thelancet.com/

Transmission of Creutzfeldt-Jakob Disease from Blood and Urine Into Mice

The Lancet, November 9, 1985

Sir,--Professor Manuelidis and his colleagues (Oct 19, p896) report
transmission to animals of Creutzfeldt-Jakob disease (CJD) from the
buffy coat from two patients. We also transmitted the disease from
whole blood samples of a patient (and of mice) infected with CJD.1
Brain, Cornea, and urine from this patient were also infectious, and
the clinicopathological findings2 are summarised as follows.

snip...

Department of Neuropathology,
Neurological Institute,
Faculty of Medicine,
Kyushu University,
Fukuoka812, Japan

JUN TATEISHI

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Retrieve&list_uids=2865558&dopt=Citation

This observation represents the first documented transmission of BSE
from the blood of an experimentally infected primate...

http://www.blackwell-synergy.com/servlet/useragent?func=synergy&synergyAction=showAbstract&doi=10.1046/j.1537-2995.2002.00098.x

Transmission of prion diseases by blood transfusion

Nora Hunter,1 James Foster,1 Angela Chong,1 Sandra McCutcheon,2 David
Parnham,1 Samantha Eaton,1 Calum MacKenzie1 and Fiona Houston2

see full text;

http://www.socgenmicrobiol.org.uk/JGVDirect/18580/18580ft.pdf

THEN one must consider these new findings of ;

Extraneural Pathologic Prion Protein in Sporadic Creutzfeldt-Jakob Disease

snip...

Conclusions Using sensitive techniques, we identified extraneural
deposition
of PrPSc in spleen and muscle samples from approximately one third of
patients
who died with sporadic Creutzfeldt-Jakob disease. Extraneural PrPSc appears
to correlate with a long duration of disease.

http://content.nejm.org/cgi/content/short/349/19/1812?query=TOC

Prions in skeletal muscle (Prusiner et al)

http://www.pnas.org/cgi/doi/10.1073/pnas.052707499

EMBO reports AOP Published online: 11 April 2003 Widespread PrPSc
accumulation in muscles of hamsters orally infected with scrapie

http://www.emboreports.org/

How much is too much? How much is not enough? What about accumulation?
What is the Threshold of exposure, to infectivity, to clinical disease?
How many strains/phenotype does sporadic CJD consist of and
What is the infectivity of each one of those phenotypes (cwdCJD)?
Until these questions are answered, you are gambling, nothing more.
I just pray that you get it right...

ALL human/animal TSEs should be made reportable Nationally and
Internationally.
ALL human TSE victims (family) should fill out mandatory CJD Questionnaire.

thank you,

Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518






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