CJD (NEW VARIANT) UPDATE 2006 (11)
**********************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
[The definition of the designations deaths, definite cases, probable
vCJD cases, and the case definitions can be found by accessing the
Department of Health website or by reference to a previous
ProMED-mail post in this thread (for example, CJD (new var.) - UK:
update March 2002 20020305.3693).
Data on vCJD cases from other parts of the world are now included in
these updates whenever available.
Also, data on other forms of CJD (sporadic, iatrogenic, familial and
GSS) are now included when they have some relevance to the incidence
and etiology of vCJD. - Mod.CP]
In this update:
[1] UK: Department of Health monthly CJD statistics, Mon 6 Nov 2006
[2] EUROCJD data as of 31 Oct 2006
[3] France: novel prion strain
******
[1] UK: Department of Health monthly CJD statistics, Mon 6 Nov 2006
Date: Mon 6 Nov 2006
From: ProMED-mail <[email protected]>
Source: UK Department of Health, Monthly Creutzfeldt-Jakob Disease
Statistics [edited]
<https://www.gnn.gov.uk/content/detail.asp?NewsAreaID=2&ReleaseID=239915ID=2>
The Department of Health is today [Mon 6 Nov 2006] issuing the latest
information about the numbers of known cases of Creutzfeldt-Jakob
disease. This includes cases of variant Creutzfeldt-Jakob disease
[abbreviated in ProMED-mail as CJD (new var.) or vCJD], the form of
the disease thought to be linked to BSE (bovine spongiform encephalopathy).
Definite and probable CJD cases in the UK, as of Fri 3 Nov 2006:
-----------------------------------------------
Summary of vCJD cases - deaths
-----------------------------
Deaths from definite vCJD (confirmed): 112
Deaths from probable vCJD (without neuropathological confirmation): 46
Deaths from probable vCJD (neuropathological confirmation pending): 0
Number of deaths from definite or probable vCJD (as above): 158
Summary of vCJD cases - alive
-----------------------------
Number of probable vCJD cases still alive: 6
Total
-----
Number of definite or probable vCJD (dead and alive): 164
(The next table will be published on Mon 4 Dec 2006).
Since the previous monthly statistics were released on Mon 6 Nov
2006, the total number of deaths from definite vCJD has increased by
2 and stands at 158, and the overall total number of definite or
probable vCJD cases (dead and alive) has increased by 2, making the
overall total 164.
These data are consistent with the view that the vCJD outbreak in the
UK is in decline. The total number of deaths due to vCJD in the UK is
now 158. The peak number of deaths was 28 in the year 2000, followed
by 20 in 2001, 17 in 2002, 18 in 2003, and 9 in 2004, 5 in 2005. The
number of deaths due to definite or probable vCJD in the UK during
the 1st 10 months of 2006 has risen to 5.
Totals for all types of CJD cases in the UK in 2005 and 2006
-----------------------------------------------
As of 3 Nov 2006, in the UK in the year 2005, there were 122
referrals of suspected CJD, and there were 65 deaths from sporadic
CJD, 6 from familial CJD, 3 from iatrogenic CJD, 6 GSS
(Gerstmann-Straussler-Scheinker) syndrome cases, and 5 deaths from vCJD.
The corresponding figures so far for the 1st 10 months of 2006 are:
87 referrals, 48 deaths from sporadic CJD, 5 from vCJD, 4 from
familial CJD, 3 from GSS and one from iatrogenic CJD.
During the period 1995, when vCJD was 1st diagnosed, up to the
present, there have been 946 deaths from all forms of CJD, including
the 158 deaths attributable to definite or probable vCJD.
[These data are accessible via
<https://www.gnn.gov.uk/content/detail.asp?NewsAreaID=2&ReleaseID=239915ID=2>.]
--
ProMED-mail
<[email protected]>
******
[2] EUROCJD data as of 31 Oct 2006
Date: Tue 31 Oct 2006
From: ProMED-mail <[email protected]>
Source: EUROCJD [edited]
<http://www.eurocjd.ed.ac.uk/vcjdworldeuro.htm>
The European And Allied Countries Collaborative Study Group of CJD (EUCJD)
-----------------------------------------------
This web-site includes information from 2 projects funded by the
European Commission. The EUROCJD project started in 1993 and compares
data from national registries in Australia, Austria, Canada, France,
Germany, Italy, the Netherlands, Slovakia, Spain, Switzerland and the
UK. The NEUROCJD project started in 1998 after the European Union
Council recommended that epidemiological surveillance of CJD should
be extended to all member states. The member states involved in this
project are Belgium, Denmark, Finland, Greece, Iceland, Ireland,
Israel, Norway and Portugal. Both projects are coordinated from the
National CJD Surveillance Unit based in Edinburgh.
Current data as of October 2006
-------------------------------
Country / Total No. of Primary cases (No. alive) / Cumulative
residence in UK (>6 months) / Secondary transmission by blood transfusion
United Kingdom / 162 (6) / 164 / 2 (0)
France / 21 (2) / 1 / 0
Republic of Ireland / 4 (1) / 2 / 0
Italy / 1 (0) / 0 / 0
USA / 2 (0) / 2 / 0
Canada / 1 (0) / 1 / 0
Saudi Arabia / 1 (1) / 0 / 0
Japan / 1* (0) / 0 / 0
Portugal / 1 (1) / 0 / 0
Spain / 1 (0) / 0 / 0
Total / 197 (12) / - / 2
Footnote:
---------
* Residence in the UK for 24 days
--
ProMED-mail
<[email protected]>
******
[3] France: novel prion strain
Date: Thu 12 Oct 2006
From: Terry Singeltary <[email protected]>
Source: PLoS Pathogens 2(10); published ahead of print [edited]
<http://pathogens.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.ppat.0020112>
Terry S. Singeltary Sr. has drawn ProMED-mail's attention to the
following paper published ahead of print in PLoS Pathogens, which
although not directly featuring vCJD, he considers is relevant to
understanding the origin of the BSE outbreak in cattle and vCJD in
humans. He comments that this research indicates that different prion
disease phenotypes result from inoculation of cattle with 2
temporally separated sources of sheep scrapie from Great Britain.
The paper is entitled "Isolation from Cattle of a Prion Strain
Distinct from That Causing Bovine Spongiform Encephalopathy" and is
authored by Vincent Beringue and 10 others. The abstract reads as follows:
"To date, bovine spongiform encephalopathy (BSE) and its human
counterpart, variant Creutzfeldt-Jakob disease, have been associated
with a single prion strain. This strain is characterized by a unique
and remarkably stable biochemical profile of abnormal
protease-resistant prion protein (PrP(res)) isolated from brains of
affected animals or humans. However, alternate PrP(res) signatures in
cattle have recently been discovered through large-scale screening.
To test whether these also represent separate prion strains, we
inoculated French cattle isolates characterized by a PrP(res) of
higher apparent molecular mass, called H-type, into transgenic mice
expressing bovine or ovine PrP. All mice developed neurological
symptoms and succumbed to these isolates, showing that these
represent a novel strain of infectious prions. Importantly, this
agent exhibited strain-specific features clearly distinct from that
of BSE agent inoculated to the same mice, which were retained on
further passage. Moreover, it also differed from all sheep scrapie
isolates passaged so far in ovine PrP-expressing mice. Our findings
therefore raise the possibility that either various prion strains may
exist in cattle, or that the BSE agent has undergone divergent
evolution in some animals."
The authors' synopsis of their paper reads as follows: Prions are
unconventional agents of proteic nature that are formed of abnormal
conformations of the host-encoded prion protein (PrP). They cause
fatal neurodegenerative diseases in both animals and humans and can
be transmitted between species, as exemplified in humans by the
emergence of variant Creutzfeldt-Jakob disease following the epidemic
of bovine spongiform encephalopathy (BSE) in the United Kingdom.
Since diagnosis of prion infection is only possible once the central
nervous system has been invaded, brains of slaughtered or fallen
cattle are routinely screened in Europe to protect the consumers from
BSE. This has unexpectedly led to the discovery of unprecedented PrP
conformations that were distinct from the single one associated so
far with BSE or BSE-related diseases. To precisely determine their
etiology, the authors have studied the transmissibility of these new
conformations, termed H-type, to transgenic mice expressing either
bovine or ovine PrP. They show that these cases are highly pathogenic
for these mice. The authors also demonstrate that they are not
directly related to the agent involved in the BSE epidemic,
supporting the view for isolation of a new prion strain from cattle,
whose prevalence and associated zoonotic risk should be carefully
monitored in the future."
--
Terry S. Singeltary Sr
<[email protected]>
[see also:
CJD (new var.) update 2006 (10) 20061002.2820
CJD (new var.) update 2006 (09) 20060904.2519
CJD (new var.) update 2006 (08) 20060807.2207
CJD (new var.) update 2006 (07) 20060703.1831
CJD (new var.) - Netherlands: 2nd case 20060623.1741
CJD (new var.) update 2006 (06) 20060605.1566
CJD (new var.) update 2006 (05) 20060508.1332
CJD (new var.) update 2006 (04) 20060404.1005
CJD (new var.) update 2006 (03) 20060306.0728
CJD (new var.) - UK: 3rd transfusion-related case 20060209.0432
CJD (new var.) update 2006 (02) 20060206.0386
CJD (new var.) update 2006 (01) 20060111.0101
CJD (new var.) update 2006 20060111.0101
2005
----
CJD (new var.) update 2005 (12) 20051209.3547
CJD (new var.) update 2005 (11) 20051108.3270
CJD (new var.) update 2005 (10) 20051006.2916
CJD (new var.) update 2005 (05) 20050505.1243
CJD (new var.) - UK: update 2005 (01) 20050111.0095
2004
----
CJD, genetic susceptibility 20041112.3064
CJD (new var.) - UK: update 2004 (14) 20041206.3242
CJD (new var.) - UK: update 2004 (01) 20040106.0064
CJD (new var.) - France: 8th case 20041022.2864
CJD (new var.) - France: 9th case 20041123.3138
CJD (new var.), blood supply - UK 20040318.0758
CJD (new var.), carrier frequency study - UK 20040521.1365
2003
----
CJD (new var.) - UK: update 2003 (13) 20031216.3072
CJD (new var.) - UK: update 2003 (01) 20030108.0057
2002
----
CJD (new var.) - UK: update Dec 2002 20021207.5997
CJD (new var.) - UK: update Jan 2002 20020111.3223
2001
----
CJD (new var.), incidence & trends - UK (02) 20011124.2875
CJD (new var.), incidence & trends - UK 20011115.2816
CJD (new var.) - UK: reassessment 20011029.2671
CJD (new var.) - UK: update Oct 2001 20011005.2419
CJD (new var.) - UK: regional variation (02) 20010907.2145
CJD (new var.) - UK: update Sep 2001 20010906.2134
CJD (new var.) - UK: update Aug 2001 20010808.1872
CJD (new var.) - UK: 9th Annual Report 20010628.1231
CJD (new var.) - UK: update June 2001 20010622.1188
CJD (new var.) - UK: update 3 Jan 2001 20010104.0025]
.............................................cp/msp/jw
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SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...
http://www.cjdsurveillance.com/resource ... eport.html
There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection.
He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.
http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.pdf
Subject: SEAC EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS FOR SUBCLINICAL vCJD POSITION STATEMENT
Date: November 7, 2006 at 9:38 am PST
© SEAC 2006
1
POSITION STATEMENT
EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS
FOR SUBCLINICAL vCJD
Issue
1. The Department of Health and the UK blood services requested
SEAC's advice on the scientific criteria by which ante mortem
diagnostic tests for subclinical vCJD could be evaluated and
validated1.
Background
2. The development of an accurate and sensitive ante mortem blood
test to identify asymptomatic individuals infected with vCJD could
substantially reduce the potential for transmission of vCJD via
blood transfusion and other medical interventions. It could also be
valuable in confirming the diagnosis of clinical cases and
monitoring the effect of potential therapies. In addition, such a test
could provide an important tool to ascertain better the prevalence
of vCJD infections.
3. The safety, quality and performance requirements for diagnostic
tests for many infectious diseases are laid down in the In Vitro
Diagnostic Medical Devices (IVD) Directive 98/79/EC. Tests
included in Annex II List A of the Directive must comply with
performance requirements set out in a Common Technical
Specification (CTS) to receive a CE mark2. Currently, diagnostic
tests for subclinical vCJD are not included in Annex IIA of the
Directive and so a CTS with clear performance requirements for
such tests has not yet been defined.
SNIP...FULL TEXT ;
SEAC
November 2006
http://www.seac.gov.uk/pdf/statement-vcjd.pdf
PRODUCT
Source Plasma, Recall # B-0054-7
CODE
Units: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891, 03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969, 03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588, 03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228, 03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628, 03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707, 03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189, 03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979, 03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707, 04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719, 04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816, 04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063, 04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485, 04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930, 04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
89 units
DISTRIBUTION
CA and Austria
END OF ENFORCEMENT REPORT FOR October 25, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00975.html
PRODUCT
Recovered Plasma, Recall # B-0084-7
CODE
Unit: GR38567
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter on May 16, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
______________________________
PRODUCT
Source Plasma, Recall # B-0085-7
CODE
Units: 03LWID9056 03LWIE0563 03LWIE1438 03LWIE1703 03LWIE2881 03LWIE7822 03LWIF5263 03LWIF5709 03LWIF6162 03LWIF6703 03LWIF7544 03LWIF8839 03LWIG0019 04LWIA0693 04LWIA1413 04LWIA6459 04LWIA7250 04LWIB7909 04LWIC0795 04LWIC2962 04LWIC3881 04LWIC4249 04LWIC5138 04LWIC7988 04LWIC8464 04LWIC9002 04LWIC9487 03LWIS2936 03LWIS3052 03LWIS3082 03LWIS3114 03LWIS3204 03LWIS3554 03LWIS4083 03LWIS4116 03LWIS4147 03LWIS4185 03LWIS4239 03LWIS4334 04LWIS0036 04LWIS0127 04LWIS0262 04LWIS0545 04LWIS0600 04LWIS0616 04LWIS0850 04LWIS1717 04LWIS1784 04LWIS1810 04LWIS1874 04LWIS2074 04LWIS2110 04LWIS2149 04LWIS2179
RECALLING FIRM/MANUFACTURER
BioLife Plasma Service L.P., Onalaska, WI, by facsimile on July 29, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION
Austria
END OF ENFORCEMENT REPORT FOR November 1, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00976.html
----- Original Message -----
From: Terry S. Singeltary Sr.
Sent: Monday, October 09, 2006 2:48 PM
Subject: FDA nvCJD MAD COW BLOOD HUMAN RECALL 2006 UPDATE
SCIENTIFIC COMMITTEE ON EMERGING AND NEWLY
IDENTIFIED HEALTH RISKS
(SCENIHR)
Opinion on
The Safety of Human-derived Products with regard to Variant
Creutzfeldt-Jakob Disease
Adopted by the SCENIHR
during the 11th plenary meeting of 11-12 May 2006
after public consultation
Synthesis Report : http://ec.europa.eu/health/ph_risk/comm ... _synth.pdf
Stakeholder comments : http://ec.europa.eu/health/ph_risk/comm ... mments.zip
EUROPEAN COMMISSION
HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL
Directorate C - Public Health and Risk Assessment
SNIP...FULL TEXT ;
snip...6 of 81 pages, full text ;
http://ec.europa.eu/health/ph_risk/comm ... o_004b.pdf
USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
______________________________
PRODUCT
Source Plasma, Recall # B-1708-6
CODE
Units: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140,
MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855,
MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136,
MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343,
04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504,
05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874,
05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236,
05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336,
05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907,
05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277,
05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355,
05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892,
05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.
Firm initiated recall is complete.
REASON
Blood products, collected from unsuitable donors based on risk factors for
Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
CA, NC, and MD
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;
b) Fresh Frozen Plasma, Recall # B-1715-6;
c) Platelets, Recall # B-1716-6
CODE
a), b), and c) Unit: 2443732
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by letters dated
November 11, 2003 and December 18, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and WI
END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00969.html
PRODUCT
Fresh Frozen Plasma, Recall # B-1751-6
CODE
Unit: 4936623
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated September
16, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk
factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00968.html
Mon Aug 7, 2006 10:24
71.248.132.189
PRODUCT
a) Red Blood Cells, Recall # B-1587-6;
b) Cryoprecipitated AHF, Recall # B-1588-6;
c) Recovered Plasma, Recal # B-1589-6
CODE
a), b) and c) Unit: 2016719
RECALLING FIRM/MANUFACTURER
Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on
March 13, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA and Germany
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;
b) Fresh Frozen Plasma, Recall # B-1591-6
CODE
a) and b) Unit: 2443595
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June
30, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;
b) Fresh Frozen Plasma, Recall # B-1593-6
CODE
a) and b) Unit: 2545596
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
December 14, 2004 and January 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;
b) Fresh Frozen Plasma, Recall # B-1551-6
CODE
a) and b) Unit 2395371
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6;
b) Platelets, Recall # B-1553-6;
c) Fresh Frozen Plasma, Recall # B-1554-6
CODE
a), b) and c) Unit 2438702
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6;
b) Fresh Frozen Plasma, Recall # B-1556-6
CODE
a) and b) Unit 2454970
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 and December 11. 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1494-6
b) Cryoprecipitated AHF, Recall # B-1495-6
CODE
a) and b) Unit 5013100
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
______________________________
PRODUCT
Source Plasma, Recall # B-1450-6
CODE
Unit numbers ST0824313 and ST0824764
RECALLING FIRM/MANUFACTURER
Stillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UK
______________________________
PRODUCT
Plasma Frozen, Recall # B-1422-6;
Recovered Plasma, Recall # B-1423-6
CODE
a) Unit 03E42218;
b) Unit 03E38153
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by telephone, e-mail or letter on February 20 or 21, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and Switzerland
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6;
b) Recovered Plasma, Recall # B-1375-6
CODE
a) and b) unit 2453906
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31 and November 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Austria
______________________________
PRODUCT
Source Plasma. Recall # B-1295-6
CODE
Units: NG0046551, NG0045950
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002, Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire appropriately, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
______________________________
PRODUCT
Source Plasma. Recall # B-1296-6
CODE
Unit: NG 0044520
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 12, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
______________________________
PRODUCT
Source Plasma. Recall # B-1297-6
CODE
Units: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020, NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
KY
______________________________
PRODUCT
Source Plasma, Recall # B-1298-6
CODE
Units: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG 0042525, NG 0042341
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who answered questions on the variant Creutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
KY
______________________________
PRODUCT
Recovered Plasma, Recall # B-1299-6
CODE
Unit: 4357117
RECALLING FIRM/MANUFACTURER
Department of the Navy, Naval Medical Center, San Diego, CA, by fax and letter on September 25, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at risk of exposure to Creutzfeldt-Jacob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany
END OF ENFORCEMENT REPORT FOR July 12, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00960.html
CJD WATCH MESSAGE BOARD
TSS
FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY
Fri Jul 7, 2006 09:37
70.110.83.160
FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1379-6;
b) Platelets, Recall # B-1380-6;
c) Fresh Frozen Plasma, Recall # 1381-6;
d) Recovered Plasma, Recall # B-1382-6
CODE
a) Unit numbers: 2343106, 2377779, and 2403533;
b) and c) Unit numbers: 2377779;
d) Unit numbers: 2343106 and 2403533
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 12, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
TX and Austria
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6;
b) Recovered Plasma, Recall # B-1468-6
CODE
a) and b) Unit numbers: 2329380
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6;
b) Cryoprecipitated AHF, Recall # B-1480-6;
c) Recovered Plasma, Recall # B-1481-6
CODE
a), b), and c) Unit numbers: 2383280
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 23 and 29, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Switzerland
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6;
b) Fresh Frozen Plasma, Recall # B-1483-6
CODE
a) and b) Unit number: 2501452
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 5, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and NY
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6;
b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6;
c) Recovered Plasma, Recall # B-1486-6
CODE
a) and c) Unit number: 2554077;
b) Unit number: 2415708
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Austria
_____________________________________
END OF ENFORCEMENT REPORT FOR July 5, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00959.html
with new atypical TSE in the bovine, in the sheep, goat, and humans, and the fact that the new BASE TSE in cattle being very very similar to sporadic CJD, rather than the nvCJD, the fact that now science showing the TSE agent of the atypical cattle in Japan showing infectivity other than CNS tissue, the fact that the latest Texas mad cow and the recent Alabama mad cow both being of the atypical strain, it would seem prudent to include all human TSE in the blood ban, in my opinion. ...
TSS
Prion infections, blood and transfusions
Adriano Aguzzi* and Markus Glatzel
Prion infections lead to invariably fatal diseases of the CNS, including
Creutzfeldt-Jakob disease (CJD) in humans, bovine spongiform
encephalopathy (BSE), and scrapie in sheep. There have been hundreds
of instances in which prions have been transmitted iatrogenically among
humans, usually through neurosurgical procedures or administration of
pituitary tissue extracts. Prions have not generally been regarded as bloodborne
infectious agents, and case-control studies have failed to identify
CJD in transfusion recipients. Previous understanding was, however,
questioned by reports of prion infections in three recipients of blood
donated by individuals who subsequently developed variant CJD. On
reflection, hematogenic prion transmission does not come as a surprise, as
involvement of extracerebral compartments such as lymphoid organs and
skeletal muscle is common in most prion infections, and prions have been
recovered from the blood of rodents and sheep. Novel diagnostic strategies,
which might include the use of surrogate markers of prion infection, along
with prion removal strategies, might help to control the risk of iatrogenic
prion spread through blood transfusions. ...
snip...
Last, despite all epidemiological evidence to
the contrary, patients who are methionine/valine
heterozygous at codon 129 of the PRNP gene are
susceptible to infection with vCJD prions, which
raises several important questions. Is the virulence
of BSE prions enhanced when passaged
from human to human, as opposed to the
original bovine to human situation? Passaging
experiments of scrapie infectivity between mice
and hamsters indicate that this scenario is highly
plausible.6 Even more importantly, can vCJD
infection of heterozygous individuals establish
a permanent subclinical carrier state? Although
this situation might constitute a best-case
scenario for the infected individuals, it could be
disastrous from an epidemiological viewpoint,
as it might lead to an unrecognized and possibly
self-sustaining epidemic. ...
snip... full text ;
JUNE 2006 VOL 2 NO 6 AGUZZI AND GLATZEL NATURE CLINICAL PRACTICE NEUROLOGY 329
http://www.nature.com/clinicalpractice/neuro
TSS
**********************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
[The definition of the designations deaths, definite cases, probable
vCJD cases, and the case definitions can be found by accessing the
Department of Health website or by reference to a previous
ProMED-mail post in this thread (for example, CJD (new var.) - UK:
update March 2002 20020305.3693).
Data on vCJD cases from other parts of the world are now included in
these updates whenever available.
Also, data on other forms of CJD (sporadic, iatrogenic, familial and
GSS) are now included when they have some relevance to the incidence
and etiology of vCJD. - Mod.CP]
In this update:
[1] UK: Department of Health monthly CJD statistics, Mon 6 Nov 2006
[2] EUROCJD data as of 31 Oct 2006
[3] France: novel prion strain
******
[1] UK: Department of Health monthly CJD statistics, Mon 6 Nov 2006
Date: Mon 6 Nov 2006
From: ProMED-mail <[email protected]>
Source: UK Department of Health, Monthly Creutzfeldt-Jakob Disease
Statistics [edited]
<https://www.gnn.gov.uk/content/detail.asp?NewsAreaID=2&ReleaseID=239915ID=2>
The Department of Health is today [Mon 6 Nov 2006] issuing the latest
information about the numbers of known cases of Creutzfeldt-Jakob
disease. This includes cases of variant Creutzfeldt-Jakob disease
[abbreviated in ProMED-mail as CJD (new var.) or vCJD], the form of
the disease thought to be linked to BSE (bovine spongiform encephalopathy).
Definite and probable CJD cases in the UK, as of Fri 3 Nov 2006:
-----------------------------------------------
Summary of vCJD cases - deaths
-----------------------------
Deaths from definite vCJD (confirmed): 112
Deaths from probable vCJD (without neuropathological confirmation): 46
Deaths from probable vCJD (neuropathological confirmation pending): 0
Number of deaths from definite or probable vCJD (as above): 158
Summary of vCJD cases - alive
-----------------------------
Number of probable vCJD cases still alive: 6
Total
-----
Number of definite or probable vCJD (dead and alive): 164
(The next table will be published on Mon 4 Dec 2006).
Since the previous monthly statistics were released on Mon 6 Nov
2006, the total number of deaths from definite vCJD has increased by
2 and stands at 158, and the overall total number of definite or
probable vCJD cases (dead and alive) has increased by 2, making the
overall total 164.
These data are consistent with the view that the vCJD outbreak in the
UK is in decline. The total number of deaths due to vCJD in the UK is
now 158. The peak number of deaths was 28 in the year 2000, followed
by 20 in 2001, 17 in 2002, 18 in 2003, and 9 in 2004, 5 in 2005. The
number of deaths due to definite or probable vCJD in the UK during
the 1st 10 months of 2006 has risen to 5.
Totals for all types of CJD cases in the UK in 2005 and 2006
-----------------------------------------------
As of 3 Nov 2006, in the UK in the year 2005, there were 122
referrals of suspected CJD, and there were 65 deaths from sporadic
CJD, 6 from familial CJD, 3 from iatrogenic CJD, 6 GSS
(Gerstmann-Straussler-Scheinker) syndrome cases, and 5 deaths from vCJD.
The corresponding figures so far for the 1st 10 months of 2006 are:
87 referrals, 48 deaths from sporadic CJD, 5 from vCJD, 4 from
familial CJD, 3 from GSS and one from iatrogenic CJD.
During the period 1995, when vCJD was 1st diagnosed, up to the
present, there have been 946 deaths from all forms of CJD, including
the 158 deaths attributable to definite or probable vCJD.
[These data are accessible via
<https://www.gnn.gov.uk/content/detail.asp?NewsAreaID=2&ReleaseID=239915ID=2>.]
--
ProMED-mail
<[email protected]>
******
[2] EUROCJD data as of 31 Oct 2006
Date: Tue 31 Oct 2006
From: ProMED-mail <[email protected]>
Source: EUROCJD [edited]
<http://www.eurocjd.ed.ac.uk/vcjdworldeuro.htm>
The European And Allied Countries Collaborative Study Group of CJD (EUCJD)
-----------------------------------------------
This web-site includes information from 2 projects funded by the
European Commission. The EUROCJD project started in 1993 and compares
data from national registries in Australia, Austria, Canada, France,
Germany, Italy, the Netherlands, Slovakia, Spain, Switzerland and the
UK. The NEUROCJD project started in 1998 after the European Union
Council recommended that epidemiological surveillance of CJD should
be extended to all member states. The member states involved in this
project are Belgium, Denmark, Finland, Greece, Iceland, Ireland,
Israel, Norway and Portugal. Both projects are coordinated from the
National CJD Surveillance Unit based in Edinburgh.
Current data as of October 2006
-------------------------------
Country / Total No. of Primary cases (No. alive) / Cumulative
residence in UK (>6 months) / Secondary transmission by blood transfusion
United Kingdom / 162 (6) / 164 / 2 (0)
France / 21 (2) / 1 / 0
Republic of Ireland / 4 (1) / 2 / 0
Italy / 1 (0) / 0 / 0
USA / 2 (0) / 2 / 0
Canada / 1 (0) / 1 / 0
Saudi Arabia / 1 (1) / 0 / 0
Japan / 1* (0) / 0 / 0
Portugal / 1 (1) / 0 / 0
Spain / 1 (0) / 0 / 0
Total / 197 (12) / - / 2
Footnote:
---------
* Residence in the UK for 24 days
--
ProMED-mail
<[email protected]>
******
[3] France: novel prion strain
Date: Thu 12 Oct 2006
From: Terry Singeltary <[email protected]>
Source: PLoS Pathogens 2(10); published ahead of print [edited]
<http://pathogens.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.ppat.0020112>
Terry S. Singeltary Sr. has drawn ProMED-mail's attention to the
following paper published ahead of print in PLoS Pathogens, which
although not directly featuring vCJD, he considers is relevant to
understanding the origin of the BSE outbreak in cattle and vCJD in
humans. He comments that this research indicates that different prion
disease phenotypes result from inoculation of cattle with 2
temporally separated sources of sheep scrapie from Great Britain.
The paper is entitled "Isolation from Cattle of a Prion Strain
Distinct from That Causing Bovine Spongiform Encephalopathy" and is
authored by Vincent Beringue and 10 others. The abstract reads as follows:
"To date, bovine spongiform encephalopathy (BSE) and its human
counterpart, variant Creutzfeldt-Jakob disease, have been associated
with a single prion strain. This strain is characterized by a unique
and remarkably stable biochemical profile of abnormal
protease-resistant prion protein (PrP(res)) isolated from brains of
affected animals or humans. However, alternate PrP(res) signatures in
cattle have recently been discovered through large-scale screening.
To test whether these also represent separate prion strains, we
inoculated French cattle isolates characterized by a PrP(res) of
higher apparent molecular mass, called H-type, into transgenic mice
expressing bovine or ovine PrP. All mice developed neurological
symptoms and succumbed to these isolates, showing that these
represent a novel strain of infectious prions. Importantly, this
agent exhibited strain-specific features clearly distinct from that
of BSE agent inoculated to the same mice, which were retained on
further passage. Moreover, it also differed from all sheep scrapie
isolates passaged so far in ovine PrP-expressing mice. Our findings
therefore raise the possibility that either various prion strains may
exist in cattle, or that the BSE agent has undergone divergent
evolution in some animals."
The authors' synopsis of their paper reads as follows: Prions are
unconventional agents of proteic nature that are formed of abnormal
conformations of the host-encoded prion protein (PrP). They cause
fatal neurodegenerative diseases in both animals and humans and can
be transmitted between species, as exemplified in humans by the
emergence of variant Creutzfeldt-Jakob disease following the epidemic
of bovine spongiform encephalopathy (BSE) in the United Kingdom.
Since diagnosis of prion infection is only possible once the central
nervous system has been invaded, brains of slaughtered or fallen
cattle are routinely screened in Europe to protect the consumers from
BSE. This has unexpectedly led to the discovery of unprecedented PrP
conformations that were distinct from the single one associated so
far with BSE or BSE-related diseases. To precisely determine their
etiology, the authors have studied the transmissibility of these new
conformations, termed H-type, to transgenic mice expressing either
bovine or ovine PrP. They show that these cases are highly pathogenic
for these mice. The authors also demonstrate that they are not
directly related to the agent involved in the BSE epidemic,
supporting the view for isolation of a new prion strain from cattle,
whose prevalence and associated zoonotic risk should be carefully
monitored in the future."
--
Terry S. Singeltary Sr
<[email protected]>
[see also:
CJD (new var.) update 2006 (10) 20061002.2820
CJD (new var.) update 2006 (09) 20060904.2519
CJD (new var.) update 2006 (08) 20060807.2207
CJD (new var.) update 2006 (07) 20060703.1831
CJD (new var.) - Netherlands: 2nd case 20060623.1741
CJD (new var.) update 2006 (06) 20060605.1566
CJD (new var.) update 2006 (05) 20060508.1332
CJD (new var.) update 2006 (04) 20060404.1005
CJD (new var.) update 2006 (03) 20060306.0728
CJD (new var.) - UK: 3rd transfusion-related case 20060209.0432
CJD (new var.) update 2006 (02) 20060206.0386
CJD (new var.) update 2006 (01) 20060111.0101
CJD (new var.) update 2006 20060111.0101
2005
----
CJD (new var.) update 2005 (12) 20051209.3547
CJD (new var.) update 2005 (11) 20051108.3270
CJD (new var.) update 2005 (10) 20051006.2916
CJD (new var.) update 2005 (05) 20050505.1243
CJD (new var.) - UK: update 2005 (01) 20050111.0095
2004
----
CJD, genetic susceptibility 20041112.3064
CJD (new var.) - UK: update 2004 (14) 20041206.3242
CJD (new var.) - UK: update 2004 (01) 20040106.0064
CJD (new var.) - France: 8th case 20041022.2864
CJD (new var.) - France: 9th case 20041123.3138
CJD (new var.), blood supply - UK 20040318.0758
CJD (new var.), carrier frequency study - UK 20040521.1365
2003
----
CJD (new var.) - UK: update 2003 (13) 20031216.3072
CJD (new var.) - UK: update 2003 (01) 20030108.0057
2002
----
CJD (new var.) - UK: update Dec 2002 20021207.5997
CJD (new var.) - UK: update Jan 2002 20020111.3223
2001
----
CJD (new var.), incidence & trends - UK (02) 20011124.2875
CJD (new var.), incidence & trends - UK 20011115.2816
CJD (new var.) - UK: reassessment 20011029.2671
CJD (new var.) - UK: update Oct 2001 20011005.2419
CJD (new var.) - UK: regional variation (02) 20010907.2145
CJD (new var.) - UK: update Sep 2001 20010906.2134
CJD (new var.) - UK: update Aug 2001 20010808.1872
CJD (new var.) - UK: 9th Annual Report 20010628.1231
CJD (new var.) - UK: update June 2001 20010622.1188
CJD (new var.) - UK: update 3 Jan 2001 20010104.0025]
.............................................cp/msp/jw
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SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...
http://www.cjdsurveillance.com/resource ... eport.html
There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection.
He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.
http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.pdf
Subject: SEAC EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS FOR SUBCLINICAL vCJD POSITION STATEMENT
Date: November 7, 2006 at 9:38 am PST
© SEAC 2006
1
POSITION STATEMENT
EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS
FOR SUBCLINICAL vCJD
Issue
1. The Department of Health and the UK blood services requested
SEAC's advice on the scientific criteria by which ante mortem
diagnostic tests for subclinical vCJD could be evaluated and
validated1.
Background
2. The development of an accurate and sensitive ante mortem blood
test to identify asymptomatic individuals infected with vCJD could
substantially reduce the potential for transmission of vCJD via
blood transfusion and other medical interventions. It could also be
valuable in confirming the diagnosis of clinical cases and
monitoring the effect of potential therapies. In addition, such a test
could provide an important tool to ascertain better the prevalence
of vCJD infections.
3. The safety, quality and performance requirements for diagnostic
tests for many infectious diseases are laid down in the In Vitro
Diagnostic Medical Devices (IVD) Directive 98/79/EC. Tests
included in Annex II List A of the Directive must comply with
performance requirements set out in a Common Technical
Specification (CTS) to receive a CE mark2. Currently, diagnostic
tests for subclinical vCJD are not included in Annex IIA of the
Directive and so a CTS with clear performance requirements for
such tests has not yet been defined.
SNIP...FULL TEXT ;
SEAC
November 2006
http://www.seac.gov.uk/pdf/statement-vcjd.pdf
PRODUCT
Source Plasma, Recall # B-0054-7
CODE
Units: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891, 03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969, 03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588, 03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228, 03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628, 03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707, 03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189, 03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979, 03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707, 04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719, 04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816, 04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063, 04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485, 04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930, 04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
89 units
DISTRIBUTION
CA and Austria
END OF ENFORCEMENT REPORT FOR October 25, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00975.html
PRODUCT
Recovered Plasma, Recall # B-0084-7
CODE
Unit: GR38567
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter on May 16, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
______________________________
PRODUCT
Source Plasma, Recall # B-0085-7
CODE
Units: 03LWID9056 03LWIE0563 03LWIE1438 03LWIE1703 03LWIE2881 03LWIE7822 03LWIF5263 03LWIF5709 03LWIF6162 03LWIF6703 03LWIF7544 03LWIF8839 03LWIG0019 04LWIA0693 04LWIA1413 04LWIA6459 04LWIA7250 04LWIB7909 04LWIC0795 04LWIC2962 04LWIC3881 04LWIC4249 04LWIC5138 04LWIC7988 04LWIC8464 04LWIC9002 04LWIC9487 03LWIS2936 03LWIS3052 03LWIS3082 03LWIS3114 03LWIS3204 03LWIS3554 03LWIS4083 03LWIS4116 03LWIS4147 03LWIS4185 03LWIS4239 03LWIS4334 04LWIS0036 04LWIS0127 04LWIS0262 04LWIS0545 04LWIS0600 04LWIS0616 04LWIS0850 04LWIS1717 04LWIS1784 04LWIS1810 04LWIS1874 04LWIS2074 04LWIS2110 04LWIS2149 04LWIS2179
RECALLING FIRM/MANUFACTURER
BioLife Plasma Service L.P., Onalaska, WI, by facsimile on July 29, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION
Austria
END OF ENFORCEMENT REPORT FOR November 1, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00976.html
----- Original Message -----
From: Terry S. Singeltary Sr.
Sent: Monday, October 09, 2006 2:48 PM
Subject: FDA nvCJD MAD COW BLOOD HUMAN RECALL 2006 UPDATE
SCIENTIFIC COMMITTEE ON EMERGING AND NEWLY
IDENTIFIED HEALTH RISKS
(SCENIHR)
Opinion on
The Safety of Human-derived Products with regard to Variant
Creutzfeldt-Jakob Disease
Adopted by the SCENIHR
during the 11th plenary meeting of 11-12 May 2006
after public consultation
Synthesis Report : http://ec.europa.eu/health/ph_risk/comm ... _synth.pdf
Stakeholder comments : http://ec.europa.eu/health/ph_risk/comm ... mments.zip
EUROPEAN COMMISSION
HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL
Directorate C - Public Health and Risk Assessment
SNIP...FULL TEXT ;
snip...6 of 81 pages, full text ;
http://ec.europa.eu/health/ph_risk/comm ... o_004b.pdf
USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
______________________________
PRODUCT
Source Plasma, Recall # B-1708-6
CODE
Units: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140,
MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855,
MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136,
MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343,
04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504,
05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874,
05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236,
05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336,
05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907,
05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277,
05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355,
05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892,
05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.
Firm initiated recall is complete.
REASON
Blood products, collected from unsuitable donors based on risk factors for
Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
CA, NC, and MD
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;
b) Fresh Frozen Plasma, Recall # B-1715-6;
c) Platelets, Recall # B-1716-6
CODE
a), b), and c) Unit: 2443732
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by letters dated
November 11, 2003 and December 18, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and WI
END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00969.html
PRODUCT
Fresh Frozen Plasma, Recall # B-1751-6
CODE
Unit: 4936623
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated September
16, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk
factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00968.html
Mon Aug 7, 2006 10:24
71.248.132.189
PRODUCT
a) Red Blood Cells, Recall # B-1587-6;
b) Cryoprecipitated AHF, Recall # B-1588-6;
c) Recovered Plasma, Recal # B-1589-6
CODE
a), b) and c) Unit: 2016719
RECALLING FIRM/MANUFACTURER
Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on
March 13, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA and Germany
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;
b) Fresh Frozen Plasma, Recall # B-1591-6
CODE
a) and b) Unit: 2443595
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June
30, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;
b) Fresh Frozen Plasma, Recall # B-1593-6
CODE
a) and b) Unit: 2545596
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
December 14, 2004 and January 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;
b) Fresh Frozen Plasma, Recall # B-1551-6
CODE
a) and b) Unit 2395371
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6;
b) Platelets, Recall # B-1553-6;
c) Fresh Frozen Plasma, Recall # B-1554-6
CODE
a), b) and c) Unit 2438702
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6;
b) Fresh Frozen Plasma, Recall # B-1556-6
CODE
a) and b) Unit 2454970
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 and December 11. 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1494-6
b) Cryoprecipitated AHF, Recall # B-1495-6
CODE
a) and b) Unit 5013100
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
______________________________
PRODUCT
Source Plasma, Recall # B-1450-6
CODE
Unit numbers ST0824313 and ST0824764
RECALLING FIRM/MANUFACTURER
Stillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UK
______________________________
PRODUCT
Plasma Frozen, Recall # B-1422-6;
Recovered Plasma, Recall # B-1423-6
CODE
a) Unit 03E42218;
b) Unit 03E38153
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by telephone, e-mail or letter on February 20 or 21, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and Switzerland
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6;
b) Recovered Plasma, Recall # B-1375-6
CODE
a) and b) unit 2453906
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31 and November 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Austria
______________________________
PRODUCT
Source Plasma. Recall # B-1295-6
CODE
Units: NG0046551, NG0045950
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002, Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire appropriately, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
______________________________
PRODUCT
Source Plasma. Recall # B-1296-6
CODE
Unit: NG 0044520
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 12, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
______________________________
PRODUCT
Source Plasma. Recall # B-1297-6
CODE
Units: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020, NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
KY
______________________________
PRODUCT
Source Plasma, Recall # B-1298-6
CODE
Units: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG 0042525, NG 0042341
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who answered questions on the variant Creutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
KY
______________________________
PRODUCT
Recovered Plasma, Recall # B-1299-6
CODE
Unit: 4357117
RECALLING FIRM/MANUFACTURER
Department of the Navy, Naval Medical Center, San Diego, CA, by fax and letter on September 25, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at risk of exposure to Creutzfeldt-Jacob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany
END OF ENFORCEMENT REPORT FOR July 12, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00960.html
CJD WATCH MESSAGE BOARD
TSS
FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY
Fri Jul 7, 2006 09:37
70.110.83.160
FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1379-6;
b) Platelets, Recall # B-1380-6;
c) Fresh Frozen Plasma, Recall # 1381-6;
d) Recovered Plasma, Recall # B-1382-6
CODE
a) Unit numbers: 2343106, 2377779, and 2403533;
b) and c) Unit numbers: 2377779;
d) Unit numbers: 2343106 and 2403533
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 12, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
TX and Austria
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6;
b) Recovered Plasma, Recall # B-1468-6
CODE
a) and b) Unit numbers: 2329380
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6;
b) Cryoprecipitated AHF, Recall # B-1480-6;
c) Recovered Plasma, Recall # B-1481-6
CODE
a), b), and c) Unit numbers: 2383280
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 23 and 29, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Switzerland
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6;
b) Fresh Frozen Plasma, Recall # B-1483-6
CODE
a) and b) Unit number: 2501452
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 5, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and NY
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6;
b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6;
c) Recovered Plasma, Recall # B-1486-6
CODE
a) and c) Unit number: 2554077;
b) Unit number: 2415708
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Austria
_____________________________________
END OF ENFORCEMENT REPORT FOR July 5, 2006
###
http://www.fda.gov/bbs/topics/enforce/2 ... 00959.html
with new atypical TSE in the bovine, in the sheep, goat, and humans, and the fact that the new BASE TSE in cattle being very very similar to sporadic CJD, rather than the nvCJD, the fact that now science showing the TSE agent of the atypical cattle in Japan showing infectivity other than CNS tissue, the fact that the latest Texas mad cow and the recent Alabama mad cow both being of the atypical strain, it would seem prudent to include all human TSE in the blood ban, in my opinion. ...
TSS
Prion infections, blood and transfusions
Adriano Aguzzi* and Markus Glatzel
Prion infections lead to invariably fatal diseases of the CNS, including
Creutzfeldt-Jakob disease (CJD) in humans, bovine spongiform
encephalopathy (BSE), and scrapie in sheep. There have been hundreds
of instances in which prions have been transmitted iatrogenically among
humans, usually through neurosurgical procedures or administration of
pituitary tissue extracts. Prions have not generally been regarded as bloodborne
infectious agents, and case-control studies have failed to identify
CJD in transfusion recipients. Previous understanding was, however,
questioned by reports of prion infections in three recipients of blood
donated by individuals who subsequently developed variant CJD. On
reflection, hematogenic prion transmission does not come as a surprise, as
involvement of extracerebral compartments such as lymphoid organs and
skeletal muscle is common in most prion infections, and prions have been
recovered from the blood of rodents and sheep. Novel diagnostic strategies,
which might include the use of surrogate markers of prion infection, along
with prion removal strategies, might help to control the risk of iatrogenic
prion spread through blood transfusions. ...
snip...
Last, despite all epidemiological evidence to
the contrary, patients who are methionine/valine
heterozygous at codon 129 of the PRNP gene are
susceptible to infection with vCJD prions, which
raises several important questions. Is the virulence
of BSE prions enhanced when passaged
from human to human, as opposed to the
original bovine to human situation? Passaging
experiments of scrapie infectivity between mice
and hamsters indicate that this scenario is highly
plausible.6 Even more importantly, can vCJD
infection of heterozygous individuals establish
a permanent subclinical carrier state? Although
this situation might constitute a best-case
scenario for the infected individuals, it could be
disastrous from an epidemiological viewpoint,
as it might lead to an unrecognized and possibly
self-sustaining epidemic. ...
snip... full text ;
JUNE 2006 VOL 2 NO 6 AGUZZI AND GLATZEL NATURE CLINICAL PRACTICE NEUROLOGY 329
http://www.nature.com/clinicalpractice/neuro
TSS
