##################### Bovine Spongiform Encephalopathy #####################
New HPA survey – the ethical and social aspects of a new vCJD test for blood donors
The Health Protection Agency has launched a consultation to look at the social and ethical implications of a blood test for variant (vCJD), should a test become available. There is currently no blood test to detect vCJD infection in people who appear to be well. Such tests may soon be developed, and this consultation aims to seek views about how these tests for vCJD could be used once they become available.
A vCJD test could be used to screen blood donors, allowing the blood services to prevent blood from people with positive tests being given to patients. This is important as there have now been three probable cases of vCJD infection being transmitted through blood transfusions and a measure such as this could further ensure the safety of blood supplies.
The consultation will explore some questions and concerns about introducing a blood test, including:
1. Should a test for vCJD be introduced when it is not known whether people with positive test results would ever develop symptoms of vCJD, and if they would, how long this would take?
2. Should the UK blood services always tell donors if their vCJD tests are positive? And how should donors’ GPs be involved?
3. If donors knew that they would be tested for vCJD, and that they would be told if they tested positive for vCJD, would they be put off giving blood?
Together with an opinion research company, the HPA is asking experts, health professionals, interest groups and members of the public for views on the possible impact and implications of a blood test for vCJD. A stakeholder audit is being complemented by an on-line questionnaire. The answers will be completely confidential and anonymous.
If you would like to join in this consultation, please take part in the online poll at http://www.hpa.org.uk/infections/topics_az/cjd/consultation.htm
http://www.hpa.org.uk/cdr/pages/news.htm#cjd
Report of Seminar on Ethical and Social Aspects
of Testing for vCJD
Chairman: Professor Albert Weale
Report compiled by: HPA Centre for Infections, CJD Section. October 2005
Contact: Helen Janecek (
[email protected])
FULL TEXT 31 PAGES ;
http://www.hpa.org.uk/infections/topics_az/cjd/ethicalsocialtesting.pdf
Report of Seminar on Ethical and Social Aspects
of Testing for vCJD
Chairman: Professor Albert Weale
Recommendations
Report compiled by: HPA Centre for Infections, CJD Section. October 2005
Contact: Helen Janecek (
[email protected])
FULL TEXT 6 PAGES ;
http://www.hpa.org.uk/infections/topics_az/cjd/ethicalsocialrecommendations.pdf
October 22, 2006 12:00am
A MELBOURNE grandmother who died this week from suspected Creutzfeldt-Jakob
disease was a blood donor for 25 years.
Valerie Powell, 68, died on Tuesday. Her husband Ron, 70, said his wife was
a regular blood donor until a year ago.
But he said doctors had told him the type of CJD his wife had could not be
transmitted by blood or blood products.
The Australian Red Cross said there had never been a reported case of
classical CJD being passed from a blood donor anywhere in the world.
CJD expert Prof Colin Masters, head of the Department of Pathology at
Melbourne University, said Victorians who may have received blood from Mrs
Powell should not be alarmed because there was no evidence classical CJD was
passed through the blood.
But he said in the past year there had been three cases, all in Britain, of
variant CJD -- more widely known as mad cow's disease -- passed from blood
donors.
Mr Powell said his wife went to her GP in July because she was feeling
unwell.
"He diagnosed depression and put her on medication," he said. "It didn't
help. Valerie's symptoms became worse."
Mrs Powell's family was told a test of her spinal fluid showed she
"probably" had sporadic CJD, which makes up 90 per cent of all classical CJD
cases.
It was not known how she developed the rare, but fatal, brain disease. Only
a biopsy will confirm suspicions that Mrs Powell died from CJD.
Prof Masters said there was no way of screening blood donors. About 20
Australians a year die from classical CJD.
THERE are support groups for families of victims of CJD. Contact Suzanne
Solvyns 1800 052 466, Carol Wilson 1800 181 683 or Mandy Newton 1800 884
897.
http://www.news.com.au/sundayheraldsun/story/0,21985,20622280-661,00.html
Prion infections, blood and transfusions
Adriano Aguzzi* and Markus Glatzel
SUMMARY
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...
TRANSMISSION OF PRION DISEASES
IN HUMANS
The cause of most human prion diseases is
unknown. In the case of sCJD, the term 'sporadic'
is used as a euphemism, meaning that we have
no idea about the origin of this form of CJD. By
contrast, gCJD always segregates within families
with mutations in the gene encoding the prion
protein (PRNP), suggesting that these mutations
are causally involved in disease pathogenesis. As
no families have been described in which gCJD
segregates with mutations in genes other than
PRNP, it has been difficult to use human genetics
to understand the pathogenesis of prion diseases.
The discovery of PRNP mutations in gCJD has
led to the proposal that at least some cases of
sCJD might be due to somatic PRNP mutations
analogous to those found in the germline of
gCJD patients. It is equally possible, however,
that some of the cases of alleged sCJD derive
from hitherto unrecognized infectious causes.
In apparent agreement with the 'intrinsic'
origin of sCJD, which accounts for more than
90% of all human prion diseases, epidemiological
studies were not able to identify a
conclusive link between this form of CJD and
external risk factors.19 This fact is reflected in
the pathological and biochemical features of
these diseases. Although low levels of PrPSc and
prion infectivity can be demonstrated in peripheral
sites such as lymphoid organs or skeletal
muscle,20,21 the highest levels of PrPSc and prion
infectivity appear to occur in the CNS. These
facts might account, at least in part, for the lack
of evidence of sCJD transmission by labile or
stable blood products.22 Indeed, several retrospective
studies have failed to identify blood
transfusion or exposure to plasma products as
risk factors for the development of sCJD,19 and
prion diseases appear to be exceedingly rare
in hemophiliacs, a group of patients that is at
particularly high risk of contracting emerging
blood-borne infectious diseases. Although these
studies cannot exclude the possibility that transmission
of sCJD might have occurred through
blood transfusions in rare cases, and despite
the fact that the etiology of sCJD is unclear,
it would appear that transmission of sCJD by
trans fusion of blood or blood products does
not play a major role in the pathogenesis of this
disease entity.
In the case of acquired prion diseases, however,
the situation is very different. For vCJD, high
levels of prion infectivity and of PrPSc have
been detected in lymphoid organs such as the
appendix and tonsils (Figure 1).23,24 For this
reason, it has been speculated for almost a decade
that vCJD might be associated with a higher risk
of blood-borne transmission than sCJD. It is
important to be cautious, however, as the differences
in the organ tropism of sCJD and vCJD
might be quantitative rather than qualitative, and
PrPSc has been detected in the lymphoid organs
of both vCJD and sCJD patients.21 Initial studies
have failed to detect PrPSc and prion infectivity
in the blood of patients with vCJD, but these
negative data are likely to be attributable to
the lack of sensitivity of the assays available at
the time.23
The recent identification of three indiv iduals
with probable transmission of vCJD via blood
transfusion has provided tragic evidence that vCJD
prions can indeed be transmitted through blood
(Figure 2). On the basis of the epi demiological
and pathogenetic considerations discussed above,
it can only be a matter of time before further
cases of blood-transfusion-associated cases of
vCJD will ensue (Figure 3). ...snip...END
JUNE 2006 VOL 2 NO 6 AGUZZI AND GLATZEL NATURE NEUROLOGY
=========================================================
SHORT REPORT
Creutzfeldt-Jakob disease 38 years after diagnostic use of human growth
hormone
E A Croes, G Roks, G H Jansen, P C G Nijssen, C M van Duijn
...............................................................
J Neurol Neurosurg Psychiatry 2002;72:792-793
A 47 year old man is described who developed pathology proven
Creutzfeldt-Jakob disease (CJD) 38 years after receiving a low dose of human
derived growth hormone (hGH) as part of a diagnostic procedure. The patient
presented with a cerebellar syndrome, which is compatible with iatrogenic
CJD. This is the longest incubation period described so far for iatrogenic
CJD. Furthermore, this is the first report of CJD after diagnostic use of
hGH. Since the patient was one of the first in the world to receive hGH,
other cases of iatrogenic CJD can be expected in the coming years.
snip...
An incubation period as long as 38 years had never been reported for
iatrogenic CJD. Huillard d'Aignaux et al7 studied the incubation period in
55 patients with hGH related CJD in a cohort of 1361 French hGH recipients.
The median incubation period was between 9 and 10 years. Under the most
pessimistic model, the upper limit of the 95% confidence interval varied
between 17 and 20 years. Although the infecting dose cannot be quantified,
it can be speculated that the long incubation period in our patient is
partly explained by the administration of a limited amount of hGH. This
hypothesis is supported by experimental models, in which higher infecting
doses usually produce shorter incubation periods.6 Since our patient was one
of the first in the world to receive hGH, this case indicates that still
more patients with iatrogenic CJD can be expected in the coming years.
Another implication of our study is that CJD can develop even after a low
dose of hGH. This case once more testifies that worldwide close monitoring
of any form of iatrogenic CJD is mandatory. ...snip...END
=====================================
Transfusion
Volume 43 Page 1687 - December 2003
doi:10.1046/j.0041-1132.2003.00586.x
Volume 43 Issue 12
Similar levels of infectivity in the blood of mice infected with
human-derived vCJD and GSS strains of transmissible spongiform
encephalopathy
Larisa Cervenakova, Oksana Yakovleva, Carroll McKenzie, Svetlana Kolchinsky,
Lisa McShane, William N. Drohan, and Paul Brown
BACKGROUND:
The possible transmission of variant CJD (vCJD) through blood transfusion or
use of plasma-derived products prompted this study comparing infectivity in
murine models of vCJD and Gerstmann-Sträussler-Scheinker (GSS) disease, a
non-vCJD form of transmissible spongiform encephalopathy (TSE).
STUDY DESIGN AND METHODS:
RIII/Fa/Dk (RIII) or Swiss-Webster (Swiss) mice were inoculated
intracerebrally (IC) with mouse-adapted strains of vCJD or GSS (Fukuoka-1)
of similar infectivity. Groups of RIII mice were euthanized 17 weeks after
inoculation (during the incubation period), and another 23 weeks after
inoculation (when symptomatic). Blood was collected, separated into
components, and inoculated into groups of healthy mice; brains and spleens
from all mice were harvested and tested for the presence of PrPres by
Western blot using 6H4 MoAb.
RESULTS:
Levels of 20-30 infectious doses per mL were present in buffy coat and
plasma during both the incubation and symptomatic stages of disease; PLT
pellet infectivity was lower (10 ID/mL) and RBCs were not infectious. The
disease was transmitted more efficiently by IV than IC inoculation of
plasma, but there was no difference observed with inoculation of buffy coat.
The incubation period was shorter after IC inoculation of GSS- than
vCJD-brain inocula. The amount of PrPres in spleens was similar for both TSE
agents, but was slightly lower in brains of vCJD than GSS mice.
CONCLUSION:
Infectivity was detected in blood components of mice infected with a
human-derived strain of vCJD during both the preclinical and clinical phases
of disease in a similarly low range of concentrations as in mice infected
with a human-derived nonvariant strain (GSS, Fukuoka-1). Other measures of
virulence, including brain infectivity titers, incubation periods, and the
accumulation of PrPres in spleens and brains, were also comparable in both
experimental models.
http://www.blackwell-synergy.com/doi/abs/10.1046/j.0041-1132.2003.00586.x
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/2006/ENF00969.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/2006/ENF00968.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/2006/ENF00963.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/2006/ENF00960.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/2006/ENF00959.html
FDA Fines American Red Cross $4.2 Million (BLOOD CJD)
Fri Sep 8, 2006 20:01
71.248.154.242
FDA Statement
FOR IMMEDIATE RELEASE
Statement
September 8, 2006
Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Fines American Red Cross $4.2 Million for Failure to Meet Established
Blood Safety Laws
The U.S. Food and Drug Administration (FDA) announced today that the
American Red Cross (ARC) is being fined $4.2 million for failure to comply
with requirements under Federal laws and FDA regulations relating to the
collection of blood products. These fines were assessed under an amended
2003 consent decree that calls for significant financial penalties when ARC
fails to comply with FDA regulations and consent decree provisions designed
to ensure the safety of the nation's blood supply.
The fines stem from a recently completed FDA review of recalls conducted by
ARC between 2003 and 2005 that found these events were preventable by ARC.
The violations include breaches of Good Manufacturing Practice (GMP) such as
a failure to ask appropriate donor screening questions and failure to follow
manufacturer test protocols. We have no evidence that these violations
resulted in serious health consequences.
Because receiving blood products always carries a degree of risk, it is
important that the blood industry complies with the full set of safeguards
in Federal laws and FDA regulations to minimize that risk. However, any
particular breach of the safeguards does not necessarily translate into
unsafe blood products, because the safeguards designed to protect the blood
supply are to some extent overlapping. The FDA continues to advise care
providers and consumers that rigorous protections are in place and that the
blood supply is safe. Patients in need of a transfusion should continue to
follow the advice of their physicians. The risks of receiving a transfusion
are far less than the risk of failing to receive a transfusion when blood
treatment is indicated.
Improvements in donor screening procedures and the use of a variety of new
tests in the last few years have made the national blood supply safer from
infectious diseases and other risks than it has been at any other time.
However, because there is always some degree of risk in receiving blood
products, each individual safeguard is considered critical to minimizing
that risk. Although the failure of an individual safeguard does not
automatically translate into the release of unsafe products, it may increase
the potential for risk. It is the potential risk that FDA insists the Red
Cross Board of Directors prioritize and support its new management's ability
to immediately address and work to improve its approach to quality.
The amended consent decree requires ARC to:
Establish clear lines of managerial control over a newly established
comprehensive quality assurance system in all regions;
To enhance training programs; and
To improve computer systems, records management, and policies for
investigating and reporting problems, including adverse reactions
Since entry of the 2003 consent decree and prior to this action, FDA has
issued the American Red Cross seven similar letters and assessed a total of
$5.7 million in penalties.
While achieving a blood supply with zero risk of transmitting infectious
disease is the ultimate objective, we recognize based on the available
science that this may not be realistic. Therefore, the FDA requires blood
processors to adopt and strictly follow a multi-layered safety program to
protect and enhance the safety of blood products at each stage of their
manufacture. At the blood collection stage, these measures generally
include:
Accurate and complete educational material for donors so that they can
assess their risk and decline to donate if that is appropriate;
Administration of donor screening questions to identify safety risks;
Checking of lists to prevent use of blood from persons known to be
ineligible to donate;
Quality controlled infectious disease testing procedures;
Inventory controls to prevent the release of units that are unsuitable;
Appropriate handling and distribution of blood and blood products for
patient use; and
Investigation and correction of deviations from standards
ARC is responsible for approximately 45% of the nation's blood supply; other
independent community-based blood centers together provide another 45%, and
hospitals collect most of the remaining 10%.
Blood donations are critically needed every day to save lives, and blood
donation is a safe procedure. FDA encourages persons who are in good health
to donate blood and to become regular blood donors.
####
http://www.fda.gov/cber/talkpapers.htm#arc
SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2004. SPORADIC CJD CASES TRIPLED, and that is
with a human TSE surveillance system that is terrible
flawed. in 1997 cases of the _reported_ cases of cjd
were at 54, to 163 _reported_ cases in 2004. see stats
here;
p.s. please note the 47 PENDING CASES to Sept. 2005
p.s. please note the 2005 Prion D. total 120(8)
8=includes 51 type pending, 1 TYPE UNKNOWN ???
p.s. please note sporadic CJD 2002(1) 1=3 TYPE UNKNOWN???
p.s. please note 2004 prion disease (6) 6=7 TYPE
UNKNOWN???
http://www.cjdsurveillance.com/resources-casereport.html
HOW MANY WERE BLOOD DONORS ???
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle
03-025IFA
03-025IFA-2
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
From: Terry S. Singeltary Sr. [
[email protected]]
Date: Monday, January 08,200l 3:03 PM
To:
[email protected]
snip...
CJDIBSE (aka madcow) Human/Animal TSE's--U.S.--Submission To Scientific
Advisors and
Consultants Staff January 2001 Meeting (short version)
I am beginning to think that the endless attempt to track
down and ban, potential victims from known BSE Countries
from giving blood will be futile. You would have to ban
everyone on the Globe eventually? AS well, I think we
MUST ACT SWIFTLY to find blood test for TSE's,
whether it be blood test, urine test, eyelid test,
anything at whatever cost, we need a test FAST.
DO NOT let the incubation time period of these TSEs fool you. ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Diagnosis and Reporting of Creutzfeldt-Jakob Disease
Singeltary, Sr et al. JAMA.2001; 285: 733-734.
http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama
Terry S. Singeltary Sr.
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