Prion Disease Risks in the 21st Century 2011 PDA European Virus-TSE Safety
PDA: A Global Association
CJD and PLASMA / URINE PRODUCTS
CJD and ATMPs
EMA Position Statements
Alberto Ganan Jimenez, European Medicines Agency
TSE Safety Forum, 30 June 2011
EMA guidance on CJD and medicinal products
EMA Position Statement on plasma/urine products 2011
- Human TSEs current status
- Plasma products: Recommendations
- Urine products: Recommendations
EMA Position Statement on ATMPs
EMA guidance on CJD and medicinal products
CHMP Position Statements:
CHMP Position Statement on CJD and plasma-derived and urine-derived
medicinal products (2011) (EMA/CHMP/BWP/303353/2010)
CAT/CHMP Position Statement on CJD and advanced therapy medicinal
products (2011) (EMA/CHMP/BWP/353632/2010)
Guidelines:
Investigation of manufacturing processes for plasma-derived medicinal
products with regards to vCJD risk (2004) (CPMP/BWP/5136/03)
Warning on transmissible agents in summary of product characteristics
(SmPC) and package leaflets for plasma-derived medicinal products (2003)
(CPMP/BPWP/BWP/561/03)
Workshops:
Report on Expert Workshop on CJD risk and urine-medicinal products (07-2007)
EMA Guidance on CJD / medicinal products
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
CHMP Position Statement
on plasma-derived
and urine-derived
medicinal products
Guid. on investigation
of manufacturing
processes for plasma
products with
regard to vCJD risk
Expert meetings at EMA
CJD related CHMP/CAT Position
Statement on ATMPs
Guid. on Warning
statements transmissible
agents SmPC / PL
Initial
Publication
(CPMP/201/98)
Rev. 1
(CPMP/BWP
/2879/02)
Rev. 2 Rev. 3
(CHMP/BWP/
303352/2010)
Initial
Publication
(CPMP/BWP/
353632/2010)
Initial
Publication
(CPMP/BWP/5136/03)
Initial
Publication
(CPMP/BPWP/BWP
561/03)
Under Revision
EMA Position Statement on plasma/urine products 2011
- Human TSEs current status
sCJD, gCJD, iCJD
Epidemiological evidence does not support transmission of s, g, iCJD by blood, blood components or plasma products
No case of sCJD, gCJD, iCJD has been causally linked to prior treatment with plasma products or blood transfusion
* It cannot formally excluded the possibility of blood transmission in a small number of cases based:
* -limitations in statistical power of epidemiological studies
* -limited experimental evidence of peripherical tissue infectivity in various subtypes of sCJD
* -potential diagnostic confusion
* Cases of sCJD with treatment of infertility have not been identified,
* -uncertainty about the validity of this observation
* -strength of evidence of exclusion transmission by urine products is less secure
vCJD
Number of cases:
UK France Ireland Italy USA Canada Saudi Arabia Japan Netherlands Portugal Spain Taiwan Total
Mar-11 175 25 4 2 3 2 1 1 3 2 5 1 224
Jun-04 146 6 1 1 1 1 156
Source NCJDRSU-University of Edinburgh
Still uncertainties on the number of cases of vCJD that will occur
UK figures for the quarterly incidence of deaths may indicate that vCJD incidence in the UK is in decline -> caution interpretation
All definitive and probable cases are Met/Met Codon 129 PrP gene
In 2009, one possible case vCJD Met/Val but could not be confirmed as autopsy was not performed
vCJD
Importance of estimation of vCJD prevalence with respect to any potential
secondary transmission while individuals are in the incubation phase
Estimated prevalence of the disease in different UK studies:
- 267 infections / million (95% CI [49-692]) (Hilton et al. 2004))
- 0-113 (95%; 1961-1995 birth cohort) (Clevlew et al. 2009)
- 109 infection / million (95% CI [3-608]) (De Marco et al. 2010)
Infectivity/ transmissibility via blood
Animal blood
Low levels of infectivity found in the blood of rodents infected with
TSE agents.
Half of infectivity is in cellular components, mainly buffy coat
Orally infected sheep or natural scrapie can be transmitted by blood
transfusion in the majority of cases collected half way through incubation period
Experiments on BSE infected sheep demonstrate that all blood components,
incl. plasma contain transmissible TSE agent and remain infectious
after leucoreduction
Human blood
Strong evidence that vCJD is transmissible through blood transfusion
Four instances of secondary transmission in blood transfusion from UK donors
- received non-leucodepleted transfusions from healthy donors that
developed vCJD 17-40 months later
- 3 recipients developed vCJD (6.5-8.5 years later)
- 1 heterozygous case died 5 yr. later by unrelated causes
and tested positive for PrPTSE in spleen
Infectivity in human blood of vCJD cases was not detected using the
methods capable of detecting in peripheral tissues (e.g. tonsil, spleen)
Human blood
Warning that some plasma derived products might contain
residual prion infectivity
Presumed case of asymptomatic vCJD infection identified in an elderly
haemophilic patient:
• heterozygous Met/Val.
• had received large quantities of intermediate purity UK-sourced factor VIII
• at least one batch included some units manufactured from a plasma
from a donor that later developed CJD
Risk assessment suggest that the most likely route of infection was the
reception of plasma products
These findings highlight the importance of national databases of blood
donors and the maintenance of an effective traceability donor/receptor system
donor <-> receptor
EMA Position Statement on plasma/urine products 2011
- Plasma products: Recommendations
Donor selection
Donor selection criteria should be implemented to minimise
the risk of developing CJD
sCJD, gCJD, iCJD
Donor selection criteria:
deferral of donors who might be at higher risk of developing CJD
(family history of TSE, corneal or dura mater graft receptors,
treated patients with medicines derived from human pituitary glands)
Donor exclusion criteria
vCJD
Country based donor selection criteria based on the identification
of high risk donors
UK
- donor exclusion who have spent long periods in UK
- recommended 1 year or more cumulative UK residence
between 1980-1996
- member States (MS) may define stricter limits but will accept
plasma products from other MS that at least 1 yr time limit is applied
France and other BSE-exposed MS
-not recommended exclusion of donors that spent cumulative periods
in these countries
• Additional further deferral criteria may be recommended
by MS
weighing the odds
safety impact vs donation volumes
Batch recall of plasma products
sCJD, gCJD, iCJD
Precautionary recalls for batches when post donation reports of CJD
or risk factors donors is NOT recommended
- not justified based on current epidemiological evidence
- risk of shortages of plasma products
vCJD
Maintenance of recommendation of batch recall where a donor to
a plasma pool subsequently develops vCJD.
vCJD
Maintenance of recommendation of batch recall where a donor to
a plasma pool subsequently develops vCJD
It applies for plasma products used as such or as excipients
The risk of infectivity transmission of albumin is particularly low
In case of albumin used as excipient or during manufacture
product recall should be considered
However, a case-by-case risk analysis taking into account the prion reduction
data and amount of albumin use could justify not needing a recall.
Plasma products used in manufacture of other medicinal products:
case–by-case consideration depending on nature, amount,
point of use in the manufacturing process.
Leucoreduction
Not appropriate to recommend the introduction of
leucoreduction steps at this moment in plasma for fractionation
• At the moment, the benefit of leucoreduction to improve safety of
plasma not demonstrated.
• UK implemented in 1999 in transfusion.
SCMPMD opinion is that:
Transfusion: might be a precautionary step
Fractionation: no compelling scientific evidence to introduce to
reduce vCJD transmission
Studies in infected hamsters showed only 42-72% reduction of
infectivity
No effective complete removal in blood of BSE sheeps
Affinity filters
The efficacy for introduction of affinity media / filter is still
under investigation.
Animal studies showed clearance capabilities of filter, resin matrix.
Oct 09 SaBTO stated that:
there was sufficient evidence of infectivity reduction by affinity
ligand filters
recommended use in children born since 1-Jan-1996
subject to satisfactory completion PRISM clinical trial
Data on prion binding capacity of an affinity ligand chromatography
step in a plasma product has been published. Further evaluation is
considered needed prior to conclusions can be drawn on possible
efficacy.
Manufacturing processes
Recommendation of estimation the potential
to reduce infectivity of manuf. processes
Stepwise approach based on:
Available relevant published data
Product specific investigational studies
on key steps
using biochemical assays is sufficient if
correlation with infectivity data has been
established
Warning Statements on CJD and plasma products
Standard texts for Warning Statements (WS) on transmissible agents
in the Summary of Product Characteristics (SmPC) and
Package leaflet (PL) for blood products.
In 2003, it was not recommended to include a specific reference to CJD
as this would give impression of increased concern about potential
transmissibility by plasma products.
In 2011, this recommendation is reconfirmed
CJD risk is already covered in the general texts:
“Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents CANNOT BE TOTALLY EXCLUDED. This also applies to unknown or emerging viruses and other pathogens.
Overview
EMA Position Statement on plasma/urine products 2011
- Urine products: Recommendations
TSE Urine: Current status
Presence of PrP in human urine has been reported. No evidence
that infectivity is present.
Low levels of TSE infectivity detected in urine in animal models
by several groups (incl. scrapie-infected rodents, deer with CWD).
Epidemiological evidence (>25 yrs) of use of urine products does not
suggest a risk form sCJD.
No epidemiological evidence of CJD/vCJD transmission by urine
products
Urine: Recommendations
Urine to be collected from countries where there is TSE surveillance
system, unless otherwise justified.
Use of exclusion criteria in donor selection is encouraged.
Feasible to apply donor selection in small well-defined donor
population
• Hormones: already in place by some manufacturers
• Urokinase: more difficult to apply
Same exclusion criteria for CJD/vCJD as for plasma donors
Manufacturers should follow up the donor criteria at defined intervals
Manufacturers are required to estimate the
potential reduction capacity of their manufacturing
processes
Same general stepwise approach as for plasma
-Extrapolation of results on investigational studies
of certain steps of plasma products is not justified
-Investigational studies should address prion:
- potential accumulation in chromatographic columns
- batch-to-batch contamination due to carry over
-If reduction capacity is limited, manufacturers should
consider including additional steps
Record keeping for traceability encouraged
when possible to trace back to donor
Overview
EMA Position Statement on ATMPs
Position Statement on CJD / ATMPs
• ATMPs: gene therapy, cell therapy and tissue engineering
medicinal products
Gene therapy
medicinal
products
Cell based medicinal
products from
autologous donors
- No specific considerations,
- Risk assessment for potential TSE
contamination with components of
human origin used as excipients raw
materials
Position Statement on CJD / ATMPs
Cell based medicinal
products from
allogeic donors
- Case-by-risk assessment
- Normally there isn’t any TSE infectivity
reduction step in the manufacturing process
- TSE Safety of the products mainly
dependent on donor selection:
- Exclusion criteria for human tissues and cells Dir:
2006/17
- Where blood cells are used -> exclusion criteria on
donor selection and TSE in Directive 2004/33/EC apply
- Additional requirements may be implemented at the
level of MS taking into account scientific evidence and
impact on donated tissues/cells.
Acknowledgements
J. Blümel (Chair Blood/Urine) – PEI, DE
S. Ruiz (Chair ATMPs) – AEMPS, ES
K. Kluge – Bfarm, DE
J. Ironside - National CJD Surveillance Unit, UK
V. Irwin – IMB, IE
S. Janssen – RIVM, NL
M. Pocchiari – ISS, IT
M. Martin – AFSSAPs, FR
P. Minor – NIBSC, UK
G. Silvester – EMA, EU
A. Thomas – MHRA, UK
J.-H. Trouvin (Chair of EMA BWP) - AFSSAPS, FR
R. Will - National CJD Surveillance Unit, UK
snip...end...tss
Prion Disease Risks in the 21st Century 2011 PDA European Virus-TSE Safety
PDA: A Global Association
CJD and PLASMA / URINE PRODUCTS
CJD and ATMPs
EMA Position Statements
Alberto Ganan Jimenez, European Medicines Agency
TSE Safety Forum, 30 June 2011
Greetings again Sporadic CJD victims and families around the globe.
here, we see the writing on the wall. the what if’s, again ???
now this report does mention sporadic CJD. but nothing about new science showing links between atypical BSE and atypical Scrapie with sporadic CJD, and the fact that atypical BSE much more virulent, and that it has a 50% shorter incubation period than typical BSE, and the link to sporadic CJD ??? this should be very disturbing to all. ...
To date the OIE/WAHO assumes that the human and animal health standards set out in the BSE chapter for classical BSE (C-Type) applies to all forms of BSE which include the H-type and L-type atypical forms. This assumption is scientifically not completely justified and accumulating evidence suggests that this may in fact not be the case. Molecular characterization and the spatial distribution pattern of histopathologic lesions and immunohistochemistry (IHC) signals are used to identify and characterize atypical BSE. Both the L-type and H-type atypical cases display significant differences in the conformation and spatial accumulation of the disease associated prion protein (PrPSc) in brains of afflicted cattle. Transmission studies in bovine transgenic and wild type mouse models support that the atypical BSE types might be unique strains because they have different incubation times and lesion profiles when compared to C-type BSE. When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures.
Thursday, August 12, 2010
Seven main threats for the future linked to prions
First threat
The TSE road map defining the evolution of European policy for protection against prion diseases is based on a certain numbers of hypotheses some of which may turn out to be erroneous. In particular, a form of BSE (called atypical Bovine Spongiform Encephalopathy), recently identified by systematic testing in aged cattle without clinical signs, may be the origin of classical BSE and thus potentially constitute a reservoir, which may be impossible to eradicate if a sporadic origin is confirmed. ***Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases constitute an unforeseen first threat that could sharply modify the European approach to prion diseases.
Second threat
snip...
Monday, October 10, 2011
EFSA Journal 2011 The European Response to BSE: A Success Story
snip...
EFSA and the European Centre for Disease Prevention and Control (ECDC) recently delivered a scientific opinion on any possible epidemiological or molecular association between TSEs in animals and humans (EFSA Panel on Biological Hazards (BIOHAZ) and ECDC, 2011). This opinion confirmed Classical BSE prions as the only TSE agents demonstrated to be zoonotic so far but the possibility that a small proportion of human cases so far classified as "sporadic" CJD are of zoonotic origin could not be excluded. Moreover, transmission experiments to non-human primates suggest that some TSE agents in addition to Classical BSE prions in cattle (namely L-type Atypical BSE, Classical BSE in sheep, transmissible mink encephalopathy (TME) and chronic wasting disease (CWD) agents) might have zoonotic potential.
snip...
see follow-up here about North America BSE Mad Cow TSE prion risk factors, and the ever emerging strains of Transmissible Spongiform Encephalopathy in many species here in the USA, including humans ;
Thursday, January 26, 2012
The Risk of Prion Zoonoses
Science 27 January 2012: Vol. 335 no. 6067 pp. 411-413 DOI: 10.1126/science.1218167
Thursday, January 26, 2012
Facilitated Cross-Species Transmission of Prions in Extraneural Tissue
Science 27 January 2012:
Vol. 335 no. 6067 pp. 472-475
DOI: 10.1126/science.1215659
FC5.1.1
Transmission Results in Squirrel Monkeys Inoculated with Human sCJD, vCJD, and GSS Blood Specimens: the Baxter Study
Brown, P1; Gibson, S2; Williams, L3; Ironside, J4; Will, R4; Kreil, T5; Abee, C3 1Fondation Alliance BioSecure, France; 2University of South Alabama, USA; 3University of Texas MD Anderson Cancer Center, USA; 4Western General Hospital, UK; 5Baxter BioSience, Austria
Background: Rodent and sheep models of Transmissible Spongiform Encephalopathy (TSE) have documented blood infectivity in both the pre-clinical and clinical phases of disease. Results in a (presumably more appropriate) non-human primate model have not been reported.
Objective: To determine if blood components (red cells, white cells, platelets, and plasma) from various forms of human TSE are infectious.
Methods: Blood components were inoculated intra-cerebrally (0.1 ml) and intravenously (0.5 ml) into squirrel monkeys from 2 patients with sporadic Creutzfeldt- Jakob disease (sCJD) and 3 patients with variant Creutzfeldt-Jakob disease (vCJD). Additional monkeys were inoculated with buffy coat or plasma samples from chimpanzees infected with either sCJD or Gerstmann-Sträussler-Scheinker disease (GSS). Animals were monitored for a period of 5 years, and all dying or sacrificed animals had post-mortem neuropathological examinations and Western blots to determine the presence or absence of the misfolded prion protein (PrPTSE).
Results: No transmissions occurred in any of the animals inoculated with blood components from patients with sporadic or variant CJD. All donor chimpanzees (sCJD and GSS) became symptomatic within 6 weeks of their pre-clinical phase plasmapheresis, several months earlier than the expected onset of illness. One monkey inoculated with purified leukocytes from a pre-clinical GSS chimpanzee developed disease after 36 months.
Conclusion: No infectivity was found in small volumes of blood components from 4 patients with sporadic CJD and 3 patients with variant CJD. ***However, a single transmission from a chimpanzee-passaged strain of GSS shows that infectivity may be present in leukocytes, and the shock of general anaesthesia and plasmspheresis appears to have triggered the onset of illness in pre-clinical donor chimpanzees.
Saturday, September 5, 2009
TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS
snip...
Wednesday, June 29, 2011
TSEAC Meeting August 1, 2011 donor deferral Saudi Arabia vCJD risk blood and blood products
P.9.21 Molecular characterization of BSE in Canada
Jianmin Yang1, Sandor Dudas2, Catherine Graham2, Markus Czub3, Tim McAllister1, Stefanie Czub1 1Agriculture and Agri-Food Canada Research Centre, Canada; 2National and OIE BSE Reference Laboratory, Canada; 3University of Calgary, Canada
Background: Three BSE types (classical and two atypical) have been identified on the basis of molecular characteristics of the misfolded protein associated with the disease. To date, each of these three types have been detected in Canadian cattle.
Objectives: This study was conducted to further characterize the 16 Canadian BSE cases based on the biochemical properties of there associated PrPres.
Methods: Immuno-reactivity, molecular weight, glycoform profiles and relative proteinase K sensitivity of the PrPres from each of the 16 confirmed Canadian BSE cases was determined using modified Western blot analysis. Results: Fourteen of the 16 Canadian BSE cases were C type, 1 was H type and 1 was L type. The Canadian H and L-type BSE cases exhibited size shifts and changes in glycosylation similar to other atypical BSE cases. PK digestion under mild and stringent conditions revealed a reduced protease resistance of the atypical cases compared to the C-type cases. N terminal- specific antibodies bound to PrPres from H type but not from C or L type. The C-terminal-specific antibodies resulted in a shift in the glycoform profile and detected a fourth band in the Canadian H-type BSE.
Discussion: The C, L and H type BSE cases in Canada exhibit molecular characteristics similar to those described for classical and atypical BSE cases from Europe and Japan. This supports the theory that the importation of BSE contaminated feedstuff is the source of C-type BSE in Canada. *** It also suggests a similar cause or source for atypical BSE in these countries.
Saturday, July 23, 2011
CATTLE HEADS WITH TONSILS, BEEF TONGUES, SPINAL CORD, SPECIFIED RISK MATERIALS (SRM's) AND PRIONS, AKA MAD COW DISEASE
Saturday, November 6, 2010
TAFS1 Position Paper on Position Paper on Relaxation of the Feed Ban in the EU
Berne, 2010 TAFS INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a non-profit Swiss Foundation
Archive Number 20101206.4364 Published Date 06-DEC-2010 Subject PRO/AH/EDR>
Prion disease update 2010 (11) PRION DISEASE UPDATE 2010 (11)
October 2009 O.11.3 Infectivity in skeletal muscle of BASE-infected cattle
Silvia Suardi1, Chiara Vimercati1, Fabio Moda1, Ruggerone Margherita1, Ilaria Campagnani1, Guerino Lombardi2, Daniela Gelmetti2, Martin H. Groschup3, Anne Buschmann3, Cristina Casalone4, Maria Caramelli4, Salvatore Monaco5, Gianluigi Zanusso5, Fabrizio Tagliavini1 1Carlo Besta" Neurological Institute,Italy; 2IZS Brescia, Italy; 33FLI Insel Riems, D, Germany; 4CEA-IZS Torino, Italy; 5University of Verona, Italy
Background: BASE is an atypical form of bovine spongiform encephalopathy caused by a prion strain distinct from that of BSE. Upon experimental transmission to cattle, BASE induces a previously unrecognized disease phenotype marked by mental dullness and progressive atrophy of hind limb musculature. Whether affected muscles contain infectivity is unknown. This is a critical issue since the BASE strain is readily transmissible to a variety of hosts including primates, suggesting that humans may be susceptible.
Objectives: To investigate the distribution of infectivity in peripheral tissues of cattle experimentally infected with BASE. Methods: Groups of Tg mice expressing bovine PrP (Tgbov XV, n= 7-15/group) were inoculated both i.c. and i.p. with 10% homogenates of a variety of tissues including brain, spleen, cervical lymph node, kidney and skeletal muscle (m. longissimus dorsi) from cattle intracerebrally infected with BASE. No PrPres was detectable in the peripheral tissues used for inoculation either by immunohistochemistry or Western blot.
Results: Mice inoculated with BASE-brain homogenates showed clinical signs of disease with incubation and survival times of 175±15 and 207±12 days. Five out of seven mice challenged with skeletal muscle developed a similar neurological disorder, with incubation and survival times of 380±11 and 410±12 days. At present (700 days after inoculation) mice challenged with the other peripheral tissues are still healthy. The neuropathological phenotype and PrPres type of the affected mice inoculated either with brain or muscle were indistinguishable and matched those of Tgbov XV mice infected with natural BASE.
Discussion: Our data indicate that the skeletal muscle of cattle experimentally infected with BASE contains significant amount of infectivity, at variance with BSE-affected cattle, raising the issue of intraspecies transmission and the potential risk for humans. Experiments are in progress to assess the presence of infectivity in skeletal muscles of natural BASE.
18.173 page 189
Experimental Challenge of Cattle with H-type and L-type Atypical BSE
A. Buschmann1, U. Ziegler1, M. Keller1, R. Rogers2, B. Hills3, M.H. Groschup1. 1Friedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany, 2Health Canada, Bureau of Microbial Hazards, Health Products & Food Branch, Ottawa, Canada, 3Health Canada, Transmissible Spongiform Encephalopathy Secretariat, Ottawa, Canada
Background: After the detection of two novel BSE forms designated H-type and L-type atypical BSE the question of the pathogenesis and the agent distribution of these two types in cattle was fully open. From initial studies of the brain pathology, it was already known that the anatomical distribution of L-type BSE differs from that of the classical type where the obex region in the brainstem always displays the highest PrPSc concentrations. In contrast in L-type BSE cases, the thalamus and frontal cortex regions showed the highest levels of the pathological prion protein, while the obex region was only weakly involved.
Methods:We performed intracranial inoculations of cattle (five and six per group) using 10%brainstemhomogenates of the two German H- and L-type atypical BSE isolates. The animals were inoculated under narcosis and then kept in a free-ranging stable under appropriate biosafety conditions.At least one animal per group was killed and sectioned in the preclinical stage and the remaining animals were kept until they developed clinical symptoms. The animals were examined for behavioural changes every four weeks throughout the experiment following a protocol that had been established during earlier BSE pathogenesis studies with classical BSE. Results and
Discussion: All animals of both groups developed clinical symptoms and had to be euthanized within 16 months. The clinical picture differed from that of classical BSE, as the earliest signs of illness were loss of body weight and depression. However, the animals later developed hind limb ataxia and hyperesthesia predominantly and the head. Analysis of brain samples from these animals confirmed the BSE infection and the atypical Western blot profile was maintained in all animals. Samples from these animals are now being examined in order to be able to describe the pathogenesis and agent distribution for these novel BSE types.
Conclusions: A pilot study using a commercially avaialble BSE rapid test ELISA revealed an essential restriction of PrPSc to the central nervous system for both atypical BSE forms. A much more detailed analysis for PrPSc and infectivity is still ongoing.
Saturday, November 19, 2011
Novel Prion Protein in BSE-affected Cattle, Switzerland
Saturday, December 3, 2011
Isolation of Prion with BSE Properties from Farmed Goat Volume 17, Number 12—December 2011
Saturday, June 25, 2011
Transmissibility of BSE-L and Cattle-Adapted TME Prion Strain to Cynomolgus Macaque
"BSE-L in North America may have existed for decades"
Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME.
snip...
The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle...
14th ICID International Scientific Exchange Brochure -
Final Abstract Number: ISE.114
Session: International Scientific Exchange
Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009
T. Singeltary
Bacliff, TX, USA
Background:
An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and fed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.
Methods:
12 years independent research of available data
Results:
I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.
Conclusion:
I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.
see where sporadic CJD cases went from 28 cases in 1990, to a high in 2008 of 88 cases of sporadic CJD, then 2009 dropped back a bit to 78 cases, and then in 2010 the sporadic CJD cases were back up to 84 cases. with a small rise in GSS and Familial cases of human TSE as well, through that time period ???
CJD Figures
These figures show the number of suspect cases referred to the NCJDRSU in Edinburgh, and the number of deaths of definite and probable cases in the UK, from 1 January 1990 up to 4th January 2012
see here ;
SO, we have atypical BSE and atypical Scrapie cases rising, we have sporadic CJD now linked to atypical BSE cases and atypical scrapie cases, and this report does not mention that $$$
BSe, and politics as usual $$$
2011 Monday, September 26, 2011
L-BSE BASE prion and atypical sporadic CJD
Tuesday, November 08, 2011
Can Mortality Data Provide Reliable Indicators for Creutzfeldt-Jakob Disease Surveillance? A Study in France from 2000 to 2008
Vol. 37, No. 3-4, 2011 Original Paper Conclusions:These findings raise doubt about the possibility of a reliable CJD surveillance only based on mortality data.
Terry S. Singeltary Sr. on the Creutzfeldt-Jakob Disease Public Health Crisis
full text with source references ;
CANADA CJD UPDATE 2011
CJD Deaths Reported by CJDSS1, 1994-20112 As of January 31, 2011
3. Final classification of 49 cases from 2009, 2010, 2011 is pending.
snip...
USA 2011
USA
National Prion Disease Pathology Surveillance Center
Cases Examined1
(November 1, 2010)
Year Total Referrals2 Prion Disease Sporadic Familial Iatrogenic vCJD
1996 & earlier 51 33 28 5 0 0
1997 114 68 59 9 0 0
1998 87 51 43 7 1 0
1999 121 73 65 8 0 0
2000 146 103 89 14 0 0
2001 209 119 109 10 0 0
2002 248 149 125 22 2 0
2003 274 176 137 39 0 0
2004 325 186 164 21 0 13
2005 344 194 157 36 1 0
2006 383 197 166 29 0 24
2007 377 214 187 27 0 0
2008 394 231 205 25 0 0
2009 425 258 215 43 0 0
2010 333 213 158 33 0 0
TOTAL 38315 22656 1907 328 4 3
1 Listed based on the year of death or, if not available, on year of referral;
2 Cases with suspected prion disease for which brain tissue and/or blood (in familial cases) were submitted;
3 Disease acquired in the United Kingdom;
4 Disease was acquired in the United Kingdom in one case and in Saudi Arabia in the other case;
5 Includes 18 cases in which the diagnosis is pending, and 18 inconclusive cases;
6 Includes 23 (22 from 2010) cases with type determination pending in which the diagnosis of vCJD has been excluded.
Please notice where sporadic CJD cases in 1996 went from 28 cases, to 215 cases in 2009, the highest recorded year to date. sporadic CJD is on a steady rise, and has been since 1996.
I also urge you to again notice these disturbing factors in lines 5 and 6 ;
5 Includes 18 cases in which the diagnosis is pending, and 18 inconclusive cases;
6 Includes 23 (22 from 2010) cases with type determination pending in which the diagnosis of vCJD has been excluded.
========end=====tss=====2011
Monday, August 9, 2010
National Prion Disease Pathology Surveillance Center Cases Examined (July 31, 2010)
(please watch and listen to the video and the scientist speaking about atypical BSE and sporadic CJD and listen to Professor Aguzzi)
THE steady rise of sporadic CJD cases in Canada AND USA, with many unusual cases of ''PENDING CLASSIFICATIONS" which have been pending now FOR 3 YEARS. HOW long can this cover-up continue $$$
The most recent assessments (and reassessments) were published in June 2005 (Table I; 18), and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.
SEE FULL TEXT AND MORE HERE ;
Saturday, March 5, 2011
MAD COW ATYPICAL CJD PRION TSE CASES WITH CLASSIFICATIONS PENDING ON THE RISE IN NORTH AMERICA
Tuesday, November 08, 2011
Can Mortality Data Provide Reliable Indicators for Creutzfeldt-Jakob Disease Surveillance?
A Study in France from 2000 to 2008 Vol. 37, No. 3-4, 2011
Original Paper
Conclusions:These findings raise doubt about the possibility of a reliable CJD surveillance only based on mortality data.
Tuesday, January 31, 2012
MM2-thalamic Creutzfeldt-Jakob disease: neuropathological, biochemical and transmission studies identify a distinctive prion strain
Monday, January 30, 2012
The First Report of a Patient with Probable Variant Creutzfeldt-Jakob Disease in Turkey
Dement Geriatr Cogn Dis Extra. 2011 Jan-Dec; 1(1): 429–432. Published online 2011 December 24. doi: 10.1159/000332024 PMCID: PMC3265806
Thursday, December 08, 2011
A case of Iatrogenic Creutzfeldt Jakob Disease (iCJD) in a patient who had received a German-manufactured human dura mater graft 23 years ago
Second iatrogenic CJD case confirmed Korea
http://creutzfeldt-jakob-disease.blogspot.com/2011/12/second-iatrogenic-cjd-case-confirmed.html
Saturday, December 18, 2010
First probable human case of mad cow disease in Taiwan was listed posthumously 2010/12/18 21:14:28
Thursday, November 25, 2010
Probable variant Creutzfeldt-Jakob disease in Asia: A case report from Taiwan and review of two prior cases
Tuesday, January 5, 2010
JOINT STATEMENT FROM USTR, USDA ON TAIWAN'S ACTIONS TO UNJUSTIFIABLY RESTRICT U.S. BEEF IMPORTS IN VIOLATION OF OUR BILATERAL AGREEMENT Release No. 0002.10 Contact: USTR, Nefeterius McPherson (202) 395-3230 USDA, Caleb Weaver (202) 720-4623
Tuesday, December 29, 2009
Taiwan to resume USA beef ban over mad cow disease threat
Friday, January 20, 2012
South Korea Lifts Canadian Beef Ban
Saturday, December 18, 2010
OIE Global Conference on Wildlife Animal Health and Biodiversity - Preparing for the Future (TSE AND PRIONS) Paris (France), 23-25 February 2011
The most recent assessments (and reassessments) were published in June 2005 (Table I; 18), and included the categorisation of Canada, the USA, and Mexico as GBR III.
Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.
Saturday, January 21, 2012
Quick facts about mad cow disease (all the facts, to date)
CWD TSE PRION UPDATE JANUARY 26, 2012
Tuesday, January 24, 2012
CWD found in two free-ranging deer from Macon County Missouri
Tuesday, December 20, 2011
CHRONIC WASTING DISEASE CWD WISCONSIN Almond Deer (Buckhorn Flats) Farm Update DECEMBER 2011
Monday, January 16, 2012
9 GAME FARMS IN WISCONSIN TEST POSITIVE FOR CWD
Wednesday, January 04, 2012
CWD NEBRASKA NGPC 26 DEER CARCASSES TESTED POSITIVE BUFFALO, CUSTER AND HOLT COUNTIES DURING NOVEMBER HUNT
Saturday, December 31, 2011
Depopulation Plan Being Developed for Captive Deer Facility in Macon County after second CWD positive confirmation
Wednesday, December 21, 2011
CWD UTAH San Juan deer hunting unit
Monday, November 14, 2011
WYOMING Creutzfeldt Jakob Disease, CWD, TSE, PRION REPORTING 2011
Wednesday, November 16, 2011
Wisconsin Creutzfeldt Jakob Disease, CWD, TSE, PRION REPORTING 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2011/11/wisconsin-creutzfeldt-jakob-disease-cwd.html
Sunday, November 13, 2011
Sunday, January 22, 2012
Chronic Wasting Disease CWD cervids interspecies transmission
Thursday, December 29, 2011
Aerosols An underestimated vehicle for transmission of prion diseases?
PRION www.landesbioscience.com please see more on Aerosols and TSE prion disease here ;. ...
Wednesday, January 18, 2012
BSE IN GOATS CAN BE MISTAKEN FOR SCRAPIE
February 1, 2012
Thursday, January 26, 2012
The Risk of Prion Zoonoses
Science 27 January 2012: Vol. 335 no. 6067 pp. 411-413 DOI: 10.1126/science.1218167
Thursday, January 26, 2012
Facilitated Cross-Species Transmission of Prions in Extraneural Tissue
Science 27 January 2012:
Vol. 335 no. 6067 pp. 472-475
DOI: 10.1126/science.1215659
Sunday, January 29, 2012
Prion Disease Risks in the 21st Century 2011 PDA European Virus-TSE Safety Dr. Detwiler
Dr. Detwiler published Prion Disease Risks in the 21st Century 2011 PDA European Virus-TSE Safety Forum\Presentations TSE\ Page 33 and 34 of 44 ;
Wednesday, February 1, 2012
Prion Disease Risks in the 21st Century 2011 PDA European Virus-TSE Safety Update on CJD and VCJD Transmission RG Will
FDA NVCJD BLOOD LATEST RECALLS
PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-0576-7; b) Red Blood Cells, Recall # B-0577-7; c) Fresh Frozen Plasma, Recall # B-0578-7; d) Recovered Plasma, Recall # B-0579-7 CODE a) Units: 4588939, 4685381,4800041, 4892978, 4882799, 4883439, 4956157; b) Unit: 4662465; c) Units: 4800041, 4883439; d) Units: 4588939, 4662465, 4685381, 4800041, 4892978, 4882799, 4956157 RECALLING FIRM/MANUFACTURER Recalling Firm: Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on March 11, 2005. 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 17 units DISTRIBUTION OK, MS, MI, CA, and Switzerland ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-0580-7; b) Recovered Plasma, Recall # B-0581-7 CODE a) and b) Unit: 5346932 RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on October 27, 2005. 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 2 units DISTRIBUTION OK and Switzerland
______________________________ PRODUCT a) Red Blood Cells Leukocytes, Recall # B-0582-7; b) Recovered Plasma, Recall # B-0583-7 CODE a) and b) Unit: 5208304 RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on April 20, 2006. Firm initiated recall is complete. REASON Blood products, collected from a donor considered to be at increased riskfor variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION OK and Switzerland
______________________________ PRODUCT Source Plasma, Recall # B-0585-7 CODE Units: 02JWIB9722, 02JWIC0263, 02JWIC0607, 02JWIC4253, 02JWIC4904, 02JWIC5216, 02JWID2018, 02JWID2958, 02JWID3310, 02JWID8505, 02JWID8842, 02JWID9390, 02JWID9844, 02JWIE0468, 02JWIE0836, 02JWIE1435, 02JWIE1812, 02JWIE2609, 02JWIE3289, 02JWIE3887, 02JWIE4309, 02JWIE4818, 02JWIE5277, 02JWIE5825, 03JWIA0857, 03JWIA1249, 03JWIA1850, 03JWIA2192, 03JWIA2825, 03JWIA3180, 03JWIA3724, 03JWIA4092, 03JWIA4691, 03JWIA5042, 03JWIA5586, 02JWIC1157, 02JWIC1458, 02JWIC2095, 02JWIC2551, 02JWIC3031, 02JWIC3491, 02JWIC3975, 02JWIC6689, 02JWIC7051, 02JWIC7609, 02JWIC7898, 02JWIC8547, 02JWIC8906, 02JWIC9494, 02JWIC9793, 02JWID0630, 02JWID1144, 02JWID1592, 02JWID3884, 02JWID4247, 02JWID4827, 02JWID5189, 02JWID5713, 02JWID6578, 02JWID6926, 02JWID7624, 02JWID7970 RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Janesville, WI, by fax on April 7, 2003. 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 62 units DISTRIBUTION MI and Austria
______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-0586-7; b) Recovered Plasma, Recall # B-0587-7 CODE a) and b) Unit: 4499508 RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on February 27, 2006. 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 2 units DISTRIBUTION OK and Switzerland
______________________________
PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0644-7; b) Recovered Plasma, Recall # B-0645-7 CODE a) and b) Units: 5219381, 4759725 RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on December 3, 2005 or by electronic notification on December 4, 2005. 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 4 units DISTRIBUTION OK, VA, and Switzerland
______________________________
END OF ENFORCEMENT REPORT FOR JANUARY 17, 2007
###
http://www.fda.gov/bbs/topics/enforce/2007/ENF00987.html
----- Original Message ----- From: Terry S. Singeltary Sr. To: FREAS@CBER.FDA.GOV Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov Sent: Wednesday, November 29, 2006 1:24 PM Subject: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION]
November 29, 2006
Greetings FDA, DHH, Dr. Freas, and Dr. Harvey et al,
a kind and warm Holiday Greetings to you all.
i kindly wish to submit the following to the TSE advisory committee for the meeting December 15, 2006, about the assessment for potential exposure to vCJD in human plasma-derived antihemophilic factor (FVIII) products manufactured from U.S. plasma donors and related communication material ;
http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-20251.htm
i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;
http://www.newsday.com/news/health/ats-ap_health14nov27,0,7955259.story?coll=ny-leadhealthnews-headlines
however, i seem to disagree. from my primitive ciphering, i see it another way. this is a huge catastrophic risk. 3 in 160 is 1.9%. so call that 2% which is 1 in 50 or twenty per thousand or 20,000 per million. also, what about the mixed genotypes/mixed susceptibility? what about the silent carriers that donated tainted blood? what about the sporadic CJDs of UNKNOWN strain or phenotype? this risk assessment is just more BSe to me. just another in a long line of industry fed crap. i pray that my assessment is the one that is wrong. but it is THEY who roll the dice with your life. it is THEY who refuse to regulate an industry that has run amok. just from a recall aspect of potentially tainted blood, and these are just recent recalls ;
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/2006/ENF00975.html
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;
SNIP...END
----- Original Message ----- From: Terry S. Singeltary Sr. To: FREAS@CBER.FDA.GOV Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov Sent: Friday, December 01, 2006 2:59 PM Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION PART III]
Lancet Neurology DOI:10.1016/S1474-4422(06)70413-6
Predicting susceptibility and incubation time of human-to-human transmission of vCJD
PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-0576-7; b) Red Blood Cells, Recall # B-0577-7; c) Fresh Frozen Plasma, Recall # B-0578-7; d) Recovered Plasma, Recall # B-0579-7 CODE a) Units: 4588939, 4685381,4800041, 4892978, 4882799, 4883439, 4956157; b) Unit: 4662465; c) Units: 4800041, 4883439; d) Units: 4588939, 4662465, 4685381, 4800041, 4892978, 4882799, 4956157 RECALLING FIRM/MANUFACTURER Recalling Firm: Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on March 11, 2005. 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 17 units DISTRIBUTION OK, MS, MI, CA, and Switzerland ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-0580-7; b) Recovered Plasma, Recall # B-0581-7 CODE a) and b) Unit: 5346932 RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on October 27, 2005. 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 2 units DISTRIBUTION OK and Switzerland
______________________________ PRODUCT a) Red Blood Cells Leukocytes, Recall # B-0582-7; b) Recovered Plasma, Recall # B-0583-7 CODE a) and b) Unit: 5208304 RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on April 20, 2006. Firm initiated recall is complete. REASON Blood products, collected from a donor considered to be at increased riskfor variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION OK and Switzerland
______________________________ PRODUCT Source Plasma, Recall # B-0585-7 CODE Units: 02JWIB9722, 02JWIC0263, 02JWIC0607, 02JWIC4253, 02JWIC4904, 02JWIC5216, 02JWID2018, 02JWID2958, 02JWID3310, 02JWID8505, 02JWID8842, 02JWID9390, 02JWID9844, 02JWIE0468, 02JWIE0836, 02JWIE1435, 02JWIE1812, 02JWIE2609, 02JWIE3289, 02JWIE3887, 02JWIE4309, 02JWIE4818, 02JWIE5277, 02JWIE5825, 03JWIA0857, 03JWIA1249, 03JWIA1850, 03JWIA2192, 03JWIA2825, 03JWIA3180, 03JWIA3724, 03JWIA4092, 03JWIA4691, 03JWIA5042, 03JWIA5586, 02JWIC1157, 02JWIC1458, 02JWIC2095, 02JWIC2551, 02JWIC3031, 02JWIC3491, 02JWIC3975, 02JWIC6689, 02JWIC7051, 02JWIC7609, 02JWIC7898, 02JWIC8547, 02JWIC8906, 02JWIC9494, 02JWIC9793, 02JWID0630, 02JWID1144, 02JWID1592, 02JWID3884, 02JWID4247, 02JWID4827, 02JWID5189, 02JWID5713, 02JWID6578, 02JWID6926, 02JWID7624, 02JWID7970 RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Janesville, WI, by fax on April 7, 2003. 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 62 units DISTRIBUTION MI and Austria
______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-0586-7; b) Recovered Plasma, Recall # B-0587-7 CODE a) and b) Unit: 4499508 RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on February 27, 2006. 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 2 units DISTRIBUTION OK and Switzerland
______________________________
PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0644-7; b) Recovered Plasma, Recall # B-0645-7 CODE a) and b) Units: 5219381, 4759725 RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on December 3, 2005 or by electronic notification on December 4, 2005. 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 4 units DISTRIBUTION OK, VA, and Switzerland
______________________________
END OF ENFORCEMENT REPORT FOR JANUARY 17, 2007
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http://www.fda.gov/bbs/topics/enforce/2007/ENF00987.html
----- Original Message ----- From: Terry S. Singeltary Sr. To: FREAS@CBER.FDA.GOV Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov Sent: Wednesday, November 29, 2006 1:24 PM Subject: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION]
November 29, 2006
Greetings FDA, DHH, Dr. Freas, and Dr. Harvey et al,
a kind and warm Holiday Greetings to you all.
i kindly wish to submit the following to the TSE advisory committee for the meeting December 15, 2006, about the assessment for potential exposure to vCJD in human plasma-derived antihemophilic factor (FVIII) products manufactured from U.S. plasma donors and related communication material ;
http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-20251.htm
i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;
http://www.newsday.com/news/health/ats-ap_health14nov27,0,7955259.story?coll=ny-leadhealthnews-headlines
however, i seem to disagree. from my primitive ciphering, i see it another way. this is a huge catastrophic risk. 3 in 160 is 1.9%. so call that 2% which is 1 in 50 or twenty per thousand or 20,000 per million. also, what about the mixed genotypes/mixed susceptibility? what about the silent carriers that donated tainted blood? what about the sporadic CJDs of UNKNOWN strain or phenotype? this risk assessment is just more BSe to me. just another in a long line of industry fed crap. i pray that my assessment is the one that is wrong. but it is THEY who roll the dice with your life. it is THEY who refuse to regulate an industry that has run amok. just from a recall aspect of potentially tainted blood, and these are just recent recalls ;
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/2006/ENF00975.html
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;
SNIP...END
----- Original Message ----- From: Terry S. Singeltary Sr. To: FREAS@CBER.FDA.GOV Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov Sent: Friday, December 01, 2006 2:59 PM Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION PART III]
Lancet Neurology DOI:10.1016/S1474-4422(06)70413-6
Predicting susceptibility and incubation time of human-to-human transmission of vCJD
snip... see full text here ;
Thursday, January 26, 2012
Prionemia and Leukocyte-Platelet-Associated Infectivity in Sheep Transmissible Spongiform Encephalopathy Models
Wednesday, August 24, 2011
All Clinically-Relevant Blood Components Transmit Prion Disease following a Single Blood Transfusion: A Sheep Model of vCJD
Wednesday, August 24, 2011
There Is No Safe Dose of Prions
Tuesday, September 14, 2010
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)
Monday, February 7, 2011
FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???
Friday, March 25, 2011
Detection of Prion Protein in Urine-Derived Injectable Fertility Products by a Targeted Proteomic Approach
Sunday, December 18, 2011
A blood test for variant Creutzfeldt‐Jakob disease: briefing note for patients, carers and health professionals
TSS
