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From: TSS ()
Subject: Department of Health publishes new reports on VCJD
Date: March 28, 2007 at 7:26 am PST

Date: March 28, 2007 Time: 12:15

Department of Health publishes new reports on VCJD

Two new reports on vCJD (variant Creutzfeldt-Jakob Disease) have been published today as part of on-going work to manage the risks associated with the disease.

The first was commissioned by the Department of Health and produced by the specially convened vCJD Clinical Governance Advisory Group (CGAG). Chaired by Sir William Stewart, it proposes the creation of patient-focused clinical governance arrangements to standardise the care that patients at risk of vCJD receive across the country. It recommends that GPs should take the lead in commissioning care for them, supported by consultant neurologists and specialist centres such as the National CJD Surveillance Unit and the National Prion Clinic.

The second report, commissioned on behalf of the Department of Health by the Health Protection Agency, examines attitudes of key stakeholders towards the possible future introduction of a vCJD test for blood donations. The findings highlight a number of issues around the potential introduction of such a test, particularly the level of accuracy that would be required; whether and how to notify those who have been tested of the results; extending the test beyond blood donors; and whether testing might affect people's willingness to donate blood.

Public Health Minister Caroline Flint said:

"We continue to monitor all aspects of vCJD very carefully, and it is timely to review support arrangements for those individuals at risk of developing the disease. Although the current arrangements for support have worked well, the CGAG report has highlighted the importance of standardising those arrangements across the whole country.

"We are also preparing for the possible availability of a test for vCJD. Whilst such a test could be valuable in helping to identify people who may be at risk, the report, published today by the Health Protection Agency, highlights some of the ethical and practical questions we are facing, both in terms of supporting the people affected, and protecting the public."

Sir William Stewart, Chairman of the CGAG, said:

"The Department of Health wisely takes a precautionary approach in dealing with the potential for vCJD infection, as there are still many gaps in our knowledge about the disease. I hope that the CGAG report provides a framework for the services available to those who, through a variety of routes, may be at potential risk of vCJD.

"It is important that the individuals affected are supported by their local GP and that they have access to more specialist sources of support, but also to participate in research opportunities, should they wish to do so."

To ensure appropriate levels of public health protection and support for individuals it is important to understand the prevalence of vCJD infection. To this end, the Health Protection Agency is currently analysing samples from the National Anonymised Tonsil Archive, and the Department of Health expects a report shortly on the potential for establishing a post mortem tissue archive to study the prevalence of vCJD.

Notes to editors:

1. Both reports can be found on-line at www.dh.gov.uk

2. Creutzfeldt-Jakob Disease (CJD) is one of a group of diseases called Transmissible Spongiform Encephalopathies. All of these diseases can have a very long incubation period, cause severe and irreversible damage to the central nervous system. There are so far no proven effective treatments.

3. vCJD was first identified in 1996 and affects younger people. Variant CJD patients show signs of behavioural disorder, depression and anxiety followed by problems with sensation and co-ordination, leading to progressive dementia and death over a period of six months to two years. The clinical, epidemiological, neuropathological and experimental data all point to variant CJD being caused by the same strain of prion as Bovine Spongiform Encephalopathy (BSE).

4. There have been four known instances of vCJD transmission through the blood supply: three of the recipients developed clinical vCJD, while the other died of unrelated causes. Although there is currently no approved blood test available, work is urgently under way to develop one and to find new ways to reduce the risks of transmission by filtering donated blood.

5. The report refers to the following as "people at risk":

- Recipients of blood components donated by people who later developed vCJD.

- Recipients of certain plasma products (clotting factors).

- Blood donors to patients who later developed vCJD.

6. For enquiries please contact 020 7210 4850.

http://www.wired-gov.net/WGLaunch.aspx?ARTCL=44998


USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN

18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.

Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...

http://www.seac.gov.uk/minutes/95.pdf


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.

***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.***


6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html

There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf


Thursday, March 15, 2007

Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD)
From Plasma-Derived Products

In recent years, questions have been raised concerning the potential risk of variant Creutzfeldt-Jakob disease (vCJD - a rare but fatal brain infection) for recipients of plasma- derived clotting factors, including United States (US) licensed Factor Eight (pdFVIII), Factor Nine (pdFIX), and other plasma-derived products such as immune globulins and albumin. In response to these questions, FDA conducted a risk assessment. Based on the risk assessment, the US Public Health Service believes that the risk of vCJD to patients who receive US licensed pdFVIII products is most likely to be extremely small, although we do not know the risk with certainty. vCJD risk from other plasma derived products, including Factor IX, is likely to be as small or smaller.

This web page provides FDA’s risk assessment for US licensed pdFVIII and risk communication materials for this product and other plasma derivatives. Included are Key Points, and Questions and Answers. Additional links are provided to FDA’s current guidance documents on deferral of blood and plasma donors who may be at increased risk of vCJD, and to other sources of information regarding vCJD.

Documents Regarding US Licensed pdFVIII, and Other US Licensed Plasma Derivatives Including pdFIX

Potential vCJD Risk From US Licensed Plasma-Derived Factor VIII (pdFVIII, Antihemophilic Factor) Products: Summary Information, Key Points
Risk Assessment (PDF, 582 KB)
Risk Assessment Appendix (PDF, 623 KB)
Questions and Answers on vCJD and pdFVIII
Questions and Answers on vCJD and Plasma Derivatives Other than pdFVIII
Guidance on Donor Deferral Related to CJD and vCJD

Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products" - 8/2006
Questions and Answers on FDA Guidance: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob (CJD) Disease and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products - 1/22/2004
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products - 1/2002
Other Sources of Information

Transmissible Spongiform Encephalopathies Advisory Committee
Blood Products Advisory Committee Meeting – Summary of Recent TSEAC Meeting and Statement about FXI from the UK, on October 21, 2004
Information on vCJD: Centers for Disease Control and Prevention
Information on Bovine Spongiform Encephalopathy (“Mad Cow Disease”): US Department of Agriculture
Patient Organizations:

Committee of Ten Thousand
Hemophilia Federation of America
National Hemophilia Foundation and/or HANDI
World Federation of Hemophilia

http://www.fda.gov/cber/blood/vcjdrisk.htm

PRODUCT
Recovered Plasma, Recall # B-0854-07
CODE
Unit: V10665
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by email on August 25, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

END OF ENFORCEMENT REPORT FOR MARCH 14, 2007

###

http://www.fda.gov/bbs/topics/enforce/2007/ENF00995.html

nvCJD mad cow blood recalls ENFORCEMENT REPORT FOR MARCH 7, 2007

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0805-07;
b) Platelets, Recall # B-0806-07;
c) Recovered Plasma, Recall # B-0807-07
CODE
a) Units: 4759943, 4677574, 4555912;
b) Units: 4759943, 4555912;
c) Units: 4677574, 4555912
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 20, 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
7 units
DISTRIBUTION
MA, OK, TX, and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0808-07;
b) Platelets, Recall # B-0809-07;
c) Recovered Plasma, Recall # B-0810-07
CODE
a), b), and c) Unit: 5249546
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N, Goldman Center, Oklahoma City, OK, by facsimile on August 1, 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
3 units
DISTRIBUTION
OK, NB, and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0811-07;
b) Recovered Plasma, Recall # B-0812-07
CODE
a) and b) Unit: 5218775
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N, Goldman Center, Oklahoma City, OK, by facsimile on July 7, 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
2 units
DISTRIBUTION
OK and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0826-07;
b) Platelets, Recall # B-0827-07;
c) Fresh Frozen Blood, Recall # B-0828-07;
d) Recovered Plasma, Recall # B-0829-07
CODE
a) Units: 5250527, 4901850, 4517058;
b) Units: 4901850, 4517058;
c) Unit: 4517058;
d) Units: 5250527, 4901850
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 27, 2006. 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
8 units
DISTRIBUTION
OK, TX, Austria, and Switzerland

___________________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0843-07;
b) Recovered Plasma, Recall # B-0844-07
CODE
a) and b) Units: 5738052, 5275313, 4801421
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on January 22, 2006. 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
6 units
DISTRIBUTION
TX, OK, and Switzerland

END OF ENFORCEMENT REPORT FOR MARCH 7, 2007

###

http://www.fda.gov/bbs/topics/enforce/2007/ENF00994.html

4th CASE VCJD VIA BLOOD TRANSFUSION, BSE, BASE, AND SPORADIC CJD

By Terry S Singeltary

Bacliff, Texas USA Jan 24, 07


http://bloodindex.org/view_news_zone.php?id=206


PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf


----- Original Message -----
From: Terry S. Singeltary Sr.
To: Terry S. Singeltary Sr. ; [log in to unmask]
Cc: [log in to unmask] ; [log in to unmask]
Sent: Thursday, November 30, 2006 1:47 PM
Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION PART II]


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&P=16159


part 1


http://bsw-uiuc.net/phpBB2/viewtopic.php?p=354&sid=971c807e383ef9e5f99ffff9da002535


THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ;


CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006


The U.S. Department of Agriculture was quick to assure the public earlier
this week that the third case of mad cow disease did not pose a risk to
them, but what federal officials have not acknowledged is that this latest
case indicates the deadly disease has been circulating in U.S. herds for at
least a decade.

The second case, which was detected last year in a Texas cow and which USDA
officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a
picture of the disease having been here for 10 years or so, since it is
thought that cows usually contract the disease from contaminated feed they
consume as calves. The concern is that humans can contract a fatal,
incurable, brain-wasting illness from consuming beef products contaminated
with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of
other undetected cases," Dr. Paul Brown, former medical director of the
National Institutes of Health's Laboratory for Central Nervous System
Studies and an expert on mad cow-like diseases, told United Press
International. "The question was, 'How many?' and we still can't answer
that."

Brown, who is preparing a scientific paper based on the latest two mad cow
cases to estimate the maximum number of infected cows that occurred in the
United States, said he has "absolutely no confidence in USDA tests before
one year ago" because of the agency's reluctance to retest the Texas cow
that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven
months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005
suspect," Brown said. ...snip...end


http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r


CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central
Nervous System ... Address for correspondence: Paul Brown, Building 36, Room
4A-05, ...


http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm

PAUL BROWN COMMENT TO ME ON THIS ISSUE

Tuesday, September 12, 2006 11:10 AM


"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."


OR, what the Honorable Phyllis Fong of the OIG found ;


Audit Report

Animal and Plant Health Inspection Service

Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II

and

Food Safety and Inspection Service

Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III

Report No. 50601-10-KC January 2006

Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain


http://www.usda.gov/oig/webdocs/50601-10-KC.pdf


EXPORTATION AND IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS:
BSE; MRR AND IMPORTATION OF COMMODITIES, 65758-65759 [E6-19042]

http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&T=0&P=3854


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&P=3381


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=498


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0702&L=sanet-mg&T=0&P=10277


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&T=0&P=9972


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=4492


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=2583


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=2470


Re: RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States


Email Terry S. Singeltary:


flounder@wt.net

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to

comment on the CDC's attempts to monitor the occurrence of emerging

forms of CJD. Asante, Collinge et al [1] have reported that BSE

transmission to the 129-methionine genotype can lead to an alternate

phenotype that is indistinguishable from type 2 PrPSc, the commonest

sporadic CJD. However, CJD and all human TSEs are not reportable

nationally. CJD and all human TSEs must be made reportable in every

state and internationally. I hope that the CDC does not continue to

expect us to still believe that the 85%+ of all CJD cases which are

sporadic are all spontaneous, without route/source. We have many TSEs in

the USA in both animal and man. CWD in deer/elk is spreading rapidly and

CWD does transmit to mink, ferret, cattle, and squirrel monkey by

intracerebral inoculation. With the known incubation periods in other

TSEs, oral transmission studies of CWD may take much longer. Every

victim/family of CJD/TSEs should be asked about route and source of this

agent. To prolong this will only spread the agent and needlessly expose

others. In light of the findings of Asante and Collinge et al, there

should be drastic measures to safeguard the medical and surgical arena

from sporadic CJDs and all human TSEs. I only ponder how many sporadic

CJDs in the USA are type 2 PrPSc?


http://www.neurology.org/cgi/eletters/60/2/176#535

LANCET INFECTIOUS DISEASE JOURNAL


Volume 3, Number 8 01 August 2003


Newsdesk


Tracking spongiform encephalopathies in North America


Xavier Bosch

My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost

my mom to hvCJD (Heidenhain variant CJD) and have been searching for

answers ever since. What I have found is that we have not been told the

truth. ...


http://infection.thelancet.com/journal/journal.isa


Full Text

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.
P.O. Box 42
Bacliff, Texas USA 77518




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