Saturday, June 22, 2013

Scare over mad cow disease was big stampede about nothing

 

 

From: Terry S. Singeltary Sr. Sent: Saturday, June 22, 2013 12:49 PM To: BSE-L@LISTS.AEGEE.ORG Subject: [BSE-L] Scare over mad cow disease was big stampede about nothing

 

Scare over mad cow disease was big stampede about nothing

 

By Froma Harrop

 

Creators Syndicate Saturday June 22, 2013 6:37 AM

 

What might we use as a corrective headline? Here’s a cute idea: “Inspectors fail to find cows of mass destruction.”

 

Froma Harrop writes for Creators Syndicate.

 

 fharrop@projo.com

 

 

 


 

 

 

 hmm, something about nothing, or, nothing about something $

 

 

 

>>> What might we use as a corrective headline? Here’s a cute idea: “Inspectors fail to find cows of mass destruction.”

 

 

 

NO, What might we use as a corrective headline? Here’s a cute idea: Froma Horrop educates herself on the TSE prion aka mad cow type disease before news media outlets like http://www.dispatch.com let’s her write about something she knows nothing about. sporadic CJD has now been linked to the atypical BSE, and atypical Scrapie, and scientist are very concerned about CWD in cervids as well. ...

 

 From: Terry S. Singeltary Sr.

 

Sent: Saturday, June 22, 2013 11:42 AM

 

To: fharrop@projo.com Cc: dgoodwin@dispatch.com ; mfisher@dispatch.com ; drowland@dispatch.com

 

Subject: mad cow disease something about nothing, or, nothing about something $$$

 

 Scare over mad cow disease was big stampede about nothing

 


 

 

 

hmm, something about nothing, or, nothing about something $$$

 

 

 

with media reporting like yours Froma, who needs the USDA inc. $$$

 

Ma’am, you seriously need to educate yourself a bit on the topic of the TSE prion disease.

 

there is much more to this than the UK typical c-BSE mad cow type TSE prion disease. that’s one strain of many. you have bought the UKBSEnvCJD theory hook-line-and-sinker, bought and paid for by USDA inc. $$$

 

they will be proud of you !

 

kind regards, terry

 

 

 

Thursday, June 20, 2013

 

atypical, BSE, CWD, Scrapie, Captive Farmed shooting pens (livestock), Wild Cervids, Rectal Mucosa Biopsy 2012 USAHA Proceedings, and CJD TSE prion Update

 


 

 

 

 Saturday, May 26, 2012

 

Are USDA assurances on mad cow case 'gross oversimplification'?

 

SNIP...

 

What irks many scientists is the USDA’s April 25 statement that the rare disease is “not generally associated with an animal consuming infected feed.”

 

The USDA’s conclusion is a “gross oversimplification,” said Dr. Paul Brown, one of the world’s experts on this type of disease who retired recently from the National Institutes of Health.

 

"(The agency) has no foundation on which to base that statement.”

 

“We can’t say it’s not feed related,” agreed Dr. Linda Detwiler, an official with the USDA during the Clinton Administration now at Mississippi State.

 

In the May 1 email to me, USDA’s Cole backed off a bit. “No one knows the origins of atypical cases of BSE,” she said

 

The argument about feed is critical because if feed is the cause, not a spontaneous mutation, the California cow could be part of a larger outbreak.

 

SNIP...

 


 

 ==============================================

 

Saturday, August 4, 2012

 

*** Final Feed Investigation Summary - California BSE Case - July 2012

 


 

=============================================

 

 SUMMARY REPORT CALIFORNIA BOVINE SPONGIFORM ENCEPHALOPATHY CASE INVESTIGATION JULY 2012

 

Summary Report BSE 2012

 

Executive Summary

 


 

 

 

Saturday, August 4, 2012

 

Update from APHIS Regarding Release of the Final Report on the BSE Epidemiological Investigation

 


 

 

 

Sunday, August 26, 2012

 

Detection of PrPSc in peripheral tissues of clinically affected cattle after oral challenge with BSE

 


 

 

 

Thursday, June 20, 2013

 

*** atypical, BSE, CWD, Scrapie, Captive Farmed shooting pens (livestock), Wild Cervids, Rectal Mucosa Biopsy 2012 USAHA Proceedings, and CJD TSE prion Update

 


 

 

 

Sunday, August 26, 2012

 

Detection of PrPSc in peripheral tissues of clinically affected cattle after oral challenge with BSE

 


 

 

 

Tuesday, May 21, 2013

 

*** Canada, USA, Bad feed, mad cows: Why we know three BSE cases had a common origin and why the SSS policy is in full force $$$

 


 

 

 

 CFIA, USDA, AND OIE SHOOT, SHOVEL, AND SHUT THE HELL UP SSS BSE TSE PRION MAD COW TYPE POLICY $$$, and the media is buying it hook, line, and sinker $$$

 

EDMONTON - Some of former Alberta premier Ralph Klein's most colourful quotes — and the reactions they elicited:

 

SNIP...

 

"This all came about through the discovery of a single, isolated case of mad cow disease in one Alberta cow on May 20th.

 

The farmer — I think he was a Louisiana fish farmer who knew nothing about cattle ranching.

 

*** I guess any self-respecting rancher would have shot, shovelled and shut up, but he didn't do that." — Klein recalls how the mad cow crisis started and rancher Marwyn Peaster's role.

 

The premier was speaking at the Western Governors Association meeting in Big Sky, Mont. September 2004.

 


 

 

 

Wednesday, December 22, 2010.

 

Manitoba veterinarian has been fined $10,000 for falsifying certification documents for U.S. bound cattle and what about mad cow disease?

 


 

 

 

CENSORSHIP IS A TERRIBLE THING $$$.

 

 

 

Canada has had a COVER-UP policy of mad cow disease since about the 17th case OR 18th case of mad cow disease. AFTER THAT, all FOIA request were ignored $$$.

 

 THIS proves there is indeed an epidemic of mad cow disease in North America, and it has been covered up for years and years, if not for decades, and it’s getting worse $$$.

 

 

 

Thursday, February 10, 2011.

 

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY REPORT UPDATE CANADA FEBRUARY 2011 and how to hide mad cow disease in Canada Current as of: 2011-01-31.

 


 

 

 

 

 

Thursday, January 17, 2013.

 

Canada, U.S. agree on animal-disease measures to protect trade, while reducing human and animal health protection.

 


 

 

 

 

 

Wednesday, August 11, 2010.

 

REPORT ON THE INVESTIGATION OF THE SIXTEENTH CASE OF BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN CANADA.

 


 

 

 

Thursday, August 19, 2010.

 

REPORT ON THE INVESTIGATION OF THE SEVENTEENTH CASE OF BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN CANADA.

 


 

 

 

Friday, March 4, 2011.

 

Alberta dairy cow found with mad cow disease.

 


 

 

 

 

 

Increased Atypical Scrapie Detections.

 

Press reports indicate that increased surveillance is catching what otherwise would have been unreported findings of atypical scrapie in sheep. In 2009, five new cases have been reported in Quebec, Ontario, Alberta, and Saskatchewan. With the exception of Quebec, all cases have been diagnosed as being the atypical form found in older animals. Canada encourages producers to join its voluntary surveillance program in order to gain scrapie-free status. The World Animal Health will not classify Canada as scrapie-free until no new cases are reported for seven years. The Canadian Sheep Federation is calling on the government to fund a wider surveillance program in order to establish the level of prevalence prior to setting an eradication date. Besides long-term testing, industry is calling for a compensation program for farmers who report unusual deaths in their flocks.

 


 

 

 

Thursday, November 18, 2010

 

Increased susceptibility of human-PrP transgenic mice to bovine spongiform encephalopathy following passage in sheep

 


 

 

 

Monday, April 25, 2011

 

Experimental Oral Transmission of Atypical Scrapie to Sheep

 

Volume 17, Number 5-May 2011

 


 

 

 

Friday, February 11, 2011

 

Atypical/Nor98 Scrapie Infectivity in Sheep Peripheral Tissues

 


 

 

 

Thursday, March 29, 2012

 

atypical Nor-98 Scrapie has spread from coast to coast in the USA 2012

 

NIAA Annual Conference April 11-14, 2011San Antonio, Texas

 


 

 

 

Wednesday, April 4, 2012

 

20120402 - Breach of quarantine/Violation de la mise en quarantaine of an ongoing Scrapie investigation

 


 

 

 

Michigan and California have had a high spike in Goat Scrapie cases, compared to elsewhere ???

 

 

 

Tuesday, February 01, 2011

 

Sparse PrP-Sc accumulation in the placentas of goats with naturally acquired scrapie

 

(Figure 6) including five goat cases in FY 2008 that originated from the same herd in Michigan. This is highly unusual for goats, and I strenuously urge that there should be an independent investigation into finding the common denominator for these 5 goats in the same herd in Michigan with Scrapie. ...

 


 

 

 

Thursday, February 23, 2012

 

Atypical Scrapie NOR-98 confirmed Alberta Canada sheep January 2012

 


 

 

 

RESEARCH

 

Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 17, No. 5, May 2011

 

Experimental Oral Transmission of Atypical Scrapie to Sheep

 

Marion M. Simmons, S. Jo Moore,1 Timm Konold, Lisa Thurston, Linda A. Terry, Leigh Thorne, Richard Lockey, Chris Vickery, Stephen A.C. Hawkins, Melanie J. Chaplin, and John Spiropoulos

 

To investigate the possibility of oral transmission of atypical scrapie in sheep and determine the distribution of infectivity in the animals’ peripheral tissues, we challenged neonatal lambs orally with atypical scrapie; they were then killed at 12 or 24 months. Screening test results were negative for disease-specifi c prion protein in all but 2 recipients; they had positive results for examination of brain, but negative for peripheral tissues. Infectivity of brain, distal ileum, and spleen from all animals was assessed in mouse bioassays; positive results were obtained from tissues that had negative results on screening. These fi ndings demonstrate that atypical scrapie can be transmitted orally and indicate that it has the potential for natural transmission and iatrogenic spread through animal feed. Detection of infectivity in tissues negative by current surveillance methods indicates that diagnostic sensitivity is suboptimal for atypical scrapie, and potentially infectious material may be able to pass into the human food chain.

 

SNIP...

 

Although we do not have epidemiologic evidence that supports the effi cient spread of disease in the fi eld, these data imply that disease is potentially transmissible under fi eld situations and that spread through animal feed may be possible if the current feed restrictions were to be relaxed. Additionally, almost no data are available on the potential for atypical scrapie to transmit to other food animal species, certainly by the oral route. However, work with transgenic mice has demonstrated the potential susceptibility of pigs, with the disturbing fi nding that the biochemical properties of the resulting PrPSc have changed on transmission (40). The implications of this observation for subsequent transmission and host target range are currently unknown.

 

How reassuring is this absence of detectable PrPSc from a public health perspective? The bioassays performed in this study are not titrations, so the infectious load of the positive gut tissues cannot be quantifi ed, although infectivity has been shown unequivocally. No experimental data are currently available on the zoonotic potential of atypical scrapie, either through experimental challenge of humanized mice or any meaningful epidemiologic correlation with human forms of TSE. However, the detection of infectivity in the distal ileum of animals as young as 12 months, in which all the tissues tested were negative for PrPSc by the currently available screening and confi rmatory diagnostic tests, indicates that the diagnostic sensitivity of current surveillance methods is suboptimal for detecting atypical scrapie and that potentially infectious material may be able to pass into the human food chain undetected.

 

Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 17, No. 5, May 2011

 


 

 

 

why do we not want to do TSE transmission studies on chimpanzees $

 

 

 

5. A positive result from a chimpanzee challenged severly would likely create alarm in some circles even if the result could not be interpreted for man. I have a view that all these agents could be transmitted provided a large enough dose by appropriate routes was given and the animals kept long enough. Until the mechanisms of the species barrier are more clearly understood it might be best to retain that hypothesis.

 

snip...

 

R. BRADLEY

 


 

 

 

1: J Infect Dis 1980 Aug;142(2):205-8

 

Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to nonhuman primates.

 

Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.

 

Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation.

 

snip...

 

The successful transmission of kuru, Creutzfeldt-Jakob disease, and scrapie by natural feeding to squirrel monkeys that we have reported provides further grounds for concern that scrapie-infected meat may occasionally give rise in humans to Creutzfeldt-Jakob disease.

 

PMID: 6997404

 


 

 

 

Recently the question has again been brought up as to whether scrapie is transmissible to man. This has followed reports that the disease has been transmitted to primates. One particularly lurid speculation (Gajdusek 1977) conjectures that the agents of scrapie, kuru, Creutzfeldt-Jakob disease and transmissible encephalopathy of mink are varieties of a single "virus". The U.S. Department of Agriculture concluded that it could "no longer justify or permit scrapie-blood line and scrapie-exposed sheep and goats to be processed for human or animal food at slaughter or rendering plants" (ARC 84/77)" The problem is emphasised by the finding that some strains of scrapie produce lesions identical to the once which characterise the human dementias"

 

Whether true or not. the hypothesis that these agents might be transmissible to man raises two considerations. First, the safety of laboratory personnel requires prompt attention. Second, action such as the "scorched meat" policy of USDA makes the solution of the acrapie problem urgent if the sheep industry is not to suffer grievously.

 

snip...

 

76/10.12/4.6

 


 

 

 

Nature. 1972 Mar 10;236(5341):73-4.

 

Transmission of scrapie to the cynomolgus monkey (Macaca fascicularis).

 

Gibbs CJ Jr, Gajdusek DC.

 

Nature 236, 73 - 74 (10 March 1972); doi:10.1038/236073a0

 

Transmission of Scrapie to the Cynomolgus Monkey (Macaca fascicularis)

 

C. J. GIBBS jun. & D. C. GAJDUSEK

 

National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland

 

SCRAPIE has been transmitted to the cynomolgus, or crab-eating, monkey (Macaca fascicularis) with an incubation period of more than 5 yr from the time of intracerebral inoculation of scrapie-infected mouse brain. The animal developed a chronic central nervous system degeneration, with ataxia, tremor and myoclonus with associated severe scrapie-like pathology of intensive astroglial hypertrophy and proliferation, neuronal vacuolation and status spongiosus of grey matter. The strain of scrapie virus used was the eighth passage in Swiss mice (NIH) of a Compton strain of scrapie obtained as ninth intracerebral passage of the agent in goat brain, from Dr R. L. Chandler (ARC, Compton, Berkshire).

 


 


 

 

 

Thursday, December 20, 2012

 

OIE GROUP RECOMMENDS THAT SCRAPE PRION DISEASE BE DELISTED AND SAME OLD BSe WITH BOVINE MAD COW DISEASE

 


 

 
 
 
Monday, November 30, 2009

 

USDA AND OIE COLLABORATE TO EXCLUDE ATYPICAL SCRAPIE NOR-98 ANIMAL HEALTH CODE

 


 

 

 

Wednesday, April 24, 2013

 

Chimpanzees Released After 30 Years Of Testing, Brace Yourself For Smiles

 


 

 

 

THE OIE, USDA, CFIA, DEFRA, MAFF, $$$ POLICY OF SPREADING THE TSE PRION DISEASE GLOBALLY, THE LEGAL TRADING OF ATYPICAL AND POSSIBLY TYPICAL SCRAPIE AS A COMMODITY. ...

 

absolutely insane, crazy, absurd, NEGLIGENT, take your pick. ...

 

 

 

Tuesday, April 30, 2013

 

Transmission of classical scrapie via goat milk

 

Veterinary Record2013;172:455 doi:10.1136/vr.f2613

 


 

 

 

Tuesday, May 7, 2013

 

Feds want five-year paper trail for livestock NAIS COOL

 


 

 

 

Thursday, May 30, 2013

 

Statement from Agriculture Secretary Tom Vilsack Regarding World Organization for Animal Health (OIE) Upgrade of United States' BSE Risk Status

 

Release No. 0106.13 Contact: USDA Office of Communications (202) 720-4623

 


 

 

 

 

 

Tuesday, May 21, 2013

 

Canada, USA, Bad feed, mad cows: Why we know three BSE cases had a common origin and why the SSS policy is in full force $$$

 


 

 

 

 Thursday, May 30, 2013

 

World Organization for Animal Health (OIE) has upgraded the United States' risk classification for mad cow disease to "negligible" from "controlled", and risk further exposing the globe to the TSE prion mad cow type disease

 

U.S. gets top mad-cow rating from international group and risk further exposing the globe to the TSE prion mad cow type disease

 


 


 

 

 

sporadic CJD has now been linked to atypical BSE, atypical Scrapie, and don’t count CWD, typical scrapie, or typical BSE (Collinge et al) out just yet. ...

 

 
 
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...

 


 


 

 

 

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...

 


 


 


 

 

 

Rural and Regional Affairs and Transport References Committee

 

The possible impacts and consequences for public health, trade and agriculture of the Government's decision to relax import restrictions on beef Final report June 2010

 

2.65 At its hearing on 14 May 2010, the committee heard evidence from Dr Alan Fahey who has recently submitted a thesis on the clinical neuropsychiatric, epidemiological and diagnostic features of Creutzfeldt-Jakob disease.48 Dr Fahey told the committee of his concerns regarding the lengthy incubation period for transmissible spongiform encephalopathies, the inadequacy of current tests and the limited nature of our current understanding of this group of diseases.49

 

2.66 Dr Fahey also told the committee that in the last two years a link has been established between forms of atypical CJD and atypical BSE. *** Dr Fahey said that: They now believe that those atypical BSEs overseas are in fact causing sporadic Creutzfeldt-Jakob disease. They were not sure if it was due to mad sheep disease or a different form. If you look in the textbooks it looks like this is just arising by itself. But in my research I have a summary of a document which states that there has never been any proof that sporadic Creutzfeldt-Jakob disease has arisen de novo-has arisen of itself. There is no proof of that. The recent research is that in fact it is due to atypical forms of mad cow disease which have been found across Europe, have been found in America and have been found in Asia. These atypical forms of mad cow disease typically have even longer incubation periods than the classical mad cow disease.50

 


 

 

 

Thursday, June 13, 2013

 

*** Experimental interspecies transmission studies of the transmissible spongiform encephalopathies to cattle: comparison to bovine spongiform encephalopathy in cattle

 


 

 

 

Tuesday, March 05, 2013

 

*** A closer look at prion strains Characterization and important implications Prion

 

7:2, 99–108; March/April 2013; © 2013 Landes Bioscience

 


 

 

 

Monday, June 3, 2013

 

*** Unsuccessful oral transmission of scrapie from British sheep to cattle

 


 

 

 

MORE FROM USDA INC. $$$

 

 Thursday, June 20, 2013

 

atypical, BSE, CWD, Scrapie, Captive Farmed shooting pens (livestock), Wild Cervids, Rectal Mucosa Biopsy 2012 USAHA Proceedings, and CJD TSE prion Update

 


 

 


 

 

Sunday, March 31, 2013

 

Creutzfeldt Jakob Disease CJD worlds youngest documented victim, 11 years old, shall we pray

 


 

 

 

Tuesday, June 26, 2012

 

Creutzfeldt Jakob Disease Human TSE report update North America, Canada, Mexico, and USDA PRION UNIT as of May 18, 2012

 

type determination pending Creutzfeldt Jakob Disease (tdpCJD), is on the rise in Canada and the USA

 


 

 

 

Monday, July 23, 2012

 

The National Prion Disease Pathology Surveillance Center July 2012

 


 

 

 

2011 Monday, September 26, 2011

 

L-BSE BASE prion and atypical sporadic CJD

 


 

 

 

 Wednesday, June 29, 2011

 

TSEAC Meeting August 1, 2011 donor deferral Saudi Arabia vCJD risk blood and blood products

 


 

 

 

 Wednesday, June 29, 2011
 
TSEAC JUNE 2, 1999
 
Welcome to the FDA traveling road show
 
From: TSS

 

Subject: TSEAC JUNE 2, 1999 Welcome to the FDA traveling road show

 

Date: October 15, 2007 at 3:18 pm PST

 

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE MEETING Thursday, June 2, 1999

 


 

 

 

Wednesday, March 2, 2011

 

Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript Posted: 3/2/2011 Posted: 3/2/2011

 

October 28, 2010

 

Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript Posted: 3/2/2011

 


 

 

 

 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 ???

 


 

 

 

October 29, 2010

 

Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript Posted: 3/2/2011

 


 

 

 

Monday, October 18, 2010

 

TSEAC Transmissible Spongiform Encephalopathies Advisory Committee Draft Agenda and Meeting Materials,

 

Posted: 10/18/2010

 

Meeting of the Transmissible Spongiform Encephalopathies Advisory Committee Center Date Time Location

 


 

 

 

 Tuesday, September 14, 2010

 

Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)

 


 

 

 

Saturday, September 5, 2009

 

TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS

 


 

 

 

Sunday, May 10, 2009

 

Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)

 

TO : william.freas@fda.hhs.gov

 

May 8, 2009

 

Greetings again Dr. Freas, TSEAC et al,

 

I would kindly, once again, wish to comment at this meeting about the urgent actions that need to be taken asap, to the Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009. Due to my disability from my neck injury, I will not be attending this meeting either, however I hope for my submission to be read and submitted. ...

 

IN reply to ;

 


 

 

 

snip...see full text ;

 

Sunday, May 10, 2009

 

Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)

 

TO : william.freas@fda.hhs.gov

 


 

 Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 INTRODUCTION The United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) held a public meeting on July 25, 2006 in Washington, D.C. to present findings from the Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 (report and model located on the FSIS website:

 


 

Comments on technical aspects of the risk assessment were then submitted to FSIS. Comments were received from Food and Water Watch, Food Animal Concerns Trust (FACT), Farm Sanctuary, R-CALF USA, Linda A Detwiler, and Terry S. Singeltary. This document provides itemized replies to the public comments received on the 2005 updated Harvard BSE risk assessment. Please bear the following points in mind:

 


 

 

 

 

 

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

 

snip...

 

ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)

 

THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone.

 

These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ...

 

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

 

snip... 48 pages...

 
 


 

 

 

 Wednesday, October 17, 2007 TSEAC MEETINGS ----- 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 [TSSSUBMISSION]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-derivedantihemophilic factor (FVIII) productsmanufactured from U.S. plasma donors and related communication material ;

 


 

i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;

 


 

 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, wha tabout 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 are call aspect of potentially tainted blood, and these are just recent recalls ;

 

PRODUCT

 

Source Plasma, Recall # B-0054-7CODEUnits: 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

 

###

 


 

 USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

 

______________________________

 

 PRODUCTSource Plasma, Recall # B-1708-6CODEUnits: 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-1716-6CODEa),

 

b), and c) Unit: 2443732RECALLING 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

 

###

 


 

 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

 

###

 


 

 Mon Aug 7, 2006 10:2471.248.132.189

 

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 June30, 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

 

CODEa) 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

 

______________________________

 


 

 PRODUCT

 

a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;b) Fresh Frozen Plasma, Recall # B-1551-6

 

CODEa) 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 increasedrisk 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

 

CODEa) 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-1494-6b) Cryoprecipitated AHF, Recall # B-1495-6

 

CODEa) and b)

 

Unit 5013100

 

RECALLING FIRM/MANUFACTURER

 

Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May17, 2005. Firm initiated recall is complete.REASONBlood 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 orletter 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-1375-6CODEa) 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/MANUFACTURERD

 

CI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 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 0044520RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 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, NG0045555RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 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, NG0042525, NG 0042341RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 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-1299-6CODEUnit: 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

 

###

 


 

 CJD WATCH MESSAGE BOARD

 

TSS

 

FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY Fri Jul 7, 2006 09:3770.110.83.160

 

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 June12, 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

 

DISTRIBUTIONTX 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

 

DISTRIBUTIONTX 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 July23 and 29, 2004. Firm initiated recall is complete.

 

REASONBlood 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 onOctober 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 August13, 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

 

###

 


 

 Greetings again Dr. Freas et al at FDA,

 

WITH new atypical TSE in the bovine, in the sheep, goat, and humans, and the fact that the new BASE TSE in cattle being very very similar to sporadic CJD, rather than the nvCJD, the fact that now science showing the TSE agent of the atypical cattle in Japan showing infectivity other than CNS tissue, the fact that the latest Texas mad cow and the recent Alabama mad cow both being of the atypical strain, it would seem prudent to include all human TSE in the blood ban, in my opinion. with sporadic CJD, you have many strains and or phenotypes, some of which are 'UNKNOWN', so we do not know how this will transmit, what tissues are infectious and or if blood transmits. that's the bottomline, however it has been reported that the BASE is more virulent to humans.With this, and the fact that sporadic CJD has tripled in the past few years or so, i see itas being prudent to take serious and immediate action ;

 

 

 

snip...see full text ;

 

 Wednesday, October 17, 2007 TSEAC MEETINGS ----- 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 [TSSSUBMISSION]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-derivedantihemophilic factor (FVIII) productsmanufactured from U.S. plasma donors and related communication material ;

 


 

i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;

 


 

 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, wha tabout 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 are call aspect of potentially tainted blood, and these are just recent recalls ;

 

PRODUCT

 

Source Plasma, Recall # B-0054-7CODEUnits: 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

 

###

 


 

 USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

 

______________________________

 

 PRODUCTSource Plasma, Recall # B-1708-6CODEUnits: 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-1716-6CODEa),

 

b), and c) Unit: 2443732RECALLING 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

 

###

 


 

 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

 

###

 


 

 Mon Aug 7, 2006 10:2471.248.132.189

 

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 June30, 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

 

CODEa) 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

 

______________________________

 


 

 PRODUCT

 

a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;b) Fresh Frozen Plasma, Recall # B-1551-6

 

CODEa) 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 increasedrisk 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

 

CODEa) 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-1494-6b) Cryoprecipitated AHF, Recall # B-1495-6

 

CODEa) and b)

 

Unit 5013100

 

RECALLING FIRM/MANUFACTURER

 

Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May17, 2005. Firm initiated recall is complete.REASONBlood 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 orletter 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-1375-6CODEa) 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/MANUFACTURERD

 

CI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 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 0044520RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 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, NG0045555RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 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, NG0042525, NG 0042341RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 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-1299-6CODEUnit: 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

 

###

 


 

 CJD WATCH MESSAGE BOARD

 

TSS

 

FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY Fri Jul 7, 2006 09:3770.110.83.160

 

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 June12, 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

 

DISTRIBUTIONTX 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

 

DISTRIBUTIONTX 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 July23 and 29, 2004. Firm initiated recall is complete.

 

REASONBlood 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 onOctober 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 August13, 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

 

###

 


 
 
 
 

 Greetings again Dr. Freas et al at FDA,

 

WITH new atypical TSE in the bovine, in the sheep, goat, and humans, and the fact that the new BASE TSE in cattle being very very similar to sporadic CJD, rather than the nvCJD, the fact that now science showing the TSE agent of the atypical cattle in Japan showing infectivity other than CNS tissue, the fact that the latest Texas mad cow and the recent Alabama mad cow both being of the atypical strain, it would seem prudent to include all human TSE in the blood ban, in my opinion. with sporadic CJD, you have many strains and or phenotypes, some of which are 'UNKNOWN', so we do not know how this will transmit, what tissues are infectious and or if blood transmits. that's the bottomline, however it has been reported that the BASE is more virulent to humans.With this, and the fact that sporadic CJD has tripled in the past few years or so, i see itas being prudent to take serious and immediate action ;

 

 

 


 

 



 

 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 ...

 


 

 

 

Tuesday, February 8, 2011

 

U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001

 


 

 

 

 

Saturday, June 22, 2013

 

Characterization of variant Creutzfeldt-Jakob disease prions in prion protein-humanized mice carrying distinct codon 129 genotypes

 


 

 

 

 

 

Saturday, June 15, 2013

 

Canada Fraser Health Statement on Creutzfeldt-Jakob Disease outbreak

 


 

 


 
 

 Wednesday, March 31, 2010

 
 
 

Atypical BSE in Cattle



 

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.



 

This study will contribute to a correct definition of specified risk material (SRM) in atypical BSE. The incumbent of this position will develop new and transfer existing, ultra-sensitive methods for the detection of atypical BSE in tissue of experimentally infected cattle.

 
 
 


 
 
 
 

 *** The potential impact of prion diseases on human health was greatly magnified by the recognition that interspecies transfer of BSE to humans by beef ingestion resulted in vCJD. While changes in animal feed constituents and slaughter practices appear to have curtailed vCJD, there is concern that CWD of free-ranging deer and elk in the U.S. might also cross the species barrier. Thus, consuming venison could be a source of human prion disease. Whether BSE and CWD represent interspecies scrapie transfer or are newly arisen prion diseases is unknown. Therefore, the possibility of transmission of prion disease through other food animals cannot be ruled out. There is evidence that vCJD can be transmitted through blood transfusion. There is likely a pool of unknown size of asymptomatic individuals infected with vCJD, and there may be asymptomatic individuals infected with the CWD equivalent. These circumstances represent a potential threat to blood, blood products, and plasma supplies.

 
 


 
 
 
 

 The chances of a person or domestic animal contracting CWD are “extremely remote,” Richards said. The possibility can’t be ruled out, however. “One could look at it like a game of chance,” he explained. “The odds (of infection) increase over time because of repeated exposure. That’s one of the downsides of having CWD in free-ranging herds: We’ve got this infectious agent out there that we can never say never to in terms of (infecting) people and domestic livestock.”


 


 
 
 
 

 *** The discovery of previously unrecognized prion diseases in both humans and animals (i.e., Nor98 in small ruminants) demonstrates that the range of prion diseases might be wider than expected and raises crucial questions about the epidemiology and strain properties of these new forms. We are investigating this latter issue by molecular and biological comparison of VPSPr, GSS and Nor98.

 
 

 VARIABLY PROTEASE-SENSITVE PRIONOPATHY IS TRANSMISSIBLE ...price of prion poker goes up again $

 
 
 

OR-10: Variably protease-sensitive prionopathy is transmissible in bank voles

 
 
 

Romolo Nonno,1 Michele Di Bari,1 Laura Pirisinu,1 Claudia D’Agostino,1 Stefano Marcon,1 Geraldina Riccardi,1 Gabriele Vaccari,1 Piero Parchi,2 Wenquan Zou,3 Pierluigi Gambetti,3 Umberto Agrimi1 1Istituto Superiore di Sanit√†; Rome, Italy; 2Dipartimento di Scienze Neurologiche, Universit√† di Bologna; Bologna, Italy; 3Case Western Reserve University; Cleveland, OH USA

 
 
 

Background. Variably protease-sensitive prionopathy (VPSPr) is a recently described “sporadic”neurodegenerative disease involving prion protein aggregation, which has clinical similarities with non-Alzheimer dementias, such as fronto-temporal dementia. Currently, 30 cases of VPSPr have been reported in Europe and USA, of which 19 cases were homozygous for valine at codon 129 of the prion protein (VV), 8 were MV and 3 were MM. A distinctive feature of VPSPr is the electrophoretic pattern of PrPSc after digestion with proteinase K (PK). After PK-treatment, PrP from VPSPr forms a ladder-like electrophoretic pattern similar to that described in GSS cases. The clinical and pathological features of VPSPr raised the question of the correct classification of VPSPr among prion diseases or other forms of neurodegenerative disorders. Here we report preliminary data on the transmissibility and pathological features of VPSPr cases in bank voles.

 
 
 

Materials and Methods. Seven VPSPr cases were inoculated in two genetic lines of bank voles, carrying either methionine or isoleucine at codon 109 of the prion protein (named BvM109 and BvI109, respectively). Among the VPSPr cases selected, 2 were VV at PrP codon 129, 3 were MV and 2 were MM. Clinical diagnosis in voles was confirmed by brain pathological assessment and western blot for PK-resistant PrPSc (PrPres) with mAbs SAF32, SAF84, 12B2 and 9A2.

 
 
 

Results. To date, 2 VPSPr cases (1 MV and 1 MM) gave positive transmission in BvM109. Overall, 3 voles were positive with survival time between 290 and 588 d post inoculation (d.p.i.). All positive voles accumulated PrPres in the form of the typical PrP27–30, which was indistinguishable to that previously observed in BvM109 inoculated with sCJDMM1 cases.

 
 
 

In BvI109, 3 VPSPr cases (2 VV and 1 MM) showed positive transmission until now. Overall, 5 voles were positive with survival time between 281 and 596 d.p.i.. In contrast to what observed in BvM109, all BvI109 showed a GSS-like PrPSc electrophoretic pattern, characterized by low molecular weight PrPres. These PrPres fragments were positive with mAb 9A2 and 12B2, while being negative with SAF32 and SAF84, suggesting that they are cleaved at both the C-terminus and the N-terminus. Second passages are in progress from these first successful transmissions.

 
 
 

Conclusions. Preliminary results from transmission studies in bank voles strongly support the notion that VPSPr is a transmissible prion disease. Interestingly, VPSPr undergoes divergent evolution in the two genetic lines of voles, with sCJD-like features in BvM109 and GSS-like properties in BvI109.

 
 
 

The discovery of previously unrecognized prion diseases in both humans and animals (i.e., Nor98 in small ruminants) demonstrates that the range of prion diseases might be wider than expected and raises crucial questions about the epidemiology and strain properties of these new forms. We are investigating this latter issue by molecular and biological comparison of VPSPr, GSS and Nor98.

 







 

 Wednesday, March 28, 2012

 

VARIABLY PROTEASE-SENSITVE PRIONOPATHY IS TRANSMISSIBLE, price of prion poker goes up again $

 


 
 
 
 

 CANADA SEE STEADY INCREASE OF THE SPORADIC CJD’S AND THE VPSPR’S (sporadic CJD’s). ...tss

 
 
 

PLEASE NOTE, type determination pending Creutzfeldt Jakob Disease (tdpCJD) in Canada is also on a steady increase.



 

please see ;

 
 
 
 

> 3. Final classification of 50 cases from 2009, 2010, 2011 and 2012 is pending.




 

CJD Deaths Reported by CJDSS1, 1994-20122

 
 

As of May 31, 2012


 

Deaths of Definite and Probable CJD

 
 

Year Sporadic Iatrogenic Familial GSS FFI vCJD Total


 

1994 2 0 0 1 0 0 3

 

1995 3 0 0 0 0 0 3

 

1996 13 0 0 0 0 0 13

 

1997 16 0 1 1 0 0 18

 

1998 22 1 0 1 0 0 24

 

1999 26 2 2 1 0 0 31

 

2000 32 0 0 3 0 0 35

 

2001 27 0 2 1 0 0 30

 

2002 31 0 2 2 0 1 36

 

2003 27 1 1 0 0 0 29

 

2004 42 0 1 0 0 0 43

 

2005 42 0 0 2 0 0 44

 

2006 39 0 1 3 1 0 44 2007 35 0 0 4 0 0 39

 

2008 48 0 1 0 0 0 49

 

2009 48 0 3 2 0 0 53

 

2010 34 0 3 0 0 0 37

 

2011 37 0 2 1 0 1 41

 

2012 1 0 0 0 0 0 1

 

Total 525 4 19 22 1 2 573

 

1. CJDSS began in 1998

 

2. Data before 1998 are retrospective and partial, data from 1998 to 2008 are complete, and data for 2009 - 2012 are provisional

 

3. Final classification of 50 cases from 2009, 2010, 2011 and 2012 is pending.

 

CJD Deaths Reported by CJDSS1, 1994-20122

 

As of May 31, 2012


 


 
 


 
 

 

 

SEE DECEMBER 2012 CANADA

 


 

 

 

USA SEE STEADY INCREASE OF THE SPORADIC CJD’S AND THE VPSPR’S (sporadic CJD’s). ...tss

 

National Prion Disease Pathology Surveillance Center

 

Cases Examined1

 

(May 18, 2012)

 

Year Total Referrals2 Prion Disease Sporadic Familial Iatrogenic vCJD

 

1996 & earlier 50 32 28 4 0 0

 

1997 114 68 59 9 0 0

 

1998 88 52 44 7 1 0

 

1999 123 74 65 8 1 0

 

2000 145 103 89 14 0 0

 

2001 210 120 110 10 0 0

 

2002 248 149 125 22 2 0

 

2003 266 168 137 31 0 0

 

2004 326 187 164 22 0 13

 

2005 344 194 157 36 1 0

 

2006 382 196 166 28 0 24

 

2007 377 213 185 28 0 0

 

2008 396 232 206 26 0 0

 

2009 423 256 212 43 1 0

 

2010 413 257 216 41 0 0

 

2011 410 257 213 43 0 0

 

2012 153 82 51 15 0 0

 

TOTAL 44685 26406 2227 387 6 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 14 cases in which the diagnosis is pending, and 18 inconclusive cases;

 

6 Includes 17 (16 from 2012) cases with type determination pending in which the diagnosis of vCJD has been excluded. The Sporadic cases include 16 cases of sporadic Fatal Insomnia (sFI) and 42 cases of Variably Protease-Sensitive Prionopathy (VPSPr) and 2118 cases of sporadic Creutzfeldt-Jakob disease (sCJD).

 

Rev 5/18/2012

 





 

 > 6 Includes

 

> 17 (16 from 2012) cases with type determination pending in which the diagnosis of vCJD has been excluded.

 



> The Sporadic cases include 16 cases of sporadic Fatal Insomnia (sFI) and 42 cases of Variably Protease-Sensitive Prionopathy (VPSPr) and 2118 cases of sporadic Creutzfeldt-Jakob disease (sCJD).

 




 WELL, it seems the USA mad cow strains in humans classified as type determination pending tdpCJD, VPSPr, sFFI, and sCJD) have steadily increased over the years, and the same old song and dance continues with sporadic CJD cases $$$

 


 

 



 

CJD CANADA WINTER 2012

 


 

 
 
 

 

 

*** The potential impact of prion diseases on human health was greatly magnified by the recognition that interspecies transfer of BSE to humans by beef ingestion resulted in vCJD. While changes in animal feed constituents and slaughter practices appear to have curtailed vCJD, there is concern that CWD of free-ranging deer and elk in the U.S. might also cross the species barrier. Thus, consuming venison could be a source of human prion disease. Whether BSE and CWD represent interspecies scrapie transfer or are newly arisen prion diseases is unknown. Therefore, the possibility of transmission of prion disease through other food animals cannot be ruled out. There is evidence that vCJD can be transmitted through blood transfusion. There is likely a pool of unknown size of asymptomatic individuals infected with vCJD, and there may be asymptomatic individuals infected with the CWD equivalent. These circumstances represent a potential threat to blood, blood products, and plasma supplies.

 

 

 


 





there has never been a proven case of any spontaneous TSE prion disease in the wild.


 
 
85%+, of all human TSE prion disease i.e. sporadic CJD, is NOT a happenstance of bad luck, from a twisted up funked out protein, that just happens to get all twisted up over nothing...

 

lost my mom to the hvCJD confirmed...just made a promise to her way back...TSS
 
 
 
layperson