Tuesday, February 8, 2011

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

Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001

Date: Tue, 9 Jan 2001 16:49:00 -0800

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

To: BSE-L@uni-karlsruhe.de


######### Bovine Spongiform Encephalopathy #########


Greetings List Members,

I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.

I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.

"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."

and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick.

(understand, these are taken from my notes for now. the spelling of names and such could be off.)

[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.

[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]

[host Richard] could you repeat the question?

[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

[not sure whom ask this] what group are you with?

[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.

[not sure who is speaking] could you please disconnect Mr. Singeltary

[TSS] you are not going to answer my question?

[not sure whom speaking] NO

from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;

[unknown woman] what group are you with?

[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now?

at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference.

IF i were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from;

RBARNS@ORA.FDA.GOV 301-827-6906

he would be glad to give you one ;-)

Rockville Maryland, Richard Barns Host

BSE issues in the U.S., How they were labelling ruminant feed? Revising issues.

The conference opened up with the explaining of the U.K. BSE epidemic winding down with about 30 cases a week.

although new cases in other countries were now appearing.

Look at Germany whom said NO BSE and now have BSE.

BSE increasing across Europe.

Because of Temporary Ban on certain rendered product, heightened interest in U.S.

A recent statement in Washington Post, said the New Administration (old GW) has a list of issues. BSE is one of the issues.

BSE Risk is still low, minimal in U.S. with a greater interest in MBM not to enter U.S.

HOWEVER, if BSE were to enter the U.S. it would be economically disastrous to the render, feed, cattle, industries, and for human health.

(human health-they just threw that in cause i was listening. I will now jot down some figures in which they told you, 'no need to write them down'. just hope i have them correct. hmmm, maybe i hope i don't ???)

80% inspection of rendering

*Problem-Complete coverage of rendering HAS NOT occurred.

sizeable number of 1st time FAILED INITIAL INSPECTION, have not been reinspected (70% to 80%).

Compliance critical, Compliance poor in U.K. and other European Firms.

Gloria Dunason Major Assignment 1998 goal TOTAL compliance. This _did not_ occur. Mixed level of compliance, depending on firm.

Rendering FDA license and NON FDA license

system in place for home rendering & feed 76% in compliance 79% cross contamination 21% DID NOT have system 92% record keeping less than 60% total compliance

279 inspectors 185 handling prohibited materials

Renderer at top of pyramid, significant part of compliance. 84% compliance

failed to have caution statement render 72% compliance & cross contamination caution statement on feed, 'DO NOT FEED TO CATTLE'

56 FIRMS NEVER INSPECTED

1240 FDA license feed mills 846 inspected

"close to 400 feed mills have not been inspected"

80% compliance for feed.

10% don't have system.

NON-FDA licensed mills There is NO inventory on non licensed mills. approximately 6000 to 8000 Firms ??? 4,344 ever inspected. "FDA does not have a lot of experience with"

40% do NOT have caution statement 'DO NOT FEED'.

74% Commingling compliance

"This industry needs a lot of work and only half gotten to"

"700 Firms that were falitive, and need to be re-inspected, in addition to the 8,000 Firms."

Quote to do BSE inspection in 19 states by end of January or 30 days, and other states 60 days. to change feed status??? Contract check and ask questions and pass info.

At this time, we will take questions.

[I was about the third or fourth to ask question. then all B.S.eee broke loose, and i lost my train of thought for a few minutes. picked back up here]

someone asking about nutritional supplements and sourcing, did not get name. something about inspectors not knowing of BSE risk??? the conference person assuring that Steve Follum? and the TSE advisory Committee were handling that.

Some other Dr. Vet, whom were asking questions that did not know what to do???

[Dennis Wilson] California Food Agr. Imports, are they looking at imports?

[Conference person] they are looking at imports, FDA issued imports Bulletin.

[Linda Singeltary ??? this was a another phone in question, not related i don't think] Why do we have non-licensed facilities?

(conference person) other feed mills do not handle as potent drugs???

Dennis Blank, Ken Jackson licensed 400 non FDA 4400 inspected of a total of 6000 to 8000,

(they really don't know how many non licensed Firms in U.S. they guess 6000 to 8000??? TSS)

Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not'

Warren-Maryland Dept. Agr. Prudent to re-inspect after 3 years. concerned of Firms that have changed owners.

THE END

TSS

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############



FROM New York TIMES


Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting of cut version...

Date: Thu, 11 Jan 2001 22:02:47 -0700

From: "Sandy Blakeslee"

To: "Terry S. Singeltary Sr." References: 1


Hi terry -- thanks for all your help. I know it made a difference with the FDA getting out that release.


----- Original Message -----

From: "Terry S. Singeltary Sr."

To: Sent: Thursday, January 11, 2001 2:06 PM

Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting of cut version...

hi sandy,

From the New York Times NYTimes.com, January 11, 2001

Many Makers of Feed Fail to Heed Rules on Mad Cow Disease By SANDRA BLAKESLEE

Large numbers of companies involved in manufacturing animal feed are not complying with regulations meant to prevent the emergence and spread of mad cow disease in the United States, the Food and Drug Administration said yesterday.

The widespread failure of companies to follow the regulations, adopted in August 1997, does not mean that the American food supply is unsafe, Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at the F.D.A., said in an interview.

But much more needs to be done to ensure that mad cow disease does not arise in this country, Dr. Sundlof said.

The regulations state that feed manufacturers and companies that render slaughtered animals into useful products generally may not feed mammals to cud-chewing animals, or ruminants, which can carry mad cow disease.

All products that contain rendered cattle or sheep must have a label that says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers must also have a system to prevent ruminant products from being commingled with other rendered material like that from chicken, fish or pork. Finally, all companies must keep records of where their products originated and where they were sold.

Under the regulations, F.D.A. district offices and state veterinary offices were required to inspect all rendering plants and feed mills to make sure companies complied. But results issued yesterday demonstrate that more than three years later, different segments of the feed industry show varying levels of compliance.

Among 180 large companies that render cattle and another ruminant, sheep, nearly a quarter were not properly labeling their products and did not have a system to prevent commingling, the F.D.A. said. And among 347 F.D.A.-licensed feed mills that handle ruminant materials - these tend to be large operators that mix drugs into their products - 20 percent were not using labels with the required caution statement, and 25 percent did not have a system to prevent commingling.

Then there are some 6,000 to 8,000 feed mills so small they do not require F.D.A. licenses. They are nonetheless subject to the regulations, and of 1,593 small feed producers that handle ruminant material and have been inspected, 40 percent were not using approved labels and 25 percent had no system in place to prevent commingling.

On the other hand, fewer than 10 percent of companies, big and small, were failing to comply with the record-keeping regulations.

The American Feed Industry Association in Arlington, Va., did not return phone calls seeking comment.

http://www.nytimes.com/2001/01/11/science/11COW.html



Subject: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001

Date: Wed, 10 Jan 2001 14:04:21 -0500

From: "Gomez, Thomas M."

Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de


######### Bovine Spongiform Encephalopathy #########

USDA/APHIS would like to provide clarification on the following point from Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.

[Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not']

Dr. Detwiler was responding to an announcement made during the call to use the FDA emergency number if anyone wanted to report a cow with signs suspect for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants to use the FDA emergency number as a last resort to report cattle suspect for BSE. What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement. Surveillance for BSE in the United States is a cooperative effort between states, producers, private veterinarians, veterinary hospitals and the USDA. The system has been in place for over 10 years. Each state has a system in place wherein cases are reported to either the State Veterinarian, the federal Veterinarian in Charge or through the veterinary diagnostic laboratory system. The states also have provisions with emergency numbers. Dr. Detwiler asked participants to use the systems currently in place to avoid the possibility of a BSE-suspect report falling through the cracks. Use of the FDA emergency number has not been established as a means to report diseased cattle of any nature.

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############


Subject: Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan.9, 2001

Date: Wed, 10 Jan 2001 13:44:49 -0800

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy

To: BSE-L@uni-karlsruhe.de References: 1


######### Bovine Spongiform Encephalopathy #########


Hello Mr. Thomas,


> What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement.


would you and the USDA/APHIS be so kind as to supply this list with a full text version of the conference call and or post on your web-site? if so when, and thank you. if not, why not?

The system has been in place for over 10 years.

that seems to be a very long time for a system to be in place, and only test 10,700 cattle from some 1.5 BILLION head (including calf crop). Especially since French are testing some 20,000 weekly and the E.U. as a whole, are testing many many more than the U.S., with less cattle, same risk of BSE/TSEs.

Why does the U.S. insist on not doing massive testing with the tests which the E.U. are using? Why is this, please explain?

Please tell me why my question was not answered?

U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

It was a very simple question, a very important question, one that pertained to the topic of BSE/feed, and asked in a very diplomatic way. why was it not answered?

If all these years, we have been hearing that pharmaceutical grade bovines were raised for pharmaceuticals vaccines etc. But yet the USA cannot comply with feed regulations of the ruminant feed ban, PLUS cannot even comply with the proper labelling of the feed, cross contamination etc. Then how in the world can you Guarantee the feed fed to pharmaceutical grade bovine, were actually non ruminant feed?

Before i was ask to be 'disconnected', i did hear someone in the background say 'we can't'-- have him ask the question again.

could you please be so kind, as to answer these questions?

thank you, Terry S. Singeltary Sr. Bacliff, Texas USA

P.S. if you will also notice, i did not post that emergency phone number and do not intend on passing it on to anyone. I was joking when i said i should call and report the whole damn U.S. Herd. So please pass that on to Dr. Detwiler, so she can rest easily.

BUT, they should be reported, some are infected with TSE. The U.S. is just acting as stupid as Germany and other Countries that insist they are free of BSE.

TSS

Subject: Report on the assessment of the Georgraphical BSE-risk of the USA July 2000 (not good)

Date: Wed, 17 Jan 2001 21:23:51 -0800

From: "Terry S. Singeltary Sr."

Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de


######### Bovine Spongiform Encephalopathy #########

Greetings List Members and ALL EU Countries,

Because of this report, and the recent findings of the 50-state BSE Conference call, I respectfully seriously suggest that these Countries and the SSC re-evaluate the U.S.A. G.B.R. to a risk factor of #3.

I attempted to post this to list in full text, but would not accept...

thank you, kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA

Report on the assessment of the Geographical BSE-risk of the USA July 2000

PART II

REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE RISK OF THE UNITED STATES OF AMERICA

- 29 -

Report on the assessment of the Geographical BSE-risk of the USA July 2000

EXECUTIVE SUMMARY

OVERALL ASSESSMENT

The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.

Stability: Before 1990 the system was extremely unstable because feeding of MBM to cattle happened, rendering was inappropriate with regard to deactivation of the BSE-agent and SRM and fallen stock were rendered for feed. From 1990 to 1997 it improved to very unstable, thanks to efforts undertaken to trace imported animals and exclude them from the feed chain and intensive surveillance. In 1998 the system became neutrally stable after the RMBM-ban of 1997.

External challenges: A moderate external challenge occurred in the period before 1990 because of importation of live animals from BSE-affected countries, in particular from the UK and Ireland. It cannot be excluded that some BSE-infected animals have been imported by this route and did enter the US rendering and feed production system. The efforts undertaken since 1990 to trace back UK-imported cattle and to exclude them from the feed chain reduced the impact of the external challenge significantly.

Interaction of external challenges and stability: While extremely unstable, the US system was exposed to a moderate external challenge, mainly resulting from cattle imports from the UK. It can not be excluded that BSE-infectivity entered the country by this route and has been recycled to domestic cattle. The resulting domestic cases would have been processed while the system was still very unstable or unstable and would hence have initiated a number of second or third generation cases. However, the level of the possible domestic prevalence must be below the low detection level of the surveillance in place.

As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent will remain at the current level.

JUSTIFICATION

1. DATA

The available information was suitable to carry out the GBR risk assessment.

- 30 -

Report on the assessment of the Geographical BSE-risk of the USA July 2000

2. STABILITY

2.1 Overall appreciation of the ability to identify BSE-cases and to eliminate animals at risk of being infected before they are processed

· Before 1989, the ability of the system to identify (and eliminate) BSE cases was limited. · Since 1990 this ability is significantly improved, thanks to a good BSE-surveillance and culling system (contingency plan). · Today the surveillance should be able to detect clinical BSE-cases within the limits set by an essential passive surveillance system, i.e. some cases might remain undetected.

2.2 Overall appreciation of the ability to avoid recycling BSE-infectivity, should it enter processing

· Before 1997 the US rendering and feed producing system would not have been able to avoid recycling of the BSE agent to any measurable extent. If the BSE-agent was introduced the feed chain, it could probably have reached cattle. · After the introduction of the RMBM-to-ruminants-ban in August 1997 the ability of the system to avoid recycling of BSE-infectivity was somewhat increased. It is still rather low due to the rendering system of ruminant material (including SRM and fallen stock) and the persisting potential for cross-contamination of cattle feed with other feeds and hence RMBM.

2.3 Overall assessment of the Stability

· Until 1990 the US BSE/cattle system was extremely unstable as RMBM was commonly fed to cattle, the rendering system was not able to reduce BSE-infectivity and SRM were rendered. This means that incoming BSE infectivity would have been most probably recycled to cattle and amplified and the disease propagated. · Between 1990 and 1995 improvements in the BSE surveillance and the efforts to trace back and remove imported cattle gradually improved the stability but the system remained very unstable. In 1998 the system became unstable because of an RMBM-ban introduced in 1997. After 1998 the ban was fully implemented and the system is regarded to be neutrally stable since 1998. The US system is therefore seen to neither be able to amplify nor to reduce circulating or incoming BSE-infectivity.

3. CHALLENGES

A moderate external challenge occurred in the period 1980-1989 because of importation of live animals from the UK. imports from other countries are regarded to have been negligible challenges. · As a consequence of this external challenge, infectivity could have entered the feed cycle and domestic animals could have been exposed to the agent. These domestic BSE-incubating animals might have again entered processing, leading to an internal challenge since 1991. · This internal challenge could have produced domestic cases of BSE, yet prevalence levels could have been below the detection limits of the surveillance system until now. (According to US calculations, the current surveillance

-31 -

Report on the assessment of the Geographical BSE-risk of the USA July 2000

system could detect clinical incidence of 1-3 cases per year per million adult cattle, i.e. in absolute numbers 43-129 cases per year). Between 1990 und 1995, with the exclusion of the imported animals from Europe from the feed chain, the effect of the external challenges decreased.

4. CONCLUSION ON THE RESULTING RISKS

4.1 Interaction of stability and challenqe

· In the late 80s, early 90s a moderate external challenges met an extremely unstable system. This would have amplified the incoming BSE-infectivity and propagated the disease. · With the exclusion of the imported animals from Europe from the feed chain between 1990 and 1995 the effect of the external challenge decreased. · Before 1998 an internal challenge, if it developed, would have met a still unstable system (inappropriate rendering, no SRM ban, RMBM ban only after 1997) and the BSE-infectivity could have been recycled and amplified. · After 1998 the neutrally stable system could still recycle the BSE-agent but due to the RMBM-ban of 1997 the BSE-infectivity circulating in the system would probably not be amplified.

4.2 Risk that BSE-infectivity enters processing

· A very low processing risk developed in the late 80s when the UK-imports were slaughtered or died. It increased until 1990 because of the higher risk to be infected with BSE of cattle imported from the UK in 1988/89, as these animals could have been processed prior to the back-tracing of the UK-imports in 1990. · From 1990 to 1995 a combination of surviving non-traced UK imports and some domestic (pre-)clinical cases could have arrived at processing resulting in an assumed constant low but non-negligible processing risk. · After 1995 any processing risk relates to assumed domestic cases arriving at processing. · The fact that no domestic cases have been shown-up in the BSE-surveillance is reassuring - it indicates that BSE is in fact not present in the country at levels above the detection limits of the country's surveillance system. This detection level has been calculated according to US-experts to be between 1 & 3 clinical cases per million adult cattle per year.

Note: The high turnover in parts of the dairy cattle population with a young age at slaughter makes it unlikely that fully developed clinical cases would occur (and could be detected) or enter processing. However, the theoretical infective load of the pre-clinical BSE-cases that under this scenario could be processed, can be assumed to remain relatively low.

4.3 Risk that BSE-infectivity is recycled and propagated

· During the period covered by this assessment (1980-1999) the US-system was not able to prevent propagation of BSE should it have entered, even if this ability was significantly improved with the MBM-ban of 1997. · However, since the likelihood that BSE-infectivity entered the system is regarded to be small but non-negligible, the risk that propagation of the disease took place is also small but not negligible.

- 32 -

Report on the assessment of the Geographical BSE-risk of the USA July 2000

5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK

5.1 The current GBR

The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.

5.2 The expected development of the GBR

As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent remains at the current level.

5.3 Recommendations for influencin.q the future GBR

· As long as the stability of the US system is not significantly enbanced above neutral levels it remains critically important to avoid any new external challenges. · All measures that would improve the stability of the system, in particular with regard to its ability to avoid recycling of the BSE-agent should it be present in the cattle population, would reduce, over time, the probability that cattle could be infected with the BSE-agent. Possible actions include: removal of SRMs and/or fallen stock from rendering, better rendering processes, improved compliance with the MBM-ban including control and reduction of cross-contamination. · Results from an improved intensive surveillance programme, targeting at risk sub-populations such as adult cattle in fallen stock or in emergency slaughter, could verify the current assessment.

snip...


http://www.regulations.gov/search/Regs/contentStreamer?objectId=09000064801f3413&disposition=attachment&contentType=msw8





The most recent assessments (and reassessments) were published in June 2005 (Table I; 18), and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.


http://www.oie.int/boutique/extrait/06heim937950.pdf





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




Saturday, January 29, 2011

Atypical L-Type Bovine Spongiform Encephalopathy (L-BSE) Transmission to Cynomolgus Macaques, a Non-Human Primate

Jpn. J. Infect. Dis., 64 (1), 81-84, 2011

http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html



Tuesday, January 25, 2011

Generation of a new form of human PrPSc in vitro by inter-species transmission from cervids prions

http://chronic-wasting-disease.blogspot.com/2011/01/generation-of-new-form-of-human-prpsc.html



Friday, February 04, 2011


NMLB and USDA allow scrapie prion infected mutton to enter food chain on the Navajo Reservation in New Mexico


----- Original Message -----

From: Terry S. Singeltary Sr.

To: President.BenShelly

Cc: sroanhorse ; opvp.nelson ; alaughing; georgehardeen; pressoffice

Sent: Thursday, February 03, 2011 12:15 PM

Subject: NMLB and USDA allow scrapie prion infected mutton to enter food chain on the Navajo Reservation in New Mexico

Greetings Honorable People of the Great Navajo Nation, and the Honorable President Ben Shelly,

I send this to you with great concern. ...


BSE: TIME TO TAKE H.B. PARRY SERIOUSLY

If the scrapie agent is generated from ovine DNA and thence causes disease in other species, then perhaps, bearing in mind the possible role of scrapie in CJD of humans (Davinpour et al, 1985), scrapie and not BSE should be the notifiable disease. ...

http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1988/06/08004001.pdf



PLEASE SEE FULL TEXT PLUS TRANSMISSION STUDIES ;



http://scrapie-usa.blogspot.com/2011/02/nmlb-and-usda-allow-scrapie-prion.html



Saturday, December 18, 2010

OIE Global Conference on Wildlife Animal Health and Biodiversity - Preparing for the Future (TSE AND PRIONS) Paris (France), 23-25 February 2011

http://transmissiblespongiformencephalopathy.blogspot.com/2010/12/oie-global-conference-on-wildlife.html


Monday, November 30, 2009

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

http://nor-98.blogspot.com/2009/11/usda-and-oie-collaborate-to-exclude.html


http://bseusa.blogspot.com/2010/04/usda-and-oie-out-of-touch-with-risk.html


Tuesday, November 02, 2010

BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only) diagnostic criteria CVL 1992

http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html





tss

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 ???

FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???

Informational Issue Summary

FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products

Transmissible Spongiform Encephalopathies Advisory Committee 22nd Meeting October 28-29, 2010

Gaithersburg, Maryland

2

Background

Beginning in 1978, results of experimental studies repeatedly demonstrated that the infectious agents causing the transmissible spongiform encephalopathies (TSE agents or prions) are often found in the blood of infected animals, both during the incubation period and throughout overt illness. Since 1983, the FDA, issuing a series of guidances, has periodically recommended to the blood industry steps intended to reduce the theoretical risk of transmitting the infectious agents of the transmissible spongiform encephalopathies (TSEs) causing Creutzfeldt-Jakob disease (CJD) and variant CJD (vCJD) by blood and blood products. The risk of transmitting most forms of CJD by transfusions of blood components and injection of plasma derivatives, remains theoretical (see Appendices I and II), however, limited but convincing evidence strongly implicates transfusions with a blood component and injections of a human plasma-derived coagulation factor in iatrogenic transmissions of vCJD in the United Kingdom (UK). The history of FDA’s policies and of the science that informed the FDA in this area is summarized in Appendices I and II, with current FDA guidance in tabular form in Appendices V and VI. (Appendices III and IV summarize certain legislation implemented in the European Union and USDA regulations relevant to FDA blood safety policies.)

In principle, when possible, several approaches are taken to reduce the risk of transmitting infectious diseases from a blood or plasma donor to a recipient:

___________________________________________________________________________

Five “tiers” of safety for blood and components as related to CJD and vCJD (modified from Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood. US FDA Publication No. FS 02-1, February 2002

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/BloodSafety/ucm095522.htm


accessed October 2010)

___________________________________________________________________________

1. Donor screening [questionnaires]: selection of blood and plasma donors based on deferrals for medical, geographical and behavioral risk factors; deferral registries to avoid collection and use of units from identified “unsuitable” donors

2. Laboratory testing of donor blood samples for markers of blood-transmissible diseases (infectious agents)

3. Donor Deferral Registries: an additional control to avoid collecting blood or releasing blood from donors deferred as unsuitable

4. Quarantine: Donor blood [and plasma] quarantined until testing results available

5. Problems and deficiencies: manufacturing problems investigated, deficiencies corrected, FDA notified of deviations

___________________________________________________________________________

1, 3 and 5 are currently applicable to TSEs; laboratory testing (2 and 4) is not yet available for TSEs. In addition to protections listed, pathogen reduction techniques are currently under study for both conventional pathogens and TSE agents but are not yet validated, approved or available.

___________________________________________________________________________

Because no validated screening tests identify TSE-agent-infected blood and there are no US-approved devices to remove TSE infectivity from blood and blood components, CJD and vCJD safety must continue to rely on precautionary deferrals of donors at increased risk for CJD and for vCJD and withdrawal of in-date components when post-donation

3

information reveals that a donor should have been deferred; and, additionally for vCJD, withdrawal of plasma derivatives if and when a donor is found to have vCJD or possible vCJD. The FDA continues to encourage the development of donor screening tests and devices to remove the infectious agents of TSEs from blood (see below). The FDA, aware of the uncertainties surrounding the magnitude of the risk, the effectiveness of available risk-reducing measures, and the potential for contributing to shortages of life-sustaining blood products, has continued to review at frequent intervals its policies regarding CJD and vCJD. In particular, FDA blood safety policies regarding CJD and vCJD have periodically been reviewed publicly with the TSEAC, especially when new information suggested that risks should be reevaluated. In the appendices we provide additional current relevant information on risks of transfusion-transmitted and plasma-derivative-transmitted vCJD.

______________________________________________________________________________________

General approaches of FDA policies to reduce risk of transmitting CJD and vCJD by blood products

______________________________________________________________________________________ ?

Reduce risk that a donor was exposed to the agent of bovine spongiform encephalopathy (BSE)

Dietary exposure “geographic” risk-adjusted deferrals: defer some donors who resided in some BSE countries (or were potentially exposed on military bases that imported beef from UK)

Other exposure: defer donors who injected UK bovine insulin

Reduce risk that donor was exposed to vCJD agent of human origin

Defer donors with a history of transfusion in UK after 1980

Defer donors with a history of transfusion in France after 1980

Other steps were discussed at TSEAC meetings, but FDA was not advised to consider: history of transfusion in other BSE country besides UK and France after 1980; history of surgery in high-risk BSE countries after 1980 (suggested by one TSEAC member)

______________________________________________________________________________________

There have been six general bases for FDA’s recommended CJD/vCJD-related deferrals since 1983:

A. General CJD risk reduction. (1) CJD in a donor, (2) history of treatment with human cadaveric pituitary growth hormone or a dura mater allograft, and (3) history of CJD in a relative unless confirmed to be other than familial CJD or the donor PRNP genotype is found to be normal

B. vCJD risk reduction. (4) history of prolonged residence in most BSE countries (defined by USDA list of BSE-related import restrictions at 9 ) currently including UK, France or other European countries west of the Former Soviet Union (or residence/employment on a US military base in Europe during periods when beef was procured from UK), (5) history of transfusion in UK, or—more recently—history of transfusion in France, in or after 1980, and (6) injection with bovine insulin of UK origin in or after 1980

The most recent FDA CJD/vCJD-related donor deferral policies and the history of those are explained in full in FDA guidance issued on May 10, 2010

(http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf),


including minor modifications of the guidance of January 12, 2002. The following is a reduced summary of the essential features of the policy:

______________________________________________________________________________________

4

Summary of Current FDA CJD/vCJD-related Recommendations for Deferral of Blood Donors and Plasma Donors (see FDA guidance document issued May 10, 2010 at

http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf)


______________________________________________________________________________________

Indefinitely defer all donors of Whole Blood and Source Plasma who

have any form of CJD or are at increased risk of CJD (received dura mater allograft, were injected with human cadaveric pituitary growth hormone, have a relative with CJD unless familial CJD has been ruled out

spent 3 mo in UK from Jan 1, 1980 to Dec 31, 1996, or

who ever had blood transfusion in UK or in France from 1980 to present, or

who ever injected UK bovine insulin prepared in or after 1980, or

spent 5 yr in France from Jan 1, 1980 to the present

spent 6 mo on US military bases from Jan 1, 1980 to end of 1990 north of Alps or end of 1996 south of Alps Indefinitely defer all donors of Whole Blood but not donors of Source Plasma who

spent 5 yr in Europe from Jan 1, 1980 to the present (including time in spent in UK 1980-1996 and France 1980-present) Exempt from deferrals are

Donors of Source Plasma who spent time of any duration in Europe except UK and France

Donors of plasma/serum to manufacture FDA-approved non-injectable products (appropriately labeled per guidance of May 10, 2010)

______________________________________________________________________________________

The FDA-recommended CJD/vCJD-related blood safety policies are intended to reduce the risk that a blood or plasma donor might be incubating CJD of any kind while not deferring so many donors as to compromise the supply of blood products. The FDA’s assessment in advance of the January 2002 guidance estimated that the recommended deferral policy would reduce donor risk of dietary exposure to BSE agent by approximately 90% while deferring some 7% of otherwise suitable blood donors. The 2010 guidance—adding a deferral of donors transfused in France from 1980 to the present, as previously recommended for donors transfused in the UK—while reducing the risk of transfusion-transmitted vCJD by only a small amount, is expected to defer very few donors who would not have been previously deferred because they resided in France for five years or more.

As always, blood and plasma establishments may implement additional more stringent requirements. If they choose to do so, FDA encourages them to assess the possibility that such actions will contribute to shortages and to undertake preemptive donor recruitment efforts to prevent shortages. Recognition by FDA of USDA BSE-related import restrictions under 9 CFR 94.18 as a basis for FDA donor deferral policies. Since the FDA’s 1999 guidance, the FDA has acknowledged the USDA’s list of countries under restriction for the importation of live cattle and beef products into the US at 9 CFR 94.18 (“USDA BSE List” summarized in Appendix V) as a basis for identifying countries with increased risk of human food-

5

associated exposure to the BSE agent; most of the countries currently on the USDA BSE list are also listed on the current FDA donor deferral list (see Appendix IV), with three exceptions: the FDA has concluded that time spent in the UK after the end of 1996 should no longer pose an unacceptable risk of food-borne exposure to donors because of stringent food and animal feed controls implemented in the UK by that time; those measures were described at a TSEAC meeting


http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf



Time spent in Israel (one case of BSE reported in 2001) and Japan (36 cases of BSE detected from 2001 through 2009) have not been taken as a reason to defer blood donors; FDA had no information to predict the number of otherwise suitable donors who would be deferred because of time spent in Israel or Japan, and FDA had concern that those numbers might be substantial in certain areas of the US.

Prospects for future modifications of FDA blood and plasma deferral policies to reduce the Possible Risk of Transmitting Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products

Prospects for donor screening tests. As mentioned above, the FDA recognizes the potential value of practical blood tests to detect and defer infected donors of blood and plasma during the asymptomatic incubation periods of vCJD and CJD. FDA continues to encourage the development and validation of such tests and has several times arranged for developers of candidate tests present interim progress reports of their investigations at open meetings of TSEAC and received advice from TSEAC regarding possible pathways leading to FDA licensure of validated donor screening tests

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t2.pdf


Effective testing would be a particularly attractive option for interdicting donors incubating forms of CJD other than vCJD, because no cases of transfusion-transmitted CJD or plasma-derivative-transmitted CJD have been detected in a lookback study (Dorsey, Zou et al. 2009), and many donors currently deferred because of risk factors for CJD might be re-entered if validated screening tests with high negative predictive values were not reactive. At the moment, no blood test has been validated as suitable for donor screening

http://biotuesday.ca/2010/05/31/amorfix-suspends-blood-testing-for-vcjd


Prospects for prion-protein and infectivity removal devices. Three TSE infectivity reduction devices, in development, have targeted the RBC component of Whole Blood. Two of the devices both deplete white blood cells (leukoreduction [LR]) and reduce the content of TSE agents in pilot studies. One of these devices is a modified LR filter containing several layers of prion-protein-removing material (Sowemimo-Coker, Demczyk et al. 2010. The second manufacturer is developing a combined LR and prion removal device (Miura M, Nirasawa H et al. in Abstracts of the AABB Meeting, 2006 SP221. Evaluation of a new combination filter for prion and leukoreduction (LR) of red cell concentrates (RCC), accessible at

http://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2006.01023_1.x/pdf


The third filter is applied to leukoreduced RBC; the active component is a proprietary ligand claimed to adsorb both brain-derived and endogenous blood infectivity (Gregori, Gurgel et al. 2006). This filter was evaluated for safety and impact on component quality in the UK (Cahill, Murphy et al 2010; Wiltshire, Thomas et al. 2010). In April 2009 an independent UK Advisory Committee on Safety of Blood, Tissues and Organs (SaBTO recommended that “ …UK blood services … prepare to enable implementation of Prion filtration as soon as

6

practicable, should a final recommendation to do so be made.”


http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_099922.pdf



and later, in October 2009, recommended, with reservations, that “… filtered red cells be provided to those born since 1 January 1996, subject to satisfactory completion of …[an ongoing]… clinical trial”


http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_108860.pdf


http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_112477.pdf



—presumably because the risk of food-borne exposure to the BSE agent should be considerably less in younger than for older UK residents, for whom the reduced risk offered by filtration might be more difficult to justify. No “prion filter” device has been licensed for use in the US. Representatives of the sponsors developing the three devices are to describe some of their findings at the FDA TSE Advisory Committee meeting on October 29, 2010


(http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm225805.htm).


Implementation of measures to reduce dietary risk of exposure to the BSE agent in countries other that the UK. As presented to the 21st meeting of TSEAC on June 12, 2009


(http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM171810.pdf),




the European Commission (EC) has promulgated legislation (EC Regulation 999, 2001) obligatory throughout the European Union (EU) requiring implementation of a number of BSE-risk-reducing steps (see Appendix IV) similar to those implemented earlier in the UK (Appendix IV). The FDA has, with some exceptions, based recommendations to defer blood and plasma donors at increased risk of BSE exposure on the USDA import restriction list at 9 CFR 94.18 to determine when those steps have been adequately and uniformly implemented in various countries.


International recognition of BSE status of countries and of the declining BSE epidemics. The EC Scientific Steering Committee, in January 2000, recommended grouping countries based on their geographical BSE risk (GBR)



http://ec.europa.eu/food/fs/sc/ssc/out68_en.pdf



Four groups were recognized:

GBR I: highly unlikely to have BSE;

GBR II: unlikely but not excluded;

GBR III: likely but not confirmed or confirmed at a low level; GBR IV: confirmed at a high level. That system for evaluating BSE risk was once widely used but is no longer supported.

The World Organisation for Animal Health (OIE) subsequently developed a system to evaluate national BSE risk based on voluntary submissions of information to an ad hoc committee for BSE status based on five main criteria used to assess the BSE risk for the cattle population of a country: risk assessment for BSE occurrence; on-going program to encourage reporting of neurological diseases in adult cattle; compulsory notification and investigation of all cattle showing BSE-like symptoms; BSE active surveillance; testing of cattle brain or other tissues. The OIE currently assigns to each country one of three BSE risk categories: negligible, controlled or undetermined (for those countries that either did not apply or failed to be classified). As of May 2010, 47 countries had been assigned a BSE risk status by the OIE: 13 countries (including three on the USDA BSE

7

Import Restriction List) had been assigned negligible BSE risk status, and 34 countries, including the US and Canada, were recognized as having controlled BSE risk—the same risk status assigned to most European countries including the UK and France (http://www.oie.int/eng/Status/BSE/en_BSE_free.htm). The FDA welcomes efforts to improve estimates of relative risk for exposure to the BSE agent in beef products of various national origins and to develop an international BSE risk evaluation system acceptable to US authorities and those of other countries. ...

snip...see full text ;


http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM231179.pdf





When the OIE and the USDA et al collaborated to make legal the trading of Transmissible Spongiform Encephalopathy, when they did away with the BSE GBR risk assessments, where the USA, Canada, and Mexico were categorized as BSE GBR III.



please see ;



EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.



http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902594180.htm



Annex to the EFSA Scientific Report (2004) 3, 1-17 on the Assessment of the Geographical BSE Risk of USA

please see full text ;


http://www.efsa.europa.eu/en/scdocs/doc/3rax1.pdf



October 28-29, 2010:

Transmissible Spongiform Encephalopathies Advisory Committee Meeting References Document Posted: 10/26/2010


http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm231016.htm



October 28-29, 2010:

Transmissible Spongiform Encephalopathies Advisory Committee Meeting A 2010 Update of the Draft Quantitative Risk Assessment of vCJD Risk Potentially Associated with the Use of Human Plasma-Derived Factor VIII Manufactured Under United States (US) License From Plasma Collected in the US (PDF - 662KB) Posted: 10/26/2010


http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm231016.htm



October 28-29, 2010:

Transmissible Spongiform Encephalopathies Advisory Committee Meeting Document: APPENDIX A Supplemental technical information for the FDA Risk Assessment (PDF - 307KB) Posted: 10/26/2010 Roster of the Transmissible Spongiform Encephalopathies Advisory Committee Updated: 10/22/2010


http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM231019.pdf



Roster of the Transmissible Spongiform Encephalopathies Advisory Committee Updated: 10/22/2010


http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm129556.htm




Tuesday, September 14, 2010


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


----- Original Message -----


http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html




----- Original Message -----

From: Emery, Bryan (CBER)

To: CBER OCOD Consumer Account ; 'flounder9@verizon.net'

Sent: Friday, September 17, 2010 10:08 AM

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

Hi Terry,

Thank you for your comments related to the Transmissible Spongiform Encephalopathy's Advisory Committee meeting on October 28-29, 2010.

Your comments will be provided to the Committee.

Thanks

Bryan Emery

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

Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010

Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512392.

http://edocket.access.gpo.gov/2010/2010-22805.htm



snip...end...full text ;


http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html




Monday, October 18, 2010


TSEAC Transmissible Spongiform Encephalopathies Advisory Committee Draft Agenda and Meeting Materials, Posted: 10/18/2010


http://tseac.blogspot.com/2010/10/tseac-transmissible-spongiform.html



__._,_.___



Tuesday, September 14, 2010


Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010


http://tseac.blogspot.com/2010/09/transmissible-spongiform.html




----- Original Message -----

From: Emery, Bryan (CBER) To: 'Terry S. Singeltary Sr.'

Cc: Emery, Bryan (CBER)

Sent: Monday, January 24, 2011 7:35 AM

Subject: RE: October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee

Hi Terry,

The minutes have not been my primary focus at this time but when they are completed they will be put online for the public. I have nothing to hide just very busy as of late. Thank you for your interest, I hope to see you again soon.

Thanks LCDR Bryan Emery

--------------------------------------------------------------------------------

From: Terry S. Singeltary Sr. [mailto:flounder9@verizon.net]

Sent: Wednesday, January 19, 2011 1:03 PM

To: Emery, Bryan (CBER)

Subject: October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee

re-October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee

Greetings Dr. Emery,

I am trying to locate the minutes or draft minutes of the October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee meeting ???

seems they are long overdue to be put online.

can you please tell me when and if they are going to be made public ???

many thanks,

kindest regards, terry

Tuesday, January 18, 2011

Agent strain variation in human prion disease: insights from a molecular and pathological review of the National Institutes of Health series of experimentally transmitted disease

http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/agent-strain-variation-in-human-prion.html




sadly, by only trying to reduce exposure from only nvCJD, they are seriously missing the bigger picture. hell, now we have mixtures of different phenotypes in one species, what about transmission of the TSE agent via mulitple phenotypes from one donor ??? transmission studies ??? etc. .......they missed the boat a long time ago. i believe i said in 2001 ;

"I am beginning to think that the endless attempt to track down and ban, potentia.1 victims from known BSE Countries from giving blood will be futile. You would have to ban everyone on the Globe eventually? AS well, I think we MUST ACT SWIFTLY to find blood test for TSE's, whether it be blood test, urine test, .eyelid test, anything at whatever cost, we need a test FAST."


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



end...tss




Saturday, September 5, 2009


TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS


http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html




From: Terry S. Singeltary Sr.

To: FREAS@CBER.FDA.GOV

Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov

Sent: Friday, December 01, 2006 2:59 PM

Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION PART III]

page 1 starts on page 13, then come back to page 1 to finish.....tss


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8




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




World's first blood test for vCJD developed in MRC lab


Thursday 3 February 2011


The world's first accurate blood test for variant Creutzfeldt-Jakob disease (vCJD) has been developed by Medical Research Council (MRC) scientists. The prototype, which is 100,000 times more sensitive than any previous attempt, could transform the diagnosis and screening of the brain disease.

Variant CJD, the human form of BSE (or mad cow disease) first emerged in 1995. The disease, which affects the brain, is believed to have passed from cattle to humans through infected food. It causes personality change, loss of body function, and eventually death.

The research team from the MRC Prion Unit, based at University College London, working with the National Prion Clinic at the National Hospital for Neurology and Neurosurgery (NHNN) tested 190 blood samples, including 21 from individuals known to have vCJD. The blood test was able to detect blood spiked with a dilution of vCJD to within one part per ten billion - 100,000 times more sensitive than any other method developed so far.

Prions, the infectious proteins which cause vCJD and other fatal prion diseases, can inhabit a person's body for up to 50 years before presenting symptoms. During this time there is a chance a carrier of vCJD infection could pass on the infection to others, for example through blood transfusion or even through surgical and medical instruments as prions can easily attach onto metal surfaces.

A widely available, accurate blood test would enable people to be diagnosed earlier and could also help identify carriers of the disease. This would help measure how widespread the prion infection is in the general population and identify those who are at risk of passing on the infection to others.

Lead author Dr Graham Jackson, Programme Leader at the MRC Prion Unit, said:

"This test comes at the end of many years of meticulous, painstaking research in our Unit and the NHS National Prion Clinic. Although further larger studies are needed to confirm its effectiveness, it's the best hope yet of a successful early diagnostic test for the disease. This test could potentially go on to allow blood services to screen the population for vCJD infection, assess how many people in the UK are silent carriers and prevent onward transmission of the disease."

Professor John Collinge, Director of the MRC Prion Unit, said:

"One of the reasons that vCJD is such a dreaded disease and has caused such disruption and expense to health services is the lack of knowledge of who is and who is not a carrier of this infection. The next step will be to test anonymously several thousand blood donors from a country unaffected by BSE in order to gain a better idea of how the test fares in practice. Longer term studies will also be needed to assess what proportion of individuals who test positive for prion infection will then go on to develop the disease later in life.

"The MRC Prion Unit's research with the NHS National Prion Clinic to improve early diagnosis is an essential part of the wider MRC strategy to develop better treatments for patients. For this to develop, it will be crucial for clinicians to be able to offer treatment before extensive irreversible damage to the brain has occurred. At the moment, a firm diagnosis of vCJD can usually be made only once serious symptoms of the disease have developed which indicate extensive damage to the brain."

The study 'A blood-based assay for the detection of vCJD prion infection' is published today in the journal The Lancet.

Ends

Notes to editors:

To arrange an interview with the researchers of this paper, please call the MRC Press Office on 0207 395 2345.

For almost 100 years the Medical Research Council has improved the health of people in the UK and around the world by supporting the highest quality science. The MRC invests in world-class scientists. It has produced 29 Nobel Prize winners and sustains a flourishing environment for internationally recognised research. The MRC focuses on making an impact and provides the financial muscle and scientific expertise behind medical breakthroughs, including one of the first antibiotics penicillin, the structure of DNA and the lethal link between smoking and cancer. Today MRC funded scientists tackle research into the major health challenges of the 21st century. www.mrc.ac.uk

While the number of vCJD samples available for analysis was inherently small, and to date only a small number of healthy donors has been studied, analysis of this blinded panel indicated an assay sensitivity for vCJD of over 71% (15/21, CI 48-89%) and a specificity of 100% (0/169, CI 98-100%).

The NHNN forms part of University College London Hospitals NHS Foundation Trust, one of the largest NHS trusts in the United Kingdom providing first-class acute and specialist services. The Trust is committed to research and development and forms part of UCL Partners which in March 2009 was officially designated as one of the UK's first academic health science centres by the Department of Health. UCLH works closely with UCL, translating research into treatments for patients. www.uclh.nhs.uk

http://www.mrc.ac.uk/Newspublications/News/MRC007683




Wednesday, February 2, 2011


Detection of prion infection in variant Creutzfeldt-Jakob disease: a blood-based assay


http://transmissiblespongiformencephalopathy.blogspot.com/2011/02/detection-of-prion-infection-in-variant.html




Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America

14th ICID International Scientific Exchange Brochure -

Final Abstract Number: ISE.114

Session: International Scientific Exchange

Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America

update October 2009

T. Singeltary

Bacliff, TX, USA

Background:

An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and fed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.

Methods:

12 years independent research of available data

Results:

I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.

Conclusion:

I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.


page 114 ;


http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf




International Society for Infectious Diseases Web: http://www.isid.org/



please see full text ;


http://transmissiblespongiformencephalopathy.blogspot.com/




Seven main threats for the future linked to prions

The NeuroPrion network has identified 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...

http://www.neuroprion.org/en/np-neuroprion.html




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.


http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2




Saturday, January 29, 2011

Atypical L-Type Bovine Spongiform Encephalopathy (L-BSE) Transmission to Cynomolgus Macaques, a Non-Human Primate

Jpn. J. Infect. Dis., 64 (1), 81-84, 2011


http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html




Tuesday, November 02, 2010

BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only) diagnostic criteria CVL 1992


http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html




Wednesday, July 28, 2010

Atypical prion proteins and IBNC in cattle DEFRA project code SE1796 FOIA Final report


http://bse-atypical.blogspot.com/2010/07/atypical-prion-proteins-and-ibnc-in.html




Thursday, November 18, 2010


UNITED STATES OF AMERICA VS GALEN J. NIEHUES FAKED MAD COW FEED TEST ON 92 BSE INSPECTION REPORTS FOR APPROXIMATELY 100 CATTLE OPERATIONS


http://bse-atypical.blogspot.com/2010/11/united-states-of-america-vs-galen-j.html




Friday, August 27, 2010


NEW ATYPICAL NOR-98 SCRAPIE CASE DETECTED IDAHO NOW 5 CASES DOCUMENTED 2010


http://nor-98.blogspot.com/2010/08/new-atypical-nor-98-scrapie-case.html




Thursday, August 19, 2010

SCRAPIE CANADA UPDATE Current as of 2010-07-31 The following table lists sheep flocks and/or goat herds confirmed to be infected with scrapie in Canada in 2010.

Current as of: 2010-07-31


http://nor-98.blogspot.com/2010/08/scrapie-canada-update-current-as-of.html




the OIE and the USDA systematically changed the science with the BSE MRR policy, and put everyone around the globe at risk by taking us back to ground zero 1984-1985 kent bse cow.

Saturday, June 19, 2010

U.S. DENIED UPGRADED BSE STATUS FROM OIE


http://usdameatexport.blogspot.com/2010/06/us-denied-upgraded-bse-status-from-oie.html




Tuesday, January 25, 2011

Generation of a new form of human PrPSc in vitro by inter-species transmission from cervids prions


http://chronic-wasting-disease.blogspot.com/2011/01/generation-of-new-form-of-human-prpsc.html




Wednesday, September 08, 2010

CWD PRION CONGRESS SEPTEMBER 8-11 2010


http://chronic-wasting-disease.blogspot.com/2010/09/cwd-prion-2010.html




Friday, February 04, 2011

NMLB and USDA allow scrapie prion infected mutton to enter food chain on the Navajo Reservation in New Mexico


http://scrapie-usa.blogspot.com/2011/02/nmlb-and-usda-allow-scrapie-prion.html




Wednesday, January 19, 2011

EFSA and ECDC review scientific evidence on possible links between TSEs in animals and humans Webnachricht 19 Januar 2011


http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/efsa-and-ecdc-review-scientific.html




Tuesday, January 18, 2011

Agent strain variation in human prion disease: insights from a molecular and pathological review of the National Institutes of Health series of experimentally transmitted disease


http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/agent-strain-variation-in-human-prion.html




Tuesday, December 14, 2010

Infection control of CJD, vCJD and other human prion diseases in healthcare and community settings part 4, Annex A1, Annex J, UPDATE DECEMBER 2010


http://creutzfeldt-jakob-disease.blogspot.com/2010/12/infection-control-of-cjd-vcjd-and-other.html




Sunday, January 30, 2011

Vaccines and Transmissible Spongiform Encephalopathy the Prion Disease, what if ?

COMMERCIAL IN CONFIDENCE


http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/vaccines-and-transmissible-spongiform.html




strictly NOT private and confidential $$$


Saturday, January 22, 2011

Alzheimer's, Prion, and Neurological disease, and the misdiagnosis there of, a review 2011


http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/alzheimers-prion-and-neurological.html




Monday, September 13, 2010


atypical BSE strains and sporadic CJD strains, is there a connection and why shouldn't there be $


http://bse-atypical.blogspot.com/2010/09/atypical-bse-strains-and-sporadic-cjd.html




Sunday, August 15, 2010


ATYPICAL BSE NOW LINKED TO CAUSING SPORADIC CJD OVERSEAS Commonwealth of Australia


http://bse-atypical.blogspot.com/2010/08/atypical-bse-now-linked-to-causing.html




Thursday, July 08, 2010


GLOBAL CLUSTERS OF CREUTZFELDT JAKOB DISEASE - A REVIEW 2010


http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html





DID EVERYONE THAT LOST A LOVED ONE FILL OUT THEIR CJD QUESIONNAIRE FROM THE CDC AND OR THE CJD FOUNDATION ???


Friday, November 30, 2007


CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION


http://cjdquestionnaire.blogspot.com/




TSS