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NORDION (US), INC., AND BIOAXONE BIOSCIENCES, INC., Settles $90M Mad Cow TSE prion Contamination Suit Cethrin(R)

Posted Sep 24 2013 3:48pm
Case 0:12-cv-60739-RNS Document 1 Entered on FLSD Docket 04/26/2012 Page 1 of 15

 

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA Ft. Lauderdale Division

 

CASE NO.

 

BIOAXONE BIOSCIENCES, INC., a Florida corporation, as successor in interest to Bioaxone Therapeutic, Inc., a Canadian Business corporation, Plaintiff,

 

v.

 

NORDION (US), INC., a Delaware corporation, formerly known as MDS, INC.; and RICERCA BIOSCIENCES, LLC., a Delaware Limited Liability Company, as successor in interest to MDS PHARMA SERVICES, INC., a Nebraska corporation, Defendants.

 

_____________________________

 

COMPLAINT FOR MONEY DAMAGES AND DEMAND FOR TRIAL BY JURY

 

Plaintiff, BIOAXONE BIOSCIENCES, INC., a Florida corporation with its principal place of business in Ft. Lauderdale, Florida ("Bioaxone" or "Plaintiff")!, by and through its undersigned counsel, files this civil action against Defendant, NORDION (US), INC., a lBioAxone acquired all of the assets, including all rights to the drug Cethrin, from BioAxoneTherapeutique, Inc., a Canadian business corporation (''Therapeutique''). Therapeutique conveyed all of its intellectual property, as well as the name "Cethrin" to BioAxone. Therapeutique also transferred all rights in the clinical trial of Cethrin, including the Clinical Master Trial File, the investigation of a new drug (INO) file with the FDA, and the Clinical Trial Application (CTA) with Health Canada. Therefore, BioAxone is the successor in interest to all rights previously owned by' Therapeutique.

 

Case 0:12-cv-60739-RNS Document 1 Entered on FLSD Docket 04/26/2012 Page 2 of 15

 

Delaware corporation ("Nordion"), formerly known as MDS, INC., with its principal place of business in Ottawa, Ontario; and RICERCA BIOSCIENCES, LLC., a Delaware limited liability company with its principal place of business in Concord, Ohio ("Ricerca"), as the successor in interest of MDS PHARMA SERVICES, INC., a Nebraska corporation, ("MDS"); collectively referred to as the "Defendants." NORDION is a foreign corporation authorized to transact business in the State of Florida. MDS PHARMA SERVICES, INC. was a wholly owned subsidiary of MDS, INC., now known as NORDION (US), INC., and was a foreign corporation authorized to do and doing business in the State of Florida. RICERCA is a foreign limited liability company authorized to transact business in the State of Florida which is the successor in interest to MDS PHARMA SERVICES, INC., through its purchase and acquisition of MDS PHARMA SERVICES, INC., on or about March 2010.

 

NATURE OF THE CASE

 

1. This is an action for negligence against the Defendants arising from the improper and negligent use of contaminated material in the preparation of the Bacterial Master Cell Bank ("MCB") for a new breakthrough drug, Cethrin" (BA-21 0), researched and developed by BIOAXONE. Cethrin is a biologic drug that will provide the most advanced treatment for patients who have suffered acute spinal cord injury. Defendants negligently prepared the MCB using kanamycin they purchased that was made in China and that contained beef broth and avian products. The MCB is contaminated with beef broth and avian products that cause human disease including bovine spongiform encephalopathy ("BSE"), commonly known as mad cow disease, which created an unreasonably dangerous risk of the development of BSE in patients to whom the Cethrin made from the contaminated MCB would be administered.

 

Case 0:12-cv-60739-RNS Document 1 Entered on FLSD Docket 04/26/2012 Page 3 of 15

 

JURISDICTION AND VENUE

 

2. This Court has subject matter jurisdiction pursuant to 28 V.S.C. § 1332 because the matter in controversy exceeds the minimum jurisdictional requirements of this Court and because the Plaintiff is a citizen of a state different from the Defendants.

 

3. Venue for this action is proper in this Court because each Defendant holds a certificate of authority to transact business in Florida. is registered to transact business in Florida. and Plaintiff resides and transacts business in this District. Many of the acts that are alleged in this Complaint occurred in this District and at least one of the Defendants can be found, resides, or transacts business in this District.

 

4. At all times material hereto, the parties hereto transacted business related to Cethrin in Florida by and through their employees and/or agents including but not limited to participating in telephonic and in person meetings, correspondence, and making and/or accepting payments.

 

5. MDS PHARMA SERVICES, INC., was a wholly owned subsidiary of MDS, INC., now known as Defendant, NORDION. As its wholly owned subsidiary, NORDION, exercised extensive control over MDS PHARMA SERVICES and, as such, MDS PHARMA SERVICES, served as the agent or apparent agent of NORD ION. In addition, NORDION sells its products in Florida and as such its products are in the stream of commerce throughout the State of Florida. PARTIES

 

6. At all times material hereto, Plaintiff, BIOAXONE, was and is the owner and developer of Cethrin, a new breakthrough biologic drug providing treatment for patients who have suffered acute spinal cord injury. Defendant, MDS was retained by BIOAXONE to create, prepare, and qualify a Bacterial Master Cell Bank to be used in the development of Cethrin.

 

7. At all times material hereto, Defendant, MDS PHARMA SERVICES, INC., provided discovery, pre-clinical studies, and clinical trial services to biopharmaceutical and biotechnology companies incorporated and doing business in Florida. such as BIOAXONE.

 

SNIP...

 

27. On or about October 16, 2008, a formal status report was provided to BIOAXONE during which BIOAXONE was informed, for the first time, that the MCB was not GMP compliant.

 

28. At all times prior to October 16, 2008, MDS/RICERCA had actual or constructive knowledge that the kanamycin it purchased and used in the preparation of the MCB for BIOAXONE was contaminated and was not fit or intended for use in humans.

 

29. At all times prior to October 16,2008, MDS/RICERCA had actual or constructive knowledge that the purchase and use of contaminated kanamycin in the preparation of the MCB for BIOAXONE created an unreasonably dangerous and foreseeable risk of adventitious agents that cause human disease including the development of BSE or mad cow disease in humans.

 

30. At all times material hereto, MDS/RICERCA knew that the preparation of the MCB for

 

 Case 0:12-cv-60739-RNS Document 1 Entered on FLSD Docket 04/26/2012 Page 9 of 15

 

BIOAXONE was for use in the development of a biologic drug, Cethrin, to be administered to humans.

 

31. At all times prior to October 16, 2008, MDS/RICERCA had actual or constructive knowledge that the purchase and use of contaminated kanamycin in the preparation of the MCB for BIOAXONE created a foreseeable risk that the FDA would deem Cethrin adulterated and cause the FDA and/or any other regulatory agency to fail to approve its use as a drug product to be administered to human patients.

 

32. At all times material hereto, MDS/RICERCA knew or should have known that it had a continuing duty to follow and comply with the GMPs in the preparation of the MCB. In addition to ensuring compliance with the GMPs, MDS/RICERCA had a duty to follow its own standard operating procedures and quality assurance standards in its purchase and use of animal-free raw materials in the preparation and qualification of the MCB for BIOAXONE.

 

33. Despite its actual or constructive knowledge of its use of the contaminated kanamycin in the preparation of the MCB, MDS/RICERCA failed to diligently, timely, properly or otherwise inform BIOAXONE that the kanamycin used in the preparation and qualification of the MCB was animal-derived, was not fit or intended for human use, and, as a result, had contaminated the MCB.

 

 SNIP...END...(no url...TSS)

 

 The Clerk shall CLOSE this case. Any party may move to re-open the case if there is a problem in reaching a final settlement agreement. Any pending motions are DENIED as moot. DONE and ORDERED in chambers, at Miami, Florida on September 19,2013.

 

 Case 0:12-cv-60739-RNS Document 115 Entered on FLSD Docket 09/20/2013 Page 1 of 1

 

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA

 

Case No. 12-60739-Civ-SCOLA/ROSENBAUM

 

Bioaxone Biosciences, Inc., Plaintiff,

 

vs.

 

Nordion Inc. f/k/a/ MDS Inc.; Nordion (Canada) Inc. f/k/a/ MDS (Canada) Inc.; and Nordion (US) Inc. f/k/a MDS Pharma Services (US) Inc., Defendants.

 

------------------------------/

 

ORDER CLOSING CASE UPON NOTICE OF SETTLEMENT

 

THIS MA TIER is before the Court upon Plaintiff notifying the Court that a settlement had been reached with the remaining Defendants. The parties have settled this matter, and it will be administratively closed pending the filing of a stipulation of [mal dismissal, pursuant to Federal Rule of Civil Procedure 41 (a)(l )(A)(ii), or the Plaintiff moving for dismissal pursuant to Rule 41(a)(2). A stipulation of [mal dismissal, or a motion for dismissal, shall be filed by October 18, 2013. If the parties file a stipulation of final dismissal pursuant to Rule 41(a)(l)(A)(ii) and wish to have this Court retain jurisdiction to enforce their settlement, the parties must include the following sentence in their stipulation of dismissal: "The effectiveness of this stipulation of dismissal is conditioned upon the Court's entry of an order retaining jurisdiction to enforce the terms of the settlement agreement reached in this case." See Anago Franchising, Inc. v. Shaz, LLC, 677 F.3d 1272, 1280 (11th Cir. 2012). This sentence is required because a joint stipulation of dismissal is otherwise self-executing and deprives the Court of jurisdiction to do anything further. See id.

 

The Clerk shall CLOSE this case. Any party may move to re-open the case if there is a problem in reaching a final settlement agreement. Any pending motions are DENIED as moot. DONE and ORDERED in chambers, at Miami, Florida on September 19,2013.

 

ROBERT N. SCOLA, JR.

 

UNITED STATES DISTRICT JUDGE

 

 

 

END...SEPTEMBER 24, 2013...TSS

 

 

Nordion Settles $90M Mad Cow Contamination Suit
 
By Juan Carlos Rodriguez 0 Comments Law360, New York (September 23, 2013, 1:52 PM ET) -- Nordion Inc. on Thursday settled a $90 million lawsuit filed by Bioaxone Biosciences Inc. accusing it of contaminating the development of a spinal cord injury drug with animal products that could cause mad cow disease, leading federal regulators to deny the drug’s approval.
 
No details about the settlement in Florida federal court were available Monday, but U.S. District Judge Robert N. Scola ordered the case closed based on Bioaxone’s notice of settlement. He said if there was a problem finalizing the settlement, either party could move...
 
 
 
Medical Co. Launches $90M Suit Over Mad Cow Contamination
 
By Juan Carlos Rodriguez
 
Law360, New York (April 26, 2012, 6:09 PM ET) -- Bioaxone Biosciences Inc. on Thursday sued two partners for $90 million for allegedly contaminating the development of a spinal cord injury drug with animal products that could cause mad cow disease, leading the U.S. Food and Drug Administration to deny the drug's approval.
 
 
 
Nordion and BioAxone BioSciences Reach an Agreement to Settle Claims by Business Wire via The Motley Fool Sep 24th 2013 7:49AM
 
Updated Sep 24th 2013 7:50AM Nordion and BioAxone BioSciences Reach an Agreement to Settle Claims
 
OTTAWA, Canada--(BUSINESS WIRE)-- Nordion Inc. (TSX:NDN) (NYS: NDZ) has reached an agreement to settle claims filed against Nordion and its subsidiaries by BioAxone BioSciences, Inc. ("BioAxone") for a nominal amount. The parties are finalizing the settlement documents, which are expected to be confidential.
 
During fiscal 2012, Nordion was served with a Complaint relating to the Company's former MDS Pharma Services business. This legal action, commenced by BioAxone in Florida, related to the preparation and qualification of a Bacterial Master Cell Bank relating to the development of a biologic drug. BioAxone further alleged that it had suffered damages in an amount greater than US$90 million.
 
The settlement is expected to have a non material impact on Nordion's financial position, which the Company intends to report in its fourth quarter fiscal 2013 results.
 
About Nordion Inc.
 
Nordion Inc. (TSX:NDN) (NYS: NDZ) is a global health science company that provides market-leading products used for the prevention, diagnosis and treatment of disease. We are a leading provider of medical isotopes and sterilization technologies that benefit the lives of millions of people in more than 40 countries around the world. Our products are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. Nordion has approximately 450 highly skilled employees in three locations. Find out more at www.nordion.com and follow us at http://twitter.com/NordionInc .
 
Forward-Looking Statements
 
Certain statements contained in this news release constitute "forward-looking statements" relating to an agreement to settle a claim against Nordion and its subsidiaries and the settlement's impact on Nordion's financial position. These statements are based on current beliefs and assumptions of management, however are subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from the forward-looking statements in this news release as the settlement documents have not yet been finalized and the Company is in the middle of its fourth quarter and results are not yet available.
 
For additional information with respect to certain of these and other beliefs, assumptions, risks and uncertainties, please refer to Nordion's Annual Information Form for fiscal 2012 available on SEDAR at www.sedar.com and on EDGAR on www.sec.gov. These documents are also available on Nordion's website at www.nordion.com.
 
 Nordion INVESTORS: Ana Raman, 613-595-4580 investor.relations@nordion.com or MEDIA: Shelley Maclean, 613-592-3400 x 2414 shelley.maclean@nordion.com
 
KEYWORDS: North America Canada
 
INDUSTRY KEYWORDS:
 
The article Nordion and BioAxone BioSciences Reach an Agreement to Settle Claims originally appeared on Fool.com.
 
 
 
BioAxone receives FDA approval for acute spinal cord injury trial MONTREAL, Jan. 11 /CNW Telbec/ -
 
BioAxone Therapeutic Inc. has announced that the US Food and Drug Administration (FDA) Centre for Drug Evaluation and Research has approved the Company's investigational new drug (IND) application for Cethrin(R) (BA-210) in acute spinal cord injury (SCI). The Company had previously received approval from Health Canada for initiation of its clinical program with Cethrin(R) in Canada. The approval of the IND submission paves the way for the initiation of the human clinical trial program in the USA.
 
BioAxone will assess the safety and efficacy of several doses of BA-210 in this clinical trial. The trial will enroll up to 48 patients with complete, thoracic or cervical SCI who have no motor or sensory function in the sacral segment of their spinal cord, and who are scheduled to undergo spinal decompression surgery within 7 days of their injury.
 
"BA-210 is a recombinant protein which acts as a Rho antagonist to promote neurogeneration and neuroprotection in the Central Nervous System (CNS). It has been designed by BioAxone to penetrate CNS tissue and is being developed for delivery at the site of spinal cord injury during surgical intervention," said Dr. Henry E. Khouri, Vice-President of Clinical Development at BioAxone.
 
"We are excited about the potential of this treatment," said the study Principal Investigator, Dr. Michael Fehlings, Neurosurgeon and Medical Director, Krembil Neuroscience Center, Toronto Western Hospital and Professor of Neurosurgery, University of Toronto.
 
"The delivery of Cethrin(R) represents a unique approach to this treatment as it requires a single application, is non-invasive and will minimize risk to patients," Dr. Fehlings added. "As the Company's first approved IND application, this is a significant and exciting milestone for BioAxone. We are eager to start the study in the US," Dr. Khouri added.
 
About BioAxone. BioAxone Therapeutic is a privately held neuroscience Company based in Montreal, whose goal is to develop and commercialize products which meet significant medical needs in spinal cord injury and retinal eye diseases, such as macular degeneration. The Company specializes in the development and commercialization of proprietary technologies that target Rho signaling. Other products in the development stage are second-generation recombinant protein compounds. The Company also has small molecule Rho kinase inhibitors under preclinical investigation.
 
 
 
BioAxone Therapeutic Study Demonstrates Positive Interim Results for Spinal Cord Injury Six-week Follow-up Results of Phase I/IIa Trial Show Safety, Tolerability and Neurological Outcome of Cethrin(R)
 
MONTREAL, Nov. 27 /PRNewswire/ -
 
BioAxone Therapeutic announced today positive interim results on its Phase I/IIa North American dose escalation clinical trial on Cethrin(R) for the treatment of acute spinal cord injury (SCI). The Company reported that data on safety, tolerability and neurological outcome from the six-week follow-up of the trial of Cethrin(R) at four dose levels (0.3, 1, 3 and 6 mg) indicates that this treatment is safe and well tolerated and that the functional benefit may be dose dependent.
 
The twelve-month study is evaluating 37 patients from 9 centers in the U.S. and Canada who suffered a complete thoracic or cervical injury (i.e. ASIA Grade A, having no sensory or motor function below the level of the spinal cord injury).
 
"We have now passed the most critical period of observation regarding the safety of Cethrin(R) with more than half of the patients having completed their six-month follow-up. None of the patients has shown any adverse events related to the administration of this drug and the outcome continues to be encouraging for patients who have completed the six-month follow-up," said Dr. Michael Fehlings, the lead investigator for the study. Dr. Fehlings is a Professor of Neurosurgery at the University of Toronto and holds the Krembil Chair in Neural Repair and Regeneration at Toronto Western Hospital.
 
The trial is not placebo controlled but has an efficacy component based on the American Spinal Injury Association's (ASIA) scale which is designed to assess sensory and motor function in patients. In this trial, 31% of patients, after six weeks, recovered some sensory and/or motor function below the level of their injury and converted from a complete injury to an incomplete injury.
 
"We are excited about Cethrin(R)'s excellent safety profile and the neurological outcomes observed to date," said Dr. Frank Bobe, President and CEO of BioAxone. "BioAxone is at the frontier of this new science and we are actively looking for commercial partners to join us in accelerating the development of Cethrin(R)."
 
Cethrin(R) is a recombinant protein that is topically delivered onto the spinal cord during decompression/stabilization surgery. "Cethrin(R) is the first of a new class of drugs that is specifically designed to penetrate cells and inhibit Rho, a signaling master switch whose activation triggers cell death and exacerbates spinal cord damage following injury," said Dr. Patrick Tremblay, Vice President of Research and Development at BioAxone.
 
There are currently no effective therapies for spinal cord injury and the nearly 12,000 new patients each year in North America alone. Despite significant scientific breakthroughs existing clinical interventions remain limited to reducing local inflammation of the spinal cord.
 
About Cethrin(R)
 
Cethrin(R)'s active ingredient, BA-210, is a recombinant protein which acts as a Rho GTPase antagonist to promote neuroprotection and neuroregeneration in the central nervous system (CNS). It was engineered by BioAxone to effectively penetrate into CNS tissue, where it has been clearly shown to elicit the rescue and repair of damaged neurons in preclinical animal models. To obtain Cethrin(R), BA-210 is mixed with a commercially available fibrin sealant, Tisseel(R), and is delivered in a single dose directly onto the dura mater of the spinal cord during decompression/stabilization surgery. Cethrin(R) was granted orphan drug status by the U.S. Food and Drug Administration (FDA) in December 2005.
 
About BioAxone Therapeutic
 
BioAxone is a privately owned neuroscience company specializing in the development and commercialization of proprietary technologies that target Rho signaling. Established in April 2000 and headquartered in Montreal, Canada, BioAxone has demonstrated expertise in recombinant protein product development and has a focused small-molecule program. SOURCE BIOAXONE THERAPEUTIC INC.
 
 
 
 
Greetings,
 
JUST MAKES me mad as hell. all these damn tort laws to protect the companies that expose you to this crap, to where if you are exposed and or even if you go on later and have the disease and die, TORT laws again protect the company that manufactures these products. but yet, the company or industry can suit each other at will, win 90 MILLION dollar verdicts (or whatever they got in this case) over potential mad cow tainted product, but yet, when the consumers consume, and are then exposed, and or infected, you just have more TORT REFORM, to these blatant acts of greed, and not much recourse. this is not right. ...
 
 
 
================================================
 
 
BioAxone Therapeutic Inc. has announced that the US Food and Drug Administration (FDA) Centre for Drug Evaluation and Research has approved the Company's investigational new drug (IND) application for Cethrin(R) (BA-210) in acute spinal cord injury (SCI). The Company had previously received approval from Health Canada for initiation of its clinical program with Cethrin(R) in Canada. The approval of the IND submission paves the way for the initiation of the human clinical trial program in the USA.
 
BioAxone will assess the safety and efficacy of several doses of BA-210 in this clinical trial. The trial will enroll up to 48 patients with complete, thoracic or cervical SCI who have no motor or sensory function in the sacral segment of their spinal cord, and who are scheduled to undergo spinal decompression surgery within 7 days of their injury.
 
"BA-210 is a recombinant protein which acts as a Rho antagonist to promote neurogeneration and neuroprotection in the Central Nervous System (CNS). It has been designed by BioAxone to penetrate CNS tissue and is being developed for delivery at the site of spinal cord injury during surgical intervention," said Dr. Henry E. Khouri, Vice-President of Clinical Development at BioAxone.
 
31. At all times prior to October 16, 2008, MDS/RICERCA had actual or constructive knowledge that the purchase and use of contaminated kanamycin in the preparation of the MCB for BIOAXONE created a foreseeable risk that the FDA would deem Cethrin adulterated and cause the FDA and/or any other regulatory agency to fail to approve its use as a drug product to be administered to human patients.
 
 
================================================
 
 
 JUST WHAT ABOUT USA TISSUE DONOR HERDS ??
 
 
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;
 
 
SNIP...SEE FULL TEXT ;
 
 
U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001
 
 
 
Monday, August 26, 2013
 
***The Presence of Disease-Associated Prion Protein in Skeletal Muscle of Cattle Infected with Classical Bovine Spongiform Encephalopathy
 
 
 
Monday, March 19, 2012
 
***Infectivity in Skeletal Muscle of Cattle with Atypical Bovine Spongiform Encephalopathy PLoS One. 2012; 7(2): e31449.
 
 
 
***Infectivity in skeletal muscle of BASE-infected cattle
 
 
 
Wednesday, April 06, 2011
 
***Presence and Seeding Activity of Pathological Prion Protein (PrPTSE) in Skeletal Muscles of White-Tailed Deer Infected with Chronic Wasting Disease
 
 
 
Sunday, November 21, 2010
 
***Preclinical Deposition of Pathological Prion Protein in Muscle of Experimentally Infected Primates and potential Iatrogenic TSE there from Preclinical Deposition of Pathological Prion Protein in Muscle of Experimentally Infected Primates
 
 
 
EMBO reports AOP Published online: 11 April 2003
 
 
***Widespread PrPSc accumulation in muscles of hamsters orally infected with scrapie
 
 
Achim Thomzig, Christine Kratzel, Gudrun Lenz, Dominique KrÒ¼ger & Michael Beekes Robert Koch-Institut, P26, Nordufer 20, D-13353 Berlin, Germany
 
Received 13 February 2003; Accepted 13 March 2003; Published online 11 April 2003.
 
Abstract :
 
Scrapie, bovine spongiform encephalopathy and chronic wasting disease are orally communicable, transmissible spongiform encephalopathies (TSEs). As zoonotic transmissions of TSE agents may pose a risk to human health, the identification of reservoirs for infectivity in animal tissues and their exclusion from human consumption has become a matter of great importance for consumer protection. In this study, a variety of muscles from hamsters that were orally challenged with scrapie was screened for the presence of a molecular marker for TSE infection, PrPSc (the pathological isoform of the prion protein PrP). Sensitive western blotting revealed consistent PrPSc accumulation in skeletal muscles from forelimb and hindlimb, head, back and shoulder, and in tongue. Previously, our animal model has provided substantial baseline information about the peripheral routing of infection in naturally occurring and orally acquired ruminant TSEs. Therefore, the findings described here highlight further the necessity to investigate thoroughly whether muscles of TSE-infected sheep, cattle, elk and deer contain infectious agents.
 
 
 
snip...see;
 
 
Monday, June 22, 2009
 
***PrPTSE in muscle-associated lymphatic tissue during the preclinical stage of mice orally-infected with BSE
 
 
 
Friday, December 05, 2008
 
***Detection of Prion Infectivity in Fat Tissues of Scrapie-Infected Mice
 
 
 
Sunday, August 26, 2012
 
Detection of PrPSc in peripheral tissues of clinically affected cattle after oral challenge with BSE
 
 
 
more here;
 
 
 
Wednesday, April 24, 2013
 
Dissociation between Transmissible Spongiform Encephalopathy (TSE) Infectivity and Proteinase K-Resistant PrPSc Levels in Peripheral Tissue from a Murine Transgenic Model of TSE Disease
 
Therefore, the assumption that the levels of peripheral infectivity are lower than those in the central nervous system is not always correct, and this could have implications for current food safety regulations.
 
 
 
Tuesday, March 5, 2013
 
Use of Materials Derived From Cattle in Human Food and Cosmetics; Reopening of the Comment Period FDA-2004-N-0188-0051 (TSS SUBMISSION)
 
FDA believes current regulation protects the public from BSE but reopens comment period due to new studies
 
 
 
Sunday, June 9, 2013
 
TSEAC March 14, 2013: Transmissible Spongiform Encephalopathies Advisory Committee Meeting Webcast
 
 
 
 
Monday, September 02, 2013
 
Atypical BSE: role of the E211K prion polymorphism
 
Research Project: TRANSMISSION, DIFFERENTIATION, AND PATHOBIOLOGY OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES
 
Location: Virus and Prion Research Unit
 
 
 
 
Sunday, September 1, 2013
 
Evaluation of the Zoonotic Potential of Transmissible Mink Encephalopathy
 
We previously described the biochemical similarities between PrPres derived from L-BSE infected macaque and cortical MM2 sporadic CJD: those observations suggest a link between these two uncommon prion phenotypes in a primate model (it is to note that such a link has not been observed in other models less relevant from the human situation as hamsters or transgenic mice overexpressing ovine PrP [28]). We speculate that a group of related animal prion strains (L-BSE, c-BSE and TME) would have a zoonotic potential and lead to prion diseases in humans with a type 2 PrPres molecular signature (and more specifically type 2B for vCJD)
 
snip...
 
Together with previous experiments performed in ovinized and bovinized transgenic mice and hamsters [8,9] indicating similarities between TME and L-BSE, the data support the hypothesis that L-BSE could be the origin of the TME outbreaks in North America and Europe during the mid-1900s.
 
 
 
 
Volume 19, Number 4—April 2013
 
 Letter
 
 Iatrogenic Creutzfeldt-Jakob Disease from Commercial Cadaveric Human Growth Hormone
 
 To the Editor: Iatrogenic Creutzfeldt-Jakob disease (iCJD) is an acquired form of prion disease that has been declining in incidence since the mid-1990s (1). Worldwide, at least 226 cases of iCJD, including 29 US cases, have been associated with administration of contaminated human growth hormone (hGH) from cadavers. Reported incubation periods ranged from 5 to 42 years (mean 17 years) (2). Commercially produced cadaveric hGH has been associated with only 1 previously reported case of iCJD: CJD developed in a 39-year-old Austrian man ≈22 years after he received commercial cadaveric hGH (Crescormon, Kabivitrum, Stockholm, Sweden) during 1984–1985 (3). We report a second case of probable iCJD acquired through treatment with commercial cadaveric hGH.
 
 The patient was born at 32 weeks’ gestation with subsequent developmental delay, agenesis of the corpus callosum, and panhypopituitarism. He demonstrated clinical and laboratory signs of growth hormone deficiency but was denied treatment with hGH through the US government–supported National Hormone and Pituitary Program (NHPP) because he did not meet the height requirement. Treatment with commercial cadaveric hGH began when he was 5.8 years of age and continued for 23 months (1983–1985). He received 1.5 units intramuscularly 3× per week and was primarily treated with Asellacrin (Ares-Serono, Geneva, Switzerland). In early 1984, for an unspecified duration, he received Crescormon (Kabivitrum) because of an Asellacrin shortage. Treatment was halted in 1985 because of iCJD concerns and resumed 2 years later with recombinant hGH.
 
 
 
Figure
 
 
 
Figure. . . Maps showing axial fluid attenuated inversion recovery (FLAIR), diffusion-weighted imaging (DWI), and apparent diffusion coefficient (ADC) at the level of the basal nuclei (top row) and dorsal frontoparietal cortex...
 
 At age 33, 26.5 years (range 25.5–28 years) after the midpoint of commercial cadaveric hGH treatment, dizziness and gait imbalance developed, causing a fall. The patient’s mental status also began declining, and he never returned to his baseline status. Six months after illness onset, he experienced hallucinations, weakness of lower extremities, and limb ataxia. Seven months after the fall, he entered a state of akinetic mutism; he died 9 months after symptom onset. A lumbar puncture, performed 8 months after illness onset, demonstrated 14-3-3 proteins and an elevated cerebrospinal fluid (CSF) τ level of 14,111 pg/mL (decision point 1,150 pg/mL) (4), although the specimen was contaminated with blood (39,375 erythrocytes/μL). Electroencephalogram demonstrated severe diffuse encephalopathy. Two brain magnetic resonance imaging studies performed 8 months after illness onset indicated probable CJD, given lack of prior metabolic and anoxic insults (Figure). The patient was discharged from a referral hospital with this diagnosis; no postmortem analysis was conducted.
 
 On the basis of World Health Organization criteria, we conclude that this patient had probable iCJD as a result of hGH treatment (5). The patient’s condition was treated with 2 different formulations of commercial cadaveric hGH, including one of the same brands in the same year as that of the first reported patient with iCJD associated with commercial cadaveric hGH (3). The patient’s incubation period (25.5–28 years) is well within expectations (1).
 
 Despite an ongoing active surveillance program that identified ≈3,500 of ≈4,500 post-1977 cadaveric hGH recipients in the US NHPP, all 29 CJD infections in NHPP recipients occurred among the estimated ≈2,700 pre-1977 recipients (1,2). This significant reduction in iCJD was attributed to the 1977 introduction of a highly selective, column chromatography step in the hormone purification protocol that can markedly reduce prion infectivity (1,2). As shown by the many iCJD cases linked to hGH in France, the efficacy of column chromatography purification steps may vary (1). Commercially derived cadaveric hGH was produced in different laboratories from those that produced NHPP-distributed hGH, and sufficient details regarding sourcing and production methods of the commercial products are lacking. Approximately 10,000 persons, mostly outside the United States, received commercial cadaveric hGH produced by Kabivitrum, and substantially fewer persons received product from Ares-Serono (A.F. Parlow, pers. comm.). Identification through passive surveillance of 2 CJD cases among recipients of such hGH further supports a causal, rather than chance, association between commercial hormone and CJD. It also suggests a difference in iCJD risk between post-1977 NHPP-distributed hGH and commercial cadaveric hGH.
 
 Limitations of this report include the lack of neuropathologic confirmation and insufficient information to strongly implicate a single commercial cadaveric hGH product as infection source. The report of another iCJD case-patient who received Crescormon during the same period provides some evidence that the product was the source of prion contamination. Although the patient may have had sporadic CJD, his young age at disease onset (33 years) makes this unlikely (6).
 
 This report suggests that a potential risk for iCJD in persons who received commercial cadaveric hGH should be considered. Also, clinicians should not assume that all cadaveric hGH administered after 1977 carries the same risk for infectivity. In addition, when CJD is being considered as a clinical diagnosis, a history of exposure to cadaveric hGH should always be sought, even when patients have normal or tall stature. Finally, we recommend that when a clinical diagnosis of CJD is suspected, but before the patient’s death, the local caregivers, with the family, should initiate arrangements for a postmortem examination to confirm diagnosis (e.g., www.cjdsurveillance.com).
 
 
 
Brian S. Appleby , Mei Lu, Alberto Bizzi, Michael D. Phillips, Sally M. Berri, Madeleine D. Harbison, and Lawrence B. Schonberger
 
 Author affiliations: Cleveland Clinic Foundation, Cleveland, Ohio, USA (B.S. Appleby, M. Lu, M.D. Phillips); Instituto Clinico Humanitas,Milan, Italy (A. Bizzi); Case Western Reserve University, Cleveland (S.M. Berri); Mount Sinai School of Medicine, New York, New York, USA (M.D. Harbison); Centers for Disease Control and Prevention, Atlanta, Georgia, USA (L.B. Schonberger)
 
 
 
 
 
 
 Sunday, February 10, 2013
 
Creutzfeldt-Jakob disease with unusually extensive neuropathology in a child treated with native human growth hormone
 
 
 
 
Sunday, February 10, 2013
 
Creutzfeldt-Jakob disease (CJD) biannual update (February 2013) Infection report/CJD
 
 
 
 
Tuesday, May 28, 2013
 
Late-in-life surgery associated with Creutzfeldt-Jakob disease: a methodological outline for evidence-based guidance
 
 
 
 
Sunday, September 08, 2013
 
Iatrogenic Creutzfeldt-Jakob disease via surgical instruments and decontamination possibilities for the TSE prion
 
 
 
 
Saturday, July 6, 2013
 
Small Ruminant Nor98 Prions Share Biochemical Features with Human Gerstmann-Sträussler-Scheinker Disease and Variably Protease-Sensitive Prionopathy
 
Research Article
 
 
 
 
Sunday, August 11, 2013
 
Creutzfeldt-Jakob Disease CJD cases rising North America updated report August 2013
 
Creutzfeldt-Jakob Disease CJD cases rising North America with Canada seeing an extreme increase of 48% between 2008 and 2010
 
 
 
Thursday, October 25, 2012
 
Current limitations about the cleaning of luminal endoscopes and TSE prion risk factors there from
 
Article in Press
 
 
 
 
2011 TO 2012 UPDATE
 
 
Saturday, December 3, 2011
 
Candidate Cell Substrates, Vaccine Production, and Transmissible Spongiform Encephalopathies
 
Volume 17, Number 12—December 2011
 
 
snip...
 
 
 Sunday, May 18, 2008
 
 MAD COW DISEASE BSE CJD CHILDREN VACCINES
 
 Sunday, May 18, 2008
 
 MAD COW DISEASE BSE CJD CHILDREN VACCINES
 
 TIP740203/l 0424 CONFIDENTIAL
 
 
 
 
 TWA LITTLE minute
 
 2. We have identified one problem over where we are unable to act and this is the use of gonadotrophins in embryo transfer work. Some veterinary surgeons are quite legally using this exemption from the Medicines Act contained in Section 9(2) to prepare gonadotrophins from pituitary glands from various species, including cattle. These hormones are used to stimulate superovulation in donor cows.
 
 
 
 
 
 
 
 
 
 
 COMMERCIAL IN CONFIDENCE
 
 3.2 Minute 5.3 - 5.4 Bovine Spongiform Encephalopathy
 
 It was reported that some replies had been received from Companies using pituitary glands in their products. Copies of the BSE document had also been sent to DHSS and NIBSC.
 
 and then another 3 + pages of blank space. ...TSS
 
 
 
 
 COMMERCIAL IN CONFIDENCE
 
 BSE - CURRENT POSITION WITH VETERINARY LICENCED PRODUCTS (MA.1968)
 
 There are three areas of particular concern, vaccines (including emergency vaccines), pharmaceuticals which are covered by MA licences and unlicenses hormonal products produced under exemptions claimed under (Section 9(2) Medicines Act).
 
 1) Vaccines
 
 
 
 
 NOT FOR PUBLICATION
 
 another 6 pages of blank space. ...TSS
 
 
 
 
 
 
 COMMERCIAL IN CONFIDENCE
 
 
 
 
 COMMERCIAL IN CONFIDENCE
 
 Medicines Act - Veterinary Products Committee
 
 
 
 
 COMMERCIAL IN CONFIDENCE
 
 
 
 
 MANAGEMENT IN CONFIDENCE
 
 CERTIFIED BSE-FREE HERDS FOR SOURCE OF MATERIAL FOR BIOLOGICAL PRODUCTS
 
 
 
 
 COMMERCIAL IN CONFIDENCE
 
 NOT FOR PUBLICATION
 
 
 
 
 
 
 
 COMMERCIAL IN CONFIDENCE
 
 NOT FOR PUBLICATION
 
 
 
 
 NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE
 
 snip...
 
 I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use.
 
 snip...
 
 The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out...
 
 
 
 
 more on the 1968 medicine act, they forgot to follow i.e. no Scrapie-like disease. ...TSS
 
 
 
 
 Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)
 
 CONCERN ABOUT BSE IN HUMAN MEDICINE
 
 
 
 
 
 
 
 (It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.)
 
 
 
 
 
 
 
 COMMERCIAL IN CONFIDENCE
 
 
 
 
 TWA LITTLE STATEMENT 331
 
 
 
 
 snip...
 
 
 
 
 
 8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients).
 
 CONFIDENTIAL
 
 
 
 
snip...
 
 
 
 
 
 
 Subject: Re: VACCINES/CHILDREN/TSE'S -- 'CONFIDENTIAL'
 
 Date: Wed, 6 Sep 2000 18:20:09 -0800
 
 From: tom
 
 Reply-To: Bovine Spongiform Encephalopathy
 
 To: BSE-L@uni-karlsruhe.de References: 1
 
 ######### Bovine Spongiform Encephalopathy #########
 
 Just when I was thinking the Internet had reached a terminal condition of shallow pages and broken links, some young people come along and invent a really effective Internet search engine: http://www.google.com/ This works quite well to search the entire http://www.mad-cow.org site (or find 393 web sites such as GenBank that link to it, or 936 sites that cite it in text) back to 1996 as well as the BSE Inquiry http://www.bse.org.uk/
 
 Thus for louping ill (unnecessary cites suppressed):
 
 
 Witness Statements 537 - Coulthard
 
 29.Pituitary FSH from pigs has been used in the USA prior to its use in the UK and much more extensively there and Canada.... 30.Thousands of embryos were exported from this country to the USA prior to the ban being imposed... 42. No cow pituitaries were used in the preparation of FSH [follicular stimulating hormone] products compared with the case of louping ill vaccine for scrapie.
 
 
 In the 1930's: 18,000 UK sheep were inoculated against louping ill, a brain inflammatory illness spread by ticks. Despite formalin-treatment of the inoculated agent, the procedure gave rise to 1,500 cases of scrapie. Louping is a Scottish word for fleeing or leaping, related to loping. In humans, louping ill is called Russian spring-summer encephalitis, a meningo-encephalitis with muscular tremors and spasms followed by varying degrees of paralysis.... [John Lanchester 2 Dec 96 New Yorker]
 
 
 In what the story calls a grand historical irony, this landmark series of experiments was being confirmed at the same time in England as a result of an outbreak of scrapie in several hundred sheep that had been immunized against louping ill with a vaccine prepared from tissue from the brain, spinal cord, and spleen of sheep that were belatedly discovered to have been exposed to natural scrapie infection.[6.Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520] The transmissible nature of the scrapie agent was thus established beyond any doubt. [P Brown, 1755 and All That: A Historical Primer of TSE.
 
 We need to look at the full text of the article and its cites to see how they actually made the vaccine, whether they exported vaccine-infected sheep to Canada and the US, and what became of the vaccinated flocks. Perhaps there is still sample available, Moredun Institute is still around.
 
 Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520 (not covered by Medline) Gordon, Bronlee and Wilson 1939 [full cite is available only in a letter we don't have)
 
 Terry was reading Draft Factual Account 17
 
 
 
 
 
 
 
 236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282] 237. On 6 June 1988 Mr Lawrence wrote to Sir Richard Southwood and enclosed some brief answers to the questions that had been tabled at the meeting on 19 May.[283] In relation to Q6, which asked OWhat is meat and other material from scrapie infected sheep used for - does it include pet food and material for biological products?¹ Part of the answer stated: ...
 
 There has been one instance of inadvertant [sic] transmission of the scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and Wilson 1939). One of the three batches of vaccine made in 1935 at the Moredun Institute contained the scrapie agent resulting in 7% of the recipients of the 18, 000 doses in the batch developing scrapie. This vaccine was made from formalin-inactivated sheep brain, and brought to the attention of research workers that formalin, at a concentration of 0.35% for at least 3 months, which inactivated conventional viruses, did not totally inactivate the scrapie agent.
 
 ----------------------------
 
 4. Questions we might want to have answered are: the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect ("natural" infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). Are sterilisation processes adequate for the most resistant strain of scrapie agent or for CJD agent? Should companies be asked to include investigation for inclusion of scrapie agent (eg mouse innoculation [sic]) in at least some batches? If BSE behaves like scrapie, then we might expect other nervous tissue, spleen, lymph nodes and placenta to be contaminated. Infection has been described in other tissues too, eg gut wall, and we can not [sic] be sure blood is free. Do we know what bovine materials are used in which products, both as the active ingredient and in production? Bovine active ingredients in human products include insulin, vasopressin, bone, immune globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and fetal calf serum must be used in preparation of very many products. For each of these products would any "BSE agent" be destroyed or eliminated in processing? If not, and the product is administered parenterally or topically into an open wound, might there be a risk? [For oral products, there would only be a trivially increased load on top of that taken in food in omnivores/carnivores including man. But for some herbivores, this might allow the agent to be introduced into yet another species].
 
 --------------------------
 
 Medicines and medical devises;
 
 Subject: 2 known incidents of iatrogenic scrapie
 
 Date: Thu, 7 Sep 2000 09:51:14 -0800
 
 From: tom
 
 Reply-To: Bovine Spongiform Encephalopathy
 
 To: BSE-L@uni-karlsruhe.de References: 1
 
 ######### Bovine Spongiform Encephalopathy #########
 
 One really has to wonder what went on in veterinary products produced during the peak BSE years. At this point, there are only 2 known incidents, both involving sheep brain vaccines.
 
 I found a better source for needed references for iatrogenic scrapie in a nice review by Ray Bradley at http://www.iica.org.ar/Bse/6-%20Bradley.html . Disclosure has been meagre on the 1998 vaccine incident in Italy. Note 3 of the 5 references are totally off Medline and the other 2 fail to have abstracts or links, due to journal ineptness, burial in conference proceedings, and age of article.
 
 If anyone has the first 3, I would appreciate a fax 542-484-0669 US.
 
 tom
 
 GORDON , W.S., 1959. Scrapie panel. In: Proceedings of 63rd Annual Meeting of the US Livestock Sanitary Association, 63, 286-294. [no medline record]
 
 GORDON, W.S., 1946. Advances in Veterinary Research: Louping ill, tick-borne fever and scrapie. Veterinary Record, 58, 516-525. [no medline record]
 
 GORDON , W.S., BROWNLEE, A.& WILSON, D.R., 1939. Studies in louping-ill, tick-borne fever and scrapie. 3rd International Congress for microbiology, 362-363. [no medline record]
 
 -=-=--=
 
 CAPUCCHIO, M.T., GUARDA,F., ISAIA,M.C., CARACAPPÀ, S. & DiMARCO,V., 1998. Natural occurrence of scrapie in goats in Italy. Veterinary Record, 143, 452-453. [title only]
 
 AGRIMI, U., GLUSOPPE, R.U., CARDONE, F., POCCHIARI, M. & CARAMELLI, M., 1999. Epidemic transmissible spongiform encephalopathy in sheep and goats in Italy. Lancet, 353, 560-561. [title only]
 
 IATROGENIC DISEASE IN ANIMALS
 
 
 
 
Ray Bradley Private BSE Consultant Veterinary Laboratories Agency, United Kingdom
 
 There have been two reported incidents of iatrogenic disease in animals, both involving scrapie. One was in Great Britain (Gordon, Brownlee and Wilson, 1939, Gordon 1946, 1959) the other in Italy (Capucchio et al, 1998, Agrimi et al, 1999). Both resulted from infection being introduced into vaccines, louping ill vaccine in Great Britain, Mycoplasma agalactiae vaccine in Italy. Each of these vaccines was prepared from tissues that included sheep brain. In both episodes it seems most likely that natural scrapie infection was present unknowingly in some brains used for the purpose. Once prepared and having passed all the conventional vaccine tests large numbers of sheep in Great Britain, and goats and some sheep in Italy were inoculated. After the necessary incubation period large numbers (> 1,000 in each case) of inoculated animals came down with scrapie. In the meantime some inoculated clinically healthy goats and sheep may have entered food and feed chains or have been used for other purposes. In the British outbreak there appears to have been no consequence for humans who may have consumed infected sheep. It is too early to say what may be the consequences in Italy but measures have been taken to reduce any risk there may have been. .........end
 
 Louping-ill vaccine documents from November 23rd, 1946 FULL TEXT
 
 THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946
 
 NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND
 
 ANNUAL CONGRESS, 1946
 
 The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.
 
 Opening Meeting
 
 [skip to scrapie vaccine issue...tss]
 
 Papers Presented to Congress
 
 SNIP...FULL TEXT ;
 
 
 
 
 
 
although 176 products do _not_ conform to the CSM/VPC guidelines.
 
 
COMMERCIAL IN CONFIDENCE
 
 NOT FOR PUBLICATION
 
 
 
 
 8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients).
 
 CONFIDENTIAL
 
 
 
 
 CONFIDENTIAL
 
 
 
 
 more on the 1968 medicine act, they forgot to follow
 
 
 
 
 Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)
 
 
 
 
 
 
 
 2.3.Iatrogenic exposure
 
 Iatrogenic exposure of scrapie has probably occurred twice. The first report determined that the vehicle was a louping ill vaccine prepared from sheep tissues and this infected a large number of sheep sheep (Gordon, 1946, Greig, 1950). The second was more recent and in this case a vaccine against Mycoplasma agalactiae prepared from sheep tissues was incriminated (Agrimi et al 1999, Capucchio, 1998) but not all outbreaks could be linked to the use of the vaccine. In this episode goats were predominantly affected10.
 
 
 
 
 
*** 5.3.3 The greatest risk, in theory, would be from parenteral injection of material derived from bovine brain or lymphoid tissue. Medicinal products for injection or surgical implantation which are prepared from bovine tissues, or which utilise bovine serum albumin or similar agents in their manufacture, might also be capable of transmitting infectious agents. All medicinal products are licensed under the Medicines Act by the Licensing Authority following guidance, for example from the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical Materials (CDSM) and their subcommittees. The Licensing Authority have been alerted to potential concern about BSE in medicinal products and will ensure that scrutiny of source materials and manufacturing processes now takes account of BSE agent.
 
 
 
 
 
 
 BEFORE the BSE Inquiry went online, i was requesting the daily hearings and submissions, and they were sending them to me via air mail. then, when the BSE Inquiry finally went online, i was then able to go back and match up some of what i had with the YB numbers (above), with the official documents. ...TSS
 
 BSE offals used in cosmetics, toiletry and perfume industry Sun, 3 Sep 2000. Unpublished Inquiry documents obtained by CJD activist Terry S. Singeltary Sr. of Bacliff, Texas Miss Marion Kelly Cosmetic, Toiletry and Perfumery Association 35 Dover Street London W1X3RA
 
 Department of Trade and Industry 10-18 Victoria Street London SW1H ONN Enquiries 01-215 5000 Telex 8811074 DTHQ G 01 215 3324 1 February 1990
 
 
 
 
 40,000 human heart valves a year from BSE herds Sun, 3 Sep 2000. Unpublished Inquiry documents obtained by CJD activist Terry S. Singeltary Sr. of Bacliff, Texas
 
 Opinion (webmaster): Below are some shocking documents. Here is a British company preparing 40,000 heart valves a year from bovine pericardium, primarily for export, and they are not required to source this material from BSE-free herds even in peak epidemic years. It is amazing to watch health "authorities" grovelling on their bellies to wring petty concessions from middle management at obscure little companies. The main worry is not the practise of using 800 potentially infected cows a week for human heart transplant material but that the press or recipients will get wind of it, hurting business.
 
 BSE wasn't the problem, it was awkward queries from importing countries like the US. The cows are stunned using brain penetration -- can't do anything about the chunks of bovine brain blasted into the circulatory system, it's the norm. Can't use younger lower-risk animals either, patch would not be big enough. It is fascinating to see the British government worrying about, but doing nothing, with pigs with BSE 10 years ago.
 
 While scrapie was long used as an excuse for continuing with human use of BSE-tainted material, little sheep material was used medically. Bovine transplants, vaccines, insulin doeses, etc. are far more dangerous than dietary material as injections, and are done on a very wide scale. So scrapie was never a valid analogy to BSE, as MAFF knew full well.
 
 The British government deferred to the manufacturer's rep for an opinion on how contaminated pericardium might be, just as this appeared showing that this tissue is extremely dangerous:
 
 
 
England worried briefly about infecting other countries 27 Aug 00 confidential correspondence obtained by Terry S. Singeltary Sr.
 
 BSE11/2 020;
 
 SC1337p
 
 DEPARTMENT OF HEALTH AND SOCIAL SECURITY Richmond House, 79 Whitehall, London SWIA 2NS Telephone 01-210 3000 From the Chief Medical Officer Sir Donald Achson KBE DM DSc FRCP FFCM FFOM
 
 Mr K C Meldrum Chief Veterinary Officer Ministry of Agriculture, Fisheries and Food Government Buildings Hook Rise South Tolworth Surbiton Surrey KT6 7NG 3 January 1990
 
 Dear Mr Meldrum
 
 BOVINE SPONGIFORM ENCEPHALOPATHY
 
 You will recall that we have previously discussed the potential risks of BSE occurring in other countries as a result of the continuing export from the UK of meat and bone that may be contaminated by scrapie or possibly BSE.
 
 I remain concerned that we are not being consistent in our attempts to contain the risks of BSE. Having banned the feeding of meat and bone meal to ruminamts in 1988, we should take steps to prevent these UK products being fed to ruminants in other countries. This could be achieved either through a ban on the export of meat and bone meal, or at least by the proper labelling of these products to make it absolutely clear they should not be fed to ruminants [or zoo animals, including rare and endangered primates -- webmaster]. Unless some such action is taken the difficult problems we have faced with BSE may well occur in other countries who import UK meat and bone meal. Surely it is short sighted for us to risk being seen in future as having been responsible for the introduction of BSE to the food chain in other countries.
 
 
 
 
 The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.
 
 TIP740203/l 0424 CONFIDENTIAL
 
 Mr Cunningham CMP3 From: D O Hagger MBI Dr Salisbury MED/IMCD3 Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989 Mr Dudley PD/AD4
 
 BOVINE SPONGIFORM ENCEPHALOPATHY
 
 
 
 
 Other US BSE risks: the imported products picture 24 Jul 00 Trade Statistics: UK to US Compiled by Terry S. Singeltary Sr of Bacliff, Texas
 
 [Opinion (webmaster): The US has focused for years on tracing, containing, and eradicating live animal imports from the UK or other countries with acknowledged BSE like Belgium, including some 499 cattle and the Vermont sheep. This strategy does not acknowledge imports of rendered bovine products from England during the BSE period nor secondary products such as surgical catgut, which is to say surgical cowgut, or dairy cattle embryos, vaccines for veterinarian and human medicines. What has become of these?
 
 Mr. Singeltary, who lost his mother to CJD of unexplained origin a few years back and went on to became a well-known TSE activist, has tracked down voluminous pertinent import data through correspondence with UK officials and searches of government web sites. Imports of such products are frequently cited by Europeans in rating BSE risks in the US and in shutting out US exports.
 
 Many people's eyes glaze over when reviewing reams of sometimes older trade statistics. There is no proof that any of the imported products was contaminated with BSE nor if so, any evidence that any BSE product lead to infection in US livestock, surgical patients, or what not. Nonetheless, the data obtained by Mr. Singeltary establish that an appalling variety and tonnage of products that were imported by the US from the UK and othr BSE-affected countries during the peak of the BSE epidemic years.]
 
 10 January 1990 COMMERCIAL IN CONFIDENCE
 
 NOT FOR PUBLICATION
 
 COMMITTEE ON SAFETY OF MEDICINES WORKING PARTY ON BOVINE SPONGIFORM ENCEPHALOPATHY
 
 SURGICAL CATGUT SUTURES 2.1 At the first meeting of the Working Party on Bovine Spongiform Encephalopathy on 6 September 1989, detailed consideration was given to XXXXX Surgical Catgut. This arose from the Company's response to the Letter to Licence Holders, indicating that the bovine small intestine source material was derived from UK cattle, unlike 8 other licenced catgut sutures. In contrast XXXXX Surgical Catgut was stated to hold over 90% share of the market for catgut sutures, and to constitute approximately 83% of all sutures used in U.K. IMPORTS OF SUTURES FROM THE KNOWN BSE COUNTRY;
 
 
 
 
 
 
 
 Procedures Manual
 
 Bovine Spongiform Encephalopathy (BSE)
 
 Ongoing Surveillance Plan
 
 Ongoing Surveillance Plan Implementation July 20, 2006
 
 snip...
 
 Personal Safety
 
 If BSE is transmissible to humans in the occupational setting, the most likely routes would be through contact with infective tissues through wounds or open lesions on the skin, contact with mucous membranes (eyes and mouth), or exceptionally, by swallowing. .....snip...end
 
 
 
 
 SO, looks like to me the most likely route of transmission of BSE to humans would be through inoculation i.e., the most likely routes would be through contact with infective tissues through wounds or open lesions on the skin, IF you look at all the successful transmission studies in the lab with TSE, inoculations was the most successful route.
 
 
BSE-L@LISTS.AEGEE.ORG
 
Bovine Spongiform Encephalopathy
 
BSE-L is a discussion forum for scientists who are interested in Bovine Spongiform Encephalopathy (BSE). BSE-L has been created on 20th July, 1994 by Siegfried Schmitt. Impressum: http://www.kaliv.de/impressum.html
 
LISTS.AEGEE.ORG ( BSE-L: 484 matches (only the first 50 will be shown).. )
 
 
 
 
 From: TSS (216-119-138-163.ipset18.wt.net)
 
 Subject: Louping-ill vaccine documents from November 23rd, 1946 Date:
 
 September 10, 2000 at 8:57 am PST
 
 Subject: Louping-ill vaccine documents from November 23rd, 1946
 
 Date: Sat, 9 Sep 2000 17:44:57 -0700
 
 From: "Terry S. Singeltary Sr."
 
 Reply-To: Bovine Spongiform Encephalopathy
 
 To: BSE-L@uni-karlsruhe.de
 
 ######### Bovine Spongiform Encephalopathy #########
 
 THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946
 
 NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND
 
 ANNUAL CONGRESS, 1946
 
 The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.
 
 Opening Meeting
 
 [skip to scrapie vaccine issue...tss]
 
 Papers Presented to Congress
 
 The papers presented to this year's Congress had as their general theme the progressive work of the profession during the war years. Their appeal was clearly demonstrated by the large and remarkably uniform attendance in the Grand Hall of the Royal Veterinary College throughout the series; between 200 and 250 members were present and they showed a keen interest in every paper, which was reflected in the expression of some disappointment that the time available for discussion did not permit of the participation of more than a small proportion of would-be contributors.
 
 In this issue we publish (below) the first to be read and discussed, that by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E., "Advances in Veterinary Research." Next week's issue will contain the paper on "Some Recent Advances in Veterinary Medicine and Surgery in Large-Animal Practice" by Mr. T. Norman Gold, M.R.C.V.S. In succeeding numbers of the Record will be reproduced, also with reports of discussions, that by Mr. W. L. Weipers, M.R.C.V.S., D.V.S.M., on the same subject as relating to small-animal practice, and the papers by Mr. J. N. Ritchie, B.SC., M.R.C.V.S., D.V.S.M., and Mr. H.W. Steele-Bodger, M.R.C.V.S., on "War-time Achievements of the British Home Veterinary Services."
 
 The first scientific paper of Congress was read by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E. on Monday, September 23rd, 1946, when Professor J. Basil Buxton, M.A., F.R.C.V.S, D.V.H., Prinicipal of the Royal Veterinary College, presided.
 
 Advances in Veterinary Research
 
 by
 
 W.S. GORDON, PH.D., M.R.C.V.S., F.R.S.E.
 
 Agriculteral Research Council, Field Station, Compton, Berks.
 
 Louping-ill, Tick-borne Fever and Scrapie
 
 In 1930 Pool, Browniee; Wilson recorded that louping-ill was a transmissible disease. Greig et al, (1931) showed that the infective agent was a filter-passing virus with neurotropic characters and Browniee & Wilson (1932) that the essential pathology was that of an encephalomyelitis. Gordon, Browniee, Wilson & MacLeod (1932) and MacLeod & Gordon (1932) confirmed and extended this work. It was shown that on louping-ill farms the virus was present in the blood of many sheep which did not show clinical symptoms indicating involvement of the central nervous system and that for the perpetuation and spread of the disease these subclinical cases were probably of greater importance that the frank clinical cases because, in Nature, the disease was spread by the tick, lxodes ricinus L. More recently Wilson (1945, 1946) has described the cultivation of the virus in a chick embryo medium, the pathogenic properties of this culture virus and the preparation of louping-ill antiserum.
 
 Between 1931 and 1934 I carried out experiments which resulted in the development of an effective vaccine for the prevention of louping-ill.* This vaccine has been in general use since 1935 and in his annual report to the Animal Diseases Research Association this year, Dr. Greig stated that about 227,000 doses of vaccine had been issued from Moredun alone.
 
 Dr. Gordon illustrated this portion of his paper by means of graphs and diagrams projected by the epidiascope.
 
 This investigation, however, did not begin and end with the study of louping-ill; it had, by good fortune, a more romantic turn and less fortunately a final dramatic twist which led almost to catastrophe. After it had been established that a solid immunity to louping-ill could be induced in sheep, a group of immunized and a group of susceptible animals were placed together on the tick-infected pasture of a louping-ill farm. Each day all the animals were gathered and their temperatures were recorded. It was anticipated that febrile reactions with some fatalities would develop in the controls while the louping-ill immunes would remain normal. Contrary to expectation, however, every sheep, both immune and control, developed a febrile reaction. This unexpected result made necessary further investigation which showed that the febrile reaction in the louping-ill immunes was due to a hitherto undescribed infective agent, a Rickettsia-like organism which could be observed in the cytoplasm of the granular leucocytes, especially the neutrophil polymorphs (MacLeod (1932), Gordon, Browniee, Wilson & MacLeod. MacLeod & Gordon (1933). MacLeod (1936). MacLeod collected ticks over many widely separated parts of Scotland and all were found to harbour the infective agent of tick-borne fever, and it is probable that all sheep on tick-infested farms develop this disease, at least on the first occasion that they become infested with ticks. When the infection is passed in series through susceptible adult sheep it causes a sever, febrile reaction, dullness and loss of bodily condition but it rarely, if ever, proves fatal. It is clear, however, that it aggravates the harmful effects of a louping-ill infection and it is a serious additional complication to such infections as pyaemia and the anacrobic infections which beset lambs on the hill farms of Northern Britain.
 
 Studying the epidemiology of louping-ill on hill farms it became obvious that the pyaemic condition of lambs described by M'Fadyean (1894) was very prevalent on tick infested farms Pyaemia is a crippling condition of lambs associated with tick-bite and is often confused with louping-ill. It is caused by infection with Staphylococcus aureus and affected animals may show abscess formation on the skin, in the joints, viscera, meninges and elsewhere in the body. It was thought that tick-borne fever might have been a predisposing factor in this disease and unsuccessful attempts were made by Taylor, Holman & Gordon (1941) to reproduce the condition by infecting lambs subcutaneously with the staphylococcus and concurrently producing infections with tickborne fever and louping-ill in the same lambs. Work on pyaemia was then continued by McDiarmid (1946a, 1946b, 1946c), who succeeded in reproducing a pyaemic disease in mice, guinea-pigs and lambs similar to the naturally occurring condition by intravenous inoculation of Staphylococcus aureus. He also found a bacteraemic form of the disease in which no gross pyaemic lesions were observed. The prevention or treatment of this condition presents a formidable problem. It is unlikely that staphylococcal ??oid will provide an effective immunity and even if penicillin proved to be a successful treatment, the difficulty of applying it in adequate and sustained dosage to young lambs on hill farms would be almost insurmountable.
 
 From 1931 to 1934 field trials to test the immunizing value and harmlessness of the loup-ill vaccine were carried out on a gradually increasing scale. Many thousands of sheep were vaccinated and similar numbers, living under identical conditions were left as controls. The end result showed that an average mortability of about 9 percent in the controls was reduced to less than 1 percent in the vaccinated animals. While the efficiency of the vaccine was obvious after the second year of work, previous bitter experience had shown the wisdom of withholding a biological product from widespread use until it had been successfully produced in bulk, as opposed to small-scale experimental production and until it had been thoroughly tested for immunizing efficiency and freedom from harmful effects. It was thought that after four years testing this stage had been reached in 1935, and in the spring of that year the vaccine was issued for general use. It comprised a 10 percent saline suspension of brain, spinal cord and spleen tissues taken from sheep five days after infection with louping-ill virus by intracerebral inoculation. To this suspension 0-35 percent of formalin was added to inactivate the virus and its safety for use as a vaccine was checked by intracerbral inoculation of mice and sheep and by the inoculation of culture medium. Its protective power was proved by vaccination sheep and later subjecting them, along with controls, to a test dose of living virus.
 
 Vaccine for issue had to be free from detectable, living virus and capable of protecting sheep against a test dose of virus applied subcutaneously. The 1935 vaccine conformed to these standards and was issued for inoculation in March as three separate batches labelled 1, 2, and 3. The tissues of 140 sheep were employed to make batch 1 of which 22,270 doses were used; 114 to make batch 2 of which 18,000 doses were used and 44 to make batch 3 of which 4,360 doses were used. All the sheep tissues incorporated in the vaccine were obtained from yearling sheep. During 1935 and 1936 the vaccine proved highly efficient in the prevention of loup-ill and no user observed an ill-effect in the inoculated animals. In September, 1937, two and a half years after vaccinating the sheep, two owners complained that scrapie, a disease which had not before been observed in the Blackface breed, was appearing in their stock of Blackface sheep and further that it was confined to animals vaccinated with louping-ill vaccine in 1935. At that stage it was difficult to conceive that the occurrence could be associated with the injection of the vaccine but in view of the implications, I visited most of the farms on which sheep had been vaccinated in 1935. It was at this point that the investigation reached its dramatic phase; I shall not forget the profound effect on my emotions when I visited these farms and was warmly welcomed because of the great benefits resulting from the application of louping-ill vaccine, wheras the chief purpose of my visit was to determine if scrapie was appearing in the inoculated sheep. The enquiry made the position clear. Scrapie was developing in the sheep vaccinated in 1935 and it was only in a few instances that the owner was associating the occurrence with louping-ill vaccination. The disease was affecting all breeds and it was confined to the animals vaccinated with batch 2. This was clearly demonstrated on a number of farms on which batch 1 had been used to inoculate the hoggs in 1935 and batch 2 to inoculate the ewes. None of the hoggs, which at this time were three- year-old ewes. At this time it was difficult to forecast whether all of the 18,000 sheep which had received batch 2 vaccine would develop scrapie. It was fortunate, however, that the majority of the sheep vaccinated with batch 2 were ewes and therfore all that were four years old and upwards at the time of vaccination had already been disposed of and there only remained the ewes which had been two to three years old at the time of vaccination, consequently no accurate assessment of the incidence of scrapie could be made. On a few farms, however, where vaccination was confined to hoggs, the incidence ranged from 1 percent, to 35 percent, with an average of about 5 percent. Since batch 2 vaccine had been incriminated as a probable source of scrapie infection, an attempt was made to trace the origin of the 112 sheep whose tissues had been included in the vaccine. It was found that they had been supplied by three owners and that all were of the Blackface or Greyface breed with the exception of eight which were Cheviot lambs born in 1935 from ewes which had been in contact with scrapie infection. Some of these contact ewes developed scrapie in 1936-37 and three surviving fellow lambs to the eight included in the batch 2 vaccine of 1935 developed scrapie, one in September, 1936, one in February, 1937, and one in November, 1937. There was, therefore, strong presumptive evidence that the eight Cheviot lambs included in the vaccine although apparently healthy were, in fact, in the incubative stage of a scrapie infection and that in their tissues there was an infective agent which had contaminated the batch 2 vaccine, rendering it liable to set up scrapie. If that assumption was correct then the evidence indicated that:-
 
 (1) the infective agent of scrapie was present in the brain, spinal cord and or spleen of infected sheep: (2) it could withstand a concentration of formalin of 0-35 percent, which inactivated the virus of louping-ill: (3) it could be transmitted by subcutaneous inoculation; (4) it had an incubative period of two years and longer.
 
 Two Frenchmen, Cuille & Chelle (1939) as the result of experiments commenced in 1932, reported the successful infection of sheep by inoculation of emulsions of spinal cord or brain material by the intracerebral, epidural, intraocular and subcutaneous routes The incubation period varied according to the route employed, being one year intracerebrally, 15 months intraocularly and 20 months subcutaneously. They failed to infect rabbits but succeeded in infecting goats. Another important part of their work showed that the infective agent could pass through a chamberland 1.3 filter, thus demonstrating that the infective agent was a filtrable virus. It was a curious coincidence that while they were doing their transmission experiments their work was being confirmed by the unforeseeable infectivity of a formalinized tissue vaccine.
 
 As a result of this experience a large-scale transmission experiment involving the ue of 788 sheep was commenced in 1938 on a farm specially taken for the purpose by the Animal Diseases Research Association with funds provided by the Agricultural Research Council. The experiment was designed to determine the nature of the infective agent and the pathogenesis of the disease. It is only possible here to give a summary of the result which showed that (1) saline suspensions of brain and spinal cord tissue of sheep affected with scrapie were infective to normal sheep when inoculated intracerebrally or subcutaneously; (2) the incubation period after intracerebral inoculation was seven months and upwards and only 60 percent of the inoculated sheep developed scrapie during a period of four and a half years; (3) the incubation period after subcutaneous inoculation was 15 months and upwards and only about 30 percent of the inoculated sheep developed the disease during the four and a half years: (4) the infective agent was of small size and probably a filtrable virus.
 
 The prolonged incubative period of the disease and the remarkable resistance of the causal agent to formalin are features of distinct interest. It still remains to determine if a biological test can be devised to detect infected animals so that they can be killed for food before they develop clinical symptoms and to explore the possibilities of producing an immunity to the disease.
 
 ==================================================================
 
 Scrapie Louping-ill Vaccine
 
‘There has been one instance of inadvertant [sic] transmission of the scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and Wilson 1939). One of the three batches of vaccine made in 1935 at the Moredun Institute contained the scrapie agent resulting in 7% of the recipients of the 18, 000 doses in the batch developing scrapie. This vaccine was made from formalin-inactivated sheep brain, and brought to the attention of research workers that formalin, at a concentration of 0.35% for at least 3 months, which inactivated conventional viruses, did not totally inactivate the scrapie agent.
 
 ----------------------------
 
 4. Questions we might want to have answered are:
 
 the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect (“natural” infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). Are sterilisation processes adequate for the most resistant strain of scrapie agent or for CJD agent? Should companies be asked to include investigation for inclusion of scrapie agent (eg mouse innoculation [sic]) in at least some batches? If BSE behaves like scrapie, then we might expect other nervous tissue, spleen, lymph nodes and placenta to be contaminated. Infection has been described in other tissues too, eg gut wall, and we can not [sic] be sure blood is free. Do we know what bovine materials are used in which products, both as the active ingredient and in production? Bovine active ingredients in human products include insulin, vasopressin, bone, immune globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and fetal calf serum must be used in preparation of very many products. For each of these products would any “BSE agent” be destroyed or eliminated in processing? If not, and the product is administered parenterally or topically into an open wound, might there be a risk? [For oral products, there would only be a trivially increased load on top of that taken in food in omnivores/carnivores including man. But for some herbivores, this might allow the agent to be introduced into yet another species].
 
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 Sunday, May 18, 2008
 
 MAD COW DISEASE BSE CJD CHILDREN VACCINES
 
 
 
 
snip...see full text ;
 
 
Saturday, December 3, 2011
 
Candidate Cell Substrates, Vaccine Production, and Transmissible Spongiform Encephalopathies
 
Volume 17, Number 12—December 2011
 
 
 
 
 
Sunday, June 26, 2011
 
Risk Analysis of Low-Dose Prion Exposures in Cynomolgus Macaque
 
 
 
 
Saturday, January 16, 2010
 
Evidence For CJD TSE Transmission Via Endoscopes 1-24-3 re-Singeltary to Bramble et al
 
Evidence For CJD/TSE Transmission Via Endoscopes
 
From Terry S. Singletary, Sr flounder@wt.net 1-24-3
 
 
 
 
 
To date the OIE/WAHO assumes that the human and animal health standards set out in the BSE chapter for classical BSE (C-Type) applies to all forms of BSE which include the H-type and L-type atypical forms. This assumption is scientifically not completely justified and accumulating evidence suggests that this may in fact not be the case. Molecular characterization and the spatial distribution pattern of histopathologic lesions and immunohistochemistry (IHC) signals are used to identify and characterize atypical BSE. Both the L-type and H-type atypical cases display significant differences in the conformation and spatial accumulation of the disease associated prion protein (PrPSc) in brains of afflicted cattle. Transmission studies in bovine transgenic and wild type mouse models support that the atypical BSE types might be unique strains because they have different incubation times and lesion profiles when compared to C-type BSE. When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures.
 
 
 
 
Thursday, August 12, 2010
 
Seven main threats for the future linked to prions
 
First threat
 
The TSE road map defining the evolution of European policy for protection against prion diseases is based on a certain numbers of hypotheses some of which may turn out to be erroneous. In particular, a form of BSE (called atypical Bovine Spongiform Encephalopathy), recently identified by systematic testing in aged cattle without clinical signs, may be the origin of classical BSE and thus potentially constitute a reservoir, which may be impossible to eradicate if a sporadic origin is confirmed.
 
***Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases constitute an unforeseen first threat that could sharply modify the European approach to prion diseases.
 
Second threat
 
snip...
 
 
 
 
 
TSS
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