Monday, August 17, 2015

FDA Says Endoscope Makers Failed to Report Superbug Problems OLYMPUS

Health Aug 17 2015, 2:38 pm ET

 

FDA Says Endoscope Makers Failed to Report Superbug Problems

 

by Associated Press

 

Federal regulators have uncovered new violations by the manufacturer of medical scopes recently linked to outbreaks of deadly "superbug" bacteria at U.S. hospitals.

 

Olympus Corp. failed to alert regulators to a cluster of 16 infections in patients who underwent procedures with the company's scope in 2012, according to a warning letter posted online Monday by the Food and Drug Administration. Olympus did not report the problems to the FDA until 2015, when the company was already under scrutiny for a more recent series of outbreaks.

 

Medical device manufacturers are required to report serious device problems to the FDA within 30 days of learning about them. The infections reported to the company involved a bacterial strain called pseudomonas, which can cause pneumonia, severe sickness and death in hospital patients.

 

Additionally, FDA inspectors found that the company has no standard procedure for promptly reporting serious problems with its devices, a requirement for medical device companies. The FDA inspected four company sites in Japan and the U.S. between March and April this year.

 

A spokesman for the Tokyo manufacturer said in a statement: "We are reviewing the FDA's warning letter so that we can provide the required response in a timely manner."

 

The FDA also posted warning letters Monday to two other scope manufacturers -- Hoya Corporation and Fujifilm Corporation -- citing problems with the testing, design and quality control of their devices. All of the letters are dated Aug. 12.

 

Olympus is the market leader for the devices in the U.S., accounting for about 85 percent of sales, according to the FDA.

 

Medical scopes from Olympus were linked to infections of antibiotic-resistant bacteria at two separate Los Angeles hospitals earlier this year. Hospital staff at Cedars-Sinai and UCLA medical centers said the infections occurred despite following Olympus' instructions for cleaning the devices, known as duodendoscopes.

 

The specialized scopes consist of a flexible fiber-optic tube that is inserted down the throat into the stomach and small intestine to diagnose and treat conditions in the pancreas and bile ducts. The tip of the scope includes moveable instruments designed to remove tumors, gallstones and other blockages.

 

This complex design also makes the instruments difficult to clean. Bodily fluids and other debris can stay in the device's joints and crevices even after cleaning and disinfection.

 

Since 2013, there have been eight outbreaks of antibiotic-resistant bacteria linked to the devices at U.S. hospitals, according to government figures.

 

The FDA previously disclosed that Olympus did not seek federal clearance for the latest version of its duodenoscope, which it began selling in 2010.

 

Despite these problems the FDA has repeatedly said the devices should stay on the market because they fill an important need in a half-million procedures performed each year.

 


 

 

I told Olympus 15 years ago about these risk factors from endoscopy equipment, disinfection, even spoke with the Doctor at Olympus, this was back in 1999. I tried to tell them that they were exposing patients to dangerous pathogens such as the CJD TSE prion, because they could not properly clean them. even presented my concern to a peer review journal GUT, that was going to publish, but then it was pulled by Professor Michael Farthing et al... see ;

 

 some old history on Endoscopy equipment and CJD TSE Prion concerns ;

 

 1999

 

 Subject: CJD * Olympus Endoscope

 

 Date: Sun, 10 Oct 1999 16:41:49 –0500

 

 From: "Terry S. Singeltary Sr."

 

 To: GOLDSS@...

 

 Dear Dr. Goldstine,

 

 Hello Sir, I understand that Olympus has issued a letter to the medical institutions and the CDC, about the dangers of _not_ being able to decontaminate the instruments (endoscope's) via modern autoclaving techniques (boil 3 minutes in 3% SDS or another ionic detergent and autoclave for 1 hour at 134 degrees C). I understand that; "Olympus" has issued a warning, _not_ to attempt to decontaminate the instrument, that they are instructed to destroy them.

 

 (very very wise move);

 

 Please Sir, it is imminent that I receive a copy of this letter, it is very important. This could lead to other company's following through, and lead to awareness of the potential health threats from human T.S.E.'s and the risks through surgery, and not just from endoscopes. It would be most appreciated, if you could send a copy of this document to;

 

 Fax: xxxxx

 

 I look forward, to hearing back from you....

 

 Many Thanks,

 

 Terry S. Singeltary Sr./ Mom DOD 12-14-97 hvCJD

 

 Subject: Re: CJD * Olympus Endoscope

 

 Date: Tue, 12 Oct 1999 15:57:03 –0500

 

 From: "Terry S. Singeltary Sr."

 

 To: GOLDSS@...

 

 References: 1

 

 Dear Mr. Goldstine, Hello again, I hope the CDC has not changed your mind, since our phone call, about sending me the information, in which we spoke of. I am still waiting for the information, re-fax. Someone had told me, you would not send me the information, but I told them you would, due to the importance of it pertaining to public safety, and the fact, you are a Doctor. I hope you don't disappoint me, and the rest of the public, and hide the facts, as the CDC and NIH have for years. Olympus can be part of the Truth, or you can be part of the cover-up. We are going to find out, sooner or later.

 

 I already know, as do many more.

 


 

 Still waiting,

 

Kind Regards,

 

 Terry S. Singeltary Sr.

 

"Terry S. Singeltary Sr." wrote:

 

Dear Dr. Goldstine,

 

 Hello Sir, I understand that Olympus has issued a letter to the medical institutions and the CDC, about the dangers of _not_ being able to decontaminate the instruments (endoscope's) via modern autoclaving techniques (boil 3 minutes in 3% SDS or another ionic detergent and autoclave for 1 hour at 134 degrees C). I understand that; "Olympus" has issued a warning, _not_ to attempt to decontaminate the instrument, that they are instructed to destroy them.

 

 (very very wise move);

 

 Please Sir, it is imminent that I receive a copy of this letter, it is very important. This could lead to other company's following through, and lead to awareness of the potential health threats from human T.S.E.'s and the risks through surgery, and not just from endoscopes. It would be most appreciated, if you could send a copy of this document to;

 

 Fax: xxxxxxx

 

 I look forward, to hearing back from you....

 

 Many Thanks,

 

 Terry S. Singeltary Sr./ Mom DOD 12-14-97 hvCJD

 

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

 

 Something I submitted to GUT previously;

 

 Subject: Re: gutjnl_el;21 Terry S. Singeltary Sr. (3 Jun 2002) "CJDs (all human TSEs) and Endoscopy Equipment"

 

 Date: Thu, 20 Jun 2002 16:19:51 –0700

 

 From: "Terry S. Singeltary Sr."

 

 To: Professor Michael Farthing

 

 CC: lcamp@BMJgroup.com

 

References: 001501c21099$5c8bc620$7c58d182@mfacdean1.cent.gla.ac.uk

 

Greetings again Professor Farthing and BMJ,

 

I was curious why my small rebuttal of the article described below was not listed in this month's journal of GUT? I had thought it was going to be published, but I do not have full text access. Will it be published in the future? Regardless, I thought would pass on a more lengthy rebuttal of mine on this topic, vCJD vs sCJDs and endoscopy equipment. I don't expect it to be published, but thought you might find it interesting, i hope you don't mind and hope to hear back from someone on the questions I posed...

 

Here is my short submission I speak of, lengthy one to follow below that:

 

Date submitted: 3 Jun 2002

 

>> eLetter ID: gutjnl_el;21

 

>> >> Gut eLetter for Bramble and Ironside 50 (6): 888

 

>> >>Name: Terry S. Singeltary Sr.

 

>>Email: flounder@wt.net

 

>>Title/position: disabled {neck injury}

 

>>Place of work: CJD WATCH

 

>>IP address: 216.119.162.85

 

>>Hostname: 216-119-162-85.ipset44.wt.net

 

>>Browser: Mozilla/5.0 (Windows; U; Win98; en-US; rv:0.9.4)

 

>>Gecko/20011019 Netscape6/6.2

 

>> >>Parent ID: 50/6/888

 

>>Citation:

 

>> Creutzfeldt-Jakob disease: implications for gastroenterology

 

>> M G Bramble and J W Ironside

 

>> Gut 2002; 50: 888-890 (Occasional viewpoint)

 


 


 

 >>-----------------------------------------------------------------

 

>>"CJDs (all human TSEs) and Endoscopy Equipment"

 

>>-----------------------------------------------------------------

 

 regarding your article;

 

 Creutzfeldt-Jakob disease: implications for gastroenterology

 

 >>I belong to several support groups for victims and relatives

 

>>of CJDs. Several years ago, I did a survey regarding

 

>>endoscopy equipment and how many victims of CJDs have

 

>>had any type of this procedure done. To my surprise, many

 

>>victims had some kind of endoscopy work done on them.

 

>>As this may not be a smoking gun, I think it should

 

>>warrant a 'red flag' of sorts, especially since data now

 

>>suggests a substantial TSE infectivity in the gut wall

 

>>of species infected with TSEs. If such transmissions

 

>>occur, the ramifications of spreading TSEs from

 

>>endoscopy equipment to the general public would be

 

>>horrible, and could potential amplify the transmission

 

>>of TSEs through other surgical procedures in that

 

>>persons life, due to long incubation and sub-clinical

 

>>infection. Science to date, has well established

 

>>transmission of sporadic CJDs with medical/surgical

 

>>procedures.

 

 Terry S. Singeltary Sr. >>CJD WATCH

 

 Again, many thanks, Kindest regards,

 

 Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 flounder@wt.net CJD WATCH

 

 [scroll down past article for my comments]

 

 snip...

 

 were not all CJDs, even nvCJD, just sporadic, until proven otherwise?

 

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

 


 

Professor Michael Farthing wrote: Louise Send this to Bramble (author) for a comment before we post. Michael

 

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

 

snip... see full text ;

 

 2003

 

 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

 


 

Monday, December 26, 2011

 

Prion Uptake in the Gut: Identification of the First Uptake and Replication Sites

 


 

 Friday, August 10, 2012

 

 Incidents of Potential iatrogenic Creutzfeldt-Jakob disease (CJD) biannual update (July 2012)

 


 

 SNIP...

 

 see more history here ;

 

 OLYMPUS ENDOSCOPY CJD

 


 


 

Tuesday, May 26, 2015

 

Minimise transmission risk of CJD and vCJD in healthcare settings

 

Last updated 15 May 2015

 


 

Saturday, February 21, 2015

 

Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

 


 

 Thursday, January 22, 2015

 

 *** Transmission properties of atypical Creutzfeldt-Jakob disease: a clue to disease etiology? ***

 


 


 

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

 

Tuesday, August 4, 2015

 

*** FDA U.S. Measures to Protect Against BSE ***

 


 

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

 

*** now, from all the consumption and exposure above, now think iatrogenic cjd tse prion at a hospital near you, what if?

 

Thursday, August 13, 2015

 

Iatrogenic CJD due to pituitary-derived growth hormone with genetically determined incubation times of up to 40 years

 


 

Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC.

 

Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892.

 

Stereotactic multicontact electrodes used to probe the cerebral cortex of a middle aged woman with progressive dementia were previously implicated in the accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger patients. The diagnoses of CJD have been confirmed for all three cases. More than two years after their last use in humans, after three cleanings and repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were implanted in the cortex of a chimpanzee. Eighteen months later the animal became ill with CJD. This finding serves to re-emphasise the potential danger posed by reuse of instruments contaminated with the agents of spongiform encephalopathies, even after scrupulous attempts to clean them.

 


 

SOURCE REFERENCES

 

The infectious agents responsible for transmissible spongiform encephalopathy (TSE) are notoriously resistant to most physical and chemical methods used for inactivating pathogens, including heat. It has long been recognized, for example, that boiling is ineffective and that higher temperatures are most efficient when combined with steam under pressure (i.e., autoclaving). As a means of decontamination, dry heat is used only at the extremely high temperatures achieved during incineration, usually in excess of 600°C. It has been assumed, without proof, that incineration totally inactivates the agents of TSE, whether of human or animal origin.

 


 

Prion Infected Meat-and-Bone Meal Is Still Infectious after Biodiesel Production

 

Histochemical analysis of hamster brains inoculated with the solid residue showed typical spongiform degeneration and vacuolation. Re-inoculation of these brains into a new cohort of hamsters led to onset of clinical scrapie symptoms within 75 days, suggesting that the specific infectivity of the prion protein was not changed during the biodiesel process. The biodiesel reaction cannot be considered a viable prion decontamination method for MBM, although we observed increased survival time of hamsters and reduced infectivity greater than 6 log orders in the solid MBM residue. Furthermore, results from our study compare for the first time prion detection by Western Blot versus an infectivity bioassay for analysis of biodiesel reaction products. We could show that biochemical analysis alone is insufficient for detection of prion infectivity after a biodiesel process.

 


 

Detection of protease-resistant cervid prion protein in water from a CWD-endemic area

 

The data presented here demonstrate that sPMCA can detect low levels of PrPCWD in the environment, corroborate previous biological and experimental data suggesting long term persistence of prions in the environment2,3 and imply that PrPCWD accumulation over time may contribute to transmission of CWD in areas where it has been endemic for decades. This work demonstrates the utility of sPMCA to evaluate other environmental water sources for PrPCWD, including smaller bodies of water such as vernal pools and wallows, where large numbers of cervids congregate and into which prions from infected animals may be shed and concentrated to infectious levels.

 


 

A Quantitative Assessment of the Amount of Prion Diverted to Category 1 Materials and Wastewater During Processing

 

Keywords:Abattoir;bovine spongiform encephalopathy;QRA;scrapie;TSE

 

In this article the development and parameterization of a quantitative assessment is described that estimates the amount of TSE infectivity that is present in a whole animal carcass (bovine spongiform encephalopathy [BSE] for cattle and classical/atypical scrapie for sheep and lambs) and the amounts that subsequently fall to the floor during processing at facilities that handle specified risk material (SRM). BSE in cattle was found to contain the most oral doses, with a mean of 9864 BO ID50s (310, 38840) in a whole carcass compared to a mean of 1851 OO ID50s (600, 4070) and 614 OO ID50s (155, 1509) for a sheep infected with classical and atypical scrapie, respectively. Lambs contained the least infectivity with a mean of 251 OO ID50s (83, 548) for classical scrapie and 1 OO ID50s (0.2, 2) for atypical scrapie. The highest amounts of infectivity falling to the floor and entering the drains from slaughtering a whole carcass at SRM facilities were found to be from cattle infected with BSE at rendering and large incineration facilities with 7.4 BO ID50s (0.1, 29), intermediate plants and small incinerators with a mean of 4.5 BO ID50s (0.1, 18), and collection centers, 3.6 BO ID50s (0.1, 14). The lowest amounts entering drains are from lambs infected with classical and atypical scrapie at intermediate plants and atypical scrapie at collection centers with a mean of 3 × 10−7 OO ID50s (2 × 10−8, 1 × 10−6) per carcass. The results of this model provide key inputs for the model in the companion paper published here.

 


 

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

 

*** Infectious agent of sheep scrapie may persist in the environment for at least 16 years ***

 

Gudmundur Georgsson1, Sigurdur Sigurdarson2 and Paul Brown3

 


 


 

Friday, January 30, 2015

 

Scrapie: a particularly persistent pathogen

 


 


 


 


 

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

 

Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA

 

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

 

To the Editor: In their Research Letter, Dr Gibbons and colleagues1 reported that the annual US death rate due to Creutzfeldt-Jakob disease (CJD) has been stable since 1985. These estimates, however, are based only on reported cases, and do not include misdiagnosed or preclinical cases. It seems to me that misdiagnosis alone would drastically change these figures. An unknown number of persons with a diagnosis of Alzheimer disease in fact may have CJD, although only a small number of these patients receive the postmortem examination necessary to make this diagnosis. Furthermore, only a few states have made CJD reportable. Human and animal transmissible spongiform encephalopathies should be reportable nationwide and internationally.

 

Terry S. Singeltary, Sr Bacliff, Tex

 

1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Creutzfeldt-Jakob disease in the United States: 1979-1998. JAMA. 2000;284:2322-2323.

 


 

26 March 2003

 

Terry S. Singeltary, retired (medically) CJD WATCH

 

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc?

 


 

2 January 2000

 

British Medical Journal

 

U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well

 


 

15 November 1999

 

British Medical Journal

 

vCJD in the USA * BSE in U.S.

 


 

Self-Propagative Replication of Ab Oligomers Suggests Potential Transmissibility in Alzheimer Disease

 

Received July 24, 2014; Accepted September 16, 2014; Published November 3, 2014

 

Singeltary comment Alzheimer’s, transmission, what if ???

 


 

Friday, January 10, 2014

 

vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial type prion disease, what it ???

 


 


 

Monday, November 3, 2014

 

USA CJD TSE PRION UNIT, TEXAS, SURVEILLANCE UPDATE NOVEMBER 2014

 

National Prion Disease Pathology Surveillance Center Cases Examined1 (October 7, 2014)

 

***6 Includes 11 cases in which the diagnosis is pending, and 19 inconclusive cases;

 

***7 Includes 12 (11 from 2014) cases with type determination pending in which the diagnosis of vCJD has been excluded.

 

***The sporadic cases include 2660 cases of sporadic Creutzfeldt-Jakob disease (sCJD),

 

***50 cases of Variably Protease-Sensitive Prionopathy (VPSPr)

 

***and 21 cases of sporadic Fatal Insomnia (sFI).

 


 


 

Sunday, December 14, 2014

 

ALERT new variant Creutzfeldt Jakob Disease nvCJD or vCJD, sporadic CJD strains, TSE prion aka Mad Cow Disease United States of America Update December 14, 2014 Report

 


 

Thursday, July 24, 2014

 

*** Protocol for further laboratory investigations into the distribution of infectivity of Atypical BSE SCIENTIFIC REPORT OF EFSA New protocol for Atypical BSE investigations

 


 

Discussion: The C, L and H type BSE cases in Canada exhibit molecular characteristics similar to those described for classical and atypical BSE cases from Europe and Japan.

 

*** This supports the theory that the importation of BSE contaminated feedstuff is the source of C-type BSE in Canada.

 

*** It also suggests a similar cause or source for atypical BSE in these countries. ***

 

see page 176 of 201 pages...tss

 


 

*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics of BSE in Canada Singeltary reply ;

 


 

ruminant feed ban for cervids in the United States ?

 

31 Jan 2015 at 20:14 GMT

 


 

Saturday, January 24, 2015

 

Bovine Spongiform Encephalopathy: Atypical Pros and Cons

 


 

Saturday, January 31, 2015

 

RAPID ADVICE 17-2014 : Evaluation of the risk for public health of casings in countries with a “negligible risk status for BSE” and on the risk of modification of the list of specified risk materials (SRM) with regard to BSE

 


 

Thursday, February 19, 2015

 

Inspections Circumvented for Condemned Cows STATEMENT OF THE HONORABLE PHYLLIS K. FONG INSPECTOR GENERAL

 


 

Tuesday, February 17, 2015

 

Could we spot the next BSE?, asks BVA President

 


 

> Could we spot the next BSE?

 

we have not spotted all the cases the first time around. with Nations like the United States and Canada, organizations like the USDA, OIE, and WTO et al, it was never about ‘spotting’ all the BSE TSE prion cases, it was more about how not to find them. the triple BSE mad cow firewall, was and still is, nothing but ink on paper. ...please see facts ;

 

Saturday, February 14, 2015

 

Canadian Food Inspection Agency Confirms Bovine Spongiform Encephalopathy (BSE) in Alberta

 


 

Tuesday, February 10, 2015

 

Alberta Canada First case of chronic wasting disease found in farm elk since 2002

 


 

2014

 

***Moreover, L-BSE has been transmitted more easily to transgenic mice overexpressing a human PrP [13,14] or to primates [15,16] than C-BSE.

 

***It has been suggested that some sporadic CJD subtypes in humans may result from an exposure to the L-BSE agent.

 

*** Lending support to this hypothesis, pathological and biochemical similarities have been observed between L-BSE and an sCJD subtype (MV genotype at codon 129 of PRNP) [17], and between L-BSE infected non-human primate and another sCJD subtype (MM genotype) [15].

 

snip...

 


 

PRION 2015 ORAL AND POSTER CONGRESSIONAL ABSTRACTS

 

THANK YOU PRION 2015 TAYLOR & FRANCIS, Professor Chernoff, and Professor Aguzzi et al, for making these PRION 2015 Congressional Poster and Oral Abstracts available freely to the public. ...Terry S. Singeltary Sr.

 

O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations

 

Emmanuel Comoy, Jacqueline Mikol, Val erie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France

 

Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods. We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period, with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold longe incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), is the third potentially zoonotic PD (with BSE and L-type BSE), ***thus questioning the origin of human sporadic cases. We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health.

 

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

 

*** Scrapie, as recently evoked in humanized mice (Cassard, 2014), is the third potentially zoonotic PD (with BSE and L-type BSE), ***thus questioning the origin of human sporadic cases.

 

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

 


 

PRION 2015 CONFERENCE FT. COLLINS CWD RISK FACTORS TO HUMANS

 

*** LATE-BREAKING ABSTRACTS PRION 2015 CONFERENCE ***

 

O18

 

Zoonotic Potential of CWD Prions

 

Liuting Qing1, Ignazio Cali1,2, Jue Yuan1, Shenghai Huang3, Diane Kofskey1, Pierluigi Gambetti1, Wenquan Zou1, Qingzhong Kong1 1Case Western Reserve University, Cleveland, Ohio, USA, 2Second University of Naples, Naples, Italy, 3Encore Health Resources, Houston, Texas, USA

 

Chronic wasting disease (CWD) is a widespread and expanding prion disease in free-ranging and captive cervid species in North America. The zoonotic potential of CWD prions is a serious public health concern. Current literature generated with in vitro methods and in vivo animal models (transgenic mice, macaques and squirrel monkeys) reports conflicting results. The susceptibility of human CNS and peripheral organs to CWD prions remains largely unresolved. In our earlier bioassay experiments using several humanized transgenic mouse lines, we detected protease-resistant PrPSc in the spleen of two out of 140 mice that were intracerebrally inoculated with natural CWD isolates, but PrPSc was not detected in the brain of the same mice. Secondary passages with such PrPSc-positive CWD-inoculated humanized mouse spleen tissues led to efficient prion transmission with clear clinical and pathological signs in both humanized and cervidized transgenic mice. Furthermore, a recent bioassay with natural CWD isolates in a new humanized transgenic mouse line led to clinical prion infection in 2 out of 20 mice. These results indicate that the CWD prion has the potential to infect human CNS and peripheral lymphoid tissues and that there might be asymptomatic human carriers of CWD infection.

 

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

 

***These results indicate that the CWD prion has the potential to infect human CNS and peripheral lymphoid tissues and that there might be asymptomatic human carriers of CWD infection.***

 

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

 

P.105: RT-QuIC models trans-species prion transmission

 

Kristen Davenport, Davin Henderson, Candace Mathiason, and Edward Hoover Prion Research Center; Colorado State University; Fort Collins, CO USA

 

The propensity for trans-species prion transmission is related to the structural characteristics of the enciphering and heterologous PrP, but the exact mechanism remains mostly mysterious. Studies of the effects of primary or tertiary prion protein structures on trans-species prion transmission have relied primarily upon animal bioassays, making the influence of prion protein structure vs. host co-factors (e.g. cellular constituents, trafficking, and innate immune interactions) difficult to dissect. As an alternative strategy, we used real-time quakinginduced conversion (RT-QuIC) to investigate trans-species prion conversion.

 

To assess trans-species conversion in the RT-QuIC system, we compared chronic wasting disease (CWD) and bovine spongiform encephalopathy (BSE) prions, as well as feline CWD (fCWD) and feline spongiform encephalopathy (FSE). Each prion was seeded into each host recombinant PrP (full-length rPrP of white-tailed deer, bovine or feline). We demonstrated that fCWD is a more efficient seed for feline rPrP than for white-tailed deer rPrP, which suggests adaptation to the new host.

 

Conversely, FSE maintained sufficient BSE characteristics to more efficiently convert bovine rPrP than feline rPrP. Additionally, human rPrP was competent for conversion by CWD and fCWD. ***This insinuates that, at the level of protein:protein interactions, the barrier preventing transmission of CWD to humans is less robust than previously estimated.

 

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

 

***This insinuates that, at the level of protein:protein interactions, the barrier preventing transmission of CWD to humans is less robust than previously estimated.***

 

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

 


 

Monday, October 10, 2011

 

EFSA Journal 2011 The European Response to BSE: A Success Story

 

snip...

 

EFSA and the European Centre for Disease Prevention and Control (ECDC) recently delivered a scientific opinion on any possible epidemiological or molecular association between TSEs in animals and humans (EFSA Panel on Biological Hazards (BIOHAZ) and ECDC, 2011). This opinion confirmed Classical BSE prions as the only TSE agents demonstrated to be zoonotic so far

 

*** but the possibility that a small proportion of human cases so far classified as "sporadic" CJD are of zoonotic origin could not be excluded.

 

*** Moreover, transmission experiments to non-human primates suggest that some TSE agents in addition to Classical BSE prions in cattle (namely L-type Atypical BSE, Classical BSE in sheep, transmissible mink encephalopathy (TME) and chronic wasting disease (CWD) agents) might have zoonotic potential.

 

snip...

 


 


 

Thursday, August 12, 2010

 

Seven main threats for the future linked to prions

 

First threat

 

The TSE road map defining the evolution of European policy for protection against prion diseases is based on a certain numbers of hypotheses some of which may turn out to be erroneous. In particular, a form of BSE (called atypical Bovine Spongiform Encephalopathy), recently identified by systematic testing in aged cattle without clinical signs, may be the origin of classical BSE and thus potentially constitute a reservoir, which may be impossible to eradicate if a sporadic origin is confirmed.

 

*** Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans.

 

*** These atypical BSE cases constitute an unforeseen first threat that could sharply modify the European approach to prion diseases.

 

Second threat

 

snip...

 


 

Thursday, January 15, 2015

 

41-year-old Navy Commander with sporadic Creutzfeldt–Jakob disease CJD TSE Prion: Case Report

 


 

Saturday, January 17, 2015

 

*** Becky Lockhart 46, Utah’s first female House speaker, dies diagnosed with the extremely rare Creutzfeldt-Jakob disease

 


 

FDA SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION BOVINE HEPARIN Wednesday, June 4, 2014

 

SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION

 

Wednesday, June 4, 2014

 

FDA White Oak Campus

 

Building 31, Room 1503

 

10903 New Hampshire Avenue

 

Silver Spring, Maryland 20993

 

The meeting was convened at 8:32 a.m., Russ ALTMAN,

 

snip...

 

So it has been shown -- so how would you -- there is a risk, though. There is a theoretical risk of any herd or whatever having contamination. So how can you mitigate even that very small risk? It has been shown that the existing manufacturing processes could remove or inactive BSE agents if present. This is because they're an extremely robust extraction under very harsh conditions.SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION

 

The FDA has guidelines regarding TSEs that can be applied to heparin, and these generally were developed by CBER and include control of animal sources, which obviously is critical, selection of the type of tissue used, incorporation of risk-reduction steps into the production process. And, of course, this is typical for any animal source material or even human source material that we use in other people, and so that's what we'd like to talk about today.

 

UNIDENTIFIED SPEAKER: Janet, what's a TSE?

 

DR. WOODCOCK: Pardon me?

 

UNIDENTIFIED SPEAKER: What is a TSE?

 

snip...see ;

 

Sunday, February 08, 2015

 

FDA SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION BOVINE HEPARIN BSE CJD TSE PRION Wednesday, June 4, 2014

 


 

From: Terry S. Singeltary Sr.

 

Sent: Saturday, November 15, 2014 9:29 PM

 

To: Terry S. Singeltary Sr.

 

Subject: THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE R. G. WILL 1984

 

THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE

 

R. G. WILL

 

1984

 

*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). (SEE LINK IN REPORT HERE...TSS) PLUS, THE CDC DID NOT PUT THIS WARNING OUT FOR THE WELL BEING OF THE DEER AND ELK ;

 

snip...

 


 

Evidence That Transmissible Mink Encephalopathy Results from Feeding Infected Cattle

 

Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME.

 

snip...

 

The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle...

 


 

In Confidence - Perceptions of unconventional slow virus diseases of animals in the USA - APRIL-MAY 1989 - G A H Wells

 

3. Prof. A. Robertson gave a brief account of BSE. The US approach was to accord it a very low profile indeed. Dr. A Thiermann showed the picture in the ''Independent'' with cattle being incinerated and thought this was a fanatical incident to be avoided in the US at all costs. ...

 


 

human cwd will NOT look like nvCJD. in fact, see ;

 

*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).***

 


 

Thursday, July 30, 2015

 

*** Professor Lacey believes sporadic CJD itself originates from a cattle infection number of cattle farmers falling victim to Creutzfeld-Jakob Disease is much too high to be mere chance

 


 

 

TEXAS CWD TSE PRION IN CERVID DEER

 

 

where is the official announcement of this 4th case (or more cases), by the TAHC and or the TPWD?

 

why is the media having to do the TAHC and or the TPWD job, and reporting this critical information to the public domain?

 

of course, it took 7+ months and an act of Congress to finally confirm and announce to the public that last mad cow in Texas as well. political science as usual in Texas.

 

TAHC TPWD CATERING PROTECTING THE INDUSTRY AT ALL COST, INCLUDING HUMAN AND ANIMAL HEALTH, TO HELL WITH THE PUBLIC. out of sight, out of mind...not!

 

a review since the TEXAS 84th Legislature commencing this January, deer breeders are expected to advocate for bills that will seek to further deregulate their industry...

 

Sunday, December 14, 2014

 

TEXAS 84th Legislature commencing this January, deer breeders are expected to advocate for bills that will seek to further deregulate their industry

 


 

Tuesday, December 16, 2014

 

Texas 84th Legislature 2015 H.R. No. 2597 Kuempel Deer Breeding Industry TAHC TPWD CWD TSE PRION

 


 

Wednesday, July 01, 2015

 

TEXAS Chronic Wasting Disease Detected in Medina County Captive Deer

 


 

Thursday, July 09, 2015

 

TEXAS Chronic Wasting Disease (CWD) Herd Plan for Trace-Forward Exposed Herd with Testing of Exposed Animals

 


 

Tuesday, July 14, 2015

 

Texas Parks and Wildlife Commission Special Meeting Thursday on Chronic Wasting Disease CWD

 


 

Tuesday, July 21, 2015

 

*** Texas CWD Medina County Herd Investigation Update July 16, 2015 ***

 


 

Thursday, August 06, 2015

 

WE HAVE LOST TEXAS TO CWD TASK FORCE CATERING TO INDUSTRY

 


 

Friday, August 07, 2015

 

Texas CWD Captive, and then there were 4 ?

 


 

*** Danger of Canned Hunting Indiana Wildlife ***

 


 

I spoke with MASTER Obi-Wan Kenobi about all this. see Obi’s reply ;

 

GRASSHOPPER TO MASTER Obi-Wan Kenobi CWD TEXAS CAPTIVE

 

‘’I see no evidence whatsoever here for a genetic link. The numbers are statistically insignificant and co-housing in contaminated facilities would strongly predispose to this outcome.’’

 

‘’if the father did have a bad amino acid variant allele, it would be diluted to heterozygozity with a normal gene in the half the four descendants since the father never would have survived to breeding age with two bad copies. sort of like met/val at position 129 in humans with greatly lengthened incubation times if prnp is propagating at all. Mutations such as repeat expansion leading to positive dominant infection have not been documented in cervids.’’

 

On 09 08 15, at 9:09 AM, Terry S. Singeltary Sr. wrote: ‘’

 

cwd Texas and then there were 4?

 

genetic link ?

 

He said 42 deer have been killed and tested since July 28, and three additional positives were the result.

 

***He added that all four deer confirmed to have the disease were males from the same father, which leads him to believe the problem is genetic.

 

snip...

 


 

HAVE YOU BEEN THUNDERSTRUCK ?

 


 

on my mothers grave, when I wrote up the ‘have you been thunderstruck’ about super ovulation, and what if? I had no clue about all this. hell, I had it in draft for a month. then a week or so later, bam.

 

it’s been like this all along Obi-Wan Kenobi.

 

every shooting pen owner in Texas are praying this familial cwd is the going thing now.

 

no link to sperm.

 

no link to super ovulation.

 

they sell those sperm straws like the meth heads and crack heads sell meth and crack.

 

genetic link with four deer in the same herd, same father ?

 

familial ?

 

sperm ?

 

super ovulation ?

 

what say ye master ?

 

grasshopper

 

Friday, August 07, 2015

 

Texas CWD Captive, and then there were 4 ?

 


 

PRION 2015 CONFERENCE FT. COLLINS CWD RISK FACTORS TO HUMANS

 

*** LATE-BREAKING ABSTRACTS PRION 2015 CONFERENCE ***

 

O18

 

Zoonotic Potential of CWD Prions

 

Liuting Qing1, Ignazio Cali1,2, Jue Yuan1, Shenghai Huang3, Diane Kofskey1, Pierluigi Gambetti1, Wenquan Zou1, Qingzhong Kong1 1Case Western Reserve University, Cleveland, Ohio, USA, 2Second University of Naples, Naples, Italy, 3Encore Health Resources, Houston, Texas, USA

 

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

 

***These results indicate that the CWD prion has the potential to infect human CNS and peripheral lymphoid tissues and that there might be asymptomatic human carriers of CWD infection.***

 

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

 

P.105: RT-QuIC models trans-species prion transmission

 

Kristen Davenport, Davin Henderson, Candace Mathiason, and Edward Hoover Prion Research Center; Colorado State University; Fort Collins, CO USA

 

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

 

***This insinuates that, at the level of protein:protein interactions, the barrier preventing transmission of CWD to humans is less robust than previously estimated.***

 

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

 


 

From: Terry S. Singeltary Sr.

 

Sent: Saturday, November 15, 2014 9:29 PM

 

To: Terry S. Singeltary Sr.

 

Subject: THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE R. G. WILL 1984

 

THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE

 

R. G. WILL

 

1984

 

*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). (SEE LINK IN REPORT HERE...TSS) PLUS, THE CDC DID NOT PUT THIS WARNING OUT FOR THE WELL BEING OF THE DEER AND ELK ;

 

snip...

 


 

*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).***

 


 

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

 


 

Saturday, December 13, 2014

 

*** Terry S. Singeltary Sr. Publications TSE prion disease Peer Review ***

 

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

 

Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA

 

snip...

 


 

Tuesday, May 26, 2015

 

*** Minimise transmission risk of CJD and vCJD in healthcare settings ***

 

Last updated 15 May 2015

 


 

 

NOW THINK EXPOSURE THERE FROM ALL THE ABOVE, AT A HOSPITAL NEAR YOU, what if ???
 

 

Terry S. Singeltary Sr.

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