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.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8006664&dopt=Abstract
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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