November 6, 2013
Increased Usage By Pro Athletes Drives Deer Antler Supplement Popularity
Among Amateur Athletes
Increased media coverage has driven interest in deer antler velvet,
previously used only by professional athletes, in amateur athletes and fitness
enthusiasts as well. WEBWIRE – Wednesday, November 06, 2013 Performance
enhancing scandals among professional athletes are not a new phenomenon. Sports
fans can hardly tune their TV to their favorite sports coverage without seeing
another well-known athlete caught up in accusations of performance enhancing
drugs, blood doping, or some other substance usage that gives them a perceived
physical edge over the competition.
Most people presume that professional athletes, being richly compensated
for their physical feats, are the people most likely to use (and have access to)
any substance that would enhance athletic performance. In most cases that would
be true, but an unusual exception to that rule is deer antler velvet. Because of
its popular usage as a performance enhancing alternative to steroids among
professional athletes, several governing bodies (most notably the NFL and PGA),
have banned its usage. At one time Major League Baseball also banned it, but
then later reversed course. The NCAA currently allows it, as does professional
hockey. While some organizations technically “ban” its usage by their players,
no test exists for a natural substance like antler velvet, so any ban would be
largely unenforceable. Professional athletes know this, so their usage
continues.
Deer antler velvet’s alleged effects on performance stem from it being a
potent natural source of IGF-1, or Insulin-like Growth Factor. Found naturally
in the body, IGF-1 is a chemical “cousin” to the body’s own human growth
hormone. It spikes during periods of high anabolic activity, and is a key part
of the body’s ability to regenerate after exhaustive physical activity, such as
lifting weights or sports. The IGF-1 in deer antler velvet (along with other
micro-nutrients and minerals found in the velvet) is primarily responsible for
the rapid growth of new antler racks in the horns of male deer each year. This
same form is easily absorbed by the human body, and these nutrients can be
utilized by muscle tissue to rebuild, grow, and repair itself according to one
Deer antler velvet spokesperson, Gabe Uris.
“The effects of deer antler velvet are well-documented both in clinical
studies out of New Zealand, and in anecdotal evidence from pro-caliber athletes
who swear by it” says Mr. Uris, a long-time proponent of deer antler velvet
supplementation. “Most of our athletes see an effect literally within an hour of
their first dose, 60 minutes after taking it they feel better recovered after
strenuous workouts, and the science performed by researchers in New Zealand
backs that.” While some researchers discount the effects of deer antler velvet,
or doubt its ability to provide more than a negligible amount of IGF-1 to muscle
tissue in a spray dosage, there is no indication that any negative side effects
have occurred from its usage by either pro or amateur athletes.
For many amateurs, the attractiveness of no side effects, usage by
professional athletes at the pinnacle of their sports, and the relative low cost
(a 6-month cycle of one of the most popular products, AntlerX, retails online
for less than forty dollars a bottle) of antler velvet usage may prove to
alluring to resist. Until science finds the holy grail of inexpensive and safe
“performance enhancers” to promote muscle gain and athletic performance,
products like deer antler velvet spray will have a place in the sports world.
For more information about deer antler velvet sprays visit
May 2, 2013
Professional Athletes in Some Sports Now Allowed to Use Deer Antler Velvet
Sprays
just a reminder for folks taking these type nutritional
supplements...
Volume 15, Number 5—May 2009
Research
Chronic Wasting Disease Prions in Elk Antler Velvet
Abstract Chronic wasting disease (CWD) is a contagious, fatal prion disease
of deer and elk that continues to emerge in new locations. To explore the means
by which prions are transmitted with high efficiency among cervids, we examined
prion infectivity in the apical skin layer covering the growing antler (antler
velvet) by using CWD-susceptible transgenic mice and protein misfolding cyclic
amplification. Our finding of prions in antler velvet of CWD-affected elk
suggests that this tissue may play a role in disease transmission among cervids.
Humans who consume antler velvet as a nutritional supplement are at risk for
exposure to prions. The fact that CWD prion incubation times in transgenic mice
expressing elk prion protein are consistently more rapid raises the possibility
that residue 226, the sole primary structural difference between deer and elk
prion protein, may be a major determinant of CWD pathogenesis.
SNIP...
The appearance of variant Creutzfeldt-Jakob disease in humans exposed to
bovine spongiform encephalopathy (BSE) (19,20) and the demonstration of CWD
prions in muscle (3) placed the human species barrier to CWD prions at the
forefront of public health concerns. Our studies indicate that antler velvet
represents an additional source for human exposure to CWD prions. Widely used in
traditional Asian medicine to treat a variety of ailments including impotence,
arthritis, and high blood pressure, antler velvet can be readily purchased in
caplet form and its usage has increased worldwide.
Volume 15, Number 5—May 2009
Research
Chronic Wasting Disease Prions in Elk Antler Velvet
PO-031: Aerosol transmission of chronic wasting disease to white-tailed
deer
Nathaniel Denkers,1 Jeanette Hayes-Klug,1 Kelly Anderson,1 Sally Dahmes,2
David Osborn,3 Karl Miller,3 Robert Warren,3 Candace Mathiason,1 Edward Hoover1
1Colorado State University; Fort Collins, CO USA; 2WASCO Inc.; Monroe, GA USA;
3Warnell School of Forestry and Natural Resources, University of Georgia;
Athens, GA USA
Purpose. A signature feature of chronic wasting disease (CWD) is its
efficient lateral transmission in nature, almost surely by mucosal exposure. Our
previous studies employing Tg(cerPrP) mice determined that CWD can be
transmitted to a susceptible host by aerosol exposure, a route with relatively
little investigation. The present study was designed to determine whether CWD is
transmissible by aerosol to a native cervid host, white-tailed deer.
Materials and Methods. Nine white-tailed deer were exposed to two (2)
aerosol doses of a 5% w/v CWD+ (n = 6) or CWD- (n = 3) brain homogenate,
delivered via the nasal passages using a customized aerosol apparatus. At
3-month intervals post inoculation (mpi), tonsil and recto-anal
mucosa-associated lymphoid tissue (RAMALT) biopsies were collected and assayed
for CWD infection by protein misfolding cyclic amplification (PMCA), western
blotting (WB), and immunohistochemistry (IHC).
Results. At 3 mpi and 6 mpi, tonsil and RAMALT biopsies were collected from
5 of the 6 CWD + aerosol-exposed deer. Three of the 5 (60%) tested positive for
CWD by PMCA but not IHC or western blot analysis at 3 mpi. By 6 mpi, 5 of 5
(100%) were tonsil and/or RAMALT biopsy positive by at least two of the three
assays. Biopsies were collected from all CWD+ aerosol-exposed deer at 9 mpi,
with 6 of 6 (100%) tonsil and/ or RAMALT positive by western blot or IHC. At 10
mpi 3 of the 6 prion-exposed deer have developed early clinical signs of CWD
infection (hyperphagia, polydypsia, wide leg stance and head/neck
dorsi-flexion). All sham-inoculated deer are showing no clinical signs and have
remained CWD negative as assessed by all three assays. Interestingly, the prion
dose delivered to the deer by aerosol-exposure is estimated to be 20-fold lower
than the historical oral dose that has resulted in detectable CWD infection at 6
or 12 mpi.
Conclusions. This study documents the first aerosol transmission of CWD in
deer. These results further infer that aerosolized prions facilitate CWD
transmission with greater efficiency than does oral exposure to a larger prion
dose. Thus exposure via the respiratory mucosa may be significant in the facile
spread of CWD in deer and perhaps in prion transmission overall.
PO-073: Multiple routes of prion transepithelial transport in the nasal
cavity following inhalation
Anthony Kincaid, Shawn Feilmann, Melissa Clouse, Albert Lorenzo, Jason
Bartz Creighton University; Omaha, NE USA
Introduction. Inhalation of either prion-infected brain homogenate or
aerosolized prions has been shown to cause disease, and in the case of
inhalation of infected brain homogenate, the nasal route of infection has been
shown to be 10–100 times more efficient than the oral route. The cell types
involved in the in vivo transport of prions across the nasal cavity epithelium
have not been determined. M cells in the follicular associated epithelium have
been shown to mediate transcellular transport of prions in vitro and in the gut
of experimentally infected mice. We tested the hypothesis that M-cell mediated
transport was responsible for prion entry across nasal cavity epithelium
following inhalation.
Materials and Methods. Hamsters were inoculated extranasally with 50 or
100ul of infected (n = 31) or mock-infected (n = 13) brain homogenate. Control
animals were inoculated with buffer (n = 4) or were untreated (n = 5). Following
survival periods ranging from 15 to 180 min, animals were perfused, skulls were
decalcified and nasal cavities were embedded in paraffin. Tissue sections were
cut and processed immunohistochemically for glial fibrillary acidic protein to
identify brain homogenate, or for the disease-associated form of the prion
protein. Tissue sections not further than 112 um apart through the entire extent
of the nasal cavity were analyzed using light microscopy; photomicrographs were
obtained wherever inoculum was observed on the surface of, within, or deep to
the nasal mucosa for each animal.
Results. Infected or uninfected brain homogenate was identified within the
nasal cavities of animals at all time points and was seen crossing the nasal
cavity epithelium within minutes of inoculation; the transepithelial transport
of brain homogenate continued for up to 3 h after inoculation. Infected or
uninfected brain homogenate was seen adhering to, or located within, M cells at
all time points. However, larger volumes of infected or uninfected brain
homogenate were identified crossing between cells of the olfactory and
respiratory epithelia in multiple locations. In addition, infected or uninfected
brain homogenate was identified within the lumen of lymphatic vessels in the
lamina propria beneath the nasal mucosa at all time points.
Conclusion. Transepithelial transport of prions across nasal cavity mucosa
begins within minutes of inhalation and can continue for up to 3 h. While M
cells appear to transport prions across the follicular associated epithelium,
larger amounts of prions are transported between the cells of the respiratory
and olfactory epithelia, where they immediately enter the lymphatic vessels in
the lamina propria. Thus, inhaled prions can be spread via lymph draining the
nasal cavity and have access to somatic and autonomic nerves in the lamina
propria of the nasal cavity. The increased efficiency of the nasal cavity route
of infection compared with the oral route may be due to the rapid and prolonged
transport of prions between cells of the respiratory and olfactory
epithelia.
Aerosols Transmit Prions to Immunocompetent and Immunodeficient Mice
Johannes Haybaeck1.¤a, Mathias Heikenwalder1.¤b, Britta Klevenz2., Petra
Schwarz1, Ilan Margalith1, Claire Bridel1, Kirsten Mertz1,3, Elizabeta Zirdum2,
Benjamin Petsch2, Thomas J. Fuchs4, Lothar Stitz2*, Adriano Aguzzi1*
1 Department of Pathology, Institute of Neuropathology, University Hospital
Zurich, Zurich, Switzerland, 2 Institute of Immunology,
Friedrich-Loeffler-Institut, Tu¨ bingen, Germany, 3 Department of Pathology,
Clinical Pathology, University Hospital Zurich, Zurich, Switzerland, 4
Department of Computer Science, Machine Learning Laboratory, ETH Zurich, Zurich,
Switzerland
Abstract
Prions, the agents causing transmissible spongiform encephalopathies,
colonize the brain of hosts after oral, parenteral, intralingual, or even
transdermal uptake. However, prions are not generally considered to be airborne.
Here we report that inbred and crossbred wild-type mice, as well as tga20
transgenic mice overexpressing PrPC, efficiently develop scrapie upon exposure
to aerosolized prions. NSE-PrP transgenic mice, which express PrPC selectively
in neurons, were also susceptible to airborne prions. Aerogenic infection
occurred also in mice lacking B- and T-lymphocytes, NK-cells, follicular
dendritic cells or complement components. Brains of diseased mice contained
PrPSc and transmitted scrapie when inoculated into further mice. We conclude
that aerogenic exposure to prions is very efficacious and can lead to direct
invasion of neural pathways without an obligatory replicative phase in lymphoid
organs. This previously unappreciated risk for airborne prion transmission may
warrant re-thinking on prion biosafety guidelines in research and diagnostic
laboratories.
Citation: Haybaeck J, Heikenwalder M, Klevenz B, Schwarz P, Margalith I, et
al. (2011) Aerosols Transmit Prions to Immunocompetent and Immunodeficient Mice.
PLoS Pathog 7(1): e1001257. doi:10.1371/journal.ppat.1001257
Editor: David Westaway, University of Alberta,
Thursday, May 31, 2012
CHRONIC WASTING DISEASE CWD PRION2012 Aerosol, Inhalation transmission,
Scrapie, cats, species barrier, burial, and more
Monday, September 17, 2012
Rapid Transepithelial Transport of Prions Following Inhalation
Prion2013
Chronic Wasting Disease CWD risk factors, humans, domestic cats, blood, and
mother to offspring transmission
HD.13: CWD infection in the spleen of humanized transgenic mice
Liuting Qing and Qingzhong Kong
Case Western Reserve University; Cleveland, OH USA
Chronic wasting disease (CWD) is a widespread prion disease in free-ranging
and captive cervid species in North America, and there is evidence suggesting
the existence of multiple CWD strains. The susceptibility of human CNS and
peripheral organs to the various CWD prion strains remains largely unclear.
Current literature suggests that the classical CWD strain is unlikely to infect
human brain, but the potential for peripheral infection by CWD in humans is
unknown. We detected protease-resistant PrpSc in the spleens of a few humanized
transgenic mice that were intracerebrally inoculated with natural CWD isolates,
but PrpSc was not detected in the brains of any of the CWD-inoculated mice. Our
ongoing bioassays in humanized Tg mice indicate that intracerebral challenge
with such PrpSc-positive humanized mouse spleen already led to prion disease in
most animals. These results indicate that the CWD prion may have the potential
to infect human peripheral lymphoid tissues.
=====
HD.12: Comparative study of the distribution of the prion protein in the
squirrel monkey (Saimiri sciureus) following experimental challenge with variant
and sporadic CJD
Diane L. Ritchie,1 Paul Brown,2 Susan Gibson,3 Thomas R. Kreil,4 Christian
Abee3 and James W. Ironside1
1National CJD Surveillance Unit; Edinburgh, UK; 2Bethesda; Bethesda, MD
USA; 3Deparment of Comparative Medicine; University of South Alabama; Mobile, AL
USA; 4Baxter Bioscience; Vienna, Austria
Introduction, Reports suggest that the number of tissues and organs showing
the presence of the abnormal prion protein (PrPTSE) in variant CJD (vCJD)
patients may be greater than previously thought. A limited peripheral
involvement in some cases of sporadic CJD (sCJD) has also been reported. This
accumulation of PrPTSE outside the brain has raised concerns about the possible
iatrogenic transmission risk of vCJD. The squirrel monkey (Saimiri sciureus) has
been shown to be highly susceptible to experimental challenge with human prion
disease. Neuropathological and biochemical analyses of CNS tissue have shown
that sCJD and vCJD can be distinguished in the squirrel monkey and that many of
the strain characteristics that define these agents are conserved after
transmission. Following on from these initial studies, immunohistochemistry and
western blot analysis were performed on a wide range of peripheral tissues
including, lymphoreticular tissues and peripheral neural tissue to establish the
full-body distribution of PrPTSE in this primate animal model.
Materials and Methods. Brain homogenates from sCJD or vCJD patients were
inoculated into the frontal cortex of squirrel monkeys. Animals were kept under
constant clinical surveillance. At post-mortem, formalin fixed CNS tissue and a
wide range of peripheral tissues were taken for immunohistochemical analysis
together with frozen tissues taken for the biochemical detection of PrPTSE.
Results. Immunohistochemical analysis showed no evidence of PrPTSE
deposition in peripheral tissues in either variant or sporadic CJD-infected
animals. However, western blot assays detected PrPTSE in the spleen of a
proportion of the vCJD- infected animals. The PrPTSE isotype resembled that
detected in CNS tissue from the vCJD- infected animals and from human vCJD
cases. ***In addition, western blot analysis detected PrPTSE in the spleen of a
single animal following challenge with sporadic CJD. The PrPTSE type in this
animal resembled that found in CNS tissue from the same animal, with a PrPTSE
type similar to that found in human sCJD type 1 cases.
Conclusion. This study confirms the accumulation of PrPTSE in the CNS and
spleen of a proportion of squirrel monkeys infected intra-cerebrally with human
vCJD. Furthermore, this study extends the evidence that there may be a
peripheral involvement in some cases of sCJD. PrPTSE typing confirms the
conservation of PrPTSE type on transmission to the squirrel monkey and suggests
that there are no tissue-specific adaptations in the biochemical phenotype of
the agent strain following primate-to-primate transmission.
=====
Oral.15: Molecular barriers to zoonotic prion transmission: Comparison of
the ability of sheep, cattle and deer prion disease isolates to convert normal
human prion protein to its pathological isoform in a cell-free system
Marcelo A.Barria,1 Aru Balachandran,2 Masanori Morita,3 Tetsuyuki
Kitamoto,4 Rona Barron,5 Jean Manson,5 Richard Kniqht,1 James W. lronside1 and
Mark W. Head1
1National CJD Research and Surveillance Unit; Centre for Clinical Brain
Sciences; School of Clinical Sciences; The University of Edinburgh; Edinburgh,
UK; 2National and OIE Reference Laboratory for Scrapie and CWD; Canadian Food
Inspection Agency; Ottawa Laboratory; Fallowfield. ON Canada; 3Infectious
Pathogen Research Section; Central Research Laboratory; Japan Blood Products
Organization; Kobe, Japan; 4Department of Neurological Science; Tohoku
University Graduate School of Medicine; Sendai. Japan; 5Neurobiology Division;
The Roslin Institute and R(D)SVS; University of Edinburgh; Easter Bush;
Midlothian; Edinburgh, UK
Background. Bovine spongiform encephalopathy (BSE) is a known zoonotic
prion disease, resulting in variant Creurzfeldt- Jakob disease (vCJD) in humans.
In contrast, classical scrapie in sheep is thought to offer little or no danger
to human health. However, a widening range of prion diseases have been
recognized in cattle, sheep and deer. The risks posed by individual animal prion
diseases to human health cannot be determined a priori and are difficult to
assess empirically. The fundamemal event in prion disease pathogenesis is
thought to be the seeded conversion of normal prion protein (PrPC) to its
pathological isoform (PrPSc). Here we report the use of a rapid molecular
conversion assay to test whether brain specimens from different animal prion
diseases are capable of seeding the conversion of human PrPC ro PrPSc.
Material and Methods. Classical BSE (C-type BSE), H-type BSE, L-type BSE,
classical scrapie, atypical scrapie, chronic wasting disease and vCJD brain
homogenates were tested for their ability to seed conversion of human PrPC to
PrPSc in protein misfolding cyclic amplification (PMCA) reactions. Newly formed
human PrPSc was detected by protease digestion and western blotting using the
antibody 3F4.
Results. C-type BSE and vCJD were found to efficiently convert PrPC to
PrPSc. Scrapie failed to convert human PrPC to PrPSc. Of the other animal prion
diseases tested only chronic wasting disease appeared to have the capability ro
convert human PrPC to PrPSc. The results were consistent whether the human PrPC
came from human brain, humanised transgenic mouse brain or from cultured human
cells and the effect was more pronounced for PrPC with methionine at codon 129
compared with that with valine.
Conclusion. Our results show that none of the tested animal prion disease
isolates are as efficient as C-type BSE and vCJD in converting human prion
protein in this in vitro assay. However, they also show that there is no
absolute barrier ro conversion of human prion protein in the case of chronic
wasting disease.
=====
Invited.16: Studies of chronic wasting disease transmission in cervid and
non-cervid species
Edward A, Hoover,1 Candace K. Mathiason,1 Davin M. Henderson,1 Nicholas J.
Haley,1 Davis M. Seelig,1 Nathaniel D. Denkers,1 Amy V. Nalls,1 Mark D. Zabe,1
Glenn C. Telling,1 Fernando Goni2 and Thomas Wisniewski,2
1Prion Research Center; Colorado State University; Fort Collins, CO USA;
2New York University School of Medicine; New York, NY USA
How and why some misfolded proteins become horizontally transmitted agents
and occasionally cross species barriers are issues fundamental to understanding
prion disease. Chronic wasting disease (CWD) of cervids is perhaps a prototype
of horizontal prion transmission, encompassing efficient mucosal uptake,
lymphoid amplification, neuroinvasion, peripheralization, and dissemination via
mucosal excretion. Efficient mucosal transmission of CWD in deer has been
demonstrated by oral, nasal, aerosol, and indirect contact exposure. In
addition, other studies (Mathiason CK, et al.) reported at the symposium support
a significant role for pre- and/or postnatal transmission of CWD from doe to
offspring. Accumulating, yet still incomplete, evidence also suggests that the
period of relatively covert CWD infection may be longer than originally thought.
Given the above, minimally invasive sensitive assays based on body fluids from
live animals would aid substantially in understanding the biology of CWD. We
have been applying seeded realtirne quaking-induced amplification of recombinant
PrP substrates (i.e., RT-QuIC methodology) to: (1) investigate antemortem CWD
detection, and (2) model PrP-based species barriers and trans-species
adaptation-topics we previously explored using sPMCA and in vivo bioassays. At
this symposium, we report sensitive and specific detection CWD prions in saliva,
urine, blood (Mathiason lab), and rectal and pharyngeal lymph node samples
(Haley NJ, et al.) from pre-symptomatic and symptomatic experimentally and
naturally exposed deer. Other ongoing studies are employing RT-QuIC methodology
to model amplification barriers among CWD, FSE, BSE, and CJD prions using
cervine, feline, bovine, human, and promiscuous rPrP substrates and the above
species prion seeds, cellular co-factors, and transgenic mice. Finally, in
collaboration with the Wisniewski laboratory, we are conducting of experimental
CWD vaccination studies in deer employing oral administration of an attenuated
Salmonella vector expressing cervid PrP epitopes.
=====
AD.06: Detecting prions in the brain and blood of TSE-infected deer and
hamsters
Alan Elder,1 Davin Henderson,1 Anca Selariu,1 Amy Nalls,1 Byron Caughey,2
Richard Bessen,1 Jason Bartz3 and Candace Mathiason1
1Colorado State University; Fort Collins, CO USA; 2NIH Rocky Mountain
Laboratories; Hamilton, MT USA; 3Creighton University; Omaha, NE USA
While large quantities of protease resistant prion protein (PrPres) can be
demonstrated by western blot or IHC in lymphoid biopsies or post-mortem brain
tissues harvested from prion-infected animals, these conventional assays are
less reliable as means to detect the small quantities of prions thought to be
present in bodily fluids or associated with early and asymptomatic phases of TSE
disease. The Real Time-Quaking Induced Conversion (RT-QuIC) assay is capable of
detecting prions at concentrations below the level of sensitivity of
conventional assays and provides a real-time fluorescent readout negating the
use of proteases. We have made modifications to the RT-QuIC assay to utilize it
for the detection of PrPres in brain and blood harvested from various species
infected with prions. In this study, we analyzed CWD-infected deer and
CWD/TME-infected hamster whole blood to determine the effect of:
(1) various anticoagulants,
(2) freezing and
(3) NaPTA precipitation.
Brain tissue and blood collected from naive deer and hamsters served as
negative controls.
We were able to demonstrate amplifiable prions in
(1) brain and blood samples harvested from CWD/TME-infected animals,
(2) heparinized blood,
(3) frozen vs. fresh blood and
(4) NaPTA treated samples.
The RT-QuIC assay is able to detect PrPres in various species of animals
and shows promise as an antemortem diagnostic tool for blood-borne TSEs.
=====
Oral.08: Mother to offspring transmission of chronic wasting disease in
Reeve's Muntjac deer
Amy Nalls,1 Erin McNulty,1 Jenny Powers,2 Davis Seelig,1 Clare Hoover,1
Nicholas Haley,1 Jeanette Hayes-Klug,1 Kelly Anderson,1 Paula Stewart,3 Wilfred
Goldmann,3 Edward A. Hoover1 and Candace K. Mathiason1
1Colorado State University; Fort Collins, CO USA; 2National Park Service;
Fort Collins, CO USA; 3The Roslin Institute and Royal School of Veterinary
Studies; Edinburgh, UK
To investigate the role mother to offspring transmission plays in chronic
wasting disease (CWD), we have developed a cervid model employing the Reeve's
muntjac deer (Muntiacus reevesi). Eight muntjac doe were orally inoculated with
CWD and tested PrPCWD lymphoid positive by 4 mo post infection. Fourteen fawns
were born to these eight CWD-infected doe-3 were born viable, 6 were born
non-viable and 5 were harvested as fetuses from early or end-stage CWD-infected
doe. All three viable fawns have demonstrated CWD IHC lymphoid biopsy positivity
between 43 d post birth and 11 mo post birth. Two of these three CWD positive
viable offspring have developed clinical signs consistent with TSE disease
(28-33 mo post birth). Moreover, CWD prions have been detected by sPMCA in 11 of
16 tissues harvested from 6 full-term non-viable fawns and in 7 of 11 fetal
tissues harvested in utero from the second and third trimester fetuses.
Additional tissues and pregnancy related fluids from doe and offspring are being
analyzed for CWD prions. In summary, using the muntjac deer model we have
demonstrated CWD clinical disease in offspring born to CWD-infected doe, and in
utero transmission of CWD from mother to offspring. These studies provide basis
to further investigate the mechanisms of maternal transfer of prions.
=====
AD.63: Susceptibility of domestic cats to chronic wasting disease
Amy V.Nalls,1 Candace Mathiason,1 Davis Seelig,2 Susan Kraft,1 Kevin
Carnes,1 Kelly Anderson,1 Jeanette Hayes-Klug1 and Edward A. Hoover1
1Colorado State University; Fort Collins, CO USA; 2University of Minnesota;
Saint Paul, MN USA
Domestic and nondomestic cats have been shown to be susceptible to feline
spongiform encephalopathy (FSE), almost certainly caused by consumption of
bovine spongiform encephalopathy (BSE)-contaminated meat. Because domestic and
free-ranging nondomestic felids scavenge cervid carcasses, including those in
areas affected by chronic wasting disease (CWD), we evaluated the susceptibility
of the domestic cat (Felis catus) to CWD infection experimentally. Cohorts of 5
cats each were inoculated either intracerebrally (IC) or orally (PO) with
CWD-infected deer brain. At 40 and 42 mo post-inoculation, two IC-inoculated
cats developed signs consistent with prion disease, including a stilted gait,
weight loss, anorexia, polydipsia, patterned motor behaviors, head and tail
tremors, and ataxia, and progressed to terminal disease within 5 mo. Brains from
these two cats were pooled and inoculated into cohorts of cats by IC, PO, and
intraperitoneal and subcutaneous (IP/SC) routes. Upon subpassage, feline-adapted
CWD (FelCWD) was transmitted to all IC-inoculated cats with a decreased
incubation period of 23 to 27 mo. FelCWD was detected in the brains of all the
symptomatic cats by western blotting and immunohistochemistry and abnormalities
were seen in magnetic resonance imaging, including multifocal T2 fluid
attenuated inversion recovery (FLAIR) signal hyper-intensities, ventricular size
increases, prominent sulci, and white matter tract cavitation. Currently, 3 of 4
IP/SQ and 2 of 4 PO inoculared cats have developed abnormal behavior patterns
consistent with the early stage of feline CWD. These results demonstrate that
CWD can be transmitted and adapted to the domestic cat, thus raising the issue
of potential cervid-to- feline transmission in nature.
Sunday, July 21, 2013
*** As Chronic Wasting Disease CWD rises in deer herd, what about risk for
humans?
*** PRION2013 ***
Sunday, August 25, 2013
Prion2013 Chronic Wasting Disease CWD risk factors, ***humans, domestic
cats, blood, and mother to offspring transmission
Prion2013
Friday, August 09, 2013
***CWD TSE prion, plants, vegetables, and the potential for environmental
contamination
Uptake of Prions into Plants
Wednesday, September 04, 2013
*** cwd - cervid captive livestock escapes, loose and on the run in the
wild...
Thursday, August 08, 2013
*** Characterization of the first case of naturally occurring chronic
wasting disease in a captive red deer (Cervus elaphus) in North America
*** 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.
Envt.07:
Pathological Prion Protein (PrPTSE) in Skeletal Muscles of Farmed and Free
Ranging White-Tailed Deer Infected with Chronic Wasting Disease
Martin L. Daus,1,† Johanna Breyer,2 Katjs Wagenfuehr,1 Wiebke Wemheuer,2
Achim Thomzig,1 Walter Schulz-Schaeffer2 and Michael Beekes1 1Robert Koch
Institut; P24 TSE; Berlin, Germany; 2Department of Neuropathology, Prion and
Dementia Research Unit, University Medical Center Göttingen; Göttingen, Germany
†Presenting author; Email: dausm@rki.de
Chronic wasting disease (CWD) is a contagious, rapidly spreading
transmissible spongiform encephalopathy (TSE) occurring in cervids in North
America. Despite efficient horizontal transmission of CWD among cervids natural
transmission of the disease to other species has not yet been observed. Here, we
report a direct biochemical demonstration of pathological prion protein PrPTSE
and of PrPTSE-associated seeding activity in skeletal muscles of CWD-infected
cervids. The presence of PrPTSE was detected by Western- and postfixed frozen
tissue blotting, while the seeding activity of PrPTSE was revealed by protein
misfolding cyclic amplification (PMCA). The concentration of PrPTSE in skeletal
muscles of CWD-infected WTD was estimated to be approximately 2000- to
10000-fold lower than in brain tissue. Tissue-blot-analyses revealed that PrPTSE
was located in muscle- associated nerve fascicles but not, in detectable
amounts, in myocytes. The presence and seeding activity of PrPTSE in skeletal
muscle from CWD-infected cervids suggests prevention of such tissue in the human
diet as a precautionary measure for food safety, pending on further
clarification of whether CWD may be transmissible to humans.
Monday, August 26, 2013
***The Presence of Disease-Associated Prion Protein in Skeletal Muscle of
Cattle Infected with Classical Bovine Spongiform Encephalopathy
Wednesday, September 25, 2013
Presence of subclinical infection in gene-targeted human prion protein
transgenic mice exposed to atypical BSE
Nutritional Supplements, animal organ tissues, and CJD ? vCJD in the USA *
BSE in U.S.15 November 1999
My neighbors Mom also died from CJD. She had been taking a nutritional
supplement which contained the following; vacuum dried bovine BRAIN, bone meal,
bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine
kidney, and vacuum dried porcine stomach. As I said, this woman taking these
nutritional supplements, died from CJD. The particular batch of pills that was
located, in which she was taking, was tested. From what I have heard, they came
up negative, for the prion protein. But, in the same breath, they said their
testing, may not have been strong enough to pick up the infectivity. Plus, she
had been taking these type pills for years, so, could it have come from another
batch?
IPLEX NUTRITIONAL SUPPLEMENTS STILL HAVE BOVINE BY-PRODUCTS
see recall, but _not_ for prion disease. ....
Enforcement Report - Week of July 25, 2012
Product Detail Product Description SP Standard Process, Cataplex ACP
(Product #0700 and 0750) , Dietary supplement, 90 & 360 Tablets, Proprietary
Blend: Dried buckwheat ( leaf) juice, buckwheat (seed), carrot (root), calcium
lactate, nutritional yeast, bovine adrenal, bovine kidney, alfalfa flour, dried
alfalfa, (whole plant) juice, magnesium citrate, mushroom, bovine bone,
Echinacea (root, deflated wheat, (germ), oat flour, soybean lecithin, yeast
bone, calcium acid, phosphate, mixed tocopherols, (soy), rice (bran), and carrot
oil., Other ingredients: Honey ascorbic acid, calcium stearate, arabic, gum,
starch, sucrose, vitamin A palmate., UPC 8 12122 01003 0 18. Recall Number
F-1764-2012 Classification Class I Code Info Lot 114, Lot 114, Best Used By
dates of 05/13.
Product Distributed Qty 29,044 Reason For Recall Standard Process, Inc. is
voluntarily recalling 3 dietary supplements due to potential Salmonella
contamination.
Event Detail Event Id 62477 Product Type Food/Cosmetics Status Ongoing
Recalling Firm Standard Process, Inc. City Palmyra State WI Country US Voluntary
/ Mandated Voluntary: Firm Initiated Recall Initiation Date 2012-06-27 Initial
Firm Notification of Consignee or Public Letter Distribution Pattern AL, AZ, AR,
CA,CO, CT, DE, DC, FL,GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,
NE, NV, NY, NH,NM, NY, NC, OH, OK, PA, RI,SC, TN,TX,VT, VA, WA, WV, WI.
Enforcement Report - Week of July 25, 2012
Product Detail Product Description SP Standard Process, Cataplex C, Dietary
Supplement, (Product # 1650 and 1655) , 90 & 360 Tablets, Proprietary Blend:
Veal bone PMG extract, bovine adrenal, dried buckwheat (leaf) juice, buckwheat
(seed), nutritional yeast, dried alfalfa( whole plant) juice, alfalfa flour,
mushroom , magnesium citrate, bovine bone, deflated wheat (germ), calcium acid
phosphate, Echinacea(root), carrot (root), veal bone, soybean lecithin, mixed
tocopherols (soy , and rice (bran)., Other Ingredients calcium lactate, honey,
aerola (berry), camu camu (berry), manloc (root), calcium stearate, and arabic
gum, UPC 8 12122 01029 0 16. Recall Number F-1765-2012 Classification Class I
Code Info Lot 114, Lot 114, Best Used By dates of 05/13.
Product Distributed Qty 23,874 bottles Reason For Recall Standard Process,
Inc. is voluntarily recalling 3 dietary supplements due to potential Salmonella
contamination.
Event Detail
Event Id 62477 Product Type Food/Cosmetics Status Ongoing Recalling Firm
Standard Process, Inc. City Palmyra State WI Country US Voluntary / Mandated
Voluntary: Firm Initiated Recall Initiation Date 2012-06-27 Initial Firm
Notification of Consignee or Public Letter Distribution Pattern AL, AZ, AR,
CA,CO, CT, DE, DC, FL,GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,
NE, NV, NY, NH,NM, NY, NC, OH, OK, PA, RI,SC, TN,TX,VT, VA, WA, WV, WI.
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
----- Original Message -----
From: Terry S. Singeltary Sr.
To: LISTSERV@VM.CFSAN.FDA.GOV
Cc: FDA-DSFL@vm.cfsan.fda.gov ; Amy.Odegaard@fda.hhs.gov ;
Kathleen.Smith1@fda.hhs.gov ; Diane.Schmit@fda.hhs.gov
Sent: Saturday, September 16, 2006 12:46 PM
Subject: NUTRITIONAL SUPPLEMENTS and USA MAD COW STRAINS TYPICAL AND
ATYPICAL AND CJD
Greetings FDA list serve,
WHEN is the fda going to get tough on these nutritional supplements that
still contain potential TSE agent that could cause CJD. after years and years of
complaining about bovine brain in the standard process IPLEX supplements, they
finally sometime recently changed this from bovine brain to porcine brain, but
what about all the human guinea pigs that did take these supplements IPLEX, when
it did contain bovine brain? i suppose they are just walking 'case studies' for
a long incubating disease i.e. USA strain of human bovine TSE, dare i say BSE or
BASE? BUT, if we look at the total ingredient list just for IPLEX, it is still a
potential supplement for mad cow disease i.e. CJD of whatever phenotypes that
exist in the USA and all of North America.
right, we dont have mad cow disease in the USA and all CJD in USA is
spontaneous, and mission accomplished in Iraq.
FACT is sCJD in the USA has tripled in the past few years or so, and we now
have unknown strains in the USA;
snip...
you must NOT continue to ignore this! please..........
IPLEX R
Proprietary Blend: 967 MG Arrowroot flour, inositol, calcium lactate,
porcine eye PMG™ extract, phosphoric acid, dried buckwheat (leaf) juice,
buckwheat (seed), veal bone PMG™ extract, carrot (root), bovine liver, magnesium
citrate, porcine stomach, choline bitartrate, nutritional yeast, bovine adrenal,
defatted wheat (germ), alfalfa flour, bovine kidney, dried alfalfa juice,
allantoin, mushroom, manganese glycerophosphate, bovine adrenal Cytosol™
extract, porcine brain, bovine bone, dl-methionine, oat flour, soybean lecithin,
veal bone, mixed tocopherols (soy), carrot oil, and peanut (bran).
HERE IS OLD INGREDIENT LIST FOR IPLEX ;
IPLEX (neighbors mom died from CJD while taking these pills for years)
bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach,
bovine adrenal, bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN,
bovine bone, veal bone meal
IF you go to Standard Process FAQ page, the very first question and answer
is a lie ;
Where do the bovine organs used in the supplements come from?
We purchase animal tissues and glands only from facilities inspected by the
U.S. Food and Drug Administration, U.S. Department of Agriculture, and state
departments of agriculture. The USDA will not allow the import of bovine
materials from BSE infected countries.
IT seems Standard Process uses the excuse of USDA stamp of approval, and we
all know that this stamp of approval is nothing more than a stamp of lies and
deciet, proven time and time again by the OIG ;
MORE LIES HERE ;
When Standard Process received the FDA's November 1992 letter to dietary
supplement manufacturers regarding BSE and imports, the company promptly
instituted further procedures to assure that its USDA inspected suppliers were
aware of and adhering to the FDA's advice not to use bovine materials from BSE
affected countries. Standard Process was inspected by the FDA with respect to
this issue and the FDA was satisfied that the company had proper procedures in
place.
TRY telling this to my old neighbors mother, whom died after taking IPLEX
for years of CJD on 12-14-96 CONFIRMED. oddly enough exactly one year later, to
the day, my mother died from the Heidenhain Variant of CJD, also CONFIRMED.
There have been other instances where victims of CJD were taking supplements
that could carry the 100% lethal agent of TSE in the USA, that died from CJD.
coincidence or source? until this agent can be destroyed by standard process,
until this TSE agent can be detected in standard process and other supplement
products, the following rule should be repealed, and a ban on all tissues and
organs from any species that has been documented to have a TSE should be
implemented immediately. ...
FOR IMMEDIATE RELEASE Media Inquiries: Michael Herndon P05-58 301-827-6242
September 6, 2005 Consumer Inquiries: 888-INFO-FDA
FDA Amends Interim Final Rule "Use of Materials Derived from Cattle in
Human Food and Cosmetics"
The U.S. Food and Drug Administration today published several amendments to
the July 2004 interim final rule, "Use of Materials Derived from Cattle in Human
Food and Cosmetics," that will allow the use of certain cattle-derived material
in human foods and cosmetics.
The rule prohibits the use of cattle-derived materials that can carry the
infectious agent for bovine spongiform encephalopathy (BSE), or mad cow disease,
in human foods, dietary supplements, and in cosmetics. Based on the scientific
information provided during the interim final rule's comment period, which
demonstrates that a part of the cow's digestive tract called the distal ileum
can be consistently and effectively removed from the other sections of the small
intestine, it is no longer necessary to designate the entire small intestine as
a prohibited cattle material.
As a result, FDA is amending the rule to allow use of the small intestine
in human food and cosmetics, provided that the distal ileum has been removed.
The U.S. Department of Agriculture is publishing today a similar amendment to
its interim final rule on BSE.
The amendments also clarify that milk and milk products, hides and
hide-derived products, and tallow derivatives are not prohibited for use in
human food and cosmetics.
Finally, FDA has reconsidered the recommended method for determining
insoluble impurities in a type of solid fat known as tallow, in response to
information submitted to the agency, to cite a method that is less costly to use
and requires less specialized equipment.
FDA issued the interim final rule to minimize human exposure to materials
that studies have demonstrated are highly likely to contain the BSE agent in
cattle with the disease. The amended interim final rule provides the same level
of protection against the agent that causes BSE as the original provisions.
The amendments to the interim final rule are effective on October 7, 2005
and comments are being are accepted on the amendments through November 7, 2005.
###
2003 - 2004 Product Catalog
Standard Process Inc.
NATURAL COCOA STANDARDBAR (mad cow candy bar) (i will just list animal
organs) bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine
kidney...
NATURAL PEANUT BUTTER STANDARDBAR
bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...
USF (MAD COW) OINTMENT (RUB A DUB DUB, KURU ETC) ;
bovine orhic glandular extract
UTROPHIN PMG
bovine uterus PMG
VASCULIN
bovine heart PMG extract, veal bone PMG extract, bovine liever, porcine
duodenum, bovine adrenal Cytosol extract, bovine spleen, ovine spleen
IPLEX (neighbors mom died from CJD while taking these pills for years)
bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach,
bovine adrenal, bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN,
bovine bone, veal bone meal
MYO-PLUS
bovine heart PMG, bovine liver, porcine stomach, bovine orchic extract,
bovine spleen, ovine spleen, bovine adrenal Cytosol extract, BOVINE BRAIN
NEUROPLEX
bovine orchic Cytosol extract, bovine spleen, BOVINE BRAIN PMG EXTRACT,
BOVINE ANTERIOR PITUITARY, bovine liver, BOVINE PITUITARY PMG EXTRACT, AND MORE
BOVINE BRAIN...
NEUROTROPHIN PMG
BOVINE BRAIN PMG
NIACINAMIDE B6 VM
bovine liver, porcine stomach, bovine spleen ovine spleen, BOVINE BRAIN
OCULOTROPHIN PMG BOVINE EYE PMG
ORCHEX
bovine liver, bovine orchic Cytosol extract, porcine stomch, bovine spleen,
ovine spleen, BOVINE BRAIN
OSTARPLEX
veal bone PMG extract, veal bone PMG extract, bovine liver, porcine
stomach, bovine adrenal, bovine spleen, ovine spleen, BOVINE BRAIN
PARAPLEX
bovine pancreas PMG extract, porcine duodenum, bovine adrenal PMG, BOVINE
PITUITARY PMG EXTRACT, bovine thyroid PMG extract
PITUITROPHIN PMG
RUMAPLEX
BOVINE BRAIN, veal bone PMG extract, bovine adrenal, bovine prostate
Cytosol extract, veal bone meal, bovine liver PMG extract, bovine spleen, ovine
spleen, bovine liver
SENAPLEX
bovine liver PMG extract, bovine adrenal, BOVNE BRAIN, veal bone meal,
bovine kidney, bovine orchic extract, bovine spleen, ovine spleen ..........
THESE are just a few of MANY of just this ONE COMPANY.
FOR the following reason, I implore that the FDA take serious action in
further protecting the consumer from the TSE agent via nutritional supplements.
Does all that e-mail spam promising sexual vitality actually hide serious
risk of contracting MAD COW DISEASE?
Volume 361, Number 9368 03 May 2003
Correspondence
Tighter regulation needed for dietary supplements in USA
Sir--Mary Palmer and colleagues (Jan 11, p 101)1 found that dietary
supplements have the potential to cause serious adverse effects. The
investigators state that research on the hazards and risks of dietary
supplements should be a priority. The safety of individuals who consume these
products is important, and organisations such as the US Food and Drug
Administration (FDA) need to take initiative by enforcing stricter regulations
on supplements. Several commonly used products--for example ginkgo biloba, St
John's Wort, and ephedrine--can have serious adverse effects.2 Although the FDA
requires multiple studies on the safety and efficacy for pharmaceutical products
before placing them on the market, standards are less robust for dietary
supplements. In the USA, under the Dietary Supplement Health and Education Act
(DSHEA) of 1994, supplements are subject to the same regulatory requirements as
food. There are no provisions that require FDA approval for the safety or
effectiveness of supplements,3 which leaves consumers and manufacturers
essentially responsible for the health effects of these products. The DSHEA of
1994 needs to be revised so that dietary supplements are subject to the same
regulations as pharmacological drugs. The FDA needs to review clinical studies
on the safety and efficacy of dietary supplements. Organisations such as Public
Citizen and the American Medical Association are already taking steps to achieve
these changes. However, they face immense opposition from groups such as the
National Nutritional Foods Association, the American Herbal Association, and the
Council for Responsible Nutrition. To overcome such resistance, consumer
organisations, health-care providers, and government agencies need to approach
this subject in unison. The public needs to be able to assess the risks and
benefits of dietary supplements before consuming them. Health-care providers and
the more than 100 million Americans who consume these products4 should encourage
the FDA to treat supplements with the stringent regulations it enforces on
pharmaceutical products.
Nipa Kinariwala
----------------------------------------------------------
700 Bolinwood Drive, Apartment 12A, Chapel Hill, NC 27514, USA (e-mail
nskinari at aol.com) 1 Palmer ME, Haller C, McKinney PE, et al. Adverse events
associated with dietary supplements: an observational study. Lancet 2003; 361:
101-06. [Text ] 2 Cupp MJ. Herbal remedies: adverse effects and drug
interactions. Am Fam Physician 1999; 59: 1239-45. [PubMed ] 3 Unites States Food
and Drug Administration. Overview of dietary supplements. Jan 3, 2001.
http://www.cfsan.fda.gov/~dms/ds-oview.html
(accessed Feb 20, 2002). 4 Pear R. Feds call for tighter control over
nutritional supplements. Organic Consumers Association, April 17, 2001.
http://www.organicconsumers.org/Organic/dietsupp.cfm
(accessed Feb 20, 2002).
snip...end tss letter to fda.
=================== 2013 ================
Wednesday, March 20, 2013
GAO-13-244, Mar 18, 2013 Dietary Supplements FDA May Have Opportunities to
Expand Its Use of Reported Health Problems to Oversee Product
From: Terry S. Singeltary Sr.
Sent: Tuesday, March 19, 2013 2:46 PM
To: mailto:gomezj%40gao.gov Cc: mailto:siggerudk%40gao.gov ;
mailto:youngc1%40gao.gov ; mailto:oighotline%40gao.gov
Monday, February 01, 2010
Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and
Cosmetics Import Alert 17-04
Thursday, March 19, 2009
Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional
Supplements and CJD)
10.3201/eid1505.081458 Suggested citation for this article: Angers RC,
Seward TS, Napier D, Green M, Hoover E, Spraker T, et al. Chronic wasting
disease prions in elk antler velvet. Emerg Infect Dis. 2009 May; [Epub ahead of
print]
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in
Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC –2
Accepted - Volume 7
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in
Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2
Accepted - Volume 7
snip...
what did Paul Brown say about this previously;
i bring your attention to (page 500) Dr. Paul Brown statements;
253 1 DR. BOLTON: I have an additional question about 2 that. What is the
assurance that additional locally sourced 3 tracheas are not added into that
manufacturing process, thus 4 boosting the yield, if you will, but being
returned to the 5 U.S. as being produced from U.S.-sourced raw material? 6 DR.
McCURDY: Are there data to indicate how many 7 grams, or whatever, of infected
brain are likely to infect 8 an organism, either animal or man, when taken
orally? 9 DR. BROWN: If I am not mistaken, and I can be 10 corrected, I think a
half a gram is enough in a cow, orally; [FULL TEXT ABOUT 600 PAGES] 3681t2.rtf
http://www.fda.gov/ohrms/dockets/ac/cber01.htm
snip...
Unregulated "foods" such as 'nutritional supplements' containing various
extracts from ruminants, whether imported or derived from 3 US
cattle/sheep/cervids ("antler velvet" extracts!) should be forbidden or at least
very seriously regulated.
(neighbors Mom, whom also died from CJD, had been taking bovine based
supplement, which contained brain, eye, and many other bovine/ovine tissues for
years, 'IPLEX').
my plight with metabolife and there 'bovine complex' about risk factors of
TSE in there product ;
Terry S. Singeltary Sr. wrote:
> ######## Bovine Spongiform Encephalopathy > #########
> > 1. Dietary Supplements: Review of Health-Related Call Records for
> Users of Metabolife 356. GAO-03-494, March 31.
> > -------- Original Message --------
> > Subject: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
> Date: Thu, 01 May 2003 11:23:01 –0500
> From: "Terry S. Singeltary Sr."
> To: NelliganJ at gao.gov
> > The General Accounting Office (GAO) today released the following
reports
> and testimonies: >
> REPORTS >
> 1. Dietary Supplements: Review of Health-Related Call Records for
> Users of Metabolife 356. GAO-03-494, March 31.
> GREETINGS GAO:
> i was suprised that i did not see any listing of bovine tissue in
metabolife
> on it's label. have they ceased using these desiccated tissues???
> > i see that the lable on this product METABOLIFE 356,
> does not state that it has any tissues of desiccated bovine organs? i
no the product use to, so i am curious if they have
> ceased the use of the tissues of cattle they _use_ to use (see
below)???
> METABOLIFE 356
> BOVINE COMPLEX/GLANDULAR SYSTEM
> OVARIES, PROSTATE, SCROTUM AND ADRENAL
> USDA SOURCE CATTLE
> > i tried warning them years ago of this potential threat of
CJD/TSEs;
> > From: Randy Smith
> To: "'flounder at wt.net'"
> Subject: Metabolife
> Date: Mon, 7 Dec 1998 14:21:35 –0800
> > Dear Sir,
> > We are looking at reformulation. I agree that slow virus diseases
> present a problem in some areas of the world.
> > Our product uses healthy USDA inspected cattle for the glandular
> extract.
> > If you have any links to more information on this subject I would
like
> to examine them.
> > Thank you for your interest and concern,
> > Dr. Smith
> ============
> > From: Randy Smith
> To: "'flounder at wt.net'"
> Subject: RE: [Fwd: Your submission to the Inquiry]
> Date: Wed, 9 Dec 1998 10:37:07 –0800
> > Terry,
> > Thank you for your note and the information links you forwarded
to me.
> I am new to Metabolife International, however hopefully as my role
here
> enlarges I well have a greater impact on formulation and product
> development.
> > Metabolife International does believe in placing safety first.
And I am
> going to do my best to see that we continue to do so.
> > Sincerely,
> Dr. Smith
> ============
> -----Original Message-----
> From: Terry S. Singeltary Sr. [mailto:flounder at wt.net]
> Sent: Wednesday, December 09, 1998 5:49 PM
> To: rsmith at metabolife.com
> Subject: [Fwd: Your submission to the Inquiry]
> > Dr. Smith, I am truly impressed with you honesty, THANKS.....I am
not
> just spouting off about the potential dangers, here. THEY ARE
REAL.....I
> have forwarded an e-mail from the BSE Inquiry, in which I made a
> statement about them........You might want to go to the site and read
> through it........IT WILL TAKE A WHILE........ THINGS ARE HAPPENING
HERE
> SIR, THAT YOU ARE NOT AWARE OF, AND AS MOST PEOPLE ARE
> NOT...............I JUST HOPE, THAT THE REFORMULATION YOU SPEAK OF, IS
> IN FACT GOING TO TAKE PLACE.
> The Department of Health, here in the U.S., is also worried about the
> potential dangers involved hear............Terry/MADSON
> ==================================================
> From: Randy Smith
> To: "'flounder at wt.net'"
> Subject: RE: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]
> Date: Fri, 18 Dec 1998 09:55:17 –0800
> Return-Receipt-To: Randy Smith
> > Thanks very much for the info. I appreciate all these articles I
can
> get. It does sound very familiar - just follow the green ($) trail.
> > -----Original Message-----
> From: Terry S. Singeltary Sr. [mailto:flounder at wt.net]
> Sent: Friday, December 18, 1998 5:15 PM
> To: rsmith at metabolife.com
> Subject: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]
> > Randy, thought you might be interested in
this...............MADSON!!!!!1
> > snip...
> ===============================
> Sender: "Patricia Cantos"
> To: "Terry S Singeltary Sr. (E-mail)"
> Subject: Your submission to the Inquiry
> Date: Fri, 3 Jul 1998 10:10:05 +0100
> > 3 July 1998
> Mr Terry S Singeltary Sr.
> E-Mail: Flounder at wt.net
> Ref: E2979
> > Dear Mr Singeltary,
> > Thank you for your E-mail message of the 30th of June 1998
providing the
> Inquiry with your further comments. Thank you for offering to provide
the
> Inquiry with any test results on the nutritional supplements your
> mother was taking before she died.
> > As requested I am sending you our general Information Pack and a
copy of the
> Chairman's letter. Please contact me if your system cannot read the
attachments.
> > Regarding your question, the Inquiry is looking into many aspects
of the > scientific evidence on BSE and nvCJD. I would refer you to the >
transcripts > of evidence we have already heard which are found on our
internet site at >
> > Could you please provide the Inquiry with a
> copy of
> the press article you refer to in your e-mail? If not an approximate
date
> for the article so that we can locate it?
> In the meantime, thank you for you comments. Please do not hesitate to
> contact me on 0171 261 8332 should you have any queries.
> > Yours sincerely
> Patricia Cantos
> Families Team Leader
> Attachments
> TSS
> ==============
> -------- Original Message --------
> Subject: re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
> Date: Thu, 01 May 2003 16:04:35 –0400
> From: "Marcia G Crosse"
> To:
> CC: "Charles W Davenport" , "Carolyn Feis
Korman" > , "Martin Gahart" >
> Mr. Singletary,
> > We were informed by representatives of Metabolife, Inc. that
Metabolife
> 356 was reformulated to remove bovine complex as an ingredient in the
> product, approximately September 2001. We did not independently verify
> the contents of the product.
> > Sincerely,
> Marcia Crosse
> Acting Director
> Health CarePublic Health and Science Issues
> U.S. General Accounting Office
> 441 G Street, N.W.
> Washington, D.C. 20548
> ===================
> > -------- Original Message --------
> Subject: Re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''
> Date: Thu, 01 May 2003 15:48:52 –0500
> From: "Terry S. Singeltary Sr."
> To: Marcia G Crosse
> CC: Charles W Davenport , Carolyn Feis
Korman > , Martin Gahart > References: >
> THANK YOU!
> > MIRACLES DO HAPPEN! ;-)
> > now all we need to do is; >
> snip......
> > one small step for man, one giant leap for mankind ;-)
> > however; >
> ''We did not independently verify the contents of the product''
> > ???
>
> TSS >
Could you get mad cow from a pill ? Some doctors say a class of pills that
promise smarts, energy, and sexual vitality may cause mad-cow disease.
The government isn't worried. Should you be?
June 1, 2001
Health Magazine
by Susan Freinkel
The German Magazine Der Spiegel came out to the house here and interviewed
me in 2001 (I think), about that token purina mad cow feed mill blunder, and
they were very concerned about these type supplements that carried the SRMs that
could very well carry the TSE prion agent. ...please see ;
GERMAN DER SPIEGEL MAGAZINEDie
BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas
verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden sind
lax.
DER SPIEGEL (9/2001) - 24.02.2001 (9397 Zeichen) USA: Loch in der Mauer Die
BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes
Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehördensind lax.Link
auf diesen Artikel im Archiv:
"Löcher wie in einem Schweizer Käse" hat auch Terry Singeltary im Regelwerk
der FDA ausgemacht. Der Texaner kam auf einem tragischen Umweg zu dem Thema:
Nachdem seine Mutter 1997 binnen weniger Wochen an der
Creutzfeldt-Jakob-Krankheit gestorben war, versuchte er, die Ursachen der
Infektion aufzuspüren. Er klagte auf die Herausgabe von Regierungsdokumenten und
arbeitete sich durch Fachliteratur; heute ist er überzeugt, dass seine Mutter
durch die stetige Einnahme von angeblich kräftigenden Mitteln erkrankte, in
denen - völlig legal - Anteile aus Rinderprodukten enthalten sind.
Von der Fachwelt wurde Singeltary lange als versponnener Außenseiter
belächelt. Doch mittlerweile sorgen sich auch Experten, dass ausgerechnet diese
verschreibungsfreien Wundercocktails zur Stärkung von Intelligenz, Immunsystem
oder Libido von den Importbeschränkungen ausgenommen sind. Dabei enthalten die
Pillen und Ampullen, die in Supermärkten verkauft werden, exotische Mixturen aus
Rinderaugen; dazu Extrakte von Hypophyse oder Kälberföten, Prostata, Lymphknoten
und gefriergetrocknetem Schweinemagen. In die USA hereingelassen werden auch
Blut, Fett, Gelatine und Samen. Diese Stoffe tauchen noch immer in US-Produkten
auf, inklusive Medizin und Kosmetika. Selbst in Impfstoffen waren möglicherweise
gefährliche Rinderprodukte enthalten. Zwar fordert die FDA schon seit acht
Jahren die US-Pharmaindustrie auf, keine Stoffe aus Ländern zu benutzen, in
denen die Gefahr einer BSE-Infizierung besteht. Aber erst kürzlich
verpflichteten sich fünf Unternehmen, darunter Branchenführer wie
GlaxoSmithKline, Aventis und American Home Products, ihre Seren nur noch aus
unverdächtigem Material herzustellen.
"Its as full of holes as Swiss Cheese" says Terry Singeltary of the FDA
regulations. ...
STILL IS FULL OF HOLES 2013 ;
Thursday, June 6, 2013
BSE TSE PRION USDA FDA MAD COW FEED COMPLIANCE REPORT and NAI, OAI, and VAI
ratings as at June 5, 2013
Greetings,
since our fine federal friends have decided not to give out any more
reports on the USA breaches of the feed ban and surveillance etc. for the BSE
TSE prion mad cow type disease in the USDA livestock, I thought I might attempt
it. I swear, I just don’t understand the logic of the SSS policy, and that
includes all of it. I assure you, it would be much easier, and probably better
for the FDA and the USDA INC., if they would simply put some kind of report out
for Pete’s sake, instead of me doing it after I get mad, because I am going to
put it all out there. the truth.
PLEASE BE ADVISED, any breach of any of the above classifications OAI, VAI,
RTS, CAN lead to breaches into the feed BSE TSE prion protocols, and CAN lead to
the eventual suspect tainted feed reaching livestock. please, if any USDA
official out there disputes this, please explain then how they could not.
paperwork errors can eventually lead to breaches of the BSE TSE prion mad cow
feed ban reaching livestock, or contamination and exposure there from, as well.
I would sure like to see the full reports of just these ;
4018 CHI-DO 3007091297 Rancho Cantera 2866 N Sunnyside Rd Kent IL
61044-9605 OPR FR, OF HP 11/26/2012 OAI Y
9367 3008575486 Rocky Ford Pet Foods 21693 Highway 50 East Rocky Ford CO
81067 OPR RE, TH HP 2/27/2013 OAI N
9446 DEN-DO 1713202 Weld County Bi Products, Inc. 1138 N 11th Ave Greeley
CO 80631-9501 OPR RE, TH HP 10/12/2012 OAI N
9447 DEN-DO 3002857110 Weld County Bi-Products dba Fort Morgan Pet Foods
13553 County Road 19 Fort Morgan CO 80701-7506 OPR RE HP 12/7/2011 OAI N
see full list of the fda mad cow bse feed follies, toward the bottom, after
a short brief update on the mad cow bse follies, and our good friend Lester
Crawford that was at the FDA.
ALSO, I would kindly like to comment on this FDA BSE/Ruminant Feed
Inspections Firms Inventory (excel format)4 format, for reporting these breaches
of BSE TSE prion protocols, from the extensive mad cow feed ban warning letters
the fda use to put out for each violations. simply put, this excel format sucks,
and the FDA et al intentionally made it this difficult to follow the usda fda
mad cow follies. this is an intentional format to make it as difficult as
possible to follow these breaches of the mad cow TSE prion safety feed
protocols. to have absolutely no chronological or numerical order, and to format
such violations in a way that they are almost impossible to find, says a lot
about just how far the FDA and our fine federal friends will go through to hide
these continued violations of the BSE TSE prion mad cow feed ban, and any
breaches of protocols there from. once again, the wolf guarding the henhouse $$$
NAI = NO ACTION INDICATED
OAI = OFFICIAL ACTION INDICATED
VAI = VOLUNTARY ACTION INDICATED
RTS = REFERRED TO STATE
Inspections conducted by State and FDA investigators are classified to
reflect the compliance status at the time of the inspection, based upon whether
objectionable conditions were documented. Based on the conditions found,
inspection results are recorded in one of three classifications:
OAI (Official Action Indicated) when inspectors find significant
objectionable conditions or practices and believe that regulatory sanctions are
warranted to address the establishment’s lack of compliance with the regulation.
An example of an OAI classification would be findings of manufacturing
procedures insufficient to ensure that ruminant feed is not contaminated with
prohibited material. Inspectors will promptly re-inspect facilities classified
OAI after regulatory sanctions have been applied to determine whether the
corrective actions are adequate to address the objectionable conditions.
VAI (Voluntary Action Indicated) when inspectors find objectionable
conditions or practices that do not meet the threshold of regulatory
significance, but warrant an advisory to inform the establishment that
inspectors found conditions or practices that should be voluntarily corrected.
VAI violations are typically technical violations of the 1997 BSE Feed Rule.
These violations include minor recordkeeping lapses or conditions involving
non-ruminant feeds.
NAI (No Action Indicated) when inspectors find no objectionable conditions
or practices or, if they find objectionable conditions, those conditions are of
a minor nature and do not justify further actions.
From: TSS (216-119-138-121.ipset18.wt.net)
Subject: Re: CJD/aka madcow DISEASE $$$ Nutritional Supplements (letter
from FDA)
Date: January 22, 2001 at 2:46 pm PST
In Reply to: Re: CJD/aka madcow DISEASE $$$ Nutritional Supplements posted
by TSS on January 22, 2001 at 11:15 am:
I have been on a crusade so to speak, for going on to 3 years. trying to
convince the world of the threat of human TSE's. The U.S. is not immune to these
deadly disease's. My name is Terry S. Singeltary Sr., and on 12/14/97 i lost my
mother to heidenhain variant creutzfeldt jakob disease.
Exactly one year earlier, to the day 12/14/96, my neighbor lost his mother
to CJD. Both cases confirmed, in fact my Mothers brain is scattered across
America for research.
To cut to the thick of things, i am writing this particular letter in
reference of the meetings on nutritional supplements and their potential risks
of human TSE, through desiccated animal tissue/organs. This industry is mostly
unregulated, and only regulated as foods, and this is not good enough. Since
when is BOVINE SCROTUM/100% natural herb? it's not. and these manufacturers of
these drug also claim, without proof, that their supplement will cure everything
from the common cold to aids. This must stop as well.
Now, i do not know how my Mother became infected with the prion protein or
hvCJD, personally i think it was through contaminated instruments during a
surgery. I don't know how my neighbors mother became infected with the CJD prion
protein, but i will tell you she could have become infected through the
nutritional supplements she had been taking for years, (IPLEX).
Iplex ingredients; Vacuum Dried Bovine BRAIN, Bone Meal, Bovine EYE, Veal
Bone, Bovine Liver Powder, Bovine Adrenal, Vacuum Dried Bovine Kidney, Vacuum
Dried Porcine Stomach.
This is just one of many supplements that contain these potentially lethal
organs, if infected with a TSE. With what little is known about human/animal
TSE's, it would be wise to stop these ingredients from being introduced to the
public, with no apparent or proven method of assuring the product is free of the
prion protein. it is urgent, that this is done immediately.
they have known of this potential route of infection since 1992, or longer.
the letter below from Fred Shank about this problem, is not intended to
intimidate anyone, but only to prove they were worried back then and nothing was
done. they are still worried 8 years later, and _still_ nothing has been
done.
this is very much long overdue about the nutritional supplements. once
again, i will post, how the public has been mis-lead by this industry. This
industry has _very little_ regulations. They are not regulated as
pharmaceuticals, but as foods. The Herbal/Nutritional Supplements industry have
been responsible for many sickness/deaths, do to the FDA lack of control over
this industry.
Another fine example would be; they are still to this day, allowed to claim
complete HERBAL INGREDIENTS/ALL NATURAL. Since when is a bovine scrotum, all
natural, re-METABLOLIFE ingredient. they list this product as all natural '100%
HERBAL'. Ingredients-bovine complex/glandular system, ovaries, prostate,
scrotum, and adrenal.
An interesting note about this supplement. Most of us know by now, my
mother died from heidenhain variant creutzfeldt jakob disease, but, my neighbors
mother had been taking these Iplex supplements for years, and she _also_ died
from creutzfeldt jakob disease. The particular batch of these supplements that
was located after her death, were tested. of those, no contaminants of the prion
agent were found. But, in the N.I.H. same breath, they said that their testing
techniques may have not been strong enough to pick up low infectivity levels.
Also, could have been another batch. She had been taking these for a long period
of time.
So, the possibility is there? I also would like to post a letter about this
from the Gov. to the Industry;
Letter to Manufacturers of Biological Products - Recommendations Regarding
Bovine Spongiform Encephalopathy (BSE)
Department of Health and Human Services Public Health Service Food and Drug
Administration 1401 Rockville Pike Rockville, MD 20852-1448
April 19, 2000
To Manufacturers of Biological Products
The Food and Drug Administration (FDA) has issued letters (date May 3,
1991, December 17, 1993, and May 9, 1996) and a guidance document (September
1997) requesting that materials derived from ruminants which have resided in or
originated from countries where Bovine Spongiform Encephalopathy (BSE) has been
diagnosed not be used in the manufacture of FDA-regulated products intended for
administration to humans. The United States Department of Agriculture (USDA)
also issued an interim rule on January 6, 1998, restricting the importation of
ruminants, meat and meat products from ruminants, and certain ruminant products
and byproducts from all countries of Europe. Because of the serious nature of
this issue, the Center for Biologics Evaluation and Research (CBER) believes it
critical to update the current recommendations.
CBER strongly recommends that manufacturers take whatever steps are
necessary to assure that materials derived from all species of ruminant animals
born, raised or slaughtered in countries where BSE is known to exist, or
countries where the USDA has been unable to assure FDA that BSE does not exist,
are not used in the manufacture of FDA-regulated products intended for
administration to humans. The Agency has previously recommended that
manufacturers take the following steps to prevent this occurrence:
1.Identify all ruminant-derived materials (e.g., culture medium,
transferrin, albumin, enzymes, lipids) used in the manufacture of regulated
products. FDA considers the manufacture of biological products to include the
preparation of master (including the original cell line) and working cell banks,
as well as materials used in fermentation, harvesting, purification and
formulation of the products.
2.Document the country of origin and all countries where the live animal
source has resided for each ruminant-derived material used in the manufacture of
the regulated product. The regulated-product manufacturer should obtain this
information from the supplier of the ruminant-derived product. The
regulated-product manufacturer should also obtain the appropriate veterinary
regulatory inspection certification of slaughter, as required by the country of
origin of live animals, from the supplier. Documentation should be maintained
for any new or in-process lots of licensed, cleared or approved products;
products pending clearance or approval; and investigational products intended to
be administered to humans.
3.Maintain traceable records for each lot of ruminant material and each lot
of FDA-regulated product manufactured using these materials. These records
should be part of the product batch records and available for FDA inspection.
Such records should be maintained for products manufactured at foreign as well
as domestic facilities.
It is the responsibility of the manufacturer to obtain up-to-date
information regarding countries where BSE is known to exist, or countries where
the USDA has been unable to assure FDA that BSE does not exist. This information
is available from the USDA's Animal and Plant Health Inspection Service (APHIS)
at telephone number 301-734-8364, website address
http://www.aphis.usda.gov/ncie, and
codified at 9 CFR 94.18 (see attached).
Specific product-related questions should be directed to the appropriate
application division within CBER's product offices. The phone numbers are:
Dr. David Asher, Office of Blood Research and Review 301-827-3524 Dr. Paul
Richman, Office of Vaccines Research and Review 301-827-3070 James Crim, Office
of Therapeutics Research and Review 301-827-5101
Thank you for your attention to this matter.
Sincerely,
---- signature ---
Kathryn C. Zoon, Ph.D. Director Center for Biologics Evaluation And
Research
Attachment
Subject: Re: human/animal TSEs $$$ Nutritional Supplements $
STANDARDPROCESS CO.
Date: Mon, 22 Jan 2001 10:43:39 –0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de References: 1 , 2
######### Bovine Spongiform Encephalopathy #########
Greetings again,
hmmm, the FDA says;
Q. Does FDA routinely analyze the contents of Dietary Supplements?
FDA has limited resources to analyze the composition of food products,
including dietary supplements. So, FDA focuses first on public health
emergencies and products that may have caused injury or illness. Then products
thought to be fraudulent or in violation of the law are analyzed. FDA uses the
remaining funds for routine monitoring of products pulled from store shelves.
FDA does not analyze supplement products before they are sold to consumers. The
manufacturer is responsible for ensuring that the ingredient list is accurate
and that the ingredients are safe. They are also required to make sure that the
content matches the amount declared on the label.
FDA does not have adequate resources to analyze dietary products sent by
consumers who want to know their content. Instead, consumers may contact the
manufacturer or a commercial laboratory.
snip...
Are all ingredients required to be declared on the label and what kind of
claims can be made on the labels of dietary supplements?
Other ingredients in the product must be listed in the ingredient statement
beneath the "Supplement Facts" panel. The types of ingredients listed there
would include gelatin, sugars, starch, colors, stabilizers and
preservatives.
What kinds of claims can be made on the labels of Dietary
Supplements?
As with other food products, the manufacturer can put certain claims on the
product label. These claims tell consumers about the nutritional value of the
product. Claims defined by FDA to describe the nutrient content of a product,
like "good source" or "high", can appear on the label if one serving meets the
definition. There are specific rules as to which substances can be listed using
these nutrient content claims.
Manufacturers can also put FDA-approved "health claims" on a product label.
Health claims describe the connection between a nutrient or food substance and a
disease or health-related condition. Claims about these diet/disease
relationships can appear on the label if the content of the product meets the
FDA requirements and if the claim is one of the approved health claims.
Why do some supplements have wording that says: "This statement has not
been evaluated by the FDA. This product is not intended to diagnose, treat,
cure, or prevent any disease"?
Certain statements may be included on the label that give the
manufacturer's description of the role of the dietary supplement. These
statements are not authorized by FDA. The manufacturer is responsible for
ensuring that these statements are accurate and truthful. For this reason, the
law says that if a dietary supplement label includes this information, it must
also state that FDA has not evaluated the statement.
Who assures the safety of dietary supplements?
As with food, federal law requires manufacturers of dietary supplements to
ensure that the products they put on the market are safe. But supplement
manufacturers do not have to provide information to FDA to get a product on the
market, unlike the food additive process often required of new food
ingredients.
FDA review and approval of supplement ingredients and products is not
required before marketing.
now, who ya gonna believe???
If the FDA cannot regulate these industry's, what good is the FDA???
with sad regards, Terry S. Singeltary Sr., Bacliff, Texas USA
==============================================
Wednesday, September 25, 2013
*** Inspections, Compliance, Enforcement, and Criminal Investigations BSE
TSE PRION 2013
Wednesday, October 30, 2013
*** SPECIFIED RISK MATERIAL (SRM) CONTROL VERIFICATION TASK FSIS NOTICE
70-13 10/30/13
Tuesday, September 24, 2013
*** NORDION (US), INC., AND BIOAXONE BIOSCIENCES, INC., Settles $90M Mad
Cow TSE prion Contamination Suit Cethrin(R)
Case 0:12-cv-60739-RNS Document 1 Entered on FLSD Docket 04/26/2012 Page 1
of 15
snip...
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
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.
Case 0:12-cv-60739-RNS Document 1 Entered on FLSD Docket 04/26/2012 Page 9
of 15
snip...see full text and more here ;'
Tuesday, September 24, 2013
*** NORDION (US), INC., AND BIOAXONE BIOSCIENCES, INC., Settles $90M Mad
Cow TSE prion Contamination Suit Cethrin(R)
Case 0:12-cv-60739-RNS Document 1 Entered on FLSD Docket 04/26/2012 Page 1
of 15
with great sadness and disgust, I must inform you that our federal
government has failed us again, and chose the industry over sound science, with
regards to TSE prion disease, aka mad cow type disease...tss
Saturday, November 2, 2013
APHIS Finalizes Bovine Import Regulations in Line with International Animal
Health Standards while enhancing the spread of BSE TSE prion mad cow type
disease around the Globe
Tuesday, October 29, 2013
***Risk of Prion Disease Transmission through Bovine-Derived Bone
Substitutes: A Systematic Review
Saturday, November 2, 2013
***APHIS Finalizes Bovine Import Regulations in Line with International
Animal Health Standards while enhancing the spread of BSE TSE prion mad cow type
disease around the Globe
Saturday, November 2, 2013
***Exploring the risks of a putative transmission of BSE to new
species
Wednesday, October 30, 2013
***SPECIFIED RISK MATERIAL (SRM) CONTROL VERIFICATION TASK FSIS NOTICE
70-13 10/30/13
Monday, August 26, 2013
***The Presence of Disease-Associated Prion Protein in Skeletal Muscle of
Cattle Infected with Classical Bovine Spongiform Encephalopathy
Saturday, November 2, 2013
*** Recommendation of the Swiss Expert Committee for Biosafety on the
classification of activities using prion genes and prion protein January 2013
***
Wednesday, October 09, 2013
*** WHY THE UKBSEnvCJD ONLY THEORY IS SO POPULAR IN IT'S FALLACY,
£41,078,281 in compensation REVISED ***
Thursday, October 10, 2013
*** CJD REPORT 1994 increased risk for consumption of veal and venison and
lamb ***
Monday, October 14, 2013
*** Researchers estimate one in 2,000 people in the UK carry variant CJD
proteins ***
Friday, August 16, 2013
*** Creutzfeldt-Jakob disease (CJD) biannual update August 2013 U.K. and
Contaminated blood products induce a highly atypical prion disease devoid of
PrPres in primates
WHAT about the sporadic CJD TSE proteins ?
WE now know that some cases of sporadic CJD are linked to atypical BSE and
atypical Scrapie, so why are not MORE concerned about the sporadic CJD, and all
it’s sub-types $$$
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
Sunday, October 13, 2013
CJD TSE Prion Disease Cases in Texas by Year, 2003-2012
Tuesday, October 29, 2013
*** VARIANT CJD PRESENTS DIFFERENTLY IN OLDER PATIENTS
