greetings,
this is another lengthy post, but some might just be interested in the data ;
SUPPLEMENTAL STATEMENT BY DR ANNE MADDOCKS
Oxytocin (pituitary posterior lobe extract):
Another potential route of BSE infection in the livestock herd
http://www.bseinquiry.gov.uk/files/ws/s467c.pdf
ANNEX A to witness statement 467C of Dr Anne Maddocks
ANNEX A
Oxytocin (pituitary posterior lobe extract):
Another potential route of BSE infection in the livestock herd
http://www.bseinquiry.gov.uk/files/ws/s467cx.pdf
Let us not forget about PITUITARY EXTRACT. This was used to help COWS
super ovulate. This tissue was considered to be of greatest risk of
containing BSE and consequently transmitting the disease.
ANNEX 6
MEETING HELD ON 8 JUNE 1988 TO DISCUSS THE IMPLICATIONS OF BSE TO
BIOLOGICAL PRODUCTS CONTAINING BOVINE - EXTRACTED MATERIAL
How much of this was used in the U.S.?
Please do not keep making the same mistakes;
'Absence of evidence is not evidence of absence'.
What are the U.S. rules for importing and manufacturing vaccines,
medicines and medical devices?
Does the U.S.A. allow sourcing of raw material of ruminants from
the U.S.A.?
U.S. cattle, what kind of guarantee can you give for serum or
tissue donor herds.?
. .
The U.S. rendering system would easily amplify T.S.E.'s:
Have we increased the stability of the system (improved heat treatments)
since the EU SSC report on the U.S.A. was published
in july 2000?
What is done to avoid cross-contaminations in the U.S.A.?
How can the U.S. control absence of cross-contaminations of animal
TSE's when pig and horse MBM and even deer and elk are allowed in
ruminant feed, as well as bovine blood? I sadly think of the rendering
and feeding policy before the Aug. 4, 1997 'partial'
feed ban, where anything went, from the city police horse, to the circus
elephant, i will not mention all the scrapie infected sheep.
I am surprised that we have not included man 'aka soyent green'.
It is a disgusting industry and nothing more than greed fuels it.
When will the U.S.. start real surveillance of the U.S. bovine
population (not passive, this will not work)?
When will U.S. start removing SRMs?
Have they stopped the use of pneumatic stunners in the U.S.?
If so, will we stop it in all U.S. abattoirs or only in those
abattoirs exporting to Europe?
If not, WHY NOT?
same questions for removal of SRM in the U.S.A.,
or just for export?
If not, WHY NOT?
How do we now sterilize surgical/dental instruments in the U.S.A.?
Where have we been sourcing surgical catgut?
(i have copies of imports to U.S., and it would floor you)
hen will re-usable surgical instruments be banned?
see full text;
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Pituitary Injection (Willington) Pituitary (posterior lobe) Injection B
VET C OXYTOCIN LEO* PITOCIN* Pituitary Injection (Dales) 137 *
(Willington Medicals Ltd) Pituitary Extract (VDC) 557 Pituitary
Injection (Dales) 161 Pituitary (Posterior Lobe) Injection (Univet) 534
Pituitary (Posterior) Injection (Pharmavet) 464 Pituitary (Posterior
Lobe) Injection B vet C Posterior Pituitary Injection BVETC Pituitary
(Posterior Lobe) Injection BVetC 1965 Pituitary Extract Injection 10 i.u./ml
http://www.bseinquiry.gov.uk/files/ws/s467cx.pdf
http://www.bse.org.uk/files/ws/s467cx.pdf
1043 Posterior pituitary extracts obtained from oxen or other mammals were used as a source
1044 of oxytocin for veterinary purposes through the period 1950-I 989. Use of anterior pituitary
1045 extracts as a source of follicle stimulating hormone or bovine growth hormone occurred but was
1046 not widespread (Horn 2001). Early epidemiologic investigations of the BSE outbreak dismissed
1047 hormone extracts as a cause of the disease's spread (Wilesmith 1988). Recall that growth
Investigators have proposed that BSE could be an autoimmune disease caused by
exposure of cattle to bacteria containing proteins that induce immunologic cross-reactivity with
central nervous system tissue (Ebringer 1997; Tiwana 1999). According to this theory, the BSE
epidemic resulted from the production of feed rich in the specific bacteria with proteins that
mimic brain tissue. Because of exposure to these bacteria, bovine anti-bacterial antibodies may
have reacted with myelin proteins in the brain that were sufficiently similar to bacterial antigens.
The damage caused by such an auto-immune disease would be chronic and would be consistent
with some of the characteristics of BSE (European Union Scientific Steering Committee 2000b).
Autoimmune brain (disease can be experimentally transmitted to animals but only by injecting
large amounts of brain protein and adjuvants. In contrast, TSE can be transmitted by injecting
only a few nanograms of brain without adjuvant (Horn 2001). In addition, the neuropathology of
autoimmune brain disease differs from that observed in TSE.
SSC has concluded that this theory is not consistent with the BSE epidemic for several
reasons. First, the morphology and distribution of vacuolar or spongifomn-like changes due to
BSE are not the same as those caused by an auto-immune reaction. Second, lymphocytic
infiltrates that are typical of and are a pathogenetically important component of auto-immune
disease are atypical of TSE. Third, high infectious titers cannot be explained by the autoimmune
hypothesis (European Union Scientific Steering Committee 2000b). Fourth, as pointed out by the
BSE Inquiry (Lord Phillips 2000), mouse-adapted BSE can be transmitted i.c. to mice lacking a
functional immune system. Fifth, common bacteria do not have the resistance to chemical and
physical inactivation. shown by the agents of transmissible spongiform encephalopathies,
including bovine spongiform encephalopathy. Finally, this theory fails to explain why many
thousands of animals suddenly became affected and why the BSE epidemic occurred
predominantly in the UK (Horn 2001).
2.2.3.5 Use of Pituitary Hormones
- 19-
104X hormone, prepared from cadaver pituitary glands, has caused transmission of CJD in humans, and
1049 this theory suggests that a similar phenomenon may have occurred in cattle (Airtime 2001). This
1050 hypothesis suggests that pituitary hormones contaminated by BSE caused the epidemic in the UK
1051 but not in other countries. The source of the original infectivity (in humans it was one or more
1052 pituitaries from CJD cases) is not explained by this theory.
http://www.fda.gov/ohrms/dockets/DOCKETS/04n0081/04n-0081-bkg0001-Tab-29-01-vol3.pdf
In addition to the LRS and CNS infectivity has been detected in the
PITUITARY and adrenal glands, bone marrow, pancreas, thymus,
liver and peripheral nerves (Hadlow et al)
before looking further into this, please don't forget the
Looping-ill vaccine issue. not only has this transmission
to humans occured, but also to sheep, hundreds and hundreds
of them. so, we know this mode of transmission can occur in
humans and sheep, so why not cattle?
Subject: Louping-ill vaccine documents from November 23rd, 1946
Date: Sat, 9 Sep 2000 17:44:57 -0700
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To:
[email protected]
######### Bovine Spongiform Encephalopathy #########
THE VETERINARY RECORD
516 No 47. Vol. 58
November 23rd, 1946
NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND
ANNUAL CONGRESS, 1946
The annual Congress, 1946, was held at the Royal Veterinary College,
Royal College Street, London, N.W.I. from September 22nd to September
27th.
Opening Meeting
[skip to scrapie vaccine issue...tss]
Papers Presented to Congress
The papers presented to this year's Congress had as their general theme
the progressive work of the profession during the war years. Their
appeal was clearly demonstrated by the large and remarkably uniform
attendance in the Grand Hall of the Royal Veterinary College throughout
the series; between 200 and 250 members were present and they showed a
keen interest in every paper, which was reflected in the expression of
some disappointment that the time available for discussion did not
permit of the participation of more than a small proportion of
would-be contributors.
In this issue we publish (below) the first to be read and discussed,
that by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E., "Advances in Veterinary
Research." Next week's issue will contain the paper on "Some Recent
Advances in Veterinary Medicine and Surgery in Large-Animal Practice"
by Mr. T. Norman Gold, M.R.C.V.S. In succeeding numbers of the Record
will be reproduced, also with reports of discussions, that by Mr. W. L.
Weipers, M.R.C.V.S., D.V.S.M., on the same subject as relating to
small-animal practice, and the papers by Mr. J. N. Ritchie, B.SC.,
M.R.C.V.S., D.V.S.M., and Mr. H.W. Steele-Bodger, M.R.C.V.S., on
"War-time Achievements of the British Home Veterinary Services."
The first scientific paper of Congress was read by Dr. W. S.
Gordon, M.R.C.V.S., F.R.S.E. on Monday, September 23rd, 1946,
when Professor J. Basil Buxton, M.A., F.R.C.V.S, D.V.H., Prinicipal
of the Royal Veterinary College, presided.
Advances in Veterinary Research
by
W.S. GORDON, PH.D., M.R.C.V.S., F.R.S.E.
Agriculteral Research Council, Field Station, Compton, Berks.
Louping-ill, Tick-borne Fever and Scrapie
In 1930 Pool, Browniee & Wilson recorded that louping-ill was
a transmissible disease. Greig et al, (1931) showed that the infective
agent was a filter-passing virus with neurotropic characters and
Browniee & Wilson (1932) that the essential pathology was that of an
encephalomyelitis. Gordon, Browniee, Wilson & MacLeod (1932) and
MacLeod & Gordon (1932) confirmed and extended this work. It was
shown that on louping-ill farms the virus was present in the blood
of many sheep which did not show clinical symptoms indicating
involvement of the central nervous system and that for the perpetuation
and spread of the disease these subclinical cases were probably of
greater importance that the frank clinical cases because, in Nature,
the disease was spread by the tick, lxodes ricinus L. More recently
Wilson (1945, 1946) has described the cultivation of the virus in a
chick embryo medium, the pathogenic properties of this culture
virus and the preparation of louping-ill antiserum.
Between 1931 and 1934 I carried out experiments which resulted
in the development of an effective vaccine for the prevention
of louping-ill.* This vaccine has been in general use since 1935
and in his annual report to the Animal Diseases Research Association
this year, Dr. Greig stated that about 227,000 doses of vaccine
had been issued from Moredun alone.
Dr. Gordon illustrated this portion of his paper by means of graphs
and diagrams projected by the epidiascope.
This investigation, however, did not begin and end with the
study of louping-ill; it had, by good fortune, a more romantic
turn and less fortunately a final dramtic twist which led almost
to catastrope. After it had been established that a solid immunity
to louping-ill could be induced in sheep, a group of
immunized and a group of susceptible animals were placed together
on the tick-infected pasture of a louping-ill farm. Each day all
the animals were gathered and their temperatures were recorded.
It was anticipated that febrile reactions with some fatalities would
develop in the controls while the louping-ill immunes would remain
normal. Contrary to expectation, however, every sheep, both immune
and control, developed a febrile reaction. This unexpected
result made neccessary further investigation which showed that the
febrile reaction in the louping-ill immunes was due to a hitherto
undescribed infective agent, a Rickettsia-like organism which could
be observed in the cytoplasm of the grannular leucocytes, especially
the neutrophil polymorphs (MacLeod (1932), Gordon, Browniee,
Wilson & MacLeod. MacLeod & Gordon (1933). MacLeod (1936).
MacLeod collected ticks over many widely separated parts of
Scotland and all were found to harbour the infective agent of
tick-borne fever, and it is probable that all sheep on tick-infested
farms develop this disease, at least on the first occasion that they
become infested with ticks. When the infection is passed in series
through susceptible adult sheep it causes a sever, febrile reaction,
dullness and loss of bodily condition but it rarely, if ever, proves
fatal. It is clear, however, that it aggravates the harmful effects
of a louping-ill infection and it is a serious additional complication
to such infections as pyaemia and the anacrobic infections which
beset lambs on the hill farms of Northern Britain.
Studying the epidemiology of louping-ill on hill farms it became
obvious that the pyaemic condition of lambs described by
M'Fadyean (1894) was very prevalent on tick infested farms
Pyaemia is a crippling condition of lambs associated with tick-bite
and is often confused with louping-ill. It is caused by infection
with Staphylococcus aureus and affected animals may show abscess
formation on the skin, in the joints, viscera, meninges and elsewhere
in the body. It was thought that tick-borne fever might
have ben a predisposing factor in this disease and unsuccessful
attempts were made by Taylor, Holman & Gordon (1941) to reproduce
the condition by infecting lambs subcutaneously with the
staphylococcus and concurrently produceing infections with tickborne
fever and louping-ill in the same lambs. Work on pyaemia
was then continued by McDiarmid (1946a, 1946b, 1946c), who
succeeded in reproducing a pyaemic disease in mice, guinea-pigs
and lambs similar to the naturally occuring condition by intravenous
inoculation of Staphylococcus aureus. He also found a
bacteraemic form of the disease in which no gross pyaemic lesions
were observed. The prevention or treatment of this condition
presents a formidable problem. It is unlikely that staphylococcal
???oid will provide an effective immunity and even if penicillin
proved to be a successful treatment, the difficulty of applying it
in adequate and sustained dosage to young lambs on hill farms
would be almost insurmountable.
>From 1931 to 1934 field trials to test the immunizing value
and harmlessness of the loup-ill vaccine were carried out on a
gradually increasing scale. Many thousands of sheep were vaccinated
and similar numbers, living under identical conditions
were left as controls. The end result showed that an average
mortability of about 9 percent in the controls was reduced to less
than 1 percent in the vaccinated animals. While the efficiency
of the vaccine was obvious after the second year of work, previous
bitter experience had shown the wisdom of withholding a biological
product from widespread use until it had been successfully produced
in bulk, as opposed to small-scale experimental production
and until it had been thoroughly tested for immunizing efficiency
and freedom from harmful effects. It was thought that after
four years testing this stage had been reached in 1935, and in
the spring of that year the vaccine was issued for general use. It
comprised a 10 percent saline suspension of brain, spinal cord
and spleen tissues taken from sheep five days after infection with
louping-ill virus by intracerebral inoculation. To this suspension
0-35 percent of formalin was added to inactivate the virus and
its safety for use as a vaccine was checked by intracerbral inoculation
of mice and sheep and by the inoculation of culture medium.
Its protective power was proved by vaccination sheep and later
subjecting them, along with controls, to a test dose of living virus.
Vaccine for issue had to be free from detectable, living virus
and capable of protecting sheep against a test dose of virus applied
subcutaneously. The 1935 vaccine conformed to these standards
and was issued for inoculation in March as three separate batches
labelled 1, 2, and 3. The tissues of 140 sheep were employed
to make batch 1 of which 22,270 doses were used; 114 to make
batch 2 of which 18,000 doses were used and 44 to make batch 3
of which 4,360 doses were used. All the sheep tissues incorporated
in the vaccine were obtained from yearling sheep. During 1935
and 1936 the vaccine proved highly efficient in the prevention
of loup-ill and no user observed an ill-effect in the inoculated
animals. In September, 1937, two and a half years after vaccinating
the sheep, two owners complained that scrapie, a disease which
had not before been observed in the Blackface breed, was appearing
in their stock of Blackface sheep and further that it was confined
to animals vaccinated with louping-ill vaccine in 1935. At that
stage it was difficult to conceive that the occurrence could be
associated with the injection of the vaccine but in view of the
implications, I visited most of the farms on which sheep had been
vaccinated in 1935. It was at this point that the investigation
reached its dramatic phase; I shall not forget the profound effect
on my emotions when I visited these farms and was warmly welcomed
because of the great benefits resulting from the application
of louping-ill vaccine, wheras the chief purpose of my visit was
to determine if scrapie was appearing in the inoculated sheep.
The enquiry made the position clear. Scrapie was developing in
the sheep vaccinated in 1935 and it was only in a few instances
that the owner was associating the occurrence with louping-ill
vaccination. The disease was affecting all breeds and it was
confined to the animals vaccinated with batch 2. This was clearly
demonstrated on a number of farms on which batch 1 had been
used to inoculate the hoggs in 1935 and batch 2 to inoculate
the ewes. None of the hoggs, which at this time were three-
year-old ewes. At this time it was difficult to forecast whether all
of the 18,000 sheep which had received batch 2 vaccine would
develop scrapie. It was fortunate, however, that the majority of
the sheep vaccinated with batch 2 were ewes and therfore all
that were four years old and upwards at the time of vaccination
had already been disposed of and there only remained the ewes
which had been two to three years old at the time of vaccination,
consequently no accurate assessment of the incidence of scrapie
could be made. On a few farms, however, where vaccination was
confined to hoggs, the incidence ranged from 1 percent, to 35 percent,
with an average of about 5 percent. Since batch 2 vaccine
had been incriminated as a probable source of scrapie infection,
an attempt was made to trace the origin of the 112 sheep whose
tissues had been included in the vaccine. It was found that they
had been supplied by three owners and that all were of the
Blackface or Greyface breed with the exception of eight which
were Cheviot lambs born in 1935 from ewes which had been in
contact with scrapie infection. Some of these contact ewes
developed scrapie in 1936-37 and three surviving fellow lambs to
the eight included in the batch 2 vaccine of 1935 developed
scrapie, one in September, 1936, one in February, 1937, and one
in November, 1937. There was, therefore, strong presumptive
evidence that the eight Cheviot lambs included in the vaccine
althought apparently healthy were, in fact, in the incubative stage
of a scrapie infection and that in their tissues there was an
infective agent which had contaminated the batch 2 vaccine,
rendering it liable to set up scrapie. If that assumption was
correct then the evidence indicated that:-
(1) the infective agent of scrapie was present in the brain, spinal
cord and or spleen of infected sheep:
(2) it could withstand a concentration of formalin of 0-35 percent,
which inactivated the virus of louping-ill:
(3) it could be transmitted by subcutaneous inoculation;
(4) it had an incubative period of two years and longer.
Two Frenchmen, Cuille & Chelle (1939) as the result of experiments
commenced in 1932, reported the successful infection of
sheep by inoculation of emulsions of spinal cord or brain material
by the intracerebral, epidural, intraocular and subcutaneous routes
The incubation period varied according to the route employed,
being one year intracerebrally, 15 months intraocularly and 20
months subcutaneously. They failed to infect rabbits but succeeded
in infecting goats. Another important part of their work
showed that the infective agent could pass throught a chamberland
1.3 filter, thus demonstrating that the infective agent was a
filtrable virus. It was a curious coincidence that while they
were doing their transmission experiments their work was being
confirmed by the unforeseeable infectivity of a formalinized tissue
vaccine.
As a result of this experience a large-scale transmision experiment
involving the ue of 788 sheep was commenced in 1938 on a
farm specially taken for the purpose by the Animal Diseases
Research Association with funds provided by the Agricultural
Research Council. The experiment was designed to determine the
nature of the infective agent and the pathogenesis of the disease.
It is only possible here to give a summary of the result which
showed that (1) saline suspensions of brain and spinal cord tissue
of sheep affected with scrapie were infective to normal sheep
when inoculatted intracerebrally or subcutaneously; (2) the incubation
period after intracerebral inoculation was seven months and
upwards and only 60 percent of the inoculated sheep developed
scrapie during a period of four and a half years; (3) the incubation
period after subcutaneous inoculation was 15 months and upwards
and only about 30 percent of the inoculated sheep developed
the disease during the four and a half years: (4) the infective
agent was of small size and probably a filtrable virus.
The prolonged incubative period of the disease and the remarkable
resistance of the causal agent to formalin are features of
distinct interest. It still remains to determine if a biological test
can be devised to detect infected animals so that they can be
killed for food before they develop clinical symptoms and to
explore the possibilities of producing an immunity to the disease.
==================================================================
Greetings List Members,
pretty disturbing document. now, what would stop this from happening
with the vaccineCJD in children???
kind regards,
Terry S. Singeltary Sr., Bacliff, Texas USA
-------- Original Message --------
Subject: [Docket No. 04-116-1] USE of veterinary biological products on the topic of Transmissible Spongiform Encephalopathies (TSS SUBMISSION)
Date: Fri, 05 Nov 2004 11:49:49 -0600
From: "Terry S. Singeltary Sr."
To:
[email protected]
CC:
[email protected].,
[email protected]., BSE-L
> Meeting topics and proposed presentation titles should be submitted
> to Steven A. Karli, director, CVB, APHIS, Veterinary Services, 510
> South 17 St., Suite 104, Ames, IA 50010-8197; phone (515) 232-5785,
> fax (515) 232-7120 or e-mail
[email protected]. For registration
> information contact Nicole Ruffcorn at the same address and fax number
> or via phone dial (515) 232-5785 extension 127 or e-mail
>
[email protected]..
http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/E4-3008.htm
I wish to kindly submit the following to Mr. Steven A. Karli for the
13th public
meeting to discuss regulatory and policy issues related to the manufacture,
distribution, and use of veterinary biological products on the topic of
Transmissible Spongiform Encephalopathies (all of them).
[Docket No. 04-116-1]
Greetings APHIS/USDA et al,
INOCULATION of the TSE agent is the most effected mode
of transmission, or so it seems.
MOST people have forgotten the medicines act of 1968 where
they state not to use scrapie associated fibers SAF for any
pharmaceuticals for animals in vet products;
June 1983
MEDICINES ACT 1968
''Unless there is a risk from a heat-resistant pathogen such as the
scrapie agent,
no restrictions are placed on substances sterilized by autoclaving
provided that the
complete mass is held at a minimum of 115°C for at least 15 minutes''...
http://www.bseinquiry.gov.uk/files/yb/1983/06/00001001.pdf
PLEASE do not forget the infamous 'Louping-ill vaccine' incident;
III.3.1 VACCINES
Reference has already been made to the occurrence of at least several
hundred cases of scrapie in British sheep as a direct result of the use
of a vaccine against the tick transmitted, viral disease, louping-ill
(Gordon, Brownlee and Wilson, 1939, Gordon, 1946 and Greig, 1950). This
occurrence resulted from the accidental use of scrapie-infected source
material and processing methods that did not inactivate the scrapie
agent that was unknowingly present. A more recent possible occurrence of
possible iatrogenic scrapie has recently been reported in Etna Silver
crossbred goats in Italy by Cappucchio et al., (1998). The goats were
kept at grass and concentrate rations were not fed, thus eliminating a
source of infection from feed via mammalian proteins. Animals over two
months old were annually vaccinated against contagious agalactia caused
by Mycoplasma agalactiae. The vaccine included central nervous system
from pathogen-free sheep. The mortality rate in the goats reached
28% in 1 herd, 60% in the second and 5.5% in a third herd. About half
the 56 goats were between 2.5 - 3 years old. Only 1.15% of sheep that
were kept with the goats developed scrapie. Scrapie was confirmed by
microscopic examination of the brain and by detection of PrPSc including
by immunocytochemistry. PrPSc was widespread in the brain and beyond
sites of vacuolar change. The high mortality, severe loss of weight and
simultaneous appearance in the three herds were distinctly unusual
features in this outbreak. The source of infection remains uncertain and
unproven but iatrogenic transmission must be considered.
A larger epidemic involving 20 outbreaks of scrapie in sheep and goats,
also in Italy, has been even more recently reported by Agrimi et al.,
(1999). The annual incidence ranged from 1% to 90% with a mean incidence
for goats of 26% and for sheep of 10%. The total number of cases in
sheep and goats together was 1040. The clinical disease was confirmed by
microscopic examination of the brain and PrP immunocytochemistry or
Western blotting. The high incidence in goats, the high
within-flock/herd incidence, the temporal clustering, absence of
commercial concentrate feeding in eight flocks and association with the
use of a sub-cutaneously administered M. agalactiae vaccine, prepared
locally using brain and mammary tissue from clinically healthy sheep,
strongly suggests an iatrogenic origin. Scrapie appeared between 23 and
35 months after the vaccine was administered. A third outbreak in
southern Italy attributed also to the same vaccine has been described by
Caramelli et al, (2001) in a mixed flock of Comisana sheep and half-bred
goats in an upland area of southern Italy. High crude mortality and
scrapie incidence occurred in both species and a large proportion of
aged animals were affected. The neuropathology was similar to that in
other sheep in Italy with iatrogenic disease but different from
conventional natural scrapie. Affected sheep were all of the most
susceptible genotype (Codon 171 QQ). It is stressed that the vaccines
incriminated in the transmission of scrapie in all these incidents are
not commercially produced. They have been prepared and distributed
locally within the country. Dr Subash Arya has repeatedly drawn
attention to the possible risk of transmitting CJD to humans vaccinated
with sheep-brain derived vaccines in India, e.g. Arya, (1994). However,
neither Dr Arya nor any of his colleagues has yet found any such case.
The episodes of scrapie resulting from the use of vaccines prepared from
infected sheep tissues emphasises the need for caution and mandatory
selection of safe sources for starting materials used in the manufacture
of vaccines. Such vaccines could theoretically at least, be used in
cattle thus creating a potential risk, though it is most unlikely that
they would be licensed for this purpose in Europe. Vaccines have not
been incriminated in the transmission of BSE (Wilesmith et al., 1988,
J.W.Wilesmith, personal communication). Furthermore, large numbers of
doses of commercially produced vaccines that have used bovine starting
materials, have been inoculated by parenteral and oral routes into
cattle throughout the world and a substantial proportion have been
produced in Europe, but no incident of BSE has been attributed to their
use. This is important because, since there is no species barrier, any
chink in the armour protecting vaccines from contamination would have
been revealed, but none has.
III.3.2.OTHER MEDICINAL PRODUCTS DERIVED FROM TSE-SUSCEPTIBLE SPECIES
Animal sources of material used in medicinal products vary, but mostly
are derived from cattle. There is thus at least a possibility that
unless strict precautions are taken, disease could be transmitted in
this way. It cannot be ruled out that no case ever arose by this means,
but it is clear that the majority did not, even at the very beginning of
the BSE epidemic before publication of information on BSE, and before
any legislation was in place (Wilesmith et al., 1988). The highest risk
tissue is bovine brain from a clinically affected animal or one in the
immediate pre-clinical phase. Posterior pituitary extract (now prepared
biosynthetically), was available and used in veterinary practice mainly
in adult female cattle at the time of parturition, to assist treatment
of retained placenta or to assist in milk let down. However, no
association was found between its use and the occurrence of BSE
(Wilesmith et al., 1988).
http://europa.eu.int/comm/food/fs/sc/ssc/out236_en.pdf
1: Indian J Pediatr. 1991 Sep-Oct;58(5):563-5.
Acquisition of spongiform encephalopathies in India through sheep-brain
rabies vaccination.
Arya SC.
Centre for Logistical Research and Innovation, Greater Kailash, New Delhi.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1813404&dopt=Abstract
THERE have been concerns about using drugs to super-ovulate cattle
abroad and
in the USA. How much (if any) of this product is still used in the USA,
I do not know,
but if any is used and or has been used in the past, should be stopped
ASAP for
risk of TSE;
Super-ovulate cattle. (Not to forget about the potential for some BSE
cases to come from vaccinations containing pituitary-derived SRMs.)
TWA LITTLE minute
2. We have identified one problem over where we are unable to act and
this is
the use of gonadotrophins in embryo transfer work. Some veterinary surgeons
are quite legally using this exemption from the Medicines Act contained in
Section 9(2) to prepare gonadotrophins from pituitary glands from various
species, including cattle. These hormones are used to stimulate
superovulation in
donor cows.
3. The extraction is from a pool of pituitary glands collected from
abbatoirs and the
process used is unlikely to have any effect on the BSE agent. Hormones
extracted
from human pituitary glands have been responsible for a small number of
cases of
Creutzfeldt Jacob disease in man.
http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf
COMMERCIAL IN CONFIDENCE
Medicines Act - Veterinary Products Committee
Minutes of the Biologicals Committee meeting held on Tuesday 6 September
1988,
at 10:00 am in the Old Library, Central Veterinary laboratory, Weybridge.
It was reported that some replies had been received from Companies using
pituitary glands in their products...(rest are 4 blank pages...TSS)
http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf
NOT FOR PUBLICATION
http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf
http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf
NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE
snip...
I was quite prepared to believe in unofficial pituitary hormones, also
in the 1970's, whether as described by Dr. Little, or in other
circumstances, for animal use.
snip...
The fact that there were jars of pituitaries (or extract) around on
shelves is attested by the still potent 1943 pituitaries, described in
Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at
Mill Hill. Having taken the trouble to collect them, they were not
lightly thrown out...
http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf
more on the 1968 medicine act, they forgot to follow
http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf
Draft cover letter to product licence holders (considered by Human and
Vet Medicines including deer)
http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf
(It was noted with concern that hormone extracts could be manufactured
by a veterinary surgeon for administration to animals under his care
without any Medicines Act Control.)
http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf
PITUITARY EXTRACT
This was used to help cows super ovulate. This tissue was considered to
be of
greatest risk of containing BSE and consequently transmitting the disease...
http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf
(pages blank...TSS)
http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf
TWA LITTLE STATEMENT 331
The BSE Inquiry / Statement No 331
Dr TWA Little
(not scheduled to give oral evidence)
THE BSE INQUIRY
STATEMENT OF DR T W A LITTLE
1. This statement is given by Dr Thomas William Anthony Little (TWAL). I am
currently Chief Executive of the Veterinary Laboratories Agency (VLA) and my
professional address is New Haw, Addlestone, Surrey KT15 3NB.
2. In 1966 I joined the Central Veterinary Laboratory (CVL).3. In the
period 1973 -
1996 I held the following posts:
· 1973 - 1982 Senior Research Officer
· 1982 - 1985 Deputy Regional Veterinary Officer (Tolworth)
· 1985 - 1986 Veterinary Head of Section (Tolworth)
· 1986 - 1990 Deputy Director of the CVLThis included responsibility for the
Veterinary Medicines Unit and the Biological Products and Standards
Department
most of which became part of the Veterinary Medicines Directorate in
April 1989.
· 1990 - 1996 Director and Chief Executive of the CVL which become the
Veterinary Laboratories Agency on merger with the Veterinary Investigation
Service in 1995.
4. When I returned to the CVL in 1986 as one of two Deputy Directors I
took over
specific responsibility for veterinary medicines. This involved fairly
frequent contact
with the Veterinary Medicines Division and the Animal Health Groups in
Tolworth. The
Veterinary Medicines Division dealt with the policy and administration
side of veterinary
medicines. I also briefed the Chairman of the Veterinary Products
Committee (VPC)
before meetings and attended meetings of the VPC. I chaired the meetings
of the
Scientific Secretariat of the VPC and the Biologicals Committee of the
VPC. I also
attended meetings of the Medicines Commission and various other
committees which
dealt with human medicines when necessary. This included the Committee
on Safety of
Medicines (CSM) Sub Committee on Biological Products. I also attended
occasionally
meetings of the Committee of Veterinary Medicinal Products (CVMP) in
Brussels.
5. Within CVL I had responsibility for:-
· The Medicines Unit - headed by Alastair Kidd
· The Biologicals Products and Standards Department - headed by Dr Denise
Thornton
Progressively during 1987 staff at CVL become aware of and
discuss
informally the potential of BSE to contaminate immunological
products. Such
concerns were discussed with administrators in the Veterinary
Medicines
Division. Following Wells et al publication TWAL discussed with
Prof J
Armour, Chairman VPC.
November 1987 As a result of informal discussions, Peter
Luff was asked to produce a paper on BSE - implications for
biologicals products.
6 January 1988 Biologicals Committee of VPC. Peter Luffs paper
tabled (Annex 2 )(YB 88/01.06/1.1-1.5) detailed discussion at next
meeting.
3 February 1988 Biologicals Committee of VPC (chaired by A Kidd)
(Veterinary Medicines Division represented by Mr Muriel and Mrs
Buckler)
Detailed discussion of Mr Luffs paper. (YB 87/12.00/1.1-1.3)
Report to senior officers in MAFF (CVL, VMD and AH Division)
further consideration of whether certification of cattle for freedom
from BSE was possible. (Annex 3) (YB 88/02.03/1.1-1.2)
During the next few months, discussions were held with staff of the
National Institute for
Biological Standards and Controls (NIBSC) leading to arrangements for a
meeting at
NIBSC by Dr P Minor.
16 May 1988 Meeting at NIBSC attended by Mr J Wilesmith CVL,
Drs R Ridley and H Baker MRC, Dr Schild, Minor and Ferguson
NIBSC and Drs Beale and Garland Wellcome
Laboratories.Recommendation of this meeting (Annex 4)(YB
88/08.00/2.1 ; YB 88/07.11/13.1 ; YB 88/05.16/2.1-2.12) sent to
Julymeeting of Biological Sub committee of CSM.
7 June 1988 Biologicals Committee of VPC
Agreed to a set of guidelines for pharmaceutical industry produced
by Geoff Wood.
Further internal meeting to be arranged between CVL staff to
progress the guidelines and any urgent matters relating to products.
(Annex 5) (YB 88/06.07/10.1-10.6)
8 June 1988 Internal CVL meeting to discuss the implications of
BSE to Biologicals Products containing bovine extracted material
(Annex 6). (YB 88/06.08/11.1-11.2) Following a detailed review
of situation the following recommendations were made:1.
Specific concern over use of pituitary gland
products by veterinary surgeons and companies. Paper to
be produced for Tolworth (Veterinary Medicines Division).
2. Urgent review of all products both immunological
and pharmaceutical for possible inclusion of ingredients of
bovine origin.
3. Draft guidelines to be presented in full to the
National Office of Animal Health (NOAH), the trade body
representing the Veterinary Medicines part of the
pharmaceutical industry, at next meeting on 11 July 1988
5 July 1988 Biologicals Committee Meeting
Detailed discussion of Geoff Wood's draft guidelines (SP3875.2)
(Annex 7) (YB 88/07.05/6.1-6.4)Major concern over pituitary
gland products and a letter being sent to all licence holders.
Amended paper to be presented to NOAH on 11 July and sent to
NIBSC and DHSS.
11 July 1988 Meeting with NOAH. (Annex 8) (YB
88/07.11/12.1-12.4)Dr Little briefed the meeting on the emergence
of BSE and showed the MAFF Video.Mr Wood presented the
proposed guidelines which were discussed. Mr Cook on behalf of
NOAH agreed to comment as soon as possible and agreed to
obtain information on pharmaceutical products which contained
bovine material of UK origin.
6 September 1988 Biologicals Committee of VPCSome replies
from companies using pituitary glands in their products received.
Copies of draft guidelines have been sent to NIBSC and DHSS.
(Annex 9) (YB 88/09.06/5.1-5.4)
8 November 1988 Meeting with NOAH. (Annex 10)(YB
88/11.25/5.1 ; YB 88/11.08/5.1-5.6)
Dr Little briefed the meeting on the current BSE situation. Some
problems with implementing the guidelines were discussed but
NOAH were keen to see them published quickly.
20 December 1988 Letter from Sir Richard Southwood asking what
detailed consideration had been given to this issue and asking for
views on whether some form of guidance to industry might be
useful. (Annex 11) (YB 88/12.20/2.1)
3 January 1989 Meeting between Medicines Division of
DHSS (Dr Adams, Dr Jeffreys and Dr Purves) and MAFF (CVL)
(Dr Little, Mr Kidd and Mr Bradley) Detailed review of the
situation and the need to 'keep in step'. A further meeting to be
held after MAFF guidelines have been reviewed by the VPC at its
January meeting. (Annex 12) (YB 89/01.03/2.1-2.2)
19 January 1989 Veterinary Products Committee
The draft guidelines to assist manufacturers of biological products
containing materials of bovine origin was provided for members'
comments. Mr Ray Bradley provided members with an extensive
briefing on the BSE problem. Written comments on the guidelines
were requested before the February meeting. (Annex 13) (YB
89/01.19/6.1 ; YB 89/01.00/2.1-2.3)
26 January 1989 Reply sent to Sir Richard Southwood
(Annex 14) (YB 89/01.26/2.1-2.4)
1 February 1989 Meeting between MAFF officials (Dr Little,
Mr Kidd, Mr Bradley) and D of H (Drs Jeffrey and Adams) from
Medicines Division) plus representation from NIBSC and
Biologicals Committee of CSM.The meeting agreed the text of
what were now joint MAFF/DH guidance for manufacturers plus a
timetable for clearance by various advisory committees to enable
publication in MAIL before Easter.
15/16 February 1989 Veterinary Products Committee Meeting (Annex 15)
(YB 89/02.15/6.1 ; YB 88/02.15/7.1)VPC (89) 38 containing the
revised CSM/VPC guidelines for industry were presented for
comment together with the correspondence with Sir Richard
Southwood.Subject to some minor changes the Guidelines were
agreed.
22 February 1989 Human and Veterinary Medicines Briefing
Group on BSEThe meeting was called to consider the DH/MAFF
draft guidelines to advise CSM. The meeting consisted of members
of the Biologicals Sub Committee of CSM, invited experts,
representatives of the Department of Health Medicines Division,
the Department of Health and MAFF prior to the publication of the
Southwood Report (Annex 16) (YB 89/2.22/11.1-11.8)
7 March 1989 Biologicals Committee of VPCA joint set of
guidelines had been agreed with D of H. A separate (MAFF)
questionnaire had been prepared asking for details of all products
had been sent out to all licence holders for reply by May 1989.
(Annex 17)(YB 89/03.07/2.1-2.5)
21 March 1989 Meeting with NOAH (Annex 18) (YB
89/03.21/13.1-13.4)Dr Little outlined the current situation and
explained why members had received the guidelines from both D
of H and MAFF. He explained that the guidelines set a very high
standard but indicated that manufacturers may present equivalent
methods to obtain the required standard.
1 April 1989 VMD establishedColleagues from Veterinary
Medicines Division, the Medicines Unit and part of BP&S join up
to become the VMD as recommended by the Cunliffe Review. Dr
Rutter was appointed as Chief Executive designate. I moved on to
take over the Agency Project Team for CVL.
Contact with the Department of Health
9. I have been asked specifically about my attendance at the Biological Sub
Committee of the CSM. (Annex 19) (YB 87/09.09/1.1-12)
10. On 9 September 1987 I attended a meeting of the Biological
Sub-Committee of
the CSM. This Sub-Committee is made up of independent experts. The
function of the
Sub-Committee is to advise the Committee on Safety of Medicines, which
is also made
up of independent experts. A number of officials, mainly from the
Department of Health,
attend both committees. Both committees advise on the safety of human
medicines,
including vaccines, but do not normally address matters relating to
animal health.
11. The 9 September 1987 was (I believe) the only time I attended a
meeting of the
Biological Sub-Committee. On this occasion, I attended in place of the
usual MAFF
representative, Dr Brinley-Morgan who retired in 1986.
12. A copy of the minutes of the meeting is Annexed to this statement. (YB
87/09.09/1.1-1.12) The meeting was chaired by Professor Collee, who had
lectured to me
in Edinburgh when I was an undergraduate. Dr Paul Adams was also at the
meeting. I
knew him as we both attended as officials the Veterinary Products
Committee meetings
and were both members of that Committee's Scientific Secretariat. I do
not believe I
knew any of the other attendees at the meeting personally.
13. One of the products discussed during the meeting was composed of
human dura
mater. This was under review at the meeting because of a case of CJD
associated with its
use. The official from the Department of Health presenting the case was
Dr Adams.
14. Although the minutes of the meeting make no reference to it, I made
a mention at
the meeting of the occurrence of BSE in cattle. I believe (although I
cannot now be sure)
that I mentioned BSE during the course of the formal meeting. I can
remember that a
discussion of scrapie resulted from my mention of BSE. Professor Collee
impressed me
with his knowledge of scrapie. It may be that my mention of BSE and
Professor Collee's
comments on scrapie arose during discussion on Dr Adams's paper on the
dura mater
products.
15. Although I am uncertain about the precise context in which I raised
BSE, I am
certain that Professor Collee and Dr Adams were present when I mentioned
BSE.
16. I also believe that Dr Adams introduced me to a number of his
colleagues from
the Department of Health after the meeting, although I cannot remember
who they were.
We most probably informally discussed BSE in relation to the use of
bovine material in
medicinal products, both human and veterinary.
17. I am not aware of any action taken by the Department of Health or
the Biologicals
Sub-Committee as a result of my mention of BSE at this meeting. I have
seen a minute
from Dr Watson to Mr Rees of 10 September 1987 (YB 87/9.10/1.1)
18. I believe the minute accurately reflects what I told Dr Watson. It
was my
understanding that someone from the Department of Health would be writing or
otherwise getting in touch with MAFF.
19. There was frequent contact between myself and other senior CYL staff
with the D
of H Medical Assessors who attended the VPC meetings and the Scientific
Secretariat.
Normally either Dr Paul Adams, Dr Geoffrey Diggle or Dr Kevin Woodward
attended.
20. There was a good working relationship. As can be seen from the
chronology there
was also contacts with NIBSC which performed a role for D of H which was
similar to
that which CVL carried out for MAFF.
21. At this stage it is difficult to determine when BSE was first
discussed in these
informal discussions. Formal meetings are listed in the chronology.
Southwood Committee Recommendation - 24 February 1989
22. One of the Southwood recommendations (8.2) was "the attention of the
Licensing
Authority, the CSM and the VPC be drawn to the emergence of BSE so that
they can take
appropriate action".
23. From the chronology it can be seen that the Biologicals Committee of
the VPC
were alert to this problem from November 1987 and had commissioned
papers and the
draft guidelines which were made available to the Southwood Committee.
24. The full VPC considered the guidelines in January 1989.
Contacts with the Pharmaceutical Industry
25. As can be seen from the chronology, the draft guidelines were first
given to
NOAH in July 1988 for their comments and contact was being made with
product licence
holders in June 1988 regarding some specific products.
26. The industry started searching for alternatives to UK bovine
products at an early
stage and were anxious to protect the safety aspect of their products.
27. Meetings with NOAH also took place in November 1988 and March1989.
28. The Consultative Committee chaired by Dr Tyrrell recommended in its
Interim
Report (June 1989) that there should be more detailed investigations
into the fate of
bovine and ovine tissues which might lead to the spreading of infection.
29. Urgent activity on the veterinary aspects of inclusion of bovine
material in
vaccines and other drugs (mainly hormones) commenced in June 1988 and a
detailed
questionnaire was circulated in May 1989.
30. There was similar activity by the medical assessors of the CSM.
31. Dr Tyrell was a member of the Biologicals Sub Committee of the CSM
at this
time.
Diagnosis of Scrapie and BSE by the Veterinary Investigation Service
32. I have been asked to comment on this matter. Between 1982 and 1985 I
was a
Deputy Regional Veterinary Officer based at Tolworth in the Veterinary
Investigation
Section which managed the VI Service. I was a frequent visitor to VI
Centres and was
particularly concerned with project work. In 1995, the VI Service merged
with the CVL
to form the VLA of which I am currently Chief Executive and Director.
33. At the time of the first cases of BSE (in the mid 1980s) there were many
veterinarians in the VIS with experience in general histopathology. This
experience was
promoted and encouraged through regional, informal meetings of the
Histopathology
Study Groups, at which participants from Veterinary Investigation
Centres ("VIC"), the
CVL and Veterinary School Pathology Departments would discuss cases.
34. Although not every Veterinary Investigation Officer ("VIO") was
trained in
histopathological diagnosis, and not every VIC had the capacity to
process tissue samples
for histopathology as a routine, all VIOs considering a clinical
differential diagnosis of
neurological disease would have collected material for histopathological
examination and
referred it to a colleague with the necessary expertise. The colleague
could have been
within the VICs or the in the Pathology Department at CVL or at the Lasswade
Laboratory. Some of these VIOs with an interest and experience in
histopathology would
also have had formal training in pathology, but very few would, at that
time, have
claimed complete confidence in making histopathological examinations of
brain or other
nervous system tissues.
35. If the indication, particularly from the case history, was that an
unusual
neurological problem was occurring, the VIO usually referred the whole
fixed brain,
intact, direct to the Consultant Pathology Unit ("CPU") at CVL. The
exception to this
would have been the examination, by VIOs in some instances, of brains of
sheep for
diagnosis of scrapie and ruminants generally, for diagnosis for
listeriosis. However, brain
material from some scrapie cases was passed to the CPU, CVL sometimes
for primary
diagnosis or for second opinions.
36. Very few cases of neurological disease in adult cattle were
presented to VIOs for
post mortem examination and thus the examination of cow brains by any
pathologist at
that time was a relatively rare event.
37. The original cases to be diagnosed, of the disease which later
became known as
BSE, were referred to by Mr Carl Johnson a VIO at Wye VIC, Kent, to Mr
Gerald Wells
at CVL but, as Dr Matthews statement indicates, another case was
diagnosed at a VIC.
The transcript of Dr Matthews statement states: "Roger Hancock, who I
think first picked
[it] up down in the south west."
38. Roger Hancock was a VIO working at the Truro VIC who had experience
of the
histopathological diagnosis of scrapie. He was thus able to recognise
similarities between
spongiform changes in scrapie and those found in a brain of a cow
submitted to him. In
view of this highly unusual finding, tissues from the case were
submitted to Mr Wells at
CVL for a second opinion.T W A Little
Issued on behalf of the witness by:
The BSE Inquiry Press Office
6th Floor Hercules House
Hercules Road
London SE1 7DU
Fax: 0171 803 0893
Website: http://www.bse.org.uk
Email:
[email protected]
OTHER DOCUMENTS ANNEXED TO DR LITTLES STATEMENT CAN
BE FOUND AT THE FOLLOWING YEAR BOOK REFERENCES
YB 89/1.9/3.1-3.3
YB 90/11.00/5.1-5.2 attaching YB 89/03.15/4.1-4.4
YB 88/11.02/5.1
YB 88/12.07/1.1
YB 88/11.14/2.1
http://www.bseinquiry.gov.uk/files/ws/s331.pdf
Minutes of the Biologicals Committee Meeting Held on Wednesday 6 January
1988, at 10.00am in the Old Library, Central Veterinary Laboratory,
Webridge.
http://www.bseinquiry.gov.uk/files/yb/1988/01/06001001.pdf
Minutes of the meeting held on 6 January 1988 in the 19th floor
Conference room , Market Towers at 10.30am
http://www.bseinquiry.gov.uk/files/yb/1988/01/06002001.pdf
BOVINE SPONGIFORM ENCEPHALOPATHY - IMPLICATIONS FOR
BIOLOGICAL PRODUCTS
snip...
There are two special cases to consider - hormones and similar extracts, and
cell cultures.
HORMONES etc,: Although the extraction of processes involve the use of
various
organic solvents, which tend to have a deliterioius effect on scrapie
infectivity,
extracts must be considered to be potentially contaminated - indeed
Creutzfeldt-
Jakob disease has been transmitted by the use of human growth hormone
extracted
from cadaver pituitaries. It is therfore not possible to regard bovine
gland extracts
as deserving special consideration: they must be autoclaved as above.
Such products
are not likely to be effective after such treatment. The use of
pituitary extracts for super-ovulation is not apparently controlled
under the Medicines Act. This is an
anomaly which requires urgent consideration...
http://www.bseinquiry.gov.uk/files/yb/1987/12/00001001.pdf
Greetings again USDA/APHIS et al,
I VOICED my concerns of the potential risk from this mode of transmission on
more than one occasion on the BSE-L which is full of Government and Industry
officials for years (see below), but my concern today has grown due to
the new
TSE in cattle called (BASE) ;
THE new findings of BASE in cattle in Italy of Identification of a
second bovine amyloidotic spongiform encephalopathy: Molecular
similarities with sporadic Creutzfeldt-Jakob disease
http://www.pnas.org/cgi/content/abstract/0305777101v1
PLUS, we have new atypical TSEs in sheep and goats, with the new findings
of BSE in a GOAT;
THE recent discoveries of previously unidentified strains of
Scrapie such as 221C44 and the Nor9845;
FULL TEXT APPRX. 91 PAGES
UK Strategy for Research and
Development on Human and Animal
Health Aspects of Transmissible
Spongiform Encephalopathies
2004-2007
http://www.mrc.ac.uk/pdf-uk_strategy_v5.2.pdf
Commission submits French Research Findings on TSE in a goat to
Expert Panel
------------------------------------------------------------------------
Reference: IP/04/1324 Date: 28/10/2004
HTML: EN
IP/04/1324
Brussels, 28 October 2004
Commission submits French Research Findings on TSE in a goat to Expert
Panel
Following the findings by a research group in France that they suspect
the presence of a TSE infection in a goats brain which tests cannot
distinguish from BSE, the European Commission has submitted data
received from the French authorities to the Community Reference
Laboratory (CRL) for TSEs based in Weybridge, England, for an evaluation
by an expert panel. TSEs are transmissible spongiform encephalopathies,
namely BSE affecting cattle, and scrapie affecting goats and sheep. The
expert panel will evaluate, over the next two weeks or so, the
scientific evidence to see if it indicates the presence of BSE in the
goat. This isolated incident does not present a risk to public health as
the goat and its herd did not enter the food and feed chain...
snip...
http://europa.eu.int/rapid/pressReleasesAction.do?reference=IP/04/1324&format=HTML&aged=0&language=EN&guiLanguage=en
Approved-By: "Terry S. Singeltary Sr."
Message-ID: <
[email protected]>
Date: Fri, 4 Feb 2000 16:23:50 -0600
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: Bovine Pituitary Injections * USA
######### Bovine Spongiform Encephalopathy
#########
Greetings list members,
I was curious if any U.S. or other Vets. would know of the use in the
U.S., if any, of Pituitary hormones in cows in the U.S. I will throw a
few names at you, maybe some may recognize, maybe not.....
Pituitary Injection (Willington) Pituitary (posterior lobe) Injection B
VET C OXYTOCIN LEO* PITOCIN* Pituitary Injection (Dales) 137 *
(Willington Medicals Ltd) Pituitary Extract (VDC) 557 Pituitary
Injection (Dales) 161 Pituitary (Posterior Lobe) Injection (Univet) 534
Pituitary (Posterior) Injection (Pharmavet) 464 Pituitary (Posterior
Lobe) Injection B vet C Posterior Pituitary Injection BVETC Pituitary
(Posterior Lobe) Injection BVetC 1965 Pituitary Extract Injection 10
i.u./ml
Or any other type, you get the picture, there are way too many to list,
but do any of the Veterinarians on the list in the U.S. know of any of
these or other type of pituitary hormones that were used in cows in the
U.S.?
Thank you, Terry S. Singeltary Sr., Bacliff, Texas USA
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
Approved-By: "Terry S. Singeltary Sr."
Message-ID: <
[email protected]>
Date: Fri, 11 Feb 2000 14:55:19 -0600
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: The Possible relationshipt between BSE and use of pituitary
hormones in cows...
######### Bovine Spongiform Encephalopathy
#########
Greetings list members,
I find this article most interesting. Might be old news to some, but
thought some might find it as interesing as I did........
Kind Regards, Terry S. Singeltary Sr., Bacliff, Texas USA
___________________________________________________________________ Dr
Anne Maddocks 16/06/99
THE BSE INQUIRY
Statement of Dr Anne C Maddocks M.A, B.M, B.Ch, F.R.C.Path
The possible relationship between BSE and use of pituitary hormones in cows
1. Introduction
1.1 It is suggested in this statement that the promiscuous use of
pituitary hormones in cows may have resulted in BSE in the same way that
treatment with pituitary growth hormone (hGH) or follicular stimulating
hormone (FSH) has been shown to cause iatrogenic CJD in humans.
1.2 The important difference between the medical and veterinary use of
these hormones being that slaughtered cattle subsequently entered the
animal food chain as meat and bone meal (MBM) creating the likelihood of
a widespread dispersal of any infectivity able to survive the rendering
process.
1.3 The use of hormones in cows has a very complex background which is
little known among ordinary farmers. Although 'published' the material
from which the findings in this paper have been drawn was only available
via several visits to the library at Wye College (University of London
Department of Agriculture), The Scientific Periodicals Library at
Cambridge, The Royal Society Library, The Royal Society of Medicine's
Library, The British Library at St. Pancras, British Library Science
Collections at Holborn and extensive use of the Aldwych branch of the
British Library Science Collections and their stock from Boston Spa.
(This search was part of wide BSE studies which do not relate to the
Inquiry).
1.4 This extensive trawl was necessary to locate both the original
experimental work and reports of cattle breeders' conferences reflecting
the later practical application of that work because there is little
direct publication of findings and outcomes by the commercial cattle
breeding sector in the UK. (The journal "Theriogenology" has
contributions from US commercial Embryo Transfer (ET) workers). Whilst
the underlying science is abstruse and reported only haphazardly it
should be noted however the 'ordinary farmers' do use the M.O.E.T.
system (see Appendix Five to this statement) to breed from their best
cows. This may involve an ET centre or may be done on the farm.
1.5 The background to this area lies in the science of Endocrinology
which is applied in both Medicine as therapy, and Agriculture as
manipulatory techniques to increase milk yield and enhance production.
This is the reason for the wide spectrum of ultra specialist journals
which has to be consulted and whose normal readership will consist
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only of the most scientific of obstetricians, agribusiness or breeding
specialists, none of whom would be likely to read right across the
spectrums' medical and veterinary aspects.
1.6 I should like to point out that professionally, while I do not
belong to those groups, I am a very experienced control of infection
specialist, as well as a clinical microbiologist. It is professional
suicide for infection control doctors to accept as 'mere' coincidences
similar events which are close in space or time. It must be assumed that
in depth investigation may reveal links or common factors, and it is
necessary to 'hack in' to specialist areas through research. This is my
position in this instance.
1.7 Please note for clarity this account is written without the
historical background and most of the scientific detail - important
though these are to the argument. It has been thought better to put this
detail into Appendices at the end of the document where they can be
separately considered, rather than have one very detailed and lengthy
account.
2. The argument for the transmission of a TSE which became the BSE
outbreak through use of cadaveric hormones
2.1 Transmissible Spongiform Encephalopathies (TSEs) are rare diseases.
Since Kuru was described in 1957 only familial variants have been found
but suddenly in 1985 two previously unknown TSEs emerged at once, a
striking coincidence that merits attention.
2.2 The possible significance of BSE and hormone related CJD occurring
at about the same time has been obscured because:
(a) neither disease was publicised for some time and then when they were
publicised it was through articles which appeared in different
sub-speciality journals.
(b) hormone therapy related CJD (so far as it was discussed at all) was
seen as obviously an iatrogenic disease with a known origin. BSE on the
other hand was portrayed as a "mystery disease" which baffled scientists.
2.3 An in depth look at historical events gives a different perspective
on these two diseases and a possible reason why they appeared at the
same time.
2.4 The most important point to have in mind when reflecting on this
coincidence is that advances made in endocrinology are applied in both
medicine and veterinary science. Endocrinology is a "free-standing"
science rooted in physiology, with its own specialist departments and
techniques drawing on animal experiments, endocrine biochemistry and
electron microscopical ultra structure studies. As advances are made in
endocrinology they are fed across into both medicine and agriculture at
about the same time like a rising tide advancing on all fronts.
2.5 Given that the human disease is undoubtedly related to pituitary
hormone therapy, is there any possibility of a similar pituitary hormone
relationship with BSE?
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2.6 We know that use of pituitary hormones in the 1970s and 1980s
resulted in deaths from CJD throughout the world but most notably in the
UK, France, USA and Australia. Thinking about BSE has focussed
(understandably) upon the way in which the original isolated cases of
the diseases were magnified into an epidemic, less attention has been
paid to the reasons for its original emergence in different places but
at the same time. If it could be shown that cows had been given
pituitary hormones, then it would seem reasonable to look to see if:
(a) these might
minute only) Dr Harris Mr Wilson Dr Jones Dr Adams Dr Jefferys Dr