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From: TSS (
Date: October 8, 2004 at 12:15 pm PST

Drug Company Ailing After Vaccine Delay

By Andrew Pollack
10/08/04 10:44 AM PT

Vaccines accounted for about US$700 million of Chiron's $1.75 billion in revenue last year. Fluvirin, the flu vaccine, accounted for $219 million of the total. Chiron had increased spending in R&D and other areas of its business. Now the company may have to scale back its plans, and prospects for its future flu vaccine business are clouded.

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Howard Pien, chief executive of Chiron, said he wanted to help meet the U.S. need for more flu vaccine while expanding the business of his company. So Pien began sharply increasing the production of flu vaccine at a British factory Chiron acquired in 2003.

Chiron had expected that plant to supply about 50 million vaccine doses to the United States this year, up from 26 million in 2002, when the plant was owned by another company.

But now Pien's aggressive plan has backfired. Finding contamination problems, British regulators suspended the license for vaccine production at the Liverpool factory on Tuesday, a move that will deprive the United States of nearly half the flu vaccine it expected for this winter. The suspension has cost Chiron not only three-quarters of the profit it expected this year, but some of its credibility with investors and customers.

Chiron Shares Suffer

Some analysts downgraded Chiron's stock and Moody's Investor Services said it was looking at lowering the company's debt rating.

Mark Augustine, an analyst at Credit Suisse First Boston, called Chiron a "broken" stock. Shares of Chiron plummeted 16 percent on Tuesday, rebounding very modestly Wednesday to close at US$38.32, up 34 cents. But on Thursday, the stock fell $1.79, or 4.7 percent, to close at $36.53.

Vaccines accounted for about $700 million of the company's $1.75 billion in revenue last year. Fluvirin, the flu vaccine, accounted for $219 million of the total. With the big increase in production, analysts had expected more than $300 million in revenue from Fluvirin this year.
Vaccine Remains Priority

Chiron, anticipating higher revenue, had increased spending in research and development and other areas of its business. It is also building a new office for its vaccine business in Philadelphia. Now the company may have to scale back its plans, and prospects for its future flu vaccine business are clouded.

Pien has said the company remains committed to being a major flu vaccine supplier next year. But he conceded at a news conference on Tuesday that addressing the problems at the Liverpool factory might extend past next February or March, when production would have to begin for next winter.

Pien, who rose quickly in the management ranks in several major pharmaceutical companies before becoming chief executive of Chiron in April 2003, did not make himself available for an interview Wednesday.

He said on Tuesday that the British regulatory decision was "disappointing and unexpected, but we respect the regulatory authority's judgment because it is based on concerns over safety."
Stressing the System

One question is whether the contamination problems may have been a consequence of Pien's push to increase vaccine output quickly at the aging factory.

"The problem was they really stressed the system this year to get to that 50, 52 million doses," said Geoffrey Porges, an analyst at Sanford C. Bernstein who formerly worked in the vaccines business at Merck.

David Smith, Chiron chief financial officer, said Wednesday that the company had not expanded its production too quickly. About $75 million has been spent to upgrade the Liverpool factory in the past five years, the company said. Chiron said it is committed to spending another $100 million to replace part of the plant.
Change of Hands

The plant dates back to the 1970s and has had a series of owners and problems in the last decade as pharmaceutical companies merged and divested assets. Chiron acquired the owner of the Liverpool plant, PowderJect Pharmaceuticals, in July 2003 to expand its vaccine production capacity. PowderJect, in turn, had acquired the factory in 2000 from CellTech, which owned it for about seven months.

Contamination problems were not new to the plant. Polio vaccines made there by Medeva, another previous owner, before 1996 were recalled in October 2000 after British authorities said they might be contaminated with mad cow disease. In 1999, the U.S. Food and Drug Administration Latest News about Food and Drug Administration notified Medeva that there were risks of contamination in the flu vaccine produced at the plant.

"It's an old facility that was sold by Glaxo to Medeva, who spent some money on it, though probably not in the right spot, then to Celltech, who didn't give a toss," said one British pharmaceutical executive.
Regulatory Challenges

Still, J. Leighton Read, former chief executive of Aviron, said that he would not necessarily blame the age of the factory for Chiron's problems.

"Every vaccine plant that's more than a year old that I'm aware of has a history of challenges in complying with the regulatory regime," said Read, now a venture capitalist. "In our extreme concern for safety, which is largely appropriate, we have evolved systems that are too rigid and brittle to adapt to circumstances such as this."

Chiron, based in Emeryville, California, is one of the nation's oldest biotech companies, founded in 1981 by three scientists from the University of California campuses in San Francisco and Berkeley. Perhaps its biggest claim to fame is the discovery of the hepatitis C virus.
Growth Via Acquisitions

But Chiron has not had as much success in developing biotech drugs as some of its competitors like Amgen and Genentech. The company has grown in large part through acquisitions and now has three businesses drugs, the testing of donated blood for viruses like HIV and hepatitis C, and vaccines.

The shutdown of its vaccine production could damage Chiron's business beyond the immediate loss of revenue. The U.S. government could become more aggressive in acquiring flu vaccine from additional suppliers next year, or encourage other companies to enter the business, which would cut Chiron's market share in the future.

© 2004 International Herald Tribune. All rights reserved.
© 2004 ECT News Network. All rights reserved.

What was last week's polio BSE scare about?
An oral polio vaccine, Medeva, was recalled last week over fears of CJD. The vaccine, which had been used in up to a third of inoculations for children and travellers, contained tiny traces of a feoetal calf growth serum from potentially BSE-contaminated animals. However, the risks of infection from the vaccine were said to be "incalcuably small". The Department of Health said the firm, also Medeva, had misled them on assurances the vaccine met new BSE safety guidelines.,6512,343393,00.html

Earlier this year, according to an October, 2000 article by the The Observer, a leading British newspaper, British pharmaceutical company Medeva's Liverpool plant was found by the U.S. Food and Drug Administration to be producing vaccines in filthy conditions. The FDA report found that Medeva neither maintained nor cleaned its equipment. It also reported that Medeva was unable to prove that its vaccines were not contaminated with bacteria or fungi.

Certain fungi provide the medium in which the prion protein crystal that causes bovine spongiform encephalopathy (BSE or “mad cow” disease) to proliferate.

Because it exports flu vaccine to America, Medeva got a U.S. Food and Drug Administration (FDA) “warning” to clean up its act. However, in a report dated October 22, 2000, The Observer noted that the FDA had not re-inspected the filthy Medeva factory since it sent the warning letter earlier this year and has given the company the green light to sell an estimated 20,000,000 doses of its “Fluvarin” flu vaccine in the U.S. during this cold and flu season.

The British government recently recalled Medeva's oral polio vaccine (OPV) as it had been grown from “bovine material of UK origin” contrary to mandated vaccine production protocols. Until its removal from the marketplace last month, Medeva's OPV had been injected into 11 million people, mostly children, commented another British newspaper the International Herald Tribune.

Hundreds of thousands of “mad” cattle in Great Britain have been destroyed since 1993 in an attempt to control the spread of prion disease that is epidemic in England. Ingestion of beef and other products derived from prion-infected cattle have been linked to the epidemic of prion disease in humans.

Prion disease is called mad cow disease in cattle, scrapie in pigs and sheep, whirling disease in fish and wasting disease in deer and elk, is called Creutzfeldt-Jakob Disease (CJD) in humans. It is estimated that as many as 200,000 Americans that have been misdiagnosed with Alzheimer's disease are actually victims of CJD.

The Medeva Fluvarin vaccine, produced in the same plant that produced the recalled OPV, may have the potential of opening the floodgates of a “mad cow” epidemic in the U.S. Though the administration of possibly contaminated Fluvarin may be a public health disaster of unprecedented proportions, the dominant media has failed to sound the alarm and the FDA has not ordered that Fluvarin be tested for the presence of prions or the fungi in which they grow.


FDA approval of the potentially contaminated Fluvarin for sale in the U.S. was likely influenced by a shortage of flu vaccine here this season. According to Centers for Disease Control and Prevention (CDC) National Immunization Program Director Dr. William Atkinson, the A-Moscow-1099 strain of flu virus did not incubate properly this year and, therefore, did not produce “serum” in large enough quantities to produce sufficient doses of flu vaccine to meet demand. So, despite Medeva's “history of contamination and production blunders,” FDA has authorized the distribution of Fluvarin to clinics and hospitals all over the nation.

According to The Observer, the FDA claims that the vaccine is safe. The FDA also, at one time, claimed that silicone breast implants and Phen-Phen were “safe” -- and those are just two of many FDA-approved products that have ultimately been linked to serious health side-effects that include chronic degenerative disease and death.

“It stands to reason that Medeva's flu vaccine -- manufactured in the same reportedly filthy plant as the recalled polio vaccine -- could also contain BSE (prion)-contaminated materials,” commented Dr. Len Horowitz. Dr. Horowitz is the author of several books including “Healing Codes for the Biological Apocalypse” in which he meticulously documented the development and spread of prion disease world wide by following the path of published science.

An official at the National Institutes of Health describes the prion which causes BSE as, “The single most resistant organism on the face of the Earth. You can boil it, you can put it in formaldehyde, you can autoclave it for a little while, you can treat it with the usual disinfectants...and it's like you didn't do anything.”

If Fluvarin is contaminated with BSE, then millions of unsuspecting Americans may be injected this year with a terminal neurological disease. Prion crystals, 100 times smaller than a virus, cause lesions in brain tissue (encephalopathies) that turn the brain to mush and gradually causes dementia and death. British officials predict that hundreds of thousands of Brits will eventually show symptoms of this terminal malady.

CJD is so dangerous that medical examiners are afraid to perform autopsies on people and animals that are suspected as having succumbed to prion disease. Continental Europe, which originally considered itself safe from prion disease, is in a panic over recent discoveries that some of their animals and citizens are showing symptoms.

Fluvarin is currently on the shelves of doctors' offices and health departments all over the country and is being administered to the public. Medical personnel in the northwest U.S. who confirm that they have administered Fluvarin are unaware of the Medeva scandal or the likelihood that the triple-antigen flu vaccine is contaminated.

There are at least two facilities in the U.S. that are capable of testing Fluvarin for prion contamination: The National Prion Disease Pathology Surveillance Center in Cleveland, Ohio, and the National Institutes of Health in Maryland. Since neither the FDA nor the dominant media have demanded that Fluvarin be tested for contamination, anyone about to receive Fluvarin should demand the vaccine be properly tested.

Due to this year's flu vaccine shortage, the CDC urges health officials to prioritize the administration of flu vaccines. The CDC recommends that the most immunologically vulnerable members of society -- the elderly and the chronically ill; babies and small children -- be priority one. Healthcare workers exposed to flu victims are priority number two. Otherwise healthy people between the ages of 17-65 should be the last people to receive a flu shot.

If your health officials haven't heard about Medeva's track record, it's time to get them educated. You can copy for them a series of British media reports covering the Medeva scandals. The web address is:

Go to “Information,” then “Archive,” then type “Medeva” in the keyword box. See especially the October 22 article “Revealed: full scale of vaccine blunders.”

What measures have the FDA taken to ensure that people are not exposed to the BSE agent in vaccines?

It is believed that variant CJD was acquired from eating food products containing the BSE agent. However, FDA wants to minimize any chance that the BSE agent could be introduced into biologic products during manufacture. The Center for Biologics Evaluation and Research (CBER) is responsible for regulation of biologic products, including vaccines. In a 1991 letter to manufacturers CBER expressed concern about bovine sourced material. In December 1993 and May 1996 FDA issued letters advising that bovine derived materials from animals born in or residing in countries where BSE had occurred should not be used to manufacture FDA-regulated products intended for administration to humans. A 1993 Points to Consider document ("Points to Consider in the Characterization of Cell Lines Used for the Production of Biologics") stressed the importance of control of sourcing of bovine materials. On April 19, 2000, CBER issued a letter reminding manufacturers that the USDA list of BSE-countries had been expanded to include not only those countries where BSE was known to exist but also those where BSE may exist (FR, January 6, 1998). CBER strongly recommended "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." Although Canada and the US have each reported one case of BSE and the USDA has placed Canada on the list of countries with BSE, FDA has not recommended that manufacturers find a new source for bovine derived materials obtained from these countries for use in manufacture of drugs or biological products. The FDA believes that the control measures in place assure the safety of bovine derived materials sourced from these countries and used in manufacture of vaccines.

Are bovine derived materials from North America used in the manufacture of vaccines?

Yes, bovine derived materials from North America, specifically the US and Canada, are used in vaccine manufacture. Since there has been extensive movement of live cows and cow-derived materials between Canada and the US it is difficult to establish that an animal has not been born, raised or slaughtered in Canada. Moreover, control measures, such as the ruminant-to-ruminant feed ban have been similar in the two countries. Therefore, FDA has not recommended that manufacturers using bovine derived material from Canada replace those materials with materials from countries not on the USDA list of countries that have BSE or are at risk
of BSE...

There is no evidence that any case of vCJD has resulted from use of a vaccine, and there is no evidence that any vaccines harbor the BSE agent...


If vaccines are safe why did the UK recall their polio vaccine?

The UK recalled the Evans/Medeva Oral Polio Vaccine in October, 2000. This vaccine has never been licensed for use in the US. The Medicines Control Agency (MCA) had requested and received assurances from drug companies that they were implementing guidance not to use UK-sourced bovine materials in the manufacture of injectable medicinal products. The recall was prompted by evidence that the Evans/Medeva vaccine was manufactured using fetal calf serum from the UK at a time when there was a risk of BSE in that country. This is in contravention of European Union guidelines. According to a statement from the Chief Medical Officer at the UK Dept. of Health (10.20.00) the company had assured the MCA of the UK that UK-sourced bovine materials were not used in the manufacture of the vaccine. However, these assurances were inaccurate, thus the vaccine was withdrawn. (

What was the concern in the Republic of Ireland about polio vaccine and vCJD?

In December, 2000 the Irish Government issued a statement indicating that an oral polio vaccine distributed in 1998 and 1999 in Ireland had been manufactured using human serum albumin from a pool of donors, one of whom had since been diagnosed with vCJD. Evans/Medeva manufactured this oral polio vaccine. This vaccine is not licensed for use in the US.

Have there been vaccines produced using cow materials from countries where there is a significant risk of BSE?

During review of a license application, FDA learned that one manufacturer had used bovine-derived material from a country in which the USDA had determined that BSE might exist. CBER requested all vaccine manufacturers review the source of any bovine derived material used in the manufacture of their vaccines. Additional vaccines manufactured using bovine derived products from European countries were identified. These vaccines are identified in the “Recommendations for the Use of Vaccines Manufactured with Bovine Derived Materials” section of this web site. (See Section I)

When will vaccine manufacturers finish replacing cow-derived materials in vaccines with materials obtained from countries free of BSE?

The time to make a vaccine and bring it to market can take several months to a year. Most vaccine made using bovine derived material from non-BSE risk countries was available at the end of 2001...


Shouldn't all potentially contaminated vaccine be destroyed?

Also see above “Why is FDA leaving on the market vaccines which may be contaminated with the BSE agent?” FDA and other PHS agencies believe that the vaccines currently licensed for use in the US are safe. A special joint meeting of the TSE and Vaccines and Related Biological Products Advisory Committees concluded that the real risk of disease due to not vaccinating far outweighs the theoretical risk posed by exposure to vaccines that have a remote chance of containing the BSE agent.


Let us first review just how safe the source of bovine by-products
from 'tissue donor' herds really are from the donor herds being
fed feed with ruminant protein. I just happen to ask this question
at one of those TSE Advisory Meetings;

Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy

######### Bovine Spongiform Encephalopathy

Greetings List Members,

I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.

I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly

"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."

and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.

(understand, these are taken from my notes for now.
the spelling of names and such could be off.)

[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.

yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question

[host Richard]
could you repeat the question?

U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[not sure whom ask this]
what group are you with?

CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.

[not sure who is speaking]
could you please disconnect Mr. Singeltary

you are not going to answer my question?

[not sure whom speaking]

from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;

[unknown woman]
what group are you with?

CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?

at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.

IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;


he would be glad to give you one ;-)

Rockville Maryland,
Richard Barns Host

BSE issues in the U.S.,
How they were labelling ruminant feed?
Revising issues.

The conference opened up with the explaining of
the U.K. BSE epidemic winding down with about 30
cases a week.

although new cases in other countries were now

Look at Germany whom said NO BSE and now have BSE.

BSE increasing across Europe.

Because of Temporary Ban on certain rendered product,
heightened interest in U.S.

A recent statement in Washington Post, said the
New Administration (old GW) has a list of issues.
BSE is one of the issues.

BSE Risk is still low, minimal in U.S. with a greater
interest in MBM not to enter U.S.

HOWEVER, if BSE were to enter the U.S.
it would be economically disastrous
to the render, feed, cattle, industries,
and for human health.

(human health-they just threw that in cause i was listening. I will now
jot down some figures in
which they told you, 'no need to write them down'.
just hope i have them correct. hmmm, maybe i hope
i don't ???)

80% inspection of rendering

*Problem-Complete coverage of rendering HAS NOT

sizeable number of 1st time FAILED INITIAL INSPECTION,
have not been reinspected (70% to 80%).

Compliance critical, Compliance poor in U.K.
and other European Firms.

Gloria Dunason
Major Assignment 1998 goal TOTAL compliance.
This _did not_ occur. Mixed level of compliance,
depending on firm.

Rendering FDA license and NON FDA license

system in place for home rendering & feed
76% in compliance
79% cross contamination
21% DID NOT have system
92% record keeping
less than 60% total compliance

279 inspectors
185 handling prohibited materials

Renderer at top of pyramid, significant
part of compliance.
84% compliance

failed to have caution statement render
72% compliance & cross contamination
caution statement on feed, 'DO NOT FEED TO CATTLE'


1240 FDA license feed mills
846 inspected

"close to 400 feed mills have not been inspected"

80% compliance for feed.

10% don't have system.

NON-FDA licensed mills
There is NO inventory on non licensed mills.
approximately 6000 to 8000 Firms ???
4,344 ever inspected.
"FDA does not have a lot of experience with"

40% do NOT have caution statement 'DO NOT FEED'.

74% Commingling compliance

"This industry needs a lot of work and only half
gotten to"

"700 Firms that were falitive, and need to be
re-inspected, in addition to the 8,000 Firms."

Quote to do BSE inspection in 19 states by end
of January or 30 days, and other states 60 days.
to change feed status??? Contract check and ask
questions and pass info.

At this time, we will take questions.

[I was about the third or fourth to ask question.
then all B.S.eee broke loose, and i lost my train
of thought for a few minutes. picked back up here]

someone asking about nutritional supplements and
sourcing, did not get name. something about inspectors
not knowing of BSE risk??? the conference person assuring that Steve
Follum? and the TSE advisory Committee were
handling that.

Some other Dr. Vet, whom were asking questions
that did not know what to do???

[Dennis Wilson]
California Food Agr.
Imports, are they looking at imports?

[Conference person]
they are looking at imports,
FDA issued imports Bulletin.

[Linda Singeltary ??? this was a another phone in
question, not related i don't think]
Why do we have non-licensed facilities?

(conference person)
other feed mills do not handle as potent drugs???

Dennis Blank, Ken Jackson
licensed 400
non FDA 4400 inspected of a total of 6000 to 8000,

(they really don't know how many non licensed Firms
in U.S. they guess 6000 to 8000??? TSS)

Linda Detwiler
asking everyone (me) not to use emergency BSE number,
unless last resort.
(i thought of calling them today, and reporting the
whole damn U.S. cattle herd ;-) 'not'

Warren-Maryland Dept. Agr.
Prudent to re-inspect after 3 years.
concerned of Firms that have changed





Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version...
Date: Thu, 11 Jan 2001 22:02:47 -0700
From: "Sandy Blakeslee"
To: "Terry S. Singeltary Sr."
References: 1

Hi terry -- thanks for all your help. I know it made a difference with
the FDA getting out that release.

----- Original Message -----
From: "Terry S. Singeltary Sr."
Sent: Thursday, January 11, 2001 2:06 PM
Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version...

> hi sandy,

>From the New York Times, January 11, 2001

Many Makers of Feed Fail to Heed Rules on Mad Cow Disease

Large numbers of companies involved in manufacturing animal feed are not
complying with regulations meant to prevent the
emergence and spread of mad cow disease in the United States, the Food
and Drug Administration said yesterday.

The widespread failure of companies to follow the regulations, adopted
in August 1997, does not mean that the American food supply is unsafe,
Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at
the F.D.A., said in an interview.

But much more needs to be done to ensure that mad cow disease does not
arise in this country, Dr. Sundlof said.

The regulations state that feed manufacturers and companies that render
slaughtered animals into useful products generally may not feed mammals
to cud-chewing animals, or ruminants, which can carry mad cow disease.

All products that contain rendered cattle or sheep must have a label
that says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers
must also have a system to prevent ruminant products from being
commingled with other rendered material like that from chicken, fish or
pork. Finally, all companies must keep records of where their products
originated and where they were sold.

Under the regulations, F.D.A. district offices and state veterinary
offices were required to inspect all rendering plants and feed mills to
make sure companies complied. But results issued yesterday demonstrate
that more than three years later, different segments of the feed
industry show varying levels of compliance.

Among 180 large companies that render cattle and another ruminant,
sheep, nearly a quarter were not properly labeling their products and
did not have a system to prevent commingling, the F.D.A. said. And among
347 F.D.A.-licensed feed mills that handle ruminant materials - these
tend to be large operators that mix drugs into their products - 20
percent were not using labels with the required caution statement, and
25 percent did not have a system to prevent commingling.

Then there are some 6,000 to 8,000 feed mills so small they do not
require F.D.A. licenses. They are nonetheless subject
to the regulations, and of 1,593 small feed producers that handle
ruminant material and have been inspected, 40 percent
were not using approved labels and 25 percent had no system in place to
prevent commingling.

On the other hand, fewer than 10 percent of companies, big and small,
were failing to comply with the record-keeping

The American Feed Industry Association in Arlington, Va., did not return
phone calls seeking comment.

Jan. 9, 2001
Wed, 10 Jan 2001 14:04:21 -0500
"Gomez, Thomas M."
Bovine Spongiform Encephalopathy

######### Bovine Spongiform Encephalopathy

USDA/APHIS would like to provide clarification on the following point
Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.

[Linda Detwiler asking everyone (me) not to use emergency BSE number,
last resort. (i thought of calling them today, and reporting the whole
U.S. cattle herd ;-) 'not']

Dr. Detwiler was responding to an announcement made during the call to
the FDA emergency number if anyone wanted to report a cow with signs
for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants
use the FDA emergency number as a last resort to report cattle suspect
BSE. What Mr. Singeltary failed to do was provide the List with Dr.
Detwiler's entire statement. Surveillance for BSE in the United States
is a
cooperative effort between states, producers, private veterinarians,
veterinary hospitals and the USDA. The system has been in place for
over 10
years. Each state has a system in place wherein cases are reported to
either the State Veterinarian, the federal Veterinarian in Charge or
the veterinary diagnostic laboratory system. The states also have
provisions with emergency numbers. Dr. Detwiler asked participants to
the systems currently in place to avoid the possibility of a BSE-suspect
report falling through the cracks. Use of the FDA emergency number has
been established as a means to report diseased cattle of any nature.


CALL Jan.9, 2001
Wed, 10 Jan 2001 13:44:49 -0800
"Terry S. Singeltary Sr."
Bovine Spongiform Encephalopathy

######### Bovine Spongiform Encephalopathy

Hello Mr. Thomas,

> What Mr. Singeltary failed to do was provide
> the List with Dr. Detwiler's entire statement.

would you and the USDA/APHIS be so kind as to supply
this list with a full text version of the conference
call and or post on your web-site?
if so when, and thank you.
if not, why not?

> The system has been in place for over 10 years.

that seems to be a very long time for a system to be in
place, and only test 10,700 cattle from some 1.5 BILLION head (including
calf crop). Especially since French
are testing some 20,000 weekly and the E.U. as a whole,
are testing many many more than the U.S., with less
cattle, same risk of BSE/TSEs.

Why does the U.S. insist on not doing massive testing
with the tests which the E.U. are using?
Why is this, please explain?

Please tell me why my question was not answered?

> U.S. cattle, what kind of guarantee can you
> give for serum or tissue donor herds?

It was a very simple question, a very important
question, one that pertained to the topic of
BSE/feed, and asked in a very diplomatic way.
why was it not answered?

If all these years, we have been hearing that
pharmaceutical grade bovines were raised for
pharmaceuticals vaccines etc. But yet the
USA cannot comply with feed regulations of
the ruminant feed ban, PLUS cannot even
comply with the proper labelling of the feed,
cross contamination etc.
Then how in the world can you Guarantee the feed
fed to pharmaceutical grade bovine, were actually
non ruminant feed?

Before i was ask to be 'disconnected',
i did hear someone in the background
say 'we can't'-- have him ask the question again.

could you please be so kind, as to answer these

thank you,
Terry S. Singeltary Sr. Bacliff, Texas USA

P.S. if you will also notice, i did not post that
emergency phone number and do not intend on passing
it on to anyone. I was joking when i said i should
call and report the whole damn U.S. Herd. So please
pass that on to Dr. Detwiler, so she can rest easily.

BUT, they should be reported, some are infected with TSE.
The U.S. is just acting as stupid as Germany and other
Countries that insist they are free of BSE.


Subject: Report on the assessment of the Georgraphical BSE-risk of the
USA July 2000 (not good)
Date: Wed, 17 Jan 2001 21:23:51 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy

######### Bovine Spongiform Encephalopathy

Greetings List Members and ALL EU Countries,

Because of this report, and the recent findings
of the 50-state BSE Conference call, I respectfully
seriously suggest that these Countries and the SSC
re-evaluate the U.S.A. G.B.R. to a risk factor of #3.

I attempted to post this to list in full text,
but would not accept...

thank you,
kind regards,
Terry S. Singeltary Sr., Bacliff, Texas USA

Report on the assessment of the Geographical BSE-risk of the USA



- 29 -

Report on the assessment of the Geographical BSE-risk of the USA



The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely
but cannot be excluded that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent.

Stability: Before 1990 the system was extremely unstable because feeding
of MBM to cattle happened, rendering was inappropriate with regard to
deactivation of the BSE-agent and SRM and fallen stock were rendered for
feed. From 1990 to 1997 it improved to very unstable, thanks to efforts
undertaken to trace imported animals and exclude them from the feed
chain and intensive surveillance. In 1998 the system became neutrally
stable after the RMBM-ban of 1997.

External challenges: A moderate external challenge occurred in the
period before 1990 because of importation of live animals from
BSE-affected countries, in particular from the UK and Ireland. It cannot
be excluded that some BSE-infected animals have been imported by this
route and did enter the US rendering and feed production system. The
efforts undertaken since 1990 to trace back UK-imported cattle and to
exclude them from the feed chain reduced the impact of the external
challenge significantly.

Interaction of external challenges and stability: While extremely
unstable, the US system was exposed to a moderate external challenge,
mainly resulting from cattle imports from the UK. It can not be excluded
that BSE-infectivity entered the country by this route and has been
recycled to domestic cattle. The resulting domestic cases would have
been processed while the system was still very unstable or unstable and
would hence have initiated a number of second or third generation cases.
However, the level of the possible domestic prevalence must be below the
low detection level of the surveillance in place.

As long as there are no changes in stability or challenge the
probability of cattle to be (pre-clinically or clinically) infected with
the BSE-agent will remain at the current level.



The available information was suitable to carry out the GBR risk

- 30 -

Report on the assessment of the Geographical BSE-risk of the USA


2.1 Overall appreciation of the ability to identify BSE-cases and to
eliminate animals at risk of being infected before they are processed

· Before 1989, the ability of the system to identify (and
eliminate) BSE cases was limited.
· Since 1990 this ability is significantly improved, thanks to a
good BSE-surveillance and culling system (contingency plan).
· Today the surveillance should be able to detect clinical
BSE-cases within the limits set by an essential passive surveillance
system, i.e. some cases might remain undetected.

2.2 Overall appreciation of the ability to avoid recycling
BSE-infectivity, should it enter processing

· Before 1997 the US rendering and feed producing system would not
have been able to avoid recycling of the BSE agent to any measurable
extent. If the BSE-agent was introduced the feed chain, it could
probably have reached cattle.
· After the introduction of the RMBM-to-ruminants-ban in August
1997 the ability of the system to avoid recycling of BSE-infectivity was
somewhat increased. It is still rather low due to the rendering system
of ruminant material (including SRM and fallen stock) and the persisting
potential for cross-contamination of cattle feed with other feeds and
hence RMBM.

2.3 Overall assessment of the Stability

· Until 1990 the US BSE/cattle system was extremely unstable as
RMBM was commonly fed to cattle, the rendering system was not able to
reduce BSE-infectivity and SRM were rendered. This means that incoming
BSE infectivity would have been most probably recycled to cattle and
amplified and the disease propagated.
· Between 1990 and 1995 improvements in the BSE surveillance and
the efforts to trace back and remove imported cattle gradually improved
the stability but
the system remained very unstable.
In 1998 the system became unstable because of an RMBM-ban introduced in
1997. After 1998 the ban was fully implemented and the system is
regarded to be neutrally stable since 1998. The US system is therefore
seen to neither be able to amplify nor to reduce circulating or incoming


A moderate external challenge occurred in the period 1980-1989 because
of importation of live animals from the UK. imports from other countries
are regarded to have been negligible challenges.
· As a consequence of this external challenge, infectivity could
have entered the feed cycle and domestic animals could have been exposed
to the agent. These domestic BSE-incubating animals might have again
entered processing, leading to an internal challenge since 1991.
· This internal challenge could have produced domestic cases of
BSE, yet prevalence levels could have been below the detection limits of
the surveillance system until now. (According to US calculations, the
current surveillance

-31 -

Report on the assessment of the Geographical BSE-risk of the USA July

system could detect clinical incidence of 1-3 cases per year per million
adult cattle, i.e. in absolute numbers 43-129 cases per year). Between
1990 und 1995, with the exclusion of the imported animals from Europe
from the feed chain, the effect of the external challenges decreased.


4.1 Interaction of stability and challenqe

· In the late 80s, early 90s a moderate external challenges met an
extremely unstable system. This would have amplified the incoming
BSE-infectivity and propagated the disease.
· With the exclusion of the imported animals from Europe from the
feed chain between 1990 and 1995 the effect of the external challenge
· Before 1998 an internal challenge, if it developed, would have
met a still unstable system (inappropriate rendering, no SRM ban, RMBM
ban only after 1997) and the BSE-infectivity could have been recycled
and amplified.
· After 1998 the neutrally stable system could still recycle the
BSE-agent but due to the RMBM-ban of 1997 the BSE-infectivity
circulating in the system would probably not be amplified.

4.2 Risk that BSE-infectivity enters processing

· A very low processing risk developed in the late 80s when the
UK-imports were slaughtered or died. It increased until 1990 because of
the higher risk to be infected with BSE of cattle imported from the UK
in 1988/89, as these animals could have been processed prior to the
back-tracing of the UK-imports in 1990.
· From 1990 to 1995 a combination of surviving non-traced UK
imports and some domestic (pre-)clinical cases could have arrived at
processing resulting in an assumed constant low but non-negligible
processing risk.
· After 1995 any processing risk relates to assumed domestic cases
arriving at processing.
· The fact that no domestic cases have been shown-up in the
BSE-surveillance is reassuring - it indicates that BSE is in fact not
present in the country at levels above the detection limits of the
country's surveillance system. This detection level has been calculated
according to US-experts to be between 1 & 3 clinical cases per million
adult cattle per year.

Note: The high turnover in parts of the dairy cattle population with a
young age at slaughter makes it unlikely that fully developed clinical
cases would occur (and could be detected) or enter processing. However,
the theoretical infective load of the pre-clinical BSE-cases that
under this scenario could be processed, can be assumed to remain
relatively low.

4.3 Risk that BSE-infectivity is recycled and propagated

· During the period covered by this assessment (1980-1999) the
US-system was not able to prevent propagation of BSE should it have
entered, even if this ability was significantly improved with the
MBM-ban of 1997.
· However, since the likelihood that BSE-infectivity entered the
system is regarded to be small but non-negligible, the risk that
propagation of the disease
took place is also small but not negligible.

- 32 -

Report on the assessment of the Geographical BSE-risk of the USA


5.1 The current GBR

The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely
but cannot be excluded that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent.

5.2 The expected development of the GBR

As long as there are no changes in stability or challenge the
probability of cattle to be (pre-clinically or clinically) infected with
the BSE-agent remains at the current level.

5.3 Recommendations for influencin.q the future GBR

· As long as the stability of the US system is not significantly
enbanced above neutral levels it remains critically important to avoid
any new external
· All measures that would improve the stability of the system, in
particular with regard to its ability to avoid recycling of the
BSE-agent should it be present in the cattle population, would reduce,
over time, the probability that cattle could be infected with the
BSE-agent. Possible actions include:
removal of SRMs and/or fallen stock from rendering, better rendering
processes, improved compliance with the MBM-ban including control and
reduction of cross-contamination.
· Results from an improved intensive surveillance programme,
targeting at risk sub-populations such as adult cattle in fallen stock
or in emergency slaughter, could verify the current assessment.


FULL TEXT about 16 pages

Moms death from hvCJD


CJD/BSE aka madcow disease in the U.S., please let me count the Ways$$$


-------- Original Message --------
Subject: Transmissible Spongiform Encephalopathies Advisory Committee
Date: Wed, 06 Oct 2004 21:21:44 -0500
From: "Terry S. Singeltary Sr."
To: "Freas, William"
CC: "Langford, Sheila" , "Smallwood, Linda"
References: <>

Transmissible Spongiform Encephalopathies Advisory Committee;
[FR Doc. 04-21282 Filed 9-21-04; 8:45 am] (TSS SUB. short version 10/4/04)

Greetings Dr. Freas, Dr. Langford, Dr. Smallwood and all FDA,

I WISH to make the following submission and comments about all
topics of this meeting about human/animal TSEs. My comments and
submissions as follows please;

>>>>USDA-licensed tests for the diagnosis of bovine
>>>>spongiform encephalopathy (BSE) and other transmissible spongiform
>>>>encephalopathies (TSE),

IN the past all we have heard is the fact that the present BSEs test
do not guarantee public health safety. I request that the USA implement a
BSE/TSE test that DOES guarantee public health safety, one approved for
protection, a test for live cattle, one that would detect all TSEs in the
bovine, one that would detect sub clinical TSEs; EFSA Scientific Report
on the Design of a Field Trial Protocol for the Evaluation of BSE Tests for
Live Cattle This report provides a protocol for the design
of a field trial protocol for the evaluation of BSE tests for live cattle
for the purpose of consumer protection only.
Publication date: 17 September 2004
Adopted on 1 July 2004

>>>> review of the worldwide BSE situation,

THE most disturbing factor of this topic are the new atypical TSEs
showing up in not only cattle, but also sheep, and no one knows yet
about how many different strains of cwdTSE in deer/elk. WITH evidence of
sporadic CJD being very similar to these atypical TSEs in cattle and sheep,
and the findings from Asante, Collinge et al that BSE prions propagate
as either nvCJD or sporadic CJD, the ramifications of these findings are
very very worrisome and should not go ignored any further. WITH
the fact that there are over 20 documented strains of scrapie, and the
most logical hypothesis is scrapie to BSE, why would one believe in
only one phenotype of TSE in the bovine. IN fact, we have a new study
of two distinct prion strains derived from BSE in mice. YOU must not
continue to ignore these studies;

BSE prions propagate as either variant CJD-like or sporadic CJD-like
prion strains in transgenic mice expressing human prion protein

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

Characterization of two distinct prion strains
derived from bovine spongiform encephalopathy
transmissions to inbred mice

Adaptation of the bovine spongiform encephalopathy agent to primates
and comparison with Creutzfeldt-Jakob disease: Implications for
human health

In an experimental study of the transmissibility of BSE to the pig,
seven of 10 pigs, infected at 1-2 weeks of age by multiple-route
parenteral inoculation with a homogenate of bovine brain from
natural BSE cases developed lesions typical of spongiform

THE recent discoveries of previously unidentified strains of
Scrapie such as 221C44 and the Nor9845;


UK Strategy for Research and
Development on Human and Animal
Health Aspects of Transmissible
Spongiform Encephalopathies


WHEN in fact, the findings from Marsh and the findings at
MISSION, TEXAS support even further evidence that there
are further strains of TSE in the USA besides that one
accidentally documented BSE case in Washington on
Dec. 23, 2003;

In Confidence - Perceptions of unconventional slow virus diseases of
animals in the USA - Report of a visit to the USA - April-May 1989 - G A H
Wells [head of England's main veterinary lab]

Evidence That Transmissible Mink Encephalopathy
Results from Feeding Infected Cattle

>>>>labeling claims for TSE clearance studies for plasma derivative
>>>>The committee will then discuss and make recommendations
>>>>regarding presumptive transfusion transmissions of variant Creutzfeldt
>>>>Jakob Disease (vCJD) and current FDA-recommended safeguards.

ONE of the things i have been most worried about and will continue to
bring to the attention of the TSE advisory committee is the continued
denial of the potential of transmission of sporadic CJD via blood and
blood products. THERE are studies showing infectivity in the blood of
sporadic CJD, and just how many phenotypes there are of sporadic CJD is
anyone's guess at this point in time. WE have already documented
transmission of sporadic CJD via tissues and organs. TO continue the
BSE/nvCJD only theory will only continue to spread this agent. WE must
move away from this mentality and move on with all TSEs and treat all
TSEs as one, until proven otherwise, not the other way around. with
6,000 'DEAR nvCJD LETTERS' due to blood and blood products so far, i can
only imagine the number, once sporadic CJD is documented to have
transmitted via blood, what that number will be when those 'DEAR
SPORADIC CJD LETTERS' go out and how many will become clinical once
exposed, a frightening thought. OR, has infection by sporadic CJD
already happened, i don't think they are too sure if the 2nd
_infection_ of CJD was sporadic or variant;

Summary of SEAC’s discussion on the second presumed case of blood
transfusion-associated infection with vCJD

>> 7. SEAC agreed that the western blot results and glycotype profile
>> suggested it was unlikely that the infection was preclinical sporadic
>> CJD (sCJD). The committee noted that a single study by Glatzel et al
>> (2003) had reported PrPres in the spleen of sCJD clinical cases.
>> However, the levels of PrPres present in sCJD cases were low and
>> detected in patients with a lengthy clinical illness from sporadic CJD.

vCJD: Blood Transfusion Incident

MOST importantly, the 1968 MEDICINES ACT where it states 'NO SAF' was
blatantly ignored,
for animals and humans.

8. The Secretary of State has a number of licences. We understand that
the inactivated polio vaccine is no longer being used. There is a stock
of smallpox vaccine. We have not been able to determine the source
material. (Made in sheep very unlikely to contain bovine ingredients).

although 176 products do _not_ conform to the CSM/VPC



U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)

<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
WORLD TOTAL . . . . . . . 25,702 26,150 550,258 378,735
Austria . . . . . . . . . --- --- 45 225
Belgium . . . . . . . . . 14,311 12,029 248,041 199,036
Canada . . . . . . . . . 1,109 1,527 15,798 16,305
Denmark . . . . . . . . . 80 234 246 682
Federal Rep. of Germany 1,064 4,073 12,001 6,329
France . . . . . . . . . 3,902 4,859 87,879 92,845
Ireland . . . . . . . . . --- --- 120 478
Italy . . . . . . . . . . --- --- 2,359 81
Japan . . . . . . . . . . 445 1,903 11,350 11,298
Netherlands . . . . . . . --- --- 94 6
Republic Of South Africa --- --- 2 1
Spain . . . . . . . . . . --- --- 60 30
Switzerland . . . . . . . 716 353 9,303 4,271
United Kingdom . . . . . 4,075 1,172 162,960 47,148


Transmissible encephalopathies and biopharmaceutical production.

Blood donated after vaccination with rabies vaccine derived from sheep brain
cells might transmit CJD

Blood to be screened for CJD

***Similar levels of infectivity in the blood of mice infected with
human-derived vCJD and GSS strains of transmissible spongiform

Spongiform encephalopathy transmitted experimentally from
Creutzfeldt-Jakob and familial Gerstmann-Straussler-Scheinker diseases.

Lancet 2000; 356: 955 - 956


Blood from four of 37 human beings with clinically evident sporadic CJD has
reported to transmit the disease after intracerebral inoculation into
mice, or hamsters. But each success has been questioned on technical grounds
and has not been reproducible;

Transmission of Creutzfeldt-Jakob Disease from Blood and Urine Into Mice

The Lancet, November 9, 1985

Sir,--Professor Manuelidis and his colleagues (Oct 19, p896) report
transmission to animals of Creutzfeldt-Jakob disease (CJD) from the
buffy coat from two patients. We also transmitted the disease from
whole blood samples of a patient (and of mice) infected with CJD.1
Brain, Cornea, and urine from this patient were also infectious, and
the clinicopathological findings2 are summarised as follows.


Department of Neuropathology,
Neurological Institute,
Faculty of Medicine,
Kyushu University,
Fukuoka812, Japan


This observation represents the first documented transmission of BSE
from the blood of an experimentally infected primate...

Transmission of prion diseases by blood transfusion

Nora Hunter,1 James Foster,1 Angela Chong,1 Sandra McCutcheon,2 David
Parnham,1 Samantha Eaton,1 Calum MacKenzie1 and Fiona Houston2

see full text;

THEN one must consider these new findings of ;

Extraneural Pathologic Prion Protein in Sporadic Creutzfeldt-Jakob Disease


Conclusions Using sensitive techniques, we identified extraneural
of PrPSc in spleen and muscle samples from approximately one third of
who died with sporadic Creutzfeldt-Jakob disease. Extraneural PrPSc appears
to correlate with a long duration of disease.

Prions in skeletal muscle (Prusiner et al)

EMBO reports AOP Published online: 11 April 2003 Widespread PrPSc
accumulation in muscles of hamsters orally infected with scrapie

How much is too much? How much is not enough? What about accumulation?
What is the Threshold of exposure, to infectivity, to clinical disease?
How many strains/phenotype does sporadic CJD consist of and
What is the infectivity of each one of those phenotypes (cwdCJD)?
Until these questions are answered, you are gambling, nothing more.
I just pray that you get it right...

ALL human/animal TSEs should be made reportable Nationally and
ALL human TSE victims (family) should fill out mandatory CJD Questionnaire.

thank you,

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

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