From: TSS (216-119-130-166.ipset10.wt.net)
Subject: MAD COW DISEASE AND NUTRITIONAL SUPPLEMENTS...
Date: August 13, 2001 at 1:23 pm PST
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
*****
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
*****
Friday, January 19, 2001
8:30
a.m.
Holiday Inn Bethesda Versailles I and II
8120 Wisconsin Avenue Bethesda, Maryland
2 PARTICIPANTS
Paul W. Brown, M.D., Chairperson
William Freas, Ph.D., Executive Secretary
VOTING MEMBERS
Ermias D. Belay, M.D.
David C. Bolton, Ph.D. Donald S. Burke, M.D. Dean O. Cliver, Ph.D.
Bruce M. Ewenstein, M.D., Ph.D. Peter G. Lurie, M.D.
Pedro Piccardo, M.D. Stanley B. Prusiner, M.D. Raymond P. Roos, M.D.
Elizabeth S. Williams, D.V.M., Ph.D.
VOTING CONSULTANTS
Linda A. Detwiler, D.V.M.
David Gaylor, Ph.D.
Paul R. McCurdy, M.D. Kenrad E. Nelson, M.D.
NONVOTING CONSULTANT
Susan Leitman, M.D. GUESTS
Richard Davey, M.D. Louis Katz, M.D.
snip...
page 501
253
1 DR. BOLTON: I have an additional question about
2 that. What is the assurance that additional locally sourced
3 tracheas are not added into that manufacturing process, thus
4 boosting the yield, if you will, but being returned to the
5 U.S. as being produced from U.S.-sourced raw material?
6 DR. McCURDY: Are there data to indicate how many
7 grams, or whatever, of infected brain are likely to infect
8 an organism, either animal or man, when taken orally?
9 DR. BROWN: If I am not mistaken, and I can be
10 corrected, I think a half a gram is enough in a cow, orally;
11 in other words, one good dietary-supplement pill.
12 DR. McCURDY: What I am driving at is the question
13 we are asked is really not do we wish to regulate these
14 things coming in. I think the statements about difficulties
15 in regulating things in the future or near future for new
16 regulations were probably accurate.
17 But I think that we could exhibit some quite
18 reasonable concern about blood donors who are taking dietary
19 supplements that contain a certain amount of unspecified-
20 origin brain, brain-related, brain and pituitary material.
21 If they have done this for more than a sniff or something
22 like that, then, perhaps, they should be deferred as blood
23 donors.
24 That is probably worse than spending six months in
25 the U.K.
1/19/01
3681t2.rtf(845) page 501
http://www.fda.gov/ohrms/dockets/ac/cber01.htm
MY submission;
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2.htm
This is the online version, with the hard copy
editorial on page 3. added. you can get
hard copy at barnes and noble...
NEW SCIENTIST MAGAZINE 4/02/01
NEW SCIENTIST EDITORIAL PAGE 3
MAD SHEEP DISEASE?
IF THERE is one categorical pronouncement you can safely make about
prion diseases like BSE or CJD, it is that one should not make
categorical pronouncements. "British beef is safe" and "there is no BSE
in Germany" come to mind. Now there are two more: "scrapie is safe", and
"people don't catch sporadic CJD". Scrapie is the most
widespread prion disease, infecting untold
numbers of sheep worldwide. Sporadic CJD is the old-fashioned pre-BSE
kind that is supposed to happen spontaneously in unlucky people. But a
surprise observation in France suggests some
sCJD cases--though by no means all--may be linked to scrapie after all
(see p 4).
For years, British authorities asserted that BSE was harmless because it
was a form of scrapie.
In fact, the only evidence scrapie is safe is
some broad-brush epidemiology, good as far as it goes but unable to
reveal occasional risks for
some people from some sheep. Alarm bells
should have rung in 1980 when researchers gave monkeys scrapie by
feeding them infected brains. But that research, like so much other work
on prion diseases, was never followed up. We
still have little idea what BSE does in pigs and chickens. The
Queniborough vCJD outbreak (see p 5)
would be easier to understand if we knew how much brain we must eat to
be infected. As for scrapie, it shouldn't take a chance finding to tell
us that there may be dangerous sheep out there.
FULL TEXT BELOW;
NEWSCIENTIST
SUSPECT SYMPTOMS
http://www.newscientist.com/dailynews/news.jsp?id=ns9999560
Then follow up with PNAS studies from which
new scientist article written from;
PNAS FULL TEXT;
PNAS
http://www.vegsource.com/talk/lyman/messages/8973.html
http://www.vegsource.com/talk/lyman/messages/8974.html
PNAS
http://www.vegsource.com/talk/lyman/messages/8975.html
http://www.vegsource.com/talk/lyman/messages/8976.html
Scrapie to Humans?
http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=3915057&dopt=Abstract
BSE NEWS
http://www.vegsource.com/wwwboard/lyman/wwwboard.html
CJD NEWS
http://www3.bravenet.com/forum/show.asp?userid=qn99925
CJD WATCH
http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm
Moms death from hvCJD
http://www.vegsource.com/talk/lyman/messages/7252.html
'MOMS AUTOPSY REPORT'
http://www.vegsource.com/talk/lyman/messages/7548.html
SOMETHING TO CHEW ON
http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2
http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1
also;
Diagnosis and Reporting of Creutzfeldt-Jakob Disease
T. S. Singeltary, Sr; D. E. Kraemer; R. V. Gibbons,
R. C. Holman, E. D. Belay, L. B. Schonberger
http://jama.ama-assn.org/issues/v285n6/ffull/jlt0214-2.html
Tom from mad-cow.org/ had the last word.
I was glad of that, hate for the same
screw-balls at CDC to always get last word
in all the time;
http://www.mad-cow.org/00/feb01_news_mid.html#mmm
also;
http://www.spiegel.de/spiegel/0,1518,119306,00.html
also;
http://vegancowboy.org/schedule.htm
HEALTH magazine JUNE 2001 page 66, 68 and 70...
Could you get mad cow from a pill ?
Some doctors say a class of pills that promise smarts, energy, and
sexual vitality may cause mad-cow disease. The government isn't worried.
Should you be?
BY SUSAN FREINKEL
ON SEPTEMBER 27, 1997, an otherwise healthy
Barbara Poulter noted in her journal that she was seeing brown spots.
Ten days later she was blind. In another week, her coordination went
missing and her speech failed her. By the end of November, she was
bedridden with violent seizures. On December 14, she died. Her son,
Terry Singeltary, was by her side through her rapid decline, and he
became obsessed with the sickness that destroyed her: Creutzfeldt-Jakob
disease. As he soon learned, CJD belongs to a lethal family of diseases
that waste victims' brains by riddling them with spongelike holes. The
more the retired machinist dug into the issue, the more he was convinced
that what had really killed his mother, and countless others diagnosed
with CJD, was the related, better-known scourge, mad-cow disease.
A weird coincidence helped cement this belief in Singeltary's mind.
Though CJD is a rare disease, his next-door neighbor's mother also
succumbed to it. When the neighbor was clearing out his
mother's effects, he came across some strange nutritional supplements
the woman had been taking.
"Hey, Terry," the neighbor called across the backyard fence, "take a
look at these." The pills were what is known in the industry as
glandulars--ground-up dried animal glands and tissue, most often derived
from cows. Though glandulars make up just a minute part of the
supplement industry's sales, you can find them in any health food store,
marketed under no-nonsense terms such as Raw Pituitary (taken for
energy) or coy names such as Brain Nutrition or Ultramale (a formula
containing, the industry's euphemism for testicle). When Singeltary saw
what was in his neighbor's pills, he gasped. There was bovine brain,
eye, and bone--the tissues most likely to harbor the rogue proteins
known as prions that are thought to cause mad-cow disease. "These are
the most infectious parts," Singeltary exclaimed.
As he later began insisting to anyone who would listen, "This isn't
merely cow in a pill, it's mad cow in a pill."
It's easy to dismiss Singeltary as a grief-stricken crank, and many
have. He's a high-school dropout; most of what he's learned about mad
cow has been garnered from obsessive Web surfing. But lately folks with
much better credentials than his have been echoing his concerns. In a
letter last year to the prestigious New England Journal of
Medicine, a Maryland doctor pointed out that the supplement industry is
so loosely regulated that prion-contaminated products could easily find
their way onto American shelves. The scientific
experts who advise the Food and Drug
Administration on mad-cow policies came to much
the same conclusion when they met in January.
"It's important to know these products are safe," the group's chairman,
Paul Brown, a neuroscientist at the National Institutes of Health, said
at the close of the meeting. "I think we've heard enough evidence to
suggest they may not be."
Nonsense, say U.S. regulators. Experts agree there's no evidence that
anyone, including Singeltary's mother, has caught the human version of
mad-cow disease in this country. What's more, regulators say they've
blocked the routes by which pills could be tainted. There's no way,
according to them, that manufacturers could use diseased cattle, whether
raised here or in countries where bovine spongiform encephalopathy--the
scientific name of mad-cow disease--has become a crisis.
Is the source safe?
In ten years of testing, the USDA has only 13,000 cows.
"Hell, we raise 100 million cattle a year in the United States," says
one critic.
On the domestic front, the U.S. Department of Agriculture has monitored
American cattle for the disease since 1990 and has yet to find a single
case. "There's no evidence of BSE in this country,'' asserts USDA
veterinarian Linda Detwiler, the agency's point person on mad cow.
And the USDA says a 1989 ban on the importation
of cows or sheep from the United Kingdom (later expanded to include all
of Europe and to cover organs and glands) has kept potentially infected
animal parts from crossing the U.S. border. Meanwhile, for nearly a
decade the FDA has cautioned supplement makers about the risks of using
bovine ingredients, and since 1995 it has threatened to detain shipments
of high-risk animal parts unless the organs come from safe countries.
Phillip Harvey, scientific director of the
National Nutritional Foods Association, says
"most, if not all" companies use tissue only from cows from disease-free
countries. Some have switched from bovine tissue to tissue from pigs.
To Harvey's thinking, a person is more likely to
be hit by lightning than to catch a prion disease
from a supplement. "The risks are basically zero,
he says, pointing to the formidable barriers the United States has put
in place against BSE. "And the walls are getting thicker and taller."
So why are top-notch scientists concerned? When
the FDA advisory task force on glandulars met
last winter, the group asked the FDA to consider
barring people who use the supplements from donating blood. As task
force chairman Brown wryly said, "There is a spongy quality to the
precautions."
First, the trade bans have been leaky.
At the height of the BSE epidemic in England,
and after the USDA ban had gone into effect, that country shipped tons
of bovine by-products to the United States.
And critics question the much-vaunted safety of American cattle. In ten
years of testing, the USDA has checked about 13,000 cows. "Hell, we
raise 100 million cattle a year in this country, notes
investigative journalist John Stauber, coauthor
of Mad Cow USA, Could the Nightmare Happen Here? Stauber and others
believe the agency isn,t
testing enough cows to detect a low-level outbreak of BSE. By contrast,
Germany--which for years insisted its herds were free and
clear--checked
270,000 cattle between last November and March and found 40 infected
with the disease.
But the FDA advisory committee believes the
biggest problem is the limited power of the FDA. Though the agency is
the official watchdog of the supplement industry, it has no teeth--it
cannot pull a single box from a store shelf unless it can
prove beyond a doubt the product pose a danger.
Nor does the agency have the man power to
regularly check imports entering the country or
to inspect more than 60 supplement-manufacturing plants out of 1,O00--a
year. And currently it
can't require the makers of glandulars to tell
people if they're buying bovine tissue.
Even if companies wanted to, there's no method available to test the
pills for prions.
"The plain fact of it is the FDA is so feeble
that there's no way of knowing whether a dietary supplement has British
cow brain in it," says
Peter Lurie, deputy director of the Public Citizen's Health Research
Group and a member
of the advisory committee.
To be sure, many companies follow the rules,
buying organs only from BSE-free countries and opening plants to USDA
and FDA inspectors. But
the supplement industry is also rife with shadowy, hard-to-trace
outfits. One pill with the name Meganephrine--it contains 190 milligrams
of brain tissue--is made by Cardiovascular Research. The label places CR
in Concord, California, but
there's no phone listing, nor does it turn up on
an Internet search. The company may scrupulously follow regulations. Or
it may not: It'll be tough for a regulatory agency to find out. As one
FDA official recently told the New York Times,
"We rely on the industry to do the right thing."
That's scant comfort to skeptics like the NIH'S Brown. "As long as the
FDA has no power to compel companies to prove that the source of their
glandulars is safe, then we're working on faith. And faith generally
doesn't work in business."
In the end, Brown thinks the strongest argument against glandulars has
nothing to do with mad-cow disease. Extracts of pituitary, thymus,
ovary, or other glands are powerful enough to upset a person's hormonal
balance. Endocrinologists report seeing women who sprouted facial hair
because an adrenal formula sent their testosterone levels soaring.
Others suffered heavy menstrual bleeding when they went off an ovary
preparation. In the worst cases, a supplement can cause a person's
own glands to cease working altogether.
And there's no research to suggest that the pills have any health
benefits. Add up the potential risks, and you might wonder why anyone
would take these supplements. "I just don't think it's very smart to eat
materials derived from animal
glands," says Brown. "As long as people are
taking these pills, any mistakes could have terrible consequences."
WWW.HEALTH.COM
June issue
coming up soon--readers digest august issue
and houston chronicle...
TSE STUDIES $ DOCUMENTS
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=fr17mr00-44
USDA issued a press release on this. Go to:
www.usda.gov/news/realeases/2000/01/january.htm and click on 0011 --
"Glickman announces $100 million Assistance Package for Sheep and Lamb
Producers."
The Federal Register docket can be found at:
www.aphis.usda.gov/ppd/rad/webrepor.html and then look up docket #$
99-061-1.
DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E.
(PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&doci
d=fr20jy00-32
DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E
(PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES [2]
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&doci
d=fr20jy00-31
Research on BSE and Scrapie 'confidential'
http://www.vegsource.com/talk/lyman/messages/7531.html
Research on BSE and Scrapie {part 2}
http://www.vegsource.com/talk/lyman/messages/7532.html
In Confidence - Perceptions of unconventional slow virus diseases
of animals in the USA - APRIL-MAY 1989 - G A H Wells
http://www.vegsource.com/talk/lyman/messages/7535.html
part 2
http://www.vegsource.com/talk/lyman/messages/7536.html
http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh
http://www.vegsource.com/talk/lyman/messages/7538.html
Research on BSE and Scrapie 'confidential'
http://www.vegsource.com/talk/lyman/messages/7531.html
Research on BSE and Scrapie 'Confidential' {part 2}
http://www.vegsource.com/talk/lyman/messages/7532.html
In Confidence - Perceptions of unconventional slow virus diseases
of animals in the USA - APRIL-MAY 1989 - G A H Wells
http://www.vegsource.com/talk/lyman/messages/7535.html
part 2
http://www.vegsource.com/talk/lyman/messages/7536.html
BSE transmission to Sheep by Whole Blood
http://www.vegsource.com/talk/lyman/messages/7638.html
Louping-ill vaccine blunder to scrapie
http://www.vegsource.com/talk/lyman/messages/7634.html
'v' CJD could it be vaccineCJD???
http://www.vegsource.com/talk/lyman/messages/7622.html
kind regards,
Terry S. Singeltary Sr., Bacliff, Texas USA
=======================
this message will self destruct in 10 seconds ;-)
Terry S. Singeltary Sr.,
P.O. Box 42,
Bacliff, Texas USA 77518
OTHER STUDIES
http://www.vegsource.com/talk/lyman/messages/7524.html
http://www.vegsource.com/talk/lyman/messages/7526.html
http://www.vegsource.com/talk/lyman/messages/7531.html
http://www.vegsource.com/talk/lyman/messages/7532.html
http://www.vegsource.com/talk/lyman/messages/7539.html
http://www.vegsource.com/talk/lyman/messages/7541.html
(v) BSE passaged through sheep and goats produced disease in mice very
similar to the original inoculum.
http://www.vegsource.com/talk/lyman/messages/7616.html
http://www.vegsource.com/talk/lyman/messages/7550.html
http://www.vegsource.com/talk/lyman/messages/7617.html
http://www.vegsource.com/talk/lyman/messages/7624.html
http://www.vegsource.com/talk/lyman/messages/7638.html
http://www.vegsource.com/talk/lyman/messages/7650.html
http://www.vegsource.com/talk/lyman/messages/7282.html
http://www.vegsource.com/talk/lyman/messages/7768.html
http://www.vegsource.com/talk/lyman/messages/7793.html
http://www.vegsource.com/talk/lyman/messages/7794.html
http://www.vegsource.com/talk/lyman/messages/7795.html
MORE EVIDENCE OF TRANSMISSION OF SCRAPIE AGENT
BY VACCINE
http://www.vegsource.com/talk/lyman/messages/9300.html
Louping-ill vaccine (scrapie transmission by vaccine)
http://www.vegsource.com/talk/lyman/messages/7634.html
VACCINES and CJD
http://www.vegsource.com/talk/lyman/messages/7622.html
http://www.vegsource.com/talk/lyman/messages/7631.html
sporadic CJD is _NOT_ a strain.
it is potentially multiple strains,
of many different routes/sources...
this message will self destruct in 10 seconds ;-)
The 'TRUTH' will come $$$
and now, you have the rest of the story...
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
