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From: TSS (wt-d6-133.wt.net)
Subject: Scientists Raise Concerns about Second Wave of 'Mad Cow' Prion Infection; Leading Experts Address Need to Reduce Risk to Global Blood Supply
Date: October 26, 2004 at 10:13 am PST

-------- Original Message --------
Subject: Scientists Raise Concerns about Second Wave of 'Mad Cow' Prion Infection; Leading Experts Address Need to Reduce Risk to Global Blood Supply
Date: Tue, 26 Oct 2004 12:22:46 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy


http://www.pall.com

October 26, 2004 11:29 AM US Eastern Timezone

Scientists Raise Concerns about Second Wave of 'Mad Cow' Prion
Infection; Leading Experts Address Need to Reduce Risk to Global Blood
Supply

EAST HILLS, N.Y.--(BUSINESS WIRE)--Oct. 26, 2004--There is increasing
evidence that infectious prions that can cause variant Creutzfeldt-Jakob
Disease (vCJD), the human form of "mad cow" disease, can be transmitted
through blood transfusion, according to Roger Eglin, Ph.D., Head of
National Transfusion Microbiology Laboratories for the English National
Blood Service. He spoke at a symposium on Transmissible Spongiform
Encephalopathies (TSEs) where he was joined by prominent government,
public health and blood safety experts from around the globe, including
the U.S. and Canada, who raised concerns about a second wave of the
disease brought about by human-to-human transmission via blood
transfusions.

The panelists convened to discuss the adequacy of safeguards and
precautionary measures to prevent human-to-human transmission of this
fatal, neurodegenerative prion disease at a symposium held last night at
the annual AABB blood banking conference in Baltimore, Maryland. The
symposium was sponsored by Pall Corporation (NYSE: PLL), the global
leader in filtration technology.

Citing two confirmed cases in the UK, where vCJD was transmitted via
blood transfusions from donors who were young and apparently healthy at
the time of donation, Dr. Eglin said the current decline in reported
cases could be followed by a new wave of vCJD infections around the
world of unknown magnitude. These concerns were echoed by the panelists,
who noted the increase of vCJD in France from six to eight cases in just
the past few months and the news that blood from a vCJD-infected donor
was transfused to 10 people and used to manufacture medicines.

"This may not be a disease in decline, despite the low number of cases
today," said Dr. Eglin. "There is much uncertainty over the number of
cases predicted for the UK. Estimates of up to 25,000 total cases have
been predicted with an incidence of one in 24,000 of the UK population."

The second case of transfusion-transmitted vCJD in the UK demonstrated
that two human genotypes are susceptible to the infectious prion, rather
than one, as had been previously reported. According to Dr. Eglin, this
extends the number of people at risk from 40 to 90 percent of the UK
population.

Since people can incubate vCJD with no clinical signs or symptoms of
disease for a decade or more, there is no way to determine who or how
many people may be harboring the fatal prion nor how many of these
people may be blood donors. A single vCJD-infected blood donor has the
potential to amplify transmission to several people, creating the basis
for a far more widespread infection.

Dr. Eglin described the measures taken by the UK, including deferral of
previously transfused donors and 100 percent leukocyte (white blood
cell) reduction, to increase the safety of the blood supply.

Heightened vCJD Blood Concern in U.S.

David M. Asher, M.D., Chief and Supervisory Medical Officer with the FDA
Division of Emerging and Transfusion-Transmitted Diseases at the Center
of Biologics Evaluation and Research (CBER), expressed heightened
concern about vCJD transmission by blood due to the two cases in the UK.
He concurred that a second wave is possible and said that the number of
people who may be harboring the infection in the UK, 237 per million, is
a minimum estimate and may be too low.

The U.S. has a number of measures in place to protect blood safety, he
said, but stated that it is not possible to remove every blood risk by
donor deferral. "If we attempt to defer every donor who spent time in
the UK from 1980 to 1996, the blood donor loss would be enormous," he
explained. On October 14, the FDA TSE Advisory Committee made the
recommendation that no additional residency deferrals are necessary in
the U.S. at this time.

"If exposure to an infectious agent can be stopped, then the disease can
be stopped," said Dr. Asher. "Physical removal of vCJD from blood
appears to be the most promising line of attack."

Dr. Asher also commented that species barrier protection from TSEs other
than BSE is not absolute. He listed several TSE infections found in
animals in the U.S., including Chronic Wasting Disease (CWD), which is
found in both farmed and wild deer and elk in many Midwestern and
Western states and parts of Canada. Although there is no evidence of
transmission to humans, hunters are being warned to avoid contact with
or eating the meat of animals that may be infected with CWD.

Precautionary Principle in Canada

Although Canada has detected only one case of BSE and one of vCJD to
date, the country has taken a number of precautionary measures to help
prevent further infections, similar to those taken in the UK, according
to Dr. Peter R. Ganz, Director of the Centre for Biologics Evaluation
(CBE), Health Canada. Dr. Ganz cited the Precautionary Principle - "If
risk is possible, then we must err on the side of caution" - which, he
said, drove Canada's actions even before the emergence of possible vCJD
transmission through blood.

Dr. Ganz noted that Canada's surveillance system, its three deferral
directives to exclude donors with the potential for infectious disease
and the implementation of universal leukocyte reduction has reduced the
potential risk of vCJD transfusion transmission by about 92 percent. He
also spoke about the problems of balancing more stringent donor
exclusion policies against the loss of available supplies of blood.

Laurie Garrett, Gates Senior Fellow in Global Health for the Council on
Foreign Relations and award-winning author and journalist, stressed the
need to take measures to prevent the spread of newly emerging infectious
threats before they reach epidemic proportions. "Whatever microbes exist
in developing and third world nations will eventually exist in our blood
system because humankind is on the move as never before," she stated.
"Because of the speed of global travel, the risks of developing
countries are our risks. You may not feel global, but your microbes are."

She explained that we cannot rely on the developing world or even
countries such as China, as evidenced by SARS, to stop infections before
they are on everyone's doorstep. "Fortunately, SARS is not
transfusion-transmitted, but our own history of dealing with AIDS, our
lack of proactive policies and the economics of action beg the question
of whether we are ready to stop the spread of the next major blood-borne
infection," Ms. Garrett added. "The most cost-effective approach is to
be proactive and keep microbes out of the blood in the first place," she
concluded.

Sam Coker, Ph.D., principal scientist and technical director at Pall
Medical, presented the results of two new research studies with its
Leukotrap(R) Affinity Prion Reduction Filter, which is in late stage
testing. The filter has been shown to reduce infectious vCJD prions from
red blood cell concentrates below the limit of detection of the Western
blot assay. It was also found that the filter can remove different
strains of infectious prions from blood, including scrapie. The new
filter, which reduces both leukocytes and prions in a single step, is
expected to be introduced commercially in Europe early next year
followed by submission to the U.S. FDA.

Paul M. Ness, M.D., Director of Transfusion Medicine at The Johns
Hopkins Hospital in Baltimore, editor-in-chief of Transfusion and former
president of AABB, who moderated the symposium, reviewed issues in the
U.S., commenting that inadequate reimbursement often prevents or delays
the adoption of new technology to enhance blood safety. He said that
improvements in transfusion safety are not likely to be implemented in
the U.S. without patient advocacy.

Dr. Ness reviewed U.S. blood safety measures and noted that leukocyte
reduction removes prions from blood, resulting in a 45 percent reduction
of risk of vCJD transmission. He pointed out that although leukocyte
reduction is valuable, and explained the importance of 100 percent
implementation to improve patient safety, it is still not sufficient.
"Filtration technology that removes both prions and leukocytes would be
an example of adding value without adding another process that would
significantly increase costs," he concluded.

About Pall Corporation

Pall Corporation is the leader in the rapidly growing fields of
filtration, separations and purification. Pall's business is organized
around two broad markets: Life Sciences and Industrial. The Company
provides leading-edge products to meet the demanding needs of customers
in biotechnology, pharmaceuticals, transfusion medicine, semiconductors,
municipal drinking water, aerospace and broad industrial markets. Total
revenues are $1.77 billion. The Company headquarters are in East Hills,
NY, with operations in about 40 countries. Visit Pall at www.pall.com
.

This release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. These statements are
based on current Company expectations and are subject to risk and
uncertainties, which could cause actual results to differ materially.
Such risks and uncertainties include, but are not limited to:
fluctuations in foreign currency exchange rates; regulatory approval and
market acceptance of new technologies; changes in product mix and
product pricing and in interest rates and cost of raw materials; the
Company's success in enforcing its patents and protecting its
proprietary products and manufacturing techniques and its ability to
achieve the savings anticipated from its cost reduction initiatives;
global and regional economic conditions and legislative, regulatory and
political developments; and domestic and international competition in
the Company's global markets. Additional information regarding these and
other factors is available on the Web at www.pall.com
and is included in the Company's reports filed
with the U.S. Securities and Exchange Commission. Copies of such reports
can be obtained, without charge, at www.sec.gov .

Editors Notes:

-- Additional information and photos are available on
http://www.pall.com/pressroom

-- Interviews with leading experts are available upon request.

Contacts

Pall Corporation
Marcia Katz, 516-801-9128
Email: Marcia_katz@pall.com

http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20041026005771&newsLang=en

TSS





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