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From: TSS (216-119-143-239.ipset23.wt.net)
Subject: TSE Advisory Committee October 14-15, 2004
Date: September 10, 2004 at 2:28 pm PST

-------- Original Message --------
Subject: TSE Advisory Committee October 14-15, 2004
Date: Fri, 10 Sep 2004 16:34:24 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy


Transmissible Spongiform Encephalopathies Advisory Committee


Committee Roster
Suzette Priola PhD, National Institute of Allergy & Infectious Diseases
(Chair) 1/31/05
Val Bias, National Hemophilia Foundation 1/31/07
Lynn Creekmore DVM, U.S. Department of Agriculture 1/31/07
Lisa Ferguson DVM, U.S. Department of Agriculture Animal & Plant Health
Inspection Service 1/31/04
R. Nick Hogan MD/PhD, University of Texas Southwestern Medical School
1/31/07
Rima Khabbaz MD, National Center for Infectious Disease
Shirley Walker, Dallas Urban League (Consumer Representative) 1/31/04
John Bailar MD/PhD, University of Chicago 1/31/05
Arthur Bracey MD, St. Luke's Episcopal Hospital 1/31/07
Stephen DeArmond MD/PhD, University of California San Francisco School
of Medicine 1/31/05
Pierluigi Gambetti MD, Case Western Reserve University 1/31/05
Richard Johnson MD, Johns Hopkins University Schoo of Medicine 1/31/06
Stephen Petteway PhD, Bayer (Non-voting Industry Representative) 1/31/05
Sidney Wolfe MD, Public Citizen's Health Research Group 1/31/04
William Freas PhD, FDA (Executive Secretary)

Tentative Meetings
October 14-15, 2004

Upcoming Meetings Date
Plasma-Derived Product Label Claims For TSE Testing; BSE Diagnosis, Food
Rules; vCJD Transmission


Plasma-Derived Product Labeling Claims For TSE Clearance To Be Discussed
By Cmte.

FDAs Transmissible Spongiform Encephalopathies Advisory Committee will
discuss labeling claims for TSE clearance studies for plasma-derived
products on Oct. 14.

The committee will also receive updates on U.S. Department of
Agriculture licensed tests for the diagnosis of bovine spongiform
encephalopathy, FDA BSE food safety rules, and the BSE situation worldwide.

Presumptive transfusion transmissions of variant Creutzfeldt-Jakob
Disease and FDA recommended safeguards will also be addressed by the
committee.

To watch a webcast of this meeting, click the button below. To arrange
for live videoconferencing, or to order videotapes & DVDs, email
webcasthelp@elsevier.com or call
800-627-8171.

Posted: Friday, September 10, 2004


Sign up to view this meeting.

October 14, 2004
------------------------------------------------------------------------

Previous Meetings Date
Mad Cow Disease: FDA Recommendations To Minimize Risk From TSE Agents In
Medical Products -Day 2


February 13, 2004
------------------------------------------------------------------------
Mad Cow Disease: Risk Models For Bovine Sourcing For Medical Products;
First U.S. Case


February 12, 2004
------------------------------------------------------------------------
TSE Removal From Medical Devices and Equipment


July 18, 2003
------------------------------------------------------------------------
Bovine Bone Gelatin Safety; BSE In Canada


July 17, 2003
------------------------------------------------------------------------
Variant Creutzfeldt-Jakob Disease Guidance Implementation


February 20, 2003
------------------------------------------------------------------------
Blood Donor Deferral Implementation


June 27, 2002
------------------------------------------------------------------------
CJD Transmission Risk Reduction Draft Guidance


June 26, 2002
------------------------------------------------------------------------
TSE/Blood Products Joint Cmte. Meeting


January 17, 2002
------------------------------------------------------------------------
Creutzfeldt-Jakob Disease FDA Draft Guidance


October 25, 2001
------------------------------------------------------------------------
For information about additional meetings, email
webcasthelp@elsevier.com or call Julie
D. Robenson at (800) 332-1370.


http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Transmissible+Spongiform+Encephalopathies/default.htm

GREETINGS LIST MEMBERS,

talk about spooky. i was just going over a few old Advisory Committee
meetings;


FOOD AND DRUG ADMINISTRATION


NATIONAL INSTITUTES OF HEALTH


Advisory Committee on:

TRANSMISSIBLE


SPONGIFORM


ENCEPHALOPATHIES


December 18, 1998

Holiday Inn

8120 Wisconsin Avenue

Bethesda, Maryland


Proceedings by:

CASET Associates, Ltd

10201 Lee Highway, Suite 160

Fairfax, Virginia 22030


snip...

DR. ROOS: I have a question for Dr. Metters. I guess I just wanted to
make sure that I understood the rationale for the present policies in
the United Kingdom; that is that there is no pooled plasma products that
have UK donors. Nevertheless, there is no curtailment of blood
transfusions and labile products from UK individuals.

I just wanted to make sure I understood the rationale for that. That was
just -- in other words, if there is a safety problem with a particular
unit bearing CJD, then presumably those individual blood transfusions
also carry that risk. Maybe you could explain that.

DR. METTERS: First of all, all blood products. At the moment there are,
because we haven't completed the change-over from UK source to non-UK
source. Once that change-over takes place, there will be no UK sourced
blood products. We are making that change as soon as possible.

The reason why blood products may be different from blood is that, of
course, blood products go into an enormous pool.

The potential disbursement of a unit that is contaminated with new
variant depends on the size of the pool, whether it is a pool of 500 or
6,500 units.

As I said, we have to find an alternative source of blood products. The
most units it would go to is three recipients.

The other point to make is that this relates to the follow up. By far,
those who receive blood in the United Kingdom will die from the current
disease for which they receive the blood within 12 to 18 months. That is
a real problem when you come to holding it up, because of the
attenuation and so on.

The blood products, that does present a disbursal factor. As I said, we
do actually have steps to monitor who receives the blood, and are taking
steps to out-source blood products.

DR. BROWN: Just to add, on the disbursal factor, we don't know what is
going on in new variant. We don't know if there are a million infectious
units per unit of blood. We just don't know.

I received this comment about CJD. If new variant is, indeed, like
ordinary CJD, there is a logical curiosity about the disposal factor.
Infectivity is a functional definition. We don't necessarily know what
it is.

So, if there are 15 infectious units, we are talking about 15
transmissions of the disease. It is likely, after all the experimental
and epidemiologic evidence that any level of infectivity in the blood of
normal CJD is very, very low.

It doesn't much matter if that 100 infectious units is distributed to
10,000 or a million. There are going to be 100 transmissions. The notion
that you can dilute out infectivity has no scientific basis.

The other thing, if the unit of blood that is donor is fractionated with
an infectious agent, then disbursal may be higher. Unfortunately, we
don't know the answer to that yet.

DR. SCHONBERGER: I am wondering if our colleagues from the United
Kingdom can tell us what type of screening for blood donors is done to
reduce the chances of new variant disease specifically in the donor group.

Is there any kind of screening specifically directed toward new variant CJD.

The other issue, again, of screening, is there any screening that is
done in the United Kingdom that is focused specifically on ruling out
somebody who is symptomatic, for example, with new variant.

I understand that new variant's onset can be subtle and not really very
apparent for a while.

DR. BROWN: So, what you are asking is whether or not there are any
special criteria that are in place or being thought of to reduce the
risk of a new variant patient who is either -- according to Bob Will's
criteria -- either probable or definite. I can't imagine a definite, but
shall we say a suspect.

DR. METTERS: I think the general answer has to be no. There is nothing
you can ask somebody. There is, on the other hand, the donor is at least
asked about their general health.

Then if there is any suspicion at the time that they are not 100 percent
fit, and they have their blood count done before they are accepted.

If someone is physically unwell in any way, hopefully they will not get
through the screening system. So, while it isn't specific to that, it is
-- I would be doing a very bad job if I let someone who was unhealthy in
any way to get through our screening system.

DR. SCHONBERGER: So, there is no set of questions that is standard --

DR. METTERS: The questions of about CJD are there, right. To avoid
getting classes of donors, you may be able to avoid getting classes of
donors.

I would be very interested if any of you at the table could answer the
question that was asked.

We haven't yet had one who has been identified that in the time that
they were labile, was a donor.

DR. METTERS: As you know, most of the patients, or many of them, have
psychiatric onsets. So, if their response to the very first question you
ask is moo, you know to be suspicious.

DR. ROHWER: I have a question for Dr. Ferguson. When the provisions
against importations from the United Kingdom were extended in February
of 1998, was there any attempt by the USDA to go back to see what level
of exposure the United States had to European bovine products and cattle
since 1980, for example, or since 1988 when the provisions were put in
place for the United Kingdom?

For example, between 1980 and 1989, apparently we imported some 500
cattle. Now that we have recognized that there may have also been a risk
from imports from Europe and others before this change in policy, have
we gone back and looked at how exposed we were from that risk? I mean,
how many imports were there, and what kind of things were imported.

DR. FERGUSON: Yes, actually we have gone back and looked at live animal
imports from continental Europe at that same time.

They were fairly restricted at that point in time because cattle in
Europe were infected with other animal diseases, such as FMB.

snip...

MR. SUDIERI(?): My name is Sal Sudieri. I am the vice president for
medical affairs at the New York Blood Center.

Regarding this section A, there is a piece of information that I think
is important for you to have.

For the last 25 years, the American Blood Center has had a program with
Switzerland, Holland and Germany, where centers that produce plasma
derivatives in this country collect units of whole blood from volunteer
donors.

They became licensed centers, collection centers, from the New York
Blood Center, by our FDA license, and they will ship us the red cells,
where we do the processing, dedicate the plasma and the plasma is
fractionated.

About 30 percent of the blood, or about 200,000 units of red cells a
year, come to New York through this method.

DR. BROWN: Is the committee happy about what everybody considers and
knows to be an other BSE country or do we want to get clarification of that?

DR. LEITMAN: Clarification.

DR. BROWN: Are we talking about the United Kingdom plus France, plus
Portugal, plus the whole of Europe? What are we talking about?

DR. LURIE: Who is to make that decision?

DR. BROWN: That is what we want to know. Is that a decision that is
going to be made? If they can't tell us what is meant by other BSE
country, we can't really answer the question.

DR. LURIE: The procedural approach would be to vote on it separately. I
think the vote is more providing guidance.

DR. BROWN: Good suggestion. Ditto for periods of higher and lower risk,
I suppose, and ditto for possible versus probable. We can move along in
that way. That is a good idea.

DR. LURIE: Another parallel type suggestion would be, I think the
question that we do need some clarification on is the definition of reside.

While obviously it is more efficient to exclude residents from Britain
and visitors from Britain because, a, there are presumably fewer
residents than there are visitors, and the duration of exposure and
presumably severity of exposure would be different.

DR. BROWN: Maybe the best way to do it is to go piecemeal and nibble, in
which case we might, for example, phrase the first question, should the
FDA recommend excluding donors who are British citizens and see what you
get in answer to that, and see just how far the committee is willing to go.

On the other hand, that is going to require about 117 votes this afternoon.

DR. HOEL: There is another approach. First, we have to answer the first
question first.

DR. BROWN: I know. That was going to be my next point. Depending on our
answer to one, we can either dismiss A through E or take them up. I
think that is why Dr. Epstein phrased these two questions in this way.
Maybe I am wrong, but that is the way it is going to be done.

If the committee is ready to vote without further discussion on question
one -- not A, B, C, D and E, but just question one as a question -- we
will then vote and see what we then have to do, or we can have a little,
a moderate or a large amount of discussion before we get to that.

DR. LEITMAN: I have always had a problem with reducing a theoretical
risk or reducing a hypothetical risk or reducing a potential risk,
because perhaps, as I was talking to one of my colleagues earlier today,
perhaps it is a speculative risk and not a theoretical risk that, in
actuality, hasn't occurred.

How do we reduce speculative risk? How do you reduce zero?

DR. BROWN: That is an interesting kind of semantic question. It is the
virtual reduction of a theoretical risk. Does anyone want to get into
semantics?

DR. CLIVER: Clearly question one turns on the perception of nvCJD as a
food borne disease that is somehow derived from cattle.

I think I am prepared to accept that. The period of emphasis ending at
1990, though, I think is not indicated. The observations that Dr.
Detweiler had before, the data on this would have been very valuable for
risk on people on farms, however, there is no imputation here that the
risk was associated with people on farms with cattle.

[try 15 times more likely to get CJD...TSS]

http://www.bseinquiry.gov.uk/files/yb/1995/01/31004001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/10/13007001.pdf


http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf

http://www.bseinquiry.gov.uk/files/yb/1995/10/20006001.pdf

CONFIRMATION OF CJD IN FOURTH FARMER

http://www.bseinquiry.gov.uk/files/yb/1995/11/03008001.pdf

now story changes from;

SEAC concluded that, if the fourth case were confirmed, it would be
worrying, especially as all four farmers with CJD would have had BSE
cases on their farms.

to;

This is not unexpected...

was another farmer expected?

http://www.bseinquiry.gov.uk/files/yb/1995/11/13010001.pdf

4th farmer, and 1st teenager

http://www.bseinquiry.gov.uk/files/yb/1996/02/27003001.pdf

snip...

DR. BROWN: The question, Robert, is there any instance of maternal
transmission of new variant CJD?

DR. WILL: The answer is no, although tragically, at least one of the
individuals was pregnant when diagnosed with new variant CJD.

MS. HARRELL: Was she delivered?

DR. WILL: She did delivered. The child is alive and well, but we are
only talking two or three years. Of course, therefore, we rely on
previous evidence, which does not suggest that there was maternal
transmission.

DR. BROWN: It is an interesting question. If it were to have occurred,
it would be one more very striking example of a particular biological
behavior of new variant from sporadic.

We have information about half a dozen children born to patients who
were sick with CJD on delivery, who now have -- they have lived for as
long as 30 years after that event -- that is, after they were born --
and are quite healthy...

snip...

DON'T count your chickens again before they hatch there Dr. Brown,
remember the 38 years incubation period on the iCJD of a small
dose;

SHORT REPORT
Creutzfeldt-Jakob disease 38 years after diagnostic use of human growth
hormone
E A Croes, G Roks, G H Jansen, P C G Nijssen, C M van Duijn
...............................................................
J Neurol Neurosurg Psychiatry 2002;72:792-793


We describe the second patient with hGH related CJD in the Netherlands.
The patient developed the disease 38 years after hGH injections. To our
knowledge, this is the longest incubation period described for any form
of iatrogentic CJD. Furthermore, our patient was _not_ treated with hGH,
but only received a _low_ dose as part of a diagnostic procedure...

and this was not a case of nv/v CJD, but spordic CJD...TSS


http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3484t1.rtf

ACTION TAKEN BY THE UK MEDICINES CONTROL
AGENCY ON BOVINE INGREDIENTS IN MEDICINAL
PRODUCTS

6.1 Information is held on a especial data base from the initial BSE
survey in 1989. More current products, which were vetted during
their initial licensing assessment, after the UK BSE quideline was
published, may not appear in the listing, since BSE was considering
in their initial licensing assessment.

http://www.bseinquiry.gov.uk/files/yb/1994/09/01003001.pdf

RESTRICTED-COMMERCIAL..............CSM/BIOLS/94/6th Meeting

NOT FOR PUBLICATION

COMMITTEE ON SAFETY OF MEDICINES

SUB-COMMITTEE ON BIOLOGICALS

snip...

1.1 The chairman reminded the Sub-Committee that the papers and
proceedings were confidential and should not be disclosed...

snip...

4.6 BOVINE SERA

4.6.1 There was a discussion of the problem of the paper trail audit,
and countries of sourcing for bovine sera. Concern was expressed about
the fact that bogus certificates of origin had been produced and circulated.
It was noted that in the USA bovine protein was still being fed to cattle.
Sera from the USA could be used in the initial production and subsequent
large scale manufacture of hybridomas, rDNA products and vaccines
(some of which may be used in healthy children)...

http://www.bseinquiry.gov.uk/files/yb/1994/09/14003001.pdf

RESTRICTED-COMMERCIAL CSM/94/8th Meeting

NOT FOR PUBLICATION

COMMITTEE ON SAFETY OF MEDICINES

(7 blank pages to follow...TSS)

http://www.bseinquiry.gov.uk/files/yb/1994/09/22006001.pdf

http://www.bseinquiry.gov.uk/files/yb/1994/09/22007001.pdf

7.4 The Committee was informed that, since the publication of Hunter et al.
(2002), two further sheep had succumbed to BSE; one of these sheep had
been transfused with buffy coat, while the other had been transfused with
whole blood. Of the remaining 20 sheep that received transfusions, one died
of unrelated causes and 19 animals remain apparently healthy. The healthy
animals are at varying times post-transfusion  ranging from less than
100 to
over 1000 days.
7.5 Members were informed that among the 21 sheep transfused with blood from
scrapie infected animals (761 to 1080 days of age), 4 had developed scrapie
between 614 and 737 days post-transfusion. One animal received the buffy
coat preparation from the blood of an animal with clinical disease. The
remaining 3 animals received whole blood from donors not yet showing
clinical
signs. Of the remaining 17 transfused sheep, one died of unrelated causes
and two further sheep were showing clinical signs of scrapie; one of
these had
received buffy coat, while the other had received whole blood.
7.6 The Committee noted that it would not be possible to confirm that
the negative
controls are free of TSEs until the end of the study, when they would be
culled
and analysed post mortem for signs of subclinical infection. Of the 10
positive
controls that received BSE-infected cattle brain homogenate intravenously, 5
have developed disease or appear to be in the early stages of the disease.
3 Hunter, N., Foster, J., Chong, A., McCutcheon, S., Parnham, D., Eaton,
S., MacKenzie, C. and Houston, F.
(2002). Transmission of prion disease by blood transfusion. Journal of
General Virology 83.
www.socgenmicrobiol.org.uk/JGVDirect/18580/18580ft.pdf


CJD: Transmission

Lord Lucas asked Her Majesty's Government:

Further to the Written Answer by Lord Hunt of Kings Heath on 27
March (WA 59), what is the "strong epidemiological evidence to
suggest that classic CJD is not transmitted through blood"; which
of the many variants of "classic CJD" this evidence applies to;
and whether they will place copies of the relevant papers in the
Library of the House.[HL1864]

The Parliamentary Under-Secretary of State, Department of Health (Lord
Hunt of Kings Heath): The following, peer reviewed articles, relate to
this subject and will be placed in the Library:


T F G Esmonde et al, 1993, Creutzfeldt-Jakob disease and blood
transfusion, Lancet 341; 205-207;


P Brown, 1995, Can Creutzfeldt-Jakob disease be transmitted by
transfusion?, Current Opinion in Haematology, vol 2, pp 472-477;


C M van Duijn et al, 1998, Case-control study of risk factors of
Creutzfeldt-Jakob disease in Europe during 1993-95, Lancet 351:
1081-1085;

11 Apr 2000 : Column WA32


Ricketts MN et al: Is Creutzfeldt-Jakob Disease transmitted in
blood?, Energ Infect Dids 1997:3, 155-166; and


Heye N et al: Creutzfeldt-Jakob Disease and blood transfusion,
Lancet 1994; 343; 298-299.

These studies cover all types of CJD. Sporadic (classic) CJD, however,
accounts for some 85 per cent of non-variant cases.

The European Committee for Proprietory Medicinal Products (CPMP)
reviewed the evidence in December 1995 and advised that there was no
experimental or epidemiological evidence that classical CJD is
transmitted by blood transfusions or plasma-derived products. A recall
policy was not considered justified for plasma derived products from
plasma pools incorporating a donation implicated for classical CJD. It
reaffirmed that advice in March 1997. CPMP concluded on the basis of
currently available information from epidemiological and experimental
studies that there is no scientific justification for changing from the
current CPMP position on classical CJD. CPMP further stated there to be
no evidence that classical CJD is transmitted via blood or plasma
derived products. This issue was also subsequently considered by the US
Food and Drugs Administration, which came to the same conclusion.


New-variant CJD

Lord Lucas asked Her Majesty's Government:

Further to the Written Answer by Lord Hunt of Kings Heath on 27
March (WA 55-6), whether they will provide data on those who have
died from, or been diagnosed with, new-variant CJD in the United
Kingdom as to:


(a) the status of nucleotide-21 preceding the prion ATG start codon;


(b) the status of codons 26, 56 and 174 of doppel;


(c) the dates of onset and confirmation for those patients
diagnosed with new-variant CJD but still living;


(d) the definition of "onset"; and


(e) the age of the patients at onset to the nearest month.[HL1807]

Lord Hunt of Kings Heath: The genetic information requested is not
available. However, extensive studies of polymorphisms in and around the
prion protein and doppel genes have been under way for some time at the
St Mary's Prion Unit, London. The results of these investigations will
be published in the scientific literature, subject to peer review, in
due course.

Confirmation of a diagnosis of vCJD is currently obtained by postmortem
neuropathology. There are therefore no "confirmed" patients still
living. The dates of onset for patients still living and defined as
"probable" to the nearest month are as follows:

http://www.publications.parliament.uk/pa/ld199900/ldhansrd/vo000411/text/00411w02.htm

25 Apr 2002 : Column WA58


Bovine Embryos and Live Cattle: Imports from North America

The Earl of Caithness asked her Majesty's Government:

When the ban on the importation of embryos and live cattle from
North America will be lifted; and [HL3912]

What is the scientific evidence for the imposition of a ban on the
importation of embryos and live cattle from North America. [HL3913]

Lord Whitty: Her Majesty's Government have not imposed a ban on imports
of bovine embryos and live cattle from North America.

The European Parliament and European Council introduced legislation in
May last year laying down rules for the prevention, control and
eradication of certain transmissible spongiform encephalopathies (TSEs).
The legislation was introduced in response to the recommendations of the
Office International des Epizooties (OIEthe international animal health
organisation) and advice from the Commission's scientific comittees. The
legislation (and the transitional measures which came into effect in
October last year) includes requirement that imports into the EU of
bovine embryos and live cattle must be accompanied by certification
confirming that the feeding of ruminants with protein derived from
mammals has been banned and that the ban has been effectively enforced.
Some exporting countries, such as Canada and the USA, are currently
unable to meet these new requirements.

http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds02/text/20425w04.htm


BSE: US Export of Specified Risk Material

Lord Kennet asked Her Majesty's Government:

Whether the United States contends that under the provisions
enforceable by the World Trade Organisation the European Union may
not ban the import into Europe from the United States of
"specified risk material" (that is, material at possible risk of
BSE infection).

Lord Donoughue: Yes. But their position on the Specified Risk Material
legislation is based on the assumption that the United States can safely
be regarded as a "BSE free" country. Their case for such treatment has
not been accepted by the EU Commission's Scientific Veterinary Committee.


http://www.publications.parliament.uk/pa/ld199798/ldhansrd/vo971215/text/71215w02.htm

Baroness Masham of Ilton: My Lords, as blood products which infected
haemophiliacs with HIV came from the USA, is the Minister confident that
something else nasty may not come again from imported blood from the
USA? Is he aware that there are ways of cleaning blood to make it safer?
I know that that is done in Vienna, in Austria. Will the Minister look
into that? Following the question asked by the noble Lord, Lord
Clement-Jones, about people using their own blood, I am sure that, when
this Statement goes out into the wider community, people will want to
know that information.

http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds03/text/31217-09.htm

However, the Bio Products Laboratory who produce plasma products did
export surplus products, under the Income Generation Regulations for the
NHS, and used the income for the benefit of the health service.[21
]


http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/20703.htm#n21

43. Do you sell any of it abroad at all?
(Mr Gorham) No. The only circumstances in which we would export blood
would be if there was an approach to the British Government and the
British Government felt that it was appropriate to support an
international emergency or something like that. We do supply the British
Forces. We occasionally help out our colleagues in Wales and Scotland
and they would reciprocate with us if that was appropriate. At the
moment it is more or less totally contained within the United Kingdom.

http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/1012904.htm


Blood and Blood Products

Mr. Hinchliffe: To ask the Secretary of State for Health what estimate
he has made of the number of persons who have been inoculated with blood
or blood products over the past three years in the United Kingdom. [61681]

Ms Jowell [holding answer 2 December 1998]: It is estimated that about
one million people in the United Kingdom receive blood and blood
products every year.

http://www.parliament.the-stationery-office.co.uk/pa/cm199899/cmhansrd/vo990210/text/90210w02.htm


CJD blood products given to 3,000 patients

December 16 1997 BY AUDREY MAGEE AND IAN MURRAY

UP TO 3,000 people treated in 100 British hospitals may have been
injected with blood products taken from a donor who died six weeks ago
from new variant Creutzfeldt-Jakob disease, the human form of BSE. None
of them is to be told because the Health Department believes the risk of
them developing the disease is so slight that there is no reason to
cause alarm.

Although hospitals have been advised to return the product, used in
X-ray screenings to detect lung disease, so far only 15 per cent has
been recovered. There is no order obliging hospitals to return it and
some clinicians may go on using up stocks on the basis that patients are
far more likely to die from infections or cancer that can be diagnosed
with the product than from CJD.

Another 268 patients in Ireland are known to have been given injections
from the same batch of the product. The Irish Health Ministry has
decided to notify all the patients concerned.

Even though the identity of all those who have been given an injection
of the product is known, it was decided not to tell them because there
is no evidence that the illness can be transmitted through the blood or
the serum derived from it to make the product and the risk of developing
CJD is regarded as negligible.

"You are putting an enormous burden on people by telling them they
have a remote risk of contracting the disease," the department said
last night. "The ethics committee which advises us on these matters
decided it was just not appropriate to tell them."

The blood from the donor was sent 18 months ago to the National Blood
Authority laboratory, where it was split into a number of different
products. The donor's plasma was mixed with some taken from 49,000 other
donors to make 8,174 bottles of albumin, the water-soluble protein found
in blood.

Many were exported but 210 of the 50ml bottles remained in Britain and
were sent to eight different hospitals and companies. Some of the
bottles were used intravenously to rehydrate burn victims.

One bottle was sent to Nycomed Amersham which used it to produce 14,000
vials of Amerscan Pulmonate II, an agent which is injected into the
lungs so that infections and cancer show up under X-ray. The company
sent almost 3,700 vials to 100 British hospitals.

At the end of October the European Committee on Proprietary Medicinal
Products called for the withdrawal of blood products derived from donors
who were confirmed CJD cases. On November 1 the Blood Transfusion
Service was notified that one of its donors had died from the disease so
the Amersham company was told.

In turn the company got in touch with the Medicines Control Agency which
informed the Health Department and it recommended withdrawal of the
product on November 17.

Despite regular alarms, there has never been any convincing evidence
that blood or blood products can transmit CJD (Nigel Hawkes writes).
Unless new variant CJD, the human form of "mad cow" disease, is more
easily transmitted than classic CJD via blood or blood products, there
does not appear to be any cause for concern. [This is no medical basis
for this statement -- webmaster]

For classic CJD the risk seems negligible. About 50 people a year die of
the disease, so it is certain that every year some of them give blood
after they have the infection but before its symptoms appear. Studies
show that classic CJD can be passed on in human tissue, but not - so far
as we know - in blood. [This is not an accurate summary of current
scientific knowledge -- webmaster]

http://www.mad-cow.org/~tom/dec15_news.html

South Africa has been exporting plasma for many years. From 1983-86,
human plasma was falsely labelled "animal plasma" and illegally exported
to Europe. This illegal practice resulted in a court case and one
conviction in Belgium. In 1996, Austrian police seized 4000 L of
infected blood from a Linz-based company, Albovina.

The Sunday Times report said that Austrian officials have investigated
two British companies, based in Guernsey and Berkshire. Police are still
trying to find out where the companies' plasma products were used.
Johann Kurz, head of unit for biologicals with the federal Ministry of
Social Security & Generation in Vienna, Austria, told The Lancet, "We
suspect that in 1996 and earlier, some products coming from South Africa
were transferred to India, China, and Hong Kong, among other countries".
The products were albumin and intravenous immunoglobulins.

Nevertheless, Luc Noel, Coordinator of Blood Safety with the WHO in
Geneva, Switzerland, emphasised that: "There should not be any confusion
of the transfusion services in South Africa--which are now world
class--with these criminal activities". While it is important that this
trafficking is exposed, the public can be confident in their blood
services, Noel added.

Sanjay Kumar

Kirsten Myhr, MScPharm, MPH Bygdøy alle 58B 0265 Oslo, Norway Tel.: +47
22 56 05 85, fax: +47 22 24 90 17 myhr@online.no

http://www.freerepublic.com/focus/f-news/889385/posts


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