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From: TSS ()
Subject: Doctors at NHS hospital carry out secret 'mad cow' analysis without permission
Date: June 2, 2007 at 8:27 pm PST

Patients' fury over blood test 'betrayal'


Doctors at NHS hospital carry out 'mad cow' analysis without permission

Ned Temko
Sunday June 3, 2007
The Observer


Doctors were accused of gross betrayal last night after haemophiliac
patients discovered that their blood samples were being tested for the human
form of 'mad cow' disease without their knowledge.
They compared the move by one of Britain's leading NHS hospitals to the
Alder Hey organ scandal, when samples were taken from the bodies of dead
children without their parents' permission.

The secret blood testing for new variant CJD was discovered in the minutes
of a meeting of America's Food and Drug Administration, which was attended
last year by a leading member of Britain's National Institute for Biological
Standards Control.


The minutes revealed that the British scientist told the FDA that
haemophiliac blood samples taken from the Royal Free Hospital in London
would be 'provided for variant CJD analysis'. He described the samples as 'a
bit of serendipity' that could provide 'icing on the cake' for testing the
development of an effective blood test for the disease.
Last night testing was criticised by Professor Christine Lee, until recently
the head of the Royal Free's haemophilia unit, who said that passing on
blood samples without patients' knowledge or consent raised serious ethical
issues - particularly in the wake of controversies like the Alder Hey organ
scandal.

'You can't go around just grabbing stored samples,' she said. Acknowledging
that she had used samples for hepatitis and HIV infection research 'at an
earlier time' in her two decades at the hospital, she said that attitudes
had changed. 'You can't go ahead and test people without their knowledge.
It's just not on.'

She said she had been shocked when she had learnt of the disclosure of the
blood testing plan and had strongly urged both the institute and her
successor at the Royal Free, Professor Edward Tuddenham, to drop the idea.

But when contacted yesterday Tuddenham said: 'Yes, we are in the process of
transferring them [the blood samples] to the CJD surveillance group at the
National Institute for Biological Standards Control. We still have them in
the freezers here.' He said the samples had been taken during testing for
hepatitis C and HIV, but that those analyses were finished and the samples
'were just going to be incinerated otherwise'.

'I got in touch because it occurred to me that the CJD people might be
interested, and they were indeed extremely interested. So I was pleased to
find a useful research end for the samples.'

But patients are demanding that the blood testing be halted until they have
been consulted. 'I'm sickened by this,' said Mark Ward, 38, a longtime
haemophiliac patient at the Royal Free. Ward, who contracted HIV from
US-sourced blood but was not informed until the hospital had tested him for
the virus without his knowledge, said: 'They're doing the same to us as they
did 20 years ago.'

He said that, if asked, he might agree to have his blood samples used to
speed the development of a test for vCJD. But to do so without telling him
was 'simply wrong,' he said. 'We live in a world where we are supposed to
have rights, but I feel I'm being treated like a laboratory rat.'

Though the Royal Free knows the identity of the sample donors, the plan is
to 'anonymyse' them for the purpose of the variant CJD research.

But Lee warned her successor that even that approach was fraught with
enormous 'patient counselling issues'. She said that, if indications of vCJD
were found in any of the samples, the question would arise of whether and
how to inform the individual of the possible health risks to himself or
others. She said the hospital's plan 'has to come above the parapet. The
patients have got to know about it - and give explicit permission'.

So far 160 people in Britain have contracted variant CJD, including four
transfusion patients who have either begun showing signs of the disease or
were found to have symptoms following a post mortem. So far, no haemophiliac
has developed the disease, but concern has centred on the fact that two
dozen batches of blood used for transfusion have included samples given by
people who went on to contract the disease.

http://www.guardian.co.uk/medicine/story/0,,2094321,00.html

To continue on the same theme, I am showing you an update or new information
that has recently come out concerning the study by Hilton et al that was
published in 2004.

This was a United Kingdom tissue survey where anonymized tonsil and appendix
samples were taken from subjects that had undergone surgery between 1996 and
1999 in the United Kingdom.

The samples that were studied were from patients aged 20 to 29. Very
interesting and important, three out of the 12,674 samples that were deemed
adequate for study were positive, suggesting one in 4,225 people in this age
group might actually be infected with variant CJD. All of the positive
samples did come from appendices.


Now, what is new about this is that prion protein genotyping was done on two
of these samples. In this first sample, there was not enough to do genotype
testing, but the tissue was taken and used in a transmission study into
mice, and those results are pending. We don't know what has happened to
those mice just yet.

In the second subject sampled, the genotype was found to be valine
homozygous. So, this was the first report of an infection in a valine
homozygous person. The second was also a valine homozygous individual.

So, to summarize, variant CJD clinical cases are declining in the United
Kingdom. We have had three transfusion transmission infections reported in
the United Kingdom, one fairly recently.


snip...


At the meeting of this committee on October 14, 2004, the committee reviewed
current FDA regulations regarding vCJD related donor eligibility.

After considerable discussion, they did not make recommendations for further
FDA actions to protect the blood supply.

However, there were discussions at the meeting concerning the predictive
value of donor questions that were used to exclude TSE risk and just how
effective the questions were, as well as the feasibility of deferral for
history of transfusion outside of the United Kingdom, but no specific
recommendations were made at that meeting.


snip...

So, the blood from the forms of Creutzfeldt Jakob disease generally
available in the United States, the hypothesis that there is enough
infectivity present to be detected at all with any of these assays has not
been demonstrated.

With variant Creutzfeldt Jakob disease, as Dot pointed out, the number of
patients available has been very small.

In the two cases in the United States, I believe that Dr. Gambetti has a
small amount of blood, and I know the Canadian case there is a small amount
of plasma available, but nothing approaching what would be needed for the
kinds of studies that we have been talking about.

I am afraid at the moment we are stuck with blood from endogenous
infectivity. We are stuck with blood from animal sources.

DR. GESCHWIND: So, at UCSF we have actually shown that it is pretty feasible
to get large volumes of blood from patients with CJD.

We have -- Jiri Safar probably can give you the fact numbers, but probably
we have over 50 patients in whom we have gotten 200 to 400 mls of blood.

So, bring in patients from around the country and at certain points when we
have funding we have been sending out a nurse to get 200 mls of blood from
patients with CJD, and we have been collecting it every two to three months
from patients during the course of their disease, depending upon -- we do
very strict safety tests that are more conservative than for the Red Cross
blood donations, prior to doing this.

So, it is feasible, particularly in patients whom we have diagnosed earlier
in the disease course, and in patients who have a slower course.

DR. SCOTT: I think that Dr. Minor also has a comment maybe about the variant
CJD cases.

DR. MINOR: Well, I am very jealous of the comment that has just been made. I
have discussed this extensively with the people at the CJD surveillance unit
in Edinburgh, and they won't touch it.

They basically say that the ethical concerns are such that they will not
take a unit from people who have variant CJD, no matter who wants it.

I will be talking a little bit about human samples tomorrow in the
diagnostic presentation, and the availability of human samples is absolutely
tiny, relevant human samples, like within the United Kingdom, is absolutely
zero.

There has also been a recent introduction of a thing called the human
tissues act, which means that if you don't do it right, you get sent to
prison. That has actually been a major inhibitory effect on actually trying
to get these kinds of samples.

snip...end...full text ;


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


Agenda Item: Algorithm for Approval of Human TSE Tests in Europe.

DR. TURNER: Thank you very much, Dr. Piccardo, and thank you, ladies and gentlemen. I have somewhat modified the slides again, overnight, to make them a bit more succinct.

So, they will be updated from what you have in your packs, but the updated slides will be on the FDA web site if you should wish to download them later.


snip...

If you will bear with me, in this small horse experiment, per a million donors or donations tested, we are currently working in the United Kingdom with point estimates all around one in 10,000 donors with subclinical variant CJD.

Clearly, there are wide confidence intervals around that
kind of estimate, but that is the point estimate that we are currently working with.

If one assumes one has an assay which is 99 percent sensitive and 99 percent specific, then that breaks down into four boxes.

There are the true positives, those who are infected with the condition and will test positive, and you get around 99 of those.

There are false negatives, those who have the condition but test negative, with a 99 percent sensitive assay. So, there would only be one of those. That is a reasonably favorable outcome.

The true negatives, those who don't have disease and test negative, are clearly the majority of individuals. The real problem is the false positives, those who are not infected but are testing positive. That is, for every million donors, with a 99 percent specific assay, you would get about 10,000 donors in that category.

So, in the United Kingdom, for example, where we test about 2.5 to three million individuals per annum, we would be looking at 30,000 positive individuals per annum, the vast majority of whom would be false positives. Of course we wouldn't know which -- the negative predictive value of the assay would be very, very good, better than 99 percent. The positive predictive value would be less than one percent.

Just to remind you, of course, that in a country without cases of clinical variant CJD, like the United States, for example, it seems like to me that the prevalence of subclinical variant CJD is at least an order or two of magnitude less than that which we are likely to have in the United Kingdom.

So, the true positive rates, of course, would be extremely low, but the false positive rates would be no different.

You would still be looking at the same rates of false positives, and obviously a much lower positive predictive value. So, that is a problem for any country which wishes to implement such an assay.

Then we need, of course, to think therefore of the impact on the blood donors of such an assay and, indeed, of the blood supply.

What we are talking about here is trying to balance the public health, the overriding imperative to try to protect public health and protect patients from transmission of clinical variant CJD against the potential negative impact on blood donors and the potential or possibly catastrophic impact on the blood supply.

Those issues around how would we manage these test positive individuals, with apologies for split infinities, to tell or not to tell, to bleed or not to bleed. In Europe that is not an issue.

We would not be allowed to bleed people and discard their blood without informing them of that, but continuing to bleed them.

They would have to be deferred, but not just being deferred, they would clearly need an explanation why they were being deferred.

So, these individuals would have to be told. The previous speaker has touched on the issue of how we are going to find truth in the false positives. Clearly, the number of false positives would have a direct impact on the blood supply.

Then there is the issue of, even if we have a group of individuals we think are truly positive, what does that mean?

The current mathematical modeling suggests that maybe 95 percent of individuals could have long term subclinical disease.


snip...


Thirdly, there is a broad spectrum of people who are considered at risk of variant CJD for public health purposes, again by the CJD incidence panel.

These tend to be individuals, for example, who have received plasma products from a pool to which a donor who donated went on to have clinical variant CJD, or patients who have been exposed to peripheral surgical implementation.

So, there is a larger number of such individuals, but clearly there is less confidence that any of these individuals are actually infected. Those would clearly be key samples which we need to try to collate in some way.

Finally, we need to look at peripheral blood samples from blood donors in order to try to establish specificity, and the UK blood services have established what they call the test assessment facility, the purpose of which is to collect 10,000 whole blood units from normal donors.


snip...


The aim is to develop or provide a comparative specificity panel. We have chosen -- clearly, the panel is not sized -- this is a misunderstanding -- to give accurate epidemiological data, even in the United Kingdom if the subclinical prevalence is one in 10,000. We might not expect to pick up a true positive in this panel. So, it is very much a specificity panel.

The typical view is that it would be prudent, given that we don't know the prevalence of subclinical variant CJD in the United Kingdom, to use at least half the samples from a country where the prevalence is likely to be extremely low or negligible. So, we have 5,000 U.S. samples and 5,000 United Kingdom. If I may, chairman, I will stop at that point. Thank you.


snip...


DR. BROOKMEYER: We are dealing with a very long incubation period, as you pointed out. The key is that we have high sensitivity during that window period.

You spoke a little bit about our ability to determine if we have sensitivity during that incubation period.

I was wondering, the kind of data that we have that could speak to that, and how difficult that is going to be, to determine whether or not you could, with good sensitivity, detect during that long window period.

I am wondering -- in your last slide you mentioned 5,000 UK and 5,000 US samples. If you assume that the prevalence, say, of silent infection is higher in the United Kingdom than in the United States, then if one were to do a test and found higher prevalence in the United Kingdom than the United States, would that provide some indirect evidence that you are detecting -- you have some sensitivity for detecting the silent infection, if you see in two populations, one where you are assuming epidemiologically there is more silent infection going on than in another.

Then if you apply these tests and actually see you are detecting more in one population than the other, would that be a way of indirectly providing some evidence that you can actually detect during that window period?

DR. TURNER: Part of the thinking when we adopted that strategy, as I said earlier, and as you remarked, if the prevalence really is around one in 10,000, then we wouldn't expect to maybe pick up more than one true positive in the UK sample.

Say, for the sake of discussion that we were to pick up, say, 10 UK positives. There would be two issues. One, having the US samples would allow us to establish whether they were really true positives, or were they more likely to be false positives.

Clearly, also, if we were to find 10 true positives out of 5,000 samples, that would be an extremely worrying finding.


snip...

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t2.htm

Again, another major point is that none of the plasma derived products or factor VIII products have been made from the plasma of anyone known to have developed variant CJD in the United States, and no one who has received any of these products is known to have developed the disease.

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4271t1.pdf


WHAT ABOUT ???


MAD COW nvCJD blood recalls May 2007 FDA


PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1221-07
CODE
Unit: 7113661
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on April 5, 2005. Firm
initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1222-07;
b) Recovered Plasma, Recall # B-1223-07
CODE
a) and b) Units: 5587539, 9710079
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile, and e-mail
beginning August 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
LA and Switzerland

___________________________________

http://www.fda.gov/bbs/topics/enforce/2007/ENF01002.html


PRODUCT
Source Plasma, Recall # B-1239-07
CODE
Units: 90002025 and 90003068
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., dba Biomat USA, Inc., Clarksville, TN, by
facsimile on December 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Spain

___________________________________


http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01003.html


PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1085-07;
b) Fresh Frozen Plasma, Cryoprecipitate Reduced, Recall # B-1086-07;
c) Cryoprecipitated AHF, Recall # B-1087-07;
d) Recovered Plasma, Recall # B-1088-07
CODE
a) and c) Units: 7114289, 9703931;
b) Unit: 9703931;
d) Unit: 7114289
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile
transmissions and e-mails beginning on October 25, 2005. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor who had risk factors for variant
Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
LA, MI, WA, and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1089-07;
b) Recovered Plasma, Recall # B-1090-07
CODE
a) and b) Unit: 026FW04563
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Alabama Region, Birmingham, AL, by
telephone on February 9, 2006 and by letters dated February 9, 2006. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor who had risk factors for variant
Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL and Switzerland

___________________________________
PRODUCT
Recovered Plasma, Recall # B-1240-07
CODE
Units: 203121278 and 207272514
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by email on January 3,
2006.
Manufacturing Firm: Blood Systems, Inc., Lafayette, LA. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland
___________________________________


http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01004.html

WHAT ABOUT BASE, AND HUMAN TSE AND DONOR BLOOD THERE OF ???


USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN

18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.

Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...

http://www.seac.gov.uk/minutes/95.pdf


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western
Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.

***These results indicate that BASE is transmissible to humans and suggest
that BASE is more virulent than
classical BSE in humans.***


6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html

There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Singeltary, Sr et al. JAMA.2001; 285: 733-734.

http://jama.ama-assn.org/http://www.neurology.org/cgi/eletters/60/2/176#535

BRITISH MEDICAL JOURNAL


BMJ


vCJD in the USA * BSE in U.S.
15 November 1999


http://www.bmj.com/cgi/eletters/319/7220/1312/b#5406


BMJ


U.S. Scientist should be concerned with a CJD epidemic in the U.S., as
well...
2 January 2000


http://www.bmj.com/cgi/eletters/320/7226/8/b#6117


JOURNAL OF NEUROLOGY

MARCH 26, 2003

RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States

Email Terry S. Singeltary:

flounder@wt.net

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to

comment on the CDC's attempts to monitor the occurrence of emerging

forms of CJD. Asante, Collinge et al [1] have reported that BSE

transmission to the 129-methionine genotype can lead to an alternate

phenotype that is indistinguishable from type 2 PrPSc, the commonest

sporadic CJD. However, CJD and all human TSEs are not reportable

nationally. CJD and all human TSEs must be made reportable in every

state and internationally. I hope that the CDC does not continue to

expect us to still believe that the 85%+ of all CJD cases which are

sporadic are all spontaneous, without route/source. We have many TSEs in

the USA in both animal and man. CWD in deer/elk is spreading rapidly and

CWD does transmit to mink, ferret, cattle, and squirrel monkey by

intracerebral inoculation. With the known incubation periods in other

TSEs, oral transmission studies of CWD may take much longer. Every

victim/family of CJD/TSEs should be asked about route and source of this

agent. To prolong this will only spread the agent and needlessly expose

others. In light of the findings of Asante and Collinge et al, there

should be drastic measures to safeguard the medical and surgical arena

from sporadic CJDs and all human TSEs. I only ponder how many sporadic

CJDs in the USA are type 2 PrPSc?

http://www.neurology.org/cgi/eletters/60/2/176#535


doi:10.1016/S1473-3099(03)00715-1
Copyright © 2003 Published by Elsevier Ltd.
Newsdesk

Tracking spongiform encephalopathies in North America

Xavier Bosch

Available online 29 July 2003.


Volume 3, Issue 8, August 2003, Page 463


“My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my
mom to hvCJD (Heidenhain variant CJD)
and have been searching for answers ever since. What I have found is that we
have not been told the truth. CWD
in deer and elk is a small portion of a much bigger problem.”
............................


http://www.thelancet.com/journals/laninf/article/PIIS1473309903007151/fulltext

http://download.thelancet.com/pdfs/journals/1473-3099/PIIS1473309903007151.pdf


4th CASE VCJD VIA BLOOD TRANSFUSION, BSE, BASE, AND SPORADIC CJD
By Terry S Singeltary


Bacliff, Texas USA Jan 24, 07


http://www.bloodindex.com/view_news_zone.php?id=206


http://www.bloodindex.com/view_news_zone.php?id=207


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





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