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From: TSS ()
Subject: TSE ADVISORY COMMITTEE Transcript for the 02/08/05 meeting
Date: March 4, 2005 at 4:34 pm PST

-------- Original Message --------
Subject: TSE ADVISORY COMMITTEE Transcript for the 02/08/05 meeting
Date: Fri, 4 Mar 2005 17:09:46 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE


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

TSE ADVISORY COMMITTEE Transcript for the 02/08/05 meeting

snip...

CHAIRPERSON PRIOLA: Doctor DeArmond?

DOCTOR DeARMOND: Could you explain what the compliance rules
are? Is this still voluntary? How are you getting these? How are you
encouraging people to give you these samples, and what do they actually
send you?

DOCTOR FERGUSON: Okay.

We have a field force throughout the U.S., where we have
APHIS employees in every state, and they are working with the various
facilities and with on-farm producers to obtain these samples.

The whole question of voluntary versus mandatory does get a
bit complicated. At this point in time, these industries are
cooperating with us. We've built up a lot of good will with them over
the past several years. We recognize that we each need the other, so
they've always been very cooperative, and we're building on that...

snip...

We have chosen to try to work cooperatively with the industry, first of
all, and not go in with a big hammer and make people do things. And, we
feel like we're getting very good cooperation.

snip...

DOCTOR DeARMOND: And, the tissues that you get?

DOCTOR FERGUSON: Oh, sorry, sorry, yeah, they are
collecting, essentially, brain stem, sending those in, fresh tissues.
It's either an APHIS person doing the collecting, either a permanent
employee, we've hired a bunch of temporary employees also, in some
instances we have hired a contractor to do that collection for us, but
it is fresh tissue that they are sending in to one of the designated
labs. If you are in a given state you send stuff to a designated lab.

DOCTOR DeARMOND: Do they scoop it out from the foramen magnum?

DOCTOR FERGUSON: Yes, yes, the standard scoon -- spoon scoop
technique, yes. Sorry. It's too early for me.

CHAIRPERSON PRIOLA: Doctor Gambetti?

DOCTOR GAMBETTI: Can you tell us what are the criteria to
declare an animal positive, or a result positive? I see that you run
two tests, the ELISA and the immunohistochemistry. What are the
criteria to run the two tests, or do you run two tests, the two tests
together, or alternatively, and what are the criteria for declare an
animal positive? Is it just positive with one criteria or both, or can
you tell us about this?

DOCTOR FERGUSON: Yes. I can tell you in somewhat general
terms. If you want to get into specifics about literally how we are
doing each of the tests at NVSL I'll call on one of my colleagues on the
committee.

But, in general terms, the first screening test is done at
one of our network laboratories. We have seven state/federal labs that
are working with us, and they are using one of the
commercially-available rapid screening tests. They are running that
according to manufacturer's instructions, and if they get a reactive ?
or, above a certain OD reading, in accordance with the manufacturer's
instructions, that's deemed to be an inconclusive. They then forward
that tissue to NVSL, fresh tissue at this point in time.

NVSL reruns the rapid screening test, concurrently then they
are putting that tissue in formalin to fix for IHC, and then they are
running IHC according to their standard SOP to do an IHC test.

If for some reason they got that tissue and it was not of
adequate quality to do an IHC, then we would use a Western Blot in that
instance. Also, if we got an IHC positive, we'd then also do a Western
Blot to help us characterize what we might have.

DOCTOR GAMBETTI: And, both have to be positive, or only one
can be positive?

DOCTOR FERGUSON: Okay.

Essentially, we are calling things positive based on the
IHC. So, if we got reactions on the rapid screening test, you know, a
strong reaction at the network lab, a strong reaction at NVSL, that
would still be inconclusive. We are not going to call that positive
until we get an IHC positive, and then at that point that would be
deemed positive, based on the IHC results.

DOCTOR GAMBETTI: Let's assume the Western Blot is positive,
and the IHC is negative, then it will be called negative?

DOCTOR FERGUSON: Well, we are using Western Blot only if we
have tissue that is not of sufficient quality to do IHC at this point in
time, or if we already have an IHC positive.

CHAIRPERSON PRIOLA: Doctor Hogan?

DOCTOR HOGAN: Yes

My understanding is you are testing animals that are
submitted to some facility or rendering plant or something like that.
Is there any ? what's the percentage, if you can guess, of dead or
downers never make it to a facility that aren't even submitted for testing?

DOCTOR FERGUSON: I don't know that you'd ever be able to
come up with a percentage. I mean, you know, it's a wild guess to try
to say how many animals die on a farm in a given year. We've done
different surveys to try to come up with, or used information from
general animal health surveys that we've done to try to come up with
estimates of that. Whether that's accurate or not, we have no clue....

snip...

==================================

> we have no clue....

amen;

Subject: I have dead cow photos
Date: Fri, 4 Mar 2005 06:53:43 -0800 (PST)
From:
To: flounder@wt.net

Hi Terry,
Don't know what this may lead to, but I've got photos
of dead cows coming to me later today. I heard of a
farm west of Phoenix in Buckeye where dead cows have
been seen lying in plain sight by a road. There have
been at least six in the last month or so. I just got
a call there are new dead cows this morning, and my
guy's got photos. I don't know the name of the farm,
or exact location. But I know I've got to do
something with these photos. What are possible
reasons for cows to just be laying around by the side
of the road? What else can they die from? I think
these will make nice companion photos to all the
letters I plan to write...


=================

That's the weird thing, "my guy" is my dad. He works
at the prison in Buckeye. Once he said those dead
cows were out there for at least six days! He's seen
the dead cows out there three times now. Everyone who
drives by there on the way to the prison talks about
it. He'll get me the photos tonight. I'll send them
to you. I'll send them everywhere. What else could
kill cows like this beside BSE? I'm trying to figure
out how the beef lobby will try to explain this away. I keep telling my
dad to find out which farm it is. It might be a small farm.
--- "Terry S. Singeltary Sr." wrote:

=======================


Hi Terry,
I've got more info on my favorite cow for you.
It's one dead cow today. It's not mutilated. It did
not look as though it had been attacked by other
animals. (I managed to get a hold of my dad inside
the prison just now). He said it's a black diary cow.
He also said it is frothing at the nostrils. Do you
kow what it means when a dead cow is frothing like
that? What that froth would be indicating as the
cause of the cow's death?

snip...

I'll keep digging. My dad took his photos before 7am
this morning with his crappy camera, so they may not
be good. He's going to see if the cow is still there
this afternoon when he leaves. The farm isn't one of
the reputable ones. He said it's a sh!tty one that
has no name, that it looks like a backyard farm. He
says he's seen about 6 cows in the last month. I
don't know what's going on out there, but I'm going to
call the media.
xxxxxxxxxx

END...TSS
====================

And, there's where we could use some more data, not just the data on the
model, but the data on what is the effectiveness of the routine
sterilization procedures used in the United States on lowering the
infectivity of these instruments. And, my understanding is that, Dave
Asher, if he's here, is that we talked about, at some point, trying to
look at that issue and get some data on that, which would then affect,
you know, these kinds of concerns that are being raised on the negative
side of sending out 6,000 letters and alerting people, because just the
very fact that you are sending out 6,000 letters may convey a higher
risk to the recipients of those letters than actually we can document or
feel exists. And, that would be a concern that I would have.

But, now that the U.K. has done what they've done, I don't
see how we cannot inform those 50 people, our Factor XI people, about at
least what has happened in the U.K., so they are not caught totally off
guard that this has happened, and then give them some additional
information, more of the type that we've heard here around the table,
that at least in the United States at this point stay tuned, we are not
as alarmed, and we don't think it's, perhaps, as necessary to be
informing all your physicians and so on about the situation, but be
informed. And, if you want to, fine, but this is the danger, you can
get the kind of discrimination you were talking about, or the alarm, but
put it into a context that shows that we are not all that concerned.

snip...

DOCTOR SALMAN: And, that's taking me to the second question about the
BSE, you are taking relative risk, which I think is a good indicator for
France versus U.K., and versus Europe, but these are whatever is the
output from the surveillance data. There are other countries,
specifically, in Europe, in which they have much, much higher cases, but
they have poor surveillance, and you are actually penalizing countries
in which they showed result, where the other countries they don't show
results, such as East Europe. I can tell you, if I'm traveling in East
Europe I will be at much higher risk there to be exposed to the BSE
agent as compared to France or Switzerland.

DOCTOR ANDERSON: Right. I mean, I would agree with you.
Right now we haven't gotten to the refinements in the model. I mean,
right now we are making large blanket assumptions, but, eventually we'll
refine those estimates.

I think a good source to potentially do that could be the
geographic-based risk assessments, but, you know, the information on
those countries that aren't doing surveillance are really poor, but you
can also consider other factors in risk, as far as do they have food
chain controls in place, do they have surveillance, et cetera, and then
link it to what's been determined by the GBR, the geographic-based risk
assessment.

DOCTOR SALMAN: I really believe, like if you take the GBR
classification that will be much better, and associate that with your
calculation of relative risk.

=============================

NOT IF GWs BSE MRR IMPLEMENTATION OF TRADING TSEs
GLOBALLY GOES INTO EFFECT...TSS

==============================

DOCTOR DeARMOND: Not specific. All I can say is, there are multiple new
ways of enhancing the sensitivity of the detection tests that our lab
have, but Aguzzi's lab and other labs are using, and the most remarkable
part about it is that they show positivity even when the pathology is
negative, that is, there's no vacuolation and when immunohistochemistry
is negative.

And, what I was trying to say this morning is that today,
because of these newer developments, and as I say, it's not just our
group, it's multiple groups have done this, we are in a new era of
detecting abnormal prion protein.

snip...

kay. So, the diagnosis of vCJD patients in France, the five definite
cases had typical neuropathological data, just to remind you that to
make the diagnosis of definite you need the neuropathology, and florid
plaques, and the Western Blot analysis showed a type 2B according to a
specification of Parchi and Gambetti. As you know, different ? I mean,
there are basically two groups that have a slightly different version of
how to classify PrP, and one is John Collinge's group, and the other is
Parchi and Gambetti, so this was classified as 2B, type 2B, according to
the Parchi and Gambetti specification, and there are four probable
cases, and to make it probable cases you need the clinical consistent
with a vCJD case, plus the MRI that showed the typical posterior
thalamic sign, and positive tonsillar biopsy shown by positivity for PrP
by immunohistochemistry or Western Blot analysis.

Genetic analysis was done in all these cases, and in nine
out of nine cases were met/met homozygous for the 129 polymorphic site
on PrP, and there were no mutations detected.

Actually, this slide was not provided by Doctor Brandel, but
we decided to include just a few slides to exemplify what we mean, and
this is the MRI of a patient with vCJD, sorry, with sporadic CJD, that
show high signal on the basal ganglia, and this is the classical or
typical MRI for a patient with vCJD, that shows this high signal,
pulvinar signal, or in the posterior thalamus.

And, what you see here is, basically, a case of sporadic CJD
with a typical vacuolation, and usually patients with sporadic CJD show
PrPres, or PK-resistant PrP that could be of approximately 21 or
approximately 19 kV of the non-glycosylated isoform. Patients with vCJD
that show in the pathology this typical florid plaque, usually show a
pattern that is slightly different that is notorious for the presence ?
for the over-representation of the de-glycosylated PrP isoform as shown
here.

Actually, this slide was provided by Doctor James Ironside,
and this slide was ? these two slides were generated at the Indiana
Alzheimer's Disease Center, working for the WHO.

The other thing is that patients with vCJD, with clinical
vCJD, that are positive, usually there is immunhistochemistry positive
for PrP in tonsils.

Now, talking about, once again, specifically, about these
nine patients that were recognized in France, these patients had no
specific medical risk factor, so therefore there was no history of human
growth hormone treatment, or dura mater graft, or neurosurgery, were not
blood recipients, or treatment with albumin, immune globulins or
clotting factors. Well, no other risk factors, for example, there was
no family history of dementia or CJD, or contact with CJD patients, or
contact ? frequent contact with animals or animal products that ? are
considered to at risk, there were no professional risk factor, no
special diet, and traveling the U.K., except for short stays for three
patients.

And now, what about, once again, we go out of the nine
cases, two cases with vCJD happened to be blood donors. The first
patient provided 14 donations between 1993 and 2003, that result in 13
transfusion of red cells and one transfusion of platelets, and the
recipients, five are still alive, and nine are dead.

The second patient provided two donations in 1984, and the
two ? resulting two transfusions of red cells, and two transfusions of
plasma, and seven donations between 1996 and 2002, that resulted in five
transfusions of red cells and three transfusions of platelets.

Okay, what about risk for vCJD in France? And, the sources
of exposure to BSE of the French population could be bovine carcases and
other beef products imported from the United Kingdom, endogenous BSE in
French cattle, or travel to the U.K. It has also been recognized that
the distribution of the incubation period and age-specific
susceptibility happens to be similar or the same to that seen in the
U.K. population.

And, continuing with the risk factors, the predicted number
of vCJD cases in France by birth cohort and gender, according to this
publication, the total number of vCJD cases would be up to 33 cases, and
67 percent in the post-1969 birth cohort, and the number of cases would
be equal to the number of infection, meaning that very few cases would
be censored by death, meaning that if they are patients they will tend
to die in that birth cohort due to vCJD, and not to other causes. And,
no expected cases attributed to travel in the U.K., which is something
that is not very clear to me.

And now, I'll pass on the podium to Steve Anderson, who is
going to present the risk assessment, the French risk assessment.

DOCTOR ANDERSON: All right, I'm going to talk about the risk
assessment that was done in France.

snip...

CHAIRPERSON PRIOLA: Doctor Rohwer, do you have a comment?

DOCTOR ROHWER: Yeah, thanks.

I would like to have this opportunity to stir this up a
little bit more.

I think the science behind deferring transfusion recipients
is just about the smartest thing you can do scientifically, and let me
give you the arguments.

Let me remind you that we have iatrogenic transmissions of
this disease, at least 250 of them are known from human growth hormone
and dura mater, so that's a fact, it does happen. And, the largest
exposure that we have to human-derived tissues is probably through the
blood supply and the use of blood.

This use of human-derived tissues is as close as we come to
an analogous situation to what happened to BSE in cows. There we had a
disease that was being recycled in that population for probably a decade
at least before the first case was recognized. It's now estimated that
there were probably somewhere like 100,000 animals that were already
infected by 1985, that then showed up in that peak that we saw six,
seven years later.

And so, the risk from these diseases is really the risk ?
the public health risk from them, and I'm talking about a population
risk more than an individual risk, from the silent propagation of an
infection with a very long incubation time, that doesn't reveal itself
in symptoms until the last moments of the disease.

We also have heard today, or just since ? during this last
year, that the prevalence of this disease may be much higher than we had
ever expected from the tonsil/appendix survey, and something that hasn't
come up today, but that has concerned me considerably about that study,
is we have no idea what the ascertainment rate is for those tissues. It
can't possibly be 100 percent, and we know that it's imperfect because
the second transfusion case had neither an appendix or a tonsil signal,
they found it in the spleen.

So, we are not getting them all that way, and we have no
idea whether we are getting 1 percent, 10 percent, or whatever.

We also have all this new data about infectivity in muscles,
which is extremely alarming to me personally, because it suggests that
we may have completely underestimated the exposure. It may have been
much greater than we actually thought. It didn't come, necessarily,
just from SBOs and MRM and things like that.

So, and finally, we have these two transfusion transmissions
that have already occurred, and this is giving us a warning that we may
be on the same path to iatrogenic transmission that we saw with, you
know, in 1985 there was one case of human growth hormone transmission as
well. Now, we've got 150 or something like that on the books.

Finally, let's consider what has worked in terms of the
management of these diseases. We have a proven management method in the
feed ban that was implemented in Great Britain. It took an epidemic
that was expanding exponentially and stopped it in its tracks over about
a four or five-year period. We are down, we heard down, down to 80 or
something cases a year in Great Britain, from a high of 1,000 cases a
week in 1993, I think, 1992, and that's amazingly effective.

The only analogous tool that we have right now for doing the
same thing with these transfusion ? with a potential for transfusion
transmitted infections, is to defer transfusion recipients. It doesn't
prevent a person from getting the disease from having been in the United
Kingdom, or Europe, or something like that, but it does prevent the
propagation of the disease, if, in fact, that's an issue, and we just
don't know.

So, it is precautionary in that sense, but in terms of the
science it seems to me, and always has seemed to me, that this is
absolutely the most effective thing you could do to prevent a ? to stop
an incipient epidemic that may be incubating in our midst from going
anywhere.

CHAIRPERSON PRIOLA: Thank you, Doctor Rohwer.

snip...

EXECUTIVE SECRETARY FREAS: We don't need a motion.

CHAIRPERSON PRIOLA: Yeah, I guess my comment would be that
if you vote and then you have to reverse, then you are not sure enough
to vote yet about how you want to do this, you know, whether you want to
vote for deferral or not for deferral in France and/or other European
countries.

So, should we take a vote? Let's go around and vote.

EXECUTIVE SECRETARY FREAS: This will be an official vote,
and there are 16 voting members at the table, and, of course, at the end
we'll ask the industry for their recommendation.

I'm going to start with you, Doctor Schonberger.

DOCTOR SCHONBERGER: In agree with the argument that Doctor
DiMichele put forward, and I vote for the deferment of people from
France for donations of blood.

EXECUTIVE SECRETARY FREAS: Next, Doctor Hogan?

DOCTOR HOGAN: I'm going to vote for it, but I'm concerned
about how much everyone said, how much really we are significantly
decreasing the risk. However, I'm compelled by Doctor Rohwer's
argument, and that's that we have to be extremely cautious.

EXECUTIVE SECRETARY FREAS: Doctor Bracey?

DOCTOR BRACEY: I'll vote against the exclusion.

EXECUTIVE SECRETARY FREAS: Doctor Jenny?

DOCTOR JENNY: I'll vote for it, but I still have concerns
about that we don't have enough information. I would have been ? the
person from France that was to be here, I think, could have helped this
discussion a lot.

EXECUTIVE SECRETARY FREAS: Doctor Gaylor?

DOCTOR GAYLOR: May I abstain?

EXECUTIVE SECRETARY FREAS: Yes, you may abstain, yes.

Doctor Nemo?

DOCTOR NEMO: In vote for.

EXECUTIVE SECRETARY FREAS: Doctor Johnson?

DOCTOR JOHNSON: Aye.

EXECUTIVE SECRETARY FREAS: Doctor Allen?

DOCTOR ALLEN: Yes, but not strongly.

EXECUTIVE SECRETARY FREAS: Doctor Priola?

CHAIRPERSON PRIOLA: In vote no.

EXECUTIVE SECRETARY FREAS: Doctor Telling?

DOCTOR TELLING: I have no concern for voting for the deferment.

EXECUTIVE SECRETARY FREAS: Mr. Bias?

MR. BIAS: I vote for.

AUDIENCE: What was your vote?

DOCTOR TELLING: I voted for the deferment with no concerns.

MR. BIAS: I vote for the deferment.

EXECUTIVE SECRETARY FREAS: Doctor Creekmore?

DOCTOR CREEKMORE: In vote for.

EXECUTIVE SECRETARY FREAS: Doctor DeArmond?

DOCTOR DeARMOND: We're talking about a small number of
people that would be affected. France defers them, and I like Val Bias'
argument that we have to consider the patient receiving transfusions,
and they are the second largest number, they have the second largest
number of vCJD cases, so I vote for.

EXECUTIVE SECRETARY FREAS: Doctor Belay?

DOCTOR BELAY: I vote yes for the deferment.

EXECUTIVE SECRETARY FREAS: Doctor Salman?

DOCTOR SALMAN: I vote against it.

EXECUTIVE SECRETARY FREAS: Doctor DiMichele?

DOCTOR DiMICHELE: In vote for it, and continue to urge,
though, that we continue to evaluate every decision.

EXECUTIVE SECRETARY FREAS: May we get the industry opinion?

DOCTOR PETTEWAY: In think the decision in October is still
the correct one, I vote no.

EXECUTIVE SECRETARY FREAS: Okay, that was an opinion, not a
vote, for point of clarification.

So, we have two no votes, one abstention and the rest were
for the deferral.

Oops, my math is not that good, it's three no votes, one
abstention, and that should leave 12 yes votes.

CHAIRPERSON PRIOLA: Let's move on to the second part of the
question, should we recommend deferral of blood donors transfused since
1980 in other countries of Europe?

So, let's go around and vote on the second part of the
question then.

EXECUTIVE SECRETARY FREAS: Going around the table the same
way, Doctor Schonberger?

DOCTOR SCHONBERGER: No.

EXECUTIVE SECRETARY FREAS: Doctor Hogan?

DOCTOR HOGAN: No deferral.

EXECUTIVE SECRETARY FREAS: Doctor Bracey?

DOCTOR BRACEY: No.

EXECUTIVE SECRETARY FREAS: Doctor Jenny?

DOCTOR JENNY: No.

EXECUTIVE SECRETARY FREAS: Doctor Gaylor?

DOCTOR GAYLOR: No.

EXECUTIVE SECRETARY FREAS: Doctor Nemo?

DOCTOR NEMO: No.

EXECUTIVE SECRETARY FREAS: Doctor Johnson?

DOCTOR JOHNSON: No.

EXECUTIVE SECRETARY FREAS: Doctor Allen?

DOCTOR ALLEN: No.

EXECUTIVE SECRETARY FREAS: Doctor Priola?

CHAIRPERSON PRIOLA: No.

EXECUTIVE SECRETARY FREAS: Doctor Telling?

DOCTOR TELLING: I vote no, but with the caveat that I'm
concerned about the increased rise in cases in Switzerland, which has
the second highest incidence of BSE in Europe, and the fact that new
variant CJD may manifest in more than one molecular form.

EXECUTIVE SECRETARY FREAS: Mr. Bias?

MR. BIAS: I'm going to abstain.

EXECUTIVE SECRETARY FREAS: Doctor Creekmore?

DOCTOR CREEKMORE: No, with the comment, though, that I think
we should remain vigilant, we should be continuing to investigate that
situation, and consider using this risk analysis tool for both
continuing to look at these other countries and also, as has been
mentioned before, as we get down the road making decisions about
changing policies we've already made.

EXECUTIVE SECRETARY FREAS: Doctor DeArmond?

DOCTOR DeARMOND: No, but with the same caveats that Glenn
and Lynne had.

EXECUTIVE SECRETARY FREAS: Doctor Belay?

DOCTOR BELAY: No.

EXECUTIVE SECRETARY FREAS: Doctor Salman?

DOCTOR SALMAN: No.

EXECUTIVE SECRETARY FREAS: Doctor DiMichele?

DOCTOR DiMICHELE: No, with ? and I concur with careful
reevaluation.

EXECUTIVE SECRETARY FREAS: And, industry's recommendation?

DOCTOR PETTEWAY: No.

EXECUTIVE SECRETARY FREAS: Okay.

We have one person abstained, and then it was unanimous no
votes with caveats.

CHAIRPERSON PRIOLA: Okay.

So, we can move on to the second question, which is, based
upon the available scientific information, does the Committee recommend
deferral of source plasma donors transfused since 1980 in France or in
other countries of Europe, and I guess this is with the caveat that
there is probably some degree of TSE clearance in sourced plasma products.

Discussion from the Committee, comments?

Doctor DeArmond?

DOCTOR DeARMOND: As I recall, or I can't remember the
details, of where plasma byproducts are obtained. Are they mostly from
industry in Europe, or do we have a large industry here? As I recall,
it's mostly European, but I don't remember.

CHAIRPERSON PRIOLA: Doctor Petteway, do you want to comment?

DOCTOR PETTEWAY: By byproducts, you mean where is the plasma
obtained for U.S. products? It's U.S. plasma.

DOCTOR DeARMOND: And, where is it processed into the
sub-fractions?

DOCTOR PETTEWAY: It depends on the company, yes.

CHAIRPERSON PRIOLA: But, the source of it all is U.S. blood.

Doctor Allen?

DOCTOR ALLEN: I'm concerned by the degree to which it's
believed that the prion infectivity is in plasma, I think the figure
that was mentioned was about 50 percent.

On the other hand, the processing seems to clear, and if one
looks at the epidemiological data that has been cited several times,
particularly, within England and looking at the absence of any apparent
cases in people who have received regular infusions of clotting factor
and other products, you know, I'm convinced that it seems as though the
risk is within acceptable limits at the present time, and I'm assuming
the FDA will, of course, continue to monitor the situation carefully.

CHAIRPERSON PRIOLA: Doctor DiMichele?

DOCTOR DiMICHELE: In would just like to ask a question for
clarification.

I think I understand that all of the deferrals so far for
transfusion and for other reasons for the blood product industry also
applies to source plasma, except for the clarification of greater than
or equal to five years residence, travel in Europe, applying only to
France for source plasma, is that correct?

CHAIRPERSON PRIOLA: In believe so. Would someone from ?
Doctor Williams will answer that.

DOCTOR WILLIAMS: Yes, that is correct.

DOCTOR DiMICHELE: That is correct?

DOCTOR WILLIAMS: That is correct.

DOCTOR DiMICHELE: Okay.

So, there's already a special precaution for France in
source plasma that doesn't apply to, from what I'm understanding, I
mean, there's already a special exclusion, or in the absence of
exclusion of Europe for blood donors there is an exclusion ? no, wait a
second ? there is ? what I want to say is, is that France is out for
source plasma anyway, with respect to five years of residence and
travel, I think, from what I'm understanding here then.

So, there has already been sort of a caution relating to
France already.

Am I reading this correctly?

AUDIENCE: Yes.

DOCTOR DiMICHELE: Yes, okay.

So, I would have to say that, you know, this is a tough
question, because I think that the epidemiology of it isn't quite
clear. In one way we are being told that certainly source plasma donors
are the younger donors, they are the ones we have to worry about with
new variant CJD by and large, rather than the older donors. We know
that 58 percent of the CJD is in plasma, so we can't say that plasma is
not a source of concern.

By the same token, most of it is going into plasma
derivatives, you know, and, you know, we are a little less concerned
about plasma derivatives.

On the other hand, I would have to say that there's already
a caution for France, so I would have to say that this would have to be
considered seriously.

CHAIRPERSON PRIOLA: Other comments from Committee members?

If there are no other comments or questions, should we take
a vote on this second issue then? Okay, let's do that.

EXECUTIVE SECRETARY FREAS: Same order?

CHAIRPERSON PRIOLA: Let's reverse the order, so that Steve
doesn't have to wait so long.

DOCTOR PETTEWAY: Appreciate that, I vote no for both A and B.

EXECUTIVE SECRETARY FREAS: Okay.

Doctor DiMichele?

DOCTOR DiMICHELE: In don't think I quite answered my own
question yet. Oh, gee, I don't know that I'm ready for this vote, if I
have to ?

EXECUTIVE SECRETARY FREAS: You may pass and we'll come back
and get you.

DOCTOR DiMICHELE: Okay, well, yeah, I think I have to
abstain, because I'm just not sure.

EXECUTIVE SECRETARY FREAS: Doctor Salman?

DOCTOR SALMAN: No.

EXECUTIVE SECRETARY FREAS: Doctor Belay?

DOCTOR BELAY: I vote yes.

EXECUTIVE SECRETARY FREAS: Doctor DeArmond?

DOCTOR DeARMOND: Well, based on the epidemiology I'd have to
say no.

EXECUTIVE SECRETARY FREAS: Doctor Creekmore?

DOCTOR CREEKMORE: I'd like to pass.

EXECUTIVE SECRETARY FREAS: That's an abstain.

DOCTOR CREEKMORE: Or abstain.

EXECUTIVE SECRETARY FREAS: Okay. If it was a pass we'd come
back and get you.

Mr. Bias?

MR. BIAS: Can you state the question one more time?

CHAIRPERSON PRIOLA: It's, based upon the available
scientific information does the Committee recommend deferral of source
plasma donors transfused since 1980 in France?

MR. BIAS: Yes.

EXECUTIVE SECRETARY FREAS: Doctor Telling?

DOCTOR TELLING: Yes.

EXECUTIVE SECRETARY FREAS: I'm sorry, Mr. Bias, your answer was?

MR. BIAS: Yes.

EXECUTIVE SECRETARY FREAS: Okay.

And, Doctor Telling, yours was yes, too.

Doctor Priola?

CHAIRPERSON PRIOLA: No.

EXECUTIVE SECRETARY FREAS: Doctor Allen?

DOCTOR ALLEN: No.

EXECUTIVE SECRETARY FREAS: Doctor Johnson?

DOCTOR JOHNSON: Yes.

EXECUTIVE SECRETARY FREAS: Doctor Nemo?

DOCTOR NEMO: No.

EXECUTIVE SECRETARY FREAS: Doctor Gaylor?

DOCTOR GAYLOR: In abstain.

EXECUTIVE SECRETARY FREAS: Doctor Jenny?

DOCTOR JENNY: Abstain.

EXECUTIVE SECRETARY FREAS: Doctor Bracey?

DOCTOR BRACEY: No.

EXECUTIVE SECRETARY FREAS: Doctor Hogan?

DOCTOR HOGAN: No.

EXECUTIVE SECRETARY FREAS: Doctor Schonberger?

DOCTOR SCHONBERGER: Yes.

EXECUTIVE SECRETARY FREAS: My count, five yes votes, four
abstain, and the rest would be no votes.

The yes votes were Doctor Schonberger, Doctor Johnson,
Doctor Telling, Mr. Bias and Doctor Belay.

There are 16 people voting, so it's 5-7-4.

CHAIRPERSON PRIOLA: Yes, so seven no.

EXECUTIVE SECRETARY FREAS: Seven no.

CHAIRPERSON PRIOLA: Five yes, seven no, four abstain.

As to the second part of the question, deferral for source
plasma donors transfused since 1980 in other countries of Europe.

DOCTOR PETTEWAY: No.

Oh, Doctor Petteway already voted.

EXECUTIVE SECRETARY FREAS: Okay.

DOCTOR DiMICHELE: No.

EXECUTIVE SECRETARY FREAS: Doctor Salman?

DOCTOR SALMAN: No.

EXECUTIVE SECRETARY FREAS: Mr. Belay ? Doctor Belay?

DOCTOR BELAY: No.

EXECUTIVE SECRETARY FREAS: Doctor DeArmond?

DOCTOR DeARMOND: Using Doctor Schonberger's epidemiology
argument, I still say no.

EXECUTIVE SECRETARY FREAS: Doctor Creekmore?

DOCTOR CREEKMORE: No.

EXECUTIVE SECRETARY FREAS: Mr. Bias?

MR. BIAS: No.

EXECUTIVE SECRETARY FREAS: Doctor Telling?

DOCTOR TELLING: No.

EXECUTIVE SECRETARY FREAS: Doctor Priola?

CHAIRPERSON PRIOLA: No.

EXECUTIVE SECRETARY FREAS: Doctor Allen?

DOCTOR ALLEN: No.

EXECUTIVE SECRETARY FREAS: Doctor Johnson?

DOCTOR JOHNSON: No.

EXECUTIVE SECRETARY FREAS: Doctor Nemo?

DOCTOR NEMO: No.

EXECUTIVE SECRETARY FREAS: Doctor Gaylor?

DOCTOR GAYLOR: No.

EXECUTIVE SECRETARY FREAS: Doctor Jenny?

DOCTOR JENNY: No.

EXECUTIVE SECRETARY FREAS: Doctor Bracey?

DOCTOR BRACEY: No.

EXECUTIVE SECRETARY FREAS: Doctor Hogan?

DOCTOR HOGAN: No.

EXECUTIVE SECRETARY FREAS: Doctor Schonberger?

DOCTOR SCHONBERGER: No.

EXECUTIVE SECRETARY FREAS: Unanimous no.

CHAIRPERSON PRIOLA: Okay.

With that, that concludes the meeting. I appreciate
everybody's efforts. These were not easy questions.

Thank you all for being here, and I'd like to thank all our
speakers, especially the speakers from the U.K. Their input was greatly
appreciated.

(Whereupon, the above-entitled matter was concluded at 5:49
p.m.)


http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4088t1.htm

just ran across this ;
http://www.bseinquiry.gov.uk/files/yb/1989/10/00005001.pdf

TSS

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