From: TSS
Subject: TSEAC JUNE 2, 1999 Welcome to the FDA traveling road show
Date: October 15, 2007 at 3:18 pm PST
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE MEETING Thursday, June 2, 1999
CHAIRMAN BROWN: My name is Dr. Paul Brown. Welcome to the FDA traveling road show. We are asked yet once more by the FDA to consider a question of theoretical risk in the absence of sufficient knowledge on which to base any firm conclusion.
The issue before us today is that of excluding categories of American blood donors who have either visited or resided for longer periods of time in Great Britain. The issue is sufficiently delicate, as you see that we have been moved outside the Beltway. (Laughter.)
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"Dr. Alan Williams is employed by the American Red Cross, Holland Labs, and is Scientific Adviser for the Florida Blood Services and Canadian Blood Services. In addition, he has financial interests in firms that could be affected by the general discussions.
"Dr. Richard Race has financial interests in firms that could be affected by the general discussions and is a public health science researcher. "In the event that the discussions involve specific products or specific firms for which FDA participants have a financial interest, the participants are aware of the need to exclude themselves from such involvement. And their exclusion will be noted for the public record. A copy of the waivers is available by written request under the Freedom of Information Act. "With respect to all other meeting participants, we ask in the interest of fairness that they address any current or previous financial involvement with any firm whose product they may wish to comment upon."
So ends the reading of the conflict of interest statement. Dr. Brown, I turn the meeting over to you.
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DR. JACOBS: Thank you, Dr. Brown, and welcome to members of the Committee. Today we are again bringing the question of deferral from blood donation of persons with possible foodborne exposure to bovine spongiform encephalopathy, BSE, as a precautionary measure to reduce the risk of blood transmission of new variant Creutzfeldt Jakob disease. And we are asking the Committee at this time, as we did in December, to consider this in the light of possible shortages.
Next, the current status. So far there have been no cases of either BSE or new variant CJD reported in the U.S. We're aware and we discussed in December the precautionary measures which have been taken in the U.K. First, they are not using U.K.?sourced plasma; and, secondly, they are implementing universal leukoreduction.
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Next. In December, we asked the Committee to vote on two votes. I'm going to go through what those votes were. The first one is: Should FDA recommend new deferral criteria for blood donors to attempt to reduce a theoretical risk for transmitting new variant Creutzfeldt Jakob disease be excluding donors potentially exposed to the agent of bovine spongiform encephalopathy? The Committee voted nine yes and six no.
Next overhead. Should FDA recommend excluding donors who have resided in the United Kingdom or other BSE countries? The Committee voted 15 yes, unanimous, to remove "or other BSE countries."
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I want to just put on the record and mention the other votes which were taken in December. Should FDA recommend withdrawal for blood components based on these donor deferral criteria? The vote was seven yes, five no. And should FDA recommend withdrawal for plasma derivatives based on these donor deferral criteria? Voted eleven no, one yes.
Next one, please. In addition to these questions on deferral of donors, in December we also asked the Committee to consider the actions that FDA would take if there were a report of a possible case of new variant CJD. We're going to refer those to CDC, but considering our precautionary withdrawal policy for new variant CJD, we asked: Should FDA recommend precautionary quarantine or withdrawal for plasma derivatives to which a possible new variant CJD donor contributed pending confirmation of the clinical diagnosis?
The Committee voted eight yes, one no, one abstained, but they asked us to revisit this question of our operational definition of a possible new variant CJD case. And in the second part of today's deliberations, after the vote on deferral, we will go back to that question.
The Committee also voted that a tonsil biopsy negative for protease?resistant prion would not be sufficient to make product withdrawals unnecessary.
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We now have a presentation by Dr. Philip Comer, who will give us the Det Norsk Veritas risk assessment. Dr. Comer?
MR. COMER: Thank you very much, Chairman, and thank you for the opportunity to come and talk about the study that we were asked to do by the Department of Health in the United Kingdom as a result of a recommendation from the United Kingdom's Spongiform Encephalopathy Advisory Committee.
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I am just going to go very quickly over the evidence for infectivity in blood. I think probably that will have already been looked at significantly by this Committee, but it was very much part of the background for what we were doing in the study that we did.
If we look at blood transfusions, we know that all attempts to transmit infectivity of blood, blood transfusion, so across a species barrier, have failed and that within animal models, as far as I am aware, the one case which has been reported by Bob Rohwer is still the only case that I have heard of in which there has been a positive transmission by the i/v route within an animal model.
Epidemiology studies have shown that's from sporadic CJD. There is no evidence that there has been any transmission through the blood route. And when we look at blood from human CJD cases, primarily sporadic CJD cases and certainly no variant CJD cases, and look at that, their infectivity through the i/c route into animal models, there have been a few experiments which have shown positive infectivity into rodents but negative results from a significant number of studies into primates and other species. And there have been some questions asked about ?? these cases, these experiments all involve very small numbers of animals and some sort of significant questions asked about those and, in particular, the fact that it is a bit odd that we have got no positive infections in the primates, which you might have expected would be more susceptible than the rodents. Then when we look at actually within animal models themselves, there have been quite a number of cases, experiments where positive infections have been reported from animals infected with some form of TSE and have been through the i/c route infected in the same species, so again with no species barrier.
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CHAIRMAN BROWN: A couple of points just to bring your experimental data up to speed. Unpublished further experiments on the mouse model have produced good news and bad news.
The bad news is that we have a disappointingly large number of transmissions following intravenous inoculation of either plasma or Buffy coat. We also have a transmission using whole blood as a transfusion into these mice. So that's not good news.
The other thing that is not too good is that we have now got in this particular model a ratio of five to one, as opposed to ten to one, which was also disappointing.
The only piece of good news in that in terms of experimental data is that we found that, again, in this model, the level of infectivity during the entire incubation period is almost negligible compared to the level of infectivity during the clinical phase of illness. And that is very good news indeed. So these are data that are not yet published but ??
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CHAIRMAN BROWN: Right, right. And, as I say, if it turns out to be the case with the human disease, ?? and I'm guessing it probably will be ?? with you, I think the likelihood of disease, natural disease, whether it be scrapie in sheep, BSE in cattle, or CJD in humans, is going to be quite a lot less virulent than the experimentally induced disease.
Even under the experimental conditions I mentioned, however, infectivity in all components of the blood during the incubation period is so low that it virtually poses I think no risk, at least in terms of plasma derivatives.
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Dr. Chan
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So the issue that we dealt with in early May was "do variants of CJD pose a risk to blood safety?" And we sort of divided it into the classic variant and others. The others came out of, I'm sure you're all aware, of the scare that we all had over the Utah donor was this a possible chronic wasting disease, etc.
So we just put that issue on the table and let's see where it went. Our process -- we circulated a notice widely to all associations, consumer groups. We've sort of got a mailing list that's growing.
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And thirdly, the question was: What is the biological plausibility, from our experimental data, that there will be other variants of CJD? I won't go into the attempts of answering these.
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The rest of the recommendations I'll go through very briefly. Health Canada had not standardized its -- not finalized its policy on classic CJD, and we advised that they do so.
The blood services should provide clear statements about the reasons for believing that there are no longer concerns regarding the classic sporadic CJD; that Health Canada and the blood services provide communication regarding all aspects of product quarantine.
And that was because there's considerable confusion over the Utah donor case. Health Canada identify and provide information that all products that contain trace amounts of blood products -- this was interesting. Many of the physicians did not even know which products that were being distributed contained blood products. We thought this was an important issue. All products can be tracked in the event of an infected donor. And that they take steps to discourage manufacturers from using blood products in the production or formulation of other products.
That mechanisms are developed to ensure that -- oh, this is the surveillance for CJD. That criteria have to be established to determine between classic and variant forms, which I know is the topic that you are going to be discussing this afternoon.
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CHAIRMAN BROWN: This afternoon's program will begin with several presentations as a part of the open public hearing.
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CAPTAIN RUTHERFORD: Good afternoon.
The Department of Defense would like to thank you for allowing us to offer public comment.
I am Captain Bruce D. Rutherford, Medical Service Corps, United States Navy, the present Director of the Armed Services Blood Program. On 5 February, 1999, Dr. Sue Bailey, the Assistant Secretary of Defense for Health Affairs, forwarded a letter to Vice Admiral David Satcher, Public Health Service, the Surgeon General of the United States.
In that letter, Dr. Bailey expressed her opposition and the opposition of the Surgeon Generals of the Army, Navy and Air Force on deferring individuals as blood donors based on "perception" of a "possible" risk of transfusion transmission of the agent for "new variant" CJD. There has not been a single case, repeat, single case of transfusion transmitted new variant CJD or classical CJD reported in the world in more than 55 years since transfusion of blood products became widely accepted as a treatment regime.
In November of 1991, the Department of Defense issued an advisory recommending that individuals participating in Operation Desert Storm be deferred as blood donors after a number of Desert Storm troops were identified with cutaneous and visceral Leishmania tropica. Knowing that Leishmania donavani was transfusion transmissible, and now knowing the extent of infection rate of the "at risk" population, the DOD decided to defer those individuals as blood donors who participated in country in the Persian Gulf.
It was not until December of 1993, or two years later, that the DOD stopped asking leishmaniasis related questions of its blood donors. The cessation was due to a concentrated effort by the military health system in identifying an extremely small number of infected individuals and the follow-on screening questions' ability in identifying an extremely small number of donors with symptoms where leishmaniasis could have been a possibility.
However, a study in the survivability and infectivity of viscerotropic Leishmania tropica in human blood donors from ODS participants was later shown to support our concern and was published in the American Journal of Tropical Medicine and Hygiene in 1993.
Transfusion transmission by Leishmania species was a known, not theoretical. We know the calculatable risk of being injured in a car accident, yet millions of individuals a day drive their cars with hundreds of thousands being injured per year and tends of thousands killed each year. It is the same with airplanes, lightening and other activities.
In theory, anything is possible. I remember back a few years ago when the Institutes of Medicine came out with this HIV report. Yes, hindsight was better, but that has always been true.
I think in this case we have hindsight, 55 years of hindsight. We do not need to institute a UK deferral policy which will only lead to further crippling of our nation's blood supply and more product shortages.
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CHAIRMAN BROWN: Thank you, Captain Rutherford. Are there any questions that any of the panel would wish to address to Captain Rutherford?
The next presentation will be by Kay R. Gregory of the American Association of Blood Banks.
MS. GREGORY: Good afternoon.
snip...page 148
In conclusion, AABB notes that there is no evidence that nvCJD is transmitted by blood transfusion. There are no cases of nvCJD in the United States. It is unknown whether travel to Great Britain correlates with exposure to or infection with the agent of BSE.
And there is no evidence that any proposed criteria will decrease the theoretical risk of acquiring nvCJD from transfusion. In contrast, there is good evidence that even a one to two percent loss of donors due to new deferral criteria will have a significant impact on blood availability and, hence, on the safety of those transfusion recipients who cannot tolerate a delay in receiving blood products.
The country should contemplate nvCJD deferral criteria only when it is apparent that such a policy would improve blood safety more than the loss of donors and the associated decrease in blood availability would compromise blood safety.
Thank you.
CHAIRMAN BROWN: Thank you, Ms. Gregory.
The word theoretical has been used many, many, many times this morning and will continue to be used, and it's being used correctly. I'd just point out that, for ten years, between 1985 and 1995, the risk of new variant CJD from BSE was also theoretical.
The next speaker is Dave Cavenaugh from the Government Relations Committee of Ten Thousand.
MR. CAVENAUGH: I'm the government relations person at the Committee of Ten Thousand. The organization is the Committee of Ten Thousand. CHAIRMAN BROWN: Yes, that's fine. Thank you.
MR. CAVENAUGH: Okay, COTT, which is the Committee of Ten Thousand, is gravely concerned about the industry logic favoring UK donors over additional U.S. replacement donors even with the survey, and even with the lack of data on paid and unpaid high volume pheresis donors. This morning's discussion showed a glaring omission in the analysis to date of the impact of excluding well paid, highly educated, non-incentive provided pheresis donors in addition to the larger, understood group of paid pheresis donors.
We've heard quite a bit in terms of the studies and in terms of some of the questions about the likely blood borne nature of this never documented entity of prion and its ability to be transmitted by blood.
There's a perceived link between new variant and beef that's been raised based on proximity, but the BSE classical CJD link should not be forgotten. It should be entertained at the minimum. Living in the United Kingdom in the late '80s seemed to be a major factor, for example.
What was it about living there, that's proximity. Both statistic presenters showed clear risk of new variant in the blood, not even enlarging the scope to include classical CJD. There are no nv cases in the U.S., but plenty of classical -- arguably, much more than the one in one million rate alleged.
Just ask CJD Voice, the patient-family support group which spoke before you 18 months ago. Small then, its numbers have mushroomed. Something is getting transmitted. Can it all be through beef? But most disturbing is the recent news confirming a second mutated form of prions also causing death in under a year.
This doubling of the number of ways prions can be malformed with fatal results raises our concern levels considerably. The explanation that it is spontaneous sounds like an early catch all. With an entity so new, so unknown and so dangerous, the committee should be providing every protection possible, not bowing to arguments of relative risk.
Thank you.
CHAIRMAN BROWN: Thank you.
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CHAIRMAN BROWN: Well, this is exactly why we're here today. Dr. Satcher and the other groups have already decided that this is not worth significant worry with respect to classical CJD, and that new variant was an unknown. And so that's why we're considering specifically new variant because we don't have information specifically on it. I mean, everything we don't have information on becomes a subject for this committee. (Laughter.)
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DR. LEITMAN: We seem to be extrapolating the partitioning data of classical CJD -- the agent of classical CJD to the agent of new variant CJD. That may or may not be okay.
I'd like to ask Dr. Prusiner if we can at all extrapolate the lack of transmissibility through blood components of classical CJD agent to new variant?
DR. PRUSINER: I don't know that I'm qualified to answer this. I can only tell you that the little bit of work that we've done now on new variant CJD says that it is a dramatically different strain of prion. That means that the confirmation of PRP scrapie is dramatically different than anything else we've studied.
So let me give you an example. We've looked at 40 different cases of sporadic CJD, and we know that there's several different confirmations there at least. And all of these are transmissible in about 200 days to either mice that have a human PRP gene or have a chimeric mouse human PRP gene. If you look at new variant CJD, it takes more than 500 days and only about 60 percent of the animals get sick. Now, as I said before, if we take new variant CJD and we passage it into a mouse that expresses a bovine PRP gene on a null background, then all the mice are getting sick in 240 days. The piece of data I don't have that you want is you want to know if I take sporadic CJD or familial CJD cases and passage those into mice with a bovine PRP gene, do they get sick? And the answer is I don't know yet.
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MS. HARRELL: Well, I asked him the question, was there a deferral ?? was there deferral criteria for blood donors for classic CJD for people who have either resided or visited the UK.
CHAIRMAN BROWN: I'm sorry. Repeat that, the question.
MS. HARRELL: Is there a deferral policy for blood donors to attempt to reduce the risk of transmitting classic CJD for people who either resided or visited the UK?
DR. SCHONBERGER: The answer is no.
MS. HARRELL: And if there is no risk, if we think that there is no risk of transmitting the whatever to ?? for CJD, what makes this different, for new variant CJD much different?
CHAIRMAN BROWN: That's the first time, Stan, you'll ever hear of prion referred to as a whatever. (Laughter.)
CHAIRMAN BROWN: I mean, I've heard it referred to as a lot of different things. I'm ??
DR. PRUSINER: You've said that many times, Paul. (Laughter.)
CHAIRMAN BROWN: It may be that ??
DR. PRUSINER: Is that in the Congressional Record?
CHAIRMAN BROWN: The issue is not about sporadic CJD. That is the issue we can sort of generically say CJD. Presumably, if the blood from a patient with new variant CJD were infectious, the disease that it would transmit would be new variant CJD. So it's not ??
MS. HARRELL: Okay. So CJD is not transmitted through the blood is what you're saying?
CHAIRMAN BROWN: We have no evidence from looking at populations that that has ever happened. The question is: since we know it can happen when we use experimental models of CJD, we can take CJD blood from one animal and produce the disease in another animal.
So there is the "theoretical possibility" that this might also happen in humans, particularly with a different strain of the disease, which new variant is, about which we don't know a whole lot. That's the question. DR. SCHONBERGER: Isn't the answer to her question that the incidence of CJD, REDS, classic CJD, is not influenced by whether or not you've lived in the UK between 1980 and 1996 ??
CHAIRMAN BROWN: Yes.
DR. SCHONBERGER: ?? but the incidence of new variant CJD is?
CHAIRMAN BROWN: Yes, 40-love. (Laughter.)
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CHAIRMAN BROWN: I agree. We're starting to vote, and we'll start with Larry. Hold on. All right. The question is: should FDA recommend new deferral criteria for donors of transfusable components, to attempt to reduce the theoretical risk of transmitting new variant CJD from transfusions based on donor exposure to BSE in the UK?
DR. SCHONBERGER: Yes.
CHAIRMAN BROWN: Incidentally, just to remind the committee, it is possible to vote punt; that is to say, you can vote yes, no, or no vote ?? abstain.
DR. HUESTON: Well, for my own benefit, I suppose, to walk through the logic ?? and maybe for the benefit of Barbara because I think she raises a good point about how we proceed ?? we have a situation with a small number of known cases of variant Creutzfeldt Jakob, all but one of which are in the UK.
However, we know there is a potential for widespread exposure to BSE that has already occurred. Therefore, we expect more cases, but we really don't have a good idea of the magnitude of the epidemic that we're going to expect.
Part number 2 says, "While there is no known whole blood or blood product transmission of classical CJD in humans, variant Creutzfeldt Jakob differs substantially from classical CJD." So we recognize that there is the potential for transmission of some of the transmissible spongiform encephalopathies via blood, albeit controversial We have an animal model, and we can identify infectivity in lymphoid tissues with variant Creutzfeldt Jakob, which is different from classical Creutzfeldt Jakob.
At the same time, it has been pointed out many times by a number of people that there have been no observed risk ?? or no observed cases at this point of transfusion or blood product related variant Creutzfeldt Jakob cases in the UK. I think that's a little premature. One might say the absence of evidence is not evidence of absence.
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At the same time, there are look-back studies in place in the UK, and there is a natural experiment ?? a huge natural experiment ongoing in the United Kingdom, where if, in fact, there is a risk, I believe that the risk will first be apparent in the United Kingdom far before we would see it anywhere else.
At the same time, in looking at the precautionary principle ??
CHAIRMAN BROWN: Is this the preamble for a vote?
DR. HUESTON: Yes, sir. You got it. (Laughter.)
DR. HUESTON: If our goal is to be precautionary, but at the same time we have to preclude having more negative impacts for any action that we take, then positive ?? in other words, impacts on the blood supply. And I have struggled through the whole time, but I'm going to vote no at this time.
CHAIRMAN BROWN: Could I urge the remaining members of the committee ?? (Laughter.)
CHAIRMAN BROWN: ?? to vote rather than ?? I appreciate it, and I let Will, you know, chatter on because he hasn't said a whole lot, and I wanted to hear what he had to say. And so thank you, but we'll never get through if we continue to explain the reasons for our votes, each one and all. So, Susan?
DR. LEITMAN: I take the opportunity to disagree with what you just said. I think the vote at this table is so critical, it will have such a huge impact potentially on the way America collects its blood, that if we go beyond our designated time it's worth it.
And I was influenced, and it was helpful to hear the last speaker's discussion. So I think if any of us have discussions or points to mention now, they might be valuable.
The deliberations of this committee are among the most difficult of any advisory committee I've ever been on because there are simply inadequate data upon which to base a decision. For myself, in the absence of data suggesting or, rather, documenting risk, I cannot vote yes based on assumptions, perceptions, possibilities, uncertainties, theoretical risks, and potential risks.
On the other hand, there are tangible measurable data that deferral of any percentage of donors, whether it's half, one and a half, two percent, will lead to replacement by donors by a small proportion of donors that are at increased risk for measurable diseases such as hepatitis B and C. So I vote no.
CHAIRMAN BROWN: Dr. Leitman votes no.
Dr. Prusiner?
DR. PRUSINER: I would like to vote yes, and I would like to say I have 23 points that I want to go through. (Laughter.)
DR. PRUSINER: I only want to say very quickly that I don't think that economics and the availability of donors is a reason to vote yes or no in this. I think that the economy has a way of solving these problems, and I think that will happen. I think the real problem here lies that we have a very imperfect data set, and we're dealing with a disease which is universally fatal. This is really the problem that we face.
CHAIRMAN BROWN: Dr. Prusiner votes yes. Dr. Roos?
DR. ROOS: I think we're dealing with a situation in which we have no evidence of any transfusion that has transmitted either classical or new variant Creutzfeldt. And we have a situation where there are risks involved with blood transfusions that the donors accept at this point.
That is, we were informed about ?? I guess about 14 percent of individuals do donate blood that have I guess the recipients. About 14 percent of individuals that donate blood have some risky behavior. And maybe I might include living in UK part of that risky behavior.
And so I kind of accept this as, at the moment, acceptable risk for donated blood and I am awaiting evidence to prove that there is more danger involved. So I'm voting no here.
CHAIRMAN BROWN: Dr. Roos votes no. Dr. Belay?
DR. BELAY: I'm concerned about two issues. The first one is the studies that showed the presence of the new variant CJD agent in lymphoreticular tissues. And the second concern I have is the absence of evidence against blood-borne transmission of new variant CJD. The kind of data that's available for classic CJD is not available for new variant CJD, so I vote yes.
CHAIRMAN BROWN: Dr. Belay votes yes. Dr. Lurie?
DR. LURIE: Really, what we're doing is balancing one risk against two others. The two risks are the problem of the replacement donor, which is not zero but it is probably very small, given that we're only talking about one, two perhaps, percent replacement of donors here, depending on what happens in B if we get that far.
The second has to do with the diminution in the blood supply itself. And, again, there are scenarios available to us under B that allow us to minimize that. So we really have, on the one hand, two small risks that can more or less be quantified, and on the other hand we have another risk, which may itself be small, but if we are wrong could be very, very large. And that's really the benefit ?? the risk benefit calculation that we're making. For me, there remain too many uncertainties, and so I vote yes.
CHAIRMAN BROWN: Dr. Lurie votes yes. Dr. Hoel?
DR. HOEL: Yes. I'm changing my vote from last time, and I'm going to vote yes, mainly because of what I see in the epidemiology data of the cases in England and the modeling work. I think this needs to be monitored further to see how it comes in because the risks could be quite large, and so I would vote yes.
CHAIRMAN BROWN: Dr. Hoel votes yes. Dr. Bolton?
DR. BOLTON: I believe that there is insufficient documentation of the risk at this time. And in light of that, I can't ?? I don't think that the information warrants changing the current policy. I vote no.
CHAIRMAN BROWN: Dr. Bolton votes no. Dr. Nelson?
DR. NELSON: Well, this is a pretty difficult vote. Last time I voted no, and I'm going to vote no again, although I am ?? really, it's disturbing that there is no really good data at this point.
And I am impressed with a comment that was made earlier, and that is that there is an experiment in the UK of many people who have been exposed to UK donors over a period of many years. And I am somewhat reassured that there have been no cases, and I'm also reassured with the quality of the epidemiologic surveillance and data from the UK.
I think that that has been well done, carefully done, and presumably it will continue to be closely monitored. You know, if a single case had occurred, we would really need to change our policy immediately. That's number one.
But the other problem I have is if I voted yes, then I would have to make a decision on 1B. And the only ?? (Laughter.)
DR. NELSON: ?? the only reasonable decision on 1B would be to remove ?? to exclude all donors who had lived in the UK. I see no basis for any arbitrary decision. Once you go down that route, then you have to exclude anybody from the UK or who visited the UK or Ireland during this period. I don't see any alternative.
CHAIRMAN BROWN: Dr. Nelson votes no. Dr. McCullough?
DR. McCULLOUGH: I agree with Susan. This is one of the most difficult groups I have had to deal with. I'm impressed by the epidemiologic data. I'm also impressed by having sat through in 1983 and 1984 discussions of there ain't been a case reported yet, and also that we are concerned about the impact on the blood supply.
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TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVIS
And possibly also, I'm influenced by having been the fodder for congressional hearings and 60-minute expose on things that might have been done differently at some of those times. So I'm going to vote yes. I have tremendous confidence in the blood systems of this country that they will be able to ?? not easily ?? respond if changes are made.
CHAIRMAN BROWN: Dr. McCullough votes yes. Dr. Brown votes yes. Dr. Ewenstein?
DR. EWENSTEIN: Yes. I'm impressed by the modeling data. I believe that we have biologic data as well as at least the potential epidemiology coming out of England to suggest that this is a new disease and on that basis should be handled with a lot more caution, because we don't have the comfort that we have with the long-standing classical CJD. And so I'm going to vote yes.
CHAIRMAN BROWN: Dr. Ewenstein votes yes. Dr. Detwiler?
ORY COMMITTEE MEETING Thursday, June 3, 1999???????http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3518t2.rtf DR.
DETWILER: I'm going to vote yes, because with these diseases, a long incubation and the lack of a pre-clinical screening test, that the day you find out there is transmission you're already years too late, and you can't easily clean up the problem. And I think they found out that even with the human transmission because that was based on there is no theoretical ?? or it's only a theoretical risk until 1996.
CHAIRMAN BROWN: Dr. Detwiler votes yes. Dr. Piccardo?
DR. PICCARDO: I would vote yes because all of the data from classical CJD cannot be extrapolated into the new variant.
CHAIRMAN BROWN: Dr. Piccardo votes yes. Dr. Williams?
DR. WILLIAMS: I'm going to vote no. I think that this is truly a balancing act, and it's a tradeoff between a known problem, I believe related to the blood supply, and the problems that may follow from a reduced supply and the perception of a risk of new variant CJD.
And I completely agree that an experiment is going on right now. Those data are going to come in, and, obviously, there is going to be close attention paid to those data, and that surely this committee and FDA will respond should information indicate that we need to take another look at the issue.
CHAIRMAN BROWN: Dr. Williams votes no. Dr. Hollinger?
DR. HOLLINGER: I'm voting no also, for the same reasons that have been addressed. I think there is ?? by doing something now doesn't mean that everything is going to be turned around and you don't have to worry about it, if you do have a long incubation situation and one can wait to see if there is some risk down the line, and I think we do have those things going on ?? natural and experimental ?? in England. So I'm voting no. CHAIRMAN BROWN: Dr. Hollinger votes no. Ms. Harrell?
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Case Report of V MS. HARRELL: Okay. Sitting next to my ex-learned colleague ?? (Laughter.)
MS. HARRELL: Okay. I'm voting to be prudent, and I think that this will buy us time to get the data in and have it analyzed from the UK. But right now, we don't have time, and so I vote yes.
CHAIRMAN BROWN: Ms. Harrell votes yes. Dr. Cliver?
DR. CLIVER: No.
CHAIRMAN BROWN: Dr. Cliver votes no. Dr. Burke?
DR. BURKE: This is a balancing act, and I can ?? there are measurable negatives here. In the face of a theoretical, I vote no.
CHAIRMAN BROWN: Dr. Burke votes no. Dr. Tramont?
DR. TRAMONT: I vote yes.
CHAIRMAN BROWN: Dr. Tramont votes yes. Twelve yes. Nine no. Well, at the least, Dr. Epstein can come away from the day with the understanding that he has not been given a mandate. (Laughter.)
DR. FREAS: Can I just make a comment? I did verify the count. There are 21 voting people at the table. Dr. Roos is a non-voting participant. And the total does add up to 21.
Excuse me. I apologize. Dr. Rohwer is ??
CHAIRMAN BROWN: I don't have to ask Bob what he would have voted, had he been allowed to vote. (Laughter.)
CHAIRMAN BROWN: But I will if you'd like to put it on the record. This is simply a question to Bob, since he's at the table. Were his vote to be counted, what would it have been?
DR. ROHWER: I'll use this soapbox opportunity.
CHAIRMAN BROWN: Uh-oh. (Laughter.)
DR. ROHWER: I am very concerned that we may be facing the grave possibility of an epidemic of new variant CJD, an epidemic that, if it occurs, could be made much worse through the mechanism of interspecies transmission, such as would occur through blood products. But I recognize the real risks of insufficient supply.
However, I am impressed by Dr. Donnelly's warning that if the feed ban in the case of BSE had been delayed just one year, the epidemic would have been vastly worse than it was. And, therefore, I feel we should take whatever opportunities for implementing mitigating measures that we can that do not simultaneously jeopardize the supply unduly.
So I recognize that what we have ?? the opportunity we have here is very, very imperfect, but I feel like it is possible to do something, and we should do it.
CHAIRMAN BROWN: Jay, you wanted a recount, or just a reexpression? DR. EPSTEIN: Just a reexpression.
CHAIRMAN BROWN: Okay. The vote on question 1A is 12 votes yes, nine votes no. Therefore, the committee is obliged now to consider what deferral criteria might be recommended. And presumably, based on the evidence, the only deferral criteria that are offered us that make any sense are duration of residence in the UK.
snip...258
Dr. Scott
skip
In addition, we do know, as Dr. Prusiner has pointed out several times, that the new variant agent is biologically different from the classical CJD agent, so we can't necessarily extrapolate all of the information that we have on classical CJD to new variant.
For example, he talked about the differences in the protein and its behavior, and we also know that there is enhanced expression of the new variant agent in lymphoid tissues compared with CJD. And we don't know much about its virulence or infectivity compared with the classical CJD. And, of course, we haven't had time to get or enough patients or subjects or transfused people to get the kind of epidemiologic data that we have which tells us that transmission of classical CJD by blood or blood products at worst is rare and may not occur.
So, currently, the diagnosis of new variant CJD is based upon neuropathology, and these are the three most characteristic features ?? numerous widespread kuru type amyloid plaques, which obviously can occur in a few other kinds of CJD but are quite common in new variant CJD; spongiform change, which is predominant in certain areas of the brain; and a high density prion protein accumulation, especially the cerebrum and the cerebellum by immunohistochemistry, and tonsillar biopsy may ultimately play a role in this diagnosis as well as analysis of prion glycoforms.
Current age, if alive, or age at death, less than 55. Since the typical age of a new variant patient is about late 20s, and the typical age of a classical CJD patient is about 65, this is one criteria that is useful. And new variant patients tend to have persistent painful sensory symptoms early in presentation and/or psychiatric symptoms.
I can go into this further if people want to know about it. But there were a couple of articles published in the Lancet from the CJD surveillance unit in September 1997, which goes into this in great detail.
In addition, the patient must have dementia and a delayed development of neurologic symptoms, particularly movement disorders, about a four-month delay. And, again, this is somewhat different from classical CJD in its course. They may have a normal or abnormal EEG, but not the diagnostic EEG, which is a pseudo periodic sharp wave that's often seen in classical CJD. The duration of illness should be greater than six months. Again, this is in marked distinction to most cases of classical CJD which average four to four and a half months of duration. Whereas, the new variant case typically is around 14 months duration, although there is a spread.
In addition, routine investigations will not suggest an alternate diagnosis. And this is a criteria, really, for the U.S. There should be history of possible exposure to BSE; that is, consumption of local beef products as resident or traveler to a BSE-affected country.
And there is only two more. No history of iatrogenic exposures that are related to development of classical CJD, and, finally, of course, such a patient, if they had a prion protein gene mutation, it was associated with familiar CJD. That would not fall under ?? that would not be a patient that we would worry about new variant CJD in.
page...284
DR. ROOS: Thanks, Dr. Scott. So we're not asked to take a vote, but just to discuss these issues. Yes?
DR. NELSON: I'm concerned a little bit about the explanation for the age criteria, and I can see that this is very useful because the one thing you do know, when somebody gets sick, you can estimate what their age is. And so that's an easy ?? you know, an easy early marker for a possible case that's not classical.
And I assume that probably the reason for the classical CJD patients being much older is that the incubation period is so long that they probably had an exposure much longer. But as this epidemic ?? or as the ?? if it's exposure to the BSE agent from the epidemic, it seems like over time this age criteria will probably change, and that the under 55 may no longer be a useful criteria 10 years from now or 40 years from now.
And I just wonder if Larry or anybody could comment on that.
DR. SCHONBERGER: We definitely agree, and it underscores the evolving nature of these diagnoses. All I can say is the age is an excellent and easy criteria for us to use now. All cases, as you know, in the world of new variant CJD have been under age 55. In fact, I think the oldest was ?? I think the median age is like 29 or so, 28 at onset and 29 at death. So that's why that particular criteria came into existence.
However, obviously, if the epidemic should change and we should start seeing older cases, then, obviously, we would have to change.
There is some semantic problems. We actually investigate every case under 55. So, in a sense, all cases under 55 in the United States could be regarded as under investigation or possible. We have not used the word "probable," in part because that's the word they use in the United Kingdom, and they count those cases as amongst the cases of new variant CJD that we count.
The 40 cases in the UK, I think, includes one, is it? One probable? That was a case in a teenager whose brain tissue was unavailable for study. And they indicate that it's too early in the epidemic. Their experience is too small for them to be absolutely sure about that, but they're willing to ?? at this point to call it a case.
And I've been told that with these new MRI criteria, and so on, that maybe we'll be able to call cases without necessarily having the tissue, depending on what they find the specificity and sensitivity of those to be. So all cases essentially under 55 right now are under investigation.
Plus, we have established amongst pathologists the concept that any case that has the pathology of new variant CJD, regardless of age, or even regardless of whether they've diagnosed it as CJD, should be reported. And those two would count as new variant even though they are not under 55. DR. ROOS: Just a quick question, Larry. What is your timeframe of reporting, or what is the goal here? Obviously, with respect to these new guidelines, you want to identify these cases fairly quickly and make some disposition as far as blood products.
DR. SCHONBERGER: Precisely because we are looking at all cases under 55, I was encouraging FDA to encourage the blood establishments ?? or the first to identify these cases at least, and that has been the history ?? to report to us any case of CJD under 55.
Once we get that report, it may be very easy for us and very quickly making it ?? to very quickly make a determination that we're dealing with, say, a dura mater case or a human growth hormone case. But then, another part of FDA will probably become interested in that.
So we think it's worth the blood establishments reporting all of their cases in donors. There just are not that many CJD cases that are going to occur among donors that the blood establishment is going to be able to identify that quickly. But if they do, we want it reported right away. DR. ROOS: Just a quick question. So, I mean, how about if this patient donates to some large blood pool or has donated whole blood? It doesn't go back to the blood establishment. It goes to a neurologist, gets diagnosed, etcetera. What's the timeframe then?
DR. SCHONBERGER: Well, frequently, our experience with the withdrawals ?? and I'll use the Utah case as an example as that came out ?? we handled that very, very rapidly. But even handling it very, very rapidly, you'll find that huge, huge numbers of recipients were exposed to this donor's blood products.
So the withdrawal program is relatively inefficient, compared to what we just did, which was to get deferral criteria. And I think that's why it was important to try to be preemptive in a sense and have the deferral criteria up front.
The withdrawal procedure, even when you do it very quickly as in the Utah case, I would not encourage people to depend on that for considerable safety. What we will do is we will modify and ameliorate the situation. But it certainly won't eliminate even the majority of the risk.
DR. ROOS: I just think it might be good to publicize these new policies widely to the neurological community, so that they alert you, Larry, or the FDA quickly. The Utah case, in fact, was kind of a very aberrant case. It could be that there are other cases that get less sophisticated care. And if you really want to identify things in a timely manner, you obviously have to publicize the program and new policies to the neurological community. DR. SCHONBERGER: Well, let me clarify that the primary group doing the surveillance on this are blood establishments. And if this group wants to recommend that blood establishments, you know, provide blood donors with cards or something that would, you know, speed up any type of reporting, that's possible.
The surveillance that CDC is conducting is not designed for that type of rapid turnaround or rapid identification in reporting. That's another weakness of the system and relying on this withdrawal system for tremendous protection of the population.
DR. ROOS: Peter?
DR. LURIE: My question/concern is whether or not requiring all nine of these criteria is too restrictive a set of criterion. I guess the data question that I have is: of the 30-odd new variant CJD cases in Britain, how many of them have met all nine of these criteria?
DR. SCOTT: Well, could I also respond to that question?
DR. LURIE: Yes, please do.
DR. SCOTT; I don't know the answer to how many have had all nine of those criteria, but most. However, the CJD surveillance unit has somewhat altered their criteria with time such that the current organization is similar to this but not the same. And most critically, they have gotten rid of the age criteria and added an MRI criteria. But this is not yet published material, and it's very recent. We just got that information on May 31st. And I think the other thing to mention is that we weren't considering only using all nine criteria. But, really, that's the purpose of the third way, if I can say it, which is to have a very low threshold for identifying even potential cases and then to make a rapid decision on a case-by-case basis. But what we're anticipating is probably what you're thinking, that not all of those criteria are going to be met, just due to a lack of information, time hasn't passed, we don't have material to analyze. And so I think what we're anticipating is that we would be ?? we would err on the side of caution unless investigation showed us that it was most unlikely that this was a new variant case.
snip...page 292
DR. HUESTON: You don't know to what you've been exposed. So it's ?? the second thing is it draws ?? I think it gives a false sense of security and directs, potentially, attention to the wrong products, because the average person thinks of beef as primal cuts of beef. And that's, at this point, the least likely of the sources of exposure, given meat products. The third comment is that I personally am very concerned about the proposed ?? this criteria of possible new variant CJD by FDA. And I have two major reasons for that. The first is that I see the potential for conflict arising between FDA and CDC, where FDA is stepping forward or making a pronouncement of possible new variant CJD, and at the same time CDC says, "We're still investigating; you know, it's premature." And I think that puts the FDA in a very awkward position, and I think an inappropriate ?? Larry is telling me that they are investigating 25 ?? DR. SCHONBERGER: There's about 25 cases under 55 a year. DR. HUESTON: So my fear ?? here is my fear based on my experience. Item number 2 says, "Donor has physician's clinical or pathologic diagnosis of CJD."
DR. SCHONBERGER: They're not all donors, by the way. Very few of them are donors. Okay?
DR. HUESTON: Okay. Fair enough. But once you get a terminology like this established, my concern is that it's going to spread further, that people are going to say, "Well, the FDA would have called this a possible case." Number 2 says, "Has a physician's clinical or pathologic diagnosis," it doesn't say anything about the physician. And no offense to my distinguished colleagues, but there are a number of physicians that are simply not in the position to make a clinical diagnosis or a pathologic diagnosis of Creutzfeldt Jakob. That has not precluded some of these same physicians from making a proclamation.
Third, I think that the public health and the risk communication implications of this are potentially massive. And having been on the firing ?? you know, on the other end of trying to deal with these, you know, the press grabbing hold of a case and blowing it totally out of proportion and creating a great deal of concern, I don't see why you need another term. I think you coordinate with the CDC, you coordinate your investigation when it comes back from a blood collection center that you have a donor less than 55 years of age, where you have some suspicion of Creutzfeldt Jakob Disease. You go through the same CDC workup, and you base ?? on a case-by-case basis, you base your decision on that coordination with CDC.
snip...page 296
see full text and all voting results
http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3518t1.rtf
TSEAC MEETING JUNE 3 1999
http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3518t2.rtf
http://transmissiblespongiformencephalopathy.blogspot.com/
Wednesday, June 29, 2011
Wednesday, March 2, 2011
Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript Posted: 3/2/2011
Posted: 3/2/2011
October 28, 2010
Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript Posted: 3/2/2011
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm244061.htm
October 29, 2010
Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript Posted: 3/2/2011
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm244062.htm
Tuesday, September 14, 2010
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)
http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html
Monday, February 7, 2011
FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???
http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html
Sunday, May 10, 2009
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)
TO : william.freas@fda.hhs.gov
May 8, 2009
Greetings again Dr. Freas, TSEAC et al,
I would kindly, once again, wish to comment at this meeting about the urgent actions that need to be taken asap, to the Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009. Due to my disability from my neck injury, I will not be attending this meeting either, however I hope for my submission to be read and submitted. ...
IN reply to ;
http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html
Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 INTRODUCTION The United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) held a public meeting on July 25, 2006 in Washington, D.C. to present findings from the Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 (report and model located on the FSIS website: http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp).
Comments on technical aspects of the risk assessment were then submitted to FSIS. Comments were received from Food and Water Watch, Food Animal Concerns Trust (FACT), Farm Sanctuary, R-CALF USA, Linda A Detwiler, and Terry S. Singeltary. This document provides itemized replies to the public comments received on the 2005 updated Harvard BSE risk assessment. Please bear the following points in mind:
http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf
From: Terry S. Singeltary Sr.
To: FREAS@CBER.FDA.GOV
Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov
Sent: Friday, December 01, 2006 2:59 PM
Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION
snip...
ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)
THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone.
These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ...
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
snip... 48 pages...
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Tuesday, February 8, 2011
U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001
http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html
Thursday, February 24, 2011
The risk of variant Creutzfeldt-Jakob disease among UK patients with bleeding disorders, known to have received potentially contaminated plasma products
http://vcjdtransfusion.blogspot.com/2011/02/risk-of-variant-creutzfeldt-jakob.html
Friday, February 11, 2011
Creutzfeldt-Jakob disease (CJD) biannual update (2010/1) Emerging infections/CJD
http://creutzfeldt-jakob-disease.blogspot.com/2011/02/creutzfeldt-jakob-disease-cjd-biannual.html
Saturday, January 29, 2011
Atypical L-Type Bovine Spongiform Encephalopathy (L-BSE) Transmission to Cynomolgus Macaques, a Non-Human Primate
Jpn. J. Infect. Dis., 64 (1), 81-84, 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html
Wednesday, December 29, 2010
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY PRION END OF YEAR REPORT DECEMBER 29, 2010
http://transmissiblespongiformencephalopathy.blogspot.com/2010/12/transmissible-spongiform-encephalopathy.html
Thursday, February 10, 2011
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY REPORT UPDATE CANADA FEBRUARY 2011 and how to hide mad cow disease in Canada Current as of: 2011-01-31
http://madcowtesting.blogspot.com/2011/02/transmissible-spongiform-encephalopathy.html
Wednesday, January 5, 2011
ENLARGING SPECTRUM OF PRION-LIKE DISEASES Prusiner Colby et al 2011
Prions
David W. Colby1,* and Stanley B. Prusiner1,2
http://betaamyloidcjd.blogspot.com/2011/01/enlarging-spectrum-of-prion-like.html
TSS
October 28, 2010
Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript Posted: 3/2/2011
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm244061.htm
October 29, 2010
Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript Posted: 3/2/2011
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm244062.htm
Tuesday, September 14, 2010
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)
http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html
Monday, February 7, 2011
FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???
http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html
Sunday, May 10, 2009
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)
TO : william.freas@fda.hhs.gov
May 8, 2009
Greetings again Dr. Freas, TSEAC et al,
I would kindly, once again, wish to comment at this meeting about the urgent actions that need to be taken asap, to the Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009. Due to my disability from my neck injury, I will not be attending this meeting either, however I hope for my submission to be read and submitted. ...
IN reply to ;
http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html
Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 INTRODUCTION The United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) held a public meeting on July 25, 2006 in Washington, D.C. to present findings from the Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 (report and model located on the FSIS website: http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp).
Comments on technical aspects of the risk assessment were then submitted to FSIS. Comments were received from Food and Water Watch, Food Animal Concerns Trust (FACT), Farm Sanctuary, R-CALF USA, Linda A Detwiler, and Terry S. Singeltary. This document provides itemized replies to the public comments received on the 2005 updated Harvard BSE risk assessment. Please bear the following points in mind:
http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf
From: Terry S. Singeltary Sr.
To: FREAS@CBER.FDA.GOV
Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov
Sent: Friday, December 01, 2006 2:59 PM
Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION
snip...
ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)
THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone.
These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ...
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
snip... 48 pages...
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Tuesday, February 8, 2011
U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001
http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html
Thursday, February 24, 2011
The risk of variant Creutzfeldt-Jakob disease among UK patients with bleeding disorders, known to have received potentially contaminated plasma products
http://vcjdtransfusion.blogspot.com/2011/02/risk-of-variant-creutzfeldt-jakob.html
Friday, February 11, 2011
Creutzfeldt-Jakob disease (CJD) biannual update (2010/1) Emerging infections/CJD
http://creutzfeldt-jakob-disease.blogspot.com/2011/02/creutzfeldt-jakob-disease-cjd-biannual.html
Saturday, January 29, 2011
Atypical L-Type Bovine Spongiform Encephalopathy (L-BSE) Transmission to Cynomolgus Macaques, a Non-Human Primate
Jpn. J. Infect. Dis., 64 (1), 81-84, 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html
Wednesday, December 29, 2010
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY PRION END OF YEAR REPORT DECEMBER 29, 2010
http://transmissiblespongiformencephalopathy.blogspot.com/2010/12/transmissible-spongiform-encephalopathy.html
Thursday, February 10, 2011
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY REPORT UPDATE CANADA FEBRUARY 2011 and how to hide mad cow disease in Canada Current as of: 2011-01-31
http://madcowtesting.blogspot.com/2011/02/transmissible-spongiform-encephalopathy.html
Wednesday, January 5, 2011
ENLARGING SPECTRUM OF PRION-LIKE DISEASES Prusiner Colby et al 2011
Prions
David W. Colby1,* and Stanley B. Prusiner1,2
http://betaamyloidcjd.blogspot.com/2011/01/enlarging-spectrum-of-prion-like.html
TSS
Tuesday, February 8, 2011
U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy#########
Greetings List Members,
I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.
I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.
"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."
and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick.
(understand, these are taken from my notes for now. the spelling of names and such could be off.)
[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.
[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]
[host Richard] could you repeat the question?
[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
[not sure whom ask this] what group are you with?
[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.
[not sure who is speaking] could you please disconnect Mr. Singeltary
[TSS] you are not going to answer my question?
[not sure whom speaking] NO
from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;
[unknown woman] what group are you with?
[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now?
at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference.
IF i were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from;
RBARNS@ORA.FDA.GOV 301-827-6906
he would be glad to give you one ;-)
Rockville Maryland, Richard Barns Host
BSE issues in the U.S., How they were labelling ruminant feed? Revising issues.
The conference opened up with the explaining of the U.K. BSE epidemic winding down with about 30 cases a week.
although new cases in other countries were now appearing.
Look at Germany whom said NO BSE and now have BSE.
BSE increasing across Europe.
Because of Temporary Ban on certain rendered product, heightened interest in U.S.
A recent statement in Washington Post, said the New Administration (old GW) has a list of issues. BSE is one of the issues.
BSE Risk is still low, minimal in U.S. with a greater interest in MBM not to enter U.S.
HOWEVER, if BSE were to enter the U.S. it would be economically disastrous to the render, feed, cattle, industries, and for human health.
(human health-they just threw that in cause i was listening. I will now jot down some figures in which they told you, 'no need to write them down'. just hope i have them correct. hmmm, maybe i hope i don't ???)
80% inspection of rendering
*Problem-Complete coverage of rendering HAS NOT occurred.
sizeable number of 1st time FAILED INITIAL INSPECTION, have not been reinspected (70% to 80%).
Compliance critical, Compliance poor in U.K. and other European Firms.
Gloria Dunason Major Assignment 1998 goal TOTAL compliance. This _did not_ occur. Mixed level of compliance, depending on firm.
Rendering FDA license and NON FDA license
system in place for home rendering & feed 76% in compliance 79% cross contamination 21% DID NOT have system 92% record keeping less than 60% total compliance
279 inspectors 185 handling prohibited materials
Renderer at top of pyramid, significant part of compliance. 84% compliance
failed to have caution statement render 72% compliance & cross contamination caution statement on feed, 'DO NOT FEED TO CATTLE'
56 FIRMS NEVER INSPECTED
1240 FDA license feed mills 846 inspected
"close to 400 feed mills have not been inspected"
80% compliance for feed.
10% don't have system.
NON-FDA licensed mills There is NO inventory on non licensed mills. approximately 6000 to 8000 Firms ??? 4,344 ever inspected. "FDA does not have a lot of experience with"
40% do NOT have caution statement 'DO NOT FEED'.
74% Commingling compliance
"This industry needs a lot of work and only half gotten to"
"700 Firms that were falitive, and need to be re-inspected, in addition to the 8,000 Firms."
Quote to do BSE inspection in 19 states by end of January or 30 days, and other states 60 days. to change feed status??? Contract check and ask questions and pass info.
At this time, we will take questions.
[I was about the third or fourth to ask question. then all B.S.eee broke loose, and i lost my train of thought for a few minutes. picked back up here]
someone asking about nutritional supplements and sourcing, did not get name. something about inspectors not knowing of BSE risk??? the conference person assuring that Steve Follum? and the TSE advisory Committee were handling that.
Some other Dr. Vet, whom were asking questions that did not know what to do???
[Dennis Wilson] California Food Agr. Imports, are they looking at imports?
[Conference person] they are looking at imports, FDA issued imports Bulletin.
[Linda Singeltary ??? this was a another phone in question, not related i don't think] Why do we have non-licensed facilities?
(conference person) other feed mills do not handle as potent drugs???
Dennis Blank, Ken Jackson licensed 400 non FDA 4400 inspected of a total of 6000 to 8000,
(they really don't know how many non licensed Firms in U.S. they guess 6000 to 8000??? TSS)
Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not'
Warren-Maryland Dept. Agr. Prudent to re-inspect after 3 years. concerned of Firms that have changed owners.
THE END
TSS
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############
FROM New York TIMES
Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting of cut version...
Date: Thu, 11 Jan 2001 22:02:47 -0700
From: "Sandy Blakeslee"
To: "Terry S. Singeltary Sr."References: 1
Hi terry -- thanks for all your help. I know it made a difference with the FDA getting out that release.
----- Original Message -----
From: "Terry S. Singeltary Sr."
To:Sent: Thursday, January 11, 2001 2:06 PM
Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting of cut version...
hi sandy,
From the New York Times NYTimes.com, January 11, 2001
Many Makers of Feed Fail to Heed Rules on Mad Cow Disease By SANDRA BLAKESLEE
Large numbers of companies involved in manufacturing animal feed are not complying with regulations meant to prevent the emergence and spread of mad cow disease in the United States, the Food and Drug Administration said yesterday.
The widespread failure of companies to follow the regulations, adopted in August 1997, does not mean that the American food supply is unsafe, Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at the F.D.A., said in an interview.
But much more needs to be done to ensure that mad cow disease does not arise in this country, Dr. Sundlof said.
The regulations state that feed manufacturers and companies that render slaughtered animals into useful products generally may not feed mammals to cud-chewing animals, or ruminants, which can carry mad cow disease.
All products that contain rendered cattle or sheep must have a label that says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers must also have a system to prevent ruminant products from being commingled with other rendered material like that from chicken, fish or pork. Finally, all companies must keep records of where their products originated and where they were sold.
Under the regulations, F.D.A. district offices and state veterinary offices were required to inspect all rendering plants and feed mills to make sure companies complied. But results issued yesterday demonstrate that more than three years later, different segments of the feed industry show varying levels of compliance.
Among 180 large companies that render cattle and another ruminant, sheep, nearly a quarter were not properly labeling their products and did not have a system to prevent commingling, the F.D.A. said. And among 347 F.D.A.-licensed feed mills that handle ruminant materials - these tend to be large operators that mix drugs into their products - 20 percent were not using labels with the required caution statement, and 25 percent did not have a system to prevent commingling.
Then there are some 6,000 to 8,000 feed mills so small they do not require F.D.A. licenses. They are nonetheless subject to the regulations, and of 1,593 small feed producers that handle ruminant material and have been inspected, 40 percent were not using approved labels and 25 percent had no system in place to prevent commingling.
On the other hand, fewer than 10 percent of companies, big and small, were failing to comply with the record-keeping regulations.
The American Feed Industry Association in Arlington, Va., did not return phone calls seeking comment.
http://www.nytimes.com/2001/01/11/science/11COW.html
Subject: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Wed, 10 Jan 2001 14:04:21 -0500
From: "Gomez, Thomas M."
Reply-To: Bovine Spongiform EncephalopathyTo: BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy#########
USDA/APHIS would like to provide clarification on the following point from Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.
[Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not']
Dr. Detwiler was responding to an announcement made during the call to use the FDA emergency number if anyone wanted to report a cow with signs suspect for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants to use the FDA emergency number as a last resort to report cattle suspect for BSE. What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement. Surveillance for BSE in the United States is a cooperative effort between states, producers, private veterinarians, veterinary hospitals and the USDA. The system has been in place for over 10 years. Each state has a system in place wherein cases are reported to either the State Veterinarian, the federal Veterinarian in Charge or through the veterinary diagnostic laboratory system. The states also have provisions with emergency numbers. Dr. Detwiler asked participants to use the systems currently in place to avoid the possibility of a BSE-suspect report falling through the cracks. Use of the FDA emergency number has not been established as a means to report diseased cattle of any nature.
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############
Subject: Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan.9, 2001
Date: Wed, 10 Jan 2001 13:44:49 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de References: 1
######### Bovine Spongiform Encephalopathy#########
Hello Mr. Thomas,
> What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement.
would you and the USDA/APHIS be so kind as to supply this list with a full text version of the conference call and or post on your web-site? if so when, and thank you. if not, why not?
The system has been in place for over 10 years.
that seems to be a very long time for a system to be in place, and only test 10,700 cattle from some 1.5 BILLION head (including calf crop). Especially since French are testing some 20,000 weekly and the E.U. as a whole, are testing many many more than the U.S., with less cattle, same risk of BSE/TSEs.
Why does the U.S. insist on not doing massive testing with the tests which the E.U. are using? Why is this, please explain?
Please tell me why my question was not answered?
U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
It was a very simple question, a very important question, one that pertained to the topic of BSE/feed, and asked in a very diplomatic way. why was it not answered?
If all these years, we have been hearing that pharmaceutical grade bovines were raised for pharmaceuticals vaccines etc. But yet the USA cannot comply with feed regulations of the ruminant feed ban, PLUS cannot even comply with the proper labelling of the feed, cross contamination etc. Then how in the world can you Guarantee the feed fed to pharmaceutical grade bovine, were actually non ruminant feed?
Before i was ask to be 'disconnected', i did hear someone in the background say 'we can't'-- have him ask the question again.
could you please be so kind, as to answer these questions?
thank you, Terry S. Singeltary Sr. Bacliff, Texas USA
P.S. if you will also notice, i did not post that emergency phone number and do not intend on passing it on to anyone. I was joking when i said i should call and report the whole damn U.S. Herd. So please pass that on to Dr. Detwiler, so she can rest easily.
BUT, they should be reported, some are infected with TSE. The U.S. is just acting as stupid as Germany and other Countries that insist they are free of BSE.
TSS
Subject: Report on the assessment of the Georgraphical BSE-risk of the USA July 2000 (not good)
Date: Wed, 17 Jan 2001 21:23:51 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform EncephalopathyTo: BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy#########
Greetings List Members and ALL EU Countries,
Because of this report, and the recent findings of the 50-state BSE Conference call, I respectfully seriously suggest that these Countries and the SSC re-evaluate the U.S.A. G.B.R. to a risk factor of #3.
I attempted to post this to list in full text, but would not accept...
thank you, kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA
Report on the assessment of the Geographical BSE-risk of the USA July 2000
PART II
REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE RISK OF THE UNITED STATES OF AMERICA
- 29 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
EXECUTIVE SUMMARY
OVERALL ASSESSMENT
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
Stability: Before 1990 the system was extremely unstable because feeding of MBM to cattle happened, rendering was inappropriate with regard to deactivation of the BSE-agent and SRM and fallen stock were rendered for feed. From 1990 to 1997 it improved to very unstable, thanks to efforts undertaken to trace imported animals and exclude them from the feed chain and intensive surveillance. In 1998 the system became neutrally stable after the RMBM-ban of 1997.
External challenges: A moderate external challenge occurred in the period before 1990 because of importation of live animals from BSE-affected countries, in particular from the UK and Ireland. It cannot be excluded that some BSE-infected animals have been imported by this route and did enter the US rendering and feed production system. The efforts undertaken since 1990 to trace back UK-imported cattle and to exclude them from the feed chain reduced the impact of the external challenge significantly.
Interaction of external challenges and stability: While extremely unstable, the US system was exposed to a moderate external challenge, mainly resulting from cattle imports from the UK. It can not be excluded that BSE-infectivity entered the country by this route and has been recycled to domestic cattle. The resulting domestic cases would have been processed while the system was still very unstable or unstable and would hence have initiated a number of second or third generation cases. However, the level of the possible domestic prevalence must be below the low detection level of the surveillance in place.
As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent will remain at the current level.
JUSTIFICATION
1. DATA
The available information was suitable to carry out the GBR risk assessment.
- 30 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
2. STABILITY
2.1 Overall appreciation of the ability to identify BSE-cases and to eliminate animals at risk of being infected before they are processed
· Before 1989, the ability of the system to identify (and eliminate) BSE cases was limited. · Since 1990 this ability is significantly improved, thanks to a good BSE-surveillance and culling system (contingency plan). · Today the surveillance should be able to detect clinical BSE-cases within the limits set by an essential passive surveillance system, i.e. some cases might remain undetected.
2.2 Overall appreciation of the ability to avoid recycling BSE-infectivity, should it enter processing
· Before 1997 the US rendering and feed producing system would not have been able to avoid recycling of the BSE agent to any measurable extent. If the BSE-agent was introduced the feed chain, it could probably have reached cattle. · After the introduction of the RMBM-to-ruminants-ban in August 1997 the ability of the system to avoid recycling of BSE-infectivity was somewhat increased. It is still rather low due to the rendering system of ruminant material (including SRM and fallen stock) and the persisting potential for cross-contamination of cattle feed with other feeds and hence RMBM.
2.3 Overall assessment of the Stability
· Until 1990 the US BSE/cattle system was extremely unstable as RMBM was commonly fed to cattle, the rendering system was not able to reduce BSE-infectivity and SRM were rendered. This means that incoming BSE infectivity would have been most probably recycled to cattle and amplified and the disease propagated. · Between 1990 and 1995 improvements in the BSE surveillance and the efforts to trace back and remove imported cattle gradually improved the stability but the system remained very unstable. In 1998 the system became unstable because of an RMBM-ban introduced in 1997. After 1998 the ban was fully implemented and the system is regarded to be neutrally stable since 1998. The US system is therefore seen to neither be able to amplify nor to reduce circulating or incoming BSE-infectivity.
3. CHALLENGES
A moderate external challenge occurred in the period 1980-1989 because of importation of live animals from the UK. imports from other countries are regarded to have been negligible challenges. · As a consequence of this external challenge, infectivity could have entered the feed cycle and domestic animals could have been exposed to the agent. These domestic BSE-incubating animals might have again entered processing, leading to an internal challenge since 1991. · This internal challenge could have produced domestic cases of BSE, yet prevalence levels could have been below the detection limits of the surveillance system until now. (According to US calculations, the current surveillance
-31 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
system could detect clinical incidence of 1-3 cases per year per million adult cattle, i.e. in absolute numbers 43-129 cases per year). Between 1990 und 1995, with the exclusion of the imported animals from Europe from the feed chain, the effect of the external challenges decreased.
4. CONCLUSION ON THE RESULTING RISKS
4.1 Interaction of stability and challenqe
· In the late 80s, early 90s a moderate external challenges met an extremely unstable system. This would have amplified the incoming BSE-infectivity and propagated the disease. · With the exclusion of the imported animals from Europe from the feed chain between 1990 and 1995 the effect of the external challenge decreased. · Before 1998 an internal challenge, if it developed, would have met a still unstable system (inappropriate rendering, no SRM ban, RMBM ban only after 1997) and the BSE-infectivity could have been recycled and amplified. · After 1998 the neutrally stable system could still recycle the BSE-agent but due to the RMBM-ban of 1997 the BSE-infectivity circulating in the system would probably not be amplified.
4.2 Risk that BSE-infectivity enters processing
· A very low processing risk developed in the late 80s when the UK-imports were slaughtered or died. It increased until 1990 because of the higher risk to be infected with BSE of cattle imported from the UK in 1988/89, as these animals could have been processed prior to the back-tracing of the UK-imports in 1990. · From 1990 to 1995 a combination of surviving non-traced UK imports and some domestic (pre-)clinical cases could have arrived at processing resulting in an assumed constant low but non-negligible processing risk. · After 1995 any processing risk relates to assumed domestic cases arriving at processing. · The fact that no domestic cases have been shown-up in the BSE-surveillance is reassuring - it indicates that BSE is in fact not present in the country at levels above the detection limits of the country's surveillance system. This detection level has been calculated according to US-experts to be between 1 & 3 clinical cases per million adult cattle per year.
Note: The high turnover in parts of the dairy cattle population with a young age at slaughter makes it unlikely that fully developed clinical cases would occur (and could be detected) or enter processing. However, the theoretical infective load of the pre-clinical BSE-cases that under this scenario could be processed, can be assumed to remain relatively low.
4.3 Risk that BSE-infectivity is recycled and propagated
· During the period covered by this assessment (1980-1999) the US-system was not able to prevent propagation of BSE should it have entered, even if this ability was significantly improved with the MBM-ban of 1997. · However, since the likelihood that BSE-infectivity entered the system is regarded to be small but non-negligible, the risk that propagation of the disease took place is also small but not negligible.
- 32 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK
5.1 The current GBR
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
5.2 The expected development of the GBR
As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent remains at the current level.
5.3 Recommendations for influencin.q the future GBR
· As long as the stability of the US system is not significantly enbanced above neutral levels it remains critically important to avoid any new external challenges. · All measures that would improve the stability of the system, in particular with regard to its ability to avoid recycling of the BSE-agent should it be present in the cattle population, would reduce, over time, the probability that cattle could be infected with the BSE-agent. Possible actions include: removal of SRMs and/or fallen stock from rendering, better rendering processes, improved compliance with the MBM-ban including control and reduction of cross-contamination. · Results from an improved intensive surveillance programme, targeting at risk sub-populations such as adult cattle in fallen stock or in emergency slaughter, could verify the current assessment.
snip...
http://www.regulations.gov/search/Regs/contentStreamer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
The most recent assessments (and reassessments) were published in June 2005 (Table I; 18), and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.
http://www.oie.int/boutique/extrait/06heim937950.pdf
Terry S. Singeltary Sr., P.O. Box 42, Bacliff, Texas USA 77518
Saturday, January 29, 2011
Atypical L-Type Bovine Spongiform Encephalopathy (L-BSE) Transmission to Cynomolgus Macaques, a Non-Human Primate
Jpn. J. Infect. Dis., 64 (1), 81-84, 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html
Tuesday, January 25, 2011
Generation of a new form of human PrPSc in vitro by inter-species transmission from cervids prions
http://chronic-wasting-disease.blogspot.com/2011/01/generation-of-new-form-of-human-prpsc.html
Friday, February 04, 2011
NMLB and USDA allow scrapie prion infected mutton to enter food chain on the Navajo Reservation in New Mexico
----- Original Message -----
From: Terry S. Singeltary Sr.
To: President.BenShelly
Cc: sroanhorse ; opvp.nelson ; alaughing; georgehardeen; pressoffice
Sent: Thursday, February 03, 2011 12:15 PM
Subject: NMLB and USDA allow scrapie prion infected mutton to enter food chain on the Navajo Reservation in New Mexico
Greetings Honorable People of the Great Navajo Nation, and the Honorable President Ben Shelly,
I send this to you with great concern. ...
BSE: TIME TO TAKE H.B. PARRY SERIOUSLY
If the scrapie agent is generated from ovine DNA and thence causes disease in other species, then perhaps, bearing in mind the possible role of scrapie in CJD of humans (Davinpour et al, 1985), scrapie and not BSE should be the notifiable disease. ...
http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1988/06/08004001.pdf
PLEASE SEE FULL TEXT PLUS TRANSMISSION STUDIES ;
http://scrapie-usa.blogspot.com/2011/02/nmlb-and-usda-allow-scrapie-prion.html
Saturday, December 18, 2010
OIE Global Conference on Wildlife Animal Health and Biodiversity - Preparing for the Future (TSE AND PRIONS) Paris (France), 23-25 February 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2010/12/oie-global-conference-on-wildlife.html
Monday, November 30, 2009
USDA AND OIE COLLABORATE TO EXCLUDE ATYPICAL SCRAPIE NOR-98 ANIMAL HEALTH CODE
http://nor-98.blogspot.com/2009/11/usda-and-oie-collaborate-to-exclude.html
http://bseusa.blogspot.com/2010/04/usda-and-oie-out-of-touch-with-risk.html
Tuesday, November 02, 2010
BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only) diagnostic criteria CVL 1992
http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html
tss
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy
Greetings List Members,
I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started.
I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so.
"They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating."
and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick.
(understand, these are taken from my notes for now. the spelling of names and such could be off.)
[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.
[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]
[host Richard] could you repeat the question?
[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
[not sure whom ask this] what group are you with?
[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.
[not sure who is speaking] could you please disconnect Mr. Singeltary
[TSS] you are not going to answer my question?
[not sure whom speaking] NO
from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;
[unknown woman] what group are you with?
[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now?
at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference.
IF i were another Country, I would take heed to my notes, BUT PLEASE do not depend on them. ask for transcript from;
RBARNS@ORA.FDA.GOV 301-827-6906
he would be glad to give you one ;-)
Rockville Maryland, Richard Barns Host
BSE issues in the U.S., How they were labelling ruminant feed? Revising issues.
The conference opened up with the explaining of the U.K. BSE epidemic winding down with about 30 cases a week.
although new cases in other countries were now appearing.
Look at Germany whom said NO BSE and now have BSE.
BSE increasing across Europe.
Because of Temporary Ban on certain rendered product, heightened interest in U.S.
A recent statement in Washington Post, said the New Administration (old GW) has a list of issues. BSE is one of the issues.
BSE Risk is still low, minimal in U.S. with a greater interest in MBM not to enter U.S.
HOWEVER, if BSE were to enter the U.S. it would be economically disastrous to the render, feed, cattle, industries, and for human health.
(human health-they just threw that in cause i was listening. I will now jot down some figures in which they told you, 'no need to write them down'. just hope i have them correct. hmmm, maybe i hope i don't ???)
80% inspection of rendering
*Problem-Complete coverage of rendering HAS NOT occurred.
sizeable number of 1st time FAILED INITIAL INSPECTION, have not been reinspected (70% to 80%).
Compliance critical, Compliance poor in U.K. and other European Firms.
Gloria Dunason Major Assignment 1998 goal TOTAL compliance. This _did not_ occur. Mixed level of compliance, depending on firm.
Rendering FDA license and NON FDA license
system in place for home rendering & feed 76% in compliance 79% cross contamination 21% DID NOT have system 92% record keeping less than 60% total compliance
279 inspectors 185 handling prohibited materials
Renderer at top of pyramid, significant part of compliance. 84% compliance
failed to have caution statement render 72% compliance & cross contamination caution statement on feed, 'DO NOT FEED TO CATTLE'
56 FIRMS NEVER INSPECTED
1240 FDA license feed mills 846 inspected
"close to 400 feed mills have not been inspected"
80% compliance for feed.
10% don't have system.
NON-FDA licensed mills There is NO inventory on non licensed mills. approximately 6000 to 8000 Firms ??? 4,344 ever inspected. "FDA does not have a lot of experience with"
40% do NOT have caution statement 'DO NOT FEED'.
74% Commingling compliance
"This industry needs a lot of work and only half gotten to"
"700 Firms that were falitive, and need to be re-inspected, in addition to the 8,000 Firms."
Quote to do BSE inspection in 19 states by end of January or 30 days, and other states 60 days. to change feed status??? Contract check and ask questions and pass info.
At this time, we will take questions.
[I was about the third or fourth to ask question. then all B.S.eee broke loose, and i lost my train of thought for a few minutes. picked back up here]
someone asking about nutritional supplements and sourcing, did not get name. something about inspectors not knowing of BSE risk??? the conference person assuring that Steve Follum? and the TSE advisory Committee were handling that.
Some other Dr. Vet, whom were asking questions that did not know what to do???
[Dennis Wilson] California Food Agr. Imports, are they looking at imports?
[Conference person] they are looking at imports, FDA issued imports Bulletin.
[Linda Singeltary ??? this was a another phone in question, not related i don't think] Why do we have non-licensed facilities?
(conference person) other feed mills do not handle as potent drugs???
Dennis Blank, Ken Jackson licensed 400 non FDA 4400 inspected of a total of 6000 to 8000,
(they really don't know how many non licensed Firms in U.S. they guess 6000 to 8000??? TSS)
Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not'
Warren-Maryland Dept. Agr. Prudent to re-inspect after 3 years. concerned of Firms that have changed owners.
THE END
TSS
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############
FROM New York TIMES
Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting of cut version...
Date: Thu, 11 Jan 2001 22:02:47 -0700
From: "Sandy Blakeslee"
To: "Terry S. Singeltary Sr."
Hi terry -- thanks for all your help. I know it made a difference with the FDA getting out that release.
----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting of cut version...
hi sandy,
From the New York Times NYTimes.com, January 11, 2001
Many Makers of Feed Fail to Heed Rules on Mad Cow Disease By SANDRA BLAKESLEE
Large numbers of companies involved in manufacturing animal feed are not complying with regulations meant to prevent the emergence and spread of mad cow disease in the United States, the Food and Drug Administration said yesterday.
The widespread failure of companies to follow the regulations, adopted in August 1997, does not mean that the American food supply is unsafe, Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at the F.D.A., said in an interview.
But much more needs to be done to ensure that mad cow disease does not arise in this country, Dr. Sundlof said.
The regulations state that feed manufacturers and companies that render slaughtered animals into useful products generally may not feed mammals to cud-chewing animals, or ruminants, which can carry mad cow disease.
All products that contain rendered cattle or sheep must have a label that says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers must also have a system to prevent ruminant products from being commingled with other rendered material like that from chicken, fish or pork. Finally, all companies must keep records of where their products originated and where they were sold.
Under the regulations, F.D.A. district offices and state veterinary offices were required to inspect all rendering plants and feed mills to make sure companies complied. But results issued yesterday demonstrate that more than three years later, different segments of the feed industry show varying levels of compliance.
Among 180 large companies that render cattle and another ruminant, sheep, nearly a quarter were not properly labeling their products and did not have a system to prevent commingling, the F.D.A. said. And among 347 F.D.A.-licensed feed mills that handle ruminant materials - these tend to be large operators that mix drugs into their products - 20 percent were not using labels with the required caution statement, and 25 percent did not have a system to prevent commingling.
Then there are some 6,000 to 8,000 feed mills so small they do not require F.D.A. licenses. They are nonetheless subject to the regulations, and of 1,593 small feed producers that handle ruminant material and have been inspected, 40 percent were not using approved labels and 25 percent had no system in place to prevent commingling.
On the other hand, fewer than 10 percent of companies, big and small, were failing to comply with the record-keeping regulations.
The American Feed Industry Association in Arlington, Va., did not return phone calls seeking comment.
http://www.nytimes.com/2001/01/11/science/11COW.html
Subject: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Wed, 10 Jan 2001 14:04:21 -0500
From: "Gomez, Thomas M."
Reply-To: Bovine Spongiform Encephalopathy
######### Bovine Spongiform Encephalopathy
USDA/APHIS would like to provide clarification on the following point from Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.
[Linda Detwiler asking everyone (me) not to use emergency BSE number, unless last resort. (i thought of calling them today, and reporting the whole damn U.S. cattle herd ;-) 'not']
Dr. Detwiler was responding to an announcement made during the call to use the FDA emergency number if anyone wanted to report a cow with signs suspect for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants to use the FDA emergency number as a last resort to report cattle suspect for BSE. What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement. Surveillance for BSE in the United States is a cooperative effort between states, producers, private veterinarians, veterinary hospitals and the USDA. The system has been in place for over 10 years. Each state has a system in place wherein cases are reported to either the State Veterinarian, the federal Veterinarian in Charge or through the veterinary diagnostic laboratory system. The states also have provisions with emergency numbers. Dr. Detwiler asked participants to use the systems currently in place to avoid the possibility of a BSE-suspect report falling through the cracks. Use of the FDA emergency number has not been established as a means to report diseased cattle of any nature.
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############
Subject: Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan.9, 2001
Date: Wed, 10 Jan 2001 13:44:49 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de References: 1
######### Bovine Spongiform Encephalopathy
Hello Mr. Thomas,
> What Mr. Singeltary failed to do was provide the List with Dr. Detwiler's entire statement.
would you and the USDA/APHIS be so kind as to supply this list with a full text version of the conference call and or post on your web-site? if so when, and thank you. if not, why not?
The system has been in place for over 10 years.
that seems to be a very long time for a system to be in place, and only test 10,700 cattle from some 1.5 BILLION head (including calf crop). Especially since French are testing some 20,000 weekly and the E.U. as a whole, are testing many many more than the U.S., with less cattle, same risk of BSE/TSEs.
Why does the U.S. insist on not doing massive testing with the tests which the E.U. are using? Why is this, please explain?
Please tell me why my question was not answered?
U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?
It was a very simple question, a very important question, one that pertained to the topic of BSE/feed, and asked in a very diplomatic way. why was it not answered?
If all these years, we have been hearing that pharmaceutical grade bovines were raised for pharmaceuticals vaccines etc. But yet the USA cannot comply with feed regulations of the ruminant feed ban, PLUS cannot even comply with the proper labelling of the feed, cross contamination etc. Then how in the world can you Guarantee the feed fed to pharmaceutical grade bovine, were actually non ruminant feed?
Before i was ask to be 'disconnected', i did hear someone in the background say 'we can't'-- have him ask the question again.
could you please be so kind, as to answer these questions?
thank you, Terry S. Singeltary Sr. Bacliff, Texas USA
P.S. if you will also notice, i did not post that emergency phone number and do not intend on passing it on to anyone. I was joking when i said i should call and report the whole damn U.S. Herd. So please pass that on to Dr. Detwiler, so she can rest easily.
BUT, they should be reported, some are infected with TSE. The U.S. is just acting as stupid as Germany and other Countries that insist they are free of BSE.
TSS
Subject: Report on the assessment of the Georgraphical BSE-risk of the USA July 2000 (not good)
Date: Wed, 17 Jan 2001 21:23:51 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
######### Bovine Spongiform Encephalopathy
Greetings List Members and ALL EU Countries,
Because of this report, and the recent findings of the 50-state BSE Conference call, I respectfully seriously suggest that these Countries and the SSC re-evaluate the U.S.A. G.B.R. to a risk factor of #3.
I attempted to post this to list in full text, but would not accept...
thank you, kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA
Report on the assessment of the Geographical BSE-risk of the USA July 2000
PART II
REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE RISK OF THE UNITED STATES OF AMERICA
- 29 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
EXECUTIVE SUMMARY
OVERALL ASSESSMENT
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
Stability: Before 1990 the system was extremely unstable because feeding of MBM to cattle happened, rendering was inappropriate with regard to deactivation of the BSE-agent and SRM and fallen stock were rendered for feed. From 1990 to 1997 it improved to very unstable, thanks to efforts undertaken to trace imported animals and exclude them from the feed chain and intensive surveillance. In 1998 the system became neutrally stable after the RMBM-ban of 1997.
External challenges: A moderate external challenge occurred in the period before 1990 because of importation of live animals from BSE-affected countries, in particular from the UK and Ireland. It cannot be excluded that some BSE-infected animals have been imported by this route and did enter the US rendering and feed production system. The efforts undertaken since 1990 to trace back UK-imported cattle and to exclude them from the feed chain reduced the impact of the external challenge significantly.
Interaction of external challenges and stability: While extremely unstable, the US system was exposed to a moderate external challenge, mainly resulting from cattle imports from the UK. It can not be excluded that BSE-infectivity entered the country by this route and has been recycled to domestic cattle. The resulting domestic cases would have been processed while the system was still very unstable or unstable and would hence have initiated a number of second or third generation cases. However, the level of the possible domestic prevalence must be below the low detection level of the surveillance in place.
As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent will remain at the current level.
JUSTIFICATION
1. DATA
The available information was suitable to carry out the GBR risk assessment.
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Report on the assessment of the Geographical BSE-risk of the USA July 2000
2. STABILITY
2.1 Overall appreciation of the ability to identify BSE-cases and to eliminate animals at risk of being infected before they are processed
· Before 1989, the ability of the system to identify (and eliminate) BSE cases was limited. · Since 1990 this ability is significantly improved, thanks to a good BSE-surveillance and culling system (contingency plan). · Today the surveillance should be able to detect clinical BSE-cases within the limits set by an essential passive surveillance system, i.e. some cases might remain undetected.
2.2 Overall appreciation of the ability to avoid recycling BSE-infectivity, should it enter processing
· Before 1997 the US rendering and feed producing system would not have been able to avoid recycling of the BSE agent to any measurable extent. If the BSE-agent was introduced the feed chain, it could probably have reached cattle. · After the introduction of the RMBM-to-ruminants-ban in August 1997 the ability of the system to avoid recycling of BSE-infectivity was somewhat increased. It is still rather low due to the rendering system of ruminant material (including SRM and fallen stock) and the persisting potential for cross-contamination of cattle feed with other feeds and hence RMBM.
2.3 Overall assessment of the Stability
· Until 1990 the US BSE/cattle system was extremely unstable as RMBM was commonly fed to cattle, the rendering system was not able to reduce BSE-infectivity and SRM were rendered. This means that incoming BSE infectivity would have been most probably recycled to cattle and amplified and the disease propagated. · Between 1990 and 1995 improvements in the BSE surveillance and the efforts to trace back and remove imported cattle gradually improved the stability but the system remained very unstable. In 1998 the system became unstable because of an RMBM-ban introduced in 1997. After 1998 the ban was fully implemented and the system is regarded to be neutrally stable since 1998. The US system is therefore seen to neither be able to amplify nor to reduce circulating or incoming BSE-infectivity.
3. CHALLENGES
A moderate external challenge occurred in the period 1980-1989 because of importation of live animals from the UK. imports from other countries are regarded to have been negligible challenges. · As a consequence of this external challenge, infectivity could have entered the feed cycle and domestic animals could have been exposed to the agent. These domestic BSE-incubating animals might have again entered processing, leading to an internal challenge since 1991. · This internal challenge could have produced domestic cases of BSE, yet prevalence levels could have been below the detection limits of the surveillance system until now. (According to US calculations, the current surveillance
-31 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
system could detect clinical incidence of 1-3 cases per year per million adult cattle, i.e. in absolute numbers 43-129 cases per year). Between 1990 und 1995, with the exclusion of the imported animals from Europe from the feed chain, the effect of the external challenges decreased.
4. CONCLUSION ON THE RESULTING RISKS
4.1 Interaction of stability and challenqe
· In the late 80s, early 90s a moderate external challenges met an extremely unstable system. This would have amplified the incoming BSE-infectivity and propagated the disease. · With the exclusion of the imported animals from Europe from the feed chain between 1990 and 1995 the effect of the external challenge decreased. · Before 1998 an internal challenge, if it developed, would have met a still unstable system (inappropriate rendering, no SRM ban, RMBM ban only after 1997) and the BSE-infectivity could have been recycled and amplified. · After 1998 the neutrally stable system could still recycle the BSE-agent but due to the RMBM-ban of 1997 the BSE-infectivity circulating in the system would probably not be amplified.
4.2 Risk that BSE-infectivity enters processing
· A very low processing risk developed in the late 80s when the UK-imports were slaughtered or died. It increased until 1990 because of the higher risk to be infected with BSE of cattle imported from the UK in 1988/89, as these animals could have been processed prior to the back-tracing of the UK-imports in 1990. · From 1990 to 1995 a combination of surviving non-traced UK imports and some domestic (pre-)clinical cases could have arrived at processing resulting in an assumed constant low but non-negligible processing risk. · After 1995 any processing risk relates to assumed domestic cases arriving at processing. · The fact that no domestic cases have been shown-up in the BSE-surveillance is reassuring - it indicates that BSE is in fact not present in the country at levels above the detection limits of the country's surveillance system. This detection level has been calculated according to US-experts to be between 1 & 3 clinical cases per million adult cattle per year.
Note: The high turnover in parts of the dairy cattle population with a young age at slaughter makes it unlikely that fully developed clinical cases would occur (and could be detected) or enter processing. However, the theoretical infective load of the pre-clinical BSE-cases that under this scenario could be processed, can be assumed to remain relatively low.
4.3 Risk that BSE-infectivity is recycled and propagated
· During the period covered by this assessment (1980-1999) the US-system was not able to prevent propagation of BSE should it have entered, even if this ability was significantly improved with the MBM-ban of 1997. · However, since the likelihood that BSE-infectivity entered the system is regarded to be small but non-negligible, the risk that propagation of the disease took place is also small but not negligible.
- 32 -
Report on the assessment of the Geographical BSE-risk of the USA July 2000
5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK
5.1 The current GBR
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely but cannot be excluded that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
5.2 The expected development of the GBR
As long as there are no changes in stability or challenge the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent remains at the current level.
5.3 Recommendations for influencin.q the future GBR
· As long as the stability of the US system is not significantly enbanced above neutral levels it remains critically important to avoid any new external challenges. · All measures that would improve the stability of the system, in particular with regard to its ability to avoid recycling of the BSE-agent should it be present in the cattle population, would reduce, over time, the probability that cattle could be infected with the BSE-agent. Possible actions include: removal of SRMs and/or fallen stock from rendering, better rendering processes, improved compliance with the MBM-ban including control and reduction of cross-contamination. · Results from an improved intensive surveillance programme, targeting at risk sub-populations such as adult cattle in fallen stock or in emergency slaughter, could verify the current assessment.
snip...
http://www.regulations.gov/search/Regs/contentStreamer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
The most recent assessments (and reassessments) were published in June 2005 (Table I; 18), and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.
http://www.oie.int/boutique/extrait/06heim937950.pdf
Terry S. Singeltary Sr., P.O. Box 42, Bacliff, Texas USA 77518
Saturday, January 29, 2011
Atypical L-Type Bovine Spongiform Encephalopathy (L-BSE) Transmission to Cynomolgus Macaques, a Non-Human Primate
Jpn. J. Infect. Dis., 64 (1), 81-84, 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html
Tuesday, January 25, 2011
Generation of a new form of human PrPSc in vitro by inter-species transmission from cervids prions
http://chronic-wasting-disease.blogspot.com/2011/01/generation-of-new-form-of-human-prpsc.html
Friday, February 04, 2011
NMLB and USDA allow scrapie prion infected mutton to enter food chain on the Navajo Reservation in New Mexico
----- Original Message -----
From: Terry S. Singeltary Sr.
To: President.BenShelly
Cc: sroanhorse ; opvp.nelson ; alaughing; georgehardeen; pressoffice
Sent: Thursday, February 03, 2011 12:15 PM
Subject: NMLB and USDA allow scrapie prion infected mutton to enter food chain on the Navajo Reservation in New Mexico
Greetings Honorable People of the Great Navajo Nation, and the Honorable President Ben Shelly,
I send this to you with great concern. ...
BSE: TIME TO TAKE H.B. PARRY SERIOUSLY
If the scrapie agent is generated from ovine DNA and thence causes disease in other species, then perhaps, bearing in mind the possible role of scrapie in CJD of humans (Davinpour et al, 1985), scrapie and not BSE should be the notifiable disease. ...
http://collections.europarchive.org/tna/20090505194948/http://bseinquiry.gov.uk/files/yb/1988/06/08004001.pdf
PLEASE SEE FULL TEXT PLUS TRANSMISSION STUDIES ;
http://scrapie-usa.blogspot.com/2011/02/nmlb-and-usda-allow-scrapie-prion.html
Saturday, December 18, 2010
OIE Global Conference on Wildlife Animal Health and Biodiversity - Preparing for the Future (TSE AND PRIONS) Paris (France), 23-25 February 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2010/12/oie-global-conference-on-wildlife.html
Monday, November 30, 2009
USDA AND OIE COLLABORATE TO EXCLUDE ATYPICAL SCRAPIE NOR-98 ANIMAL HEALTH CODE
http://nor-98.blogspot.com/2009/11/usda-and-oie-collaborate-to-exclude.html
http://bseusa.blogspot.com/2010/04/usda-and-oie-out-of-touch-with-risk.html
Tuesday, November 02, 2010
BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only) diagnostic criteria CVL 1992
http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html
tss
Monday, February 7, 2011
FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???
FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???
Informational Issue Summary
FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
Transmissible Spongiform Encephalopathies Advisory Committee 22nd Meeting October 28-29, 2010
Gaithersburg, Maryland
2
Background
Beginning in 1978, results of experimental studies repeatedly demonstrated that the infectious agents causing the transmissible spongiform encephalopathies (TSE agents or prions) are often found in the blood of infected animals, both during the incubation period and throughout overt illness. Since 1983, the FDA, issuing a series of guidances, has periodically recommended to the blood industry steps intended to reduce the theoretical risk of transmitting the infectious agents of the transmissible spongiform encephalopathies (TSEs) causing Creutzfeldt-Jakob disease (CJD) and variant CJD (vCJD) by blood and blood products. The risk of transmitting most forms of CJD by transfusions of blood components and injection of plasma derivatives, remains theoretical (see Appendices I and II), however, limited but convincing evidence strongly implicates transfusions with a blood component and injections of a human plasma-derived coagulation factor in iatrogenic transmissions of vCJD in the United Kingdom (UK). The history of FDA’s policies and of the science that informed the FDA in this area is summarized in Appendices I and II, with current FDA guidance in tabular form in Appendices V and VI. (Appendices III and IV summarize certain legislation implemented in the European Union and USDA regulations relevant to FDA blood safety policies.)
In principle, when possible, several approaches are taken to reduce the risk of transmitting infectious diseases from a blood or plasma donor to a recipient:
___________________________________________________________________________
Five “tiers” of safety for blood and components as related to CJD and vCJD (modified from Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood. US FDA Publication No. FS 02-1, February 2002
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/BloodSafety/ucm095522.htm
accessed October 2010)
___________________________________________________________________________
1. Donor screening [questionnaires]: selection of blood and plasma donors based on deferrals for medical, geographical and behavioral risk factors; deferral registries to avoid collection and use of units from identified “unsuitable” donors
2. Laboratory testing of donor blood samples for markers of blood-transmissible diseases (infectious agents)
3. Donor Deferral Registries: an additional control to avoid collecting blood or releasing blood from donors deferred as unsuitable
4. Quarantine: Donor blood [and plasma] quarantined until testing results available
5. Problems and deficiencies: manufacturing problems investigated, deficiencies corrected, FDA notified of deviations
___________________________________________________________________________
1, 3 and 5 are currently applicable to TSEs; laboratory testing (2 and 4) is not yet available for TSEs. In addition to protections listed, pathogen reduction techniques are currently under study for both conventional pathogens and TSE agents but are not yet validated, approved or available.
___________________________________________________________________________
Because no validated screening tests identify TSE-agent-infected blood and there are no US-approved devices to remove TSE infectivity from blood and blood components, CJD and vCJD safety must continue to rely on precautionary deferrals of donors at increased risk for CJD and for vCJD and withdrawal of in-date components when post-donation
3
information reveals that a donor should have been deferred; and, additionally for vCJD, withdrawal of plasma derivatives if and when a donor is found to have vCJD or possible vCJD. The FDA continues to encourage the development of donor screening tests and devices to remove the infectious agents of TSEs from blood (see below). The FDA, aware of the uncertainties surrounding the magnitude of the risk, the effectiveness of available risk-reducing measures, and the potential for contributing to shortages of life-sustaining blood products, has continued to review at frequent intervals its policies regarding CJD and vCJD. In particular, FDA blood safety policies regarding CJD and vCJD have periodically been reviewed publicly with the TSEAC, especially when new information suggested that risks should be reevaluated. In the appendices we provide additional current relevant information on risks of transfusion-transmitted and plasma-derivative-transmitted vCJD.
______________________________________________________________________________________
General approaches of FDA policies to reduce risk of transmitting CJD and vCJD by blood products
______________________________________________________________________________________ ?
Reduce risk that a donor was exposed to the agent of bovine spongiform encephalopathy (BSE)
Dietary exposure “geographic” risk-adjusted deferrals: defer some donors who resided in some BSE countries (or were potentially exposed on military bases that imported beef from UK)
Other exposure: defer donors who injected UK bovine insulin
Reduce risk that donor was exposed to vCJD agent of human origin
Defer donors with a history of transfusion in UK after 1980
Defer donors with a history of transfusion in France after 1980
Other steps were discussed at TSEAC meetings, but FDA was not advised to consider: history of transfusion in other BSE country besides UK and France after 1980; history of surgery in high-risk BSE countries after 1980 (suggested by one TSEAC member)
______________________________________________________________________________________
There have been six general bases for FDA’s recommended CJD/vCJD-related deferrals since 1983:
A. General CJD risk reduction. (1) CJD in a donor, (2) history of treatment with human cadaveric pituitary growth hormone or a dura mater allograft, and (3) history of CJD in a relative unless confirmed to be other than familial CJD or the donor PRNP genotype is found to be normal
B. vCJD risk reduction. (4) history of prolonged residence in most BSE countries (defined by USDA list of BSE-related import restrictions at 9 ) currently including UK, France or other European countries west of the Former Soviet Union (or residence/employment on a US military base in Europe during periods when beef was procured from UK), (5) history of transfusion in UK, or—more recently—history of transfusion in France, in or after 1980, and (6) injection with bovine insulin of UK origin in or after 1980
The most recent FDA CJD/vCJD-related donor deferral policies and the history of those are explained in full in FDA guidance issued on May 10, 2010
(http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf),
including minor modifications of the guidance of January 12, 2002. The following is a reduced summary of the essential features of the policy:
______________________________________________________________________________________
4
Summary of Current FDA CJD/vCJD-related Recommendations for Deferral of Blood Donors and Plasma Donors (see FDA guidance document issued May 10, 2010 at
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf)
______________________________________________________________________________________
Indefinitely defer all donors of Whole Blood and Source Plasma who
have any form of CJD or are at increased risk of CJD (received dura mater allograft, were injected with human cadaveric pituitary growth hormone, have a relative with CJD unless familial CJD has been ruled out
spent 3 mo in UK from Jan 1, 1980 to Dec 31, 1996, or
who ever had blood transfusion in UK or in France from 1980 to present, or
who ever injected UK bovine insulin prepared in or after 1980, or
spent 5 yr in France from Jan 1, 1980 to the present
spent 6 mo on US military bases from Jan 1, 1980 to end of 1990 north of Alps or end of 1996 south of Alps Indefinitely defer all donors of Whole Blood but not donors of Source Plasma who
spent 5 yr in Europe from Jan 1, 1980 to the present (including time in spent in UK 1980-1996 and France 1980-present) Exempt from deferrals are
Donors of Source Plasma who spent time of any duration in Europe except UK and France
Donors of plasma/serum to manufacture FDA-approved non-injectable products (appropriately labeled per guidance of May 10, 2010)
______________________________________________________________________________________
The FDA-recommended CJD/vCJD-related blood safety policies are intended to reduce the risk that a blood or plasma donor might be incubating CJD of any kind while not deferring so many donors as to compromise the supply of blood products. The FDA’s assessment in advance of the January 2002 guidance estimated that the recommended deferral policy would reduce donor risk of dietary exposure to BSE agent by approximately 90% while deferring some 7% of otherwise suitable blood donors. The 2010 guidance—adding a deferral of donors transfused in France from 1980 to the present, as previously recommended for donors transfused in the UK—while reducing the risk of transfusion-transmitted vCJD by only a small amount, is expected to defer very few donors who would not have been previously deferred because they resided in France for five years or more.
As always, blood and plasma establishments may implement additional more stringent requirements. If they choose to do so, FDA encourages them to assess the possibility that such actions will contribute to shortages and to undertake preemptive donor recruitment efforts to prevent shortages. Recognition by FDA of USDA BSE-related import restrictions under 9 CFR 94.18 as a basis for FDA donor deferral policies. Since the FDA’s 1999 guidance, the FDA has acknowledged the USDA’s list of countries under restriction for the importation of live cattle and beef products into the US at 9 CFR 94.18 (“USDA BSE List” summarized in Appendix V) as a basis for identifying countries with increased risk of human food-
5
associated exposure to the BSE agent; most of the countries currently on the USDA BSE list are also listed on the current FDA donor deferral list (see Appendix IV), with three exceptions: the FDA has concluded that time spent in the UK after the end of 1996 should no longer pose an unacceptable risk of food-borne exposure to donors because of stringent food and animal feed controls implemented in the UK by that time; those measures were described at a TSEAC meeting
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf
Time spent in Israel (one case of BSE reported in 2001) and Japan (36 cases of BSE detected from 2001 through 2009) have not been taken as a reason to defer blood donors; FDA had no information to predict the number of otherwise suitable donors who would be deferred because of time spent in Israel or Japan, and FDA had concern that those numbers might be substantial in certain areas of the US.
Prospects for future modifications of FDA blood and plasma deferral policies to reduce the Possible Risk of Transmitting Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
Prospects for donor screening tests. As mentioned above, the FDA recognizes the potential value of practical blood tests to detect and defer infected donors of blood and plasma during the asymptomatic incubation periods of vCJD and CJD. FDA continues to encourage the development and validation of such tests and has several times arranged for developers of candidate tests present interim progress reports of their investigations at open meetings of TSEAC and received advice from TSEAC regarding possible pathways leading to FDA licensure of validated donor screening tests
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t2.pdf
Effective testing would be a particularly attractive option for interdicting donors incubating forms of CJD other than vCJD, because no cases of transfusion-transmitted CJD or plasma-derivative-transmitted CJD have been detected in a lookback study (Dorsey, Zou et al. 2009), and many donors currently deferred because of risk factors for CJD might be re-entered if validated screening tests with high negative predictive values were not reactive. At the moment, no blood test has been validated as suitable for donor screening
http://biotuesday.ca/2010/05/31/amorfix-suspends-blood-testing-for-vcjd
Prospects for prion-protein and infectivity removal devices. Three TSE infectivity reduction devices, in development, have targeted the RBC component of Whole Blood. Two of the devices both deplete white blood cells (leukoreduction [LR]) and reduce the content of TSE agents in pilot studies. One of these devices is a modified LR filter containing several layers of prion-protein-removing material (Sowemimo-Coker, Demczyk et al. 2010. The second manufacturer is developing a combined LR and prion removal device (Miura M, Nirasawa H et al. in Abstracts of the AABB Meeting, 2006 SP221. Evaluation of a new combination filter for prion and leukoreduction (LR) of red cell concentrates (RCC), accessible at
http://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2006.01023_1.x/pdf
The third filter is applied to leukoreduced RBC; the active component is a proprietary ligand claimed to adsorb both brain-derived and endogenous blood infectivity (Gregori, Gurgel et al. 2006). This filter was evaluated for safety and impact on component quality in the UK (Cahill, Murphy et al 2010; Wiltshire, Thomas et al. 2010). In April 2009 an independent UK Advisory Committee on Safety of Blood, Tissues and Organs (SaBTO recommended that “ …UK blood services … prepare to enable implementation of Prion filtration as soon as
6
practicable, should a final recommendation to do so be made.”
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_099922.pdf
and later, in October 2009, recommended, with reservations, that “… filtered red cells be provided to those born since 1 January 1996, subject to satisfactory completion of …[an ongoing]… clinical trial”
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_108860.pdf
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_112477.pdf
—presumably because the risk of food-borne exposure to the BSE agent should be considerably less in younger than for older UK residents, for whom the reduced risk offered by filtration might be more difficult to justify. No “prion filter” device has been licensed for use in the US. Representatives of the sponsors developing the three devices are to describe some of their findings at the FDA TSE Advisory Committee meeting on October 29, 2010
(http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm225805.htm).
Implementation of measures to reduce dietary risk of exposure to the BSE agent in countries other that the UK. As presented to the 21st meeting of TSEAC on June 12, 2009
(http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM171810.pdf),
the European Commission (EC) has promulgated legislation (EC Regulation 999, 2001) obligatory throughout the European Union (EU) requiring implementation of a number of BSE-risk-reducing steps (see Appendix IV) similar to those implemented earlier in the UK (Appendix IV). The FDA has, with some exceptions, based recommendations to defer blood and plasma donors at increased risk of BSE exposure on the USDA import restriction list at 9 CFR 94.18 to determine when those steps have been adequately and uniformly implemented in various countries.
International recognition of BSE status of countries and of the declining BSE epidemics. The EC Scientific Steering Committee, in January 2000, recommended grouping countries based on their geographical BSE risk (GBR)
http://ec.europa.eu/food/fs/sc/ssc/out68_en.pdf
Four groups were recognized:
GBR I: highly unlikely to have BSE;
GBR II: unlikely but not excluded;
GBR III: likely but not confirmed or confirmed at a low level; GBR IV: confirmed at a high level. That system for evaluating BSE risk was once widely used but is no longer supported.
The World Organisation for Animal Health (OIE) subsequently developed a system to evaluate national BSE risk based on voluntary submissions of information to an ad hoc committee for BSE status based on five main criteria used to assess the BSE risk for the cattle population of a country: risk assessment for BSE occurrence; on-going program to encourage reporting of neurological diseases in adult cattle; compulsory notification and investigation of all cattle showing BSE-like symptoms; BSE active surveillance; testing of cattle brain or other tissues. The OIE currently assigns to each country one of three BSE risk categories: negligible, controlled or undetermined (for those countries that either did not apply or failed to be classified). As of May 2010, 47 countries had been assigned a BSE risk status by the OIE: 13 countries (including three on the USDA BSE
7
Import Restriction List) had been assigned negligible BSE risk status, and 34 countries, including the US and Canada, were recognized as having controlled BSE risk—the same risk status assigned to most European countries including the UK and France (http://www.oie.int/eng/Status/BSE/en_BSE_free.htm). The FDA welcomes efforts to improve estimates of relative risk for exposure to the BSE agent in beef products of various national origins and to develop an international BSE risk evaluation system acceptable to US authorities and those of other countries. ...
snip...see full text ;
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM231179.pdf
When the OIE and the USDA et al collaborated to make legal the trading of Transmissible Spongiform Encephalopathy, when they did away with the BSE GBR risk assessments, where the USA, Canada, and Mexico were categorized as BSE GBR III.
please see ;
EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902594180.htm
Annex to the EFSA Scientific Report (2004) 3, 1-17 on the Assessment of the Geographical BSE Risk of USA
please see full text ;
http://www.efsa.europa.eu/en/scdocs/doc/3rax1.pdf
October 28-29, 2010:
Transmissible Spongiform Encephalopathies Advisory Committee Meeting References Document Posted: 10/26/2010
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm231016.htm
October 28-29, 2010:
Transmissible Spongiform Encephalopathies Advisory Committee Meeting A 2010 Update of the Draft Quantitative Risk Assessment of vCJD Risk Potentially Associated with the Use of Human Plasma-Derived Factor VIII Manufactured Under United States (US) License From Plasma Collected in the US (PDF - 662KB) Posted: 10/26/2010
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm231016.htm
October 28-29, 2010:
Transmissible Spongiform Encephalopathies Advisory Committee Meeting Document: APPENDIX A Supplemental technical information for the FDA Risk Assessment (PDF - 307KB) Posted: 10/26/2010 Roster of the Transmissible Spongiform Encephalopathies Advisory Committee Updated: 10/22/2010
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM231019.pdf
Roster of the Transmissible Spongiform Encephalopathies Advisory Committee Updated: 10/22/2010
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm129556.htm
Tuesday, September 14, 2010
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)
----- Original Message -----
http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html
----- Original Message -----
From: Emery, Bryan (CBER)
To: CBER OCOD Consumer Account ; 'flounder9@verizon.net'
Sent: Friday, September 17, 2010 10:08 AM
Subject: FW: Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)
Hi Terry,
Thank you for your comments related to the Transmissible Spongiform Encephalopathy's Advisory Committee meeting on October 28-29, 2010.
Your comments will be provided to the Committee.
Thanks
Bryan Emery
Subject: Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010
Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512392.
http://edocket.access.gpo.gov/2010/2010-22805.htm
snip...end...full text ;
http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html
Monday, October 18, 2010
TSEAC Transmissible Spongiform Encephalopathies Advisory Committee Draft Agenda and Meeting Materials, Posted: 10/18/2010
http://tseac.blogspot.com/2010/10/tseac-transmissible-spongiform.html
__._,_.___
Tuesday, September 14, 2010
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010
http://tseac.blogspot.com/2010/09/transmissible-spongiform.html
----- Original Message -----
From: Emery, Bryan (CBER) To: 'Terry S. Singeltary Sr.'
Cc: Emery, Bryan (CBER)
Sent: Monday, January 24, 2011 7:35 AM
Subject: RE: October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee
Hi Terry,
The minutes have not been my primary focus at this time but when they are completed they will be put online for the public. I have nothing to hide just very busy as of late. Thank you for your interest, I hope to see you again soon.
Thanks LCDR Bryan Emery
--------------------------------------------------------------------------------
From: Terry S. Singeltary Sr. [mailto:flounder9@verizon.net]
Sent: Wednesday, January 19, 2011 1:03 PM
To: Emery, Bryan (CBER)
Subject: October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee
re-October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee
Greetings Dr. Emery,
I am trying to locate the minutes or draft minutes of the October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee meeting ???
seems they are long overdue to be put online.
can you please tell me when and if they are going to be made public ???
many thanks,
kindest regards, terry
Tuesday, January 18, 2011
Agent strain variation in human prion disease: insights from a molecular and pathological review of the National Institutes of Health series of experimentally transmitted disease
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/agent-strain-variation-in-human-prion.html
sadly, by only trying to reduce exposure from only nvCJD, they are seriously missing the bigger picture. hell, now we have mixtures of different phenotypes in one species, what about transmission of the TSE agent via mulitple phenotypes from one donor ??? transmission studies ??? etc. .......they missed the boat a long time ago. i believe i said in 2001 ;
"I am beginning to think that the endless attempt to track down and ban, potentia.1 victims from known BSE Countries from giving blood will be futile. You would have to ban everyone on the Globe eventually? AS well, I think we MUST ACT SWIFTLY to find blood test for TSE's, whether it be blood test, urine test, .eyelid test, anything at whatever cost, we need a test FAST."
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
end...tss
Saturday, September 5, 2009
TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS
http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html
From: Terry S. Singeltary Sr.
To: FREAS@CBER.FDA.GOV
Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov
Sent: Friday, December 01, 2006 2:59 PM
Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION PART III]
page 1 starts on page 13, then come back to page 1 to finish.....tss
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
World's first blood test for vCJD developed in MRC lab
Thursday 3 February 2011
The world's first accurate blood test for variant Creutzfeldt-Jakob disease (vCJD) has been developed by Medical Research Council (MRC) scientists. The prototype, which is 100,000 times more sensitive than any previous attempt, could transform the diagnosis and screening of the brain disease.
Variant CJD, the human form of BSE (or mad cow disease) first emerged in 1995. The disease, which affects the brain, is believed to have passed from cattle to humans through infected food. It causes personality change, loss of body function, and eventually death.
The research team from the MRC Prion Unit, based at University College London, working with the National Prion Clinic at the National Hospital for Neurology and Neurosurgery (NHNN) tested 190 blood samples, including 21 from individuals known to have vCJD. The blood test was able to detect blood spiked with a dilution of vCJD to within one part per ten billion - 100,000 times more sensitive than any other method developed so far.
Prions, the infectious proteins which cause vCJD and other fatal prion diseases, can inhabit a person's body for up to 50 years before presenting symptoms. During this time there is a chance a carrier of vCJD infection could pass on the infection to others, for example through blood transfusion or even through surgical and medical instruments as prions can easily attach onto metal surfaces.
A widely available, accurate blood test would enable people to be diagnosed earlier and could also help identify carriers of the disease. This would help measure how widespread the prion infection is in the general population and identify those who are at risk of passing on the infection to others.
Lead author Dr Graham Jackson, Programme Leader at the MRC Prion Unit, said:
"This test comes at the end of many years of meticulous, painstaking research in our Unit and the NHS National Prion Clinic. Although further larger studies are needed to confirm its effectiveness, it's the best hope yet of a successful early diagnostic test for the disease. This test could potentially go on to allow blood services to screen the population for vCJD infection, assess how many people in the UK are silent carriers and prevent onward transmission of the disease."
Professor John Collinge, Director of the MRC Prion Unit, said:
"One of the reasons that vCJD is such a dreaded disease and has caused such disruption and expense to health services is the lack of knowledge of who is and who is not a carrier of this infection. The next step will be to test anonymously several thousand blood donors from a country unaffected by BSE in order to gain a better idea of how the test fares in practice. Longer term studies will also be needed to assess what proportion of individuals who test positive for prion infection will then go on to develop the disease later in life.
"The MRC Prion Unit's research with the NHS National Prion Clinic to improve early diagnosis is an essential part of the wider MRC strategy to develop better treatments for patients. For this to develop, it will be crucial for clinicians to be able to offer treatment before extensive irreversible damage to the brain has occurred. At the moment, a firm diagnosis of vCJD can usually be made only once serious symptoms of the disease have developed which indicate extensive damage to the brain."
The study 'A blood-based assay for the detection of vCJD prion infection' is published today in the journal The Lancet.
Ends
Notes to editors:
To arrange an interview with the researchers of this paper, please call the MRC Press Office on 0207 395 2345.
For almost 100 years the Medical Research Council has improved the health of people in the UK and around the world by supporting the highest quality science. The MRC invests in world-class scientists. It has produced 29 Nobel Prize winners and sustains a flourishing environment for internationally recognised research. The MRC focuses on making an impact and provides the financial muscle and scientific expertise behind medical breakthroughs, including one of the first antibiotics penicillin, the structure of DNA and the lethal link between smoking and cancer. Today MRC funded scientists tackle research into the major health challenges of the 21st century. www.mrc.ac.uk
While the number of vCJD samples available for analysis was inherently small, and to date only a small number of healthy donors has been studied, analysis of this blinded panel indicated an assay sensitivity for vCJD of over 71% (15/21, CI 48-89%) and a specificity of 100% (0/169, CI 98-100%).
The NHNN forms part of University College London Hospitals NHS Foundation Trust, one of the largest NHS trusts in the United Kingdom providing first-class acute and specialist services. The Trust is committed to research and development and forms part of UCL Partners which in March 2009 was officially designated as one of the UK's first academic health science centres by the Department of Health. UCLH works closely with UCL, translating research into treatments for patients. www.uclh.nhs.uk
http://www.mrc.ac.uk/Newspublications/News/MRC007683
Wednesday, February 2, 2011
Detection of prion infection in variant Creutzfeldt-Jakob disease: a blood-based assay
http://transmissiblespongiformencephalopathy.blogspot.com/2011/02/detection-of-prion-infection-in-variant.html
Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America
14th ICID International Scientific Exchange Brochure -
Final Abstract Number: ISE.114
Session: International Scientific Exchange
Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America
update October 2009
T. Singeltary
Bacliff, TX, USA
Background:
An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and fed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.
Methods:
12 years independent research of available data
Results:
I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.
Conclusion:
I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.
page 114 ;
http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf
International Society for Infectious Diseases Web: http://www.isid.org/
please see full text ;
http://transmissiblespongiformencephalopathy.blogspot.com/
Seven main threats for the future linked to prions
The NeuroPrion network has identified seven main threats for the future linked to prions.
First threat
The TSE road map defining the evolution of European policy for protection against prion diseases is based on a certain numbers of hypotheses some of which may turn out to be erroneous. In particular, a form of BSE (called atypical Bovine Spongiform Encephalopathy), recently identified by systematic testing in aged cattle without clinical signs, may be the origin of classical BSE and thus potentially constitute a reservoir, which may be impossible to eradicate if a sporadic origin is confirmed. Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases constitute an unforeseen first threat that could sharply modify the European approach to prion diseases.
Second threat
snip...
http://www.neuroprion.org/en/np-neuroprion.html
Wednesday, March 31, 2010
Atypical BSE in Cattle
To date the OIE/WAHO assumes that the human and animal health standards set out in the BSE chapter for classical BSE (C-Type) applies to all forms of BSE which include the H-type and L-type atypical forms. This assumption is scientifically not completely justified and accumulating evidence suggests that this may in fact not be the case. Molecular characterization and the spatial distribution pattern of histopathologic lesions and immunohistochemistry (IHC) signals are used to identify and characterize atypical BSE. Both the L-type and H-type atypical cases display significant differences in the conformation and spatial accumulation of the disease associated prion protein (PrPSc) in brains of afflicted cattle. Transmission studies in bovine transgenic and wild type mouse models support that the atypical BSE types might be unique strains because they have different incubation times and lesion profiles when compared to C-type BSE. When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures.
This study will contribute to a correct definition of specified risk material (SRM) in atypical BSE. The incumbent of this position will develop new and transfer existing, ultra-sensitive methods for the detection of atypical BSE in tissue of experimentally infected cattle.
http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2
Saturday, January 29, 2011
Atypical L-Type Bovine Spongiform Encephalopathy (L-BSE) Transmission to Cynomolgus Macaques, a Non-Human Primate
Jpn. J. Infect. Dis., 64 (1), 81-84, 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html
Tuesday, November 02, 2010
BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only) diagnostic criteria CVL 1992
http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html
Wednesday, July 28, 2010
Atypical prion proteins and IBNC in cattle DEFRA project code SE1796 FOIA Final report
http://bse-atypical.blogspot.com/2010/07/atypical-prion-proteins-and-ibnc-in.html
Thursday, November 18, 2010
UNITED STATES OF AMERICA VS GALEN J. NIEHUES FAKED MAD COW FEED TEST ON 92 BSE INSPECTION REPORTS FOR APPROXIMATELY 100 CATTLE OPERATIONS
http://bse-atypical.blogspot.com/2010/11/united-states-of-america-vs-galen-j.html
Friday, August 27, 2010
NEW ATYPICAL NOR-98 SCRAPIE CASE DETECTED IDAHO NOW 5 CASES DOCUMENTED 2010
http://nor-98.blogspot.com/2010/08/new-atypical-nor-98-scrapie-case.html
Thursday, August 19, 2010
SCRAPIE CANADA UPDATE Current as of 2010-07-31 The following table lists sheep flocks and/or goat herds confirmed to be infected with scrapie in Canada in 2010.
Current as of: 2010-07-31
http://nor-98.blogspot.com/2010/08/scrapie-canada-update-current-as-of.html
the OIE and the USDA systematically changed the science with the BSE MRR policy, and put everyone around the globe at risk by taking us back to ground zero 1984-1985 kent bse cow.
Saturday, June 19, 2010
U.S. DENIED UPGRADED BSE STATUS FROM OIE
http://usdameatexport.blogspot.com/2010/06/us-denied-upgraded-bse-status-from-oie.html
Tuesday, January 25, 2011
Generation of a new form of human PrPSc in vitro by inter-species transmission from cervids prions
http://chronic-wasting-disease.blogspot.com/2011/01/generation-of-new-form-of-human-prpsc.html
Wednesday, September 08, 2010
CWD PRION CONGRESS SEPTEMBER 8-11 2010
http://chronic-wasting-disease.blogspot.com/2010/09/cwd-prion-2010.html
Friday, February 04, 2011
NMLB and USDA allow scrapie prion infected mutton to enter food chain on the Navajo Reservation in New Mexico
http://scrapie-usa.blogspot.com/2011/02/nmlb-and-usda-allow-scrapie-prion.html
Wednesday, January 19, 2011
EFSA and ECDC review scientific evidence on possible links between TSEs in animals and humans Webnachricht 19 Januar 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/efsa-and-ecdc-review-scientific.html
Tuesday, January 18, 2011
Agent strain variation in human prion disease: insights from a molecular and pathological review of the National Institutes of Health series of experimentally transmitted disease
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/agent-strain-variation-in-human-prion.html
Tuesday, December 14, 2010
Infection control of CJD, vCJD and other human prion diseases in healthcare and community settings part 4, Annex A1, Annex J, UPDATE DECEMBER 2010
http://creutzfeldt-jakob-disease.blogspot.com/2010/12/infection-control-of-cjd-vcjd-and-other.html
Sunday, January 30, 2011
Vaccines and Transmissible Spongiform Encephalopathy the Prion Disease, what if ?
COMMERCIAL IN CONFIDENCE
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/vaccines-and-transmissible-spongiform.html
strictly NOT private and confidential $$$
Saturday, January 22, 2011
Alzheimer's, Prion, and Neurological disease, and the misdiagnosis there of, a review 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/alzheimers-prion-and-neurological.html
Monday, September 13, 2010
atypical BSE strains and sporadic CJD strains, is there a connection and why shouldn't there be $
http://bse-atypical.blogspot.com/2010/09/atypical-bse-strains-and-sporadic-cjd.html
Sunday, August 15, 2010
ATYPICAL BSE NOW LINKED TO CAUSING SPORADIC CJD OVERSEAS Commonwealth of Australia
http://bse-atypical.blogspot.com/2010/08/atypical-bse-now-linked-to-causing.html
Thursday, July 08, 2010
GLOBAL CLUSTERS OF CREUTZFELDT JAKOB DISEASE - A REVIEW 2010
http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html
DID EVERYONE THAT LOST A LOVED ONE FILL OUT THEIR CJD QUESIONNAIRE FROM THE CDC AND OR THE CJD FOUNDATION ???
Friday, November 30, 2007
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION
http://cjdquestionnaire.blogspot.com/
TSS
Informational Issue Summary
FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
Transmissible Spongiform Encephalopathies Advisory Committee 22nd Meeting October 28-29, 2010
Gaithersburg, Maryland
2
Background
Beginning in 1978, results of experimental studies repeatedly demonstrated that the infectious agents causing the transmissible spongiform encephalopathies (TSE agents or prions) are often found in the blood of infected animals, both during the incubation period and throughout overt illness. Since 1983, the FDA, issuing a series of guidances, has periodically recommended to the blood industry steps intended to reduce the theoretical risk of transmitting the infectious agents of the transmissible spongiform encephalopathies (TSEs) causing Creutzfeldt-Jakob disease (CJD) and variant CJD (vCJD) by blood and blood products. The risk of transmitting most forms of CJD by transfusions of blood components and injection of plasma derivatives, remains theoretical (see Appendices I and II), however, limited but convincing evidence strongly implicates transfusions with a blood component and injections of a human plasma-derived coagulation factor in iatrogenic transmissions of vCJD in the United Kingdom (UK). The history of FDA’s policies and of the science that informed the FDA in this area is summarized in Appendices I and II, with current FDA guidance in tabular form in Appendices V and VI. (Appendices III and IV summarize certain legislation implemented in the European Union and USDA regulations relevant to FDA blood safety policies.)
In principle, when possible, several approaches are taken to reduce the risk of transmitting infectious diseases from a blood or plasma donor to a recipient:
___________________________________________________________________________
Five “tiers” of safety for blood and components as related to CJD and vCJD (modified from Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood. US FDA Publication No. FS 02-1, February 2002
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/BloodSafety/ucm095522.htm
accessed October 2010)
___________________________________________________________________________
1. Donor screening [questionnaires]: selection of blood and plasma donors based on deferrals for medical, geographical and behavioral risk factors; deferral registries to avoid collection and use of units from identified “unsuitable” donors
2. Laboratory testing of donor blood samples for markers of blood-transmissible diseases (infectious agents)
3. Donor Deferral Registries: an additional control to avoid collecting blood or releasing blood from donors deferred as unsuitable
4. Quarantine: Donor blood [and plasma] quarantined until testing results available
5. Problems and deficiencies: manufacturing problems investigated, deficiencies corrected, FDA notified of deviations
___________________________________________________________________________
1, 3 and 5 are currently applicable to TSEs; laboratory testing (2 and 4) is not yet available for TSEs. In addition to protections listed, pathogen reduction techniques are currently under study for both conventional pathogens and TSE agents but are not yet validated, approved or available.
___________________________________________________________________________
Because no validated screening tests identify TSE-agent-infected blood and there are no US-approved devices to remove TSE infectivity from blood and blood components, CJD and vCJD safety must continue to rely on precautionary deferrals of donors at increased risk for CJD and for vCJD and withdrawal of in-date components when post-donation
3
information reveals that a donor should have been deferred; and, additionally for vCJD, withdrawal of plasma derivatives if and when a donor is found to have vCJD or possible vCJD. The FDA continues to encourage the development of donor screening tests and devices to remove the infectious agents of TSEs from blood (see below). The FDA, aware of the uncertainties surrounding the magnitude of the risk, the effectiveness of available risk-reducing measures, and the potential for contributing to shortages of life-sustaining blood products, has continued to review at frequent intervals its policies regarding CJD and vCJD. In particular, FDA blood safety policies regarding CJD and vCJD have periodically been reviewed publicly with the TSEAC, especially when new information suggested that risks should be reevaluated. In the appendices we provide additional current relevant information on risks of transfusion-transmitted and plasma-derivative-transmitted vCJD.
______________________________________________________________________________________
General approaches of FDA policies to reduce risk of transmitting CJD and vCJD by blood products
______________________________________________________________________________________ ?
Reduce risk that a donor was exposed to the agent of bovine spongiform encephalopathy (BSE)
Dietary exposure “geographic” risk-adjusted deferrals: defer some donors who resided in some BSE countries (or were potentially exposed on military bases that imported beef from UK)
Other exposure: defer donors who injected UK bovine insulin
Reduce risk that donor was exposed to vCJD agent of human origin
Defer donors with a history of transfusion in UK after 1980
Defer donors with a history of transfusion in France after 1980
Other steps were discussed at TSEAC meetings, but FDA was not advised to consider: history of transfusion in other BSE country besides UK and France after 1980; history of surgery in high-risk BSE countries after 1980 (suggested by one TSEAC member)
______________________________________________________________________________________
There have been six general bases for FDA’s recommended CJD/vCJD-related deferrals since 1983:
A. General CJD risk reduction. (1) CJD in a donor, (2) history of treatment with human cadaveric pituitary growth hormone or a dura mater allograft, and (3) history of CJD in a relative unless confirmed to be other than familial CJD or the donor PRNP genotype is found to be normal
B. vCJD risk reduction. (4) history of prolonged residence in most BSE countries (defined by USDA list of BSE-related import restrictions at 9 ) currently including UK, France or other European countries west of the Former Soviet Union (or residence/employment on a US military base in Europe during periods when beef was procured from UK), (5) history of transfusion in UK, or—more recently—history of transfusion in France, in or after 1980, and (6) injection with bovine insulin of UK origin in or after 1980
The most recent FDA CJD/vCJD-related donor deferral policies and the history of those are explained in full in FDA guidance issued on May 10, 2010
(http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf),
including minor modifications of the guidance of January 12, 2002. The following is a reduced summary of the essential features of the policy:
______________________________________________________________________________________
4
Summary of Current FDA CJD/vCJD-related Recommendations for Deferral of Blood Donors and Plasma Donors (see FDA guidance document issued May 10, 2010 at
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf)
______________________________________________________________________________________
Indefinitely defer all donors of Whole Blood and Source Plasma who
have any form of CJD or are at increased risk of CJD (received dura mater allograft, were injected with human cadaveric pituitary growth hormone, have a relative with CJD unless familial CJD has been ruled out
spent 3 mo in UK from Jan 1, 1980 to Dec 31, 1996, or
who ever had blood transfusion in UK or in France from 1980 to present, or
who ever injected UK bovine insulin prepared in or after 1980, or
spent 5 yr in France from Jan 1, 1980 to the present
spent 6 mo on US military bases from Jan 1, 1980 to end of 1990 north of Alps or end of 1996 south of Alps Indefinitely defer all donors of Whole Blood but not donors of Source Plasma who
spent 5 yr in Europe from Jan 1, 1980 to the present (including time in spent in UK 1980-1996 and France 1980-present) Exempt from deferrals are
Donors of Source Plasma who spent time of any duration in Europe except UK and France
Donors of plasma/serum to manufacture FDA-approved non-injectable products (appropriately labeled per guidance of May 10, 2010)
______________________________________________________________________________________
The FDA-recommended CJD/vCJD-related blood safety policies are intended to reduce the risk that a blood or plasma donor might be incubating CJD of any kind while not deferring so many donors as to compromise the supply of blood products. The FDA’s assessment in advance of the January 2002 guidance estimated that the recommended deferral policy would reduce donor risk of dietary exposure to BSE agent by approximately 90% while deferring some 7% of otherwise suitable blood donors. The 2010 guidance—adding a deferral of donors transfused in France from 1980 to the present, as previously recommended for donors transfused in the UK—while reducing the risk of transfusion-transmitted vCJD by only a small amount, is expected to defer very few donors who would not have been previously deferred because they resided in France for five years or more.
As always, blood and plasma establishments may implement additional more stringent requirements. If they choose to do so, FDA encourages them to assess the possibility that such actions will contribute to shortages and to undertake preemptive donor recruitment efforts to prevent shortages. Recognition by FDA of USDA BSE-related import restrictions under 9 CFR 94.18 as a basis for FDA donor deferral policies. Since the FDA’s 1999 guidance, the FDA has acknowledged the USDA’s list of countries under restriction for the importation of live cattle and beef products into the US at 9 CFR 94.18 (“USDA BSE List” summarized in Appendix V) as a basis for identifying countries with increased risk of human food-
5
associated exposure to the BSE agent; most of the countries currently on the USDA BSE list are also listed on the current FDA donor deferral list (see Appendix IV), with three exceptions: the FDA has concluded that time spent in the UK after the end of 1996 should no longer pose an unacceptable risk of food-borne exposure to donors because of stringent food and animal feed controls implemented in the UK by that time; those measures were described at a TSEAC meeting
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf
Time spent in Israel (one case of BSE reported in 2001) and Japan (36 cases of BSE detected from 2001 through 2009) have not been taken as a reason to defer blood donors; FDA had no information to predict the number of otherwise suitable donors who would be deferred because of time spent in Israel or Japan, and FDA had concern that those numbers might be substantial in certain areas of the US.
Prospects for future modifications of FDA blood and plasma deferral policies to reduce the Possible Risk of Transmitting Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
Prospects for donor screening tests. As mentioned above, the FDA recognizes the potential value of practical blood tests to detect and defer infected donors of blood and plasma during the asymptomatic incubation periods of vCJD and CJD. FDA continues to encourage the development and validation of such tests and has several times arranged for developers of candidate tests present interim progress reports of their investigations at open meetings of TSEAC and received advice from TSEAC regarding possible pathways leading to FDA licensure of validated donor screening tests
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t2.pdf
Effective testing would be a particularly attractive option for interdicting donors incubating forms of CJD other than vCJD, because no cases of transfusion-transmitted CJD or plasma-derivative-transmitted CJD have been detected in a lookback study (Dorsey, Zou et al. 2009), and many donors currently deferred because of risk factors for CJD might be re-entered if validated screening tests with high negative predictive values were not reactive. At the moment, no blood test has been validated as suitable for donor screening
http://biotuesday.ca/2010/05/31/amorfix-suspends-blood-testing-for-vcjd
Prospects for prion-protein and infectivity removal devices. Three TSE infectivity reduction devices, in development, have targeted the RBC component of Whole Blood. Two of the devices both deplete white blood cells (leukoreduction [LR]) and reduce the content of TSE agents in pilot studies. One of these devices is a modified LR filter containing several layers of prion-protein-removing material (Sowemimo-Coker, Demczyk et al. 2010. The second manufacturer is developing a combined LR and prion removal device (Miura M, Nirasawa H et al. in Abstracts of the AABB Meeting, 2006 SP221. Evaluation of a new combination filter for prion and leukoreduction (LR) of red cell concentrates (RCC), accessible at
http://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2006.01023_1.x/pdf
The third filter is applied to leukoreduced RBC; the active component is a proprietary ligand claimed to adsorb both brain-derived and endogenous blood infectivity (Gregori, Gurgel et al. 2006). This filter was evaluated for safety and impact on component quality in the UK (Cahill, Murphy et al 2010; Wiltshire, Thomas et al. 2010). In April 2009 an independent UK Advisory Committee on Safety of Blood, Tissues and Organs (SaBTO recommended that “ …UK blood services … prepare to enable implementation of Prion filtration as soon as
6
practicable, should a final recommendation to do so be made.”
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_099922.pdf
and later, in October 2009, recommended, with reservations, that “… filtered red cells be provided to those born since 1 January 1996, subject to satisfactory completion of …[an ongoing]… clinical trial”
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_108860.pdf
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_112477.pdf
—presumably because the risk of food-borne exposure to the BSE agent should be considerably less in younger than for older UK residents, for whom the reduced risk offered by filtration might be more difficult to justify. No “prion filter” device has been licensed for use in the US. Representatives of the sponsors developing the three devices are to describe some of their findings at the FDA TSE Advisory Committee meeting on October 29, 2010
(http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm225805.htm).
Implementation of measures to reduce dietary risk of exposure to the BSE agent in countries other that the UK. As presented to the 21st meeting of TSEAC on June 12, 2009
(http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM171810.pdf),
the European Commission (EC) has promulgated legislation (EC Regulation 999, 2001) obligatory throughout the European Union (EU) requiring implementation of a number of BSE-risk-reducing steps (see Appendix IV) similar to those implemented earlier in the UK (Appendix IV). The FDA has, with some exceptions, based recommendations to defer blood and plasma donors at increased risk of BSE exposure on the USDA import restriction list at 9 CFR 94.18 to determine when those steps have been adequately and uniformly implemented in various countries.
International recognition of BSE status of countries and of the declining BSE epidemics. The EC Scientific Steering Committee, in January 2000, recommended grouping countries based on their geographical BSE risk (GBR)
http://ec.europa.eu/food/fs/sc/ssc/out68_en.pdf
Four groups were recognized:
GBR I: highly unlikely to have BSE;
GBR II: unlikely but not excluded;
GBR III: likely but not confirmed or confirmed at a low level; GBR IV: confirmed at a high level. That system for evaluating BSE risk was once widely used but is no longer supported.
The World Organisation for Animal Health (OIE) subsequently developed a system to evaluate national BSE risk based on voluntary submissions of information to an ad hoc committee for BSE status based on five main criteria used to assess the BSE risk for the cattle population of a country: risk assessment for BSE occurrence; on-going program to encourage reporting of neurological diseases in adult cattle; compulsory notification and investigation of all cattle showing BSE-like symptoms; BSE active surveillance; testing of cattle brain or other tissues. The OIE currently assigns to each country one of three BSE risk categories: negligible, controlled or undetermined (for those countries that either did not apply or failed to be classified). As of May 2010, 47 countries had been assigned a BSE risk status by the OIE: 13 countries (including three on the USDA BSE
7
Import Restriction List) had been assigned negligible BSE risk status, and 34 countries, including the US and Canada, were recognized as having controlled BSE risk—the same risk status assigned to most European countries including the UK and France (http://www.oie.int/eng/Status/BSE/en_BSE_free.htm). The FDA welcomes efforts to improve estimates of relative risk for exposure to the BSE agent in beef products of various national origins and to develop an international BSE risk evaluation system acceptable to US authorities and those of other countries. ...
snip...see full text ;
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM231179.pdf
When the OIE and the USDA et al collaborated to make legal the trading of Transmissible Spongiform Encephalopathy, when they did away with the BSE GBR risk assessments, where the USA, Canada, and Mexico were categorized as BSE GBR III.
please see ;
EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902594180.htm
Annex to the EFSA Scientific Report (2004) 3, 1-17 on the Assessment of the Geographical BSE Risk of USA
please see full text ;
http://www.efsa.europa.eu/en/scdocs/doc/3rax1.pdf
October 28-29, 2010:
Transmissible Spongiform Encephalopathies Advisory Committee Meeting References Document Posted: 10/26/2010
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm231016.htm
October 28-29, 2010:
Transmissible Spongiform Encephalopathies Advisory Committee Meeting A 2010 Update of the Draft Quantitative Risk Assessment of vCJD Risk Potentially Associated with the Use of Human Plasma-Derived Factor VIII Manufactured Under United States (US) License From Plasma Collected in the US (PDF - 662KB) Posted: 10/26/2010
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm231016.htm
October 28-29, 2010:
Transmissible Spongiform Encephalopathies Advisory Committee Meeting Document: APPENDIX A Supplemental technical information for the FDA Risk Assessment (PDF - 307KB) Posted: 10/26/2010 Roster of the Transmissible Spongiform Encephalopathies Advisory Committee Updated: 10/22/2010
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM231019.pdf
Roster of the Transmissible Spongiform Encephalopathies Advisory Committee Updated: 10/22/2010
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/ucm129556.htm
Tuesday, September 14, 2010
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)
----- Original Message -----
http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html
----- Original Message -----
From: Emery, Bryan (CBER)
To: CBER OCOD Consumer Account ; 'flounder9@verizon.net'
Sent: Friday, September 17, 2010 10:08 AM
Subject: FW: Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)
Hi Terry,
Thank you for your comments related to the Transmissible Spongiform Encephalopathy's Advisory Committee meeting on October 28-29, 2010.
Your comments will be provided to the Committee.
Thanks
Bryan Emery
Subject: Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010
Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512392.
http://edocket.access.gpo.gov/2010/2010-22805.htm
snip...end...full text ;
http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html
Monday, October 18, 2010
TSEAC Transmissible Spongiform Encephalopathies Advisory Committee Draft Agenda and Meeting Materials, Posted: 10/18/2010
http://tseac.blogspot.com/2010/10/tseac-transmissible-spongiform.html
__._,_.___
Tuesday, September 14, 2010
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010
http://tseac.blogspot.com/2010/09/transmissible-spongiform.html
----- Original Message -----
From: Emery, Bryan (CBER) To: 'Terry S. Singeltary Sr.'
Cc: Emery, Bryan (CBER)
Sent: Monday, January 24, 2011 7:35 AM
Subject: RE: October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee
Hi Terry,
The minutes have not been my primary focus at this time but when they are completed they will be put online for the public. I have nothing to hide just very busy as of late. Thank you for your interest, I hope to see you again soon.
Thanks LCDR Bryan Emery
--------------------------------------------------------------------------------
From: Terry S. Singeltary Sr. [mailto:flounder9@verizon.net]
Sent: Wednesday, January 19, 2011 1:03 PM
To: Emery, Bryan (CBER)
Subject: October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee
re-October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee
Greetings Dr. Emery,
I am trying to locate the minutes or draft minutes of the October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee meeting ???
seems they are long overdue to be put online.
can you please tell me when and if they are going to be made public ???
many thanks,
kindest regards, terry
Tuesday, January 18, 2011
Agent strain variation in human prion disease: insights from a molecular and pathological review of the National Institutes of Health series of experimentally transmitted disease
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/agent-strain-variation-in-human-prion.html
sadly, by only trying to reduce exposure from only nvCJD, they are seriously missing the bigger picture. hell, now we have mixtures of different phenotypes in one species, what about transmission of the TSE agent via mulitple phenotypes from one donor ??? transmission studies ??? etc. .......they missed the boat a long time ago. i believe i said in 2001 ;
"I am beginning to think that the endless attempt to track down and ban, potentia.1 victims from known BSE Countries from giving blood will be futile. You would have to ban everyone on the Globe eventually? AS well, I think we MUST ACT SWIFTLY to find blood test for TSE's, whether it be blood test, urine test, .eyelid test, anything at whatever cost, we need a test FAST."
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
end...tss
Saturday, September 5, 2009
TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS
http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html
From: Terry S. Singeltary Sr.
To: FREAS@CBER.FDA.GOV
Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov
Sent: Friday, December 01, 2006 2:59 PM
Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION PART III]
page 1 starts on page 13, then come back to page 1 to finish.....tss
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
World's first blood test for vCJD developed in MRC lab
Thursday 3 February 2011
The world's first accurate blood test for variant Creutzfeldt-Jakob disease (vCJD) has been developed by Medical Research Council (MRC) scientists. The prototype, which is 100,000 times more sensitive than any previous attempt, could transform the diagnosis and screening of the brain disease.
Variant CJD, the human form of BSE (or mad cow disease) first emerged in 1995. The disease, which affects the brain, is believed to have passed from cattle to humans through infected food. It causes personality change, loss of body function, and eventually death.
The research team from the MRC Prion Unit, based at University College London, working with the National Prion Clinic at the National Hospital for Neurology and Neurosurgery (NHNN) tested 190 blood samples, including 21 from individuals known to have vCJD. The blood test was able to detect blood spiked with a dilution of vCJD to within one part per ten billion - 100,000 times more sensitive than any other method developed so far.
Prions, the infectious proteins which cause vCJD and other fatal prion diseases, can inhabit a person's body for up to 50 years before presenting symptoms. During this time there is a chance a carrier of vCJD infection could pass on the infection to others, for example through blood transfusion or even through surgical and medical instruments as prions can easily attach onto metal surfaces.
A widely available, accurate blood test would enable people to be diagnosed earlier and could also help identify carriers of the disease. This would help measure how widespread the prion infection is in the general population and identify those who are at risk of passing on the infection to others.
Lead author Dr Graham Jackson, Programme Leader at the MRC Prion Unit, said:
"This test comes at the end of many years of meticulous, painstaking research in our Unit and the NHS National Prion Clinic. Although further larger studies are needed to confirm its effectiveness, it's the best hope yet of a successful early diagnostic test for the disease. This test could potentially go on to allow blood services to screen the population for vCJD infection, assess how many people in the UK are silent carriers and prevent onward transmission of the disease."
Professor John Collinge, Director of the MRC Prion Unit, said:
"One of the reasons that vCJD is such a dreaded disease and has caused such disruption and expense to health services is the lack of knowledge of who is and who is not a carrier of this infection. The next step will be to test anonymously several thousand blood donors from a country unaffected by BSE in order to gain a better idea of how the test fares in practice. Longer term studies will also be needed to assess what proportion of individuals who test positive for prion infection will then go on to develop the disease later in life.
"The MRC Prion Unit's research with the NHS National Prion Clinic to improve early diagnosis is an essential part of the wider MRC strategy to develop better treatments for patients. For this to develop, it will be crucial for clinicians to be able to offer treatment before extensive irreversible damage to the brain has occurred. At the moment, a firm diagnosis of vCJD can usually be made only once serious symptoms of the disease have developed which indicate extensive damage to the brain."
The study 'A blood-based assay for the detection of vCJD prion infection' is published today in the journal The Lancet.
Ends
Notes to editors:
To arrange an interview with the researchers of this paper, please call the MRC Press Office on 0207 395 2345.
For almost 100 years the Medical Research Council has improved the health of people in the UK and around the world by supporting the highest quality science. The MRC invests in world-class scientists. It has produced 29 Nobel Prize winners and sustains a flourishing environment for internationally recognised research. The MRC focuses on making an impact and provides the financial muscle and scientific expertise behind medical breakthroughs, including one of the first antibiotics penicillin, the structure of DNA and the lethal link between smoking and cancer. Today MRC funded scientists tackle research into the major health challenges of the 21st century. www.mrc.ac.uk
While the number of vCJD samples available for analysis was inherently small, and to date only a small number of healthy donors has been studied, analysis of this blinded panel indicated an assay sensitivity for vCJD of over 71% (15/21, CI 48-89%) and a specificity of 100% (0/169, CI 98-100%).
The NHNN forms part of University College London Hospitals NHS Foundation Trust, one of the largest NHS trusts in the United Kingdom providing first-class acute and specialist services. The Trust is committed to research and development and forms part of UCL Partners which in March 2009 was officially designated as one of the UK's first academic health science centres by the Department of Health. UCLH works closely with UCL, translating research into treatments for patients. www.uclh.nhs.uk
http://www.mrc.ac.uk/Newspublications/News/MRC007683
Wednesday, February 2, 2011
Detection of prion infection in variant Creutzfeldt-Jakob disease: a blood-based assay
http://transmissiblespongiformencephalopathy.blogspot.com/2011/02/detection-of-prion-infection-in-variant.html
Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America
14th ICID International Scientific Exchange Brochure -
Final Abstract Number: ISE.114
Session: International Scientific Exchange
Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America
update October 2009
T. Singeltary
Bacliff, TX, USA
Background:
An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and fed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.
Methods:
12 years independent research of available data
Results:
I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.
Conclusion:
I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.
page 114 ;
http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf
International Society for Infectious Diseases Web: http://www.isid.org/
please see full text ;
http://transmissiblespongiformencephalopathy.blogspot.com/
Seven main threats for the future linked to prions
The NeuroPrion network has identified seven main threats for the future linked to prions.
First threat
The TSE road map defining the evolution of European policy for protection against prion diseases is based on a certain numbers of hypotheses some of which may turn out to be erroneous. In particular, a form of BSE (called atypical Bovine Spongiform Encephalopathy), recently identified by systematic testing in aged cattle without clinical signs, may be the origin of classical BSE and thus potentially constitute a reservoir, which may be impossible to eradicate if a sporadic origin is confirmed. Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases constitute an unforeseen first threat that could sharply modify the European approach to prion diseases.
Second threat
snip...
http://www.neuroprion.org/en/np-neuroprion.html
Wednesday, March 31, 2010
Atypical BSE in Cattle
To date the OIE/WAHO assumes that the human and animal health standards set out in the BSE chapter for classical BSE (C-Type) applies to all forms of BSE which include the H-type and L-type atypical forms. This assumption is scientifically not completely justified and accumulating evidence suggests that this may in fact not be the case. Molecular characterization and the spatial distribution pattern of histopathologic lesions and immunohistochemistry (IHC) signals are used to identify and characterize atypical BSE. Both the L-type and H-type atypical cases display significant differences in the conformation and spatial accumulation of the disease associated prion protein (PrPSc) in brains of afflicted cattle. Transmission studies in bovine transgenic and wild type mouse models support that the atypical BSE types might be unique strains because they have different incubation times and lesion profiles when compared to C-type BSE. When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures.
This study will contribute to a correct definition of specified risk material (SRM) in atypical BSE. The incumbent of this position will develop new and transfer existing, ultra-sensitive methods for the detection of atypical BSE in tissue of experimentally infected cattle.
http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2
Saturday, January 29, 2011
Atypical L-Type Bovine Spongiform Encephalopathy (L-BSE) Transmission to Cynomolgus Macaques, a Non-Human Primate
Jpn. J. Infect. Dis., 64 (1), 81-84, 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html
Tuesday, November 02, 2010
BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only) diagnostic criteria CVL 1992
http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html
Wednesday, July 28, 2010
Atypical prion proteins and IBNC in cattle DEFRA project code SE1796 FOIA Final report
http://bse-atypical.blogspot.com/2010/07/atypical-prion-proteins-and-ibnc-in.html
Thursday, November 18, 2010
UNITED STATES OF AMERICA VS GALEN J. NIEHUES FAKED MAD COW FEED TEST ON 92 BSE INSPECTION REPORTS FOR APPROXIMATELY 100 CATTLE OPERATIONS
http://bse-atypical.blogspot.com/2010/11/united-states-of-america-vs-galen-j.html
Friday, August 27, 2010
NEW ATYPICAL NOR-98 SCRAPIE CASE DETECTED IDAHO NOW 5 CASES DOCUMENTED 2010
http://nor-98.blogspot.com/2010/08/new-atypical-nor-98-scrapie-case.html
Thursday, August 19, 2010
SCRAPIE CANADA UPDATE Current as of 2010-07-31 The following table lists sheep flocks and/or goat herds confirmed to be infected with scrapie in Canada in 2010.
Current as of: 2010-07-31
http://nor-98.blogspot.com/2010/08/scrapie-canada-update-current-as-of.html
the OIE and the USDA systematically changed the science with the BSE MRR policy, and put everyone around the globe at risk by taking us back to ground zero 1984-1985 kent bse cow.
Saturday, June 19, 2010
U.S. DENIED UPGRADED BSE STATUS FROM OIE
http://usdameatexport.blogspot.com/2010/06/us-denied-upgraded-bse-status-from-oie.html
Tuesday, January 25, 2011
Generation of a new form of human PrPSc in vitro by inter-species transmission from cervids prions
http://chronic-wasting-disease.blogspot.com/2011/01/generation-of-new-form-of-human-prpsc.html
Wednesday, September 08, 2010
CWD PRION CONGRESS SEPTEMBER 8-11 2010
http://chronic-wasting-disease.blogspot.com/2010/09/cwd-prion-2010.html
Friday, February 04, 2011
NMLB and USDA allow scrapie prion infected mutton to enter food chain on the Navajo Reservation in New Mexico
http://scrapie-usa.blogspot.com/2011/02/nmlb-and-usda-allow-scrapie-prion.html
Wednesday, January 19, 2011
EFSA and ECDC review scientific evidence on possible links between TSEs in animals and humans Webnachricht 19 Januar 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/efsa-and-ecdc-review-scientific.html
Tuesday, January 18, 2011
Agent strain variation in human prion disease: insights from a molecular and pathological review of the National Institutes of Health series of experimentally transmitted disease
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/agent-strain-variation-in-human-prion.html
Tuesday, December 14, 2010
Infection control of CJD, vCJD and other human prion diseases in healthcare and community settings part 4, Annex A1, Annex J, UPDATE DECEMBER 2010
http://creutzfeldt-jakob-disease.blogspot.com/2010/12/infection-control-of-cjd-vcjd-and-other.html
Sunday, January 30, 2011
Vaccines and Transmissible Spongiform Encephalopathy the Prion Disease, what if ?
COMMERCIAL IN CONFIDENCE
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/vaccines-and-transmissible-spongiform.html
strictly NOT private and confidential $$$
Saturday, January 22, 2011
Alzheimer's, Prion, and Neurological disease, and the misdiagnosis there of, a review 2011
http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/alzheimers-prion-and-neurological.html
Monday, September 13, 2010
atypical BSE strains and sporadic CJD strains, is there a connection and why shouldn't there be $
http://bse-atypical.blogspot.com/2010/09/atypical-bse-strains-and-sporadic-cjd.html
Sunday, August 15, 2010
ATYPICAL BSE NOW LINKED TO CAUSING SPORADIC CJD OVERSEAS Commonwealth of Australia
http://bse-atypical.blogspot.com/2010/08/atypical-bse-now-linked-to-causing.html
Thursday, July 08, 2010
GLOBAL CLUSTERS OF CREUTZFELDT JAKOB DISEASE - A REVIEW 2010
http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html
DID EVERYONE THAT LOST A LOVED ONE FILL OUT THEIR CJD QUESIONNAIRE FROM THE CDC AND OR THE CJD FOUNDATION ???
Friday, November 30, 2007
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION
http://cjdquestionnaire.blogspot.com/
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