UW Hospital warning 53 patients about possible exposure to rare brain disease
THU., JUL 23, 2009 - 7:13 PM STATE JOURNAL EXCLUSIVE:
UW Hospital warning 53 patients about possible exposure to rare brain disease
By DOUG ERICKSON and MARK PITSCH Wisconsin State Journal mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000260/!x-usc:mailto:wsjcity@madison.com UW
Hospital has told 53 patients they face an “extremely low” risk of contracting a rare brain disorder because they may have been operated on with contaminated surgical instruments.
Those instruments may have been used on a woman who died of the brain disorder Tuesday and had been operated on at the hospital.
Hospital officials say they immediately stopped using the surgical instruments once tests confirmed the woman’s diagnosis. However, the 53 patients all underwent a particular kind of neurosurgery during a 40-day window when the instruments were still in use, said Dr. Carl Getto, the hospital’s chief medical officer.
The hospital plans to continue using the surgical instruments once they go through a heightened sterilization process, an approach questioned by a national expert who said his hospital destroys the instruments in all such cases.
The situation poses no risk to the general public and an “infinitesimal” risk to the 53 patients, Getto said.
The female UW Hospital patient died of Creutzfeldt-Jakob Disease (CJD), an always-fatal neurological disorder that kills about 390 people per year in the U.S. It is characterized by rapidly progressing dementia, with death often coming within a year from the onset of symptoms.
“It’s a horrible situation, and I’m sure the university is as devastated by this as they possibly can be,” said Florence Kranitz, president of the CJD Foundation in Akron, Ohio.
The disease can set off alarm bells because it belongs to a family of human and animal diseases that includes a bovine version often referred to as “mad cow” disease. However, UW Hospital officials said the woman died from a category of the disease distinct from the bovine version.
“This is not mad cow disease,” said Dr. Nasia Safdar, a specialist in infectious diseases who oversees infection control at the hospital. “(People) need not be concerned about that relationship.”
Mad cow disease occurs only in cows, although eating infected beef is thought to be the cause of the variant form of CJD, which accounts for less than 1 percent of all human cases, according to the Creutzfeldt-Jakob Disease Foundation. No case of variant CJD has been documented as originating in the U.S., the foundation said.
UW Hospital officials said the female patient died from the sporadic form of CJD, which appears even though the person has no known risk factors. This is the prevalent form of the disease, accounting for about 85 percent of cases, so it also is referred to as the classic form.
Due to patient privacy, hospital officials would say only that the woman was in her 50s and had been transferred to UW Hospital June 8 from a regional hospital in Wisconsin. The woman suffered an upper-respiratory infection in March and April and saw her family doctor in May, Getto said.
Because she showed unsteadiness walking, vision problems and memory loss, doctors at the regional hospital determined she had viral encephalitis, a brain infection. Dr. Michael Geschwind, a CJD expert at the University of California Memory and Aging Center in San Francisco, said viral encephalitis is commonly mistaken for CJD.
Geschwind said there are no national protocols guiding doctors and hospitals to treat brain diseases that could be CJD. But he said any time a patient has rapid dementia or other symptoms of the disease, such as loss of motor function, CJD should be considered a possibility.
At the UCSF Medical Center, doctors destroy all instruments after operating on patients that possibly could have CJD, he said, which costs the hospital up to $20,000 per operation.
Getto said the woman also had a brain tumor, which doctors thought was causing her symptoms. There was no reason to suspect CJD, he said.
During surgery June 11 to remove the benign brain tumor, surgeons took samples of adjacent tissue, Getto said. The tissue was tested on site during the surgery, and there was no indication of CJD, he said.
However, over the next month, the woman’s condition declined unexpectedly and rapidly, so a sample of tissue from the earlier biopsy was sent to the National Prion Disease Pathology Survey Center Case Western, Getto said. Prions are deformed proteins that can cause brain disease.
Monday, UW Hospital officials received a preliminary report that the sample had tested positive for CJD. Immediately, staff pulled all instruments used in previous neurosurgical procedures and began re-sterilizing them according to Centers for Disease Control guidelines for confirmed cases of prion diseases, Getto said.
The next day, immediately following confirmation of the positive result, the hospital staff began identifying patients to be notified. All 53 patients have been notified by Fed-Ex letter and a phone call, Safdar said.
The letter reads in part: “First and foremost, we wish to reassure you that the risk of exposure to CJD as a result of surgical instruments is extremely low. In fact, there have been no cases of transmission from surgical instruments to patients since 1976, when the standardized sterilization processes now used throughout the country were put in place.”
The patients range in age from 3 to 83, although the great majority are between 30 and 60, said hospital spokeswoman Lisa Brunette. Most are from the Midwest, primarily Wisconsin and Illinois, she said.
UW Hospital will offer them free consultations with neurosurgeons in addition to visits they already have scheduled with their regular neurosurgeons. They also can receive free psychological counseling, Getto said. Because the disease is so rare and the risk of transmission so small, the letter is meant to be “informative and reassuring,” he said.
The patients will not be able to find out immediately if they contracted the disease because there is no test for pre-symptomatic CJD, Safdar said. Symptoms might not appear for years or decades, she said.
The patients will be under no restrictions imposed by UW Hospital, although individual organizations may decide not to accept blood or organ donations from them based on their exposure, Safdar said.
Kranitz, the president of the CJD Foundation, said that if the exposed patients need to have other medical procedures, they are required to say they have been exposed to CJD. Some medical centers may deny them care, she said.
“Considering how they were exposed, I would think that (UW Hospital) should be more than willing to provide the necessary care,” Kranitz said.
Brunette, the UW Hospital spokeswoman, said the patients should be able to get medical care in the future.
“These people don’t have a disease. They don’t have a diagnosis,” she said. “That wouldn’t be a factor for us. I don’t think it should be a factor for another institution.”
Transmission of the classic form of CJD occurs only through direct implantation of tissue into the brain, spinal cord or eye, Safdar said. That’s why health-care workers and others are not at risk. “You’d have to have an instrument with a patient’s tissue on it and then penetrate it into the brain, spinal cord or eye,” she said.
Oral transmission — for instance, from a doctor’s finger into his or her mouth — has not been reported as a route, she said.
If UW surgeons had suspected CJD prior to the woman’s brain tumor surgery, they would have instituted extra layers of precaution, Safdar said. They would have disposed of the instruments used for the tissue biopsy and sequestered all other instruments used in the surgery until a conclusive diagnosis, she said.
While incinerating the instruments is an option, Safdar said the hospital chose to follow the CDC guidelines for heightened sterilization because “they do work.” The instruments are being sterilized for at least 18 minutes at 134 degrees centigrade and bleached. The usual process at the hospital is sterilization for six minutes at 132-134 degrees and no bleaching, she said.
Brunette said hospital staff has not calculated the value of the instruments and did not consider cost in deciding whether to save or destroy the instruments.
Although no sterilization process is known to completely destroy all prions, the CDC guidelines — and additional cleaning and disinfecting — lower the tissue load “several fold,” which is adequate for preventing transmission, Safdar said. Asked what risk future patients have if operated on with the surgical instruments, Safdar said, “I would say none.”
http://www.madison.com/wsj/home/local/459435
PLEASE SEE ;
Pre-surgical risk assessment for variant Creutzfeldt-Jakob disease (vCJD) risk in neurosurgery and eye surgery units
Hospitals should already be using a questionnaire in Annex J of the ACDP TSE Working Group Infection Control guidance to find out whether any patients who are about to undergo any surgery or endoscopy may be at increased risk of being infected with CJD. If a patient is found to have an increased risk of CJD prior to their surgery or endoscopy then special infection control precautions may need to be taken.
Annex J of the TSE Infection Control guidance has recently been revised, and now advises that patients who are due to have high risk surgery [1] or neuro-endoscopy should be asked an additional question: whether they have received transfusions of blood or blood components from 80 or more donors since 1980. This is because these patients may have an increased risk of being infected with variant CJD (vCJD).
On 16 July 2009 the HPA wrote to the chief executives of NHS trusts asking them to ensure that the guidance is implemented. Detailed information and tools for implementing the guidance can be downloaded from the links below.
If you have any queries about the implementation of the guidance, please contact the HPA Centre for Infections CJD Section at mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000260/!x-usc:mailto:cjd@hpa.org.uk or on 020 8327 6074/6411.
Background information on this new pre-surgical assessment is contained in this Letter to chief executives - July 2009 (PDF, 73 KB) written to all hospitals in England.
The new version of Annex J of the TSE Infection Control Guidance contains new question for patients undergoing high risk surgery and neuro-endoscopy. These questions should be used to assess patients' CJD risk factors.
Clinicians carrying out the new pre-surgical assessment should read Pre-surgical assessment Information for healthcare staff - July 2009 (PDF, 163 KB) This vCJD Algorithm for per-surgical roles - July 2009 (PDF, 28 KB) shows suggested roles and responsibilities for infection control teams, surgical teams and blood transfusion specialists.
Information on patients' transfusion histories should be collected using the Highly transfused vCJD risk assessment form - July 2009 (Word Document, 328 KB) This form is also available as a vCJD risk assessment spreadsheet - July 2009 (Excel Spreadsheet, 2.7 MB). This may help calculate the number of blood donors to a patient. The form may be posted or emailed to the HPA Centre for Infections CJD Section mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000260/!x-usc:mailto:cjd@hpa.org.uk.
Blood transfusion laboratories may wish to use this draft Letter to other blood laboratories - July 2009 (Word Document, 31 KB) when collecting transfusion information from other hospitals.
Pre-surgical assessment teams and patients may wish to read this vCJD Information for presurgical patients - July 2009 (PDF, 29 KB) about this new pre-surgical assessment.
[1] High risk surgery is defined as surgery involving any of the following organs or tissues (high risk tissues): brain, spinal cord, cranial nerves (specifically the entire optic nerve and only the intercranial components of the other cranial nerves), cranial nerve ganglia, posterior eye (specifically the posterior hyaloid face, retina, retinal pigment epithelium, choroid, subretinal fluid, optic nerve) and pituitary gland.
Letter to chief executives - July 2009 (PDF, 73 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469060207
Pre-surgical assessment Information for healthcare staff - July 2009 (PDF, 163 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469061870
vCJD Algorithm for per-surgical roles - July 2009 (PDF, 28 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469062057
Highly transfused vCJD risk assessment form - July 2009 (Word Document, 328 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469062225
Letter to other blood laboratories - July 2009 (Word Document, 31 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469062420
vCJD Information for presurgical patients - July 2009 (PDF, 29 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469062586
vCJD risk assessment spreadsheet - July 2009 (Excel Spreadsheet, 2.7 MB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247728926790
full text ;
http://www.hpa.org.uk/webw/HPAweb&Page&HPAwebAutoListName/Page/1247469069188
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247728926790
see also ;
Friday, July 17, 2009
Revision to pre-surgical assessment of risk for vCJD in neurosurgery and eye surgery units Volume 3 No 28; 17 July 2009
http://creutzfeldt-jakob-disease.blogspot.com/2009/07/revision-to-pre-surgical-assessment-of.html
Tuesday, August 12, 2008
Biosafety in Microbiological and Biomedical Laboratories Fifth Edition 2007 (occupational exposure to prion diseases)
http://creutzfeldt-jakob-disease.blogspot.com/2008/08/biosafety-in-microbiological-and.html
Thursday, January 29, 2009
Medical Procedures and Risk for Sporadic Creutzfeldt-Jakob Disease, Japan, 1999-2008 (WARNING TO Neurosurgeons and Ophthalmologists) Volume 15, Number 2-February 2009 Research
http://creutzfeldt-jakob-disease.blogspot.com/2009/01/medical-procedures-and-risk-for.html
Saturday, June 13, 2009
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009
Greetings,
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. North America seems to have the most species with documented Transmissible Spongiform Encephalopathies, most all of which have been rendered and fed back to food producing animals and to humans for years. If you look at the statistics, sporadic CJD seems to be rising in the USA, and has been, with atypical cases of the sCJD. I find deeply disturbing in the year of 2009, that Human Transmissible Spongiform Encephalopathy of any strain and or phenotype, of all age groups, and I stress all age groups, because human TSE's do not know age, and they do not know borders. someone 56 years old, that has a human TSE, that has surgery, can pass this TSE agent on i.e. friendly fire, and or passing it forward, and there have been documented nvCJD in a 74 year old. Remembering also that only sporadic CJD has been documented to transmit via iatrogenic routes, until recently with the 4 cases of blood related transmission, of which the origin is thought to be nvCJD donors. However most Iatrogenic CJD cases are nothing more than sporadic CJD, until the source is proven, then it becomes Iatrogenic. An oxymoron of sorts, because all sporadic CJD is, are multiple forms, or strains, or phenotypes of Creutzfeldt Jakob Disease, that the route and species have not been confirmed and or documented. When will the myth of the UKBSEnvCJD only theory be put to bed for good. This theory in my opinion, and the following there from, as the GOLD STANDARD, has done nothing more than help spread this agent around the globe. Politics and money have caused the terrible consequences to date, and the fact that TSEs are a slow incubating death, but a death that is 100% certain for those that are exposed and live long enough to go clinical. once clinical, there is not recourse, to date.
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 myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, surgical, blood, medical, cosmetics etc. 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. This would further have to be broken down to strain of species and then the route of transmission would further have to be broken down. Accumulation and Transmission are key to the threshold from sub-clinical to clinical disease, and key to all this, is to stop the amplification and transmission of this agent, the spreading of, no matter what strain. In my opinion, to continue with this myth that the U.K. strain of BSE (one strain TSE in cows), and the nv/v CJD (one strain TSE humans) and that all the rest of human TSE are just one single strain i.e. sporadic CJD (when to date there are 6 different phenotypes of sCJD, and growing per Gambetti et al), and that no other animal TSE transmits to humans, to continue with this masquerade will only continue to spread, expose, and kill, who knows how many more in the years and decades to come. ONE was enough for me, My Mom, hvCJD i.e. Heidenhain Variant CJD, DOD 12/14/97 confirmed, which is nothing more than another mans name added to CJD, like CJD itself, Jakob and Creutzfeldt, or Gerstmann-Straussler-Scheinker syndrome, just another CJD or human TSE, named after another human. WE are only kidding ourselves with the current diagnostic criteria for human and animal TSE, especially differentiating between the nvCJD vs the sporadic CJD strains and then the GSS strains and also the FFI fatal familial insomnia strains or the ones that mimics one or the other of those TSE? Tissue infectivity and strain typing of the many variants Manuscript of the human and animal TSEs are paramount in all variants of all TSE. There must be a proper classification that will differentiate between all these human TSE in order to do this. With the CDI and other more sensitive testing coming about, I only hope that my proposal will some day be taken seriously. ...
please see history, and the ever evolving TSE science to date ;
Saturday, June 13, 2009
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009
http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (TRANSCRIPT)
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM171810.pdf
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)
http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html
DEPARTMENT OF HEALTH AND HUMAN SERVICES UNITED STATES FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
This transcript has not been edited or corrected, but appears as received from the commercial transcribing service. Accordingly the Food and Drug Administration makes no representation as to its accuracy.
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
21st Meeting Friday, June 12, 2009 8:00 a.m. Holiday Inn
DR. ROHWER: We first detected infectivity at that point, but that was part of several measurements over the incubation period and you could extrapolate that curve and it extrapolated to zero back around 30 percent of the incubation time.
DR. HOGAN: Dr. Manuelidis?
DR. MANUELIDIS: Yes, I think there are a couple of things that concern me. One is that using one model of animals may not always be the most effective one. In 1978 we wrote an article in Science showing that infectivity was present basically from about half way in the disease and went through the end and at the end it became highly infectious, much more infectious in the guinea pig for instance than in Bob's models. I would also like to point out that, for instance, vCJD is BSE and basically in a cow blood is not infectious and in primates it is. So, one must be very careful about this. The third thing which is a concern of mine is that in the report here it says we are talking about vCJD and my
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concern is that we are limiting things to vCJD. It says because BSE has been detected in so few US cattleB-now, anybody who works with the USDA knows that the USDA has been impossible about letting anybody work with BSE and we actually had no surveillance. So, we have no idea about how many US cattle are really infected as compared to places like Japan that look at every single cow. The fourth thing is that there are recent reports that have been going back for several years and have now become more important of variants of BSE which are not vCJD, some of which people believe have more of a linkage to sporadic CJD. We also do not look for these things.
So, I think that in looking at what we say about what should be done, although this has no practical application right now to what the FDA is going to do about saying we can't use this blood or that blood, I think it is a much broader problem. I also agree with people in the audience who came and said that CJD is not a reportable disease in many places, and I think this is very frustrating in terms of knowing what is really going on in our population. So, I would like to add that.
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DR. HOGAN: I think those are most important points that a lot of us agree with, and I know that the staff is looking at some of those in the future. What we are specifically charged with today is a little bit less encompassing issue but, nonetheless, exactly what you say should be considered.
SNIP...
MR. TEMPLIN: I just want to make two comments. I am sort of troubled that we don't know how much is actually infectious. A comment too about what Dr. Manuelidis said about cattle. If a farmer has cattle that he thinks may e
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infectious he is going to throw it out in the back 40 and cover it up or throw it on the compost pile and never report it to the government because he is going to lose everything he or she owns.
DR. HOGAN: I think we are going to have some speakers this afternoon that are going to address the current USDA situation. So, we will have questions for them at that point. Miss Hamilton?
MS. HAMILTON: I have a comment about what Dr. Manuelidis said to a question. It troubles me because a few years ago there was a lot of hype about the downed cattle that were getting through and being used in food for animals and what-not, and now we don't hear anything else about it, and she was saying that there is no surveillance in that area at all. My big question is why.
DR. HOGAN: Well, we will ask the USDA this afternoon, but I am not sure that zero is correct. I think it has been lowered significantly from its initial stages but it is not zero. Dr. Kreindel?
DR. KREINDEL: We are going to have a presentation on the USDA surveillance, but we do have surveillance and our surveillance is according to international standards.
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You know, it is not surveillance that really protects the US population. You know, we do have surveillance and there was a lot of surveillance going on. We called that surveillance enhanced surveillance. We are going to have information about that. We still have surveillance going on, you know, at the level requested by international standards but we do cover a lot of mitigations about sequential interlocking that really prevent, you know, if any BSE is present to be recycled.
DR. HOGAN: Thank you. Perhaps we will defer the discussion of surveillance till this afternoon. Do any of the statistics experts on the panel have anything to say relative to the mathematical accuracy of this model, since all those equations make me dizzy?
SNIP...then the BSe picks up on page 205 with the mathmatical formula's and the junk science of the OIE, but then on page 216 please see the questions on BSE testing in the USA by Dr. Manuelidis ;
DR. MANUELIDIS: I am just curious if you can explain to me the difference between the testing that is going on now in Europe with all the other variants or other strains of BSE, the test that is used, and whether the USDA still refuses to sort of use tests that other countries use, and what might our tests have that may be different and are they still restricted, or what is the rationale for that?
DR. HUGHES: Well, the USDA uses tests that have been validated.
DR. MANUELIDIS: I believe that the tests have been validated for the European and the Japanese stuff, they all use a standard test. So, I am curious about why the USDAB-there was the import I think you were referring to where the Japanese stopped importing food because, as I understood it and this is, of course, from places like The New York Times that may be totally wrong but as I understood it, the USDAB-this must have been about three or four years ago, said that they refused to use the test even though the plant was willing to use it. They said they had their own tests and they said they would only use their own tests.
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Maybe you can clarify that for me and tell me what the difference is between the tests, and whether you think that you can pick up the variants of BSE, not just the UK version of BSE. If there is really a difference in the sensitivity of the tests, if any independent side-by-side comparison has been done.
DR. KREINDEL: I am not sure I can answer your question but I think you are referring to the fact that they wanted to test all animals, rather than following the USDA requirements for testing.
DR. HUGHES: The question was why don't we test all animals.
DR. MANUELIDIS: There is a test that is used in Europe and in Japan. It is used all over I think. It is a bioride[?] test and what the plant was willing to do, I understood from The New York Times, was to test their animals according to that protocol. The USDA said no, even though everybody else uses it, we want to use our own test. Then they never really did those tests. So, what I am really getting at is are our tests in the USDA as sensitive and as comprehensive even if we don't test every animal--
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DR. HUGHES: Yes.
DR. MANUELIDIS: -Bfor all the variants of BSE and on what basis? Have you ever picked up any cases of BSE-H or BSE-L? Would you have an independent control that shows you that you can pick up these things with the tests as currently employed? Have there been any blind controls where an animal has a little bit of this or that just to see if you can pick it up out of a group?
DR. HUGHES: I think what you might be referring to is the Creekstone case.
DR. MANUELIDIS: Yes.
DR. HUGHES: Okay. Of course, I can't comment on current litigation but, basically, the USDA is unwilling to, you know, have a test be validated as a food safety test. Again, this gets back to what I spoke about earlier, that the BSE test really isn't a food safety test. It is possible to test an animal for BSE and have it be negative and still have the animal be positive for BSE. So, using that to put on a package label is just very confusing and kind of disingenuous to the public because it gives them a false sense of security about it. Our main focus for protecting human health is on other
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mitigation measures, such as the feed ban the FDA has in place; removal of specified risk materials. So, the tissues that we know are likely to contain agent never make it into the food chain in the first place. So, that is the basis of the refusal to allow that private company to do their own testing.
DR. MANUELIDIS: I don't want to be difficult because BSE is not my specialty, minus the vCJD version of it, but as I understand, some of the BSE cases, like the typical UK BSE case, have been found in muscle where muscle has been found to be infectious. So, the food ban wouldn't really deal with those. That is why I was asking what is the test. If you did a side-by-side comparison with blind controls would you be able to pick up what Europeans and Japanese pick up? That is really what I am asking.
DR. HUGHES: And I am afraid I can't answer that, and I am not sureB-you know, the experts on that would be the folks at NVSL that are responsible for validating the test and choosing which test we use. But evidently they are not convinced that the other tests are better than what we use currently. But, again, I am sorry, I am not the expert
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in that particular category.
snip...
SEE FULL TEXT 346 PAGES ;
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM171810.pdf
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)
http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html
Monday, June 01, 2009 Biochemical typing of pathological prion protein in aging cattle with BSE
SOMETHING TO PONDER ???
O.K. confusious asks, IF all these new atypical BSEs i.e. new strains of mad cow disease is just an 'OLD COW PRION DISEASE', why then can not the 'old human prion disease' such as the sporadic CJD, be from an 'old cow prion disease', same as the nvCJD 'young people mad cow disease' (which also happens in 74 year old), but why cannot the 'old cow prion diseases', i.e. l-BSE, h-BSE, and ibncBSE, cause the 'old people prion disease', which looks like sporadic CJD. seems that is what some of the pathology is showing ???
OH, that probably makes too much sense, and that the only answer could be that it's all just a happenstance of bad luck and or a spontaneous event, that just happens out of the clear blue sky $$$
IF this is the case, then where are all the SPONTANEOUS BSE CASES OF MAD COW DISEASE IN THE U.S.A., AND WHERE HAVE THEY BEEN BURIED IN THE USA OVER THE LAST 25 YEARS ???
http://bse-atypical.blogspot.com/2009/06/biochemical-typing-of-pathological.html
Thursday, April 9, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html#comments
Sunday, April 12, 2009 r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html#comments
Tuesday, July 14, 2009
U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and BSE Red Book Date: February 14, 2000 at 8:56 am PST
WHERE did we go wrong $$$
http://madcowtesting.blogspot.com/2009/07/us-emergency-bovine-spongiform.html
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html
NEW URL
http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm
Thursday, March 19, 2009
MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL NOW, WHY IN THE WORLD DO WE TO TALK ABOUT THIS ANYMORE $$$
http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html
Sunday, May 10, 2009
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)
http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html
Wednesday, July 1, 2009
Nor98 scrapie identified in the United States J Vet Diagn Invest 21:454-463 (2009)
http://nor-98.blogspot.com/2009/07/nor98-scrapie-identified-in-united.html
Tuesday, July 14, 2009
U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and BSE Red Book Date: February 14, 2000 at 8:56 am PST
WHERE did we go wrong $$$
http://madcowtesting.blogspot.com/2009/07/us-emergency-bovine-spongiform.html
Transgenic mice expressing porcine prion protein resistant to classical scrapie but susceptible to sheep bovine spongiform encephalopathy and atypical scrapie. Emerg Infect Dis. 2009 Aug; [Epub ahead of print]
http://nor-98.blogspot.com/2009/07/transgenic-mice-expressing-porcine.html
Saturday, June 13, 2009
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009
http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html
i am no doctor, i have no phd's, and I am president and ceo of nothing. ...TSS
wasted days and waste nights...freddy fender
stupid is, as stupid does...forest gump
still sadly disgusted...
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
Wednesday, July 15, 2009
TSEAC 21st Meeting Friday, June 12, 2009 (BSE TESTING USA ???) TRANSCRIPT
http://tseac.blogspot.com/2009/07/tseac-21st-meeting-friday-june-12-2009.html
Tuesday, April 21, 2009
Doctor Antonio Ruiz Villaespesa, pathologist and CJD researcher deceased because of Creutzfeldt-Jakob Disease SPAIN
http://cjdusa.blogspot.com/2009/04/doctor-antonio-ruiz-villaespesa.html
April 20, 2009
National Prion Disease Pathology Surveillance Center Cases Examined1 (December 31, 2008)
National Prion Disease Pathology Surveillance Center Cases Examined1
(December 31, 2008)
Year Total Referrals2 Prion Disease Sporadic Familial Iatrogenic vCJD
1996 & earlier 42 32 28 4 0 0
1997 115 68 59 9 0 0
1998 93 53 45 7 1 0
1999 115 69 61 8 0 0
2000 151 103 89 14 0 0
2001 210 118 108 9 0 0
2002 258 147 123 22 2 0
2003 273 176 135 41 0 0
2004 335 184 162 21 0 13
2005 346 193 154 38 1 0
2006 380 192 159 32 0 14
2007 370 212 185 26 0 0
2008 383 228 182 23 0 0
TOTAL 30715 17756 1490 254 4 2
1 Listed based on the year of death or, if not available, on year of referral; 2 Cases with suspected prion disease for which brain tissue and/or blood (in familial cases) were submitted; 3 Disease acquired in the United Kingdom; 4 Disease acquired in Saudi Arabia; 5 Includes 20 cases in which the diagnosis is pending, and 17 inconclusive cases; 6 Includes 25 cases with type determination pending in which the diagnosis of vCJD has been excluded.
Rev 2/13/09 National
http://www.cjdsurveillance.com/pdf/case-table.pdf
http://www.cjdsurveillance.com/resources-casereport.html
http://www.aan.com/news/?event=read&article_id=4397&page=72.45.45
*5 Includes 20 cases in which the diagnosis is pending, and 17 inconclusive cases; *6 Includes 25 cases with type determination pending in which the diagnosis of vCJD has been excluded.
Greetings,
it would be interesting to know what year these atypical cases occurred, as opposed to lumping them in with the totals only.
are they accumulating ?
did they occur in one year, two years, same state, same city ?
location would be very interesting ?
age group ?
sex ?
how was it determined that nvCJD was ruled out ?
from 1997, the year i started dealing with this nightmare, there were 28 cases (per this report), up until 2007 where the total was 185 cases (per this report), and to date 2008 is at 182. a staggering increase in my opinion, for something that just happens spontaneously as some would have us believe. i don't believe it, not in 85%+ of all sporadic CJD cases. actually, i do not believe yet that anyone has proven that any of the sporadic CJD cases have been proven to be a spontaneous misfolding of a protein. there are many potential routes and sources for the sporadic CJD's. ...TSS
Sunday, April 12, 2009
r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
Monday, April 20, 2009
National Prion Disease Pathology Surveillance Center Cases Examined1 (December 31, 2008)
http://prionunitusaupdate2008.blogspot.com/2009/04/national-prion-disease-pathology.html
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
UW Hospital warning 53 patients about possible exposure to rare brain disease
By DOUG ERICKSON and MARK PITSCH Wisconsin State Journal mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000260/!x-usc:mailto:wsjcity@madison.com UW
Hospital has told 53 patients they face an “extremely low” risk of contracting a rare brain disorder because they may have been operated on with contaminated surgical instruments.
Those instruments may have been used on a woman who died of the brain disorder Tuesday and had been operated on at the hospital.
Hospital officials say they immediately stopped using the surgical instruments once tests confirmed the woman’s diagnosis. However, the 53 patients all underwent a particular kind of neurosurgery during a 40-day window when the instruments were still in use, said Dr. Carl Getto, the hospital’s chief medical officer.
The hospital plans to continue using the surgical instruments once they go through a heightened sterilization process, an approach questioned by a national expert who said his hospital destroys the instruments in all such cases.
The situation poses no risk to the general public and an “infinitesimal” risk to the 53 patients, Getto said.
The female UW Hospital patient died of Creutzfeldt-Jakob Disease (CJD), an always-fatal neurological disorder that kills about 390 people per year in the U.S. It is characterized by rapidly progressing dementia, with death often coming within a year from the onset of symptoms.
“It’s a horrible situation, and I’m sure the university is as devastated by this as they possibly can be,” said Florence Kranitz, president of the CJD Foundation in Akron, Ohio.
The disease can set off alarm bells because it belongs to a family of human and animal diseases that includes a bovine version often referred to as “mad cow” disease. However, UW Hospital officials said the woman died from a category of the disease distinct from the bovine version.
“This is not mad cow disease,” said Dr. Nasia Safdar, a specialist in infectious diseases who oversees infection control at the hospital. “(People) need not be concerned about that relationship.”
Mad cow disease occurs only in cows, although eating infected beef is thought to be the cause of the variant form of CJD, which accounts for less than 1 percent of all human cases, according to the Creutzfeldt-Jakob Disease Foundation. No case of variant CJD has been documented as originating in the U.S., the foundation said.
UW Hospital officials said the female patient died from the sporadic form of CJD, which appears even though the person has no known risk factors. This is the prevalent form of the disease, accounting for about 85 percent of cases, so it also is referred to as the classic form.
Due to patient privacy, hospital officials would say only that the woman was in her 50s and had been transferred to UW Hospital June 8 from a regional hospital in Wisconsin. The woman suffered an upper-respiratory infection in March and April and saw her family doctor in May, Getto said.
Because she showed unsteadiness walking, vision problems and memory loss, doctors at the regional hospital determined she had viral encephalitis, a brain infection. Dr. Michael Geschwind, a CJD expert at the University of California Memory and Aging Center in San Francisco, said viral encephalitis is commonly mistaken for CJD.
Geschwind said there are no national protocols guiding doctors and hospitals to treat brain diseases that could be CJD. But he said any time a patient has rapid dementia or other symptoms of the disease, such as loss of motor function, CJD should be considered a possibility.
At the UCSF Medical Center, doctors destroy all instruments after operating on patients that possibly could have CJD, he said, which costs the hospital up to $20,000 per operation.
Getto said the woman also had a brain tumor, which doctors thought was causing her symptoms. There was no reason to suspect CJD, he said.
During surgery June 11 to remove the benign brain tumor, surgeons took samples of adjacent tissue, Getto said. The tissue was tested on site during the surgery, and there was no indication of CJD, he said.
However, over the next month, the woman’s condition declined unexpectedly and rapidly, so a sample of tissue from the earlier biopsy was sent to the National Prion Disease Pathology Survey Center Case Western, Getto said. Prions are deformed proteins that can cause brain disease.
Monday, UW Hospital officials received a preliminary report that the sample had tested positive for CJD. Immediately, staff pulled all instruments used in previous neurosurgical procedures and began re-sterilizing them according to Centers for Disease Control guidelines for confirmed cases of prion diseases, Getto said.
The next day, immediately following confirmation of the positive result, the hospital staff began identifying patients to be notified. All 53 patients have been notified by Fed-Ex letter and a phone call, Safdar said.
The letter reads in part: “First and foremost, we wish to reassure you that the risk of exposure to CJD as a result of surgical instruments is extremely low. In fact, there have been no cases of transmission from surgical instruments to patients since 1976, when the standardized sterilization processes now used throughout the country were put in place.”
The patients range in age from 3 to 83, although the great majority are between 30 and 60, said hospital spokeswoman Lisa Brunette. Most are from the Midwest, primarily Wisconsin and Illinois, she said.
UW Hospital will offer them free consultations with neurosurgeons in addition to visits they already have scheduled with their regular neurosurgeons. They also can receive free psychological counseling, Getto said. Because the disease is so rare and the risk of transmission so small, the letter is meant to be “informative and reassuring,” he said.
The patients will not be able to find out immediately if they contracted the disease because there is no test for pre-symptomatic CJD, Safdar said. Symptoms might not appear for years or decades, she said.
The patients will be under no restrictions imposed by UW Hospital, although individual organizations may decide not to accept blood or organ donations from them based on their exposure, Safdar said.
Kranitz, the president of the CJD Foundation, said that if the exposed patients need to have other medical procedures, they are required to say they have been exposed to CJD. Some medical centers may deny them care, she said.
“Considering how they were exposed, I would think that (UW Hospital) should be more than willing to provide the necessary care,” Kranitz said.
Brunette, the UW Hospital spokeswoman, said the patients should be able to get medical care in the future.
“These people don’t have a disease. They don’t have a diagnosis,” she said. “That wouldn’t be a factor for us. I don’t think it should be a factor for another institution.”
Transmission of the classic form of CJD occurs only through direct implantation of tissue into the brain, spinal cord or eye, Safdar said. That’s why health-care workers and others are not at risk. “You’d have to have an instrument with a patient’s tissue on it and then penetrate it into the brain, spinal cord or eye,” she said.
Oral transmission — for instance, from a doctor’s finger into his or her mouth — has not been reported as a route, she said.
If UW surgeons had suspected CJD prior to the woman’s brain tumor surgery, they would have instituted extra layers of precaution, Safdar said. They would have disposed of the instruments used for the tissue biopsy and sequestered all other instruments used in the surgery until a conclusive diagnosis, she said.
While incinerating the instruments is an option, Safdar said the hospital chose to follow the CDC guidelines for heightened sterilization because “they do work.” The instruments are being sterilized for at least 18 minutes at 134 degrees centigrade and bleached. The usual process at the hospital is sterilization for six minutes at 132-134 degrees and no bleaching, she said.
Brunette said hospital staff has not calculated the value of the instruments and did not consider cost in deciding whether to save or destroy the instruments.
Although no sterilization process is known to completely destroy all prions, the CDC guidelines — and additional cleaning and disinfecting — lower the tissue load “several fold,” which is adequate for preventing transmission, Safdar said. Asked what risk future patients have if operated on with the surgical instruments, Safdar said, “I would say none.”
http://www.madison.com/wsj/home/local/459435
PLEASE SEE ;
Pre-surgical risk assessment for variant Creutzfeldt-Jakob disease (vCJD) risk in neurosurgery and eye surgery units
Hospitals should already be using a questionnaire in Annex J of the ACDP TSE Working Group Infection Control guidance to find out whether any patients who are about to undergo any surgery or endoscopy may be at increased risk of being infected with CJD. If a patient is found to have an increased risk of CJD prior to their surgery or endoscopy then special infection control precautions may need to be taken.
Annex J of the TSE Infection Control guidance has recently been revised, and now advises that patients who are due to have high risk surgery [1] or neuro-endoscopy should be asked an additional question: whether they have received transfusions of blood or blood components from 80 or more donors since 1980. This is because these patients may have an increased risk of being infected with variant CJD (vCJD).
On 16 July 2009 the HPA wrote to the chief executives of NHS trusts asking them to ensure that the guidance is implemented. Detailed information and tools for implementing the guidance can be downloaded from the links below.
If you have any queries about the implementation of the guidance, please contact the HPA Centre for Infections CJD Section at mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000260/!x-usc:mailto:cjd@hpa.org.uk or on 020 8327 6074/6411.
Background information on this new pre-surgical assessment is contained in this Letter to chief executives - July 2009 (PDF, 73 KB) written to all hospitals in England.
The new version of Annex J of the TSE Infection Control Guidance contains new question for patients undergoing high risk surgery and neuro-endoscopy. These questions should be used to assess patients' CJD risk factors.
Clinicians carrying out the new pre-surgical assessment should read Pre-surgical assessment Information for healthcare staff - July 2009 (PDF, 163 KB) This vCJD Algorithm for per-surgical roles - July 2009 (PDF, 28 KB) shows suggested roles and responsibilities for infection control teams, surgical teams and blood transfusion specialists.
Information on patients' transfusion histories should be collected using the Highly transfused vCJD risk assessment form - July 2009 (Word Document, 328 KB) This form is also available as a vCJD risk assessment spreadsheet - July 2009 (Excel Spreadsheet, 2.7 MB). This may help calculate the number of blood donors to a patient. The form may be posted or emailed to the HPA Centre for Infections CJD Section mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000260/!x-usc:mailto:cjd@hpa.org.uk.
Blood transfusion laboratories may wish to use this draft Letter to other blood laboratories - July 2009 (Word Document, 31 KB) when collecting transfusion information from other hospitals.
Pre-surgical assessment teams and patients may wish to read this vCJD Information for presurgical patients - July 2009 (PDF, 29 KB) about this new pre-surgical assessment.
[1] High risk surgery is defined as surgery involving any of the following organs or tissues (high risk tissues): brain, spinal cord, cranial nerves (specifically the entire optic nerve and only the intercranial components of the other cranial nerves), cranial nerve ganglia, posterior eye (specifically the posterior hyaloid face, retina, retinal pigment epithelium, choroid, subretinal fluid, optic nerve) and pituitary gland.
Letter to chief executives - July 2009 (PDF, 73 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469060207
Pre-surgical assessment Information for healthcare staff - July 2009 (PDF, 163 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469061870
vCJD Algorithm for per-surgical roles - July 2009 (PDF, 28 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469062057
Highly transfused vCJD risk assessment form - July 2009 (Word Document, 328 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469062225
Letter to other blood laboratories - July 2009 (Word Document, 31 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469062420
vCJD Information for presurgical patients - July 2009 (PDF, 29 KB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247469062586
vCJD risk assessment spreadsheet - July 2009 (Excel Spreadsheet, 2.7 MB) Added/updated: 16 July 2009
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247728926790
full text ;
http://www.hpa.org.uk/webw/HPAweb&Page&HPAwebAutoListName/Page/1247469069188
http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1247728926790
see also ;
Friday, July 17, 2009
Revision to pre-surgical assessment of risk for vCJD in neurosurgery and eye surgery units Volume 3 No 28; 17 July 2009
http://creutzfeldt-jakob-disease.blogspot.com/2009/07/revision-to-pre-surgical-assessment-of.html
Tuesday, August 12, 2008
Biosafety in Microbiological and Biomedical Laboratories Fifth Edition 2007 (occupational exposure to prion diseases)
http://creutzfeldt-jakob-disease.blogspot.com/2008/08/biosafety-in-microbiological-and.html
Thursday, January 29, 2009
Medical Procedures and Risk for Sporadic Creutzfeldt-Jakob Disease, Japan, 1999-2008 (WARNING TO Neurosurgeons and Ophthalmologists) Volume 15, Number 2-February 2009 Research
http://creutzfeldt-jakob-disease.blogspot.com/2009/01/medical-procedures-and-risk-for.html
Saturday, June 13, 2009
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009
Greetings,
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. North America seems to have the most species with documented Transmissible Spongiform Encephalopathies, most all of which have been rendered and fed back to food producing animals and to humans for years. If you look at the statistics, sporadic CJD seems to be rising in the USA, and has been, with atypical cases of the sCJD. I find deeply disturbing in the year of 2009, that Human Transmissible Spongiform Encephalopathy of any strain and or phenotype, of all age groups, and I stress all age groups, because human TSE's do not know age, and they do not know borders. someone 56 years old, that has a human TSE, that has surgery, can pass this TSE agent on i.e. friendly fire, and or passing it forward, and there have been documented nvCJD in a 74 year old. Remembering also that only sporadic CJD has been documented to transmit via iatrogenic routes, until recently with the 4 cases of blood related transmission, of which the origin is thought to be nvCJD donors. However most Iatrogenic CJD cases are nothing more than sporadic CJD, until the source is proven, then it becomes Iatrogenic. An oxymoron of sorts, because all sporadic CJD is, are multiple forms, or strains, or phenotypes of Creutzfeldt Jakob Disease, that the route and species have not been confirmed and or documented. When will the myth of the UKBSEnvCJD only theory be put to bed for good. This theory in my opinion, and the following there from, as the GOLD STANDARD, has done nothing more than help spread this agent around the globe. Politics and money have caused the terrible consequences to date, and the fact that TSEs are a slow incubating death, but a death that is 100% certain for those that are exposed and live long enough to go clinical. once clinical, there is not recourse, to date.
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 myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, surgical, blood, medical, cosmetics etc. 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. This would further have to be broken down to strain of species and then the route of transmission would further have to be broken down. Accumulation and Transmission are key to the threshold from sub-clinical to clinical disease, and key to all this, is to stop the amplification and transmission of this agent, the spreading of, no matter what strain. In my opinion, to continue with this myth that the U.K. strain of BSE (one strain TSE in cows), and the nv/v CJD (one strain TSE humans) and that all the rest of human TSE are just one single strain i.e. sporadic CJD (when to date there are 6 different phenotypes of sCJD, and growing per Gambetti et al), and that no other animal TSE transmits to humans, to continue with this masquerade will only continue to spread, expose, and kill, who knows how many more in the years and decades to come. ONE was enough for me, My Mom, hvCJD i.e. Heidenhain Variant CJD, DOD 12/14/97 confirmed, which is nothing more than another mans name added to CJD, like CJD itself, Jakob and Creutzfeldt, or Gerstmann-Straussler-Scheinker syndrome, just another CJD or human TSE, named after another human. WE are only kidding ourselves with the current diagnostic criteria for human and animal TSE, especially differentiating between the nvCJD vs the sporadic CJD strains and then the GSS strains and also the FFI fatal familial insomnia strains or the ones that mimics one or the other of those TSE? Tissue infectivity and strain typing of the many variants Manuscript of the human and animal TSEs are paramount in all variants of all TSE. There must be a proper classification that will differentiate between all these human TSE in order to do this. With the CDI and other more sensitive testing coming about, I only hope that my proposal will some day be taken seriously. ...
please see history, and the ever evolving TSE science to date ;
Saturday, June 13, 2009
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009
http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (TRANSCRIPT)
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM171810.pdf
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)
http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html
DEPARTMENT OF HEALTH AND HUMAN SERVICES UNITED STATES FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
This transcript has not been edited or corrected, but appears as received from the commercial transcribing service. Accordingly the Food and Drug Administration makes no representation as to its accuracy.
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
21st Meeting Friday, June 12, 2009 8:00 a.m. Holiday Inn
DR. ROHWER: We first detected infectivity at that point, but that was part of several measurements over the incubation period and you could extrapolate that curve and it extrapolated to zero back around 30 percent of the incubation time.
DR. HOGAN: Dr. Manuelidis?
DR. MANUELIDIS: Yes, I think there are a couple of things that concern me. One is that using one model of animals may not always be the most effective one. In 1978 we wrote an article in Science showing that infectivity was present basically from about half way in the disease and went through the end and at the end it became highly infectious, much more infectious in the guinea pig for instance than in Bob's models. I would also like to point out that, for instance, vCJD is BSE and basically in a cow blood is not infectious and in primates it is. So, one must be very careful about this. The third thing which is a concern of mine is that in the report here it says we are talking about vCJD and my
PAPER MILL REPORTING 301 495-5831 163
concern is that we are limiting things to vCJD. It says because BSE has been detected in so few US cattleB-now, anybody who works with the USDA knows that the USDA has been impossible about letting anybody work with BSE and we actually had no surveillance. So, we have no idea about how many US cattle are really infected as compared to places like Japan that look at every single cow. The fourth thing is that there are recent reports that have been going back for several years and have now become more important of variants of BSE which are not vCJD, some of which people believe have more of a linkage to sporadic CJD. We also do not look for these things.
So, I think that in looking at what we say about what should be done, although this has no practical application right now to what the FDA is going to do about saying we can't use this blood or that blood, I think it is a much broader problem. I also agree with people in the audience who came and said that CJD is not a reportable disease in many places, and I think this is very frustrating in terms of knowing what is really going on in our population. So, I would like to add that.
PAPER MILL REPORTING 301 495-5831 164
DR. HOGAN: I think those are most important points that a lot of us agree with, and I know that the staff is looking at some of those in the future. What we are specifically charged with today is a little bit less encompassing issue but, nonetheless, exactly what you say should be considered.
SNIP...
MR. TEMPLIN: I just want to make two comments. I am sort of troubled that we don't know how much is actually infectious. A comment too about what Dr. Manuelidis said about cattle. If a farmer has cattle that he thinks may e
PAPER MILL REPORTING 301 495-5831 166
infectious he is going to throw it out in the back 40 and cover it up or throw it on the compost pile and never report it to the government because he is going to lose everything he or she owns.
DR. HOGAN: I think we are going to have some speakers this afternoon that are going to address the current USDA situation. So, we will have questions for them at that point. Miss Hamilton?
MS. HAMILTON: I have a comment about what Dr. Manuelidis said to a question. It troubles me because a few years ago there was a lot of hype about the downed cattle that were getting through and being used in food for animals and what-not, and now we don't hear anything else about it, and she was saying that there is no surveillance in that area at all. My big question is why.
DR. HOGAN: Well, we will ask the USDA this afternoon, but I am not sure that zero is correct. I think it has been lowered significantly from its initial stages but it is not zero. Dr. Kreindel?
DR. KREINDEL: We are going to have a presentation on the USDA surveillance, but we do have surveillance and our surveillance is according to international standards.
PAPER MILL REPORTING 301 495-5831 167
You know, it is not surveillance that really protects the US population. You know, we do have surveillance and there was a lot of surveillance going on. We called that surveillance enhanced surveillance. We are going to have information about that. We still have surveillance going on, you know, at the level requested by international standards but we do cover a lot of mitigations about sequential interlocking that really prevent, you know, if any BSE is present to be recycled.
DR. HOGAN: Thank you. Perhaps we will defer the discussion of surveillance till this afternoon. Do any of the statistics experts on the panel have anything to say relative to the mathematical accuracy of this model, since all those equations make me dizzy?
SNIP...then the BSe picks up on page 205 with the mathmatical formula's and the junk science of the OIE, but then on page 216 please see the questions on BSE testing in the USA by Dr. Manuelidis ;
DR. MANUELIDIS: I am just curious if you can explain to me the difference between the testing that is going on now in Europe with all the other variants or other strains of BSE, the test that is used, and whether the USDA still refuses to sort of use tests that other countries use, and what might our tests have that may be different and are they still restricted, or what is the rationale for that?
DR. HUGHES: Well, the USDA uses tests that have been validated.
DR. MANUELIDIS: I believe that the tests have been validated for the European and the Japanese stuff, they all use a standard test. So, I am curious about why the USDAB-there was the import I think you were referring to where the Japanese stopped importing food because, as I understood it and this is, of course, from places like The New York Times that may be totally wrong but as I understood it, the USDAB-this must have been about three or four years ago, said that they refused to use the test even though the plant was willing to use it. They said they had their own tests and they said they would only use their own tests.
PAPER MILL REPORTING 301 495-5831 217
Maybe you can clarify that for me and tell me what the difference is between the tests, and whether you think that you can pick up the variants of BSE, not just the UK version of BSE. If there is really a difference in the sensitivity of the tests, if any independent side-by-side comparison has been done.
DR. KREINDEL: I am not sure I can answer your question but I think you are referring to the fact that they wanted to test all animals, rather than following the USDA requirements for testing.
DR. HUGHES: The question was why don't we test all animals.
DR. MANUELIDIS: There is a test that is used in Europe and in Japan. It is used all over I think. It is a bioride[?] test and what the plant was willing to do, I understood from The New York Times, was to test their animals according to that protocol. The USDA said no, even though everybody else uses it, we want to use our own test. Then they never really did those tests. So, what I am really getting at is are our tests in the USDA as sensitive and as comprehensive even if we don't test every animal--
PAPER MILL REPORTING 301 495-5831 218
DR. HUGHES: Yes.
DR. MANUELIDIS: -Bfor all the variants of BSE and on what basis? Have you ever picked up any cases of BSE-H or BSE-L? Would you have an independent control that shows you that you can pick up these things with the tests as currently employed? Have there been any blind controls where an animal has a little bit of this or that just to see if you can pick it up out of a group?
DR. HUGHES: I think what you might be referring to is the Creekstone case.
DR. MANUELIDIS: Yes.
DR. HUGHES: Okay. Of course, I can't comment on current litigation but, basically, the USDA is unwilling to, you know, have a test be validated as a food safety test. Again, this gets back to what I spoke about earlier, that the BSE test really isn't a food safety test. It is possible to test an animal for BSE and have it be negative and still have the animal be positive for BSE. So, using that to put on a package label is just very confusing and kind of disingenuous to the public because it gives them a false sense of security about it. Our main focus for protecting human health is on other
PAPER MILL REPORTING 301 495-5831 219
mitigation measures, such as the feed ban the FDA has in place; removal of specified risk materials. So, the tissues that we know are likely to contain agent never make it into the food chain in the first place. So, that is the basis of the refusal to allow that private company to do their own testing.
DR. MANUELIDIS: I don't want to be difficult because BSE is not my specialty, minus the vCJD version of it, but as I understand, some of the BSE cases, like the typical UK BSE case, have been found in muscle where muscle has been found to be infectious. So, the food ban wouldn't really deal with those. That is why I was asking what is the test. If you did a side-by-side comparison with blind controls would you be able to pick up what Europeans and Japanese pick up? That is really what I am asking.
DR. HUGHES: And I am afraid I can't answer that, and I am not sureB-you know, the experts on that would be the folks at NVSL that are responsible for validating the test and choosing which test we use. But evidently they are not convinced that the other tests are better than what we use currently. But, again, I am sorry, I am not the expert
PAPER MILL REPORTING 301 495-5831 220
in that particular category.
snip...
SEE FULL TEXT 346 PAGES ;
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM171810.pdf
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)
http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html
Monday, June 01, 2009 Biochemical typing of pathological prion protein in aging cattle with BSE
SOMETHING TO PONDER ???
O.K. confusious asks, IF all these new atypical BSEs i.e. new strains of mad cow disease is just an 'OLD COW PRION DISEASE', why then can not the 'old human prion disease' such as the sporadic CJD, be from an 'old cow prion disease', same as the nvCJD 'young people mad cow disease' (which also happens in 74 year old), but why cannot the 'old cow prion diseases', i.e. l-BSE, h-BSE, and ibncBSE, cause the 'old people prion disease', which looks like sporadic CJD. seems that is what some of the pathology is showing ???
OH, that probably makes too much sense, and that the only answer could be that it's all just a happenstance of bad luck and or a spontaneous event, that just happens out of the clear blue sky $$$
IF this is the case, then where are all the SPONTANEOUS BSE CASES OF MAD COW DISEASE IN THE U.S.A., AND WHERE HAVE THEY BEEN BURIED IN THE USA OVER THE LAST 25 YEARS ???
http://bse-atypical.blogspot.com/2009/06/biochemical-typing-of-pathological.html
Thursday, April 9, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html#comments
Sunday, April 12, 2009 r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html#comments
Tuesday, July 14, 2009
U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and BSE Red Book Date: February 14, 2000 at 8:56 am PST
WHERE did we go wrong $$$
http://madcowtesting.blogspot.com/2009/07/us-emergency-bovine-spongiform.html
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html
NEW URL
http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm
Thursday, March 19, 2009
MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL NOW, WHY IN THE WORLD DO WE TO TALK ABOUT THIS ANYMORE $$$
http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html
Sunday, May 10, 2009
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)
http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html
Wednesday, July 1, 2009
Nor98 scrapie identified in the United States J Vet Diagn Invest 21:454-463 (2009)
http://nor-98.blogspot.com/2009/07/nor98-scrapie-identified-in-united.html
Tuesday, July 14, 2009
U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and BSE Red Book Date: February 14, 2000 at 8:56 am PST
WHERE did we go wrong $$$
http://madcowtesting.blogspot.com/2009/07/us-emergency-bovine-spongiform.html
Transgenic mice expressing porcine prion protein resistant to classical scrapie but susceptible to sheep bovine spongiform encephalopathy and atypical scrapie. Emerg Infect Dis. 2009 Aug; [Epub ahead of print]
http://nor-98.blogspot.com/2009/07/transgenic-mice-expressing-porcine.html
Saturday, June 13, 2009
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009
http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html
i am no doctor, i have no phd's, and I am president and ceo of nothing. ...TSS
wasted days and waste nights...freddy fender
stupid is, as stupid does...forest gump
still sadly disgusted...
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
Wednesday, July 15, 2009
TSEAC 21st Meeting Friday, June 12, 2009 (BSE TESTING USA ???) TRANSCRIPT
http://tseac.blogspot.com/2009/07/tseac-21st-meeting-friday-june-12-2009.html
Tuesday, April 21, 2009
Doctor Antonio Ruiz Villaespesa, pathologist and CJD researcher deceased because of Creutzfeldt-Jakob Disease SPAIN
http://cjdusa.blogspot.com/2009/04/doctor-antonio-ruiz-villaespesa.html
April 20, 2009
National Prion Disease Pathology Surveillance Center Cases Examined1 (December 31, 2008)
National Prion Disease Pathology Surveillance Center Cases Examined1
(December 31, 2008)
Year Total Referrals2 Prion Disease Sporadic Familial Iatrogenic vCJD
1996 & earlier 42 32 28 4 0 0
1997 115 68 59 9 0 0
1998 93 53 45 7 1 0
1999 115 69 61 8 0 0
2000 151 103 89 14 0 0
2001 210 118 108 9 0 0
2002 258 147 123 22 2 0
2003 273 176 135 41 0 0
2004 335 184 162 21 0 13
2005 346 193 154 38 1 0
2006 380 192 159 32 0 14
2007 370 212 185 26 0 0
2008 383 228 182 23 0 0
TOTAL 30715 17756 1490 254 4 2
1 Listed based on the year of death or, if not available, on year of referral; 2 Cases with suspected prion disease for which brain tissue and/or blood (in familial cases) were submitted; 3 Disease acquired in the United Kingdom; 4 Disease acquired in Saudi Arabia; 5 Includes 20 cases in which the diagnosis is pending, and 17 inconclusive cases; 6 Includes 25 cases with type determination pending in which the diagnosis of vCJD has been excluded.
Rev 2/13/09 National
http://www.cjdsurveillance.com/pdf/case-table.pdf
http://www.cjdsurveillance.com/resources-casereport.html
http://www.aan.com/news/?event=read&article_id=4397&page=72.45.45
*5 Includes 20 cases in which the diagnosis is pending, and 17 inconclusive cases; *6 Includes 25 cases with type determination pending in which the diagnosis of vCJD has been excluded.
Greetings,
it would be interesting to know what year these atypical cases occurred, as opposed to lumping them in with the totals only.
are they accumulating ?
did they occur in one year, two years, same state, same city ?
location would be very interesting ?
age group ?
sex ?
how was it determined that nvCJD was ruled out ?
from 1997, the year i started dealing with this nightmare, there were 28 cases (per this report), up until 2007 where the total was 185 cases (per this report), and to date 2008 is at 182. a staggering increase in my opinion, for something that just happens spontaneously as some would have us believe. i don't believe it, not in 85%+ of all sporadic CJD cases. actually, i do not believe yet that anyone has proven that any of the sporadic CJD cases have been proven to be a spontaneous misfolding of a protein. there are many potential routes and sources for the sporadic CJD's. ...TSS
Sunday, April 12, 2009
r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
Monday, April 20, 2009
National Prion Disease Pathology Surveillance Center Cases Examined1 (December 31, 2008)
http://prionunitusaupdate2008.blogspot.com/2009/04/national-prion-disease-pathology.html
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
Labels: atypical CJD, bse; cwd, CJD, HOSPITAL EXPOSURE, PRION, SCRAPIE, USA
posted by Terry S. Singeltary Sr. at
9:20 PM
