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The Genetic Approach to Controlling BSE
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<blockquote data-quote="flounder" data-source="post: 272153" data-attributes="member: 3519"><p>i would have expected nothing less from some. ignorance is bliss is it not?</p><p></p><p>fact is, human TSE in the USA i.e. sporadic CJD has tripled in the past few years or so i.e. sporadic CJD some of which is of a phenotype of 'unknown' type. the last two mad cows in the USA were of atypical strain, and from there, we have what we call 'friendly fire' from various routes and sources, and believe me, behind closed doors there is much detate about just this. </p><p>but i agree, the easy way out is to just ignore it i.e. ;</p><p></p><p>AERO wrote; </p><p></p><p>why do we care? how many human cases of BSE related illness have been reported in the last few years?....end</p><p></p><p></p><p>it's like the mad cows, if you dont look, you don't find....tss</p><p></p><p></p><p>SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM</p><p>1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype</p><p>of 'UNKNOWN' strain growing. ... </p><p></p><p></p><p><a href="http://www.cjdsurveillance.com/resources-casereport.html" target="_blank">http://www.cjdsurveillance.com/resource ... eport.html</a></p><p></p><p></p><p>the ukbsenvcjd only theory is dead in the water now. ...tss</p><p></p><p></p><p>----- Original Message ----- </p><p>From: Terry S. Singeltary Sr. </p><p>To: Bovine Spongiform Encephalopathy </p><p>Cc: <a href="mailto:cjdvoice@yahoogroups.com">cjdvoice@yahoogroups.com</a> ; <a href="mailto:BLOODCJD@YAHOOGROUPS.COM">BLOODCJD@YAHOOGROUPS.COM</a> ; <a href="mailto:madcow@lists.iatp.org">madcow@lists.iatp.org</a> </p><p>Sent: Monday, August 07, 2006 10:28 AM</p><p>Subject: [BLOODCJD] MAD COW BLOOD HUMANS RECALL (these are dime a dozen)</p><p></p><p></p><p>CJD WATCH MESSAGE BOARD </p><p>TSS</p><p>MAD COW BLOOD HUMANS RECALL (these are dime a dozen)</p><p>Mon Aug 7, 2006 10:24</p><p>71.248.132.189</p><p></p><p>PRODUCT</p><p>a) Red Blood Cells, Recall # B-1587-6;</p><p>b) Cryoprecipitated AHF, Recall # B-1588-6;</p><p>c) Recovered Plasma, Recal # B-1589-6</p><p>CODE</p><p>a), b) and c) Unit: 2016719</p><p>RECALLING FIRM/MANUFACTURER</p><p>Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on</p><p>March 13, 2003. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased</p><p>risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>3 units</p><p>DISTRIBUTION</p><p>GA and Germany</p><p></p><p>______________________________</p><p>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;</p><p>b) Fresh Frozen Plasma, Recall # B-1591-6</p><p>CODE</p><p>a) and b) Unit: 2443595</p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June</p><p>30, 2004. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased</p><p>risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>2 units</p><p>DISTRIBUTION</p><p>TX</p><p></p><p>______________________________</p><p>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;</p><p>b) Fresh Frozen Plasma, Recall # B-1593-6</p><p>CODE</p><p>a) and b) Unit: 2545596</p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on</p><p>December 14, 2004 and January 3, 2005. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased</p><p>risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>2 units</p><p>DISTRIBUTION</p><p>TX</p><p></p><p>______________________________</p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html</a></p><p></p><p>these usa mad cow blood for humans are a dime a dozen, the come out just</p><p>about every week ;</p><p></p><p><a href="http://disc.server.com/discussion.cgi?disc=167318;article=2971;title=CJD%20WATCH" target="_blank">http://disc.server.com/discussion.cgi?d ... JD%20WATCH</a></p><p></p><p><a href="http://disc.server.com/discussion.cgi?disc=167318;article=2972;title=CJD%20WATCH" target="_blank">http://disc.server.com/discussion.cgi?d ... JD%20WATCH</a></p><p></p><p></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 003001.pdf</a></p><p></p><p></p><p></p><p></p><p>8. The Secretary of State has a number of licences. We understand that</p><p>the inactivated polio vaccine is no longer being used. There is a stock</p><p>of smallpox vaccine. We have not been able to determine the source</p><p>material. (Made in sheep very unlikely to contain bovine ingredients).</p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 010001.pdf</a></p><p></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf</a></p><p></p><p></p><p>although 176 products do _not_ conform to the CSM/VPC</p><p>guidelines.</p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf</a></p><p></p><p></p><p></p><p></p><p>TSS</p><p></p><p></p><p></p><p>----- Original Message ----- </p><p>From: "Terry S. Singeltary Sr." <flounder9@VERIZON.NET></p><p>To: <BSE-L@aegee.org></p><p>Sent: Wednesday, August 30, 2006 10:17 AM</p><p>Subject: TSE ADVISORY COMMITTEE MEETING SEPTEMBER 18-19 2006</p><p></p><p></p><p>##################### Bovine Spongiform Encephalopathy</p><p>#####################</p><p></p><p>TSE ADVISORY COMMITTEE MEETING SEPTEMBER 18-19 2006</p><p>Wed Aug 30, 2006 08:11</p><p>70.110.86.159</p><p></p><p></p><p></p><p>Transmissible Spongiform Encephalopathies Advisory Committee</p><p>September 18-19, 2006 Meeting</p><p></p><p></p><p>Date and Time:</p><p>The meeting will be held on September 18, 2006, 8 a.m. to 4:30 p.m. and</p><p>September 19, 2006, 8 a.m. to 1 p.m.</p><p></p><p>Location:</p><p>Holiday Inn Gaithersburg, MD, 2 Montgomery Village Avenue, Gaithersburg, MD</p><p>20879</p><p></p><p>Contact Person:</p><p>William Freas, or Rosanna L. Harvey, 301-827-0314, or FDA Advisory Committee</p><p>Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area),</p><p>code 3014512392. Please call the Information Line for up-to-date information</p><p>on this meeting.</p><p></p><p>Agenda:</p><p>On September 18, 2006 the Committee will hear updates on the following</p><p>topics: United States and worldwide bovine spongiform encephalopathies</p><p>(BSE); variant Creutzfeldt-Jakob disease (vCJD) epidemiology and</p><p>transfusion-transmission; blood and plasma donor deferral for transfusion in</p><p>France since 1980, guidance; FDA's current assessment and plans regarding</p><p>the potential exposure to vCJD from an investigational product, FXI, that</p><p>was manufactured from UK donor plasma; and a summary of World Heath</p><p>Organization Consultation on distribution of infectivity in tissues of</p><p>animals and humans with transmissible spongiform encephalopathies. The</p><p>Committee will then discuss experimental clearance of transmissible</p><p>spongiform encephalopathy infectivity in plasma-derived Factor VIII</p><p>products. In the afternoon, the Committee will discuss FDA's risk assessment</p><p>for potential exposure to vCJD from human plasma-derived antihemophilic</p><p>factor (FVIII) products and potential responses. On September 19, 2006 the</p><p>Committee will discuss possible criteria for approval of donor screening</p><p>tests for vCJD.</p><p></p><p>Oral presentations from the public will be scheduled between approximately</p><p>10:45 a.m. and 11:15 p.m. and 2:30 p.m. and 3:00 p.m. on September 18, 2006</p><p>and between approximately 10:15 a.m. and 11:45 a.m. on September 19, 2006.</p><p>Those desiring to make formal oral presentations should notify the contact</p><p>person on or before September 11, 2006.</p><p></p><p></p><p></p><p><a href="http://www.fda.gov/cber/advisory/tse/tse0906.htm" target="_blank">http://www.fda.gov/cber/advisory/tse/tse0906.htm</a></p><p></p><p></p><p></p><p>CJD WATCH MESSAGE BOARD</p><p></p><p>TSS</p><p>Prion infections, blood and transfusions Aguzzi and Glatzel</p><p>Sat Jul 8, 2006 12:18</p><p>68.238.108.213</p><p></p><p></p><p>Prion infections, blood and transfusions</p><p></p><p>Adriano Aguzzi* and Markus Glatzel</p><p></p><p></p><p></p><p></p><p><a href="http://disc.server.com/discussion.cgi?disc=167318;article=2948;title=CJD%20WATCH;pagemark=60" target="_blank">http://disc.server.com/discussion.cgi?d ... agemark=60</a></p><p></p><p></p><p></p><p></p><p></p><p>Freas, William</p><p></p><p>From:</p><p></p><p>Sent:</p><p></p><p>To:</p><p></p><p>Subject:</p><p></p><p>Terry S. Singeltary Sr. [flounder@wt.net]</p><p></p><p>Monday, January 08,200l 3:03 PM</p><p></p><p><a href="mailto:freas@CBS5055530.CBER.FDA.GOV">freas@CBS5055530.CBER.FDA.GOV</a></p><p></p><p>CJDIBSE (aka madcow) Human/Animal TSE's--U.S.--Submission To Scientific</p><p>Advisors and</p><p></p><p>Consultants Staff January 2001 Meeting (short version)</p><p></p><p>Greetings again Dr. Freas and Committee Members,</p><p></p><p>I wish to submit the following information to the</p><p></p><p>Scientific Advisors and Consultants Staff</p><p></p><p>2001 Advisory Committee (short version).</p><p></p><p></p><p></p><p>snip...</p><p></p><p></p><p></p><p>I am beginning to think that the endless attempt to track</p><p></p><p>down and ban, potential victims from known BSE Countries</p><p></p><p>from giving blood will be futile. You would have to ban</p><p></p><p>everyone on the globe eventually? AS well, I think we</p><p></p><p>MUST ACT SWIFTLY to find blood test for TSE's,</p><p></p><p>whether it be blood test, urine test, eyelid test,</p><p></p><p>anything at whatever cost, we need a test FAST. ,</p><p></p><p>DO NOT let the incubation time period of these TSEs fool you.</p><p></p><p>To think of Scrapie as the prime agent to compare CJD,</p><p></p><p>but yet overlook the Louping-ill vaccine event in 1930's</p><p></p><p>of which 1000's of sheep where infected by scrapie</p><p></p><p>from a vaccine made of scrapie infected sheep brains,</p><p></p><p>would be foolish. I acquired this full text version of the</p><p></p><p>event which was recorded in the Annual Congress of 1946</p><p></p><p>National Vet. Med. Ass. of Great Britain and Ireland.</p><p></p><p>From the BVA and the URL is posted in my (long version).</p><p></p><p>U.S.A. should make all human/animal TSE's notifiable at all ages,</p><p></p><p>with requirements for a thorough surveillance and post-mortem</p><p></p><p>examinations free of charge, if you are serious about eradicating</p><p></p><p>this horrible disease in man and animal.</p><p></p><p>There is histopathology reports describing o florid plaques"</p><p></p><p>in CJD victims in the USA and some of these victims are getting</p><p></p><p>younger. I have copies of such autopsies, there has to</p><p></p><p>be more. PLUS, sub-clinical human TSE's will most definitely</p><p></p><p>be a problem.</p><p></p><p>THEN think of vaccineCJD in children and the bovine tissues</p><p></p><p>used in the manufacturing process, think of the FACT that</p><p></p><p>this agent surviving 6OO*C.</p><p></p><p>PNAS -- Brown et al. 97 (7): 3418 scrapie agent live at 600*C</p><p></p><p>Then think of the CONFIDENTIAL documents of what was known of</p><p></p><p>human/animal TSE and vaccines in the mid to late 8Os, it was all about</p><p></p><p>depletion of stock, to hell with the kids, BUT yet they knew.</p><p></p><p></p><p></p><p>snip...</p><p></p><p></p><p></p><p>full text ;</p><p></p><p></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf" target="_blank">http://www.fda.gov/ohrms/dockets/ac/01/ ... 1s2_09.pdf</a></p><p></p><p></p><p></p><p></p><p></p><p>EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR)</p><p>of the United States of America (USA)</p><p>Last updated: 19 July 2005</p><p>Adopted July 2004 (Question N° EFSA-Q-2003-083)</p><p></p><p>Report</p><p>Summary</p><p>Summary of the Scientific Report</p><p></p><p>The European Food Safety Authority and its Scientific Expert Working Group</p><p>on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE)</p><p>Risk (GBR) were asked by the European Commission (EC) to provide an</p><p>up-to-date scientific report on the GBR in the United States of America,</p><p>i.e. the likelihood of the presence of one or more cattle being infected</p><p>with BSE, pre-clinically as well as clinically, in USA. This scientific</p><p>report addresses the GBR of USA as assessed in 2004 based on data covering</p><p>the period 1980-2003.</p><p></p><p>The BSE agent was probably imported into USA and could have reached domestic</p><p>cattle in the middle of the eighties. These cattle imported in the mid</p><p>eighties could have been rendered in the late eighties and therefore led to</p><p>an internal challenge in the early nineties. It is possible that imported</p><p>meat and bone meal (MBM) into the USA reached domestic cattle and leads to</p><p>an internal challenge in the early nineties.</p><p></p><p>A processing risk developed in the late 80s/early 90s when cattle imports</p><p>from BSE risk countries were slaughtered or died and were processed (partly)</p><p>into feed, together with some imports of MBM. This risk continued to exist,</p><p>and grew significantly in the mid 90's when domestic cattle, infected by</p><p>imported MBM, reached processing. Given the low stability of the system, the</p><p>risk increased over the years with continued imports of cattle and MBM from</p><p>BSE risk countries.</p><p></p><p>EFSA concludes that the current GBR level of USA is III, i.e. it is likely</p><p>but not confirmed that domestic cattle are (clinically or pre-clinically)</p><p>infected with the BSE-agent. As long as there are no significant changes in</p><p>rendering or feeding, the stability remains extremely/very unstable. Thus,</p><p>the probability of cattle to be (pre-clinically or clinically) infected with</p><p>the BSE-agent persistently increases.</p><p></p><p></p><p></p><p></p><p></p><p></p><p>Publication date: 20 August 2004</p><p></p><p></p><p>EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR)</p><p>of the United States of America (USA)</p><p></p><p>Adopted July 2004 (Question N° EFSA-Q-2003-083)</p><p></p><p></p><p>[Last updated 08 September 2004]</p><p>[Publication Date 20 August 2004]</p><p></p><p></p><p><a href="http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html" target="_blank">http://www.efsa.europa.eu/en/science/ts ... s/573.html</a></p><p></p><p></p><p></p><p></p><p></p><p>Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine</p><p>Spongiform Encephalopathy (BSE)</p><p></p><p></p><p><a href="http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf" target="_blank">http://www.fsis.usda.gov/OPPDE/Comments ... 0011-1.pdf</a></p><p></p><p></p><p></p><p></p><p>[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk</p><p>Materials for Human Food and Requirement for the Disposition of</p><p>Non-Ambulatory Disabled Cattle</p><p></p><p></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf" target="_blank">http://www.fda.gov/ohrms/dockets/docket ... -vol45.pdf</a></p><p></p><p></p><p></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf" target="_blank">http://www.fda.gov/ohrms/dockets/docket ... -vol40.pdf</a></p><p></p><p></p><p></p><p></p><p>THE SEVEN 1/2 SCIENTIST REPORT *** ;-)</p><p></p><p></p><p></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf" target="_blank">http://www.fda.gov/ohrms/dockets/docket ... tach-1.pdf</a></p><p></p><p></p><p></p><p></p><p><a href="https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument" target="_blank">https://web01.aphis.usda.gov/regpublic. ... enDocument</a></p><p></p><p></p><p></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf" target="_blank">http://www.fda.gov/ohrms/dockets/docket ... -vol35.pdf</a></p><p></p><p></p><p></p><p></p><p>Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE</p><p>SAFEGUARDS (comment submission)</p><p></p><p></p><p></p><p><a href="https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument" target="_blank">https://web01.aphis.usda.gov/regpublic. ... enDocument</a></p><p></p><p></p><p></p><p></p><p></p><p>03-025IF 03-025IF-631 Linda A. Detwiler [PDF]</p><p></p><p></p><p><a href="http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf" target="_blank">http://www.fsis.usda.gov/OPPDE/Comments ... IF-631.pdf</a></p><p></p><p></p><p></p><p></p><p></p><p>Specified Risk Materials (SRMs)</p><p></p><p>I am in full support of the interim final rule which prohibits SRMs from</p><p></p><p>being included in food for human consumption. In addition to the list of</p><p></p><p>tissues published in this rule, I am requesting that additional tissues be</p><p></p><p>added to the list. These would include dura</p><p></p><p>("sheath") covering the spinal cord and the ENTIRE INTESTINE (from pylorus</p><p></p><p>to rectum). The scientific justification is provided below. THESE SRMs</p><p></p><p>should also be prohibited from ANY FDA regulated food or product intended</p><p></p><p>for human consumption, including but not limited to flavorings, extracts,</p><p></p><p>etc. ...</p><p></p><p>Dr. Linda Detwiler comments in full;</p><p></p><p></p><p><a href="http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf" target="_blank">http://www.fsis.usda.gov/OPPDE/Comments ... IF-634.pdf</a></p><p></p><p></p><p></p><p></p><p>TIP740203/l 0424 CONFIDENTIAL</p><p></p><p></p><p></p><p><a href="http://www.mad-cow.org/00/may00_news.html#aaa" target="_blank">http://www.mad-cow.org/00/may00_news.html#aaa</a></p><p></p><p></p><p></p><p>TWA LITTLE minute</p><p></p><p></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 001001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 010001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 006001.pdf</a></p><p></p><p></p><p></p><p>COMMERCIAL IN CONFIDENCE</p><p></p><p></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 005001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 005001.pdf</a></p><p></p><p></p><p></p><p>NOT FOR PUBLICATION</p><p></p><p></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 012001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf" target="_blank">http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 007001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 007001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 004001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 003001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 001001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 007001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 001001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf</a></p><p></p><p></p><p></p><p>NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE snip... I</p><p>was quite prepared to believe in unofficial pituitary hormones, also in the</p><p>1970's, whether as described by Dr. Little, or in other circumstances, for</p><p>animal use. snip... The fact that there were jars of pituitaries (or</p><p>extract) around on shelves is attested by the still potent 1943 pituitaries,</p><p>described in Stockell Hartree et al. (J/RF/17/291) which had come from the</p><p>lab. at Mill Hill. Having taken the trouble to collect them, they were not</p><p>lightly thrown out...</p><p></p><p></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf</a></p><p></p><p></p><p></p><p>more on the 1968 medicine act, they forgot to follow</p><p></p><p></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 008001.pdf</a></p><p></p><p></p><p></p><p>Draft cover letter to product licence holders (considered by Human and Vet</p><p>Medicines including deer)</p><p></p><p></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 008001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf</a></p><p></p><p></p><p></p><p>(It was noted with concern that hormone extracts could be manufactured by a</p><p>veterinary surgeon for administration to animals under his care without any</p><p>Medicines Act Control.)</p><p></p><p></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf</a></p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/yb/1 ... 010001.pdf</a></p><p></p><p></p><p></p><p>TWA LITTLE STATEMENT 331</p><p></p><p><a href="http://www.bseinquiry.gov.uk/files/ws/s331.pdf" target="_blank">http://www.bseinquiry.gov.uk/files/ws/s331.pdf</a></p><p></p><p></p><p></p><p>snip...</p><p></p><p></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm" target="_blank">http://www.fda.gov/ohrms/dockets/dailys ... 7-EC-2.htm</a></p><p></p><p></p><p></p><p>RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob</p><p></p><p>disease in the United States</p><p></p><p></p><p>Email Terry S. Singeltary:</p><p></p><p></p><p><a href="mailto:flounder@wt.net">flounder@wt.net</a></p><p></p><p></p><p></p><p>I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to</p><p></p><p>comment on the CDC's attempts to monitor the occurrence of emerging</p><p></p><p>forms of CJD. Asante, Collinge et al [1] have reported that BSE</p><p></p><p>transmission to the 129-methionine genotype can lead to an alternate</p><p></p><p>phenotype that is indistinguishable from type 2 PrPSc, the commonest</p><p></p><p>sporadic CJD. However, CJD and all human TSEs are not reportable</p><p></p><p>nationally. CJD and all human TSEs must be made reportable in every</p><p></p><p>state and internationally. I hope that the CDC does not continue to</p><p></p><p>expect us to still believe that the 85%+ of all CJD cases which are</p><p></p><p>sporadic are all spontaneous, without route/source. We have many TSEs in</p><p></p><p>the USA in both animal and man. CWD in deer/elk is spreading rapidly and</p><p></p><p>CWD does transmit to mink, ferret, cattle, and squirrel monkey by</p><p></p><p>intracerebral inoculation. With the known incubation periods in other</p><p></p><p>TSEs, oral transmission studies of CWD may take much longer. Every</p><p></p><p>victim/family of CJD/TSEs should be asked about route and source of this</p><p></p><p>agent. To prolong this will only spread the agent and needlessly expose</p><p></p><p>others. In light of the findings of Asante and Collinge et al, there</p><p></p><p>should be drastic measures to safeguard the medical and surgical arena</p><p></p><p>from sporadic CJDs and all human TSEs. I only ponder how many sporadic</p><p></p><p>CJDs in the USA are type 2 PrPSc?</p><p></p><p></p><p><a href="http://www.neurology.org/cgi/eletters/60/2/176#535" target="_blank">http://www.neurology.org/cgi/eletters/60/2/176#535</a></p><p></p><p></p><p></p><p>LANCET INFECTIOUS DISEASE JOURNAL</p><p></p><p></p><p>Volume 3, Number 8 01 August 2003</p><p></p><p></p><p>Newsdesk</p><p></p><p></p><p>Tracking spongiform encephalopathies in North America</p><p></p><p></p><p>Xavier Bosch</p><p></p><p>My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost</p><p></p><p>my mom to hvCJD (Heidenhain variant CJD) and have been searching for</p><p></p><p>answers ever since. What I have found is that we have not been told the</p><p></p><p>truth. CWD in deer and elk is a small portion of a much bigger problem.</p><p></p><p></p><p>49-year-old Singeltary is one of a number of people who have remained</p><p></p><p>largely unsatisfied after being told that a close relative died from a</p><p></p><p>rapidly progressive dementia compatible with spontaneous</p><p></p><p>Creutzfeldt-Jakob disease (CJD). So he decided to gather hundreds of</p><p></p><p>documents on transmissible spongiform encephalopathies (TSE) and</p><p></p><p>realised that if Britons could get variant CJD from bovine spongiform</p><p></p><p>encephalopathy (BSE), Americans might get a similar disorder from</p><p></p><p>chronic wasting disease (CWD)the relative of mad cow disease seen among</p><p></p><p>deer and elk in the USA. Although his feverish search did not lead him</p><p></p><p>to the smoking gun linking CWD to a similar disease in North American</p><p></p><p>people, it did uncover a largely disappointing situation.</p><p></p><p></p><p>Singeltary was greatly demoralised at the few attempts to monitor the</p><p></p><p>occurrence of CJD and CWD in the USA. Only a few states have made CJD</p><p></p><p>reportable. Human and animal TSEs should be reportable nationwide and</p><p></p><p>internationally, he complained in a letter to the Journal of the</p><p></p><p>American Medical Association (JAMA 2003; 285: 733). I hope that the CDC</p><p></p><p>does not continue to expect us to still believe that the 85% plus of all</p><p></p><p>CJD cases which are sporadic are all spontaneous, without route or source.</p><p></p><p></p><p>Until recently, CWD was thought to be confined to the wild in a small</p><p></p><p>region in Colorado. But since early 2002, it has been reported in other</p><p></p><p>areas, including Wisconsin, South Dakota, and the Canadian province of</p><p></p><p>Saskatchewan. Indeed, the occurrence of CWD in states that were not</p><p></p><p>endemic previously increased concern about a widespread outbreak and</p><p></p><p>possible transmission to people and cattle.</p><p></p><p></p><p>To date, experimental studies have proven that the CWD agent can be</p><p></p><p>transmitted to cattle by intracerebral inoculation and that it can cross</p><p></p><p>the mucous membranes of the digestive tract to initiate infection in</p><p></p><p>lymphoid tissue before invasion of the central nervous system. Yet the</p><p></p><p>plausibility of CWD spreading to people has remained elusive.</p><p></p><p></p><p>Part of the problem seems to stem from the US surveillance system. CJD</p><p></p><p>is only reported in those areas known to be endemic foci of CWD.</p><p></p><p>Moreover, US authorities have been criticised for not having performed</p><p></p><p>enough prionic tests in farm deer and elk.</p><p></p><p></p><p>Although in November last year the US Food and Drug Administration</p><p></p><p>issued a directive to state public-health and agriculture officials</p><p></p><p>prohibiting material from CWD-positive animals from being used as an</p><p></p><p>ingredient in feed for any animal species, epidemiological control and</p><p></p><p>research in the USA has been quite different from the situation in the</p><p></p><p>UK and Europe regarding BSE.</p><p></p><p></p><p>Getting data on TSEs in the USA from the government is like pulling</p><p></p><p>teeth, Singeltary argues. You get it when they want you to have it,</p><p></p><p>and only what they want you to have.</p><p></p><p></p><p>Norman Foster, director of the Cognitive Disorders Clinic at the</p><p></p><p>University of Michigan (Ann Arbor, MI, USA), says that current</p><p></p><p>surveillance of prion disease in people in the USA is inadequate to</p><p></p><p>detect whether CWD is occurring in human beings; adding that, the</p><p></p><p>cases that we know about are reassuring, because they do not suggest the</p><p></p><p>appearance of a new variant of CJD in the USA or atypical features in</p><p></p><p>patients that might be exposed to CWD. However, until we establish a</p><p></p><p>system that identifies and analyses a high proportion of suspected prion</p><p></p><p>disease cases we will not know for sure. The USA should develop a</p><p></p><p>system modelled on that established in the UK, he points out.</p><p></p><p></p><p></p><p>Ali Samii, a neurologist at Seattle VA Medical Center who recently</p><p></p><p>reported the cases of three hunterstwo of whom were friendswho died</p><p></p><p>from pathologically confirmed CJD, says that at present there are</p><p></p><p>insufficient data to claim transmission of CWD into humans; adding that</p><p></p><p>[only] by asking [the questions of venison consumption and deer/elk</p><p></p><p>hunting] in every case can we collect suspect cases and look into the</p><p></p><p>plausibility of transmission further. Samii argues that by making both</p><p></p><p>doctors and hunters more aware of the possibility of prions spreading</p><p></p><p>through eating venison, doctors treating hunters with dementia can</p><p></p><p>consider a possible prion disease, and doctors treating CJD patients</p><p></p><p>will know to ask whether they ate venison.</p><p></p><p></p><p>CDC spokesman Ermias Belay says that the CDC will not be investigating</p><p></p><p>the [Samii] cases because there is no evidence that the men ate</p><p></p><p>CWD-infected meat. He notes that although the likelihood of CWD</p><p></p><p>jumping the species barrier to infect humans cannot be ruled out 100%</p><p></p><p>and that [we] cannot be 100% sure that CWD does not exist in humans&</p><p></p><p>the data seeking evidence of CWD transmission to humans have been very</p><p></p><p>limited.</p><p></p><p></p><p></p><p></p><p><a href="http://infection.thelancet.com/journal/journal.isa" target="_blank">http://infection.thelancet.com/journal/journal.isa</a></p><p></p><p></p><p></p><p></p><p>he complained in a letter to the Journal of the American Medical</p><p></p><p></p><p></p><p>Association (JAMA 2003; 285: 733). I hope that the CDC does not</p><p></p><p>continue to expect us to still believe that the 85% plus of all CJD</p><p></p><p>cases which are sporadic are all spontaneous, without route or source.<<<</p><p></p><p></p><p></p><p>actually, that quote was from a more recent article in the Journal of</p><p></p><p>Neurology (see below), not the JAMA article...</p><p></p><p></p><p></p><p>Full Text</p><p></p><p>Diagnosis and Reporting of Creutzfeldt-Jakob Disease</p><p></p><p>Singeltary, Sr et al. JAMA.2001; 285: 733-734.</p><p></p><p></p><p></p><p><a href="http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtos" target="_blank">http://jama.ama-assn.org/cgi/content/fu ... 733?maxtos</a></p><p>how=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing</p><p>+and+reporting+creutzfeldt+jakob+disease&searchid=1048865</p><p>596978_1528&stored_search=&FIRSTINDEX=0&journalcode=</p><p>jama</p><p></p><p></p><p></p><p>BRITISH MEDICAL JOURNAL</p><p></p><p></p><p></p><p>SOMETHING TO CHEW ON</p><p></p><p></p><p></p><p>BMJ</p><p></p><p></p><p></p><p><a href="http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2" target="_blank">http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2</a></p><p></p><p></p><p></p><p>BMJ</p><p></p><p></p><p></p><p><a href="http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1" target="_blank">http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1</a></p></blockquote><p></p>
[QUOTE="flounder, post: 272153, member: 3519"] i would have expected nothing less from some. ignorance is bliss is it not? fact is, human TSE in the USA i.e. sporadic CJD has tripled in the past few years or so i.e. sporadic CJD some of which is of a phenotype of 'unknown' type. the last two mad cows in the USA were of atypical strain, and from there, we have what we call 'friendly fire' from various routes and sources, and believe me, behind closed doors there is much detate about just this. but i agree, the easy way out is to just ignore it i.e. ; AERO wrote; why do we care? how many human cases of BSE related illness have been reported in the last few years?....end it's like the mad cows, if you dont look, you don't find....tss SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM 1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype of 'UNKNOWN' strain growing. ... [url=http://www.cjdsurveillance.com/resources-casereport.html]http://www.cjdsurveillance.com/resource ... eport.html[/url] the ukbsenvcjd only theory is dead in the water now. ...tss ----- Original Message ----- From: Terry S. Singeltary Sr. To: Bovine Spongiform Encephalopathy Cc: [email=cjdvoice@yahoogroups.com]cjdvoice@yahoogroups.com[/email] ; [email=BLOODCJD@YAHOOGROUPS.COM]BLOODCJD@YAHOOGROUPS.COM[/email] ; [email=madcow@lists.iatp.org]madcow@lists.iatp.org[/email] Sent: Monday, August 07, 2006 10:28 AM Subject: [BLOODCJD] MAD COW BLOOD HUMANS RECALL (these are dime a dozen) CJD WATCH MESSAGE BOARD TSS MAD COW BLOOD HUMANS RECALL (these are dime a dozen) Mon Aug 7, 2006 10:24 71.248.132.189 PRODUCT a) Red Blood Cells, Recall # B-1587-6; b) Cryoprecipitated AHF, Recall # B-1588-6; c) Recovered Plasma, Recal # B-1589-6 CODE a), b) and c) Unit: 2016719 RECALLING FIRM/MANUFACTURER Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on March 13, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION GA and Germany ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6; b) Fresh Frozen Plasma, Recall # B-1591-6 CODE a) and b) Unit: 2443595 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 30, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6; b) Fresh Frozen Plasma, Recall # B-1593-6 CODE a) and b) Unit: 2545596 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 14, 2004 and January 3, 2005. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX ______________________________ [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html[/url] these usa mad cow blood for humans are a dime a dozen, the come out just about every week ; [url=http://disc.server.com/discussion.cgi?disc=167318;article=2971;title=CJD%20WATCH]http://disc.server.com/discussion.cgi?d ... JD%20WATCH[/url] [url=http://disc.server.com/discussion.cgi?disc=167318;article=2972;title=CJD%20WATCH]http://disc.server.com/discussion.cgi?d ... JD%20WATCH[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 003001.pdf[/url] 8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients). [url=http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 010001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf[/url] although 176 products do _not_ conform to the CSM/VPC guidelines. [url=http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf[/url] TSS ----- Original Message ----- From: "Terry S. Singeltary Sr." <flounder9@VERIZON.NET> To: <BSE-L@aegee.org> Sent: Wednesday, August 30, 2006 10:17 AM Subject: TSE ADVISORY COMMITTEE MEETING SEPTEMBER 18-19 2006 ##################### Bovine Spongiform Encephalopathy ##################### TSE ADVISORY COMMITTEE MEETING SEPTEMBER 18-19 2006 Wed Aug 30, 2006 08:11 70.110.86.159 Transmissible Spongiform Encephalopathies Advisory Committee September 18-19, 2006 Meeting Date and Time: The meeting will be held on September 18, 2006, 8 a.m. to 4:30 p.m. and September 19, 2006, 8 a.m. to 1 p.m. Location: Holiday Inn Gaithersburg, MD, 2 Montgomery Village Avenue, Gaithersburg, MD 20879 Contact Person: William Freas, or Rosanna L. Harvey, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512392. Please call the Information Line for up-to-date information on this meeting. Agenda: On September 18, 2006 the Committee will hear updates on the following topics: United States and worldwide bovine spongiform encephalopathies (BSE); variant Creutzfeldt-Jakob disease (vCJD) epidemiology and transfusion-transmission; blood and plasma donor deferral for transfusion in France since 1980, guidance; FDA’s current assessment and plans regarding the potential exposure to vCJD from an investigational product, FXI, that was manufactured from UK donor plasma; and a summary of World Heath Organization Consultation on distribution of infectivity in tissues of animals and humans with transmissible spongiform encephalopathies. The Committee will then discuss experimental clearance of transmissible spongiform encephalopathy infectivity in plasma-derived Factor VIII products. In the afternoon, the Committee will discuss FDA’s risk assessment for potential exposure to vCJD from human plasma-derived antihemophilic factor (FVIII) products and potential responses. On September 19, 2006 the Committee will discuss possible criteria for approval of donor screening tests for vCJD. Oral presentations from the public will be scheduled between approximately 10:45 a.m. and 11:15 p.m. and 2:30 p.m. and 3:00 p.m. on September 18, 2006 and between approximately 10:15 a.m. and 11:45 a.m. on September 19, 2006. Those desiring to make formal oral presentations should notify the contact person on or before September 11, 2006. [url=http://www.fda.gov/cber/advisory/tse/tse0906.htm]http://www.fda.gov/cber/advisory/tse/tse0906.htm[/url] CJD WATCH MESSAGE BOARD TSS Prion infections, blood and transfusions Aguzzi and Glatzel Sat Jul 8, 2006 12:18 68.238.108.213 Prion infections, blood and transfusions Adriano Aguzzi* and Markus Glatzel [url=http://disc.server.com/discussion.cgi?disc=167318;article=2948;title=CJD%20WATCH;pagemark=60]http://disc.server.com/discussion.cgi?d ... agemark=60[/url] Freas, William From: Sent: To: Subject: Terry S. Singeltary Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM [email=freas@CBS5055530.CBER.FDA.GOV]freas@CBS5055530.CBER.FDA.GOV[/email] CJDIBSE (aka madcow) Human/Animal TSE’s--U.S.--Submission To Scientific Advisors and Consultants Staff January 2001 Meeting (short version) Greetings again Dr. Freas and Committee Members, I wish to submit the following information to the Scientific Advisors and Consultants Staff 2001 Advisory Committee (short version). snip... I am beginning to think that the endless attempt to track down and ban, potential 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. , DO NOT let the incubation time period of these TSEs fool you. To think of Scrapie as the prime agent to compare CJD, but yet overlook the Louping-ill vaccine event in 1930's of which 1000's of sheep where infected by scrapie from a vaccine made of scrapie infected sheep brains, would be foolish. I acquired this full text version of the event which was recorded in the Annual Congress of 1946 National Vet. Med. Ass. of Great Britain and Ireland. From the BVA and the URL is posted in my (long version). U.S.A. should make all human/animal TSE's notifiable at all ages, with requirements for a thorough surveillance and post-mortem examinations free of charge, if you are serious about eradicating this horrible disease in man and animal. There is histopathology reports describing o florid plaques" in CJD victims in the USA and some of these victims are getting younger. I have copies of such autopsies, there has to be more. PLUS, sub-clinical human TSE's will most definitely be a problem. THEN think of vaccineCJD in children and the bovine tissues used in the manufacturing process, think of the FACT that this agent surviving 6OO*C. PNAS -- Brown et al. 97 (7): 3418 scrapie agent live at 600*C Then think of the CONFIDENTIAL documents of what was known of human/animal TSE and vaccines in the mid to late 8Os, it was all about depletion of stock, to hell with the kids, BUT yet they knew. snip... full text ; [url=http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf]http://www.fda.gov/ohrms/dockets/ac/01/ ... 1s2_09.pdf[/url] EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Last updated: 19 July 2005 Adopted July 2004 (Question N° EFSA-Q-2003-083) Report Summary Summary of the Scientific Report The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003. The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties. A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries. 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. Publication date: 20 August 2004 EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Adopted July 2004 (Question N° EFSA-Q-2003-083) [Last updated 08 September 2004] [Publication Date 20 August 2004] [url=http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html]http://www.efsa.europa.eu/en/science/ts ... s/573.html[/url] Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) [url=http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf]http://www.fsis.usda.gov/OPPDE/Comments ... 0011-1.pdf[/url] [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle [url=http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf]http://www.fda.gov/ohrms/dockets/docket ... -vol45.pdf[/url] [url=http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf]http://www.fda.gov/ohrms/dockets/docket ... -vol40.pdf[/url] THE SEVEN 1/2 SCIENTIST REPORT *** ;-) [url=http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf]http://www.fda.gov/ohrms/dockets/docket ... tach-1.pdf[/url] [url=https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument]https://web01.aphis.usda.gov/regpublic. ... enDocument[/url] [url=http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf]http://www.fda.gov/ohrms/dockets/docket ... -vol35.pdf[/url] Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission) [url=https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument]https://web01.aphis.usda.gov/regpublic. ... enDocument[/url] 03-025IF 03-025IF-631 Linda A. Detwiler [PDF] [url=http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf]http://www.fsis.usda.gov/OPPDE/Comments ... IF-631.pdf[/url] Specified Risk Materials (SRMs) I am in full support of the interim final rule which prohibits SRMs from being included in food for human consumption. In addition to the list of tissues published in this rule, I am requesting that additional tissues be added to the list. These would include dura ("sheath") covering the spinal cord and the ENTIRE INTESTINE (from pylorus to rectum). The scientific justification is provided below. THESE SRMs should also be prohibited from ANY FDA regulated food or product intended for human consumption, including but not limited to flavorings, extracts, etc. ... Dr. Linda Detwiler comments in full; [url=http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf]http://www.fsis.usda.gov/OPPDE/Comments ... IF-634.pdf[/url] TIP740203/l 0424 CONFIDENTIAL [url=http://www.mad-cow.org/00/may00_news.html#aaa]http://www.mad-cow.org/00/may00_news.html#aaa[/url] TWA LITTLE minute [url=http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 001001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 010001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 006001.pdf[/url] COMMERCIAL IN CONFIDENCE [url=http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 005001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 005001.pdf[/url] NOT FOR PUBLICATION [url=http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 012001.pdf[/url] [url=http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf]http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 007001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 007001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 004001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 003001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 001001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 007001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 001001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf[/url] NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE snip... I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use. snip... The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out... [url=http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf]http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf[/url] more on the 1968 medicine act, they forgot to follow [url=http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 008001.pdf[/url] Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer) [url=http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 008001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf[/url] (It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.) [url=http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 011001.pdf[/url] [url=http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf]http://www.bseinquiry.gov.uk/files/yb/1 ... 010001.pdf[/url] TWA LITTLE STATEMENT 331 [url=http://www.bseinquiry.gov.uk/files/ws/s331.pdf]http://www.bseinquiry.gov.uk/files/ws/s331.pdf[/url] snip... [url=http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm]http://www.fda.gov/ohrms/dockets/dailys ... 7-EC-2.htm[/url] RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States Email Terry S. Singeltary: [email=flounder@wt.net]flounder@wt.net[/email] I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc? [url=http://www.neurology.org/cgi/eletters/60/2/176#535]http://www.neurology.org/cgi/eletters/60/2/176#535[/url] LANCET INFECTIOUS DISEASE JOURNAL Volume 3, Number 8 01 August 2003 Newsdesk Tracking spongiform encephalopathies in North America Xavier Bosch My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my mom to hvCJD (Heidenhain variant CJD) and have been searching for answers ever since. What I have found is that we have not been told the truth. CWD in deer and elk is a small portion of a much bigger problem. 49-year-old Singeltary is one of a number of people who have remained largely unsatisfied after being told that a close relative died from a rapidly progressive dementia compatible with spontaneous Creutzfeldt-Jakob disease (CJD). So he decided to gather hundreds of documents on transmissible spongiform encephalopathies (TSE) and realised that if Britons could get variant CJD from bovine spongiform encephalopathy (BSE), Americans might get a similar disorder from chronic wasting disease (CWD)the relative of mad cow disease seen among deer and elk in the USA. Although his feverish search did not lead him to the smoking gun linking CWD to a similar disease in North American people, it did uncover a largely disappointing situation. Singeltary was greatly demoralised at the few attempts to monitor the occurrence of CJD and CWD in the USA. Only a few states have made CJD reportable. Human and animal TSEs should be reportable nationwide and internationally, he complained in a letter to the Journal of the American Medical Association (JAMA 2003; 285: 733). I hope that the CDC does not continue to expect us to still believe that the 85% plus of all CJD cases which are sporadic are all spontaneous, without route or source. Until recently, CWD was thought to be confined to the wild in a small region in Colorado. But since early 2002, it has been reported in other areas, including Wisconsin, South Dakota, and the Canadian province of Saskatchewan. Indeed, the occurrence of CWD in states that were not endemic previously increased concern about a widespread outbreak and possible transmission to people and cattle. To date, experimental studies have proven that the CWD agent can be transmitted to cattle by intracerebral inoculation and that it can cross the mucous membranes of the digestive tract to initiate infection in lymphoid tissue before invasion of the central nervous system. Yet the plausibility of CWD spreading to people has remained elusive. Part of the problem seems to stem from the US surveillance system. CJD is only reported in those areas known to be endemic foci of CWD. Moreover, US authorities have been criticised for not having performed enough prionic tests in farm deer and elk. Although in November last year the US Food and Drug Administration issued a directive to state public-health and agriculture officials prohibiting material from CWD-positive animals from being used as an ingredient in feed for any animal species, epidemiological control and research in the USA has been quite different from the situation in the UK and Europe regarding BSE. Getting data on TSEs in the USA from the government is like pulling teeth, Singeltary argues. You get it when they want you to have it, and only what they want you to have. Norman Foster, director of the Cognitive Disorders Clinic at the University of Michigan (Ann Arbor, MI, USA), says that current surveillance of prion disease in people in the USA is inadequate to detect whether CWD is occurring in human beings; adding that, the cases that we know about are reassuring, because they do not suggest the appearance of a new variant of CJD in the USA or atypical features in patients that might be exposed to CWD. However, until we establish a system that identifies and analyses a high proportion of suspected prion disease cases we will not know for sure. The USA should develop a system modelled on that established in the UK, he points out. Ali Samii, a neurologist at Seattle VA Medical Center who recently reported the cases of three hunterstwo of whom were friendswho died from pathologically confirmed CJD, says that at present there are insufficient data to claim transmission of CWD into humans; adding that [only] by asking [the questions of venison consumption and deer/elk hunting] in every case can we collect suspect cases and look into the plausibility of transmission further. Samii argues that by making both doctors and hunters more aware of the possibility of prions spreading through eating venison, doctors treating hunters with dementia can consider a possible prion disease, and doctors treating CJD patients will know to ask whether they ate venison. CDC spokesman Ermias Belay says that the CDC will not be investigating the [Samii] cases because there is no evidence that the men ate CWD-infected meat. He notes that although the likelihood of CWD jumping the species barrier to infect humans cannot be ruled out 100% and that [we] cannot be 100% sure that CWD does not exist in humans& the data seeking evidence of CWD transmission to humans have been very limited. [url=http://infection.thelancet.com/journal/journal.isa]http://infection.thelancet.com/journal/journal.isa[/url] he complained in a letter to the Journal of the American Medical Association (JAMA 2003; 285: 733). I hope that the CDC does not continue to expect us to still believe that the 85% plus of all CJD cases which are sporadic are all spontaneous, without route or source.<<< actually, that quote was from a more recent article in the Journal of Neurology (see below), not the JAMA article... Full Text Diagnosis and Reporting of Creutzfeldt-Jakob Disease Singeltary, Sr et al. JAMA.2001; 285: 733-734. [url=http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtos]http://jama.ama-assn.org/cgi/content/fu ... 733?maxtos[/url] how=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing +and+reporting+creutzfeldt+jakob+disease&searchid=1048865 596978_1528&stored_search=&FIRSTINDEX=0&journalcode= jama BRITISH MEDICAL JOURNAL SOMETHING TO CHEW ON BMJ [url=http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2]http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2[/url] BMJ [url=http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1]http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1[/url] [/QUOTE]
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