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NCBA, R-CALF, COOL, USDA (No Politics!)
CJD USA UPDATE NOV. 2006
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<blockquote data-quote="flounder" data-source="post: 294580" data-attributes="member: 3519"><p>CJD (NEW VARIANT) UPDATE 2006 (11)</p><p>**********************************</p><p>A ProMED-mail post</p><p><http://www.promedmail.org></p><p>ProMED-mail is a program of the</p><p>International Society for Infectious Diseases</p><p><http://www.isid.org></p><p></p><p>[The definition of the designations deaths, definite cases, probable </p><p>vCJD cases, and the case definitions can be found by accessing the </p><p>Department of Health website or by reference to a previous </p><p>ProMED-mail post in this thread (for example, CJD (new var.) - UK: </p><p>update March 2002 20020305.3693).</p><p></p><p>Data on vCJD cases from other parts of the world are now included in </p><p>these updates whenever available.</p><p></p><p>Also, data on other forms of CJD (sporadic, iatrogenic, familial and </p><p>GSS) are now included when they have some relevance to the incidence </p><p>and etiology of vCJD. - Mod.CP]</p><p></p><p>In this update:</p><p></p><p>[1] UK: Department of Health monthly CJD statistics, Mon 6 Nov 2006</p><p>[2] EUROCJD data as of 31 Oct 2006</p><p>[3] France: novel prion strain</p><p></p><p>******</p><p>[1] UK: Department of Health monthly CJD statistics, Mon 6 Nov 2006</p><p>Date: Mon 6 Nov 2006</p><p>From: ProMED-mail <promed@promedmail.org></p><p>Source: UK Department of Health, Monthly Creutzfeldt-Jakob Disease </p><p>Statistics [edited]</p><p><https://www.gnn.gov.uk/content/detail.asp?NewsAreaID=2&ReleaseID=239915ID=2></p><p></p><p></p><p>The Department of Health is today [Mon 6 Nov 2006] issuing the latest </p><p>information about the numbers of known cases of Creutzfeldt-Jakob </p><p>disease. This includes cases of variant Creutzfeldt-Jakob disease </p><p>[abbreviated in ProMED-mail as CJD (new var.) or vCJD], the form of </p><p>the disease thought to be linked to BSE (bovine spongiform encephalopathy).</p><p></p><p>Definite and probable CJD cases in the UK, as of Fri 3 Nov 2006:</p><p>-----------------------------------------------</p><p>Summary of vCJD cases - deaths</p><p>-----------------------------</p><p>Deaths from definite vCJD (confirmed): 112</p><p>Deaths from probable vCJD (without neuropathological confirmation): 46</p><p>Deaths from probable vCJD (neuropathological confirmation pending): 0</p><p>Number of deaths from definite or probable vCJD (as above): 158</p><p></p><p>Summary of vCJD cases - alive</p><p>-----------------------------</p><p>Number of probable vCJD cases still alive: 6</p><p></p><p>Total</p><p>-----</p><p>Number of definite or probable vCJD (dead and alive): 164</p><p></p><p>(The next table will be published on Mon 4 Dec 2006).</p><p></p><p>Since the previous monthly statistics were released on Mon 6 Nov </p><p>2006, the total number of deaths from definite vCJD has increased by </p><p>2 and stands at 158, and the overall total number of definite or </p><p>probable vCJD cases (dead and alive) has increased by 2, making the </p><p>overall total 164.</p><p></p><p>These data are consistent with the view that the vCJD outbreak in the </p><p>UK is in decline. The total number of deaths due to vCJD in the UK is </p><p>now 158. The peak number of deaths was 28 in the year 2000, followed </p><p>by 20 in 2001, 17 in 2002, 18 in 2003, and 9 in 2004, 5 in 2005. The </p><p>number of deaths due to definite or probable vCJD in the UK during </p><p>the 1st 10 months of 2006 has risen to 5.</p><p></p><p>Totals for all types of CJD cases in the UK in 2005 and 2006</p><p>-----------------------------------------------</p><p>As of 3 Nov 2006, in the UK in the year 2005, there were 122 </p><p>referrals of suspected CJD, and there were 65 deaths from sporadic </p><p>CJD, 6 from familial CJD, 3 from iatrogenic CJD, 6 GSS </p><p>(Gerstmann-Straussler-Scheinker) syndrome cases, and 5 deaths from vCJD.</p><p></p><p>The corresponding figures so far for the 1st 10 months of 2006 are: </p><p>87 referrals, 48 deaths from sporadic CJD, 5 from vCJD, 4 from </p><p>familial CJD, 3 from GSS and one from iatrogenic CJD.</p><p></p><p>During the period 1995, when vCJD was 1st diagnosed, up to the </p><p>present, there have been 946 deaths from all forms of CJD, including </p><p>the 158 deaths attributable to definite or probable vCJD.</p><p></p><p>[These data are accessible via</p><p><https://www.gnn.gov.uk/content/detail.asp?NewsAreaID=2&ReleaseID=239915ID=2>.]</p><p></p><p>--</p><p>ProMED-mail</p><p><promed@promedmail.org></p><p></p><p>******</p><p>[2] EUROCJD data as of 31 Oct 2006</p><p>Date: Tue 31 Oct 2006</p><p>From: ProMED-mail <promed@promedmail.org></p><p>Source: EUROCJD [edited]</p><p><http://www.eurocjd.ed.ac.uk/vcjdworldeuro.htm></p><p></p><p></p><p>The European And Allied Countries Collaborative Study Group of CJD (EUCJD)</p><p>-----------------------------------------------</p><p>This web-site includes information from 2 projects funded by the </p><p>European Commission. The EUROCJD project started in 1993 and compares </p><p>data from national registries in Australia, Austria, Canada, France, </p><p>Germany, Italy, the Netherlands, Slovakia, Spain, Switzerland and the </p><p>UK. The NEUROCJD project started in 1998 after the European Union </p><p>Council recommended that epidemiological surveillance of CJD should </p><p>be extended to all member states. The member states involved in this </p><p>project are Belgium, Denmark, Finland, Greece, Iceland, Ireland, </p><p>Israel, Norway and Portugal. Both projects are coordinated from the </p><p>National CJD Surveillance Unit based in Edinburgh.</p><p></p><p>Current data as of October 2006</p><p>-------------------------------</p><p>Country / Total No. of Primary cases (No. alive) / Cumulative </p><p>residence in UK (>6 months) / Secondary transmission by blood transfusion</p><p></p><p>United Kingdom / 162 (6) / 164 / 2 (0)</p><p></p><p>France / 21 (2) / 1 / 0</p><p></p><p>Republic of Ireland / 4 (1) / 2 / 0</p><p></p><p>Italy / 1 (0) / 0 / 0</p><p></p><p>USA / 2 (0) / 2 / 0</p><p></p><p>Canada / 1 (0) / 1 / 0</p><p></p><p>Saudi Arabia / 1 (1) / 0 / 0</p><p></p><p>Japan / 1* (0) / 0 / 0</p><p></p><p>Portugal / 1 (1) / 0 / 0</p><p></p><p>Spain / 1 (0) / 0 / 0</p><p></p><p>Total / 197 (12) / - / 2</p><p></p><p>Footnote:</p><p>---------</p><p>* Residence in the UK for 24 days</p><p></p><p>--</p><p>ProMED-mail</p><p><promed@promedmail.org></p><p></p><p>******</p><p>[3] France: novel prion strain</p><p>Date: Thu 12 Oct 2006</p><p>From: Terry Singeltary <flounder9@verizon.net></p><p>Source: PLoS Pathogens 2(10); published ahead of print [edited]</p><p><http://pathogens.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.ppat.0020112></p><p></p><p></p><p>Terry S. Singeltary Sr. has drawn ProMED-mail's attention to the </p><p>following paper published ahead of print in PLoS Pathogens, which </p><p>although not directly featuring vCJD, he considers is relevant to </p><p>understanding the origin of the BSE outbreak in cattle and vCJD in </p><p>humans. He comments that this research indicates that different prion </p><p>disease phenotypes result from inoculation of cattle with 2 </p><p>temporally separated sources of sheep scrapie from Great Britain.</p><p></p><p>The paper is entitled "Isolation from Cattle of a Prion Strain </p><p>Distinct from That Causing Bovine Spongiform Encephalopathy" and is </p><p>authored by Vincent Beringue and 10 others. The abstract reads as follows:</p><p></p><p>"To date, bovine spongiform encephalopathy (BSE) and its human </p><p>counterpart, variant Creutzfeldt-Jakob disease, have been associated </p><p>with a single prion strain. This strain is characterized by a unique </p><p>and remarkably stable biochemical profile of abnormal </p><p>protease-resistant prion protein (PrP(res)) isolated from brains of </p><p>affected animals or humans. However, alternate PrP(res) signatures in </p><p>cattle have recently been discovered through large-scale screening. </p><p>To test whether these also represent separate prion strains, we </p><p>inoculated French cattle isolates characterized by a PrP(res) of </p><p>higher apparent molecular mass, called H-type, into transgenic mice </p><p>expressing bovine or ovine PrP. All mice developed neurological </p><p>symptoms and succumbed to these isolates, showing that these </p><p>represent a novel strain of infectious prions. Importantly, this </p><p>agent exhibited strain-specific features clearly distinct from that </p><p>of BSE agent inoculated to the same mice, which were retained on </p><p>further passage. Moreover, it also differed from all sheep scrapie </p><p>isolates passaged so far in ovine PrP-expressing mice. Our findings </p><p>therefore raise the possibility that either various prion strains may </p><p>exist in cattle, or that the BSE agent has undergone divergent </p><p>evolution in some animals."</p><p></p><p>The authors' synopsis of their paper reads as follows: Prions are </p><p>unconventional agents of proteic nature that are formed of abnormal </p><p>conformations of the host-encoded prion protein (PrP). They cause </p><p>fatal neurodegenerative diseases in both animals and humans and can </p><p>be transmitted between species, as exemplified in humans by the </p><p>emergence of variant Creutzfeldt-Jakob disease following the epidemic </p><p>of bovine spongiform encephalopathy (BSE) in the United Kingdom. </p><p>Since diagnosis of prion infection is only possible once the central </p><p>nervous system has been invaded, brains of slaughtered or fallen </p><p>cattle are routinely screened in Europe to protect the consumers from </p><p>BSE. This has unexpectedly led to the discovery of unprecedented PrP </p><p>conformations that were distinct from the single one associated so </p><p>far with BSE or BSE-related diseases. To precisely determine their </p><p>etiology, the authors have studied the transmissibility of these new </p><p>conformations, termed H-type, to transgenic mice expressing either </p><p>bovine or ovine PrP. They show that these cases are highly pathogenic </p><p>for these mice. The authors also demonstrate that they are not </p><p>directly related to the agent involved in the BSE epidemic, </p><p>supporting the view for isolation of a new prion strain from cattle, </p><p>whose prevalence and associated zoonotic risk should be carefully </p><p>monitored in the future."</p><p></p><p>--</p><p>Terry S. Singeltary Sr</p><p><flounder9@verizon.net></p><p></p><p>[see also:</p><p>CJD (new var.) update 2006 (10) 20061002.2820</p><p>CJD (new var.) update 2006 (09) 20060904.2519</p><p>CJD (new var.) update 2006 (08) 20060807.2207</p><p>CJD (new var.) update 2006 (07) 20060703.1831</p><p>CJD (new var.) - Netherlands: 2nd case 20060623.1741</p><p>CJD (new var.) update 2006 (06) 20060605.1566</p><p>CJD (new var.) update 2006 (05) 20060508.1332</p><p>CJD (new var.) update 2006 (04) 20060404.1005</p><p>CJD (new var.) update 2006 (03) 20060306.0728</p><p>CJD (new var.) - UK: 3rd transfusion-related case 20060209.0432</p><p>CJD (new var.) update 2006 (02) 20060206.0386</p><p>CJD (new var.) update 2006 (01) 20060111.0101</p><p>CJD (new var.) update 2006 20060111.0101</p><p>2005</p><p>----</p><p>CJD (new var.) update 2005 (12) 20051209.3547</p><p>CJD (new var.) update 2005 (11) 20051108.3270</p><p>CJD (new var.) update 2005 (10) 20051006.2916</p><p>CJD (new var.) update 2005 (05) 20050505.1243</p><p>CJD (new var.) - UK: update 2005 (01) 20050111.0095</p><p>2004</p><p>----</p><p>CJD, genetic susceptibility 20041112.3064</p><p>CJD (new var.) - UK: update 2004 (14) 20041206.3242</p><p>CJD (new var.) - UK: update 2004 (01) 20040106.0064</p><p>CJD (new var.) - France: 8th case 20041022.2864</p><p>CJD (new var.) - France: 9th case 20041123.3138</p><p>CJD (new var.), blood supply - UK 20040318.0758</p><p>CJD (new var.), carrier frequency study - UK 20040521.1365</p><p>2003</p><p>----</p><p>CJD (new var.) - UK: update 2003 (13) 20031216.3072</p><p>CJD (new var.) - UK: update 2003 (01) 20030108.0057</p><p>2002</p><p>----</p><p>CJD (new var.) - UK: update Dec 2002 20021207.5997</p><p>CJD (new var.) - UK: update Jan 2002 20020111.3223</p><p>2001</p><p>----</p><p>CJD (new var.), incidence & trends - UK (02) 20011124.2875</p><p>CJD (new var.), incidence & trends - UK 20011115.2816</p><p>CJD (new var.) - UK: reassessment 20011029.2671</p><p>CJD (new var.) - UK: update Oct 2001 20011005.2419</p><p>CJD (new var.) - UK: regional variation (02) 20010907.2145</p><p>CJD (new var.) - UK: update Sep 2001 20010906.2134</p><p>CJD (new var.) - UK: update Aug 2001 20010808.1872</p><p>CJD (new var.) - UK: 9th Annual Report 20010628.1231</p><p>CJD (new var.) - UK: update June 2001 20010622.1188</p><p>CJD (new var.) - UK: update 3 Jan 2001 20010104.0025]</p><p>.............................................cp/msp/jw</p><p></p><p></p><p>*##########################################################*</p><p>************************************************************</p><p>ProMED-mail makes every effort to verify the reports that</p><p>are posted, but the accuracy and completeness of the</p><p>information, and of any statements or opinions based</p><p>thereon, are not guaranteed. The reader assumes all risks in</p><p>using information posted or archived by ProMED-mail. ISID</p><p>and its associated service providers shall not be held</p><p>responsible for errors or omissions or held liable for any</p><p>damages incurred as a result of use or reliance upon posted</p><p>or archived material.</p><p>************************************************************</p><p>Become a ProMED-mail Premium Subscriber at</p><p><http://www.isid.org/ProMEDMail_Premium.shtml></p><p>************************************************************</p><p>Visit ProMED-mail's web site at <http://www.promedmail.org>.</p><p>Send all items for posting to: <a href="mailto:promed@promedmail.org">promed@promedmail.org</a></p><p>(NOT to an individual moderator). If you do not give your</p><p>full name and affiliation, it may not be posted. Send</p><p>commands to subscribe/unsubscribe, get archives, help,</p><p>etc. to: <a href="mailto:majordomo@promedmail.org">majordomo@promedmail.org</a>. For assistance from a</p><p>human being send mail to: <a href="mailto:owner-promed@promedmail.org">owner-promed@promedmail.org</a>.</p><p>############################################################</p><p>############################################################</p><p></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>There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection. </p><p></p><p>He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins. </p><p></p><p></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm" target="_blank">http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.htm</a> </p><p></p><p></p><p><a href="http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf" target="_blank">http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.pdf</a> </p><p></p><p></p><p></p><p>Subject: SEAC EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS FOR SUBCLINICAL vCJD POSITION STATEMENT</p><p>Date: November 7, 2006 at 9:38 am PST </p><p>© SEAC 2006 </p><p></p><p>1 </p><p></p><p>POSITION STATEMENT </p><p></p><p>EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS </p><p></p><p>FOR SUBCLINICAL vCJD </p><p></p><p>Issue </p><p></p><p>1. The Department of Health and the UK blood services requested </p><p></p><p>SEAC's advice on the scientific criteria by which ante mortem </p><p></p><p>diagnostic tests for subclinical vCJD could be evaluated and </p><p></p><p>validated1. </p><p></p><p>Background </p><p></p><p>2. The development of an accurate and sensitive ante mortem blood </p><p></p><p>test to identify asymptomatic individuals infected with vCJD could </p><p></p><p>substantially reduce the potential for transmission of vCJD via </p><p></p><p>blood transfusion and other medical interventions. It could also be </p><p></p><p>valuable in confirming the diagnosis of clinical cases and </p><p></p><p>monitoring the effect of potential therapies. In addition, such a test </p><p></p><p>could provide an important tool to ascertain better the prevalence </p><p></p><p>of vCJD infections. </p><p></p><p>3. The safety, quality and performance requirements for diagnostic </p><p></p><p>tests for many infectious diseases are laid down in the In Vitro </p><p></p><p>Diagnostic Medical Devices (IVD) Directive 98/79/EC. Tests </p><p></p><p>included in Annex II List A of the Directive must comply with </p><p></p><p>performance requirements set out in a Common Technical </p><p></p><p>Specification (CTS) to receive a CE mark2. Currently, diagnostic </p><p></p><p>tests for subclinical vCJD are not included in Annex IIA of the </p><p></p><p>Directive and so a CTS with clear performance requirements for </p><p></p><p>such tests has not yet been defined. </p><p></p><p></p><p>SNIP...FULL TEXT ;</p><p></p><p></p><p>SEAC </p><p></p><p>November 2006 </p><p></p><p></p><p><a href="http://www.seac.gov.uk/pdf/statement-vcjd.pdf" target="_blank">http://www.seac.gov.uk/pdf/statement-vcjd.pdf</a> </p><p></p><p></p><p></p><p></p><p>PRODUCT</p><p>Source Plasma, Recall # B-0054-7</p><p>CODE</p><p>Units: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891, 03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969, 03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588, 03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228, 03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628, 03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707, 03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189, 03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979, 03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707, 04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719, 04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816, 04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063, 04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485, 04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930, 04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578</p><p>RECALLING FIRM/MANUFACTURER</p><p>BioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>89 units</p><p>DISTRIBUTION</p><p>CA and Austria </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR October 25, 2006 </p><p></p><p>### </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00975.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00975.html</a> </p><p></p><p></p><p></p><p></p><p>PRODUCT</p><p>Recovered Plasma, Recall # B-0084-7</p><p>CODE</p><p>Unit: GR38567</p><p>RECALLING FIRM/MANUFACTURER</p><p>Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter on May 16, 2003. Firm initiated recall is complete.</p><p>REASON</p><p>Blood product, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), was distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>1 unit</p><p>DISTRIBUTION</p><p>Switzerland </p><p></p><p>______________________________</p><p>PRODUCT</p><p>Source Plasma, Recall # B-0085-7</p><p>CODE</p><p>Units: 03LWID9056 03LWIE0563 03LWIE1438 03LWIE1703 03LWIE2881 03LWIE7822 03LWIF5263 03LWIF5709 03LWIF6162 03LWIF6703 03LWIF7544 03LWIF8839 03LWIG0019 04LWIA0693 04LWIA1413 04LWIA6459 04LWIA7250 04LWIB7909 04LWIC0795 04LWIC2962 04LWIC3881 04LWIC4249 04LWIC5138 04LWIC7988 04LWIC8464 04LWIC9002 04LWIC9487 03LWIS2936 03LWIS3052 03LWIS3082 03LWIS3114 03LWIS3204 03LWIS3554 03LWIS4083 03LWIS4116 03LWIS4147 03LWIS4185 03LWIS4239 03LWIS4334 04LWIS0036 04LWIS0127 04LWIS0262 04LWIS0545 04LWIS0600 04LWIS0616 04LWIS0850 04LWIS1717 04LWIS1784 04LWIS1810 04LWIS1874 04LWIS2074 04LWIS2110 04LWIS2149 04LWIS2179 </p><p>RECALLING FIRM/MANUFACTURER</p><p>BioLife Plasma Service L.P., Onalaska, WI, by facsimile on July 29, 2004. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>54 units</p><p>DISTRIBUTION</p><p>Austria </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR November 1, 2006 </p><p></p><p>### </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00976.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00976.html</a> </p><p></p><p></p><p></p><p></p><p>----- Original Message ----- </p><p>From: Terry S. Singeltary Sr. </p><p></p><p>Sent: Monday, October 09, 2006 2:48 PM</p><p>Subject: FDA nvCJD MAD COW BLOOD HUMAN RECALL 2006 UPDATE </p><p></p><p></p><p>SCIENTIFIC COMMITTEE ON EMERGING AND NEWLY </p><p></p><p>IDENTIFIED HEALTH RISKS </p><p></p><p>(SCENIHR) </p><p></p><p>Opinion on </p><p></p><p>The Safety of Human-derived Products with regard to Variant </p><p></p><p>Creutzfeldt-Jakob Disease </p><p></p><p></p><p>Adopted by the SCENIHR </p><p></p><p>during the 11th plenary meeting of 11-12 May 2006 </p><p></p><p>after public consultation </p><p></p><p>Synthesis Report : <a href="http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_vcjd_synth.pdf" target="_blank">http://ec.europa.eu/health/ph_risk/comm ... _synth.pdf</a> </p><p></p><p>Stakeholder comments : <a href="http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_vcjd_comments.zip" target="_blank">http://ec.europa.eu/health/ph_risk/comm ... mments.zip</a> </p><p></p><p>EUROPEAN COMMISSION </p><p></p><p>HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL </p><p></p><p>Directorate C - Public Health and Risk Assessment </p><p></p><p></p><p>SNIP...FULL TEXT ;</p><p></p><p></p><p>snip...6 of 81 pages, full text ; </p><p></p><p></p><p></p><p><a href="http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_004b.pdf" target="_blank">http://ec.europa.eu/health/ph_risk/comm ... o_004b.pdf</a> </p><p></p><p></p><p>USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen) </p><p></p><p></p><p>RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II</p><p>______________________________</p><p>PRODUCT</p><p>Source Plasma, Recall # B-1708-6</p><p>CODE</p><p>Units: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140,</p><p>MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855,</p><p>MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136,</p><p>MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343,</p><p>04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504,</p><p>05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874,</p><p>05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236,</p><p>05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336,</p><p>05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907,</p><p>05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277,</p><p>05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355,</p><p>05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892,</p><p>05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962</p><p>RECALLING FIRM/MANUFACTURER</p><p>BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.</p><p>Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, collected from unsuitable donors based on risk factors for</p><p>Creutzfeldt-Jakob Disease (CJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>80 units</p><p>DISTRIBUTION</p><p>CA, NC, and MD </p><p></p><p>______________________________ </p><p></p><p>PRODUCT</p><p>a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;</p><p>b) Fresh Frozen Plasma, Recall # B-1715-6;</p><p>c) Platelets, Recall # B-1716-6</p><p>CODE</p><p>a), b), and c) Unit: 2443732</p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by letters dated</p><p>November 11, 2003 and December 18, 2003. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, collected from a donor who was at increased risk for new</p><p>variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>3 units</p><p>DISTRIBUTION</p><p>TX and WI </p><p></p><p>END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006 </p><p></p><p>### </p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00969.html</a> </p><p></p><p></p><p></p><p>PRODUCT</p><p>Fresh Frozen Plasma, Recall # B-1751-6</p><p>CODE</p><p>Unit: 4936623</p><p>RECALLING FIRM/MANUFACTURER</p><p>Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated September</p><p>16, 2005. Firm initiated recall is complete.</p><p>REASON</p><p>Blood product, which was collected from an unsuitable donor based on risk</p><p>factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>1 unit</p><p>DISTRIBUTION</p><p>TX </p><p></p><p>END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006 </p><p></p><p>### </p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00968.html</a> </p><p></p><p></p><p></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></p><p></p><p>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;</p><p>b) Fresh Frozen Plasma, Recall # B-1551-6</p><p>CODE</p><p>a) and b) Unit 2395371 </p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20, 2003. Firm initiated recall is complete. </p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased 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>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6;</p><p>b) Platelets, Recall # B-1553-6;</p><p>c) Fresh Frozen Plasma, Recall # B-1554-6</p><p>CODE</p><p>a), b) and c) Unit 2438702 </p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29, 2003. Firm initiated recall is complete. </p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased 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>TX </p><p></p><p>______________________________</p><p>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6;</p><p>b) Fresh Frozen Plasma, Recall # B-1556-6</p><p>CODE</p><p>a) and b) Unit 2454970 </p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 and December 11. 2003. Firm initiated recall is complete. </p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased 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>PRODUCT</p><p>a) Red Blood Cells, Recall # B-1494-6</p><p>b) Cryoprecipitated AHF, Recall # B-1495-6</p><p>CODE</p><p>a) and b) Unit 5013100 </p><p>RECALLING FIRM/MANUFACTURER</p><p>Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May 17, 2005. Firm initiated recall is complete. </p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased 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>GA </p><p></p><p></p><p>______________________________</p><p>PRODUCT</p><p>Source Plasma, Recall # B-1450-6</p><p>CODE</p><p>Unit numbers ST0824313 and ST0824764</p><p>RECALLING FIRM/MANUFACTURER</p><p>Stillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003. Firm initiated recall is complete. </p><p>REASON</p><p>Blood products, which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>2 units</p><p>DISTRIBUTION</p><p>UK </p><p></p><p></p><p>______________________________</p><p>PRODUCT</p><p>Plasma Frozen, Recall # B-1422-6;</p><p>Recovered Plasma, Recall # B-1423-6</p><p>CODE</p><p>a) Unit 03E42218; </p><p>b) Unit 03E38153 </p><p>RECALLING FIRM/MANUFACTURER</p><p>American Red Cross Blood Services, Atlanta, GA, by telephone, e-mail or letter on February 20 or 21, 2004. Firm initiated recall is complete. </p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased 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>GA and Switzerland </p><p></p><p></p><p>______________________________</p><p>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6;</p><p>b) Recovered Plasma, Recall # B-1375-6</p><p>CODE</p><p>a) and b) unit 2453906</p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31 and November 5, 2003. Firm initiated recall is complete. </p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased 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 and Austria </p><p></p><p></p><p>______________________________</p><p>PRODUCT</p><p>Source Plasma. Recall # B-1295-6 </p><p>CODE</p><p>Units: NG0046551, NG0045950 </p><p>RECALLING FIRM/MANUFACTURER</p><p>DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002, Firm initiated recall is complete. </p><p>REASON</p><p>Blood products, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire appropriately, were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>2 units</p><p>DISTRIBUTION</p><p>KY </p><p></p><p>______________________________</p><p>PRODUCT</p><p>Source Plasma. Recall # B-1296-6 </p><p>CODE</p><p>Unit: NG 0044520 </p><p>RECALLING FIRM/MANUFACTURER</p><p>DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 12, 2002. Firm initiated recall is complete. </p><p>REASON</p><p>Blood product, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, was distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>1 unit</p><p>DISTRIBUTION</p><p>KY </p><p></p><p>______________________________</p><p>PRODUCT</p><p>Source Plasma. Recall # B-1297-6 </p><p>CODE</p><p>Units: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020, NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555 </p><p>RECALLING FIRM/MANUFACTURER</p><p>DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete. </p><p>REASON</p><p>Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>13 units</p><p>DISTRIBUTION</p><p>KY </p><p></p><p>______________________________</p><p>PRODUCT</p><p>Source Plasma, Recall # B-1298-6 </p><p>CODE</p><p>Units: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG 0042525, NG 0042341 </p><p>RECALLING FIRM/MANUFACTURER</p><p>DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete. </p><p>REASON</p><p>Blood products, collected from a donor who answered questions on the variant Creutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>7 units</p><p>DISTRIBUTION</p><p>KY </p><p></p><p>______________________________</p><p>PRODUCT</p><p>Recovered Plasma, Recall # B-1299-6 </p><p>CODE</p><p>Unit: 4357117 </p><p>RECALLING FIRM/MANUFACTURER</p><p>Department of the Navy, Naval Medical Center, San Diego, CA, by fax and letter on September 25, 2003. Firm initiated recall is complete. </p><p>REASON</p><p>Blood product, collected from a donor considered to be at risk of exposure to Creutzfeldt-Jacob Disease (CJD), was distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>1 unit</p><p>DISTRIBUTION</p><p>Germany </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR July 12, 2006 </p><p></p><p>### </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00960.html</a> </p><p></p><p></p><p>CJD WATCH MESSAGE BOARD </p><p>TSS</p><p>FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY</p><p>Fri Jul 7, 2006 09:37</p><p>70.110.83.160 </p><p></p><p></p><p>FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY </p><p></p><p></p><p>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced, Recall # B-1379-6;</p><p>b) Platelets, Recall # B-1380-6;</p><p>c) Fresh Frozen Plasma, Recall # 1381-6;</p><p>d) Recovered Plasma, Recall # B-1382-6</p><p>CODE</p><p>a) Unit numbers: 2343106, 2377779, and 2403533;</p><p>b) and c) Unit numbers: 2377779;</p><p>d) Unit numbers: 2343106 and 2403533</p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 12, 2003. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>7 units</p><p>DISTRIBUTION</p><p>TX and Austria</p><p>______________________________ </p><p></p><p></p><p></p><p>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6;</p><p>b) Recovered Plasma, Recall # B-1468-6</p><p>CODE</p><p>a) and b) Unit numbers: 2329380</p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8, 2003. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased 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 and Switzerland </p><p></p><p>______________________________ </p><p></p><p></p><p>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6;</p><p>b) Cryoprecipitated AHF, Recall # B-1480-6;</p><p>c) Recovered Plasma, Recall # B-1481-6</p><p>CODE</p><p>a), b), and c) Unit numbers: 2383280</p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 23 and 29, 2004. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased 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>TX and Switzerland </p><p></p><p>______________________________</p><p>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6;</p><p>b) Fresh Frozen Plasma, Recall # B-1483-6</p><p>CODE</p><p>a) and b) Unit number: 2501452</p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 5, 2004. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased 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 and NY </p><p></p><p>______________________________</p><p>PRODUCT</p><p>a) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6;</p><p>b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6;</p><p>c) Recovered Plasma, Recall # B-1486-6</p><p>CODE</p><p>a) and c) Unit number: 2554077;</p><p>b) Unit number: 2415708</p><p>RECALLING FIRM/MANUFACTURER</p><p>South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 13, 2004. Firm initiated recall is complete.</p><p>REASON</p><p>Blood products, which were collected from a donor who may be at increased 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>TX and Austria </p><p></p><p></p><p>_____________________________________ </p><p></p><p></p><p>END OF ENFORCEMENT REPORT FOR July 5, 2006 </p><p></p><p>### </p><p></p><p></p><p><a href="http://www.fda.gov/bbs/topics/enforce/2006/ENF00959.html" target="_blank">http://www.fda.gov/bbs/topics/enforce/2 ... 00959.html</a> </p><p></p><p></p><p></p><p></p><p>with new atypical TSE in the bovine, in the sheep, goat, and humans, and the fact that the new BASE TSE in cattle being very very similar to sporadic CJD, rather than the nvCJD, the fact that now science showing the TSE agent of the atypical cattle in Japan showing infectivity other than CNS tissue, the fact that the latest Texas mad cow and the recent Alabama mad cow both being of the atypical strain, it would seem prudent to include all human TSE in the blood ban, in my opinion. ... </p><p></p><p>TSS </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>Prion infections lead to invariably fatal diseases of the CNS, including </p><p></p><p>Creutzfeldt-Jakob disease (CJD) in humans, bovine spongiform </p><p></p><p>encephalopathy (BSE), and scrapie in sheep. There have been hundreds </p><p></p><p>of instances in which prions have been transmitted iatrogenically among </p><p></p><p>humans, usually through neurosurgical procedures or administration of </p><p></p><p>pituitary tissue extracts. Prions have not generally been regarded as bloodborne </p><p></p><p>infectious agents, and case-control studies have failed to identify </p><p></p><p>CJD in transfusion recipients. Previous understanding was, however, </p><p></p><p>questioned by reports of prion infections in three recipients of blood </p><p></p><p>donated by individuals who subsequently developed variant CJD. On </p><p></p><p>reflection, hematogenic prion transmission does not come as a surprise, as </p><p></p><p>involvement of extracerebral compartments such as lymphoid organs and </p><p></p><p>skeletal muscle is common in most prion infections, and prions have been </p><p></p><p>recovered from the blood of rodents and sheep. Novel diagnostic strategies, </p><p></p><p>which might include the use of surrogate markers of prion infection, along </p><p></p><p>with prion removal strategies, might help to control the risk of iatrogenic </p><p></p><p>prion spread through blood transfusions. ... </p><p></p><p></p><p>snip... </p><p></p><p></p><p></p><p>Last, despite all epidemiological evidence to </p><p></p><p>the contrary, patients who are methionine/valine </p><p></p><p>heterozygous at codon 129 of the PRNP gene are </p><p></p><p>susceptible to infection with vCJD prions, which </p><p></p><p>raises several important questions. Is the virulence </p><p></p><p>of BSE prions enhanced when passaged </p><p></p><p>from human to human, as opposed to the </p><p></p><p>original bovine to human situation? Passaging </p><p></p><p>experiments of scrapie infectivity between mice </p><p></p><p>and hamsters indicate that this scenario is highly </p><p></p><p>plausible.6 Even more importantly, can vCJD </p><p></p><p>infection of heterozygous individuals establish </p><p></p><p>a permanent subclinical carrier state? Although </p><p></p><p>this situation might constitute a best-case </p><p></p><p>scenario for the infected individuals, it could be </p><p></p><p>disastrous from an epidemiological viewpoint, </p><p></p><p>as it might lead to an unrecognized and possibly </p><p></p><p>self-sustaining epidemic. ... </p><p></p><p></p><p>snip... full text ; </p><p></p><p></p><p>JUNE 2006 VOL 2 NO 6 AGUZZI AND GLATZEL NATURE CLINICAL PRACTICE NEUROLOGY 329 </p><p></p><p><a href="http://www.nature.com/clinicalpractice/neuro" target="_blank">http://www.nature.com/clinicalpractice/neuro</a> </p><p></p><p></p><p>TSS</p></blockquote><p></p>
[QUOTE="flounder, post: 294580, member: 3519"] CJD (NEW VARIANT) UPDATE 2006 (11) ********************************** A ProMED-mail post <http://www.promedmail.org> ProMED-mail is a program of the International Society for Infectious Diseases <http://www.isid.org> [The definition of the designations deaths, definite cases, probable vCJD cases, and the case definitions can be found by accessing the Department of Health website or by reference to a previous ProMED-mail post in this thread (for example, CJD (new var.) - UK: update March 2002 20020305.3693). Data on vCJD cases from other parts of the world are now included in these updates whenever available. Also, data on other forms of CJD (sporadic, iatrogenic, familial and GSS) are now included when they have some relevance to the incidence and etiology of vCJD. - Mod.CP] In this update: [1] UK: Department of Health monthly CJD statistics, Mon 6 Nov 2006 [2] EUROCJD data as of 31 Oct 2006 [3] France: novel prion strain ****** [1] UK: Department of Health monthly CJD statistics, Mon 6 Nov 2006 Date: Mon 6 Nov 2006 From: ProMED-mail <promed@promedmail.org> Source: UK Department of Health, Monthly Creutzfeldt-Jakob Disease Statistics [edited] <https://www.gnn.gov.uk/content/detail.asp?NewsAreaID=2&ReleaseID=239915ID=2> The Department of Health is today [Mon 6 Nov 2006] issuing the latest information about the numbers of known cases of Creutzfeldt-Jakob disease. This includes cases of variant Creutzfeldt-Jakob disease [abbreviated in ProMED-mail as CJD (new var.) or vCJD], the form of the disease thought to be linked to BSE (bovine spongiform encephalopathy). Definite and probable CJD cases in the UK, as of Fri 3 Nov 2006: ----------------------------------------------- Summary of vCJD cases - deaths ----------------------------- Deaths from definite vCJD (confirmed): 112 Deaths from probable vCJD (without neuropathological confirmation): 46 Deaths from probable vCJD (neuropathological confirmation pending): 0 Number of deaths from definite or probable vCJD (as above): 158 Summary of vCJD cases - alive ----------------------------- Number of probable vCJD cases still alive: 6 Total ----- Number of definite or probable vCJD (dead and alive): 164 (The next table will be published on Mon 4 Dec 2006). Since the previous monthly statistics were released on Mon 6 Nov 2006, the total number of deaths from definite vCJD has increased by 2 and stands at 158, and the overall total number of definite or probable vCJD cases (dead and alive) has increased by 2, making the overall total 164. These data are consistent with the view that the vCJD outbreak in the UK is in decline. The total number of deaths due to vCJD in the UK is now 158. The peak number of deaths was 28 in the year 2000, followed by 20 in 2001, 17 in 2002, 18 in 2003, and 9 in 2004, 5 in 2005. The number of deaths due to definite or probable vCJD in the UK during the 1st 10 months of 2006 has risen to 5. Totals for all types of CJD cases in the UK in 2005 and 2006 ----------------------------------------------- As of 3 Nov 2006, in the UK in the year 2005, there were 122 referrals of suspected CJD, and there were 65 deaths from sporadic CJD, 6 from familial CJD, 3 from iatrogenic CJD, 6 GSS (Gerstmann-Straussler-Scheinker) syndrome cases, and 5 deaths from vCJD. The corresponding figures so far for the 1st 10 months of 2006 are: 87 referrals, 48 deaths from sporadic CJD, 5 from vCJD, 4 from familial CJD, 3 from GSS and one from iatrogenic CJD. During the period 1995, when vCJD was 1st diagnosed, up to the present, there have been 946 deaths from all forms of CJD, including the 158 deaths attributable to definite or probable vCJD. [These data are accessible via <https://www.gnn.gov.uk/content/detail.asp?NewsAreaID=2&ReleaseID=239915ID=2>.] -- ProMED-mail <promed@promedmail.org> ****** [2] EUROCJD data as of 31 Oct 2006 Date: Tue 31 Oct 2006 From: ProMED-mail <promed@promedmail.org> Source: EUROCJD [edited] <http://www.eurocjd.ed.ac.uk/vcjdworldeuro.htm> The European And Allied Countries Collaborative Study Group of CJD (EUCJD) ----------------------------------------------- This web-site includes information from 2 projects funded by the European Commission. The EUROCJD project started in 1993 and compares data from national registries in Australia, Austria, Canada, France, Germany, Italy, the Netherlands, Slovakia, Spain, Switzerland and the UK. The NEUROCJD project started in 1998 after the European Union Council recommended that epidemiological surveillance of CJD should be extended to all member states. The member states involved in this project are Belgium, Denmark, Finland, Greece, Iceland, Ireland, Israel, Norway and Portugal. Both projects are coordinated from the National CJD Surveillance Unit based in Edinburgh. Current data as of October 2006 ------------------------------- Country / Total No. of Primary cases (No. alive) / Cumulative residence in UK (>6 months) / Secondary transmission by blood transfusion United Kingdom / 162 (6) / 164 / 2 (0) France / 21 (2) / 1 / 0 Republic of Ireland / 4 (1) / 2 / 0 Italy / 1 (0) / 0 / 0 USA / 2 (0) / 2 / 0 Canada / 1 (0) / 1 / 0 Saudi Arabia / 1 (1) / 0 / 0 Japan / 1* (0) / 0 / 0 Portugal / 1 (1) / 0 / 0 Spain / 1 (0) / 0 / 0 Total / 197 (12) / - / 2 Footnote: --------- * Residence in the UK for 24 days -- ProMED-mail <promed@promedmail.org> ****** [3] France: novel prion strain Date: Thu 12 Oct 2006 From: Terry Singeltary <flounder9@verizon.net> Source: PLoS Pathogens 2(10); published ahead of print [edited] <http://pathogens.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.ppat.0020112> Terry S. Singeltary Sr. has drawn ProMED-mail's attention to the following paper published ahead of print in PLoS Pathogens, which although not directly featuring vCJD, he considers is relevant to understanding the origin of the BSE outbreak in cattle and vCJD in humans. He comments that this research indicates that different prion disease phenotypes result from inoculation of cattle with 2 temporally separated sources of sheep scrapie from Great Britain. The paper is entitled "Isolation from Cattle of a Prion Strain Distinct from That Causing Bovine Spongiform Encephalopathy" and is authored by Vincent Beringue and 10 others. The abstract reads as follows: "To date, bovine spongiform encephalopathy (BSE) and its human counterpart, variant Creutzfeldt-Jakob disease, have been associated with a single prion strain. This strain is characterized by a unique and remarkably stable biochemical profile of abnormal protease-resistant prion protein (PrP(res)) isolated from brains of affected animals or humans. However, alternate PrP(res) signatures in cattle have recently been discovered through large-scale screening. To test whether these also represent separate prion strains, we inoculated French cattle isolates characterized by a PrP(res) of higher apparent molecular mass, called H-type, into transgenic mice expressing bovine or ovine PrP. All mice developed neurological symptoms and succumbed to these isolates, showing that these represent a novel strain of infectious prions. Importantly, this agent exhibited strain-specific features clearly distinct from that of BSE agent inoculated to the same mice, which were retained on further passage. Moreover, it also differed from all sheep scrapie isolates passaged so far in ovine PrP-expressing mice. Our findings therefore raise the possibility that either various prion strains may exist in cattle, or that the BSE agent has undergone divergent evolution in some animals." The authors' synopsis of their paper reads as follows: Prions are unconventional agents of proteic nature that are formed of abnormal conformations of the host-encoded prion protein (PrP). They cause fatal neurodegenerative diseases in both animals and humans and can be transmitted between species, as exemplified in humans by the emergence of variant Creutzfeldt-Jakob disease following the epidemic of bovine spongiform encephalopathy (BSE) in the United Kingdom. Since diagnosis of prion infection is only possible once the central nervous system has been invaded, brains of slaughtered or fallen cattle are routinely screened in Europe to protect the consumers from BSE. This has unexpectedly led to the discovery of unprecedented PrP conformations that were distinct from the single one associated so far with BSE or BSE-related diseases. To precisely determine their etiology, the authors have studied the transmissibility of these new conformations, termed H-type, to transgenic mice expressing either bovine or ovine PrP. They show that these cases are highly pathogenic for these mice. The authors also demonstrate that they are not directly related to the agent involved in the BSE epidemic, supporting the view for isolation of a new prion strain from cattle, whose prevalence and associated zoonotic risk should be carefully monitored in the future." -- Terry S. Singeltary Sr <flounder9@verizon.net> [see also: CJD (new var.) update 2006 (10) 20061002.2820 CJD (new var.) update 2006 (09) 20060904.2519 CJD (new var.) update 2006 (08) 20060807.2207 CJD (new var.) update 2006 (07) 20060703.1831 CJD (new var.) - Netherlands: 2nd case 20060623.1741 CJD (new var.) update 2006 (06) 20060605.1566 CJD (new var.) update 2006 (05) 20060508.1332 CJD (new var.) update 2006 (04) 20060404.1005 CJD (new var.) update 2006 (03) 20060306.0728 CJD (new var.) - UK: 3rd transfusion-related case 20060209.0432 CJD (new var.) update 2006 (02) 20060206.0386 CJD (new var.) update 2006 (01) 20060111.0101 CJD (new var.) update 2006 20060111.0101 2005 ---- CJD (new var.) update 2005 (12) 20051209.3547 CJD (new var.) update 2005 (11) 20051108.3270 CJD (new var.) update 2005 (10) 20051006.2916 CJD (new var.) update 2005 (05) 20050505.1243 CJD (new var.) - UK: update 2005 (01) 20050111.0095 2004 ---- CJD, genetic susceptibility 20041112.3064 CJD (new var.) - UK: update 2004 (14) 20041206.3242 CJD (new var.) - UK: update 2004 (01) 20040106.0064 CJD (new var.) - France: 8th case 20041022.2864 CJD (new var.) - France: 9th case 20041123.3138 CJD (new var.), blood supply - UK 20040318.0758 CJD (new var.), carrier frequency study - UK 20040521.1365 2003 ---- CJD (new var.) - UK: update 2003 (13) 20031216.3072 CJD (new var.) - UK: update 2003 (01) 20030108.0057 2002 ---- CJD (new var.) - UK: update Dec 2002 20021207.5997 CJD (new var.) - UK: update Jan 2002 20020111.3223 2001 ---- CJD (new var.), incidence & trends - UK (02) 20011124.2875 CJD (new var.), incidence & trends - UK 20011115.2816 CJD (new var.) - UK: reassessment 20011029.2671 CJD (new var.) - UK: update Oct 2001 20011005.2419 CJD (new var.) - UK: regional variation (02) 20010907.2145 CJD (new var.) - UK: update Sep 2001 20010906.2134 CJD (new var.) - UK: update Aug 2001 20010808.1872 CJD (new var.) - UK: 9th Annual Report 20010628.1231 CJD (new var.) - UK: update June 2001 20010622.1188 CJD (new var.) - UK: update 3 Jan 2001 20010104.0025] .............................................cp/msp/jw *##########################################################* ************************************************************ ProMED-mail makes every effort to verify the reports that are posted, but the accuracy and completeness of the information, and of any statements or opinions based thereon, are not guaranteed. The reader assumes all risks in using information posted or archived by ProMED-mail. ISID and its associated service providers shall not be held responsible for errors or omissions or held liable for any damages incurred as a result of use or reliance upon posted or archived material. ************************************************************ Become a ProMED-mail Premium Subscriber at <http://www.isid.org/ProMEDMail_Premium.shtml> ************************************************************ Visit ProMED-mail's web site at <http://www.promedmail.org>. Send all items for posting to: [email=promed@promedmail.org]promed@promedmail.org[/email] (NOT to an individual moderator). If you do not give your full name and affiliation, it may not be posted. Send commands to subscribe/unsubscribe, get archives, help, etc. to: [email=majordomo@promedmail.org]majordomo@promedmail.org[/email]. For assistance from a human being send mail to: [email=owner-promed@promedmail.org]owner-promed@promedmail.org[/email]. ############################################################ ############################################################ 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] There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection. He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins. [url=http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm]http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.htm[/url] [url=http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf]http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.pdf[/url] Subject: SEAC EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS FOR SUBCLINICAL vCJD POSITION STATEMENT Date: November 7, 2006 at 9:38 am PST © SEAC 2006 1 POSITION STATEMENT EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS FOR SUBCLINICAL vCJD Issue 1. The Department of Health and the UK blood services requested SEAC's advice on the scientific criteria by which ante mortem diagnostic tests for subclinical vCJD could be evaluated and validated1. Background 2. The development of an accurate and sensitive ante mortem blood test to identify asymptomatic individuals infected with vCJD could substantially reduce the potential for transmission of vCJD via blood transfusion and other medical interventions. It could also be valuable in confirming the diagnosis of clinical cases and monitoring the effect of potential therapies. In addition, such a test could provide an important tool to ascertain better the prevalence of vCJD infections. 3. The safety, quality and performance requirements for diagnostic tests for many infectious diseases are laid down in the In Vitro Diagnostic Medical Devices (IVD) Directive 98/79/EC. Tests included in Annex II List A of the Directive must comply with performance requirements set out in a Common Technical Specification (CTS) to receive a CE mark2. Currently, diagnostic tests for subclinical vCJD are not included in Annex IIA of the Directive and so a CTS with clear performance requirements for such tests has not yet been defined. SNIP...FULL TEXT ; SEAC November 2006 [url=http://www.seac.gov.uk/pdf/statement-vcjd.pdf]http://www.seac.gov.uk/pdf/statement-vcjd.pdf[/url] PRODUCT Source Plasma, Recall # B-0054-7 CODE Units: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891, 03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969, 03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588, 03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228, 03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628, 03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707, 03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189, 03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979, 03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707, 04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719, 04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816, 04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063, 04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485, 04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930, 04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578 RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 89 units DISTRIBUTION CA and Austria END OF ENFORCEMENT REPORT FOR October 25, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00975.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00975.html[/url] PRODUCT Recovered Plasma, Recall # B-0084-7 CODE Unit: GR38567 RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter on May 16, 2003. Firm initiated recall is complete. REASON Blood product, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Switzerland ______________________________ PRODUCT Source Plasma, Recall # B-0085-7 CODE Units: 03LWID9056 03LWIE0563 03LWIE1438 03LWIE1703 03LWIE2881 03LWIE7822 03LWIF5263 03LWIF5709 03LWIF6162 03LWIF6703 03LWIF7544 03LWIF8839 03LWIG0019 04LWIA0693 04LWIA1413 04LWIA6459 04LWIA7250 04LWIB7909 04LWIC0795 04LWIC2962 04LWIC3881 04LWIC4249 04LWIC5138 04LWIC7988 04LWIC8464 04LWIC9002 04LWIC9487 03LWIS2936 03LWIS3052 03LWIS3082 03LWIS3114 03LWIS3204 03LWIS3554 03LWIS4083 03LWIS4116 03LWIS4147 03LWIS4185 03LWIS4239 03LWIS4334 04LWIS0036 04LWIS0127 04LWIS0262 04LWIS0545 04LWIS0600 04LWIS0616 04LWIS0850 04LWIS1717 04LWIS1784 04LWIS1810 04LWIS1874 04LWIS2074 04LWIS2110 04LWIS2149 04LWIS2179 RECALLING FIRM/MANUFACTURER BioLife Plasma Service L.P., Onalaska, WI, by facsimile on July 29, 2004. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 54 units DISTRIBUTION Austria END OF ENFORCEMENT REPORT FOR November 1, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00976.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00976.html[/url] ----- Original Message ----- From: Terry S. Singeltary Sr. Sent: Monday, October 09, 2006 2:48 PM Subject: FDA nvCJD MAD COW BLOOD HUMAN RECALL 2006 UPDATE SCIENTIFIC COMMITTEE ON EMERGING AND NEWLY IDENTIFIED HEALTH RISKS (SCENIHR) Opinion on The Safety of Human-derived Products with regard to Variant Creutzfeldt-Jakob Disease Adopted by the SCENIHR during the 11th plenary meeting of 11-12 May 2006 after public consultation Synthesis Report : [url=http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_vcjd_synth.pdf]http://ec.europa.eu/health/ph_risk/comm ... _synth.pdf[/url] Stakeholder comments : [url=http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_vcjd_comments.zip]http://ec.europa.eu/health/ph_risk/comm ... mments.zip[/url] EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C - Public Health and Risk Assessment SNIP...FULL TEXT ; snip...6 of 81 pages, full text ; [url=http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_004b.pdf]http://ec.europa.eu/health/ph_risk/comm ... o_004b.pdf[/url] USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen) RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ______________________________ PRODUCT Source Plasma, Recall # B-1708-6 CODE Units: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140, MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855, MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136, MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343, 04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504, 05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874, 05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236, 05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336, 05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907, 05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277, 05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355, 05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892, 05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962 RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005. Firm initiated recall is complete. REASON Blood products, collected from unsuitable donors based on risk factors for Creutzfeldt-Jakob Disease (CJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 80 units DISTRIBUTION CA, NC, and MD ______________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6; b) Fresh Frozen Plasma, Recall # B-1715-6; c) Platelets, Recall # B-1716-6 CODE a), b), and c) Unit: 2443732 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by letters dated November 11, 2003 and December 18, 2003. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION TX and WI END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00969.html[/url] PRODUCT Fresh Frozen Plasma, Recall # B-1751-6 CODE Unit: 4936623 RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated September 16, 2005. Firm initiated recall is complete. REASON Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00968.html[/url] 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] PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6; b) Fresh Frozen Plasma, Recall # B-1551-6 CODE a) and b) Unit 2395371 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20, 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 2 units DISTRIBUTION TX ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6; b) Platelets, Recall # B-1553-6; c) Fresh Frozen Plasma, Recall # B-1554-6 CODE a), b) and c) Unit 2438702 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29, 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 TX ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6; b) Fresh Frozen Plasma, Recall # B-1556-6 CODE a) and b) Unit 2454970 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 and December 11. 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 2 units DISTRIBUTION TX ______________________________ PRODUCT a) Red Blood Cells, Recall # B-1494-6 b) Cryoprecipitated AHF, Recall # B-1495-6 CODE a) and b) Unit 5013100 RECALLING FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May 17, 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 GA ______________________________ PRODUCT Source Plasma, Recall # B-1450-6 CODE Unit numbers ST0824313 and ST0824764 RECALLING FIRM/MANUFACTURER Stillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION UK ______________________________ PRODUCT Plasma Frozen, Recall # B-1422-6; Recovered Plasma, Recall # B-1423-6 CODE a) Unit 03E42218; b) Unit 03E38153 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Atlanta, GA, by telephone, e-mail or letter on February 20 or 21, 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 GA and Switzerland ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6; b) Recovered Plasma, Recall # B-1375-6 CODE a) and b) unit 2453906 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31 and November 5, 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 2 units DISTRIBUTION TX and Austria ______________________________ PRODUCT Source Plasma. Recall # B-1295-6 CODE Units: NG0046551, NG0045950 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002, Firm initiated recall is complete. REASON Blood products, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire appropriately, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION KY ______________________________ PRODUCT Source Plasma. Recall # B-1296-6 CODE Unit: NG 0044520 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 12, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION KY ______________________________ PRODUCT Source Plasma. Recall # B-1297-6 CODE Units: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020, NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 13 units DISTRIBUTION KY ______________________________ PRODUCT Source Plasma, Recall # B-1298-6 CODE Units: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG 0042525, NG 0042341 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who answered questions on the variant Creutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units DISTRIBUTION KY ______________________________ PRODUCT Recovered Plasma, Recall # B-1299-6 CODE Unit: 4357117 RECALLING FIRM/MANUFACTURER Department of the Navy, Naval Medical Center, San Diego, CA, by fax and letter on September 25, 2003. Firm initiated recall is complete. REASON Blood product, collected from a donor considered to be at risk of exposure to Creutzfeldt-Jacob Disease (CJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Germany END OF ENFORCEMENT REPORT FOR July 12, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00960.html[/url] CJD WATCH MESSAGE BOARD TSS FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY Fri Jul 7, 2006 09:37 70.110.83.160 FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1379-6; b) Platelets, Recall # B-1380-6; c) Fresh Frozen Plasma, Recall # 1381-6; d) Recovered Plasma, Recall # B-1382-6 CODE a) Unit numbers: 2343106, 2377779, and 2403533; b) and c) Unit numbers: 2377779; d) Unit numbers: 2343106 and 2403533 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 12, 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 7 units DISTRIBUTION TX and Austria ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6; b) Recovered Plasma, Recall # B-1468-6 CODE a) and b) Unit numbers: 2329380 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8, 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 2 units DISTRIBUTION TX and Switzerland ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6; b) Cryoprecipitated AHF, Recall # B-1480-6; c) Recovered Plasma, Recall # B-1481-6 CODE a), b), and c) Unit numbers: 2383280 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 23 and 29, 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 3 units DISTRIBUTION TX and Switzerland ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6; b) Fresh Frozen Plasma, Recall # B-1483-6 CODE a) and b) Unit number: 2501452 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 5, 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 and NY ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6; b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6; c) Recovered Plasma, Recall # B-1486-6 CODE a) and c) Unit number: 2554077; b) Unit number: 2415708 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 13, 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 3 units DISTRIBUTION TX and Austria _____________________________________ END OF ENFORCEMENT REPORT FOR July 5, 2006 ### [url=http://www.fda.gov/bbs/topics/enforce/2006/ENF00959.html]http://www.fda.gov/bbs/topics/enforce/2 ... 00959.html[/url] with new atypical TSE in the bovine, in the sheep, goat, and humans, and the fact that the new BASE TSE in cattle being very very similar to sporadic CJD, rather than the nvCJD, the fact that now science showing the TSE agent of the atypical cattle in Japan showing infectivity other than CNS tissue, the fact that the latest Texas mad cow and the recent Alabama mad cow both being of the atypical strain, it would seem prudent to include all human TSE in the blood ban, in my opinion. ... TSS Prion infections, blood and transfusions Adriano Aguzzi* and Markus Glatzel Prion infections lead to invariably fatal diseases of the CNS, including Creutzfeldt-Jakob disease (CJD) in humans, bovine spongiform encephalopathy (BSE), and scrapie in sheep. There have been hundreds of instances in which prions have been transmitted iatrogenically among humans, usually through neurosurgical procedures or administration of pituitary tissue extracts. Prions have not generally been regarded as bloodborne infectious agents, and case-control studies have failed to identify CJD in transfusion recipients. Previous understanding was, however, questioned by reports of prion infections in three recipients of blood donated by individuals who subsequently developed variant CJD. On reflection, hematogenic prion transmission does not come as a surprise, as involvement of extracerebral compartments such as lymphoid organs and skeletal muscle is common in most prion infections, and prions have been recovered from the blood of rodents and sheep. Novel diagnostic strategies, which might include the use of surrogate markers of prion infection, along with prion removal strategies, might help to control the risk of iatrogenic prion spread through blood transfusions. ... snip... Last, despite all epidemiological evidence to the contrary, patients who are methionine/valine heterozygous at codon 129 of the PRNP gene are susceptible to infection with vCJD prions, which raises several important questions. Is the virulence of BSE prions enhanced when passaged from human to human, as opposed to the original bovine to human situation? Passaging experiments of scrapie infectivity between mice and hamsters indicate that this scenario is highly plausible.6 Even more importantly, can vCJD infection of heterozygous individuals establish a permanent subclinical carrier state? Although this situation might constitute a best-case scenario for the infected individuals, it could be disastrous from an epidemiological viewpoint, as it might lead to an unrecognized and possibly self-sustaining epidemic. ... snip... full text ; JUNE 2006 VOL 2 NO 6 AGUZZI AND GLATZEL NATURE CLINICAL PRACTICE NEUROLOGY 329 [url=http://www.nature.com/clinicalpractice/neuro]http://www.nature.com/clinicalpractice/neuro[/url] TSS [/QUOTE]
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