CBER 2007 Annual Report Assessing the Potential Risk of variant Creutzfeldt-Jakob Disease from Blood Products
FY 2007 Annual ReportInnovative Technology Advancing Public Health
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Assessing the Potential Risk of variant Creutzfeldt-Jakob Disease from Blood Products
A rare but fatal brain infection called variant Creutzfeldt-Jakob Disease (vCJD) has emerged in recent years as a potential threat to recipients of plasma-derived clotting factors and other plasma-derived products, such as immune globulin and albumin. CBER developed a computer-assisted model for estimating this risk to recipients of plasma-derived clotting factors in order to ensure that both patients and physicians understand this issue. This model was developed to assess the risk of U.S.-licensed, plasma-derived Factor VIII products and a plasma-derived Factor XI manufactured in the United Kingdom and used under IND in a small number of patients in the U.S. between 1989 and 2000. The results of the risk assessments and communication strategies were presented to FDA's Transmissible Spongiform Encephalopathies (TSE) Advisory Committee in September and December 2006.
Based on the risk assessments, the Public Health Service (PHS) believes the risk of vCJD to patients who receive U.S.-licensed, plasma-derived Factor VIII products is extremely small, although PHS does not know the risk with certainty. vCJD risk from other U.S.-licensed, plasma-derived products, including Factor IX, is likely to be as small or smaller. Additionally, the PHS believes the potential risk of vCJD infection from plasma-derived Factor XI, although not known for certain, is likely to be small.
Furthermore, CBER developed and implemented a risk communication plan in order to ensure the findings of the risk assessments reached the appropriate stakeholders. CBER partnered with patient advocates and risk communication experts to develop educational materials and arranged for hemophilia treatment centers and professional and advocacy organizations to publicize the findings through newsletters and other media. Finally, CBER launched a web page (http://www.fda.gov/cber/blood/vcjdrisk.htm) that provides the risk assessments and risk communication materials. Additional links are provided to FDA's current guidance documents on deferral of blood and plasma donors who may be at increased risk of vCJD and to other sources of information on vCJD.
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http://www.fda.gov/cber/inside/annrpt.htm#biological
----- Original Message -----
From: Terry S. Singeltary Sr.
To: FREAS@CBER.FDA.GOV
Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov
Sent: Wednesday, November 29, 2006 1:24 PM
Subject: TSE advisory committee for the meeting December 15, 2006 [TSSSUBMISSION]
November 29, 2006
Greetings FDA, DHH, Dr. Freas, and Dr. Harvey et al,
a kind and warm Holiday Greetings to you all. i kindly wish to submit the following to the TSE advisory committee for the meeting December 15, 2006, about the assessment for potential exposure to vCJD in human plasma-derived antihemophilic factor (FVIII) products manufactured from U.S. plasma donors and related communication material ;
http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-20251.htm
i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;
http://www.newsday.com/news/health/ats-ap_health14nov27,0,7955259.story?coll=ny-leadhealthnews-headlines
however, i seem to disagree. from my primitive ciphering, i see it another way. this is a huge catastrophic risk. 3 in 160 is 1.9%. so call that 2% which is 1 in 50 or twenty per thousand or 20,000 per million. also, what about the mixed genotypes/mixed susceptibility? what about the silent carriers that donated tainted blood? what about the sporadic CJDs of UNKNOWN strain or phenotype? this risk assessment is just more BSe to me. just another in a long line of industry fed crap. i pray that my assessment is the one that is wrong. but it is THEY who roll the dice with your life. it is THEY who refuse to regulate an industry that has run amok. just from a recall aspect of potentially tainted blood, and these are just recent recalls ;
PRODUCTSource Plasma, Recall # B-0054-7CODEUnits: 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, 04MMNC1578RECALLING FIRM/MANUFACTURERBioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004.Firm initiated recall is complete.REASONBlood products, collected from a donor who was at increased risk for newvariant Creutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE89 unitsDISTRIBUTIONCA and AustriaEND OF ENFORCEMENT REPORT FOR October 25, 2006###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00975.html
USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II______________________________PRODUCTSource Plasma, Recall # B-1708-6CODEUnits: 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 05MIND2962RECALLING FIRM/MANUFACTURERBioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.Firm initiated recall is complete.REASONBlood products, collected from unsuitable donors based on risk factors forCreutzfeldt-Jakob Disease (CJD), were distributed.VOLUME OF PRODUCT IN COMMERCE80 unitsDISTRIBUTIONCA, NC, and MD______________________________PRODUCTa) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;b) Fresh Frozen Plasma, Recall # B-1715-6;c) Platelets, Recall # B-1716-6CODEa), b), and c) Unit: 2443732RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by letters datedNovember 11, 2003 and December 18, 2003. Firm initiated recall is complete.REASONBlood products, collected from a donor who was at increased risk for newvariant Creutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONTX and WIEND OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.html
PRODUCTFresh Frozen Plasma, Recall # B-1751-6CODEUnit: 4936623RECALLING FIRM/MANUFACTURERGulf Coast Regional Blood Center, Houston, TX, by facsimile dated September16, 2005. Firm initiated recall is complete.REASONBlood product, which was collected from an unsuitable donor based on riskfactors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONTXEND OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html
Mon Aug 7, 2006 10:2471.248.132.189PRODUCTa) Red Blood Cells, Recall # B-1587-6;b) Cryoprecipitated AHF, Recall # B-1588-6;c) Recovered Plasma, Recal # B-1589-6CODEa), b) and c) Unit: 2016719RECALLING FIRM/MANUFACTURERWalter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile onMarch 13, 2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONGA and Germany______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;b) Fresh Frozen Plasma, Recall # B-1591-6CODEa) and b) Unit: 2443595RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June30, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;b) Fresh Frozen Plasma, Recall # B-1593-6CODEa) and b) Unit: 2545596RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile onDecember 14, 2004 and January 3, 2005. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;b) Fresh Frozen Plasma, Recall # B-1551-6CODEa) and b) Unit 2395371RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20,2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6;b) Platelets, Recall # B-1553-6;c) Fresh Frozen Plasma, Recall # B-1554-6CODEa), b) and c) Unit 2438702RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29,2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONTX______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6;b) Fresh Frozen Plasma, Recall # B-1556-6CODEa) and b) Unit 2454970RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 andDecember 11. 2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________PRODUCTa) Red Blood Cells, Recall # B-1494-6b) Cryoprecipitated AHF, Recall # B-1495-6CODEa) and b) Unit 5013100RECALLING FIRM/MANUFACTURERWalter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May17, 2005. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONGA______________________________PRODUCTSource Plasma, Recall # B-1450-6CODEUnit numbers ST0824313 and ST0824764RECALLING FIRM/MANUFACTURERStillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003.Firm initiated recall is complete.REASONBlood products, which were collected from a donor whose suitabilitypertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was notadequately determined, were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONUK______________________________PRODUCTPlasma Frozen, Recall # B-1422-6;Recovered Plasma, Recall # B-1423-6CODEa) Unit 03E42218;b) Unit 03E38153RECALLING FIRM/MANUFACTURERAmerican Red Cross Blood Services, Atlanta, GA, by telephone, e-mail orletter on February 20 or 21, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONGA and Switzerland______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6;b) Recovered Plasma, Recall # B-1375-6CODEa) and b) unit 2453906RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31and November 5, 2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX and Austria______________________________PRODUCTSource Plasma. Recall # B-1295-6CODEUnits: NG0046551, NG0045950RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002, Firm initiated recall is complete.REASONBlood products, collected from a donor who did not answer the questions onthe new variant Creutzfeldt-Jacob disease (nvCJD) questionnaireappropriately, were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONKY______________________________PRODUCTSource Plasma. Recall # B-1296-6CODEUnit: NG 0044520RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 12, 2002. Firm initiated recall is complete.REASONBlood product, collected from a donor who did not answer the questions onthe new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, wasdistributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONKY______________________________PRODUCTSource Plasma. Recall # B-1297-6CODEUnits: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020,NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002. Firm initiated recall is complete.REASONBlood products, collected from a donor considered to be at increased riskfor variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE13 unitsDISTRIBUTIONKY______________________________PRODUCTSource Plasma, Recall # B-1298-6CODEUnits: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG0042525, NG 0042341RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002. Firm initiated recall is complete.REASONBlood products, collected from a donor who answered questions on the variantCreutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, weredistributed.VOLUME OF PRODUCT IN COMMERCE7 unitsDISTRIBUTIONKY______________________________PRODUCTRecovered Plasma, Recall # B-1299-6CODEUnit: 4357117RECALLING FIRM/MANUFACTURERDepartment of the Navy, Naval Medical Center, San Diego, CA, by fax andletter on September 25, 2003. Firm initiated recall is complete.REASONBlood product, collected from a donor considered to be at risk of exposureto Creutzfeldt-Jacob Disease (CJD), was distributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONGermanyEND OF ENFORCEMENT REPORT FOR July 12, 2006###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html
CJD WATCH MESSAGE BOARDTSSFDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULYFri Jul 7, 2006 09:3770.110.83.160FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULYPRODUCTa) 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-1382-6CODEa) Unit numbers: 2343106, 2377779, and 2403533;b) and c) Unit numbers: 2377779;d) Unit numbers: 2343106 and 2403533RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June12, 2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE7 unitsDISTRIBUTIONTX and Austria______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6;b) Recovered Plasma, Recall # B-1468-6CODEa) and b) Unit numbers: 2329380RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8,2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX and Switzerland______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6;b) Cryoprecipitated AHF, Recall # B-1480-6;c) Recovered Plasma, Recall # B-1481-6CODEa), b), and c) Unit numbers: 2383280RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July23 and 29, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONTX and Switzerland______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6;b) Fresh Frozen Plasma, Recall # B-1483-6CODEa) and b) Unit number: 2501452RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile onOctober 5, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX and NY______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6;b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6;c) Recovered Plasma, Recall # B-1486-6CODEa) and c) Unit number: 2554077;b) Unit number: 2415708RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August13, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONTX and Austria_____________________________________END OF ENFORCEMENT REPORT FOR July 5, 2006###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00959.html
Greetings again Dr. Freas et al at FDA,
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. with sporadic CJD, you have many strains and or phenotypes, some of which are 'UNKNOWN', so we do not know how this will transmit, what tissues are infectious and or if blood transmits. that's the bottom line, however it has been reported that the BASE is more virulent to humans. With this, and the fact that sporadic CJD has tripled in the past few years or so, i see it as being prudent to take serious and immediate action ;
snip...full text ;
http://www.bioedonline.org/forums/messageview.cfm?thread=954
From: "Terry S. Singeltary Sr." <[log in to unmask]> Subject: Re: [BLOODCJD] Potential Risk of vCJD From Plasma-Derived Products FDA
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=19266
From: "Terry S. Singeltary Sr." <[log in to unmask]> Reply-To: SAFETY <[log in to unmask]> Date: Mon, 9 Oct 2006 16:47:14 -0500 Content-Type: text/plain
USA FDA BLOOD RECALL nvCJD aka mad cow disease
http://list.uvm.edu/cgi-bin/wa?A2=ind0610b&L=safety&P=2658
Greetings again Dr. Freas et al at FDA,
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. with sporadic CJD, you have many strains and or phenotypes, some of which are 'UNKNOWN', so we do not know how this will transmit, what tissues are infectious and or if blood transmits. that's the bottom line, however it has been reported that the BASE is more virulent to humans. With this, and the fact that sporadic CJD has tripled in the past few years or so, i see it as being prudent to take serious and immediate action..........
snip...end too long.
no pdf or doc url linked up yet for December 2006 submission.
BUT, here is my submission from about 5 years ago for anyone interested ;
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [flounder] Monday, January 08, 2001 3:03 PM freas ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
4th CASE VCJD VIA BLOOD TRANSFUSION, BSE, BASE, AND SPORADIC CJD
By Terry S Singeltary
Bacliff, Texas USA Jan 24, 07
http://bloodindex.org/view_news_zone.php?id=206
please see full text submission to TSE advisory committee for the meeting December 15, 2006, which is posted starting at part III, going to part II, and finally, the beginning, part I. ...TSS
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
ONE HUNDRED AND FIRST MEETING OF THE SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE Oct 23, 2008 at 9:00 AM
http://flounder068.vox.com/library/post/one-hundred-and-first-meeting-of-the-spongiform-encephalopathy-advisory-committee.html
P.S. just a quick update, on a recent week of recalls on blood and nvCJD. PLEASE NOTE, i did NOT list all these ;
REASONBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
WHAT does this mean ???
ONLY the nvCJD recalls ;
PRODUCT Recovered Plasma, Recall # B-0072-09CODEUnits: 7221567, 7213546, 3786729, 3780456RECALLING FIRM/MANUFACTURERFlorida’s Blood Centers, Inc., Orlando, FL, by facsimile on August 16, 2006. Firm initiated recall is complete.REASONBlood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributedVOLUME OF PRODUCT IN COMMERCE4 unitsDISTRIBUTIONAustria ___________________________________
PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-0118-09;b) Recovered Plasma, Recall # B-0119-09CODEa) and b) Unit: 54KM00587RECALLING FIRM/MANUFACTURERAmerican National Red Cross, Rio Piedras, PR, by telephone on May 9, 2007, facsimile on May 10, 2007, or by letter dated May 21, 2007. Firm initiated recall is complete.REASONBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONPR and Switzerland___________________________________
END OF ENFORCEMENT REPORT FOR OCTOBER 22, 2008
###
http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01078.html
PROTEASE SENSITIVE PRIONOPATHYSEAC discussed with Dr Pierluigi Gambetti (US National Prion Disease Pathology Surveillance Center) his recently published report5 on the identification in the United States of America of a new human prion disease. SEAC agreed that there is considerable work to be done to characterise fully this new disease, its cause and whether it is infectious or not. As preliminary unpublished data were also presented, this issue was discussed in a reserved business session in accordance with the SEAC Code of Practice.RESULTS ON HUMAN SCLERASEAC considered preliminary results provided by the HPA and National CJD Surveillance Unit from tests on eye tissue (sclera) from a vCJD case. The results suggest the presence of infectivity and, in contrast with previous testing of samples from other vCJD cases, abnormal prion protein in this tissue. However, as the sclera is very difficult to remove from surrounding eye tissues, which are themselves known to carry vCJD infectivity, the findings may have arisen as a result of contamination at autopsy. Nevertheless, even if the data are reliable, they indicate that there may only be a relatively low level of infectivity present in sclera. As preliminary unpublished data were considered, this issue was discussed in a reserved business session in accordance with the SEAC Code of Practice.5 Gambetti et al. (2008) A novel human disease with abnormal prion protein sensitive to protease. Ann. Neurol. 63, 697-708. 5 © SEAC 2008SEE FULL TEXT ;
http://www.seac.gov.uk/papers/101-summary.pdf
http://www.mad-cow.org/dec99_news.html#bbb
http://creutzfeldt-jakob-disease.blogspot.com/2008/01/cjd-hgh-body-snatchers.html
SEAC 101st meeting on Wednesday 15th October 2008 AGENDA
http://seac992007.blogspot.com/2008/10/seac-101st-meeting-on-wednesday-15th.html
A New Prionopathy OR more of the same old BSe and sporadic CJD
http://creutzfeldt-jakob-disease.blogspot.com/2008/08/new-prionopathy-or-more-of-same-old-bse.html
Communicated by: Terry S. Singeltary Sr.[In submitting these data, Terry S. Singeltary Sr. draws attention to the steady increase in the "type unknown" category, which, according to their definition, comprises cases in which vCJD could be excluded. The total of 26 cases for the current year (2007) is disturbing, possibly symptomatic of the circulation of novel agents. Characterization of these agents should be given a high priority. - Mod.CP]
http://pro-med.blogspot.com/2007/11/proahedr-prion-disease-update-2007-07.html
http://www.promedmail.org/pls/askus/f?p=2400:1001:6833194127530602005::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1010,39963
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.
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf
The Prion’s Elusive Reason for Being
Annu. Rev. Neurosci. 2008. 31:439–77First published online as a Review in Advance onApril 2, 2008
Adriano Aguzzi, Frank Baumann, and Juliane Bremer Institute of Neuropathology, University of Zurich, CH-8091 Zurich, Switzerland, email: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000142/!x-usc:mailto:Adriano.Aguzzi@usz.ch
Abstract The protein-only hypothesis posits that the infectious agent causing transmissible spongiform encephalopathies consists of protein and lacks any informational nucleic acids. This agent, termed prion by Stanley Prusiner, is thought to consist partly of PrPSc, a conformational isoform of a normal cellular protein termed PrPC. Scientists and lay persons have been fascinated by the prion concept, and it has been subjected to passionate critique and intense experimental scrutiny. As a result, PrPC and its isoforms rank among the most intensively studied proteins encoded by the mammalian genome. Despite all this research, both the physiological function of PrPC and the molecular pathways leading to neurodegeneration in prion disease remain unknown. Here we review the salient traits of those diseases ascribed to improper behavior of the prion protein and highlight how the physiological functions of PrPC may help explain the toxic phenotypes observed in prion disease.
snip...
It is important to note, however, that the above considerations apply primarily to the epidemiology of primary transmission from cows to humans. Although, by now a pool of preclinically infected humans may have been built. Human-to-human transmission may present with characteristics very different from those of primary cow-to-human transmission, including enhanced virulence, shortened incubation times, disrespect of allelic PRNP polymorphisms (129MM, MV or VV), and heterodox modes of infection including blood-borne transmission. If we account for the time it will take to eradicate these secondary transmissions in the population, vCJD is not likely to disappear entirely in the coming four decades. Iatrogenic CJD. Iatrogenic CJD is accidentally transmitted during the course of medical or surgical procedures. The first documented case of iatrogenic prion transmission occurred in 1974 and was caused by corneal transplantation of a graft derived from a patient suffering from sCJD (Duffy et al. 1974). Iatrogenic CJD is also rare, most often observed in individuals that have received cadaveric dura mater implants and human growth hormone; some of these individuals received gonadotrophin extracted from human pituitary glands or had stereotactically placed electrodes in their brains (Will 2003). Four cases of vCJD transmission by blood transfusions have been reported recently in the United Kingdom (Llewelyn et al. 2004, Peden et al. 2004, Wroe et al. 2006) (see also http://www.cjd.ed.ac.uk/TMER/TMER.htm ). The fact that preclinically infected individuals can transmit vCJD underscores the important medical need for sensitive diagnostic tools, which could be used for screening blood units prior to transfusion, for example.
snip...end
http://arjournals.annualreviews.org/doi/abs/10.1146/annurev.neuro.31.060407.125620
Monday, May 11, 2009
Rare BSE mutation raises concerns over risks to public health
http://bse-atypical.blogspot.com/2009/05/rare-bse-mutation-raises-concerns-over.html
Sunday, May 10, 2009
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)
http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html
TSS
snip...
Assessing the Potential Risk of variant Creutzfeldt-Jakob Disease from Blood Products
A rare but fatal brain infection called variant Creutzfeldt-Jakob Disease (vCJD) has emerged in recent years as a potential threat to recipients of plasma-derived clotting factors and other plasma-derived products, such as immune globulin and albumin. CBER developed a computer-assisted model for estimating this risk to recipients of plasma-derived clotting factors in order to ensure that both patients and physicians understand this issue. This model was developed to assess the risk of U.S.-licensed, plasma-derived Factor VIII products and a plasma-derived Factor XI manufactured in the United Kingdom and used under IND in a small number of patients in the U.S. between 1989 and 2000. The results of the risk assessments and communication strategies were presented to FDA's Transmissible Spongiform Encephalopathies (TSE) Advisory Committee in September and December 2006.
Based on the risk assessments, the Public Health Service (PHS) believes the risk of vCJD to patients who receive U.S.-licensed, plasma-derived Factor VIII products is extremely small, although PHS does not know the risk with certainty. vCJD risk from other U.S.-licensed, plasma-derived products, including Factor IX, is likely to be as small or smaller. Additionally, the PHS believes the potential risk of vCJD infection from plasma-derived Factor XI, although not known for certain, is likely to be small.
Furthermore, CBER developed and implemented a risk communication plan in order to ensure the findings of the risk assessments reached the appropriate stakeholders. CBER partnered with patient advocates and risk communication experts to develop educational materials and arranged for hemophilia treatment centers and professional and advocacy organizations to publicize the findings through newsletters and other media. Finally, CBER launched a web page (http://www.fda.gov/cber/blood/vcjdrisk.htm) that provides the risk assessments and risk communication materials. Additional links are provided to FDA's current guidance documents on deferral of blood and plasma donors who may be at increased risk of vCJD and to other sources of information on vCJD.
snip...
http://www.fda.gov/cber/inside/annrpt.htm#biological
----- Original Message -----
From: Terry S. Singeltary Sr.
To: FREAS@CBER.FDA.GOV
Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov
Sent: Wednesday, November 29, 2006 1:24 PM
Subject: TSE advisory committee for the meeting December 15, 2006 [TSSSUBMISSION]
November 29, 2006
Greetings FDA, DHH, Dr. Freas, and Dr. Harvey et al,
a kind and warm Holiday Greetings to you all. i kindly wish to submit the following to the TSE advisory committee for the meeting December 15, 2006, about the assessment for potential exposure to vCJD in human plasma-derived antihemophilic factor (FVIII) products manufactured from U.S. plasma donors and related communication material ;
http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-20251.htm
i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;
http://www.newsday.com/news/health/ats-ap_health14nov27,0,7955259.story?coll=ny-leadhealthnews-headlines
however, i seem to disagree. from my primitive ciphering, i see it another way. this is a huge catastrophic risk. 3 in 160 is 1.9%. so call that 2% which is 1 in 50 or twenty per thousand or 20,000 per million. also, what about the mixed genotypes/mixed susceptibility? what about the silent carriers that donated tainted blood? what about the sporadic CJDs of UNKNOWN strain or phenotype? this risk assessment is just more BSe to me. just another in a long line of industry fed crap. i pray that my assessment is the one that is wrong. but it is THEY who roll the dice with your life. it is THEY who refuse to regulate an industry that has run amok. just from a recall aspect of potentially tainted blood, and these are just recent recalls ;
PRODUCTSource Plasma, Recall # B-0054-7CODEUnits: 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, 04MMNC1578RECALLING FIRM/MANUFACTURERBioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004.Firm initiated recall is complete.REASONBlood products, collected from a donor who was at increased risk for newvariant Creutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE89 unitsDISTRIBUTIONCA and AustriaEND OF ENFORCEMENT REPORT FOR October 25, 2006###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00975.html
USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II______________________________PRODUCTSource Plasma, Recall # B-1708-6CODEUnits: 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 05MIND2962RECALLING FIRM/MANUFACTURERBioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.Firm initiated recall is complete.REASONBlood products, collected from unsuitable donors based on risk factors forCreutzfeldt-Jakob Disease (CJD), were distributed.VOLUME OF PRODUCT IN COMMERCE80 unitsDISTRIBUTIONCA, NC, and MD______________________________PRODUCTa) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;b) Fresh Frozen Plasma, Recall # B-1715-6;c) Platelets, Recall # B-1716-6CODEa), b), and c) Unit: 2443732RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by letters datedNovember 11, 2003 and December 18, 2003. Firm initiated recall is complete.REASONBlood products, collected from a donor who was at increased risk for newvariant Creutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONTX and WIEND OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.html
PRODUCTFresh Frozen Plasma, Recall # B-1751-6CODEUnit: 4936623RECALLING FIRM/MANUFACTURERGulf Coast Regional Blood Center, Houston, TX, by facsimile dated September16, 2005. Firm initiated recall is complete.REASONBlood product, which was collected from an unsuitable donor based on riskfactors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONTXEND OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html
Mon Aug 7, 2006 10:2471.248.132.189PRODUCTa) Red Blood Cells, Recall # B-1587-6;b) Cryoprecipitated AHF, Recall # B-1588-6;c) Recovered Plasma, Recal # B-1589-6CODEa), b) and c) Unit: 2016719RECALLING FIRM/MANUFACTURERWalter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile onMarch 13, 2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONGA and Germany______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;b) Fresh Frozen Plasma, Recall # B-1591-6CODEa) and b) Unit: 2443595RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June30, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;b) Fresh Frozen Plasma, Recall # B-1593-6CODEa) and b) Unit: 2545596RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile onDecember 14, 2004 and January 3, 2005. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;b) Fresh Frozen Plasma, Recall # B-1551-6CODEa) and b) Unit 2395371RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20,2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6;b) Platelets, Recall # B-1553-6;c) Fresh Frozen Plasma, Recall # B-1554-6CODEa), b) and c) Unit 2438702RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29,2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONTX______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6;b) Fresh Frozen Plasma, Recall # B-1556-6CODEa) and b) Unit 2454970RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 andDecember 11. 2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________PRODUCTa) Red Blood Cells, Recall # B-1494-6b) Cryoprecipitated AHF, Recall # B-1495-6CODEa) and b) Unit 5013100RECALLING FIRM/MANUFACTURERWalter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May17, 2005. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONGA______________________________PRODUCTSource Plasma, Recall # B-1450-6CODEUnit numbers ST0824313 and ST0824764RECALLING FIRM/MANUFACTURERStillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003.Firm initiated recall is complete.REASONBlood products, which were collected from a donor whose suitabilitypertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was notadequately determined, were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONUK______________________________PRODUCTPlasma Frozen, Recall # B-1422-6;Recovered Plasma, Recall # B-1423-6CODEa) Unit 03E42218;b) Unit 03E38153RECALLING FIRM/MANUFACTURERAmerican Red Cross Blood Services, Atlanta, GA, by telephone, e-mail orletter on February 20 or 21, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONGA and Switzerland______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6;b) Recovered Plasma, Recall # B-1375-6CODEa) and b) unit 2453906RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31and November 5, 2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX and Austria______________________________PRODUCTSource Plasma. Recall # B-1295-6CODEUnits: NG0046551, NG0045950RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002, Firm initiated recall is complete.REASONBlood products, collected from a donor who did not answer the questions onthe new variant Creutzfeldt-Jacob disease (nvCJD) questionnaireappropriately, were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONKY______________________________PRODUCTSource Plasma. Recall # B-1296-6CODEUnit: NG 0044520RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 12, 2002. Firm initiated recall is complete.REASONBlood product, collected from a donor who did not answer the questions onthe new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, wasdistributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONKY______________________________PRODUCTSource Plasma. Recall # B-1297-6CODEUnits: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020,NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002. Firm initiated recall is complete.REASONBlood products, collected from a donor considered to be at increased riskfor variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE13 unitsDISTRIBUTIONKY______________________________PRODUCTSource Plasma, Recall # B-1298-6CODEUnits: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG0042525, NG 0042341RECALLING FIRM/MANUFACTURERDCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax onDecember 20, 2002. Firm initiated recall is complete.REASONBlood products, collected from a donor who answered questions on the variantCreutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, weredistributed.VOLUME OF PRODUCT IN COMMERCE7 unitsDISTRIBUTIONKY______________________________PRODUCTRecovered Plasma, Recall # B-1299-6CODEUnit: 4357117RECALLING FIRM/MANUFACTURERDepartment of the Navy, Naval Medical Center, San Diego, CA, by fax andletter on September 25, 2003. Firm initiated recall is complete.REASONBlood product, collected from a donor considered to be at risk of exposureto Creutzfeldt-Jacob Disease (CJD), was distributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONGermanyEND OF ENFORCEMENT REPORT FOR July 12, 2006###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html
CJD WATCH MESSAGE BOARDTSSFDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULYFri Jul 7, 2006 09:3770.110.83.160FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULYPRODUCTa) 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-1382-6CODEa) Unit numbers: 2343106, 2377779, and 2403533;b) and c) Unit numbers: 2377779;d) Unit numbers: 2343106 and 2403533RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June12, 2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE7 unitsDISTRIBUTIONTX and Austria______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6;b) Recovered Plasma, Recall # B-1468-6CODEa) and b) Unit numbers: 2329380RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8,2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX and Switzerland______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6;b) Cryoprecipitated AHF, Recall # B-1480-6;c) Recovered Plasma, Recall # B-1481-6CODEa), b), and c) Unit numbers: 2383280RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July23 and 29, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONTX and Switzerland______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6;b) Fresh Frozen Plasma, Recall # B-1483-6CODEa) and b) Unit number: 2501452RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile onOctober 5, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX and NY______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6;b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6;c) Recovered Plasma, Recall # B-1486-6CODEa) and c) Unit number: 2554077;b) Unit number: 2415708RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August13, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONTX and Austria_____________________________________END OF ENFORCEMENT REPORT FOR July 5, 2006###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00959.html
Greetings again Dr. Freas et al at FDA,
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. with sporadic CJD, you have many strains and or phenotypes, some of which are 'UNKNOWN', so we do not know how this will transmit, what tissues are infectious and or if blood transmits. that's the bottom line, however it has been reported that the BASE is more virulent to humans. With this, and the fact that sporadic CJD has tripled in the past few years or so, i see it as being prudent to take serious and immediate action ;
snip...full text ;
http://www.bioedonline.org/forums/messageview.cfm?thread=954
From: "Terry S. Singeltary Sr." <[log in to unmask]> Subject: Re: [BLOODCJD] Potential Risk of vCJD From Plasma-Derived Products FDA
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=19266
From: "Terry S. Singeltary Sr." <[log in to unmask]> Reply-To: SAFETY <[log in to unmask]> Date: Mon, 9 Oct 2006 16:47:14 -0500 Content-Type: text/plain
USA FDA BLOOD RECALL nvCJD aka mad cow disease
http://list.uvm.edu/cgi-bin/wa?A2=ind0610b&L=safety&P=2658
Greetings again Dr. Freas et al at FDA,
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. with sporadic CJD, you have many strains and or phenotypes, some of which are 'UNKNOWN', so we do not know how this will transmit, what tissues are infectious and or if blood transmits. that's the bottom line, however it has been reported that the BASE is more virulent to humans. With this, and the fact that sporadic CJD has tripled in the past few years or so, i see it as being prudent to take serious and immediate action..........
snip...end too long.
no pdf or doc url linked up yet for December 2006 submission.
BUT, here is my submission from about 5 years ago for anyone interested ;
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [flounder] Monday, January 08, 2001 3:03 PM freas ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
4th CASE VCJD VIA BLOOD TRANSFUSION, BSE, BASE, AND SPORADIC CJD
By Terry S Singeltary
Bacliff, Texas USA Jan 24, 07
http://bloodindex.org/view_news_zone.php?id=206
please see full text submission to TSE advisory committee for the meeting December 15, 2006, which is posted starting at part III, going to part II, and finally, the beginning, part I. ...TSS
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
ONE HUNDRED AND FIRST MEETING OF THE SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE Oct 23, 2008 at 9:00 AM
http://flounder068.vox.com/library/post/one-hundred-and-first-meeting-of-the-spongiform-encephalopathy-advisory-committee.html
P.S. just a quick update, on a recent week of recalls on blood and nvCJD. PLEASE NOTE, i did NOT list all these ;
REASONBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
WHAT does this mean ???
ONLY the nvCJD recalls ;
PRODUCT Recovered Plasma, Recall # B-0072-09CODEUnits: 7221567, 7213546, 3786729, 3780456RECALLING FIRM/MANUFACTURERFlorida’s Blood Centers, Inc., Orlando, FL, by facsimile on August 16, 2006. Firm initiated recall is complete.REASONBlood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributedVOLUME OF PRODUCT IN COMMERCE4 unitsDISTRIBUTIONAustria ___________________________________
PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-0118-09;b) Recovered Plasma, Recall # B-0119-09CODEa) and b) Unit: 54KM00587RECALLING FIRM/MANUFACTURERAmerican National Red Cross, Rio Piedras, PR, by telephone on May 9, 2007, facsimile on May 10, 2007, or by letter dated May 21, 2007. Firm initiated recall is complete.REASONBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONPR and Switzerland___________________________________
END OF ENFORCEMENT REPORT FOR OCTOBER 22, 2008
###
http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01078.html
PROTEASE SENSITIVE PRIONOPATHYSEAC discussed with Dr Pierluigi Gambetti (US National Prion Disease Pathology Surveillance Center) his recently published report5 on the identification in the United States of America of a new human prion disease. SEAC agreed that there is considerable work to be done to characterise fully this new disease, its cause and whether it is infectious or not. As preliminary unpublished data were also presented, this issue was discussed in a reserved business session in accordance with the SEAC Code of Practice.RESULTS ON HUMAN SCLERASEAC considered preliminary results provided by the HPA and National CJD Surveillance Unit from tests on eye tissue (sclera) from a vCJD case. The results suggest the presence of infectivity and, in contrast with previous testing of samples from other vCJD cases, abnormal prion protein in this tissue. However, as the sclera is very difficult to remove from surrounding eye tissues, which are themselves known to carry vCJD infectivity, the findings may have arisen as a result of contamination at autopsy. Nevertheless, even if the data are reliable, they indicate that there may only be a relatively low level of infectivity present in sclera. As preliminary unpublished data were considered, this issue was discussed in a reserved business session in accordance with the SEAC Code of Practice.5 Gambetti et al. (2008) A novel human disease with abnormal prion protein sensitive to protease. Ann. Neurol. 63, 697-708. 5 © SEAC 2008SEE FULL TEXT ;
http://www.seac.gov.uk/papers/101-summary.pdf
http://www.mad-cow.org/dec99_news.html#bbb
http://creutzfeldt-jakob-disease.blogspot.com/2008/01/cjd-hgh-body-snatchers.html
SEAC 101st meeting on Wednesday 15th October 2008 AGENDA
http://seac992007.blogspot.com/2008/10/seac-101st-meeting-on-wednesday-15th.html
A New Prionopathy OR more of the same old BSe and sporadic CJD
http://creutzfeldt-jakob-disease.blogspot.com/2008/08/new-prionopathy-or-more-of-same-old-bse.html
Communicated by: Terry S. Singeltary Sr.[In submitting these data, Terry S. Singeltary Sr. draws attention to the steady increase in the "type unknown" category, which, according to their definition, comprises cases in which vCJD could be excluded. The total of 26 cases for the current year (2007) is disturbing, possibly symptomatic of the circulation of novel agents. Characterization of these agents should be given a high priority. - Mod.CP]
http://pro-med.blogspot.com/2007/11/proahedr-prion-disease-update-2007-07.html
http://www.promedmail.org/pls/askus/f?p=2400:1001:6833194127530602005::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1010,39963
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.
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf
The Prion’s Elusive Reason for Being
Annu. Rev. Neurosci. 2008. 31:439–77First published online as a Review in Advance onApril 2, 2008
Adriano Aguzzi, Frank Baumann, and Juliane Bremer Institute of Neuropathology, University of Zurich, CH-8091 Zurich, Switzerland, email: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000142/!x-usc:mailto:Adriano.Aguzzi@usz.ch
Abstract The protein-only hypothesis posits that the infectious agent causing transmissible spongiform encephalopathies consists of protein and lacks any informational nucleic acids. This agent, termed prion by Stanley Prusiner, is thought to consist partly of PrPSc, a conformational isoform of a normal cellular protein termed PrPC. Scientists and lay persons have been fascinated by the prion concept, and it has been subjected to passionate critique and intense experimental scrutiny. As a result, PrPC and its isoforms rank among the most intensively studied proteins encoded by the mammalian genome. Despite all this research, both the physiological function of PrPC and the molecular pathways leading to neurodegeneration in prion disease remain unknown. Here we review the salient traits of those diseases ascribed to improper behavior of the prion protein and highlight how the physiological functions of PrPC may help explain the toxic phenotypes observed in prion disease.
snip...
It is important to note, however, that the above considerations apply primarily to the epidemiology of primary transmission from cows to humans. Although, by now a pool of preclinically infected humans may have been built. Human-to-human transmission may present with characteristics very different from those of primary cow-to-human transmission, including enhanced virulence, shortened incubation times, disrespect of allelic PRNP polymorphisms (129MM, MV or VV), and heterodox modes of infection including blood-borne transmission. If we account for the time it will take to eradicate these secondary transmissions in the population, vCJD is not likely to disappear entirely in the coming four decades. Iatrogenic CJD. Iatrogenic CJD is accidentally transmitted during the course of medical or surgical procedures. The first documented case of iatrogenic prion transmission occurred in 1974 and was caused by corneal transplantation of a graft derived from a patient suffering from sCJD (Duffy et al. 1974). Iatrogenic CJD is also rare, most often observed in individuals that have received cadaveric dura mater implants and human growth hormone; some of these individuals received gonadotrophin extracted from human pituitary glands or had stereotactically placed electrodes in their brains (Will 2003). Four cases of vCJD transmission by blood transfusions have been reported recently in the United Kingdom (Llewelyn et al. 2004, Peden et al. 2004, Wroe et al. 2006) (see also http://www.cjd.ed.ac.uk/TMER/TMER.htm ). The fact that preclinically infected individuals can transmit vCJD underscores the important medical need for sensitive diagnostic tools, which could be used for screening blood units prior to transfusion, for example.
snip...end
http://arjournals.annualreviews.org/doi/abs/10.1146/annurev.neuro.31.060407.125620
Monday, May 11, 2009
Rare BSE mutation raises concerns over risks to public health
http://bse-atypical.blogspot.com/2009/05/rare-bse-mutation-raises-concerns-over.html
Sunday, May 10, 2009
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)
http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html
TSS
posted by Terry S. Singeltary Sr. at
4:49 PM
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