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From: TSS ()
100 Diabetics warned about mad cow exposure tissue came from cattle in the U.S. Jodie Sinnema, The Edmonton Journal About 100 patients of the Clinical Islet Transplant Program at the University of Alberta were told of the risk Wednesday, and yesterday, program officials went public with details. Program director Dr. James Shapiro told the patients that the program has been voluntarily shut down since March 22, when he discovered an enzyme -- used to extract insulin-producing islet cells from donor pancreases before transplantation -- is made using a solution containing cattle brain tissue. The tissue came from cattle in the U.S., where mad cow disease has been identified. "This was news to us," Dr. Shapiro said. "This was the first time we had any inkling that any cow brain products had come into contact with the enzyme." He said he told his patients about the potential contamination as soon as he had all the facts, emphasizing their risk of getting Creutzfeldt-Jakob disease is less than one in one million and even as remote as one in 10 million. No patients have shown any signs of the disease after getting about one teaspoon of tissue injected into the liver. Dr. Shapiro has spoken with 98 of his own patients by phone or in person and will be sending out an information letter to all the other islet programs around the world. MEDICAL IMPLANTS CONTAINING BOVINE MATERIAL http://www.seac.gov.uk/papers/91-2.pdf Greetings Honorable Inspector General Fong, with kindest regards, Terry S. Singeltary Sr. TUESDAY, JANUARY 9, 2001 A special "50 STATE CONFERENCE CALL" to discuss BSE (Bovine The 50 State call is scheduled for Tuesday, January 9, 2001 from We request that you forward this message to your agency management The agenda will be as follows: 1. Center For Veterinary Medicine (FDA) - Discussion of the problem 2. Office of Regional Operations (FDA) - Discussion of 3. Questions and answers. Richard H. Barnes, Director CVM Update UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES Bovine spongiform encephalopathy (BSE) is a type of “transmissible spongiform encephalopathy” disease that infects cattle. After the first case in 1986 in the United Kingdom, BSE quickly became an epidemic in cattle herds there. No cases of BSE have been found in U.S. cattle, despite active monitoring. Rendered feed ingredients contaminated with an infectious agent are believed to be the source of BSE infection in cattle. Some of the feed given to cattle includes remnants of the slaughtering process, such as the brain and spinal cord, which may harbor the agent that causes BSE. Although the material is cooked during the rendering process, the BSE agent can survive. To prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the feeding of mammalian protein to ruminant animals in most cases. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997. FDA developed an enforcement plan with the goal of 100% compliance with this rule. For the first two years it was in effect, the enforcement plan included education as well as inspections with FDA taking compliance actions for egregious actions or repeated non-compliance. As part of the enforcement plan, an assignment was issued to all FDA District Offices in 1998 to conduct inspections of 100% of all renderers and feed mills and some ruminant feeders to determine compliance. FDA's Center for Veterinary Medicine (CVM) has assembled data from the inspections conducted thus far, and presented the following data in a conference call FDA held with Federal and State feed control officials on January 9, 2001. To date, there have been a total of 9,947 inspections. The majority of these inspections (around 80%) were conducted by State officials and the remainder by FDA. Various segments of the feed industry had different levels of compliance. For Renderers, who are at the "top of the pyramid" since they are the first to handle rendered protein, and who send materials to feed mills and other ruminant feeders: Total number of inspections -- 239. Firms handling prohibited material -- 180 Firms whose products were labeled with the required caution statement -- 84% Had a system to prevent commingling -- 72% Followed recordkeeping regulations -- 96-98% For FDA Licensed Feed Mills -- 1,240 total -- Inspected -- 846. Of those feed mills inspected, 347 were handling prohibited material: Firms whose products were labeled with the required caution statement -- 80% Had a system to prevent commingling -- 91% Followed recordkeeping regulations -- 98 For Non-FDA Licensed Feed Mills -- 4,344 inspected (FDA does not know the total number since they are not required to be licensed by the Agency, but it could be 6,000 - 8,000.) Of those feed mills inspected, 1,593 were handling prohibited material: Firms whose products were labeled with the required caution statement -- 59% Had a system to prevent commingling -- 74% Followed recordkeeping regulations -- 91% FDA is continuing its enforcement efforts to achieve the goals of 100% inspection of all renderers and feed mills and some ruminant feeders and 100% compliance with the ruminant feed regulations. FDA Field offices have an assignment to re-inspect 700 firms that were not in full compliance with the rule but have committed to implementing the regulation. In addition, FDA is seeking assistance from State feed control officials to identify non-FDA licensed feed mills and to conduct additional inspections in all categories. FDA anticipates higher levels of compliance after completion of follow-up inspections. Issued by: http://www.fda.gov/cvm/bseup.htm Subject: confidential Of interest...don't repeat. On Jan 9, was somewhere snip... There must be a reason for Date: Sun, 21 Jan 2001 23:50:31 +0000 (GMT) Subject: stuff Confidential: Okay, you need to know. You don't need to pass it on And, if there is a case.......there is gonna be every Thanks as always for your help. snip...end *** TSS CORRECT AS OF 21ST SEPTEMBER 2006 17 Medical Implants Containing Bovine Material At SEAC 91 (February 2006) the Medicines and Healthcare products Regulatory Agency (MHRA) asked the committee to consider the potential BSE risks to humans from medical implants using bovine material from the USA. The regulations on medical devices containing animal materials are based on the principle that TSE risks must be eliminated or reduced as much as possible and residual risks must be acceptable when weighed against the benefits to patients. Currently no guidance exists on the acceptability of TSE risk control measures applied to animal material in medical devices. The MHRA requested advice on three 3 issues. (i) can TSE risk associated with medical implants using USA sourced bovine material be estimated given that it might vary over time? (ii) is there, or has there been a significant risk that might warrant action in addition to that already taken? (iii) can the standards that support the regulations be altered to facilitate a consistent approach about the acceptability of products? The committee concluded that: • a risk assessment should be conducted on each device because of the large number of variables that influence associated TSE risks. Key factors which should be considered when assessing risks are: • the animal source. Use of material from closed herds or from herds that are managed carefully to prevent the introduction of the BSE agent. • use of material from young animals would markedly lower risk compared with older animals. • the geographical risk of BSE. The geographical BSE risk status of a country gives an imprecise indication of BSE risk. It would be better to use an estimated prevalence of BSE in a country based on data from a robust surveillance system. • the potential TSE infectivity of the source tissue(s) based on a careful assessment of the available data on tissue infectivity. CORRECT AS OF 21ST SEPTEMBER 2006 18 • the site of implantation. Sites with contact with the blood supply or CNS may increase risk. • whether TSE testing is undertaken on the source animal(s). • the number of source animals used for each device. 44 Conformation-dependent immunoassay (CDI) for abnormal prions At SEAC 88 (June 2005), SEAC commented on a recent paper11 which had reported that the conformation-dependent immunoassay (CDI) for abnormal prions was more sensitive than other biochemical tests. The committee: • commented that, unlike most biochemical tests, it did not rely on proteinase K (PK) digestion of prions and could detect PK sensitive forms of abnormal prions. • expressed caution about the assumption that the test was capable of measuring the infectious agent, as the form of prion constituting the infectious agent was still unclear. 11 Safar et al. (2005) Diagnosis of human prion disease. Proc. Natl. Acad. Sci. U S A. 102, 3501-3506. incidence of CJD in various countries, other than the UK, indicates that there is no obvious decline in the numbers of cases being reported. However, in the UK there seems to have been a steady decline in the number of suspected cases, and therefore of confirmed cases, for the past several years. He asked 3 questions: (i) What are the causes of the decline in the number of suspected cases reported in the UK over the past few years? (ii) What is the effect of this decline in reports of suspected cases on the certainty of the decline of the number of new cases of vCJD reported in the UK? (iii) What is the effect of this decline in reports of suspected cases on the certainty that new cases of iatrogenic transmission of CJD and/or vCJD could be identified? 6. Professor Ironside commented that the number of suspected cases of sCJD reported each year had varied since surveillance began, but numbers had appeared to decline in the past 2 years. However, this was unlikely to be due to significant numbers of cases being missed. As a way of checking to see if cases had been missed, NCJDSU had looked back at diagnosed cases of atypical dementia but had not identified any cases of CJD. The recent decrease in numbers of suspected cases reported was therefore probably due to improvements in clinical diagnostic criteria and the resultant improved quality of referrals. NCJDSU had very good links with clinicians and pathologists across the UK. I find this interesting ; (i) What are the causes of the decline in the number of suspected cases reported in the UK over the past few years? the certainty of the decline of the number of new cases of vCJD reported in the UK? either variant CJD-like or sporadic CJD Date: Thu, 28 Nov 2002 10:23:43 -0000 From: "Asante, Emmanuel A" To: Dear Terry, I have been asked by Professor Collinge to respond to your request. I am a Senior Scientist in the MRC Prion Unit and the lead author on the paper. I have attached a pdf copy of the paper for your attention. Thank you for your interest in the paper. In respect of your first question, the simple answer is, yes. As you will find in the paper, we have managed to associate the alternate phenotype to type 2 PrPSc, the commonest sporadic CJD. It is too early to be able to claim any further sub-classification in respect of Heidenhain variant CJD or Vicky Rimmer's version. It will take further studies, which are on-going, to establish if there are sub-types to our initial finding which we are now reporting. The main point of the paper is that, as well as leading to the expected new variant CJD phenotype, BSE transmission to the 129-methionine genotype can lead to an alternate phenotype which is indistinguishable from type 2 PrPSc. can be of any further assistance please to not hesitate to ask. Best wishes. <> ____________________________________ Dr. Emmanuel A Asante MRC Prion Unit & Neurogenetics Dept. Imperial College School of Medicine (St. Mary's) Norfolk Place, LONDON W2 1PG Tel: +44 (0)20 7594 3794 Fax: +44 (0)20 7706 3272 email: e.asante@ic.ac.uk (until 9/12/02) New e-mail: e.asante@prion.ucl.ac.uk (active from now) ____________________________________ snip... full text ; http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf although 176 products do _not_ conform to the CSM/VPC http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN 18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7 64. A member noted that at the recent Neuroprion meeting, a study was Other work presented suggested that BSE and bovine amyloidotic spongiform http://www.seac.gov.uk/minutes/95.pdf Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain ***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than There is a growing number of human CJD cases, and they were presented last He estimates that it may be up to 14 or 15 persons which display selectively Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) In recent years, questions have been raised concerning the potential risk of variant Creutzfeldt-Jakob disease (vCJD - a rare but fatal brain infection) for recipients of plasma- derived clotting factors, including United States (US) licensed Factor Eight (pdFVIII), Factor Nine (pdFIX), and other plasma-derived products such as immune globulins and albumin. In response to these questions, FDA conducted a risk assessment. Based on the risk assessment, the US Public Health Service believes that the risk of vCJD to patients who receive US licensed pdFVIII products is most likely to be extremely small, although we do not know the risk with certainty. vCJD risk from other plasma derived products, including Factor IX, is likely to be as small or smaller. This web page provides FDA’s risk assessment for US licensed pdFVIII and risk communication materials for this product and other plasma derivatives. Included are Key Points, and Questions and Answers. 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 regarding vCJD. Documents Regarding US Licensed pdFVIII, and Other US Licensed Plasma Derivatives Including pdFIX Potential vCJD Risk From US Licensed Plasma-Derived Factor VIII (pdFVIII, Antihemophilic Factor) Products: Summary Information, Key Points Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products" - 8/2006 Transmissible Spongiform Encephalopathies Advisory Committee Committee of Ten Thousand http://www.fda.gov/cber/blood/vcjdrisk.htm PRODUCT END OF ENFORCEMENT REPORT FOR MARCH 14, 2007 ### http://www.fda.gov/bbs/topics/enforce/2007/ENF00995.html nvCJD mad cow blood recalls ENFORCEMENT REPORT FOR MARCH 7, 2007 ___________________________________ PRODUCT ___________________________________ PRODUCT ___________________________________ PRODUCT ___________________________________ PRODUCT ___________________________________ PRODUCT END OF ENFORCEMENT REPORT FOR MARCH 7, 2007 ### http://www.fda.gov/bbs/topics/enforce/2007/ENF00994.html 4th CASE VCJD VIA BLOOD TRANSFUSION, BSE, BASE, AND SPORADIC CJD By Terry S Singeltary Bacliff, Texas USA Jan 24, 07 File Format: PDF/Adobe Acrobat - Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ... http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf The second case, which was detected last year in a Texas cow and which USDA These two cases (the latest was detected in an Alabama cow) present a "The fact the Texas cow showed up fairly clearly implied the existence of Brown, who is preparing a scientific paper based on the latest two mad cow USDA officials finally retested the cow and confirmed it was infected seven "Everything they did on the Texas cow makes everything USDA did before 2005 PAUL BROWN COMMENT TO ME ON THIS ISSUE Tuesday, September 12, 2006 11:10 AM Animal and Plant Health Inspection Service Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II and Food Safety and Inspection Service Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III Report No. 50601-10-KC January 2006 Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&T=0&P=3854 Terry S. Singeltary Sr.
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