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From: TSS ()
Date: March 28, 2007 Time: 12:15 Department of Health publishes new reports on VCJD Two new reports on vCJD (variant Creutzfeldt-Jakob Disease) have been published today as part of on-going work to manage the risks associated with the disease. The first was commissioned by the Department of Health and produced by the specially convened vCJD Clinical Governance Advisory Group (CGAG). Chaired by Sir William Stewart, it proposes the creation of patient-focused clinical governance arrangements to standardise the care that patients at risk of vCJD receive across the country. It recommends that GPs should take the lead in commissioning care for them, supported by consultant neurologists and specialist centres such as the National CJD Surveillance Unit and the National Prion Clinic. The second report, commissioned on behalf of the Department of Health by the Health Protection Agency, examines attitudes of key stakeholders towards the possible future introduction of a vCJD test for blood donations. The findings highlight a number of issues around the potential introduction of such a test, particularly the level of accuracy that would be required; whether and how to notify those who have been tested of the results; extending the test beyond blood donors; and whether testing might affect people's willingness to donate blood. Public Health Minister Caroline Flint said: "We continue to monitor all aspects of vCJD very carefully, and it is timely to review support arrangements for those individuals at risk of developing the disease. Although the current arrangements for support have worked well, the CGAG report has highlighted the importance of standardising those arrangements across the whole country. "We are also preparing for the possible availability of a test for vCJD. Whilst such a test could be valuable in helping to identify people who may be at risk, the report, published today by the Health Protection Agency, highlights some of the ethical and practical questions we are facing, both in terms of supporting the people affected, and protecting the public." Sir William Stewart, Chairman of the CGAG, said: "The Department of Health wisely takes a precautionary approach in dealing with the potential for vCJD infection, as there are still many gaps in our knowledge about the disease. I hope that the CGAG report provides a framework for the services available to those who, through a variety of routes, may be at potential risk of vCJD. "It is important that the individuals affected are supported by their local GP and that they have access to more specialist sources of support, but also to participate in research opportunities, should they wish to do so." To ensure appropriate levels of public health protection and support for individuals it is important to understand the prevalence of vCJD infection. To this end, the Health Protection Agency is currently analysing samples from the National Anonymised Tonsil Archive, and the Department of Health expects a report shortly on the potential for establishing a post mortem tissue archive to study the prevalence of vCJD. Notes to editors: 1. Both reports can be found on-line at www.dh.gov.uk 2. Creutzfeldt-Jakob Disease (CJD) is one of a group of diseases called Transmissible Spongiform Encephalopathies. All of these diseases can have a very long incubation period, cause severe and irreversible damage to the central nervous system. There are so far no proven effective treatments. 3. vCJD was first identified in 1996 and affects younger people. Variant CJD patients show signs of behavioural disorder, depression and anxiety followed by problems with sensation and co-ordination, leading to progressive dementia and death over a period of six months to two years. The clinical, epidemiological, neuropathological and experimental data all point to variant CJD being caused by the same strain of prion as Bovine Spongiform Encephalopathy (BSE). 4. There have been four known instances of vCJD transmission through the blood supply: three of the recipients developed clinical vCJD, while the other died of unrelated causes. Although there is currently no approved blood test available, work is urgently under way to develop one and to find new ways to reduce the risks of transmission by filtering donated blood. 5. The report refers to the following as "people at risk": - Recipients of blood components donated by people who later developed vCJD. - Recipients of certain plasma products (clotting factors). - Blood donors to patients who later developed vCJD. 6. For enquiries please contact 020 7210 4850. http://www.wired-gov.net/WGLaunch.aspx?ARTCL=44998 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 disease in the United States I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc? LANCET INFECTIOUS DISEASE JOURNAL My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my mom to hvCJD (Heidenhain variant CJD) and have been searching for answers ever since. What I have found is that we have not been told the truth. ... Diagnosis and Reporting of Creutzfeldt-Jakob Disease Singeltary, Sr et al. JAMA.2001; 285: 733-734. http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama Terry S. Singeltary Sr.
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