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From: TSS (216-119-139-31.ipset19.wt.net)
Drug Company Ailing After Vaccine Delay By Andrew Pollack Vaccines accounted for about US$700 million of Chiron's $1.75 billion in revenue last year. Fluvirin, the flu vaccine, accounted for $219 million of the total. Chiron had increased spending in R&D and other areas of its business. Now the company may have to scale back its plans, and prospects for its future flu vaccine business are clouded. Howard Pien, chief executive of Chiron, said he wanted to help meet the U.S. need for more flu vaccine while expanding the business of his company. So Pien began sharply increasing the production of flu vaccine at a British factory Chiron acquired in 2003. Chiron had expected that plant to supply about 50 million vaccine doses to the United States this year, up from 26 million in 2002, when the plant was owned by another company. But now Pien's aggressive plan has backfired. Finding contamination problems, British regulators suspended the license for vaccine production at the Liverpool factory on Tuesday, a move that will deprive the United States of nearly half the flu vaccine it expected for this winter. The suspension has cost Chiron not only three-quarters of the profit it expected this year, but some of its credibility with investors and customers. Chiron Shares Suffer Some analysts downgraded Chiron's stock and Moody's Investor Services said it was looking at lowering the company's debt rating. Mark Augustine, an analyst at Credit Suisse First Boston, called Chiron a "broken" stock. Shares of Chiron plummeted 16 percent on Tuesday, rebounding very modestly Wednesday to close at US$38.32, up 34 cents. But on Thursday, the stock fell $1.79, or 4.7 percent, to close at $36.53. Vaccines accounted for about $700 million of the company's $1.75 billion in revenue last year. Fluvirin, the flu vaccine, accounted for $219 million of the total. With the big increase in production, analysts had expected more than $300 million in revenue from Fluvirin this year. Chiron, anticipating higher revenue, had increased spending in research and development and other areas of its business. It is also building a new office for its vaccine business in Philadelphia. Now the company may have to scale back its plans, and prospects for its future flu vaccine business are clouded. Pien has said the company remains committed to being a major flu vaccine supplier next year. But he conceded at a news conference on Tuesday that addressing the problems at the Liverpool factory might extend past next February or March, when production would have to begin for next winter. Pien, who rose quickly in the management ranks in several major pharmaceutical companies before becoming chief executive of Chiron in April 2003, did not make himself available for an interview Wednesday. He said on Tuesday that the British regulatory decision was "disappointing and unexpected, but we respect the regulatory authority's judgment because it is based on concerns over safety." One question is whether the contamination problems may have been a consequence of Pien's push to increase vaccine output quickly at the aging factory. "The problem was they really stressed the system this year to get to that 50, 52 million doses," said Geoffrey Porges, an analyst at Sanford C. Bernstein who formerly worked in the vaccines business at Merck. David Smith, Chiron chief financial officer, said Wednesday that the company had not expanded its production too quickly. About $75 million has been spent to upgrade the Liverpool factory in the past five years, the company said. Chiron said it is committed to spending another $100 million to replace part of the plant. The plant dates back to the 1970s and has had a series of owners and problems in the last decade as pharmaceutical companies merged and divested assets. Chiron acquired the owner of the Liverpool plant, PowderJect Pharmaceuticals, in July 2003 to expand its vaccine production capacity. PowderJect, in turn, had acquired the factory in 2000 from CellTech, which owned it for about seven months. Contamination problems were not new to the plant. Polio vaccines made there by Medeva, another previous owner, before 1996 were recalled in October 2000 after British authorities said they might be contaminated with mad cow disease. In 1999, the U.S. Food and Drug Administration Latest News about Food and Drug Administration notified Medeva that there were risks of contamination in the flu vaccine produced at the plant. "It's an old facility that was sold by Glaxo to Medeva, who spent some money on it, though probably not in the right spot, then to Celltech, who didn't give a toss," said one British pharmaceutical executive. Still, J. Leighton Read, former chief executive of Aviron, said that he would not necessarily blame the age of the factory for Chiron's problems. "Every vaccine plant that's more than a year old that I'm aware of has a history of challenges in complying with the regulatory regime," said Read, now a venture capitalist. "In our extreme concern for safety, which is largely appropriate, we have evolved systems that are too rigid and brittle to adapt to circumstances such as this." Chiron, based in Emeryville, California, is one of the nation's oldest biotech companies, founded in 1981 by three scientists from the University of California campuses in San Francisco and Berkeley. Perhaps its biggest claim to fame is the discovery of the hepatitis C virus. But Chiron has not had as much success in developing biotech drugs as some of its competitors like Amgen and Genentech. The company has grown in large part through acquisitions and now has three businesses drugs, the testing of donated blood for viruses like HIV and hepatitis C, and vaccines. The shutdown of its vaccine production could damage Chiron's business beyond the immediate loss of revenue. The U.S. government could become more aggressive in acquiring flu vaccine from additional suppliers next year, or encourage other companies to enter the business, which would cut Chiron's market share in the future. © 2004 International Herald Tribune. All rights reserved. What was last week's polio BSE scare about? Earlier this year, according to an October, 2000 article by the The Observer, a leading British newspaper, British pharmaceutical company Medeva's Liverpool plant was found by the U.S. Food and Drug Administration to be producing vaccines in filthy conditions. The FDA report found that Medeva neither maintained nor cleaned its equipment. It also reported that Medeva was unable to prove that its vaccines were not contaminated with bacteria or fungi. Certain fungi provide the medium in which the prion protein crystal that causes bovine spongiform encephalopathy (BSE or “mad cow” disease) to proliferate. Because it exports flu vaccine to America, Medeva got a U.S. Food and Drug Administration (FDA) “warning” to clean up its act. However, in a report dated October 22, 2000, The Observer noted that the FDA had not re-inspected the filthy Medeva factory since it sent the warning letter earlier this year and has given the company the green light to sell an estimated 20,000,000 doses of its “Fluvarin” flu vaccine in the U.S. during this cold and flu season. The British government recently recalled Medeva's oral polio vaccine (OPV) as it had been grown from “bovine material of UK origin” contrary to mandated vaccine production protocols. Until its removal from the marketplace last month, Medeva's OPV had been injected into 11 million people, mostly children, commented another British newspaper the International Herald Tribune. Hundreds of thousands of “mad” cattle in Great Britain have been destroyed since 1993 in an attempt to control the spread of prion disease that is epidemic in England. Ingestion of beef and other products derived from prion-infected cattle have been linked to the epidemic of prion disease in humans. Prion disease is called mad cow disease in cattle, scrapie in pigs and sheep, whirling disease in fish and wasting disease in deer and elk, is called Creutzfeldt-Jakob Disease (CJD) in humans. It is estimated that as many as 200,000 Americans that have been misdiagnosed with Alzheimer's disease are actually victims of CJD. The Medeva Fluvarin vaccine, produced in the same plant that produced the recalled OPV, may have the potential of opening the floodgates of a “mad cow” epidemic in the U.S. Though the administration of possibly contaminated Fluvarin may be a public health disaster of unprecedented proportions, the dominant media has failed to sound the alarm and the FDA has not ordered that Fluvarin be tested for the presence of prions or the fungi in which they grow. Why? FDA approval of the potentially contaminated Fluvarin for sale in the U.S. was likely influenced by a shortage of flu vaccine here this season. According to Centers for Disease Control and Prevention (CDC) National Immunization Program Director Dr. William Atkinson, the A-Moscow-1099 strain of flu virus did not incubate properly this year and, therefore, did not produce “serum” in large enough quantities to produce sufficient doses of flu vaccine to meet demand. So, despite Medeva's “history of contamination and production blunders,” FDA has authorized the distribution of Fluvarin to clinics and hospitals all over the nation. According to The Observer, the FDA claims that the vaccine is safe. The FDA also, at one time, claimed that silicone breast implants and Phen-Phen were “safe” -- and those are just two of many FDA-approved products that have ultimately been linked to serious health side-effects that include chronic degenerative disease and death. “It stands to reason that Medeva's flu vaccine -- manufactured in the same reportedly filthy plant as the recalled polio vaccine -- could also contain BSE (prion)-contaminated materials,” commented Dr. Len Horowitz. Dr. Horowitz is the author of several books including “Healing Codes for the Biological Apocalypse” in which he meticulously documented the development and spread of prion disease world wide by following the path of published science. An official at the National Institutes of Health describes the prion which causes BSE as, “The single most resistant organism on the face of the Earth. You can boil it, you can put it in formaldehyde, you can autoclave it for a little while, you can treat it with the usual disinfectants...and it's like you didn't do anything.” If Fluvarin is contaminated with BSE, then millions of unsuspecting Americans may be injected this year with a terminal neurological disease. Prion crystals, 100 times smaller than a virus, cause lesions in brain tissue (encephalopathies) that turn the brain to mush and gradually causes dementia and death. British officials predict that hundreds of thousands of Brits will eventually show symptoms of this terminal malady. CJD is so dangerous that medical examiners are afraid to perform autopsies on people and animals that are suspected as having succumbed to prion disease. Continental Europe, which originally considered itself safe from prion disease, is in a panic over recent discoveries that some of their animals and citizens are showing symptoms. Fluvarin is currently on the shelves of doctors' offices and health departments all over the country and is being administered to the public. Medical personnel in the northwest U.S. who confirm that they have administered Fluvarin are unaware of the Medeva scandal or the likelihood that the triple-antigen flu vaccine is contaminated. There are at least two facilities in the U.S. that are capable of testing Fluvarin for prion contamination: The National Prion Disease Pathology Surveillance Center in Cleveland, Ohio, and the National Institutes of Health in Maryland. Since neither the FDA nor the dominant media have demanded that Fluvarin be tested for contamination, anyone about to receive Fluvarin should demand the vaccine be properly tested. Due to this year's flu vaccine shortage, the CDC urges health officials to prioritize the administration of flu vaccines. The CDC recommends that the most immunologically vulnerable members of society -- the elderly and the chronically ill; babies and small children -- be priority one. Healthcare workers exposed to flu victims are priority number two. Otherwise healthy people between the ages of 17-65 should be the last people to receive a flu shot. If your health officials haven't heard about Medeva's track record, it's time to get them educated. You can copy for them a series of British media reports covering the Medeva scandals. The web address is: http://www.observer.co.uk/ Go to “Information,” then “Archive,” then type “Medeva” in the keyword box. See especially the October 22 article “Revealed: full scale of vaccine blunders.” What measures have the FDA taken to ensure that people are not exposed to the BSE agent in vaccines? It is believed that variant CJD was acquired from eating food products containing the BSE agent. However, FDA wants to minimize any chance that the BSE agent could be introduced into biologic products during manufacture. The Center for Biologics Evaluation and Research (CBER) is responsible for regulation of biologic products, including vaccines. In a 1991 letter to manufacturers CBER expressed concern about bovine sourced material. In December 1993 and May 1996 FDA issued letters advising that bovine derived materials from animals born in or residing in countries where BSE had occurred should not be used to manufacture FDA-regulated products intended for administration to humans. A 1993 Points to Consider document ("Points to Consider in the Characterization of Cell Lines Used for the Production of Biologics") stressed the importance of control of sourcing of bovine materials. On April 19, 2000, CBER issued a letter reminding manufacturers that the USDA list of BSE-countries had been expanded to include not only those countries where BSE was known to exist but also those where BSE may exist (FR, January 6, 1998). CBER strongly recommended "that manufacturers take whatever steps are necessary to assure that materials derived from all species of ruminant animals born, raised or slaughtered in countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist, are not used in the manufacture of FDA-regulated products intended for administration to humans." Although Canada and the US have each reported one case of BSE and the USDA has placed Canada on the list of countries with BSE, FDA has not recommended that manufacturers find a new source for bovine derived materials obtained from these countries for use in manufacture of drugs or biological products. The FDA believes that the control measures in place assure the safety of bovine derived materials sourced from these countries and used in manufacture of vaccines. Are bovine derived materials from North America used in the manufacture of vaccines? Yes, bovine derived materials from North America, specifically the US and Canada, are used in vaccine manufacture. Since there has been extensive movement of live cows and cow-derived materials between Canada and the US it is difficult to establish that an animal has not been born, raised or slaughtered in Canada. Moreover, control measures, such as the ruminant-to-ruminant feed ban have been similar in the two countries. Therefore, FDA has not recommended that manufacturers using bovine derived material from Canada replace those materials with materials from countries not on the USDA list of countries that have BSE or are at risk snip... snip... If vaccines are safe why did the UK recall their polio vaccine? The UK recalled the Evans/Medeva Oral Polio Vaccine in October, 2000. This vaccine has never been licensed for use in the US. The Medicines Control Agency (MCA) had requested and received assurances from drug companies that they were implementing guidance not to use UK-sourced bovine materials in the manufacture of injectable medicinal products. The recall was prompted by evidence that the Evans/Medeva vaccine was manufactured using fetal calf serum from the UK at a time when there was a risk of BSE in that country. This is in contravention of European Union guidelines. According to a statement from the Chief Medical Officer at the UK Dept. of Health (10.20.00) the company had assured the MCA of the UK that UK-sourced bovine materials were not used in the manufacture of the vaccine. However, these assurances were inaccurate, thus the vaccine was withdrawn. (www.dh.gov.uk) What was the concern in the Republic of Ireland about polio vaccine and vCJD? In December, 2000 the Irish Government issued a statement indicating that an oral polio vaccine distributed in 1998 and 1999 in Ireland had been manufactured using human serum albumin from a pool of donors, one of whom had since been diagnosed with vCJD. Evans/Medeva manufactured this oral polio vaccine. This vaccine is not licensed for use in the US. Have there been vaccines produced using cow materials from countries where there is a significant risk of BSE? During review of a license application, FDA learned that one manufacturer had used bovine-derived material from a country in which the USDA had determined that BSE might exist. CBER requested all vaccine manufacturers review the source of any bovine derived material used in the manufacture of their vaccines. Additional vaccines manufactured using bovine derived products from European countries were identified. These vaccines are identified in the “Recommendations for the Use of Vaccines Manufactured with Bovine Derived Materials” section of this web site. (See Section I) When will vaccine manufacturers finish replacing cow-derived materials in vaccines with materials obtained from countries free of BSE? The time to make a vaccine and bring it to market can take several months to a year. Most vaccine made using bovine derived material from non-BSE risk countries was available at the end of 2001... snip... Shouldn't all potentially contaminated vaccine be destroyed? Also see above “Why is FDA leaving on the market vaccines which may be contaminated with the BSE agent?” FDA and other PHS agencies believe that the vaccines currently licensed for use in the US are safe. A special joint meeting of the TSE and Vaccines and Related Biological Products Advisory Committees concluded that the real risk of disease due to not vaccinating far outweighs the theoretical risk posed by exposure to vaccines that have a remote chance of containing the BSE agent. http://www.fda.gov/cber/bse/bseqa.htm Greetings, Let us first review just how safe the source of bovine by-products Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 ######### Bovine Spongiform Encephalopathy Greetings List Members, I was lucky enough to sit in on this BSE conference I submitted a version of my notes to "They tell me it is a closed meeting and and i would have been doing just fine, (understand, these are taken from my notes for now. [host Richard Barns] [TSS] [no answer, you could hear in the back ground, [host Richard] [TSS] [not sure whom ask this] [TSS] [not sure who is speaking] [TSS] [not sure whom speaking] from this point, i was still connected, got to listen [unknown woman] [TSS] at this point the conference was turned back up, IF i were another Country, I would take heed to my RBARNS@ORA.FDA.GOV he would be glad to give you one ;-) Rockville Maryland, BSE issues in the U.S., The conference opened up with the explaining of although new cases in other countries were now Look at Germany whom said NO BSE and now have BSE. BSE increasing across Europe. Because of Temporary Ban on certain rendered product, A recent statement in Washington Post, said the BSE Risk is still low, minimal in U.S. with a greater HOWEVER, if BSE were to enter the U.S. (human health-they just threw that in cause i was listening. I will now 80% inspection of rendering *Problem-Complete coverage of rendering HAS NOT sizeable number of 1st time FAILED INITIAL INSPECTION, Compliance critical, Compliance poor in U.K. Gloria Dunason Rendering FDA license and NON FDA license system in place for home rendering & feed 279 inspectors Renderer at top of pyramid, significant failed to have caution statement render 56 FIRMS NEVER INSPECTED 1240 FDA license feed mills "close to 400 feed mills have not been inspected" 80% compliance for feed. 10% don't have system. NON-FDA licensed mills 40% do NOT have caution statement 'DO NOT FEED'. 74% Commingling compliance "This industry needs a lot of work and only half "700 Firms that were falitive, and need to be Quote to do BSE inspection in 19 states by end At this time, we will take questions. [I was about the third or fourth to ask question. someone asking about nutritional supplements and Some other Dr. Vet, whom were asking questions [Dennis Wilson] [Conference person] [Linda Singeltary ??? this was a another phone in (conference person) Dennis Blank, Ken Jackson (they really don't know how many non licensed Firms Linda Detwiler Warren-Maryland Dept. Agr. THE END TSS ############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html FROM New York TIMES Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Hi terry -- thanks for all your help. I know it made a difference with ----- Original Message ----- > http://www.vegsource.com/talk/lyman/messages/8219.html >From the New York Times NYTimes.com, January 11, 2001 Many Makers of Feed Fail to Heed Rules on Mad Cow Disease Large numbers of companies involved in manufacturing animal feed are not The widespread failure of companies to follow the regulations, adopted But much more needs to be done to ensure that mad cow disease does not The regulations state that feed manufacturers and companies that render All products that contain rendered cattle or sheep must have a label Under the regulations, F.D.A. district offices and state veterinary Among 180 large companies that render cattle and another ruminant, Then there are some 6,000 to 8,000 feed mills so small they do not On the other hand, fewer than 10 percent of companies, big and small, The American Feed Industry Association in Arlington, Va., did not return http://www.nytimes.com/2001/01/11/science/11COW.html Subject: ######### Bovine Spongiform Encephalopathy USDA/APHIS would like to provide clarification on the following point [Linda Detwiler asking everyone (me) not to use emergency BSE number, Dr. Detwiler was responding to an announcement made during the call to ############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html Subject: ######### Bovine Spongiform Encephalopathy Hello Mr. Thomas, > What Mr. Singeltary failed to do was provide would you and the USDA/APHIS be so kind as to supply > The system has been in place for over 10 years. that seems to be a very long time for a system to be in Why does the U.S. insist on not doing massive testing Please tell me why my question was not answered? > U.S. cattle, what kind of guarantee can you It was a very simple question, a very important If all these years, we have been hearing that Before i was ask to be 'disconnected', could you please be so kind, as to answer these thank you, P.S. if you will also notice, i did not post that BUT, they should be reported, some are infected with TSE. TSS Subject: Report on the assessment of the Georgraphical BSE-risk of the ######### Bovine Spongiform Encephalopathy Greetings List Members and ALL EU Countries, Because of this report, and the recent findings I attempted to post this to list in full text, thank you, Report on the assessment of the Geographical BSE-risk of the USA PART II REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE - 29 - Report on the assessment of the Geographical BSE-risk of the USA EXECUTIVE SUMMARY OVERALL ASSESSMENT The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely Stability: Before 1990 the system was extremely unstable because feeding External challenges: A moderate external challenge occurred in the Interaction of external challenges and stability: While extremely As long as there are no changes in stability or challenge the JUSTIFICATION 1. DATA The available information was suitable to carry out the GBR risk - 30 - Report on the assessment of the Geographical BSE-risk of the USA 2. STABILITY 2.1 Overall appreciation of the ability to identify BSE-cases and to · Before 1989, the ability of the system to identify (and 2.2 Overall appreciation of the ability to avoid recycling · Before 1997 the US rendering and feed producing system would not 2.3 Overall assessment of the Stability · Until 1990 the US BSE/cattle system was extremely unstable as 3. CHALLENGES A moderate external challenge occurred in the period 1980-1989 because -31 - Report on the assessment of the Geographical BSE-risk of the USA July system could detect clinical incidence of 1-3 cases per year per million 4. CONCLUSION ON THE RESULTING RISKS 4.1 Interaction of stability and challenqe · In the late 80s, early 90s a moderate external challenges met an 4.2 Risk that BSE-infectivity enters processing · A very low processing risk developed in the late 80s when the Note: The high turnover in parts of the dairy cattle population with a 4.3 Risk that BSE-infectivity is recycled and propagated · During the period covered by this assessment (1980-1999) the - 32 - Report on the assessment of the Geographical BSE-risk of the USA 5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK 5.1 The current GBR The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely 5.2 The expected development of the GBR As long as there are no changes in stability or challenge the 5.3 Recommendations for influencin.q the future GBR · As long as the stability of the US system is not significantly snip... FULL TEXT about 16 pages Moms death from hvCJD 'MOMS AUTOPSY REPORT' CJD/BSE aka madcow disease in the U.S., please let me count the Ways$$$ SOMETHING TO CHEW ON http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2 http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1 http://www.vegsource.com/talk/lyman/messages/8278.html -------- Original Message -------- Greetings Dr. Freas, Dr. Langford, Dr. Smallwood and all FDA, I WISH to make the following submission and comments about all >>>>USDA-licensed tests for the diagnosis of bovine http://www.efsa.eu.int/science/efsa_scientific_reports/bse_tse/612_en.html http://embojournal.npgjournals.com/cgi/content/full/21/23/6358 THE new findings of BASE in cattle in Italy of Identification of a http://www.pnas.org/cgi/content/abstract/0305777101v1 Characterization of two distinct prion strains http://vir.sgmjournals.org/cgi/content/abstract/85/8/2471 Adaptation of the bovine spongiform encephalopathy agent to primates http://www.pnas.org/cgi/content/full/041490898v1 In an experimental study of the transmissibility of BSE to the pig, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=npg&cmd=Retrieve&db=Pu THE recent discoveries of previously unidentified strains of FULL TEXT APPRX. 91 PAGES UK Strategy for Research and 2004-2007 http://www.mrc.ac.uk/pdf-uk_strategy_v5.2.pdf WHEN in fact, the findings from Marsh and the findings at In Confidence - Perceptions of unconventional slow virus diseases of http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf Evidence That Transmissible Mink Encephalopathy http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf >> ONE of the things i have been most worried about and will continue to Summary of SEAC’s discussion on the second presumed case of blood vCJD: Blood Transfusion Incident http://www.publications.parliament.uk/pa/ld199697/ldhansrd/pdvn/lds03/text/3 MOST importantly, the 1968 MEDICINES ACT where it states 'NO SAF' was http://www.bseinquiry.gov.uk/files/yb/1983/06/00001001.pdf 8. The Secretary of State has a number of licences. We understand that http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf http://www.bseinquiry.gov.uk/report/volume7/chapted2.htm http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf although 176 products do _not_ conform to the CSM/VPC http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf IMPORTS OF POTENTIALLY TAINTED BIOLOGICAL PRODUCTS TO USA 3002.20.0000: VACCINES FOR HUMAN MEDICINE U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date <--- Dec 1998 ---> <--- 1998 YTD ---> http://www.ita.doc.gov/industry/otea/Trade-Detail/Latest-December/Imports/30 FULL TEXT PARTIAL LISTING http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh Transmissible encephalopathies and biopharmaceutical production. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_ui Blood donated after vaccination with rabies vaccine derived from sheep brain http://bmj.bmjjournals.com/cgi/content/full/313/7069/1405/a Blood to be screened for CJD http://bmj.bmjjournals.com/cgi/content/full/313/7055/441 ***Similar levels of infectivity in the blood of mice infected with http://www.blackwell-synergy.com/openurl?genre=article&sid=nlm:pubmed&issn=0 Spongiform encephalopathy transmitted experimentally from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Ab Lancet 2000; 356: 955 - 956 snip... Blood from four of 37 human beings with clinically evident sporadic CJD has http://www.thelancet.com/ Transmission of Creutzfeldt-Jakob Disease from Blood and Urine Into Mice The Lancet, November 9, 1985 Sir,--Professor Manuelidis and his colleagues (Oct 19, p896) report snip... Department of Neuropathology, JUN TATEISHI http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Retrieve&list_ui This observation represents the first documented transmission of BSE http://www.blackwell-synergy.com/servlet/useragent?func=synergy&synergyActio Transmission of prion diseases by blood transfusion Nora Hunter,1 James Foster,1 Angela Chong,1 Sandra McCutcheon,2 David see full text; http://www.socgenmicrobiol.org.uk/JGVDirect/18580/18580ft.pdf THEN one must consider these new findings of ; Extraneural Pathologic Prion Protein in Sporadic Creutzfeldt-Jakob Disease snip... Conclusions Using sensitive techniques, we identified extraneural http://content.nejm.org/cgi/content/short/349/19/1812?query=TOC Prions in skeletal muscle (Prusiner et al) http://www.pnas.org/cgi/doi/10.1073/pnas.052707499 EMBO reports AOP Published online: 11 April 2003 Widespread PrPSc http://www.emboreports.org/ How much is too much? How much is not enough? What about accumulation? ALL human/animal TSEs should be made reportable Nationally and thank you, Terry S. Singeltary Sr.
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