Two million children innoculated with BSE vaccines
Baroness tested for CJD
CDJ tonsil study fails to answer key question
Backgrounder: what motivated tonsil and appendix study?
BSE 'to die out in seven years' (or go on via cow patties)
EU adopts tougher controls against mad cow disease
French officials report two new cases of mad cow disease
Saskatchewan CWD elk death sparks herd quarantine
10 Australian surgery patients exposed to CJD instruments
New disease passed by blood transfusions
Dead bodies harvested for parts and tissues
American, 39, dies of dura mater implant
Daily Express May 2, 200 [minor edits by webmaster]Seven vaccines potentially at risk from BSE and given to millions of children can be identified for the first time by the Daily Express. But alarmingly there is no record of which children received the jabs, produced between 1988 and 1989, at the start of Britain's "mad cow" crisis. The vaccines, using UK-sourced cattle material, were made by two companies, Wellcome and Smithkline, despite warnings that they could pose a risk. The seven vaccines are:
1. Smithkline's MMR (Measles, Mumps, Rubella), finally replaced "by end of 1992 approximately"; 2. Wellcome's combined Diphtheria and Tetanus, last issued by the company in June 1991, with a June 1993 expiry date; 3. Wellcome's DTP (Diphtheria, Tetanus, Pertussis) last issued again in June 1991, with a November 1993 expiry date; 4. Wellcome's single component Diphtheria vaccine, last issued in October 1991, with a November 1993 expiry date; 5. Wellcome's Tetanus, last issued in December 1991, with a December 1993 expiry date. 6.[Wellcome's oral polio vaccine, last issue and expiry dates are "not known". 7. Smithkline's inactivated polio vaccine, apparently used only in foreigners.]Last night Liberal Democrat MP Norman Baker, who has led a crusade on the issue, accused the Department of Health of being "potentially criminally negligent" for allowing the BSE-risk vaccines to be administered to at least two million children for the five years to 1993.
But a Department of Health spokeswoman said that if routine vaccinations had been stopped there would have been a "real risk" of serious and potentially fatal infectious diseases among children. She said all of today's vaccines are produced from non-UK bovine material, and insisted the old UK-based vaccines "appear to have no role to date" in the development of the human version of mad cow disease, new variant Creutzfeldt-Jakob Disease (nvCJD).
So far 53 people have been killed by the disease, another dozen are dying and the victims include three children, aged 13 to 15. [Today's DoH report shows 68 nvCJD victims as of 28 April 00. ]
Public Health Minister Yvette Cooper has told the Commons that some drug companies responded to 1988 reports of BSE by quickly switching to non-UK sources for bovine material for their vaccines. But after a Code of Open Government request for facts, the Daily Express has been told Wellcome continued using UK bovine material in the manufacturing process for four children's vaccines until 1989. Smithidine has said it continued to use UK-sourced material for its Measles, Mumps, Rubella (MMR) vaccine through to February 1990. [These were peak years of the BSE epidemic. A key issue is how long stocks at hand continued to be used. This was apparently until they were all sold or the expiration date reached by 1993. There was apparently never a recall.-- webmaster]
Drugs makers were asked to stop doing that in March 1989, but in an obscure sentence the Health Department suggests it "would have taken months" to eradicate UK-sourced material from the manufacturing process entirely. Wellcome's oral polio doses were also manufactured from UK-sourced bovine material through to 1989, although the last issue and expiry dates are "not known". The Medicines Control Agency told the Department of Health that Smithkline's inactivated polio vaccine was also manufactured from UK-sourced bovine material. However, it was said no such vaccine was sold by the firm in the UK.
Smithkline Beecham said: 'As of February 1990, Smithkline Beecham Biologicals, our vaccine business, ceased sourcing bovine material of UK origin, and replaced it with material from BSE-free countries. Any stock that was remaining, at the request of the UK authorities, continued to be available for sale."
That means unknown quantities of all six routine child immunisations, including Wellcome's oral polio, were kept in doctors' surgeries and were dispensed right through to expiry, towards the end of 1993. But the Health Department admits: "We are unable to provide exact dates on which vaccines manufactured before March 1989 were no longer used. At the time in question, vaccines were not purchased centrally, as they are now."
The Liberal Democrats' Mr Baker said: "The Department of Health was potentially criminally negligent in not requiring the immediate withdrawal or cessation of use of vaccines from potentially contaminated sources. "It is also beyond belief the Department should not even have monitored those who were injected, and is now trying to sweep the whole thing under the carpet"
Opinion (webmaster): This is good step forward to name the compaines and specific vaccines though it is a pity that England doesn't keep records of who received what vaccine the way normal countries do. The previous two mass outbreaks of TSE attributed to vaccines involved louping ill in the 1930's and a 1999 vaccine in Italy, both produced in sheep or goat brain. An Indian physician has also expressed concern about a widely used human rabies vaccines produced in scrapies-endemic sheep brain in India; CJD surveillance there is minimal. No details are provided above on what part of the bovine is used in producing the vaccines, apparently fetal calf serum or bovine serum albumen are used in human cell culture to grow the viruses. The vaccines had been previously discussed in a Phillips Inquiry memo: bovine blood serum, ox heart infusion, casein (milk protein), fetal calf serum, beef muscle infusion, veal, and unspecified sheep use.
14 February 1989 Dr Adams minuting Dr HarrisVaccines: We have contacted all the major vaccine product licence holders whose products are likely to be used in children. Many manufacturers use bovine material. As can be seen, this information is diverse and incomplete. Each company stressed that they could not give an accurate assessment without detailed researches, given the complexity of sourcing/purchasing arrangements. All the licences are detailed in appendix 1 [unavailable]; the overview is as follows:
1. D have polio, measles, mumps, rubella, rotavirus vaccines. All use bovine serum from a UK source and bovine commercial product from unknown source. Some agent comes from the USA and New Zealand.
2. I gave most information (see Appendix 2 [unavailable]). All their vaccines apart from yellow fever, cholera and typhoid contain bovine material: Oral polio; up to 1988, foetal calf serum was used from UK and New Zealand (pooled); since 1988 foetal calf serum only from New Zealand. Large stocks are held.
Rubella; bulk was made before 1979 from foetal calf serum from UK and New Zealand. None has been made as there are some 15 years stock.
Diphtheria; UK bovine beef muscle and ox heart is used but since the end of 1988 this has been sourced from Eire. There are 1,250 litres of stock.
Tetanus; this involves bovine material from UK mainly Scottish. There are 21,000 litres of stock.
Pertussis; uses bovine material from the UK. There are 63,000 litres of stock.
They consider that to switch to a non-UK source will take a minimum of 6-18 months and to switch to a non-bovine source will take a minimum of five years.
3. E have measles, mumps, MMR, rubella vaccines. These are sourced from the USA and the company believes that US material only is used.
4. J have a measles vaccine using bovine serum from the UK. There are 440,000 units of stock. They have also got MMR using bovine serum from the UK.
5. K have influenza, rubella, measles, MMR vaccines likely to be used in children. Of those they think that only MMR contains bovine material which is probably a French origin.
6. L have diphtheria/tetanus and pertussis on clinical trial [redacted]; These use veal material, some of which has come from the UK and has been made by I (see above).
7. M have influenza vaccines which are made up in egg medium.
8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to certain bovine ingredients).
9. N have acellular triple vaccine in which I material of UK bovine source has been used.
As far as I can see Company I is the sole supplier of pertussis vaccine which uses bovine casein digest. You should also be aware that DH has made arrangements for meningococal vaccine to be available, on a named patient basis, from D and K. Both companies use bovine media in production." The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath): No vaccines or other injectable medicines in use in the United Kingdom contain bovine serum derivatives as ingredients in the finished products.
Comment (Kelly): "It seems clear that no bovine derivatives are used in FINISHED products, however they are often used in the culture process. Does this also present a possible risk? Below is the packaging insert for one routine vaccine (inactivated injectable polio vaccine)made by Pasteur Merieux Sérums & Vaccins S. A. Lyon, France (now called Aventis):"
IPOLÒ, Poliovirus Vaccine Inactivated, produced by Pasteur Mérieux Sérums Vaccins S.A., is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). IPOLÒ is a highly purified, inactivated poliovirus vaccine produced by microcarrier culture. This culture technique and improvements in purification, concentration and standardization of poliovirus antigen produce a more potent and consistent immunogenic vaccine than the IPV available in the US prior to 1988. The viruses are grown in cultures of V.R. cells, a continuous line of monkey kidney cells, by the microcarrier technique. The cells are grown in Eagle MEM modified medium, supplemented with newborn calf serum tested for adventitious agents prior to use, originated from countries free of bovine spongiform encephalopathy. For viral growth the culture medium is replaced by M-199, without calf serum.... Neomycin, streptomycin and polymyxin B are used in vaccine production, and although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin and 25 ng polymyxin B per dose may still be present. The residual calf serum protein is less than 1 ppm in the final vaccine. The vaccine is clear and colorless and should be administered intramuscularly or subcutaneously.
The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.
TIP740203/l 0424 CONFIDENTIAL Mr Cunningham CMP3 From: D O Hagger MBI Dr Salisbury MED/IMCD3 Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989 Mr Dudley PD/AD4 BOVINE SPONGIFORM ENCEPHALOPATHY 1. The purpose of this minute is to alert you to recent developments on BSE as they affect medicines and to invite representatives to a meeting in Market Towers on 22 February 1989. 2. The report of the Working Party on Bovine Spongiform Encephalopathy (BSE) was submitted by the CMO to the Secretary of State for Health and Minister for Agriculturer on 9 February. 3. The summary at the end of the report records, inter alia: 'we have drawn the attention of the Licensing Authority to the potential of transfer of BSE agent in human and veterinary medicinal products. In paragraph 7 of his submission (Annex A), the CMO notes: "I am also putting work urgently in hand to satisfy myself that everything possible has been done to ensure .... that transfer of the BBE agent in human and veterinary medicinal products does not occur." 4. The Veterinary products Committee meets on 16 February and The committee on Safety of Medicines on 23 February when each will be considering a draft of some joint guidelines for manufacturers of medicinal products which use bovine material as an ingredient or an intermediate in the manufacturing process (Annex B)..... 6. Although a wide range of medicines may be implicated - and the present proposal is to write to companies for more information - an "instant" telephone survey of manufacturer of vaccines used for children has already been undertaken in response to a request from Dr Harris. The results are in Dr Adams' minute of 14 February (Annex C) - the proviso in his second paragraph, last sentence should be noted. 89/02.15/11.1 89/02.15/11.2 MF580439/1 0584 SOUTHWOOD REPORT: BSE AND MEDICINAL PRODUCTS 1. I attach a list of questions on BSE and medicines compiled with the aim of providing question and answer briefing to DH and MAFF Ministers upon publication of the Southwood Report. I have suggested names of those who may be able to provide answers. All recipients are invited to consider which if any important areas have been missed. Also attached is copy QA briefing being proposed by MAFF. I understand MAFF have produced General QA briefing on the reports as a whole. .. MF580439/1 0585 Question 1. Which medicines are affected? (person to provide reply) Dr. Jefferys 2. Are the risks greater with some medicines than others? Dr. Jefferys 3. Why are medicines affected? Dr. Jefferys 4. Are some affected products available over the counter from pharmacies or shops? Dr. Purves 5. Are only UK products at risk? Dr. Jefferys 6. Are existing stocks safe? Dr. Jefferys 7. Are pre 1980 stocks available? Mr. Burton 8. Are these alternatives to the use of bovine material? Dr. Purves 9. Why can't we throw away suspect stock and import or manufacture safe medicines? Dr. Jefferys 10. Which patients are at risk? Dr. Jefferys 11. Are some patients particularly vulnerable? Dr Jefferys 12. What risks exist to those who have already used these medicines? Dr. Jefferys 13. HOW might patients be affected? Dr. Jefferys 14. Can BSE be transmitted to patients by medicines? Dr. Jefferys 15. How long will it be before risks are quantified? Dr. Jefferys 100 89/02.17/10.2 MF580439/1 0586 16. What research is going on to find out if medicines can transmit this disease and if any patients have been affected? Dr Jefferys 17. Could recent cases of Creuuzfeld Jacob Disease have been caused by transmission of BSE through medicines? Dr. Jefferys 18. What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes? Dr. Jefferys/Dr. Purves 19. Are the guidelines practical? Dr. Jefferys/Dr. Purves 20. Will the guidelines remove the risk? Dr. Jefferys 21. How will the guidelines be enforced? Dr. Jefferys/Dr. Purves 22. How soon will they come into force? Dr. Jefferys 23. Will the guidelines be published? Mr. Hagger 24. What is being done to reassure patients, parents etc? Mr. Hagger/Dr. Salisbury 25. What advice is being given to doctors, pharmacists etc? Mr. Hagger 26. What advice is the Government giving about its vaccination programme? Dr. Salisbury 27. Is the vaccination programme put at risk because of BSE? Dr. Salisbury 89/02.17/10.3 Q. Will government act on this? A. Yes - thymus is not used in preparation of baby foods but it is contacting all manufacturers to seek their urgent views on use of kidneys and liver from ruminants. Will consider any necessary measures in the light of their response. VETERINARY MEDICINES Q. Can medicines spread BSE to other cattle/animals? A. The report describes any risks as remote. Q. How can risks be avoided? A. In liaison with the DOH the Veterinary Products Committee is examining guidelines for the veterinary pharmaceutical industry which will be issued shortly. Q. What will Guidelines say? A. In essence they call for non-bovine sources to be used if possible, including synthetic material of biotechnological origin. Where this is not possible the industry should look for sources which are free of BSE and which are collected in a manner which avoids risk of contamination by the BSE agent. 89/02.17/10.4 MF580439/1 0588 A. Bovine source material is used in [garbled, cannot read...TSS] and some other medicines. Q. How many medicines are involved? A. Computer records show that about 300 of the 3,050 veterinary medicines licensed in the U.K. are manufactured directly from bovine source material. However, other medicines may be produced from bovine sources and a letter is going to all license holders so that a comprehensive list can be drawn up. 89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g From: Dr H Pickles Med SEB/B Date: 3 July 1989 CATTLE BY-PRODUCTS AND BSE I was interested to see the list of by-products sent to the HSE. Those of particular concern included: * small intestines: sutures (I thought the source was ovine but you are checking this) * spinal cord: pharmaceuticals * thymus: pharmaceuticals Are you able to give me more information on which UK manufacturers use these materials? Our proposed ban on bovine offal for human consumption would not affect these uses, I assume. Id No. 1934/RD/1 89/08.10/6.1 117A BOVINE SPONGIFORM ENCEPHALAPATHY MEETING HELD ON 21 AUGUST 1989 AT 2;15 IN ROOM 720 Miss M Duncan (Chairman) Mr W Burton Dr E Hoxey Mrs J Dhell Ms K Turner Dr S Whittle Mr N Weatherhead ... 5. The MCA had sent 2700 questionnaires out, 1,124 had made valid returns; of these 122 use animal material of some kind and there are 582 products involved. ... 6. The MCA/BSE working group will meet on 6th September. Their aim is to review responses from professional officers in MCA who have suggested seven categories of importance (with 1 being the most important} for medical products: ID 2267/NRE/1 89/08.21/10.1 1. Products with Bovine brain/lymph tissue administered by injection. 2. Products with bovine tissue other than brain/lymph administered by inection. 3. Tissue implants/open wound dressing/surgical materials/dental and ophthlamic products with bovine ingredients. 4. Products with bovine ingredients administered topically. 5. Products with bovine ingredients administered orally. 6. Products with other animal/fish/insect/bird ingredients administered by injection/topically/oral routes. 7. Products with ingredients derived from animal material by chemical processing (eg stearic acid, gelatine, lanolin ext. The BSE working group will decide which of these are important, and should be examined more closely, and which categories can be eliminated. The responses by the companies were presented by Ms Turner and were categorised by MCA standards, the products that were discussed were all low volume usage products eg sutures, heart valves. 8. As the responses included some materials of human origin it was decided that more information should be sought about CJD. There had been 2 recent deaths reported associated with human growth hormone. These were being investigated. 9. Re-editing of the Paper on "Incubation of Scrapie-like Agents" It was suggested that the document could be sent out to companies with the non-standard sterilization Document. The document could have severe implications on the companies whose products have a high risk factor as decided by the MCA working group.... 11. The Need for a list of High Priority Implantables The commitee decided that no list is necessary as all implantables, including ones from a human source are of high priority. Concern was shown over Killingbeck who use human material but had not yet responded. The company will be chased for a response. Concern was shown over the fact that there may be other scrapie-like organisms in other animals and further enquiries should be made. 2334q/RD/4 89/08.21/10.7 BOVINE MATERIAL USED IN THE MANUFACTURE OF SURGICAL IMPLANTS AND BLOOD CONTACT MEDICAL DEVICES Glutaraldehyde, formaldehyde, and ethylene oxide are used in the sterilization of these devices. However, glutaraldehyde 4,10,12,19 formaldehyde 5,10,11,13,19 and ethylene oxide 19,23 are all reported to be ineffective methods for sterilization of material infected with the agents of CJD or scrapie. Previous advice and research using the agents of CJD and scrapie, has concentrated on the decontamination of equipment; protection of health care workers from contaminated human material; human growth hormone; and dura mater. The methods developed may not be directly applicable or transferable to material of bovine origin for use in human implantation. 2334q/RD/7 89/08.21/10.10 BSE11/2 020 SC1337 DEPARTMENT OF HEALTH AND SOCIAL SECURITY Richmood House 79 Whitehall, London SW1A 2NS Telephone 01-210-3000 From the Chief Medical Officer Sir Donald Acheson KBE DM DSc FRCP FFCM FFOM Mr K C Meldrum Chief Veterinary Officer Ministry of Agriculture, Fisheries and Food Government Buildings Hook Rise South Tolworth Surbiton Surrey KT6 7NG 3 January 1990 Dear Mr. Meldrum, BOVINE SPONGIFORM ENCEPHALOPATHY You will recall that we have previously discussed the potential risks of BSE occurring in other Countries as a result of the continuing export from the UK of meat and bone that may be contaminated by scrapie or possibly BSE. I remain concerned that we are not being consistent in our attempts to contain the risks of BSE. Having banned the feeding of meat and bone meal to ruminants in 1988, we should take steps to prevent these UK products being fed to ruminants in other countries. This could be achieved either through a ban on the export of meat and bone meal, or at least by the proper labelling of these products to make it absolutely clear they should not be fed to ruminants. Unless some such action is taken the difficult problems we have faced with BSE may well occur in other countries who import UK meat and bone meal. Surely it is short sighted for us to risk being seen in future as having been responsible for the introduction of BSE to the food chain in other countries. I would be very interested to hear how you feel this gap in the present prcautionary measures to eliminate BSE should be closed. We should be aiming at the global elimination of this new bovine disease. The export of our meat and bone meal is a continuing risk to other countries. Signed Sincerely Donald AchesonDid the US import fetal calf serum and vaccines from BSE-affected countries?
3002.10.0040: FETAL BOVINE SERUM (FBS)
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
=================================================================
WORLD TOTAL . . . . . . . 2,727 233 131,486 8,502
Australia . . . . . . . . --- --- 19,637 2,623
Austria . . . . . . . . . --- --- 2,400 191
Belgium . . . . . . . . . --- --- 17 32
Canada . . . . . . . . . 900 110 30,983 3,220
Costa Rica . . . . . . . 500 20 4,677 169
Federal Rep. of Germany --- --- 105 21
Finland . . . . . . . . . 1 8 9 83
France . . . . . . . . . --- --- 73 7
Guatemala . . . . . . . . --- --- 719 42
Honduras . . . . . . . . --- --- 1,108 88
Israel . . . . . . . . . --- --- 24 165
Netherlands . . . . . . . --- --- 1 5
New Zealand . . . . . . . 26 5 65,953 913
Panama . . . . . . . . . --- --- 1,195 64
Switzerland . . . . . . . 971 8 1,078 23
United Kingdom . . . . . 329 82 743 756
Uruguay . . . . . . . . . --- --- 2,764 98
------------------------------------------------------------------
3002.20.0000: VACCINES FOR HUMAN MEDICINE
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
=================================================================
WORLD TOTAL . . . . . . . 25,702 26,150 550,258 378,735
Austria . . . . . . . . . --- --- 45 225
Belgium . . . . . . . . . 14,311 12,029 248,041 199,036
Canada . . . . . . . . . 1,109 1,527 15,798 16,305
Denmark . . . . . . . . . 80 234 246 682
Federal Rep. of Germany 1,064 4,073 12,001 6,329
France . . . . . . . . . 3,902 4,859 87,879 92,845
Ireland . . . . . . . . . --- --- 120 478
Italy . . . . . . . . . . --- --- 2,359 81
Japan . . . . . . . . . . 445 1,903 11,350 11,298
Netherlands . . . . . . . --- --- 94 6
Republic Of South Africa --- --- 2 1
Spain . . . . . . . . . . --- --- 60 30
Switzerland . . . . . . . 716 353 9,303 4,271
United Kingdom . . . . . 4,075 1,172 162,960 47,148
------------------------------------------------------------------
3002.30.0000: VACCINES FOR VETRINARY MEDICINE
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
=================================================================
WORLD TOTAL . . . . . . . 6,528 237 87,149 2,715
Canada . . . . . . . . . --- --- 2,637 305
Federal Rep. of Germany --- --- 104 5
Netherlands . . . . . . . 138 64 472 192
New Zealand . . . . . . . 6,390 173 83,882 1,895
United Kingdom . . . . . --- --- 54 318
Sat, May 6, 2000 By Anjali Kwatra, PA NewsComment (webmaster): While rumors swirl about new variant CJD, fueled by the Baroness' association with animals, this case may very well be simply sporadic CJD. The BBC Radio news specifically stated that nvCJD was suspected but no supporting reasons were given out. The oldest known case is 52, a gap of some 14 years. No mention is made of a brain biopsy; pulvinar MRI has not been validated at this age.
Vice President of the RSPCA Baroness Ziki Wharton is in hospital undergoing tests for variant CJD - the human form of mad cow disease, it was revealed today. Baroness Wharton, 66, a crossbench peer in the House of Lords, is "seriously unwell" in Charing Cross Hospital in west London.
Her doctor, Angus Kennedy, a consultant neurologist at the West London Neurosciences Centre, said: "She has undergone a series of neurological investigations, including tests for Creutzfeldt-Jakob disease." He added: "The media's respect for the privacy of Baroness Wharton and her family at this difficult time would be gratefully appreciated."
The baroness, who has three sons and a daughter, has been vice president of the RSPCA since 1997. A spokeswoman for the organisation said: "We are concerned to hear that Baroness Wharton is ill in hospital and we wish her well." Her recreations listed in Who's Who include animal welfare, photography and skiing.
Variant CJD, the human form of mad cow disease which first emerged in 1995, is believed to be acquired from eating BSE-contaminated beef. To date the disease is known to have claimed more than 50 victims in the UK.
Later the Director General of the RSPCA, Peter Davies, who is also a personal friend of the baroness, said: "Baroness Wharton has shown a life-long commitment to animal welfare and we are all very concerned that someone who has devoted so much time and energy to animals is seriously ill in hospital.
"She has spoken on behalf of animal welfare issues and the RSPCA with great vigour in House of Lords debates on many occasions. "Of particular concern to her was the cruel practice of illegal puppy farming, which is now banned and she showed great concern over the quarantining of pets in the UK which is now being replaced by pet passports. Her tireless campaign on behalf of animals was a major contribution to both these successes."
London Times May 7 2000 Deborah Colcutt and Lois RogersA leading member of the RSPCA has been found to have the brain disease CJD after an illness lasting three weeks. Neurologists at Charing Cross hospital in London said yesterday that Baroness Wharton, a vice-president of the association, was "very seriously ill" with the debilitating condition, which causes cavities in the brain.
However, fears that her illness may have been linked to her work with animals have proved unjustified. She is suffering from the sporadic form of the condition, which can occur at random. The recently identified "new variant" form of CJD is the human version of "mad cow" disease.
Ziki Robertson, 66, is a popular cross-bencher in the House of Lords with a keen interest in animal welfare and photography. Her illness was first thought to be encephalitis, but her condition worsened and she was unable to recognise friends or family.
In December she took the photographs for a book called Parliament in Pictures, with Austin Mitchell, the Labour MP. "She is a brilliant photographer, a bubbly person and the rare type of peer who listens to both sides then makes up her mind. We are terribly shocked," Mitchell said.
She is being treated by Angus Kennedy, a consultant neurologist, who said: "She is very seriously ill. She has undergone neurological investigations, including tests for Creutzfeldt-Jakob disease."
New-variant CJD has claimed more than 50 victims. Sporadic CJD, which is more common, causes dementia, followed by the gradual destruction of all bodily functions.
Wharton, who was widowed in 1996, has three sons and a daughter. An RSPCA spokesman said: "We are devastated to hear of her illness."
Sunday 7 May 2000 TELEGRAPH ISSUE 1808 By Andrew Alderson and Jo KnowsleyBARONESS WHARTON, the Vice-President of the Royal Society for the Prevention of Cruelty to Animals, is critically ill in hospital and believed to be suffering from Creutzfeldt-Jakob Disease (CJD). Lady Wharton, 66, a mother of four and a crossbench peer in the House of Lords, was described as "seriously unwell" in Charing Cross Hospital in west London yesterday.
Austin Mitchell, the Labour MP who worked with Lady Wharton last year on his book Parliament in Pictures, said: "This is shocking news. I knew that she had been unwell for about three weeks. She is a brilliant photographer and loves her work at the House of Lords. She and I are joint chairs fo the all-party media group and we have worked together on a number of issues. She is a very lively, bubbly kind of person."
The Countess of Mar, who has known Lady Wharton - known by her friends as Ziki - for 25 years, said: "The prognosis is nil unfortunately. It's enormously upsetting because she is a lovely person. She is such fun to be with and very compassionate."
Angus Kennedy, Lady Wharton's doctor and a consultant neurologist at the West London Neurosciences Centre, said: "She has undergone a series of neurological investigations, including tests for Creutzfeldt-Jakob disease."
CJD is a rare disease named after the two German neurologists who in the Twenties separately described patients with its symptoms. Initial suggestions yesterday that Lady Wharton had been suffering from new variant CJD, the human form of "mad cow disease' believed to be caused from eating contaminated beef, were privately dismissed by hospital officials.
Instead, she is believed to be suffering from sporadic CJD, which is not connected to variant CJD. Sporadic CJD is responsible for the deaths of between 30 and 40 people a year in Britain, most of them over the age of 45. New variant CJD, which has claimed more than 50 lives in Britain, tends to affect younger people.
Lady Wharton, a widow who has three sons and a daughter, has been Vice-President of the RSPCA since 1997 and has long been interested in animal welfare. A spokeswoman for the organisation said yesterday: "We are concerned to hear that Baroness Wharton is ill in hospital and we wish her well."
The first symptoms she displayed were a lack of co-ordination and the inability to grasp objects. She now cannot stand unaided and has lost some of her bodily functions. Lady Wharton, who lives in south-west London, lists her recreations in Who's Who as animal welfare, photography, skiing and opera.
Fri, Apr 28, 2000 By John von Radowitz and Sam Greenhill, PA NewsA study aimed at predicting how many people are likely to die from human mad cow disease today left scientists no closer to knowing the answer. Government-funded experts found no signs of variant CJD in 3,000 tonsil and appendix specimens removed in operations since the 1980s, but warned the results should not be seen as an all-clear.
The scientists, from the CJD surveillance unit in Edinburgh and Derriford hospital in Plymouth, pointed out that these were the first findings from a survey that will eventually examine tissue from around 18,000 samples. At a news conference at the Department of Health in London, the government's chief medical officer, Professor Liam Donaldson said: "The fact that no positives have been found is welcome news, but these early results should not be taken as an indication of an `all clear'.
"The methods of analysis used on the small sample of specimens have some limitations. In addition we do not know at what point in the incubation period tissues such as tonsils or appendices would turn positive, how long the incubation period would be, or even whether any individuals who were found positive would necessarily go on to develop the disease."
Variant CJD emerged in 1995 as a previously unrecognised form of the human brain disease, and to date has claimed 53 confirmed victims in the UK. Most experts now accept that the variant CJD is a human version of the cattle disease BSE and acquired from eating contaminated beef. The majority of infections are thought to have occurred in the late 1980s before the introduction of controls to prevent contaminated meat entering the human food chain.
How many people eventually succumb to the disease largely depends on the length of its incubation period, which may be up to 20 years or more. Estimates of the size of the epidemic range from just 100 or so cases to hundreds of thousands. Variant CJD is associated with a rogue prion protein which some experts believe may be the infective agent.
It was the discovery of the abnormal protein in lymphatic tissue which led to the new study being undertaken. In late 1988 abnormal prions were found in the appendix of a man who had developed variant CJD. In addition scientists led by Professor John Collinge at St Mary's Hospital, London, discovered the abnormal protein in the tonsils of patients who had died from the disease.
Professor Les Borysiewicz from the University of Wales College of Medicine led a scientific committee which reviewed the results of the tonsil and appendix analysis. He said that the study was limited but pointed out that scientists still had no reliable diagnostic test to detect the presence of the disease while it was incubating.
"This is the best we can do at the present time, but clearly other methods as they come along will be used as well." Prof Donaldson said: "This doesn't take us any further forward. We have to still rely on the very, very wide estimates that scientists have already made. This is a complex and mysterious disease and the results of today's study throws a little bit more light on it, but it's very much an evolving conundrum."
He said a perspective study had been commissioned from Prof Collinge which would look at freshly taken samples of tonsil and appendix tissue. One of the drawbacks of the current study was that the samples had been stored for a long time.
Dot Churchill, whose 19-year-old son Stephen became the first confirmed vCJD victim in 1995, said she was not surprised by the lack of positive cases. "It's not a lot different from what we expected," she said. "They are half way through the research and this is quite a small sample. I think it's just too early to make any predictions, and as the chief medical officer said we should not see this as the all clear. The disease is a very unknown quantity and we shall just have to wait."
Mrs Churchill, from Devizes, Wiltshire, whose husband David chairs the Human BSE Foundation, nevertheless thought the study worthwhile. "Any research that gives us any answers at all has got to be welcomed," she added.
Dr Graham Medley, an expert on CJD from Warwick University, said: "We still know very little about how long people carry CJD before they develop it, and it is therefore difficult to know what the scale of the threat is. "If the incubation period is ten years, then we are in the middle of the epidemic. If the incubation time is 30 years, then we are only at the beginning. We have never before seen this disease in humans and we simply do not know at the moment."
Later, Hugh Pennington, professor of bacteriology at Aberdeen University, said: "I feel a sense of relief. If anything positive had come through, it would have been bad news. But this is just the first stage in the test. I think there are some 18,000 samples to be checked and we'll have to wait for those results to come through. It will then be up to the statisticians to tell us what the results might mean.
"It they come up zero again, that would maybe tell us that perhaps we should not expect many more cases than we have had so far. We are not that much further on with this study. But on the other hand at least we didn't get bad news, so that's something."
Comment (webmaster): In this and many similar stories, what seems to be good news is being treated by the English medical establishment as no news. Had 10, 100, or 1000 infected tonsils been found, that would have been a catastrophic but interpretable finding. Now 25% of the tonsil samples were discarded, raising the question if the criteria used for judging the quality of the specimens were reasonable and not politically distorted to achieve a nil result. If positive results were observed and discarded then this would explain the length of time these results were debated and the newspaper report of positives.
03 May 00 review of scientific literatureThe issues here are whether lymphatic tissues can serve as leading indicators of nvCJD and if so, over what window of time for which subclasses of subsequent victims. These issues must be defined relative to freshness and fixation of available samples and sensitivity of tests used.
False positives cause little concern: other kinds of CJD occur with vanishingly small probability in tonsil-removal age groups; rogue prion accumulation is basically unknown outside of CJD; and cases not going on to neurological disease and death are sources for secondary infection. Only an upper bound is needed for the epidemic.
False negatives cause the epidemic to be under-estimated. The tonsil samples used were apparently fixed in formalin, meaning that the more sensitive Western blot method could not be used. Tonsils were archived [stored] from 1996-98 on under unknown and possibly variable conditions prior to prion immunochemistry. There are no known control studies of validated nvCJD tissues still testing positive after storage under comparable periods and conditions. In fact, it is not known what fraction of the 67 neurologically confirmed cases had positive tonsil tests with any method of test.
No explanation has been given for how only 3,170 specimens (76%) could be suitable for analysis out of 4166 studied. This suggests a major systematic flaw in sample collection, storage, or handling for the remaining 996 samples, a scandal in itself for a longstanding nationwide tissue storage program.
Another grave concern is that overly rigorous standards were required for positivity. The complete absence of ambiguous, borderline, or suspicious samples, in conjunction with the large percentage of rejected tonsils, enhances this concern. Overly rigorous standards have been used in the recent past to diminish the cattle epidemic: multiple different tests had to agree, in effect allowing little-regarded cytological tests to over-rule definitive and direct prion tests. This effect may account for the Sunday Times account of a 'low number of positive cases.'
The age at which tonsils are generally removed -- childhood -- does not agree at all well with the age distribution of nvCJD onset: the 3 cases under 15 represent only 4% of nvCJD caseload. Perhaps tonsils are, like brain, a tissue with slow incremental accumulation by early adulthood. The UK apparently keeps a Tabular List of the Classification of Surgical Operations and Procedures published by the Office of Population Censuses and Surveys. Many surgical operations have been classified and coded, ie, Excision of Tonsil is F34. The next step is to call the Office of National Statistics (tel 0171 396 2236) and request particular statistics (year, etc) based on the desired code.
Eight months earlier, he had his appendix removed at a local hospital. "I saw that Mr. Barrett had an appendectomy in September 1995, and we felt some of the lymph nodes contained in the organ could reflect traces of the disease," says David Hilton, a neuropathologist at Derriford Hospital in Plymouth. "Tests revealed that we were correct, and these were corroborated at the National CJD Surveillance Unit in Edinburgh." [Science 4 Sep 1998 v281, pp. 1422 - 1423 Nigel Williams]
It does not follow from this that the tonsils also would shown infectivity 8 months out. It is not possible to infer how much earlier the appendix would have shown detectable sign, nor whether the level [detection window] was waxing, waning, or stable. Many cell types outside the central nervous system have limited lifetimes. The date and route of the victim's critical exposure to BSE is unknown.
Genetics at codon 129 are met/met for this and all other cases of positive lymphoreticular tissue; it is not known whether met/val or val/val tissues would develop a positive response.
2. In the 16 January 1999 issue of The Lancet, 353(9148):183-9, Collinge's group published a major followup study that showed tonsil data can detect nvCJD and differentiate non-BSE strains of CJD:
"Lymphoreticular tissues (68 tonsils, 64 spleens, and 40 lymph nodes) were obtained at necropsy from patients affected by prion disease and from neurological and normal controls. Tonsil biopsy sampling was done on 20 patients with suspected prion disease. Tissues were analysed by western blot to detect and type PrPSc, by PrP immunohistochemistry, or both. All lymphoreticular tissues obtained at necropsy from patients with neuropathologically confirmed variant CJD, but not from patients with other prion diseases or controls, were positive for PrPSc.... Tonsil biopsy tissue was positive in all eight patients with an adequate biopsy sample and whose subsequent course has confirmed, or is highly consistent with, a diagnosis of new variant CJD and negative in all patients subsequently confirmed to have other diagnoses. " 3. The study was inspired by an earlier finding, reported by Collinge's group in 1997, Lancet Jan 11;349(9045):99-100:
"Diagnosis of new variant Creutzfeldt-Jakob disease by tonsil biopsy. of abnormal PrP in the tonsils of a patient who had died from nvCJD. For the recent study, the team collected a large number of samples of lymphoid tissues--including tonsils, spleens, and lymph nodes--from a variety of sources. These included tonsil biopsies from 20 patients suspected of having some sort of prion disease--nine of whom were later shown to be suffering from nvCJD. The rest were from tonsillectomies or stored autopsy materials taken from nvCJD victims, normal controls, and sufferers of other neurological diseases, including "classic" forms of CJD not linked to BSE...."
Nöelle Bons, Nadine Mestre-Frances, Patrick Belli, Françoise Cathala, D. Carleton Gajdusek, and Paul Brown PNAS 1999 96: 4046-4051.This paper looked at oral transmission of BSE to primates (more relevent to humans that rodents or grazing animals), proving that tonsils in lemurs do indeed show infectivity in advance of perobable future symptoms. Immunohistochemistry of two experimentally infected but still asymptomatic lemurs, killed 5 months after infection, detected PrP in tonsil, gastrointestinal tract and associated lymphatic tissues, and spleen; in ventral and dorsal roots of the cervical spinal cord, and within the spinal cord as far as the cerebral cortex. Similar patterns of PrP immunoreactivity were seen in two symptomatic and 18 apparently healthy lemurs in three different French primate centers, all of which had been fed diets supplemented with a beef protein product manufactured by a British company that continued to include BSE beef in its veterinary nutritional products. An earlier paper, C R Acad Sci III 1997 Dec;320(12):971-9, had noted that tonsils and the walls of the lymph and blood vessels below the intestinal epithelium were also labelled with prion antibodies.
5. Now many earlier studies of scrapie show lymphoid tissue in the gut, tonsils, and spleen infected a third of the way through the incubation period, long before symptoms developed. Hadlow et al. in a landmark set of experiments, looked at the sequential appearance of infectivity in different organs in both naturally and experimentally acquired disease, continued by Kimberlin and Walker in a series of experiments on orally infected mice, and most recently extended by Beekes et al. to include parallel studies of PrP in tissues after oral infection and by Klein et al. (15) with particular attention to the role of B cells in neuroinvasion. BSE appears to be similar to scrapie in experimentally infected animals
After oral infection, infectivity and pathologic PrP first appear in the digestive tract and its lymphoid tissues (tonsils, lymph nodes, Peyer's patches, and spleen), before moving, presumably through autonomic nervous system fibers, to the spinal cord and up to the brain. Natural and experimental BSE in bovines has comparatively limited distribution of infectivity outside the central nervous system: trigeminal and dorsal root ganglia, distal ileum, and (possibly) bone marrow and retina.
Ecklund, C. M., Kennedy, R. C. & Hadlow, W. J. (1967) J. Infect. Dis. 117, 15-22. Hadlow, W. J., Eklund, C. M.,.. Whitford, H. W. & Boyle, C. C. (1974) J. Infect. Dis. 129, 559-567. Hadlow, W. J., Kennedy, R. C. & Race, R. E. (1982) J. Infect. Dis. 146, 657-664. Kimberlin, R. H. & Walker, C. A. (1988) in Novel Infectious Agents and the Central Nervous System, pp. 37-62. Kimberlin, R. H. & Walker, C. A. (1989) Virus Res. 12, 213-220. Beekes, M., Baldauf, E. & Diringer, H. (1996) J. Gen. Virol. 77, 1925-1934. Beekes, M., Mcbride, P. A. & Baldauf, E. (1998) J. Gen. Virol. 79, 601-607. Klein, M. A., Frigg, R.,..., Bootz, F., Suter, M., Zinkernagel, R. M. & Aguzzi, A. (1998) Nature (London) 390, 687-690. Wells, G. A. H., ...Chaplin, M. J., Stack, M. J. & Dawson, M. (1998) Vet. Rec. 142, 103-106.
Friday April 21, 2000 James Meikle and Paul Webster What's wrong with our food? - special report The GuardianThe BSE epidemic in Britain is expected to die out by the year 2007, according to an independent assessment of the spread of the disease by Swiss scientists. Their predictions support the government's assertion of a steadily decreasing trend, assuming that a ban on feeding the most risky parts of cattle or sheep back to cows is being rigorously observed.
Researchers at the Institute of Animal Neurology at Bern University and the Swiss Federal Veterinary Office suggest there may only be isolated cases of BSE after 2007, 21 years after the disease was first identified and possibly more than three decades after it began on an unnoticed small scale. The estimates do not take into account the unproven theory that cows may have given the disease to their calves but the unpublished work, reported by the EU's scientific steering committee, offers a real prospect of Britain emerging from the crisis.
Hundreds of suspect BSE cases are still being slaughtered - 2,250 cases were confirmed in Britain last year. The total of confirmed BSE deaths among cattle - 176,600 - dwarfs other countries, including Ireland at 466, Portugal 371 and Switzerland 356. EU scientists have accepted that Britain was entitled to lift its beef-on-the-bone ban but are likely to insist many anti-BSE controls remain in place. They and the commissioner responsible for BSE, David Byrne, want more countries, even those currently without BSE, to adopt similar measures because of the risks to consumers through imported food.
In Britain 55 people have died from the human form of BSE, variant CJD, and another 12 are thought to be fatally ill. Meanwhile in France, where entire herds are slaughtered if BSE is found, there is mounting concern over the possible length of the BSE problems, which started in 1991.
The recently established food safety agency, which provided the information which convinced Paris to maintain its ban on British beef exports, believes the disease will not be eradicated in France before 2010. One person has died from variant CJD and there are two other suspect cases. So far 94 cattle have been confirmed as BSE-related deaths.
Although the feeding of cattle with bone waste has been banned in France for six years, feed can still be given to pigs and poultry, raising the possibility of careless handling as a source of infection. But the agriculture minister, Jean Glavany, says a third way other than feed and cow to calf transmission may be the cause. So far, scientists have ruled out this possibility and health inspectors are concentrating on possible malpractice over feed.
Comment (webmaster): Scrapie has perpetuated itself in Britain for 250 years by some mix of horizontal, genetic, vertical, vaccine, and feed transmission mechanisms, why should BSE any different? New data on chronic wasting disease in Canadian elk supports both herd mate transfer as well as mother-to-calf for this TSE as well.
Sun, May 7, 2000 By Nick Mead, PA NewsThe BSE epidemic may last longer than previously thought because of a "real risk" that the disease was spread by cow pats from infected cattle, a leading scientist said today.
BSE expert Dr Alan Dickenson told Radio Four's Farming Today programme that his research suggested cattle continued to catch BSE long after the date the Government believed was possible. The new findings sparked fears that Britain was risking another trade war with France and Germany over the spread of the disease.
Microbiologist Dr Stephen Dealler told the programme that unless urgent action was taken to curb the spread of the disease, the French and Germans would impose new restrictions on British beef.
The Government has insisted that the last cattle were infected in August 1996, either through contaminated feed or, in a small number of cases, from mother to calf. But Dr Dickenson, the founding director of the Neuropathogenisis Unit in Edinburgh which researches BSE, warned that animals born after August 1996 may have caught the disease a "third way", through infected soil. His research shows that cow pats excreted on to grazing land by cattle at the height of the epidemic posed a "real risk" of infection.
If cattle born after August 1996 caught BSE through infected soil, the epidemic would last longer than the Government predicted. The disease's five-year incubation period means it will not be possible to tell whether Dr Dickenson is right until 2001.
Dr Dealler said he feared France and Germany would extend their bans on the import of British beef unless the Government takes action to stop the spread of the disease. He added that the future spread of BSE could be "drastically reduced" if cattle and sheep were injected with the drug pentosan polysulphate. The compound, used in the United States to treat cystitis, has been shown to drastically reduce BSE infectivity in laboratory mice, Dr Dealler said.
Wed, 26 Apr 2000 Associated Press Worldstream via COMTEXFrance's Agriculture Ministry on Tuesday reported two new cases of mad cow disease in western France. The two ailing milk cows, discovered in the Cotes d'Armor region, were the 15th and 16th cases of the disease reported in France this year. Workers slaughtered the animals and their herds, comprising 112 cows, as a precaution. Thirty-one cases of mad cow disease, or bovine spongiform encephalopathy, were discovered in France in 1999, up from 18 in 1998.
French Agriculture Minister Jean Glavany said this month that there could be a "mysterious, third way of spreading mad cow disease," other than through animal-based feeds and from cow to calf. He said this could mean the disease would not be wiped out of France, as hoped, in 2001 -- five years after authorities took rigorous measures to prevent more outbreaks.
Europe's beef scare was triggered in 1996, when the European Union imposed a ban on British beef after a link was established between the disease and Creutzfeldt-Jakob disease, a fatal brain-wasting condition in humans. France provoked a spat within the EU by keeping in place its ban on British beef, after an EU ruling last August that the meat was again safe for import.
Reuters World Report Tue, Apr 25, 2000Two herds of cattle totalling 112 animals were destroyed in France after the discovery of two fresh cases of mad cow disease, the farm ministry said on Tuesday. The new cases brought to 16 the number of cases of the fatal brain-wasting illness, also known as bovine spongiform encephalopathy (BSE), reported in France this year. They indicated that France was on track this year to exceed the 30 BSE cases reported in 1999. A total of 96 cases of the disease have been reported in France since the epidemic was first detected in 1991.
The ministry said in a statement the two infected animals were dairy cows born in May 1993 and August 1994. The two animals and their respective herds in the Cotes d'Armor region of western France were destroyed.
The new cases were the first to be reported in France since Farm Minister Jean Glavany said BSE may be passed to cattle in a "mysterious third way," apart from infected cattle feed and cow-to-calf transmission. Glavany's comments raised fears among consumers and farmers that France's epidemic may be more widespread than originally thought and that it may take longer than expected to expunge the disease from the country's herd of about 21 million cattle.
Indeed, the ministry has recently stopped forecasting when it expects the epidemic to die out. Previously, it had said the number of BSE cases should taper off in 2001, given that the disease has a five-year incubation period and that tougher controls on cattle feed were introduced in 1996. But the statement issued on Tuesday contained no such predictions. Instead, the ministry repeated Glavany's speculation that other means of contamination may explain the increasing number of cases in France.
France plans to begin testing 48,000 cattle beginning next month for BSE, which has been linked to a form of the human Creutzfeldt-Jakob Disease that has so far killed at least 50 people in Britain. Britain has reported a total 180,000 cases of BSE, making the French epidemic look small by comparison. But while the number of BSE cases in Britain is falling, the French epidemic is still growing. The French government is locked in a legal battle with the European Commission over its refusal to lift a ban on imports of British beef because of fears it is not entirely free from BSE.
OTC (COMTEX Newswire Wed, Apr 26, 2000Testing for bovine spongiform encephalopathy (BSE), or mad cow disease, in France will begin at the end of May instead of the beginning of May--as recently announced by the government--a spokesman from the Breton veterinary services told BridgeNews Wednesday. He added the first 5,000 tests will be carried out simultaneously by the French, Swiss and Irish testing programs instead of one single test.
France will allocate 221 million francs this year for testing for mad cow disease, according to details of the final French 2000 budget bill obtained Wednesday by BridgeNews. France is slated to launch its nationwide mad cow testing program by the end of April or the start of May.
By John Lichfield in Paris THE INDEPENDENT, London, 22 April 2000The growing French epidemic of BSE can be traced directly to farmers fattening their cattle with potentially contaminated feed that was officially banned in 1991, according to official investigations.
Paris justified its flouting of European Union rules to maintain the ban on British beef last month by arguing that it had a duty to take "extreme precautions" to protect human health. But there is now mounting evidence that the French government's own measures against bovine spongiform encephalopathy (BSE) are inadequate and loosely enforced.
Inquiries by French government vets have shown a "probable or possible" connection between all recent cases of the disease in France and the use of compound animal feed containing the ground-up remains of cattle. Officially, the findings are secret but they have been leaked to the newspaper Le Figaro and confirmed to The Independent by a source in the French food safety agency, the AFSSA.
Such feed, blamed for the vastly greater BSE epidemic in Britain, has been banned as cattle fodder in both countries since 1991. It has been banned from animal feed of all kinds in Britain since 1996, when it was realised that cattle were still being fed on contaminated feedstuffs destined for pigs and poultry. Yet it remains legally available in France to feed pigs and poultry. Officials believe that its accidental or deliberate use for cattle explains why the incidence of BSE in France is almost doubling annually.
The numbers must be kept in perspective. Contrary to claims by the Conservative Party, there is no "mass" epidemic of BSE across the Channel and there is no credible evidence that some cases are being "hidden". There have been just over 100 BSE cases in France in eight years, compared with a monumental 180,000 cases in Britain.
The fact remains, however, that the number of cases in the United Kingdom is falling rapidly while the disease is "inexplicably" gaining ground in France, where there have been 14 cases already this year, compared with 30 last year and 18 the year before.
Last week, the French Agriculture Minister, Jean Glavany, speculated that the advance of the disease might be connected to some unknown "third" method of infection. The only scientifically proved means of transmission are through tainted feed and, in rare cases, through inheritance.
However, the leaked findings show that the French government is aware of the likely real cause of the spread of BSE. Each outbreak has been investigated exhaustively by the Ministry of Agriculture's vets. The average period of incubation of BSE is five years; records of food supplied to animals, or available on the farm, have been examined for seven years before the outbreak.
The results of these inquiries have been kept secret. However, the leak to Le Figaro has revealed that every single case of BSE in France can be linked to a "probable or possible" wrongful, or "cross-over", use of animal feed officially restricted to poultry and pigs. An official at the AFSSA said it was clear that some farmers had "only in the last few months truly understood the danger" of using cheaper feeds.
The Confederation Paysanne farmers' union makes an even more serious accusation. It accuses French compound feed manufacturers of either deliberately or carelessly flouting the law and continuing to mix cattle remains in cattle feed. The union said this week that Mr Glavany's suggestion of a "third way" of catching BSE was intended to "divert public attention from the imprudent, or even fraudulent, practices of certain large manufacturers".
Officials at the French Ministry of Agriculture reject such claims. They say that there is no evidence of systematic flouting of the law by feed manufacturers. If this was so, they say, there would be a much greater BSE epidemic in France.
AP WorldStream Wed, Apr 26, 2000The German Cabinet said Wednesday it wants all domestic beef labeled as originating in Germany starting Sept. 1, ahead of a European Union schedule for rules agreed after a ban on British beef imports was lifted. Measures decided by EU farm ministers last week require only that meat be marked with the country in which the beef was slaughtered and processed on Sept. 1.
Marking information on the place of birth and where the cattle were raised is not a requirement until 2002, but Germany plans to meet all requirements by September, the Agriculture Ministry said. The German parliament was expected to debate the labeling measures on June 9.
The upper house voted on March 17 to lift a four-year ban on British beef imposed by the EU because of "mad cow" disease in Britain. The ban came after Britain announced a possible link between mad cow disease -- or bovine spongiform encephalopathy -- in British beef and a fatal brain ailment in humans.
Britain slaughtered millions of potentially BSE-infected cattle, introduced curbs on the use of potentially BSE-infected animal feed and created a comprehensive cattle tracing system. The EU commission last year allowed British beef exports to resume on Aug. 1, 1999, provided the meat was from cattle born after Aug. 1, 1996. France and Germany balked at lifting the ban, but Germany changed its mind when faced with a possible fine. According to Germany's Central Marketing Association for Agriculture, British beef accounted for less than one percent of beef consumption in Germany even before the ban.
Reuters World Report Tue, May 2, 2000 By David BroughItaly's new government plans to encourage farmers to use feed based on "natural" ingredients rather than meat and bone meal, Farm Minister Alfonso Pecoraro Scanio said on Tuesday. "We want to give farmers the incentive to feed animals with natural substances," Scanio, sworn in last week as part of Italy's new government, told Reuters in a telephone interview.
In the EU, the use of meat and bone meal has been banned for cattle, but not for other livestock. Scanio, a member of the Greens party, said he hoped the EU would work progressively towards removing meat and bone meal from the animal food chain. The practise of a feeding cattle meat and bone meal is widely believed to have been responsible for spreading "mad cow" disease, or BSE (bovine spongiform encephalopathy), in Britain and other European countries. France's Farm Minister Jean Glavany in February softened his call for an EU ban on the use of meat and bone meal in animal feed, citing the problems that would ensue, such as a shortage of proteins.
Asked to outline the main planks of his agricultural policy, Scanio said Italy aimed to promote sales of its high-quality produce, such as Parma ham, Parmesan cheese and pasta, and to help develop the rural economy. "We have to find the right balance between ecology and economics," he said. His predecessor, Paolo De Castro, had also strongly endorsed projects to boost sales of quality foods around the world. While Italy cannot compete with the world's leading agricultural producers in terms of farming area, it can do so in terms of high-quality processed foods.
Scanio said he opposed genetically modified crops as a precautionary step amid concerns about possible environmental and health risks. In a recent interview with the respected La Stampa newspaper, Scanio said he was against experimentation with GM crops in open fields and that it should be limited to restricted areas. He called for wider labelling of produce containing GM material. U.S. transgenic soybeans, for example, are incorporated into foods sold worldwide.
In October 1999, the European Commission ruled that all food products sold in the EU must be labelled as containing GM material if at least one of their ingredients contained at least one percent GM DNA or protein. Below that threshold, there is no labelling requirement. In practice, few foodstuffs sold in Italy are labelled as to their GM content. Food industry experts say one problem is how to measure food for its GM content.
Wed, 26 Apr 2000 By Karen Briere, Regina bureau, ReutersAn elk found dead on a Swift Current, Sask., ranch this winter was infected with chronic wasting disease. George Luterbach, animal health program manager at the Canadian Food Inspection Agency in Winnipeg, said the cause of death was confirmed March 10. The remaining 64 elk in the herd have been under quarantine since the death. None is displaying symptoms of the disease, he said.
Chronic wasting disease is a progressive fatal disease of the nervous system of cervids, including elk, mule deer and white-tailed deer. It is a transmissible spongiform encephalopathy, as are scrapie in sheep, bovine spongiform encephalopathy in cattle and Creutzfeldt-Jakob disease in humans.
Luterbach said the animal died at the same ranch where another elk died in 1998. At that time, several others identified as high-risk were destroyed. He said the most recent death was not a relative of the first infected animal, but was a herd mate.
"It does raise a possibility that there had been disease transmission from the particular farm," he said. "There is no known risk to humans, although there are other diseases that are, and from that perspective we are taking a cautious approach."
No animals have been sold from the farm, but animals have been purchased and brought there. "That of course is part of the investigation," Luterbach said.
This brings to three the number of cases found in Saskatchewan elk herds. The first animal died near Sedley in 1996 and the entire herd was destroyed. The animal had been imported from the United States and lived in Canada for seven years. In the 1998 case, the mother of the infected animal had come from the U.S.
Lloyd Spencer, past-president of the Saskatchewan Elk Breeders Association, said elk producers are confident that the inspection agency is properly handling the situation. He said producers are concerned, but noted that three cases out of more than 20,000 elk in the province is an extremely low number.
"Canada probably has a reputation of being the most health conscious and reliable supplier of food in the world," Spencer said. "There is no place where we take more drastic measures to eradicate disease. It will be dealt with appropriately."
Opinion (webmaster): It is a shabby half-measure to merely quarantine a herd with two cases in unrelated animals, given the steps that countries such as France take, because the Canadian data strongly suggest lateral transmission to herdmates. Given the 7-10 year incubation period established by the first affected animal and probable maternal transmission indicated by the second animal, this game farm will likely be affected for years or decades to come, placing wild herds at risk from fenceline contact and fenceline failures over a long time frame. Is it worth the risk? What use will be made of the 64 animals and their descendants in the interim -- surely not sell the antler velvet for human consumption?
A new group called MadCow [Montanans Against the Domestication and Commercialization of Wildlife] has formed in Montana that is concerned about game farms and CWD. Gary R. Holmquist is president. A ballot initiative would stop the growth of the game farm industry and stop captive shooting of big game. The group maintains an excellent collection of articles on the subject.
The group has clarified that he Boone and Crockett Club will not in the future allow game farm animals to be included in the B&C records. Dr. C. Randall Byers, who serves on the Pope and Young Club Board of Directors and the Records Chairman for the Boone and Crockett Club advises that the B&C Club is defintely NOT going to entertain the idea of accepting game farm animals into its records. Not only that but it is likely going to be issuing "cease and desist" letters to various game farms due to their fraudulent advertising of "Boone and Crockett trophies".
And they may be advising the attorney generals and the better business bureaus of the various states where the fraudulent advertising is taking place. The attorney that handles this type of thing for the B&C Club is John Poston from Helena who is one of only three Honorary Life Members of the Boone and Crockett Club. He is part of the firm of Harrison, Loendorf, Poston and Duncan, office phone 406-442-6350 in Helena.
This was is in response from a formal recommendation made by Dale Toweill and Jack Ward Thomas [unsurprisingly the former head of a major USDA agency, the US Forest Service, responsible for a vast amount of wild elk habitat destruction] at the request of B&C President Dan Pedrotti. Thomas and Toweill prepared a white paper in 1998 that recommended that Boone and Crockett create a separate but equal new category for big game trophies taken from fenced enclosures in areas where canned hunts are "in keeping with the mores of the region." The authors specifically spoke of the acceptance of such practices (fenced enclosures, supplemental feeding programs and the management of hunting to improve trophy size and conformation) in Texas. Such "intensive management" is not inconsistent with fair chase principles, they wrote, and there's no reason B&C shouldn't recognize these trophies in a new records category. In response to this draft white paper, Jim Posewitz wrote an eloquent and compelling rebuttal and the disgusting proposal is apparently dead.
Wed, 23 Feb 2000 By Ray Grass Deseret News sports writerThere are, over the course of the annual gathering of lawmakers on the hill, always a few bills better sent to the shredder than committee. Such is the case of HB283, the "Elk Ranching Enclosure Amendment."
In summary, three years ago a small group of landowners asked for and got the right to raise tame elk like cattle. If sportsmen supported it, was the agreement, they would never ask for anything more. Last year, they broke the promise and asked for rights to hold canned hunts, basically the shooting of tame elk in enclosed pens. And it passed. Nothing more? Not quite.
This session, Rep. Bill Wright, R-Elberta, asked lawmakers to "water down" the fencing requirement. Why? Because "four or five landowners" on Promontory Point "may" want to get into elk ranching and maybe elk hunts and want to cut corners on fencing by using water as a natural barrier.
The Utah Division of Wildlife Resources is resolutely opposed, as is the overseer of Utah's game animals, the Utah Department of Agriculture. Even the Utah Elk Breeders Association, supposed beneficiaries of the change, said in a letter to the House that it stands by the DWR and UDA "in opposing the proposed legislation. . . . "
So who wants it? "Four or five" landowners?
The intent of the bill is to get the DWR to recognize, among other things, water from the Great Salt Lake as a natural barrier in place of 8-foot fences. If passed, the bill could weaken the DWR's ability to protect Utah's wildlife, primarily its elk population, and its people from, among other things, chronic wasting disease, a point Wright put off because "we don't know anything about it." We do know it kills elk, it kills people and it is mainly a disease found in elk-ranching operations.
We also know CWD is in the same family of diseases as mad cow disease and that when CWD was found on a ranch in Montana all of the elk were killed and burned out of fear that it might spread. We don't know how it is spread, how to test for it in live animals -- only dead ones -- or how to cure it in either elk or humans. Several people in Utah, in fact, have died from what doctors believe is CWD. The fact that it can't be detected in live animals means it could be carried by tame elk brought onto elk ranches. Which is why the DWR is so adamant about taking all necessary precautions.
Wright says water can be a barrier and that elk won't swim, even though years back, when 17 elk were released on Antelope Island, half the animals headed directly for the water and swam toward land. So, how do you stop wild elk from swimming around natural barriers to reach the fair-haired lasses in the pens? Wright says he has not a clue. "That's why we have the Division (of Wildlife Resources). I make the law, and it's up to them to figure it out."
So, how would the DWR stop love-struck elk from getting together? Mine fields, maybe, where the fence ends and the water begins? Station guards 24 hours a day at taxpayers expense? Shoot intruding elk? How about running fencing along the shoreline, but then, that's already the law. Fencing requirements were agreed to by all parties, with the minor exception of "four or five" landowners in Promontory -- for a reason.
Game biologists said then that putting up elk fencing, a high-quality fence, around the entire property would be the best and safest way of protecting both tame and wild elk. UDA and elk ranchers themselves agreed. Period. End of story. Not quite, it seems. Sportsmen said last year -- when ranchers went back on their word to never ask for hunting rights -- that it would only be a matter of time before lawmakers would start whittling away at the laws to cut expenses and increase profits. Wright's HB283 is a case in point.
Wednesday, March 8, 2000 By Tom Wharton The Salt Lake TribuneUtah deer and elk hunters apparently don't have to worry that the animals they are killing might in turn kill them. A study in Utah, Maine, South Dakota and Oklahoma released Tuesday showed no trace of chronic wasting disease in deer and elk. According to the Utah Department of Agriculture, the tests were conducted in response to concerns that the deaths of three hunters in Utah, Maine and Oklahoma might have been related to infected deer and elk.
All three hunters died of the degenerative nerve disorder known as CreutzfeldtJakob disease (CJD). A variant of CJD is associated with mad-cow disease. Hunters in Utah became concerned two years ago when news reports linked the death of a Kaysville man, afflicted with CJD, and the consumption of game with chronic wasting disease.
The Utah study included 404 Utah deer and 196 elk. All tests for chronic wasting disease were negative. "These test results should lay to rest any notion that the Utah wildlife hunter died from his contact with Utah deer and elk," said State Veterinarian Michael Marshall. "There are few deer and elk in the country that are infected, and there is no connection between chronic wasting disease in wildlife and CreutzfeldtJakob disease in humans."
The two diseases produce similar symptoms in animals and humans but are considered separate diseases. Both are forms of spongiform encephalopathy that produce vacuoles, or holes, in the brain. Testing requires collecting a brain stem from animals at least 2 years old. Biologists from the Utah Division of Wildlife Resources operated checkpoints during hunting season to collect the samples.
Bill Morrill, president of the Nevada-based Mule Deer Foundation-- which is holding its annual meeting next week in Salt Lake City, said the results should be good news for deer hunters. "Hunters have the main interest in mule deer and supply most of the money for management of mule deer," he said. "I would hate to see anything that would hurt hunting and knock a hole in state game agencies' ability to fund management."
Some cases of chronic wasting disease have been found in elk and deer in a nine-county area in southeast Wyoming and northeast Colorado. Marshall said many Utah hunters call his office each year about abnormalities they observe in deer or elk. "Quite a few hunters called last fall that may have had a question about an animal that didn't appear too healthy," he said. "We advised them not to eat those."
Wed, 3 May 2000 Reuters North AmericaAn Australian hospital said on Wednesday it had launched an investigation after nine of its patients were possibly exposed to the human form of mad cow disease while undergoing surgery. The Royal Melbourne Hospital said the nine neurosurgery patients had been operated on with instruments which had been used on a patient thought to have Creutzfeldt-Jakob Disease (CJD), a rare, degenerative brain disease.
Their exposure to the disease comes as Melbourne endures one of Australia's worst outbreaks of Legionnaire's disease, which has been linked to air conditioning in the city's aquarium. A total of 58 cases of Legionnaire's disease have been confirmed after almost 2,000 people were tested. Two elderly women died from the flu-like disease last week.
The CJD scare comes after a patient suffering dementia underwent surgery on April 20 for possible inflammation of brain arteries. The hospital said the patient was later diagnosed as possibly suffering from CJD. Instruments used in that operation were sterilised but were then re-used on the other nine patients between April 20 and 28. [Either this patient had CJD or they didn't. No one would raise such a ruckus over a hypothetical diagnosis. 10 patients and the surgeon were exposed; one patient has subsequently died, leading to confusion over 9 or 10 exposures.-- webmaster]
"Royal Melbourne Hospital deeply regrets that a lapse in our stringent infection control procedures has occurred," said Dr Jenny Bartlett, the hospital's chief medical officer. "We regret any anxiety this has caused to our patients and their relatives. However, the risk to these patients is extremely remote," Bartlett said in a statement.
Bartlett said the instruments had been taken out of circulation and that the nine patients were being monitored for symptoms of CJD, which can incubate for up to 40 years. The symptoms of CJD are similar to those of Alzheimers disease. It has no known cure and is invariably fatal.
Victoria state health minister John Thwaites said he had also ordered an inquiry. "The government and the public cannot tolerate such breaches of infection control," Thwaites told parliament. "The risk of CJD is not eliminated by normal cleaning and sterilisation." Colin Masters, head of Australia's National CJD Registry, said he was unaware of any transmission of the disease under similar circumstances in the past 30 years. [Could he really be unaware of recent Australian study showing a significant risk enhancement for CJD in patients having a history of multiple surgeries? -- webmaster]
The biggest known outbreak of the disease was among a tribe practising cannibalism in the Papua New Guinea Highlands in the 1950s. Scientists in 1996 linked mad cow disease -- bovine spongiform encephalopathy -- to a new variant of CJD. The disease is believed to be caused by an infective protein known as a prion, which can be transmitted by direct inoculation of tissue into the central nervous system of another person.
Wed, May 3, 2000 AP WorldStreamTen people may have been exposed to Creutzfeldt Jakob Disease (CJD) after a lapse in infection control procedures at an Australian hospital, a state health official said Wednesday.
John Thwaites, health minister in southern Victoria state, said equipment used on a patient with dementia who may have had the brain disorder was used on other patients without being properly sterilized. Brain-wasting disease Creutzfeldt Jakob is the human form of so-called "mad cow" disease which is believed to have caused the deaths of 53 people in Britain. No cure is known.
The neurosurgeon who carried out a brain biopsy on the patient at the Royal Melbourne Hospital failed to ensure that the equipment used underwent special sterilization procedures against CJD. "I understand that equipment used on the patient was incorrectly allowed to be reused in a clear breach of an established protocol," Thwaites told state Parliament.
"The protocol ... is for any brain biopsy where there is a risk of CJD, equipment should not be reused until a CJD diagnosis is excluded," he said. The risk to the 10 patients is low, but there is no way to determine whether they have caught CJD, Thwaites said. The hospital would launch an inquiry into the breach, he said.
The Sydney Morning Herald, May 4, 2000.Nine patients and a leading neurosurgeon may have been exposed to the fatal brain condition Creutzfeldt-Jakob disease after a breach of infection protocol at a major hospital.
The patients at the Royal Melbourne Hospital, aged between 30 and 77, and suffering from a variety of serious conditions including brain tumours, all underwent brain surgery between April 20 and 28.
The head of the Department of Pathology at the University of Melbourne and one of Australia's foremost CJD experts, Professor Colin Masters, said he understood that the patients involved would be notified of what had happened, but that their risk of contracting CJD was "infinitesimally low". [No scientific basis exists for a quantitative risk assessment -- webmaster]
The instruments used during their operation had been used during neurosurgery on an elderly patient with dementia on April 20. This patients was later diagnosed with CJD, a rare degenerative disorder of the brain that can take more than 40 years to incubate and is untreatable and fatal within about 12 months of symptoms developing.
If there is any suggestion that a dementia patient has CJD, surgical instruments used are sterilised and quarantined until the diagnosis is confirmed. Dr Jenny Bartlett, the hospital's chief medical officer, said that in this case, the patient's dementia had been diagnosed as due to hydrocephalus and vasculitis and there was no suggestion the patient had CJD. Therefore, routine sterilisation was carried out and the instruments then reused on another 10 patients. One of those patients has since died of an unrelated condition.
The possible presence of CJD was identified when a brain sample taken during the man's operation to confirm his diagnosis of vasculitis unexpectedly showed possibility of CJD.
Professor Andrew Kaye, head of the hospital's surgery department, said if the patient has CJD he would die within six months and the disease could be confirmed conclusively during a post-mortem examination. Professor Kaye said the taking of the sample was a technical breach of infection protocol because CJD had unexpectedly been found later.
He said there was probably nothing that could have been done to avoid this situation unless the hospital treated every patient with dementia as a possible CJD case, but this would involve tremendous expense and was not warranted because the disease was so rare. Professor Kaye said the neurosurgeon performed the original operation was "utterly devastated" and was being counselled and will take time off.
"He is the most caring, compassionate doctor I've worked with and he is beside himself over what has happened," Professor Kaye said. Dr Bartlett said the first indication of CJD came late Friday afternoon when the pathology lab rang to say that the brain sample looked suspicious. The instruments were then taken out of circulation and are now in quarantine for further tests. Dr Bartlett said that by mid-afternoon yesterday, CJD was confirmed to about "80 per cent certainty." [Either it is or it isn't, there is no room for probablistic diagnoses -- webmaster]
Thu, 4 May 2000 AAPVictorian hospitals will be put on notice over infection control following the discovery 10 patients may have contracted a rare and fatal condition similar to mad cow disease. A breakdown in controls at Royal Melbourne Hospital (RMH) might have led to 10 neurosurgical patients being infected with Creutzfeldt-Jacob disease, or CJD, it was revealed yesterday. One of the patients has since died of an unrelated condition.
Health Minister John Thwaites, who described the breakdown as intolerable, said there was no test to determine whether the patients had the disease and that it may take years for them to find out. He said a tougher stand was needed and the state's six health care network chiefs would be called in and "put on notice about the seriousness with which the government considers infection control". "The seriousness of infection control appears not to be getting through to some quarters," Mr Thwaites told parliament. CJD is a degenerative disease which occurs in one in a million people and is fatal. It has an incubation period of between five and 30 years.
RMH said the 10 patients may have contracted CJD after potentially infected instruments were reused in operations at the hospital between April 20 and 28. The alarm was raised after a brain biopsy taken from a dementia patient on April 20 showed an at least 80 per cent chance the man in his 60s had the disease. However, the test results would not be conclusive for another six months. [This is too long for immunochemistry, too short for bioassay. -- webmaster]
All the equipment used in the operation had been sterilised but this did not eliminate the risk of CJD, the hospital said. RMH chief medical officer Jenny Bartlett said the risk to the patients, aged between 30 and 77 and including at least two from country Victoria, was "theoretical and infinitesimally small".
She said it was hoped all patients and their families would be contacted by today. The surgeon involved was distressed and had taken a couple of days off. The hospital has ordered an inquiry into its sterilisation procedures and the case has been referred to the Medical Practitioners' Board to investigate whether there was any professional misconduct. An independent external inquiry would also be conducted into the hospital's risk management procedures.
Friday 5 May 2000 The AGE By TANIA EWINGA biopsy taken from a Royal Melbourne Hospital patient now suspected of having Creutzfeldt-Jakob disease was left untested for almost a week because of this year's unusually long Easter break. Normally a biopsy is ready for analysis within 48 hours. However, because the man's operation took place on April 20 - the day before Good Friday - the initial analysis was not performed until six days later.
Ten patients were operated on using the same equipment before the biopsy results were known and pathologists could raise the alarm. Senior pathologists who spoke to The Age attributed the delay to the timing of the long Easter break. They said it could have occurred at any other Melbourne hospital that relies on on-call pathologists after hours. According to a pathologist at another hospital, who declined to be named, on-call pathologists are generally brought in only for urgent cases such as unconfirmed malignancies and organ transplants.
While the Royal Melbourne Hospital patient had dementia, one of the symptoms of CJD, the surgeon did not suspect the disease. The diagnosis was only made after cellular changes typical of the disease were discovered in the biopsy tissue. According to the hospital, most of the operations using the same equipment took place during the Easter-Anzac Day break.
One patient has since died of unrelated causes. The others face an uncertain future, not knowing whether they have contracted the deadly infectious disease. But Professor Colin Masters, director of the National CJD Directory, said that the risk of other patients contracting the disease from the equipment was very small, "as little as one chance in half a million". [This man has apparently been out in the sun too long. -- webmaster]
CJD is a rare degenerative condition of the brain. It can take up to 40 years before symptoms appear, with death usually following within twelve months. The disease is difficult to diagnose and a definitive diagnosis cannot be done until after death at autopsy.
Once initial concerns were raised about the Royal Melbourne Hospital patient's biopsy, further testing was performed on the tissue. The patient is now considered to have an 80 per cent chance of having CJD.
Medical negligence lawyers said yesterday that patients may find it difficult to pursue legal claims against the hospital or the neurosurgeon who operated on the man suspected of having CJD. To succeed in an action for negligence or breach of contract, the patients would need to show the hospital or its staff knew or ought to have known that the man could be suffering from CJD.
Slater Gordon senior partner Peter Gordon said that if a legal claim was made, the hospital would need to show that it had taken all the appropriate steps to determine what was wrong with the patient.
In other developments, the Australian Medical Association yesterday accused Health Minister John Thwaites of overreacting by referring the Royal Melbourne Hospital case to the Medical Practitioners Board. AMA Victorian president Michael Sedgeley said that naming the neurosurgical unit at the hospital was tantamount to naming the surgeon involved "because the unit is small and the neurosurgical community in Melbourne is also small".
Dr Sedgeley said matters referred to the board normally involved cases of professional misconduct and that there was "not a remote chance of misconduct in this instance, it is more a case of standards and safety needing to be investigated". A spokeswoman for Mr Thwaites said that the case was referred to the board because the patients involved, their families and the public had a right to know what had happened. Had the facts been hidden, "they would have rightly been outraged".
Royal Melbourne Hospital infection control procedures were breached during an operation late last year, in a separate incident to the CJD case. A meeting of the hospital's infection control working group in December was told the infection control committee "had been notified of a breach of aspesis in an operative procedure". Aspesis is an environment free from harmful bacteria or viruses.
Minutes of the meeting say: "Possible contributing factors were discussed." A report on the incident was expected following further discussions. The minutes and other hospital documents were obtained by The Age under freedom of information legislation.
Sat, 29 Apr 2000 AP, Orange County Register Liz Kowalczyk and Susan Kelleher Related discussionOpinion (webmaster): It is a matter of serious concern to see body parts from a single individual, never tested for communicable diseases such as CJD, transplanted into as many as 422 other individuals. Tissues banks need to decide whether they are charities or mercenaries -- they cannot go on stealing body parts for resale if their very existence depends on public trust and good will.
Donated human remains are processed into medical products that generate hundreds of millions of dollars for U.S. companies despite laws barring profit from body parts, The Orange County Register reported Sunday. Although grieving families are told that the donations are a gift of life, the newspaper found that material harvested from the dead fuels an industry that is expected to have $1 billion in revenues by 2003.
``I thought I was donating to a nonprofit. I didn't know I was lining someone's pocket,'' said Sandra Shadwick, whose brother's remains were given to a Los Angeles tissue bank. ``It makes me angry. It makes me appalled. If it's not illegal, it ought to be.'' The National Organ Transplant Act of 1984 banned profits from the sale of tissue, but companies and nonprofit tissue banks are allowed to charge reasonable fees to handle and process the parts. The law does not define a reasonable charge.
``The law has never been tested in court. Nobody has ever decided what is selling and what isn't,'' said Jeanne Mowe, executive director of the American Association of Tissue Banks. Nonprofit tissue banks may obtain body parts useful for up to 100 patients from a single cadaver. The parts are then sold to companies that make products used by doctors and dentists, and the banks and businesses share revenues.
Survivors urged to donate usually are told about vital organs, such as hearts or kidneys, but most of the products derived from the dead are far from lifesaving: Cadaver skin may be used to puff up the lips of models, enlarge penises or smooth out wrinkles, the newspaper said.
A single body can provide material that is worth up to $34,000 for nonprofit tissue banks, including skin, tendons, heart valves, veins and corneas that are then made available to doctors and hospitals for up to $110,000. With bone taken from the same body, a cadaver can be worth $220,000.
``People who donate have no idea tissue is being processed into products that per gram or per ounce are in the price range of diamonds,'' said Arthur Caplan, a professor at the University of Pennsylvania's Center for Bioethics.
Lives are enhanced by donations: Tendons help athletes, cadaver skin helps solve bladder problems and corneas help the blind to see, said Michael Jeffries, chief financial officer for Osteotech Inc. (NasdaqNM:OSTE - news), a leader in the bone business.
``There is a profit,'' he said. ``It's not an evil thing because the profit is put to good use.'' The two largest for-profit tissue companies had $142.3 million in sales last year and each pays its chief executive more than $460,000 annually, the newspaper said. The four largest nonprofit tissue banks will make $261 million in sales this year, it said.
The number of organ and tissue donors increased 172 percent nationwide over the past five years, according to the American Association of Tissue Banks. Last fall, Vice President Al Gore (news - web sites) announced $5 million in grants to organ and tissue agencies. ``I did not know that the amount of money involved was as large as you have pointed out,'' Gore told the Register in a recent telephone interview.
By Mark Katches, William Heisel, And Ronald Campbell The Orange County Register 4-17-00American businesses make hundreds of millions of dollars selling products crafted from donated human bodies, even though it is illegal to profit from cadaver parts, an Orange County Register investigation found.
Cadaver skin puffs up the lips of fashion models at $1,050 a shot. Dentists use ground bone about 200,000 times a year to treat their patients. Glossy catalogs advertise 650 products made from body parts. A single dead body yields raw materials worth tens of thousands of dollars to businesses whose stock is traded on Wall Street and to nonprofit agencies that obtain the parts for them, records and interviews show.
Nowhere in the country are grieving families told that their gifts fuel a fast-growing industry predicted to hit $1 billion within three years. Neither are the millions of Californians who put a pink dot on their driver's licenses indicating their willingness to donate body parts. ...
But trade in body parts has sparked questions from donor families and medical ethicists about ties between companies that sell body parts and nonprofit organizations that solicit them. The tissue banks act as middlemen for their corporate partners.
Families are led to believe they are giving the gift of life. They are not told that skin goes to enlarge penises or smooth out wrinkles, or that executives of tissue banks nonprofit groups that obtain body parts routinely earn six-figure salaries. The products are rarely life-saving as advertised.
"I thought I was donating to a nonprofit. I didn't know I was lining someone's pocket," said Sandra Shadwick of Burbank, whose brother died two years ago. Shadwick gave her brother's remains to a Los Angeles tissue bank. "It makes me angry. It makes me appalled. If it's not illegal, it ought to be. It's certainly immoral."
Industry leaders say donations would plummet if families knew their gifts generate profits. One consequence would be a potential drop in the supply of vital organs. "If donors were told at the time about profits, they wouldn't donate," said Jan Pierce, director of the Intermountain Tissue Center, a Salt Lake City nonprofit bank.
The Register began its investigation last November after allegations that the head of the Willed Body Program at the University of California, Irvine, profited from the sale of donated body parts. After interviewing hundreds of people and reviewing thousands of pages of documents, the newspaper found that donated bodies follow one of two paths. They become either research subjects or raw materials for medical products that are sold commercially for profit. It is more likely that body parts will be made into products.
Nonprofit tissue banks from Santa Ana to New Jersey screen possible donors and remove body parts. Up to 20 bones and tendons are harvested along with 4 square feet of skin and the whole heart. In some cases, eyes, veins, jawbones, ribs and the spine are taken. Bone is replaced with common PVC pipe to keep the body's shape for open-casket funerals. The tissue banks then sell the body parts to companies that make products used by doctors and dentists. The tissue banks and companies share revenue.
A typical donor produces $14,000 to $34,000 in sales for the nonprofits, records and interviews show. But yields can be far greater. Skin, tendons, heart valves, veins and corneas are listed at about $110,000. Add bone from the same body, and one cadaver can be worth about $220,000.
The National Organ Transplant Act, approved by Congress in 1984, banned profits from the sale of tissue. But no company or tissue bank has been prosecuted. "The law has never been tested in court. Nobody has ever decided what is selling and what isn't," said Jeanne Mowe, executive director of the American Association of Tissue Banks.
Companies and tissue banks step around the law by charging marked-up fees to handle and process the body parts. They avoid billing for the tissue itself. The law allows for reasonable fees to cover processing costs without defining reasonable.
Tissue banks also avoid using the word "sales." But Judy Perkins, executive director of the University of California, San Diego, Regional Tissue Bank, calls fees a euphemism for sales. The zeal to harvest tissue is underscored by the case of Heather Ramirez, a 19-year-old Arizona woman who died in an automobile crash.
Her parents accused the American Red Cross of stealing their daughter's bones, court records show. The family agreed to donate body parts, but expressly refused to give up the bones. The Red Cross admitted in court records to altering documents making it appear as if consent has been given. The bones were returned after a two-year legal fight.
"Instead of having some closure after her death, it just became an unending saga," said the father, Greg Ramirez. "It was like she was dying over and over again." The Red Cross, which has its West Coast tissue center in Costa Mesa, chalks up the mistakes to human error. "We are certainly deeply saddened by this," said Red Cross spokesman Mike Fulwider.
Osteotech's trademark bone putty, used in spinal surgery, sells for $853 for 2 teaspoons about $100 more than in 1996. Industry officials say higher processing costs have led to steeper prices. Costs can vary by hundreds or thousands of dollars. An Achilles tendon at a Seattle bank sells for $865. Georgia's CryoLife Inc., a for-profit firm, charges $2,000 for the same product.
"I know hospitals that shop for bone like you would a can of beans," said Perkins of the San Diego tissue bank. The revenue helps nonprofit banks cover perks and salaries normally associated with private business. A Register analysis of 50 of America's largest nonprofit tissue banks shows top executives earning an average of $135,000 a year. One Los Angeles bank paid its top official $533,450 in 1998 and provides him a BMW, records show.
The biggest deal in the industry was struck 13 years ago. Osteotech opened its doors in New Jersey without access to bodies. So the company spent $10 million to start a nonprofit tissue bank serving as its exclusive broker of human bones. The publicly traded company is now the nation's largest producer of bone products. As for the tissue bank? The Musculoskeletal Transplant Foundation is the world's largest. The bank's chief executive, Bruce Stroever, predicts the industry will double, to $1 billion, by 2003.
"Osteotech couldn't go it alone and had to invent us," said Stroever, who earns $350,000 a year running the nonprofit. "Neither one of us would be here without the other."
In Florida, the opposite model occurred. The nonprofit University of Florida Tissue Bank spun off a private firm, Regeneration Technologies Inc., in 1998. The nonprofit's top executive, Nancy Holland, doubles as the private company's vice president. She keeps both business cards on hand. The tissue bank and private firm share office space and phone lines. The nonprofit tissue bank sends bone to the for-profit firm.
"It's a matter of subterfuge if you're hiding behind a nonprofit," said ethicist and law professor Lori Andrews of the Chicago-Kent College of Law. Holland said telling potential donors about profits and ties to companies would complicate the consent process.
"We're already talking with someone who is in a state of grief, and we just thought it was too much information to impose on them at that time," Holland said.
Five months after the Register began asking questions, Tissue Banks International, a large Maryland chain, said that it plans to start telling prospective donors of for-profit links, but only in Southern California.
Although some industry financial figures are made public in dense reports filed with the Internal Revenue Service and Securities and Exchange Commission, key details are not revealed. The American Red Cross won't say how much it pays Irvine-based Edwards Lifesciences Corp. to market heart valves that the Red Cross recovers. "Those things are considered proprietary," said Red Cross spokeswoman Blythe Kubina.
Beverly Hills physician Steven Burres founded Fascia Biosystems and sells trademark cadaver thigh tissue to cosmetic surgeons. He refuses to name his tissue-bank suppliers. "If I was building antique chairs, you wouldn't care what lumberyard I got my wood from," he said.
Tissue banks contend most donor families do not want details. Steve Oelrich, sheriff of Alachua County, Fla., agrees. He donated tissue from his teen-age son, who died in 1995. "There are two things I don't want to know about this thing. One is the financial part, that they sell this and the hospital buys that. And I don't want to visualize what they do to your child," Oelrich said.
Tissue banks mine parts for 50 to 100 patients from a single cadaver. After John Tabachka died in 1998, doctors implanted parts from the Pittsburgh-area volunteer firefighter into 422 patients. "If he couldn't help you in life, he'd help you in death," Tabachka's widow, Sally, said. The products can make a big difference to recipients.
When Jim Muth, 47, blew out his knee, the Yorba Linda man paid $7,500 to get tendons from a 19-year-old cadaver. "They sell these things like nuts and bolts now," Muth said. "They're just another part of the tool box." A year later, Muth is swimming, biking, walking and hopes to be running soon.
Strict federal laws ban any buying or selling of hearts, lungs, livers or other organs needed for transplant. But the government has helped boost profits in the tissue trade. The Clinton administration adopted rules in 1998 requiring hospitals to notify organ agencies of all deaths. That makes it more likely that families will hear from a tissue bank within four hours of a loved one's death. The rules are designed to increase the number of organ transplants.
But organ donors rose by less than 1 percent in 1999, according to the Association of Organ Procurement Organizations. The big beneficiaries are tissue banks and companies that showed gains in donors of as much as 40 percent, records and interviews show.
The reason for the disparity: Organs can only be harvested from donors who are brain dead but whose heart and other organs are still functioning. Once the heart stops, organ donation is ruled out. Tissue still can be recovered....
In Orange County, Chief Deputy Coroner Jacque Berndt explained why she doesn't charge the Orange County Eye and Tissue Bank to use the county morgue. "They're a nonprofit, and their funds are limited in that sense," said Berndt, before learning the bank is part of a chain paying its chief executive $283,882 a year.
Berndt also was unaware of the Santa Ana bank's corporate ties. The bank's Executive Director Larry Hierholzer said he ships skin to New Jersey-based LifeCell Corp. and heart valves to Georgia-based CryoLife. Both companies are publicly traded and have developed trademark products. Berndt isn't the only coroner unaware of the business ties.
"I didn't even imagine this was such a high-paying business," said Sgt. Sharon Housouer, Imperial County's chief deputy coroner, who was approached by another tissue bank last year requesting access to her morgue. "It shocks me, but it really doesn't surprise me. I'm a cop. Nothing surprises me anymore."
Sat, 29 Apr 2000 Transfusion-associated transmissionof babesiosis in New York State. Transfusion 2000 Mar;40(3):285-9 Linden JV, Wong SJ, Chu FK, Schmidt GB, Bianco CBabesiosis can be life-threatening in immunocompromised individuals. Although the disease is usually transmitted by tick bite, more than 20 cases have been reported of infection transmitted by transfusion of blood or blood components obtained from apparently healthy donors from endemic areas in the United States. This report describes several recent cases of transfusion-transmitted babesiosis in New York State.
Transfusion-associated incidents of babesiosis infection were identified and investigated. Seroprevalence of babesiosis in healthy blood donors in a highly endemic area was ascertained.
In three incidents, babesiosis was diagnosed in five of eight patients given infected blood: two premature infants, an elderly patient with gastrointestinal bleeding, and two patients with thalassemia. Seroprevalence in blood donors on Shelter Island (Suffolk County, eastern Long Island), a highly endemic area, was 4.3 percent in May 1998.
Infected donors lived in endemic areas and were asymptomatic with no history of tick bite. Blood collected in January 1997 from one donor was infectious. Those transfusion recipients who were infected were neonatal, elderly, or chronically transfused patients. Babesiosis should be included in the differential diagnosis of febrile illness in immunocompromised recipients of blood transfusion, particularly in the Northeastern United States.
Opinion (webmaster): This problem was actually recognized by 1989 but nothing was done. It illustrates that CJD is but one of a number of diseases that cannot be effectively screened out of the blood supply at this time.
"......Asymptomatic infections occur frequently in young adults and represent a special risk through blood donations....." The New York State Journal of Medicine, June 1989 by Mahfouz H. Zaki, MD, DrPH. In the article he states "Infection with Babesia microti may lead to many outcomes ranging from the asymptomatic infection to severe, even fatal disease, with fever, chills, and hemolytic anemia. Asymptomatic infections occur frequently in young adults and represent a special risk through blood donations....
Following an incubation period of one week to several months after a tick bite, the patient experiences malaise, headache, fatigue, fever, sweats, chills, myalgia, and, in some patients, nausea and vomiting. The fever is irregular and does not follow the classical periodicity characteristic of malaria..."
Tue, 2 May 2000 Deutsche Press-AgenturThe European Union's executive Commission on Tuesday formally adopted tougher controls to fight bovine spongiform encephalopathy (BSE), known as "mad cow" disease, in a bid to seek more information on incidence of the sickness among cattle stocks in the EU. The commission introduced a monitoring program based on rapid post mortem tests which officials said would go into effect on January 1, 2001.
Annual monitoring programs will be carried out on a targeted sample of animals which are believed to be most at risk from the disease. These include cattle which die on farms, sick animals slaughtered as emergencies and animals displaying behavioural or neurological signs.
The commission estimates that there are are about 41 million cattle aged over two years in Europe, of which an estimated 1 percent are at risk. The agency wants governments to carry out about 65,000 BSE tests. The testing program will be evaluated after six months to see if any further adjustments are needed.
Fears of mad cow disease forced EU governments to ban imports of British beef for a three-year period which ended last August. However, France continues to resist demands that it should lift its embargo on imports of British beef.
Tue, May 2, 2000 By Geoff Meade, European editor, PA News in BrusselsNew measures to step up the monitoring of mad cow disease were adopted by the European Commission today. The latest testing programme has been hailed by the UK government as a boost to consumer confidence in beef throughout the EU, and therefore a fillip for British exports.
Unofficially the increased surveillance is also seen as a challenge to those governments which are still pinning the blame exclusively on Britain for triggering the BSE crisis four years ago.
The programme will be launched at the start of next year, and involves three specific post mortem tests on cattle. The targeted animals will be those which die on farms, sick animals slaughtered as emergencies and those which displayed particular behavioural or neurological signs.
A total of 65,000 such tests are expected to be conducted every year, and the Commission said today they would provide "a more accurate picture of the incidence of BSE in the EU and of the patterns of infectivity in the animal population". Member states will be required to carry out annual monitoring programmes on about 10% of carcases. A British government spokesman said the proposals would mean no change in food safety monitoring in the UK, where such tests are already carried out. But he added: "We do welcome this, as a measure which should help boost consumer confidence throughout Europe."
The EU's food safety commissioner, David Bryn, said he will review the effectiveness of the scheme after six months. UK farmers are still struggling to restore continental beef export markets following last August's EU agreement to lift the three-year-old British beef ban.
Germany recently voted to lift the measure, while France is still insisting that British beef poses a health risk. The French government is now embroiled in legal proceedings brought by the European Commission.
April 19, 2000 By RONALD CAMPBELL The Orange County RegisterA tissue implant in 1992 helped cure Karen Bissell of numbness in her hands and legs. Six years later, it probably killed her. Bissell, 39, died Sept. 21, 1998, of Creutzfeldt-Jakob Disease, or CJD, a rare neurological condition. Scientists believe she was one of about 110 people worldwide who acquired the disease since 1987 from contaminated tissue transplants.
After Bissell's death, the company that provided the tissue launched a voluntary recall, while maintaining there was no conclusive proof the implant killed her.
The disease erupted in June 1998. In her last days, Bissell did not even know that she was being moved from a Denver hospital to a hospice. "The doctor told me she did not know what was happening, and she was not in any pain," said her mother, Eleanor Bissell. "I'm thankful for that." A friend memorialized her as "an angel to everyone she touched when she walked on Earth and now an angel to all as she resides in heaven."
Bissell will get a much-longer epitaph in the medical and legal literature. The scientists who investigated her death are preparing an article for a medical journal — at least the fourth such article tying CJD to transplants of dura mater, the outer lining of the brain. Because of the growing medical evidence, the U.S. Food and Drug Administration issued guidelines last October to prevent the spread of CJD through dura mater transplants.
CJD is a rare disease, striking one person in a million. Most victims are 55 or older. When CJD strikes a younger person, "we try to see if we can find some kind of exposure," said Colorado State Epidemiologist Richard Hoffman, who investigated Bissell's death. "In this case, there was a fairly glaring possibility as to where the person acquired it." Hoffman discussed Bissell's case in general terms, without naming her. The Orange County Register independently verified her identity.
In 1992, Eleanor Bissell recalled, her daughter complained of numbness in her hands as well as numbness and a tingling sensation in her legs. A physician diagnosed Arnold-Chiari malformation, an obstruction of nerves entering her brain. He operated to relieve the obstruction and used a package of dura mater from a German processor to patch the dura he had cut. The surgery bought Bissell six years of good health.
She was the youngest of four daughters. Never married, she remained close to her parents, often sharing their house in a Denver suburb. After 15 years of working at Lowry Air Force Base, however, Bissell decided in the fall of 1997 that she wanted a change. She got a job with the U.S. Department of Agriculture in Miami.
In June 1998, home for vacation, Bissell complained of blurry vision and headaches. The next month, the symptoms worsened, and she began a long round of visits to doctors, in search of answers. Finally, on Aug. 26, she flew to Denver.
"First she was using a cane when she got home," her mother recalled. "Then she was using a walker. Then she was using a wheelchair." From cane to walker to wheelchair was a journey of 10 days. "Day by day, she just went down, down," Eleanor Bissell said. "Each day it got a little bit worse."
The doctors in Miami had not been able to figure out what was happening. The Denver doctors while conducting a test saw brain cells literally being destroyed as they watched, and made their diagnosis.
While Bissell lay dying, Hoffman and investigators for the Centers for Disease Control and Prevention and the FDA scoured her medical records. They learned of the 1992 dura mater transplant, traced it to the German manufacturer and to a donor who, Hoffman said, died of a neurological illness. An autopsy had been done, but not a microscopic examination of the brain, which might have revealed CJD.
"I don't think we can conclusively say that the donor did or did not have (CJD)," Hoffman said. But he believes the transplant was "the most likely source of exposure."
The investigation of Bissell's death prompted the American parent of the German dura mater processor, New Jersey-based Tutogen Medical Inc., in mid-1999 to voluntarily recall all dura mater processed in Germany before 1994. Little was returned. In addition, Germany imposed new requirements for dura processing that the company said cost it $350,000 in revenue and $210,000 in profit.
Manfred Kreuger, Tutogen's chief executive, expressed "our deepest sympathy to the woman's family." But, he added, "to suggest that the dura mater was the cause of her condition is, frankly, unfounded." Tutogen was denied access to Bissell's medical records, Kreuger said. But a review of the donor's records showed that while "he certainly had some neurology abnormalities" and depression, he died from heart disease.
He said he believes Tutogen's dura mater "is a very safe product." Tutogen recalled its dura anyway, the company said in a May 1999 report to the Securities and Exchange Commission, because it "cannot rule out with absolute certainty" that its dura killed Bissell.