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Mad cow 'risk to 80,000 pregnant women'
Colorado CJD tragedy and CWD concerns
US, Canada researchers pool efforts on live scrapie test
EU ban to stay, briefly, on British beef
EU thinking compared to Alice in Wonderland
EU scientists cautious about CJD risks from blood
British Cattle Movement Service (BCMS) opened
'FDA believes BSE is a concern in FDA-regulated products administered to humans.'
MAFF chief can't recall bungling and cover-up of BSE crisis
Surgical instruments could pass CJD between patients
BSE probe reveals gaps in Dutch livestock register

EU ban to stay on British beef

Wed, Nov 4, 1998    By Geoff Meade, European Editor, PA News
Comment (webmaster):

This is so bizarre. Systematic testing of cattle is now technically feasible and very affordable, yet it is not being done. Why doesn't the EU wait a couple of months until some data comes in from random screening, or have approval contingent on some independent screening? Making a billion dollar decision ahead of a hundred thousand dollar piece of data is not veterinary science or risk assessment, it is econo-political rubbish. This is supposed to be a committee of veterinarians!

If BSE has become established in England the way scrapie has become established, all the measures taken so far may not mean a great deal. How many pre-clinical cows are still in the pipeline? The EU needs to find out -- but not by seeing how many of its citizens get nvCJD from eating UK imports.

A fresh bid to lift the world-wide ban on Britain's beef exports narrowly failed in Brussels today. EU veterinary experts failed to muster the necessary majority to approve an EU Commission plan to end the 30-month-old trade blockade. But it is now almost certain that a deal will be done when the matter is passed to EU agricultural ministers meeting on November 23. Under complex EU voting procedures, today's vote of the vets was deemed insufficient - although eight of the experts were in favour of lifting the ban with only five against and two abstentions.

For the ban to end immediately a bigger "qualified majority" of the vets was needed. But when the issue is voted on by the farm ministers later this month an end to the ban will be approved on the basis of today's vote. This is because at ministerial level eight members states will be required to actively oppose lifting the ban. The vote of the vets signals that such a scale of opposition is not in prospects.

EU Commission officials refuse to reveal how the 15 veterinary experts - one from each member state - had voted today, although it is known that Germany was one of the five opposing an end to the ban. Britain's Agriculture Minister Nick Brown has been voicing hopes that an agreement can be reached to end the ban before the end of the year. Now it seems certain he will get his wish. If, as expected, the farm ministers approve an end to the ban it will mean the resumption of all British beef exports from England, Scotland and Wales and an inevitable fight to restore lucrative exports markets which have been lost since the trade was banned by the Commission in response to consumer fears over the British outbreak of mad cow disease.

Alice in Wonderland
Chap vii Mad Tea Party

`Have some BSE-free beef,' the March Hare said in an encouraging tone.

Alice looked all round the table, but there was nothing on it but scrapie-infected lamb. `I don't see any BSE-free beef,' she remarked.

`There isn't any that has passed screening' said the March Hare. "But there are models that say infectivity might be getting better."

`Then it wasn't very civil of you to offer it,' said Alice angrily.

`It wasn't very civil of you to approve imports without testing,' said the March Hare.

`I didn't know the Prionics test was available,' said Alice; `it's able to test a great many more than three quite cheaply.'

`Your Veterinary Committee needs its head examined,' said the Hatter. He had been looking at Alice for some time with great curiosity, and this was his first speech.

`You should learn not to make personnel recommentations,' Alice said with some severity; `it's very rude.'

The Hatter opened his eyes very wide on hearing this; but all he said was, `Why is a TSE epidemic like an AIDS outbreak?'

`Come, we shall have some fun now!' thought Alice. `I'm glad they've begun asking riddles.--I believe I can guess that,' she added aloud.

`Do you mean that you think you can find out the answer to it?' said the March Hare.

`Exactly so,' said Alice.

`Then you should say what you mean,' the March Hare went on.

`I do,' Alice hastily replied; `at least--at least I mean what I say--that's the same thing, you know.'

`Not the same thing a bit!' said the Hatter. `You might just as well say that "I save to eat beef " is the same thing as "Beef is safe to eat"!'

`You might just as well say,' added the March Hare, `that "absence of evidence" is the same thing as "evidence of absence"!'

`You might just as well say,' added the transgenic Dormouse, who seemed to be talking in his sleep, `that "a preclinical cow is not symptomatic" is the same thing as "an asymptomatic cow is not preclinical"!'

British government officials will be using the next few weeks to muster support among wavering member states in a bid to win the largest possible support to remove the ban. The block on beef exports to Northern Ireland was lifted last March, thanks to the province's sophisticated computerised monitoring system which convinced Brussels that the spread of BSE has been contained there. The export ban on older beef remains in place in England, Wales and Scotland.

However, the proposal which now goes to the vote on November 23 will allow the resumption of exports of beef and beef products from animals born after August 1 1996 - the date when the original ban on feeding meat and bonemeal to livestock first came into effect. As virtually all beef for exports comes from young animals born since that date, the Commission's proposals, when approved by the agriculture ministers, will effectively mean the end of the devastating global embargo on British beef which was imposed on March 27 1996.

The countries which voted against lifting the ban were Germany, France, Spain, Italy and Austria. Luxembourg and Holland abstained. But the veterinary experts from Britain, Ireland, Greece, Portugal, Sweden, Finland, Belgium and Denmark supported a return to normal beef export trade. That voting breakdown is likely to be reflected in the separate vote of EU farm ministers - giving Britain the necessary support to end the ban.

A British government spokesman commented: "This is an encouraging result today. If it is repeated when the agricultural ministers meet this will lead to a lifting of the ban." But Britain's beef export trade will not resume overnight. The government must first complete a voluntary cull now in progress of the offspring of cattle which have been infected by BSE. This is an addition to the early slaughter of millions of cattle as part of the government's battle to convince the rest of Europe that enough was being done to curb the spread of mad cow disease.

Once the latest cull is complete - involving an estimated 6,000 offspring - Commission experts will revisit British abattoirs to satisfy themselves that conditions are being fulfilled for the safe resumption of UK beef exports. Today in Brussels officials were predicting a return to normal trade conditions for the British beef sector "sometime in 1999".

Liberal Democrat agriculture spokesman Charles Kennedy said: "I welcome this decisive development which should now pave the way for the full lifting of the ban at the earliest opportunity. "These proposals will now go to the Council of Ministers later in the month for approval. If accepted, the export ban could be lifted in the near future allowing the rest of the world to eat our world class British beef."

Farmers' leaders welcomed today's vote as a further step along the road to finally lifting the ban. The National Farmers' Union said the decision in Brussels would help inject confidence into the farming community. NFU president Ben Gill said: "Today's decision is great news which puts us on track for the lifting of the beef ban before Christmas. "British cattle farmers have worked extremely hard to reach this important stage. We have done over and above what has been required of us by Europe."

Shadow Agriculture Minister Tim Yeo said: "The vote today will be another disappointment to British farmers. "They know that Labour has had 18 months to try and get the beef export ban lifted and has so far failed." He added that policies introduced by Labour, like banning beef on the bone, had made a total lifting of the export ban further away rather than closer. He said: "British farmers have done all they have been asked to do to get the ban lifted. It is time Nick Brown fulfilled his side of the bargain by ensuring an agreement that total beef exports can resume at the next European Agriculture Council meeting."

The Agriculture Minister welcomed today's efforts to lift the export ban on British beef. "This is good news for Britain's farmers and for the country as a whole. It shows that we are proving our case on the science, and that the EU procedures we have followed since the Florence Agreement are working for the UK," he said. Mr Brown added that there was still work to be done and that he hopes it will be settled later this month when it goes to the Council of Agriculture Ministers.

He said: "The Government has worked incredibly hard over the last 18 months to get to this position. "I am taking nothing for granted and will continue to explain Britain's case based on our guiding principles of protecting public health and following the science. "We have done everything asked of us and more besides, and our efforts to make British beef among the safest in the world are now being recognised," he added.

EU vets signal end in sight for British beef ban

Reuters World Report Wed, Nov 4, 1998
BRUSSELS - A majority of European Union veterinary officials on Wednesday backed the easing of a ban on British beef exports, signalling the end of a crippling embargo imposed over mad cow disease, EU officials said. But the majority vote by the panel of national veterinary experts was not enough to lift the embargo immediately and shipments are unlikely to resume before early next year.

EU officials said eight member states supported the European Commission's proposal to resume exports of mainland British beef, banned in March 1996, but France, Germany, Spain, Italy and Austria voted against the plan, with Luxembourg and the Netherlands abstaining. Under EU rules, the vote by the Standing Veterinary Committee fell short of the necessary qualified majority of members needed to allow the proposal to come into effect immediately.

It will now be passed to EU farm ministers to decide. If, as is seen likely, ministers duplicate the vote by their veterinary officials, the ban can be lifted. Only by a majority of ministers voting against will the proposal be killed off. "One would expect the vote to be at least the same, and there is always the chance of it improving," Commission spokesman Gerry Kiely said. "If there is not eight votes against, then the Commission can act on the proposal."

Under the plan, known as the Date-Based Export Scheme, meat from cattle aged between six and 30 months and born after August 1, 1996 will be eligible for export. EU officials said a favourable decision by ministers would then be followed by an inspection visit to Britain by EU health officials before a final date to resume exports could be set. This might be early next year, they added.

The vote was welcomed by British officials in Brussels as a sign the end was in sight for the ban, which has been blamed for widespread devastation in the beef industry. "This is an encouraging result, and if it is repeated (in the farm council) it will open the way for exports," a British government spokeswoman told Reuters.

Selected beef exports from Northern Ireland were approved earlier this year under a separate scheme which used a computerised database to ensure exportable meat was BSE-free. The EU imposed the global block on beef exports after the UK government admitted a possible link between mad cow disease, or BSE (bovine spongiform encephalopathy), and a new form of the human brain wasting disorder Creutzfeldt-Jakob Disease (nvCJD).

EU scientists cautious about CJD risks from blood

 Reuters North America Thu, Nov 5, 1998
BRUSSELS - European Union scientists have concluded there is no proof that the brain wasting disorder Creutzfeldt-Jakob disease (CJD) can be transmitted via the blood, according to a report released on Thursday. It was impossible to draw conclusions about the risks of transmission of a new variant of CJD (nvCJD) -- believed to be caused by eating meat from cows infected with BSE (bovine spongiform encephalopathy) or mad cow disease -- because too little was known about the disorder, the EU's Scientific Committee on Medicinal Products and Medical Devices said.

With the data available it appears there is no proof that the classic form of CJD can be transmitted via the blood, an official at the EU's executive Commission told Reuters. "But we can't rule out finding proof in the future," the official added. The 16-member committee, which advises the commission, recommended as a precautionary measure that the 15-nation EU continue to bar individuals with CJD or nvCJD, or at risk of contracting either disorder, from donating blood. The scientists also endorsed the bloc's policy of recalling plasma derivatives manufactured from the blood of donors who subsequently developed CJD or nvCJD. In its report, posted on the Internet, the committee said CJD could be transmitted between humans by certain human tissues or products derived from them -- cornea, dura mater, growth hormone and gonadotropin prepared from human pituitary glands. The disorder, believed to be caused by a mis-shaped brain protein known as a prion, could also be transmitted by silver electrodes and neurosurgical instruments, the committee said.

But, it said, there was "no evidence" that CJD could be transmitted via "other human organs, tissues or cells (including blood, blood components or manufactured plasma derivatives)." The scientists recommended that prospective blood, tissue or organ donors be systematically screened for CJD, nvCJD or other transmissible spongiform encephalopathies (TSEs), as soon as a validated test was available.

But they cautioned against stopping blood donations from people who had themselves received blood transfusions in the past, as France has done in a bid to prevent the spread of CJD and nvCJD. Such a measure could lead to the exclusion of between five and 10 percent of donors and the implications should therefore be studied "thoroughly" before action was taken, they said.

British Cattle Movement Service (BCMS) opened

COMTEX Newswire Fri, Nov 6, 1998
The British Cattle Movement Service (BCMS) has been officially opened by Nick Brown, Minister for Agriculture. The Ministry of Agriculture, Fisheries and Food (MAFF) project will help track cattle in Great Britain. The service is a major part of the Government's strategy to ensure the lifting of the export ban on British beef.

Central to the BCMS is the Cattle Tracing System (CTS) -- the IT database which records all movements of cattle. The design, development and implementation of CTS was carried out jointly by MAFF's Information Technology Directorate (ITD) and its private sector partners, including international IT and business services company, Sema Group.

Initiated in late 1996 by 'Delta', the public and private sector partnership between ITD, Sema Group and Sherwood International, the CTS is a database of all cattle and locations where they may be held in Great Britain. Sema Group's main contribution included working with MAFF to devise a viable framework for the database, business analysis, detailed systems analysis, project planning, systems integration and testing.

The British Cattle Movement Service is based in Workington and will handle all cattle movements between locations from birth or import to the abattoir or export. Each day the system will handle the standard production of approximately 20,000 cattle passports (the cattle identification documents) and the recording of around 50,000 movements. These figures are likely to double.

Further functionality will be added to the Cattle Tracing System in the next few years as part of a phased programme carried out by Delta. Once fully operational, the database will provide information regarding not only the current location of animals, but also full histories, enabling MAFF to demonstrate that the animals have not been associated with herds or other animals where cases of BSE or other diseases have occurred.

FDA believes that an animal disease such as bovine spongiform encephalopathy (BSE) is a concern in the manufacture of FDA-regulated products intended for administration to humans.

 NOTICES: DEPARTMENT OF HEALTH AND HUMAN SERVICES
                          Food and Drug Administration
                              [Docket No. 98D-0924]
                           Friday, November 6, 1998
Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; *60009 AGENCY: Food and Drug Administration, HHS. ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry." This guidance is intended to provide recommendations for information that is to be included in premarket submissions-- investigational device exemption (IDE), premarket approval application (PMA), and 510(k) submisions for medical devices that either contain or are exposed to animal-derived materials during manufacturing. DATES: Written comments concerning this guidance must be received by February 4, 1999. Comments submitted after February 4, 1999, must be submitted to one of the contact persons.

ADDRESSES: Submit written requests for single copies of the guidance document entitled "Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry" to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443- 8818. Written comments concerning this guidance must be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Karen F. Warburton, Office of Device Evaluation (HFZ-460), or Kiki B. Hellman, Office of Science and Technology (HFZ-113), Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-7158.

SUPPLEMENTARY INFORMATION:

I. Background

FDA believes that an animal disease such as bovine spongiform encephalopathy (BSE) is a concern in the manufacture of FDA-regulated products intended for administration to humans. In 1993 and, more recently, on May 6, 1996, FDA issued letters to manufacturers to request that bovine-derived materials from cattle which have resided in or originated from countries where BSE has been diagnosed (as designated by the U.S. Department of Agriculture) not be used in the manufacture of FDA-regulated products. To identify medical devices which either contain or are exposed to animal-derived materials during manufacturing, CDRH developed the biomaterials database that contains an inventory of these devices, including type of material, animal species and county of origin, and target organ or tissue for each device. Originally proposed in response to the BSE issue, the database was expanded to include all animal-derived products (including human) in order to respond to other animal-based sourcing concerns that may arise in the future.

II. Significance of Guidance

This guidance document represents the agency's current thinking on medical devices containing materials derived from animal sources. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the applicable statute, regulations, or both. The agency has adopted good guidance practices (GGP's) which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents (62 FR 8961, February 27, 1997). This guidance document is issued as a Level 1 guidance consistent with GGP's. The agency is accepting public comments, but it is implementing this guidance immediately because of public health concerns related to the use of bovine-derived materials in medical devices and the agency's previous communication to manufacturers on this subject.

III. Electronic Access

In order to receive "Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry" via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At the first voice prompt press 1 to access DSMA Facts, at second voice prompt press 2, and then enter the document number (2206) followed by the pound sign (#). Then follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the guidance may also do so using the World Wide Web (WWW). CDRH maintains an entry on the WWW for easy access to information including text, graphics, and files that may be downloaded to a personal computer with access to the Web. Updated on a regular basis, the CDRH home page includes "Medical Devices Containing Materials Derived From Animal Sources (Except In Vitro Diagnostic Devices), Guidance for FDA

Reviewers and Industry," device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturers' assistance, information on video conferencing and electronic submissions, mammography matters, and other device-oriented information. The CDRH home page may be accessed at http:// www.fda.gov/cdrh. "Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry" will be available at http://www.fda.gov/cdrh/ode/guid.html.

IV. Comments

Interested persons may, on or before February 4, 1999, submit to Dockets Management Branch (address above) written comments regarding this immediately in effect guidance. At any time after 90 days from the date of publication in the Federal Register, submit to the contact person (address above) written comments regarding this guidance. Such comments will be considered when determining whether to amend the current guidance. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance document and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. *60010 Dated: October 28, 1998. D.B. Burlington, Director, Center for Devices and Radiological Health.

MAFF chief defends handling of BSE crisis

Tue, Nov 10, 1998   By Alex Richardson, PA News
The former permanent secretary of the Ministry of Agriculture, Fisheries & Food today launched a strong defence of his department's handling of the BSE crisis. Sir Derek Andrews said repeated assurances that British beef was safe to eat were in line with the best scientific advice at the time. And he described the performance of MAFF officials and scientists over BSE as "outstanding". Sir Derek - who was the department's top civil servant from October 1987 until February 1993 - was giving evidence to the long-running BSE inquiry in south London.

The inquiry is investigating the emergence of BSE, known as Mad Cow Disease, and its human form, new variant CJD, which has been linked to eating infected beef. Sir Derek said when he became permanent secretary, MAFF was facing a worrying new disease in cattle. He said that although the number of cases at that time was small, staff worked "extremely hard" to identify the cause and eradicate the disease. He said: "While we were, of course, dealing with a significant number of unknowns I believe the early progress made... allowed us to put in place the controls that limited the occurrence of the disease."

Sir Derek added that despite some of the evidence the inquiry had heard MAFF's policy was always to put new scientific information on BSE in the public domain. "As far as I was aware all the scientific information about BSE was released and made generally available," he said. And he added: "During my time as permanent secretary various statements were made regarding the safety of beef. "I believe the public statements of the Ministry regarding the safety of beef were designed to meet the scientific advice."

He told the inquiry the expert advice of the time was that the risk to humans from BSE was negligible. He said: "What is now known about BSE and new variant CJD was not known in 1987 and 1988. "Our understanding was increasing as results became available." Sir Derek told the inquiry: "I had come to the conclusion early in 1988 that, with the number of cases of the disease increasing and our increased understanding of the disease, we should seek advice from the Department of Health as to whether there was a possible human health connection here." But he still thought BSE presented a "relatively low probability of a very serious danger".

He said expert advice from the Southwood working party and later the spongiform encephalopathy advisory committee remained that the risk to humans was low. And he insisted that Maff had approached the Department of Health chief medical officer with its concerns about BSE as soon as possible, given the limited knowledge of the disease at the time. Sir Derek was asked whether he remembered newspaper articles in the Times in January 1990, in which the then chief veterinary officer, Keith Meldrum, said he could not completely rule out the possibility of BSE posing a risk to humans, and in the Daily Telegraph the following day in which Agriculture Secretary John Gummer was quoted saying: "No scientist will ever say never." Sir Derek said he could not recall either article, or Mr Meldrum being told by Mr Gummer not to speak to the media.

Pressed by chief counsel to the inquiry, Paul Walker, he said: "Mr Walker, I'm not trying to be unhelpful, but you are talking about rather detailed stuff from 10 years ago. I cannot remember that detail." Asked about the press release dated May 15, 1990, in which Agriculture Secretary John Gummer insisted British beef was safe to eat, Sir Derek said he did not recall whether he was consulted on its contents.

In his written evidence to the inquiry Sir Derek said that at a meeting with the chief veterinary officer and others the following day it had been agreed it would be "helpful" if the Department of Health made public the advice it had given to health authorities that British beef was safe, and if the chief medical officer, Sir Donald Acheson, took a higher profile. Mr Walker told Sir Derek that Sir Donald had told the inquiry he had felt under pressure at the time to make a statement.

Asked who would have pursued the issue with the chief medical officer, Sir Derek said: "I cannot recall it was me. I don't think I would have put pressure on the chief medical officer, he was a big enough man to resist pressure put upon him."

Asked about his reaction when Sir Donald appeared on television to say there was no risk associated with eating British beef, Sir Derek said: "My thinking at the time was that, as in many food safety worries, one was in a position where one couldn't say ... there was absolutely no risk, but on the other hand the risk was in many cases remote and almost theoretical."

Surgical instruments could pass CJD between patients

 November 8 1998 Times by Michael Prescott and Steve Farrar 
THE government faces a new health service crisis and a potential billion pound bill, because of fears that equipment used in surgery is spreading CJD, the human equivalent of "mad cow disease". Scientific advisers to the department of health confirmed yesterday that a specialist group has been appointed to advise on cutting the risk of patients who undergo routine operations contracting the fatal brain condition from the implements used upon them in surgery.

The most radical option under discussion is destruction of almost all equipment used in NHS operating theatres, at a cost which would run into billions of pounds - especially as new equipment would then need to be routinely disposed of after each operation, to ensure CJD was not passed from one patient to another. Although this is one of several options, scientists say it is the only way to be 100% safe.

No known sterilisation technique can kill the "prion" organism that causes CJD, and nobody knows how many people harbour the disease, meaning any estimate of the number of surgical implements carrying the fatal "prion" is impossible. One scientist said yesterday that the number of people incubating CJD could run to millions, meaning many operations were being carried out on infected people, and infected implements then reused.

Already, the government's advisers have called for more equipment to be routinely disposed of after each operation than is currently required. Ministers, they said, would have to decide how much money they could afford to spend on the tougher policy, and on what scale the destruction of implements took place.

"Even if it leads to a small reduction in the numbers who contract CJD it will be worth it," said Dr Michael Crumpton, chairman of the joint Transmissible Spongiform Encephalopathy working group. He stood down last month from the chairmanship of the the Advisory Committee on Dangerous Pathogens (ACDP), which is studying the problem of CJD.

Crumpton also revealed that the ACDP has ordered that equipment used in brain surgery should be separated from other implements, and not used in different types of operation, because of the CJD risk.

Another scientist said this could prove just an interim step, and that an order to destroy all equipment used in brain surgery could be on the way.

"The risk wouldn't need to be very high at all before it would be economically worthwhile throwing away instruments used on brain and peripheral tissue," said Dr Stephen Dealler, a microbiologist hired by the Department of Health to devise a test to detect CJD in donated blood.

A doctor said the problem was "immense". Scalpel blades were already thrown away after operations, but the operating theatre equipment sterilised after each operation included the operating table and even light switches.

Alan Duncan, shadow health minister, criticised the health department: "It is time for ministers to stop being cagey about this. The public needs to know the extent of the problem and the likely cost." Tony Minson, professor of virology at Cambridge University, said there had been "a few cases where surgical implants have transmitted CJD" and that precautions were needed.

BSE probe reveals gaps in Dutch livestock register

 Reuters World Report  Tue, Nov 10, 1998 
THE HAGUE, - Efforts to track down the stable mates of a Dutch cow with bovine spongiform encephalophy (BSE) have again revealed major gaps in the country's livestock registration system. Twelve of the stable mates of Trix 9, the fourth and latest case of mad cow disease uncovered in the Netherlands, are missing from the national livestock register, Junior Farm Minister Geke Faber said in a letter to parliament on Tuesday.

It is the second time the register has failed in its objective of tracking livestock movements around the country. Inspectors tracing the descendants of a previous mad cow case discovered in the northern Dutch province of Groningen in August came across similar gaps in the system. A farm ministry spokeswoman said on Tuesday the ministry was working on improvements to the register, which it estimated currently fails to account for around half a million cattle.

The "floating cattle" problem stemmed from the fact that farmers and exporters did not always report to whom they had sold their livestock, the spokeswoman said. Faber has pledged to improve the registration system given its key role in tracking down and preventing disease and in reassuring other countries and consumers.

In her letter to parliament on Tuesday, Faber said Trix 9's 12 missing stable mates had all probably been slaughtered for consumption. However 83 other cattle linked to Trix 9 had all tested negative for BSE, she said.

EU requirements for BSE deactivation tightened

10 Nov 1998 Inside AMI
The original and complete text of the EU Scientific Steering Committee 'Opinion on the risk quantification for CJD transmission via substances of human origin' can be found at the Europa website

The Scientific Steering Committee of the European Commission is now calling for increased heat treatment conditions in processing raw materials to reduce BSE infectivity. Previously the conditions of 133 C, 3 bar pressure and 20 minutes were considered adequate to reduce infectivity. The new conditions are 140 C, 3.6 bar pressure for 30 minutes.

News from Dealler's site:

"Brown hints at delay over passport cost. This followed the official launch of the British Cattle Movement Scheme in Workigton a week ago. The Government paid 35 million pounds for the start up and first year running costs of the BCMS but will expect the further costs to come from farmers and beef prices (i.e. between 5 and 10 pounds per passport). At the moment they were having problems in that farmers were filling in forms wrongly.

Revised BSE aid: Compensation for animals culled because of suspected BSE: 467 pounds if they do and 583 pounds if they don't turn out to have it.

BSE test A simple successful overnight test for BSE developed in Switzerland and claimed to be 100 percent accurate is already being commercially utilised there. The Prionics Test identifies the disease from tissue samples within 12 hrs but is largely being ignored by Britain and Germany according to developer Bruno Oesch."

Mad cow 'risk to 80,000 pregnant women'

Novmber 12, 1998
PA News Cahal Milmo
Microbiologist Stephen Dealler was cited as saying today that thousands of British mothers-to-be are being exposed to potential transmission of new variant CJD, the human form of the disease, because British supplies of a vital antibody are still being used.

The story says that the substance, called Anti-D, was included in a ban announced by the Department of Health eight months ago on products manufactured with blood donated in Britain after research suggested nvCJD could be transmissible.

Health chiefs admitted today that global supplies of Anti-D, given to pregnant women with blood group opposite to their baby to avoid potentially fatal complications, are so scarce that hospitals are still using UK stocks. [By scarce they presumbably mean the expense is burdensome or that only enough is available to serve elite mothers -- webmaster]

They say the life-saving benefits of Anti-D, which stops a mother's "negative" blood from mixing with the baby's "positive" supply, outweigh the theoretical risk of new variant CJD moving from person to person.

Burnley-based Dr Dealler was quoted as saying, "If they are going to ban something then it should be done immediately and not subjected to any sort of delay. New supplies based on blood donations from abroad were supposed to have been up and running by September but it now looks like they won't be ready with the new Anti-D until next summer. In a situation where we don't know the potential for transmission of nvCJD, we have young people being exposed to a possible risk of the disease and storing up potential problems for generations to come."

A Department of Health spokesman was quoted as saying, "We are in a situation where a global shortage of Anti-D, over which we have no control, means we have not been able to implement the new production in time for this autumn. This means the theoretical and unproven risk of new variant CJD must be weighed against the very real and potentially life-threatening difficulties if Anti-D is not available to pregnant women. Given that choice, the potential risks are vastly outweighed by the benefits to these mothers-to-be and we are working to make the new supplies available as soon as possible."

Comment (webmaster):

The story says Anti-D 'stops a mother's "negative" blood from mixing with the baby's "positive" supply' -- This is way off.

Rhesus D (RhD) forms part of the Rh blood group, so one of 3 human genes with order C-E-D, the D protein being an integral erythrocyte membrane protein, part of an oligomeric complex with a transport or channel function, with known sequence. If the mother lacks the RhD gene product but the fetus produces it (or a significantly different allele or splice variant), there is increased incidence of hemolytic disease due to the production of anti-D antibody by the Rh-negative mother. The UK gives anti-D IgG to pregnant women who are RhD negative to suppress antigen and keep them from developing an immune response.

Mad All Over: This family of killer diseases hits close to home. Too close.

 By Juliet Wittman  12 Nov 98 Westwide Denver
Creutzfeldt-Jakob disease eats holes in your brain and causes you to stagger, twitch, cry out in your sleep, lose control of your bodily functions, go mad and die. The disease may have been hidden in a hamburger you ate in Europe ten years ago, a corneal transplant or your own genetic makeup. It can incubate for anywhere between five and thirty years and will make itself known only when you're within months of death.

Two Denver residents died of CJD -- a cousin of mad-cow disease -- this year.

And Colorado is the epicenter for another related malady -- chronic wasting disease, or CWD -- among mule deer and elk. In affected parts of the state, the incidence among deer is between 4 and 6 percent; it is 1 percent in elk. At the height of the mad-cow epidemic in England, the incidence of bovine spongiform encephalopathy, or BSE, in cattle in that country was less than 1 percent.

Last February, Chris Melani, a Longmont hunter, took the head of a deer he'd shot to the Colorado Division of Wildlife for testing. He was told the DOW would contact him within three weeks if the deer had chronic wasting disease. When he heard nothing, he and his family ate some of the meat. He took what was left to a packing plant, where, he says, "It got mixed up with a bunch of other people's deer and made into venison sausage" -- ending up on who knows how many dinner plates.

Six weeks after turning in the head, Melani learned his deer was among forty that had tested positive for CWD last season. "They said it was okay," he says. "They weren't going to tell anyone else about it."

Although scientists don't know if humans can become ill by eating tainted venison, the encephalopathies do transmit from species to species, and 26 people in England have succumbed to a frightening new variation of Creutzfeldt-Jakob disease that's linked to mad-cow disease.

One of the most common routes for CJD infection is tissue from human cadavers used in surgery. In September, a forty-year-old Denver woman died of CJD. Because the disease generally occurs spontaneously only in the elderly, autopsy tissues were collected and sent away for analysis.

Last month it was determined that this woman had not died of new-variant CJD -- that is, that her illness was not connected to eating meat. "It appears that she acquired the disease when she had surgery in Denver in 1992," says Dr. Richard Hoffman, a state epidemiologist with the Colorado Department of Public Health and Environment. During surgery to correct a congenital malformation of the spinal column, a portion of dura mater, tissue taken from the outer covering of the brain, was used to protect part of the woman's central nervous system.

"The material came from a company in Germany," says Hoffman. "In 1992 such material was pooled from several donors -- I don't know how many. It will never be possible to prove 100 percent that that was the cause, but the incubation period of six years is about the right length of time for this disease if it's brought on by contaminated tissue."

Between 1987 and 1992, exposure to infected dura mater killed seven people in New Zealand, Britain, Italy and Japan, according to Richard Rhodes's book, Deadly Feasts: The Prion Controversy and the Public's Health. Three Australian women died during the same period because they'd used a hormone called gonadotrophin to counteract infertility. And there have been eighty known deaths worldwide from the use of contaminated human growth hormone.

Creutzfeldt-Jakob claimed a second Denver victim this year, a 78-year-old man. "It's the worst thing there is," says Linda, one of his daughters. "It turns your brain tissue to sponge."

"He'd always been relatively healthy," says a second daughter, who asks to be identified only as Sue. "But six months before this came to a head, we noticed some things. He was becoming forgetful, unable to complete projects he'd done all of his life. We put it down to old age. In February, on a trip, he experienced some dizziness and light-headedness. He came back, and there were other problems. He had trouble walking; his speech was a little slurred; his balance was totally off. We thought perhaps he'd had a stroke, but the tests were negative."

There were other tests: for Lou Gehrig's disease, for Guillain-Barre. But their father's health continued to deteriorate, and when the hospital could offer nothing but custodial care, his family took him home. "In four months," Sue says, "he went from fairly healthy to unable to care for himself whatsoever. He was unable to swallow, and he contracted pneumonia. Less than a week later, he was dead."

At present, the only viable way of identifying Creutzfeldt-Jakob is a brain biopsy, a procedure difficult to perform on a living subject. CJD was diagnosed in this man only after death. On the death certificate, the cause of death is listed as pneumonia.

Because of misdiagnoses like this, health activists say, no one really knows how prevalent CJD is. Although federal officials say instances of CJD have not increased in this country, in most states, including Colorado, CJD is not a reportable disease -- one that states are required to document for the Centers for Disease Control. Meanwhile, alternative studies indicate that perhaps 13 percent of patients diagnosed with Alzheimer's are in fact suffering from CJD.

"Sometime, somewhere, someone has to start taking reasonable surveillance seriously and establish a baseline," says Liz Armstrong, who founded CJD Voice, a Web-based support system for the friends and families of CJD victims. "It is only then that anyone can state whether there is an increase, a decrease or no change in the number of CJD cases in the U.S." CJD Voice's membership currently numbers 242, Armstrong says, and often grows by a member a day.

Gloria, a Californian who asked that her last name not be used, knows all about the family of diseases that includes CJD. Her husband died three years ago of the disease.

Ten years ago, right before a planned trip to Israel, her husband had reconstructive surgery on an injured eye. "Right before we left, in his sleep, he would babble and scream and laugh," remembers Gloria. "We went to the doctor, and the doctor kind of laughed and said, 'Don't watch the 11 o'clock news.'" But in Israel, the sleep disturbances continued. "He came to me one night with a flashlight," Gloria says, "and said there were men climbing down from the roof and to be very quiet."

After that, the hallucinations came in droves. "Every once in a while, he would cry and say, 'What's happening to me?'" Gloria says. "At the end of nine months he was in diapers, couldn't walk, didn't know who I was, kept looking for 'Gloria,'" she continues. "I had to pick him up out of bed, dress him. He shook continuously, and he kept rubbing his left blind eye -- said it was so itchy. One morning I came out of the shower and he invited me to his bed. He couldn't do anything much. Afterward, he tried to throw me out of the apartment because his wife was going to be coming home. Finally, he went into a coma and died a few days later.

"I worked as a therapist in a day treatment program with schizophrenics and autistic kids," Gloria concludes. "But I have never seen anything like this. Never."

Despite the news from England of human deaths caused by consumption of contaminated beef, federal officials here say there's little cause for alarm. Bovine spongiform encephalopathy has never been detected in U.S. cows, they say, and there has been no confirmed case of new-variant CJD here.

But activists point out that testing has been done on only a tiny percentage of the 70 million or so cows in the United States and that the economic pressure to find nothing wrong is tremendous. In fact, there are indications that some form of BSE does exist in this country: In 1985, large numbers of mink on a Wisconsin ranch began dying of a spongiform encephalopathy; they had been fed meat from fallen dairy cattle. And Stanley Prusiner, who won a Nobel Prize for his work on the origins of CJD, said in 1996 that mad-cow disease had to be present at a low level in the U.S.

The cause of this family of diseases is generally believed to be an agent unlike anything previously known -- an errant protein called a prion that manages to multiply uncontrollably in a process like that of crystallization. But although Prusiner won a Nobel Prize for this theory, there are credible researchers who believe the infectious agent will turn out to be viral. This is no abstract argument: Any hope of finding a cure depends on a clear understanding of cause.

The first case of CWD in a Colorado mule deer was discovered in 1967. In 1979 the first two elk succumbed; they had been held in the same area as the afflicted deer. Today the incidence among mule deer in the affected areas of the state is between 4 and 6 percent. In elk, CWD is at less than 1 percent, and the Division of Wildlife no longer requires that elk heads be tested. The disease has been found in northeastern Colorado, in and around Larimer County and concentrated in the area between Fort Collins and Estes Park, according to Todd Malmsbury, DOW spokesman. There is also evidence of CWD in southeast Wyoming, in South Dakota and among captive herds in Alberta, Canada.

CWD does not arise spontaneously in the wild, and no one is sure how the animals became infected. An anonymous Utah rancher offers his opinion on the mad-cow disease. Deer have always scavenged feeder bins, this rancher says, and have therefore eaten animal renderings in cattle feed, including "not only cow, sheep and all other animal bypass, but also themselves in highway kills and deer and elk dressings from hunter processings commercially done."

The rancher is skeptical about the alleged absence of the disease in U.S. cattle, noting that cows raised for food do not live long enough to manifest BSE. "Let's be real here," the rancher concludes. "If it is ever suspected, no rancher or feeder would lay himself open to having his entire herd culled for BSE at a potential loss of several hundreds to near $1,000 per animal, and neither would the livestock-dependent industries, including pharmaceuticals, cosmetics, soaps and beyond."

believes the disease emerged in Fort Collins thirty years ago, when deer were penned with scrapie-infected sheep. Scrapie is a wasting disease that has affected sheep for at least two centuries; many people believe England's BSE epidemic started after cows there were fed the remains of sick sheep. Since scrapie had existed for so long without harming humans -- as far as anyone knew -- the British government assumed that BSE was equally harmless. It was a disastrous assumption.

"I place the blame squarely on DOW for ever allowing hypothetical scrapie sheep to be closely quartered with wild game," Pringle says, "for waiting fifteen years to autopsy facility animals suspected of having scrapie, for releasing exposed animals back to the wild, for shipping sick animals to game farms and zoos long after they knew their incompetently managed facilities were contaminated, and for years of inaction and denial over the extent of the epidemic."

Pringle postulates a hypothetical worst-case scenario: "CWD spreads all up and down the Rocky Mountains, affecting many species of ruminants and carnivores. Over time, it then spreads to the rest of the West and to the rest of the country (and continent). It becomes established in domestic ungulates, first on common pastures on public land allotments, then more generally.

Feeding, injection and in vitro studies suggest transmissibility to humans, and a new strain of CJD emerges among hunters in Colorado. Ranching interests then push for the systematic slaughter of all large wildlife in North America."

Pringle acknowledges that this X Files-worthy scenario compounds five hypothetical events: "that CWD will spread to other species in the wild in other locales; that it will be experimentally transmittable to sheep and cattle; that significant transmission to livestock occurs under field conditions; that livestock become infectious under short time scales; and that significant oral transmission will consequently occur in humans.

"I would guess the first is likely but the time scale uncertain," he says, "the second is nearly certain; the third is plausible at some level; the fourth is somewhat doubtful; and the fifth is a real unknown."

"We take a proactive approach," says the DOW's Malmsbury. "We tell people, don't take sick animals, and there are parts of the animal you should not eat -- brain tissue, nervous tissue. But meat from wild animals is a health food compared to meat we get from grocery stores. It's literally prescribed by doctors on the Western Slope because it's low in fat and has no preservatives.

"We're not a meat-inspection program," Malmsbury continues. "We're a research program. If we find CWD, we do notify people, but there's no way we can go out and certify every person's animal for every disease, and we cannot notify immediately. There's no evidence to suggest that eating the meat of wild animals is going to be a hazard to human health, and no reason for people not to hunt."

Chris Melani, the Longmont man who shot a deer and ate its meat before finding out that it had CWD, is less confident. "As far as they know, it's not transmittable to cattle and humans," he says, "but you could turn that around and say as far as they know, it is." He adds, "I shot a one-year-old deer, and they say it doesn't affect young deer. When I shot it, it seemed perfectly healthy. Maybe a little stupid, but what do you expect from a little deer?"

For his part, Pringle expects trouble. "In my opinion, a large-scale experiment is now under way on how efficiently CWD transmits to humans," he says.

"This wasting disease is higher among deer and elk in Colorado than BSE ever was among cows in England," says Jean Halloran, director of the Consumer Policy Institute of the Consumers Union. "It's huge. And I don't see a concerted effort to assess whether this might be a problem for human health."

In 1997, the U.S. Food and Drug Administration came out with regulations forbidding the use of most mammal protein in feed for cows, sheep and goats. But blood, gelatin, milk, and pig and horse protein, as well as food scraped off diners' plates in certain restaurants and institutions, were exempted from the ban, according to Rhodes's book.

Animal feed can also include euthanized cats and dogs, mink carcasses and poultry manure. Pet animals can get transmissible spongiform encephalopathies, and so can mink. Deer remains -- roadkill and hunters' waste products, including brains and spinal cords -- go into pig feed. Although pigs don't seem to get these diseases, they're usually slaughtered before a disease could manifest itself. In turn, pig carcasses are rendered for cattle feed.

"We should have a complete mammal-to-mammal ban," says Halloran. "I'm especially concerned about a new product for feeding calves. Freeze-dried blood. It's not even rendered. I've given up red meat since I've been on this project.

"If you have a taste for red meat," she adds, "my recommendation is to eat it in big chunks. That's better than something like frankfurters. Muscle meat has a very low level of infectivity compared to other parts of animal. It's the nameless organs that you want to avoid."

While Halloran is pushing for better information on CWD and BSE, Armstrong and other activists argue that CJD should be universally reportable. There has been a cluster of CJD cases in Salt Lake City. Mel Steiger, whose wife died of CJD, is spearheading the effort in Utah -- with the support of morticians, who are at risk of infection when preparing bodies. "Most of the mortuary equipment cannot be sterilized," says Steiger, "so anyone who works on it and receives a puncture wound is at risk of becoming infected."

The Colorado Department of Public Health and Environment, which is working with the Centers for Disease Control on CJD, reviews the question of which diseases should be reported annually, says Dr. Hoffman. "I don't mind considering the addition of this," he adds. "It makes the statement that the board of health thinks it's a public health concern. I can see some value in sending out the message."

In August, Dr. John Collinge, professor of neurogenetics at London's Imperial College and one of the topic's foremost experts, delivered a far more pointed message to the London Times: "There seems to be a revisionist view gaining ground in the press not only that the link between bovine spongiform encephalopathy, or 'mad cow disease,' and new-variant CJD is not clearly established, but that the epidemic is likely to be small. In fact, the link is very clearly established and there are going to be a lot more cases. We are still in the dark about how many, but we have to prepare for the worst."

"We don't have a problem of that magnitude," says Halloran, "and we can prevent having one. But we don't seem to be doing it. We're taking half- measures and taking them late."

"What upsets us the most is when we've gone to the medical establishment for answers, there haven't been any," says Sue, remembering her struggle to get help for her father. "And nobody seems to think this is important. It reminds me of AIDS in the Eighties. People didn't want to hear about it. Had we paid more attention then, possibly it wouldn't have mushroomed."

US, Canada researchers pool efforts on live scrapie test

November 3, 1998
Ontario Farmer RAY FORD
Federal researchers are stepping up efforts to find an effective live test for scrapie, and additional compensation is on the way for Canadian shepherds whose flocks have been stricken with the fatal brain disease. Canadian Food Inspection Agency scrapie specialist Dr. Ron Rogers, was cited as saying that Canadian officials have joined forces with their U.S. counterparts to study a new test for the rare disease.

While the exact details of the research haven't been worked out, scientists hope to test up to 1,000 sheep across Canada using the experimental technique, which extracts a tiny amount of lymph tissue from the corner of a sheep's eye.

The $375,000 program will, according to this story, also establish an infected flock of sheep. The flock of scrapie-stricken animals will not only allow researchers to gauge the test's effectiveness, but should give scientists a better idea of how well it works on lambs who aren't yet showing signs of the disease.

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