Blood and CJD
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Bayer Withdrawing Blood Products due to theoretical CJD risk
Utah donor, 29, spurs blood quarantine
Mandatory reporting of CJD: - open letter to Utah Bureau of Epidemiology
Hogg calls colleagues 'disorderly rabble'
EU Delays Animal Parts Ban
Bad news on game farm elk CWD
BSE in vaccines
Canada imposes blood quarantine on Utah plasma
Canadian Health Department releases blood that had been quarantined
U.S. could block British blood over mad cow
Hemophiliacs urge ban on blood donation by travelers to Britain
Foie gras to be outlawed
MAFF to kill 12,000 badgers over cattle tuberculosis

Bayer withdraws certain blood product lots

From FDA CBER Withdrawals/Recalls/Safety Issues
U.S. Food and Drug Administration
Withdrawal of Antihemophilic Factor (Human) and Factor IX Complex Because Donor Diagnosed with CJD 
See  Blood Recall/Withdrawal - CJD for more systematic coverage of blood and CJD issues.
[This passes along an FDA web page notice to the effect that Bayer has gone ahead and withdrawn blood products for theoretical non-nvCJD risk in the Utah case. While this is a good idea, recall that the a weak FDA option was recently adopted (without any scientific basis in the webmaster's opinion) to reduce shortages of various specialty blood items and that the FDA is no longer recommending withdrawals because of the expense and immediate health consequences of IgG and other shortages. So we have a regulatory oddity -- the private sector doesn't seem to think the FDA's regulations are adequate to protect the public health and has acted accordingly. -- webmaster]

From FDA CBER Withdrawals/Recalls/Safety Issues
U.S. Food and Drug Administration
Withdrawal of Antihemophilic Factor (Human) and Factor IX Complex Because
Donor Diagnosed with CJD 

BAYER STATEMENT

Withdrawal of Antihemophilic Factor (Human) and Factor IX Complex Because Donor Diagnosed with CJD

WITHDRAWAL DATE:   December 15, 1998

PRODUCTS / LOT NUMBERS / EXPIRATION DATES:

Antihemophilic Factor (Human), Koate-HP:
664T007   04/29/2000
664T007A  04/29/2000
664T009   05/12/2000
664T010   05/20/2000
664T013   07/31/2000
664T014   08/07/2000
664T014A  08/07/2000
664T015   08/11/2000
664T018   10/20/2000
664T018A  10/20/2000

Factor IX Complex (Human), Konyne 80:
626S008   08/06/1999
626S009   09/04/1999
626S009A  09/04/1999

MANUFACTURER:

Bayer Corporation
Clayton, NC

REASON:

"Bayer Corporation has received post-donation information that a plasma donor has been diagnosed with Creutzfeldt-Jakob Disease (CJD). Brain biopsy test results for this donor as reported by the National Prion Pathology Surveillance Center and the Centers for Disease Control and Prevention demonstrated findings consistent with a form of classic CJD and excluded a diagnosis of new variant CJD (nvCJD). Bayer is voluntarily withdrawing all in-date lots of Antihemophilic Factor and Factor IX Complex produced from the plasma pools which contain plasma donations from this donor. This action goes beyond FDA's current recommendation as published in the September 8, 1998 position statement, which limited withdrawal of plasma derivatives to cases of nvCJD in the donor."

49 Patients in Hong kong receive recalled blood products

 December 21, 1998  AP World News  
HONG KONG - : A blood product possibly tainted with the human form of mad cow disease has been recalled from Hong Kong hospitals _ but not before it had been given to 49 patients, hospital authorities said Saturday. The plasma product was recalled on Thursday from five hospitals and one clinic, the Hospital Authority said in a statement.

The move followed the worldwide recall by GermanyŪs Bayer AG of its blood product Koate HP after a donor had been diagnosed with Creutzfeldt-Jakob Disease, or CJD, the statement said. The company called the move a ``precautionary measure," according to the statement.

The Hospital Authority added that there was ``no practical risk" of transmission of CJD to humans through the blood product but said they would contact those injected with the product immediately.

In April, the government confirmed that 12 people in public hospitals had been diagnosed with CJD since early 1996. They were reported a month after the government ordered hospitals and doctors to return a batch of blood products collected from a donor who later died of the disease, a version of bovine spongiform encephalopathy that affects humans.

The disease, which makes cattle drool and stagger before dying, was dubbed mad cow disease in Britain. In humans, it usually affects older people.

Other CJD blood withdrawals

Wed, 23 Dec 1998
From the FDA CBER page on Recalls/Withdrawals/Safety Issues
U.S. Food and Drug Administration
FDA/Center for Biologics Evaluation and Research
Withdrawal of Antihemophilic Factor (Human) Because Donor Diagnosed with CJD 

WITHDRAWAL DATE: December 22, 1998 

PRODUCTS / LOT NUMBERS / EXPIRATION DATES: 
Antihemophilic Factor (Human), Pasteurized, Humate-P 
0326661A 04/29/1999 

MANUFACTURER:
Centeon Pharma, GMBH Marburg, Germany 
REASON:

Centeon received notification from Bayer Corporation concerning the withdrawal of cryoprecipitate intermediates produced from plasma pools which contained plasma from a donor who has been diagnosed with Creutzfeldt-Jakob Disease (CJD). Brain biopsy test results for this donor as reported by the National Prion Pathology Surveillance Center and the Centers for Disease Control and Prevention demonstrated findings consistent with a form of classic CJD and excluded a diagnosis of new variant CJD (nvCJD). Centeon is voluntarily withdrawing the above-mentioned lot of Antihemophilic Factor manufactured from the cryoprecipitate intermediates purchased from Bayer Corporation. This action goes beyond FDA's current recommendation as published in the September 8, 1998 position statement, which limited withdrawal of plasma derivatives to cases of nvCJD in the donor.

Utah donor illness spurs blood quarantine

16 Dec 98 Deseret News by Lois M. Collins Deseret News staff writer

Blood products have been quarantined after discovery that a 30-year-old blood donor has a brain disease that is distantly related to Mad Cow Disease.

Doug McEwen of Kaysville was diagnosed with CJD, a rare member of the Transmissable Spongiform Encephalopathy family that causes rapid progressive dementia and is always fatal. [Other reports state that McEwen was an avid hunter and ate deer and elk meat twice a week. This, plus disease onset in his 20's, and geographical proximity to CWD herds in Colorado raise the spectre that the victim contracted CWD. A Salt Lake City TV station reported that McEwen had brought back a deer from Wyoming. McEwen has no real known connection to the UK or British beef -- his LDS mission was in Canada. He never received growth hormone. The earliest symptoms, in retrospect, were noticed in June 1998. -- webmaster]

The Utah Department of Health plans to require reporting of the disease, which after a public comment period could take effect in two or three months. Doctors, epidemiologists and scientists know a lot about the disease, which acts like the bovine strain that caused the Mad Cow Disease outbreak in Great Britain and Chronic Wasting Disease in deer, among others. But they know very little about how it is transmitted, Craig R. Nichols, state epidemiologist, told members of the governor's science and technology advisory board Tuesday.

McEwen was a regular plasma donor and continued to donate after the onset of his symptoms. A diagnosis wasn't made until last month, based on a brain biopsy, which aside from an autopsy is the only way to confirm CJD. [The diagnosis was reported back on 25 Nov 98; biopsies are not normally large enough to distinguish CJD from nvCJD. However the Gambetti lab was reportedly able to do a western blot (Collinge strain-typing); the glycoform ratio was apparently type 1 or 2, not nvCJD type. So this is stronger than not finding florid plaques. However, we do not know how cwdCJD or a hypothetical US strain of bseCJD would type out for purposes of comparison. Blood or blood fractions are reportedly being examined by Schmerr 's capillary electrophoresis (cIEF)method developed at NADC, Ames, Iowa for rogue prion protein. This method previously could detect 135 pg of sheep PrP-Sc.-- webmaster]

As a result, the Centers for Disease Control and Prevention, the Food and Drug Administration and the blood product manufacturer are studying blood-product manufacturing and distribution practices, Nichols said. And they have quarantined all of the blood product that contains McEwen's plasma donation since last January. Plasma donated before January is believed to have been already used.

The problem is, his plasma was "pooled" with other donations. Since blood products, which have many life-saving applications, are in short supply and it's unknown whether (but thought unlikely) blood can transmit CJD, they are trying to determine whether the pooled byproducts should be released or destroyed. And because it was pooled, it's hard to determine exactly how much blood byproduct is potentially damaged.

The state could not say how much has been quarantined. There's no way to test the blood products for the disease. Since 1980, 29 Utahns have died from CJD. Six cases were diagnosed in Utah last year. But it can take up to 30 years for symptoms to develop and they can last for as long as 12 years before the patient dies. That means that, if blood products can spread the disease - the great unknown factor - many people could be affected. And it's reportedly hard to kill the prion (a malfunctioning protein) believed responsible for infection.

Even testing for the disease is difficult. While an autopsy will reveal it, a brain biopsy in a living subject is only 60 percent effective, according to the state Department of Health. Nichols said the disease could benefit from a "good detective." It has an infectious component and a hereditary component. Direct exposure to infected brain tissue will do it. But much of the public policy surrounding CJD is based on speculation. And even a good detective might get bogged down in the various plot twists.

Because it is hard to diagnose, many people, including Steiger, whose wife died from CJD, believe that some people with dementia who are diagnosed as having Alzheimer's actually have CJD. That's significant because people with CJD are not allowed to donate blood or organs, since the risk isn't known. But people with Alzheimer's can. It makes proper diagnosis urgent, Steiger told the committee.

While Utah records list 16 people as having died of CJD from 1989 to early this year, 425 death certificates list dementia. The actual causes could be Alzheimer's or CJD, Steiger said, citing a Yale study that found 6 of 46 people who reportedly died from Alzheimer's actually had CJD. If you assume even 10 percent of Alzheimer's cases are actually CDC, he told the panel, then Utah would have 2,500 CJD cases.

The Health Department wants to take the possible risks seriously, but doesn't want to alarm the public unnecessarily, said department spokesman Ross Martin. "When people don't know what causes something, they take extraordinary measures to avoid getting (it)," he said. "It's a balancing of risks. We've never seen it spread by blood transmission," Nichols said. "But there hasn't been enough investigation to say for sure."

He said that the blood-products manufacturer, the Centers for Disease Control and the Food and Drug Administration all believe that there is time to conduct more studies [??? webmaster] before a decision has to be made about the blood-products' fate. But the country can ill afford to destroy it if it doesn't have to, since the products are needed so urgently. "I don't care if only 240 people die annually (from CJD)," said McEwen's wife, Tracie, in tearful comments made to the committee. "If you add in the family and friends, potentially hundreds of thousands of people are affected."

Further details on Utah case

18 Dec 98 By Norma Wagner The Salt Lake Tribune
››› ››› ››› Utah's most recent sufferer of Creutzfeldt-Jakob disease as a frequent plasma donor, so federal agencies are studying whether the prion protein associated with the fatal cousin of mad-cow disease can be transmitted through blood. ››› Meanwhile, the national company that received the units from the Kaysville man -- and possibly pooled them with thousands of other units of plasma -- has agreed to quarantine its supplies dating back to January until the federal government determines whether they should be destroyed. State officials refused to identify the company. ›››

The investigation was revealed Tuesday by state epidemiologist Craig Nichols during a meeting of the State Advisory Council on Science and Technology. ››› ``There have been no cases reported of [CJD] infection by blood transfusion or use of blood products,'' Nichols said. ``We do not believe blood products contain the prion protein, but it is prudent the blood be held until that is proven.'' ›››

The victim, Doug McKuen, and his wife, Tracie, attended the meeting, where she made a tearful plea to make the rare illness a reportable disease in Utah so state officials can determine how prevalent it is. So far this year, six Utahns have either been diagnosed or died of CJD. State officials plan to begin requiring notification of a CJD diagnosis within the next six months. ›››

``Over the last several months, I've watched my husband forget the names of his children, forget how to drive a car, how to dress himself, how to bathe himself,'' Tracie McKuen said. ``I don't care if [nationally] only 240 people are dying of this annually. You are talking about 240 families who are devastated, who are in pain. This needs to be made reportable.'' ›››

CJD is a little-understood neurological disorder where the brain is literally eaten away. It is incurable, with symptoms growing increasingly worse until its victim goes into a coma, then dies. Researchers don't know how it is transmitted, but the most accepted theory is that CJD is caused by abnormal proteins -- called prions -- in brain cells. If there is a mutation in the prion gene, abnormally shaped prions are produced. The rogue prions then convert normal prions, accelerating the disease. ›››

State officials grew concerned when McKuen was diagnosed with the disease on Nov. 25 because he was only 30 years old. Most U.S. victims are 55 and older; they either inherit CJD or get it for no apparent reason. ››› Nichols feared that McKuen might be the first U.S. case of a variant form of CJD, known as mad-cow disease in Great Britain, that is believed to be caused by eating contaminated beef. So his epidemiology department teamed up with the University of Utah Medical Center and the Centers for Disease Control and Prevention (CDC) in Atlanta to begin an investigation. ›››

Analysis of a biopsy of McKuen's brain showed he had the classic strain of the disease, not the mad-cow variant. Further questioning revealed that McKuen had been donating plasma once or twice a month since January and during his early symptoms of forgetfulness. [Other reports state that the victim donated plasma in earlier years as well -- webmaster] Plasma is the liquid component of blood made up largely of water and proteins and small amounts of fats, sugars and minerals that is most oft-en transfused into patients for treatment of shock, severe burns and open-heart surgery. ›››

Because so little is known about the transmission of CJD, the CDC and the federal Food and Drug Administration are now studying whether the ``fractionation'' processing of plasma -- in which products like immune globulin and plasma protein are separated out -- is successful in removing abnormal prion proteins. ››› ``They'll do that by putting prions into the blood, running it through the fractionation process and see what happens -- if it reduces the levels of prions to be non-existent or non-infectious,'' Nichols said. ›››

Federal investigators also will discuss whether modifications to the blood-screening process need to be made, such as asking more questions about medical history, more sophisticated testing of blood and tighter requirements for processing plasma.

Red Cross launches huge lawsuit against governments

Fri, 18 Dec 1998  By DENNIS BUECKERT -- The Canadian Press
OTTAWA (CP) -- The Canadian Red Cross is suing federal, provincial and territorial governments to obtain coverage of legal liabilities of about $8 billion, The Canadian Press has learned. The charitable organization believes governments are responsible for uninsured claims from people harmed by tainted blood, spokeswoman Janet Lalonde said in an interview Thursday.

"We were operating the blood program on behalf of them (governments) on a not-for-profit basis," said Lalonde. "The understanding we had with the agency that represented the governments at the time (the Canadian Blood Agency) was that they would reimburse us for all operating costs, including the cost of insurance and any uninsured liability claims."

Michele Smith, senior counsel with Ontario's Attorney General, dismissed the Red Cross action as groundless. "There is no merit in the claim and we will be defending it.' Officials from other provinces wouldn't comment. "We received the claim yesterday and we're reviewing it," said a Manitoba official.

Red Cross officials still hope the liabilities issue can be resolved through negotiations, but the statement of claim filed in Ontario court last week ensures the agency can take governments to court if negotiations fail. "It's kind of keeping the options open," said Lalonde.

Red Cross negotiator Bob Rae, reached in Europe, emphasized that talks with government and tainted blood victims are going well. "It (the court action) should be seen simply as a way of maintaining, for legal reasons, our position that we should be indemnified by governments." He said the Red Cross was required to file the action because certain limitations were running out. Rae downplayed the court action as "nothing new." The Red Cross filed a notice of its intention to take legal action in February, but the action was not publicly announced.

Red Cross liabilities are huge because the agency hasn't been able get full insurance against legal claims since 1985. Since then, thousands of people have learned they were infected with hepatitis C and AIDS through the blood system. The organization's financial resources are vastly inadequate to pay claims. It has been protected from creditors and lawsuits since it was granted bankruptcy protection July 20.

The final total for liabilities is not known, partly because negotiators still have not agreed on how to disburse a $1.1-billion federal-provincial compensation package for hepatitis C victims. If recipients of compensation are required to waive the right of legal action against the Red Cross, claims will be reduced. But it is also possible more claims will be filed when the Red Cross emerges from court protection. It isn't known when that will happen.

The lawsuit also names the Canadian Blood Agency, which acted on behalf of provincial and territorial governments in funding the blood system prior to the recent establishment of the Canadian Blood Services and Hema-Quebec. The Red Cross hopes to continue its humanitarian work, although it has withdrawn from the blood system.

Hogg attacks Tory Cabinet on BSE crisis

December 17 1998 London Times BY MICHAEL HORNSBY, AGRICULTURE CORRESPONDENT 
DOUGLAS HOGG accused John Major and other Tory former Cabinet colleagues yesterday of failing to take action that could have avoided the European Union ban on British beef.

In a five-hour appearance before the BSE inquiry, Mr Hogg said the Government, instead of following his advice, had chosen to delay, allowing itself to be driven by events like "a disorderly rabble".

Mr Hogg, who was Agriculture Minister from July, 1995, until the election in May last year, said he considered resigning when his proposals were rejected but decided to abide by the principle of collective responsibility.

The clash of views occurred at a meeting chaired by Mr Major, then Prime Minister, on March 19, 1996, the day before the announcement in Parliament that "mad cow" disease had probably passed to humans.

Documents obtained by the inquiry show that Mr Hogg proposed an immediate ban on the sale and export of all beef and beef products from cattle over 30 months and said the Government should be prepared to pay farmers compensation of up to £500 million. The logic behind the proposal was that BSE was virtually unknown in cattle under that age.

Mr Hogg also recommended that the Government immediately set up a judicial inquiry under the chairmanship of a High Court judge into its handling of the BSE crisis. All the proposals were turned down.

Mr Hogg wanted to go further than the Government's scientific advisers were recommending, and other members of the Cabinet, including the Attorney-General, voiced concern that "disproportionate" measures could provoke legal action for damages from the beef industry.

Although rejected at the time, a ban on 30-month-old beef was introduced a month later under pressure from the European Union, which on March 27, 1996, had announced a world-wide ban on British beef exports. The ban is only now being lifted.Hearings before the inquiry will resume in late February.

Hogg attacks fellow tories over `mad cow' crisis

Wed, Dec 16, 1998 By Eileen Murphy, Consumer Affairs Correspondent, PA News
 
Douglas Hogg today hit out at John Major and other Conservative Cabinet colleagues, saying they should have acted on his advice to clear certain beef products from supermarket shelves and ban their export during the "mad cow disease" crisis. The former agriculture minister said that had his recommendations been followed by the former Tory Government, the BSE outbreak would have been less "acute".

Mr Hogg, agriculture minister from 1995 to the 1997 General Election, was giving evidence to the London inquiry into the crisis. He said he had tried to persuade the then Prime Minister Mr Major and senior Cabinet ministers to recommend that all beef products from cows over the age of 30 months be taken off the shelves because of a higher risk of BSE infection. It was estimated this would cost about 1 billion to implement - and even more in compensation to retailers and manufacturers.

Mr Hogg said he also advocated an export ban on these products and the setting up of a public inquiry into the crisis. Had the Government acted to stop the exports, the worldwide blanket ban on British beef may not have been imposed, or at least lifted earlier than last month, he said. He also noted that every single one of his recommendations were later implemented.

But in Cabinet meetings and ad hoc conversations, Mr Major and other senior members of Government rejected his ideas and the possibility of what was described as the "Armageddon option" of slaughtering the entire British beef herd. The minutes of a late-night meeting of senior Cabinet ministers showed Mr Major believed it was a "huge leap" from the risks to human health of BSE to then destroy the entire British herd. This would mean the destruction of the beef industry and "huge national panic".

At the time, Government scientists were sounding alarm bells over the discovery of new variant Creutzfeldt Jakob Disease - linked by many to consumption of BSE-infected products and which particularly affected young people. There had been, up to this point, nine confirmed cases of the new strain of the fatal degenerative brain illness and three suspected.

Mr Hogg said today that because of the strong Cabinet opposition to his policy proposals, he had to get on with introducing the limited action chosen by Government - even though he believed they were mistaken. He said: "I had been comprehensively rejected. There was no point in trying to overturn the view of the Prime Minister and his colleagues. I thought it was an error, but I got on with it. Either I accepted that or I resigned."

During his five hours of evidence, the former minister said: "I believe that the proposals the Ministry of Agriculture put forward were right. I think it is at least possible that if we had done that the crisis would have been less acute. "I recommended a ban on the export of goods and products which did not comply with the 30-month rule. It is at least possible that if my recommendation to that effect had been implemented we would not have had a ban, and if we had a ban we would have been more influential in the formation of it and the mechanisms for lifting it."

Earlier the inquiry heard that Mr Hogg had described the Government's position as "untenable" once he realised the anti-BSE measures were being flouted and the risk to public health increased with the appearance of nvCJD. When he came to office a ban on beef from infected cows and certain beef offal had been introduced, but Mr Hogg said he soon realised that slaughterhouses were not complying fully with the regulations. Mr Hogg said he "could not rely purely on those controls".

The inquiry heard that Mr Hogg's department had always adopted a "belt and braces" approach to the BSE crisis. He explained that the belt was the belief, held until March 1996, that BSE could not be caught by humans, while the braces were the existing controls. But when the link between BSE and CJD was made, the "belt" had gone. He added: "My view was that the trousers would not hold with the braces alone."

As the first stage of the BSE inquiry drew to a close today, it was still not clear whether Mr Major would be called to give evidence. Officials have stated that the inquiry's second stage will begin in February next year and it is known that Mr Major, and fellow former Prime Minister Lady Thatcher, have been contacted and asked to provide written statements about their handling of the BSE crisis. Both have until the end of January to reply.

Slaughterhouses Broke Bse Safety Rules, Says Hogg

PA News Tue, Dec 15, 1998 By Eileen Murphy, Consumer Affairs Correspondent, PA News
Serious failures to comply with regulations probably led to BSE-infected material getting into the food chain, former agriculture minister Douglas Hogg will tell the BSE inquiry today. Mr Hogg, who was minister from July 1995 until the General Election in 1997, said that as soon as a probable link between BSE and the human form of the disease - new variant Creutzfeldt Jakob Disease - became clear, his department worked on the issue to the "virtual exclusion" of all other business.

But in the year leading up to that announcement Mr Hogg said that, despite controls being introduced banning specified animal parts from the human food chain, in one inspection of 392 slaughterhouses and 43 head-boning plants 65% failed to comply with some of the rules. In his statement Mr Hogg said that he had been advised that the method used to split skulls and remove the brain did not necessarily clean out all of the brain material. This was in light of emerging research suggesting that as little as one gramme of contaminated brain material could prove infective.

On a series of second visits to slaughterhouses Mr Hogg said two operators were found not to be separating banned materials (Specified Bovine Offals or SBOs) from material for human consumption. He added: "These problems were not found at the earlier visits to the two plants concerned. At first sight these were serious problems which if undetected could have led to SBOs entering the human food chain, although this was by no means clear. "It is, however, important to emphasise that until late February 1996 the balance of expert opinion ... was against a link between BSE and CJD."

Mr Hogg said that even though incidents of CJD in the UK had risen to 53 in 1994, compared with 35 in 1993, a report concluded that "no causal link had been found between CJD and the consumption of various meat products". The former minister added that he had realised that the SBO ban was not "watertight" and it had not surprised experts when BSE occurred in young animals as a result of the inadequate application of the controls.

The former minister said that the Chief Medical Officer Sir Kenneth Calman began expressing concern over the cases of four farmers, all with BSE in their herds, who had contracted CJD and the increased incidence of CJD in young people. Yet Mr Hogg said the doctor was still agreeing with the statement that "there was still a strong balance of probability against the consumption of beef being related to CJD".

At a meeting in 1995 Mr Hogg recorded Dr Calman saying: "Although he could continue to say with complete confidence that there was no evidence that British beef, that is meat as commonly understood, was not safe - it could not be said with confidence that no offal which might have been contaminated had entered the food chain. "This reduced confidence that the public was being properly protected."

Following a number of meetings in mid-March 1996 Mr Hogg set out his proposals, which he described as the "very minimum" to combat the problem. They were:

   :: banning the sale of beef and beef products derived from animals from
UK herds and from animals over two and a half years of age
   :: banning the manufacture of products from bovine material from animals
from UK herds and from animals over two and a half years of age
   :: banning the export of such beef and beef products.
He also recommended the setting up of an inquiry into the Government's reaction to BSE. Mr Hogg said the age deadline for animals was "defensible, as very few BSE cases had been found in animals below this age". On March 19 1996, his recommendations were put to the Prime Minister in a meeting at Number 10 but they were rejected because it was felt they were "disproportionate".

EU Delays Animal Parts Ban

AP Online Tue, Dec 15, 1998
BRUSSELS, Belgium (AP) -- European Union farm ministers decided Tuesday to delay for one year a ban on the use of animal parts deemed most at risk of harboring "mad cow" disease. EU farm ministers decided to push back the Jan. 1 ban amid concern it could disrupt billions of dollars a year of pharmaceuticals and cosmetics trade, an EU farm official who spoke on condition of anonymity said.

The EU was due to ban Jan. 1, 1999 the use of the head and spinal cord of cattle, sheep and goats more than 12 months old and the spleen of all sheep and goats. Those parts are deemed to be most at risk of harboring mad cow disease -- or bovine spongiform encephalopathy -- in BSE-infected cattle and related brain ailments in sheep and goats. But several EU countries objected to the Jan. 1 ban, the official said.

The United States also oppose the Jan. 1 ban. They have warned the move would disrupt more than $4 billion a year of exports of U.S. pharmaceuticals and cosmetics.

BSE has been linked to a fatal brain ailment in humans -- Creutzfelt-Jakob disease -- and can go undetected in cattle for years. Pharmaceuticals and cosmetics can be made in part from the BSE risk material. The ban on animal parts was initially proposed by the EU executive Commission in 1997. It has been repeatedly delayed.

France announces two more cases of mad cow disease

16 Dec 1998 Reuters
PARIS - Two new cases of mad cow disease have been discovered in France, bringing to 48 the number of cows found suffering from bovine spongiform encephalopathy (BSE) here since 1990, the Agriculture Ministry said on Monday.

Both cows were born and raised in western France and their herds - 183 in the Sarthe region and 108 in the Mayenne area - were completely destroyed at the end of last week, it said.

France has discovered 17 BSE cases this year out of a national livestock total of 21 million, it said.

A new case of BSE was reported in the d»partement de l'Orne.

22 Dec 98 Marc Barbier  Agronomist engineer
The national epidemiosurveillance network of BSE has just reported a new case of BSE on an animal of the Orne Departement. It is the 49É case to be reported in France since 1990 and the 18É case of year 1998. The cow was born in March 93, which means after the ban. According to the French regulation the 168 cows of this herd was slaughtered and immediately incinerated.

Bad news on game farm elk

Dr. Holland, South Dakota State Veterinarian  20 Dec 98 news release
Some initial SD data released by Dr. Holland, SD State Veterinarian was verified with two of his colleagues. There are 39 game farm elk in South Dakota with confirmed chronic wasting disease in 1998, out of 179 tested (22%). There are 4 or 5 herds involved - all are from game farm animals, none are from the fall hunt. The total number of elk studied is not yet available for wild elk.

Two white-tail deer are also affected, also captive animals.

Medicines 'greater BSE risk than beef'

The Telegraph 15 Dec 98 By David Brown, Agriculture Editor
PEOPLE have been in greater danger of contracting BSE from medical injections than from eating beef, according to the Government's main scientific adviser in the early stages of the epidemic.

Prof Sir Richard Southwood, whose advisory committee reported in 1989 that there was only an "extremely remote" chance of humans being infected with BSE by eating beef, warned another key Government adviser that year that there was a "moderately high" risk of the brain disease being passed to people in cattle-based medicines.

But serum extracted from British cattle was still being used in a range of vaccines and other medicines until 1991 - four years after the existence of BSE was admitted publicly and six years after the first case was discovered on a farm in Kent.

Prof Southwood, professor of zoology and Pro-Vice Chancellor of Oxford University, expressed his fears about human medicines in a private letter to Dr David Tyrrell, the virus expert who succeeded him as the Government's leading independent adviser on BSE.

In his letter, which emerged at the BSE inquiry in London yesterday, Sir Richard criticised the then Conservative government's "ridiculous attitude" towards public spending on BSE and expressed his horror that "high priority" research into vertical transmission from cow to calf had not been put in place.

He also expressed his concern that some early BSE cases would be lost as a result. He said: "Personally, I would have thought the possibility of human infection was moderately high if some medicinal products were made from tissues of infected animals and injected into humans. That's an extreme case, but we certainly had such anxieties very much in mind."

At that time, while the Government was reassuring the public about the safety of beef, it had not moved to ban the use of a number of specified bovine offals in pharmaceuticals.

Canada imposes blood quarantine
Supply may be contaminated with sickness linked to 'mad-cow' disease

 Saturday 19 December 1998 Mark Kennedy The Ottawa Citizen 
Federal regulators have advised Canada's blood agencies to quarantine thousands of vials of blood products linked to an American donor who has Creutzfeldt-Jakob disease (CJD), a fatal neurological disorder. The move comes as a result of concerns that the donor may have a new, virulent strain of CJD that is associated with "mad cow disease."

Canadian Blood Services and Hema-Quebec announced yesterday they would comply with the Health Canada advisory for a temporary "hold" on the blood products. As well, hospitals throughout the country will be told not to distribute any of the designated products on their shelves.

Pending the results of an emergency meeting Monday involving Canadian and American regulators, federal officials say it's possible they will order a permanent withdrawal of the products -- a move that blood agency officials fear could lead to a shortage.

Blood agencies are able to pinpoint which shipments of products contain the donor's plasma. The products are used for a variety of purposes, including treatment of burn and trauma victims, people with immune disorders, liver transplants and hemophiliacs who need products to help clot their blood.

The quarantine comes after it was discovered in recent days that a 29-year-old Utah man, who has donated plasma nearly 100 times over the past two years, has been diagnosed with CJD. His plasma was fractionated by Bayer Inc. in the U.S. along with the plasma of other donors into blood products, and shipped for use within the U.S. and Canada. Already, those products have been transfused by an unknown number of patients. [Plasma product going into 120 types of medicines were reportedly exported to 21 countries and no material prior to 1 Jan 98 is still available for recall -- webmaster]

Dr. Peter Ganz, chief of the blood and tissues division at Health Canada's bureau of biologics, said in an interview yesterday that regulators were alarmed by the age of the Utah donor, who is still alive.

The common form of the neurological disease, known as "classical" CJD, typically strikes people in their 60s. Once the disorder strikes, it is always fatal and patients generally live less than a year.

Government regulators stress that although it's theoretically possible for classical CJD to be blood- borne, there is no evidence that this is the case and there have been no known instances of people getting the disease from blood transfusions. However, less is known about the "new variant" strain of CJD that researchers discovered two years ago. That variant is known to strike younger people, such as the Utah donor.

The new variant has been linked in Britain and France to ingestion of beef from animals with a similar disorder called bovine spongiform encephalopathy, or BSE -- mad cow disease. It is believed 27 people in Britain have died from the new form of CJD after eating beef products contaminated with the disease. The European Union has only recently lifted a ban imposed on on British beef in 1996.

Concerns about blood donated by Britons has U.S. regulators considering a ban on their donated blood. The Canadian Blood Service is not considering such a move at this time. Dr. Graham Sher, vice-president of the CBS, said in an interview that he has been told by officials from the U.S. Food and Drug Administration and Centres for Disease Control that the Utah donor has classical CJD -- not new variant."They have ruled that out," he said of the more mysterious strain.

But Dr. Ganz said Canada's regulators are unaware of any such conclusions and therefore called for the quarantine as a "precautionary" measure. "We have some preliminary data, but no fixed data to indicate that the diagnoses was with classical CJD," said Dr. Ganz.

At Monday's meeting, regulators will meet with Bayer and a panel of experts to review the patient's records. Since 1995, the federal government has had a simple regulatory policy on CJD: Any blood products containing the plasma of a CJD victim -- even if it is classical CJD -- should be withdrawn.

Dr. Ganz said this means that even if federal officials are assured early next week that the Utah donor has classical CJD, the temporary hold issued yesterday could be transformed into a permanent withdrawal. However, he added it's possible federal regulators might revise the ban on classical CJD-infected products if they are persuaded that a withdrawal could lead to a dangerous shortage.

Health Canada Advises Canadian Blood Services To Hold Certain Blood Products

 December 18, 1998 CNW
OTTAWA -- Health Canada has advised Canadian Blood Services (CBS) to hold certain blood products supplied by Bayer Inc. This is being done while Health Canada and the United States Food and Drug Administration investigate a situation where a donor who contributed to the plasma pools from which these products have been made has been tentatively diagnosed with classical Creutzfeldt-Jakob Disease (CJD). There are no known cases of transmission of CJD in humans from any blood product including plasma derivatives. Therefore, there is no evidence of risk associated with these products.

These are precautionary measures pending the investigation. This is not a recall.

The products implicated are:

     BayHep         Hepatitis B Immune Globulin (Human)
 Solvent/Detergent  Treated
                    Lot #636S06AA    Expiry 23 August 1999
                    Lot #636S06BA    Expiry 23 August 1999
                    Lot #636S04A     Expiry 10 April 1999
 
     Gamimune-SD    Intravenous Immune Globulin (Human)
 Solvent/Detergent  Treated
                    Lot #646S027     Expiry 19 September 1999
 
                    Lot #646T027     Expiry 28 June 2000
                    Lot #646T036     Expiry 5 August 2000
 
     Plasbumin      Albumin (Human) 25%
                    Lot #684T027     Expiry 12 May 2001
 
                    Albumin (Human) 5%
                    Lot #685S044     Expiry 9 June 2000
 
     Kogenate       Recombinant Factor VIII
                    Lot #670F093B    Expiry 10 December 1999
                    Lot #670G011A    Expiry 18 March 2000
                    Lot #670G012A    Expiry 21 March 2000
                    Lot #670G045A    Expiry 11 July 2000
                    Lot #670G064     Expiry 19 September 2000
 
 
CBS has advised hospitals to hold their inventories of these products and use alternative material if at all possible and is not instructing hospitals to return the implicated products. CBS is actively trying to acquire non implicated and alternative products on the international market.

Canadian Blood Services is a national, not-for-profit, charitable organization whose sole mission is to manage the blood supply in all provinces and territories outside of Quebec. CBS operates 14 blood centres and two plasma centres and countless blood donor clinics.

U.S. could block British blood over mad cow

 December 19, 1998 Reuters
BETHESDA, Maryland -- Federal advisers said on Friday the U.S. government should consider barring blood donations from people who lived in or visited Britain because of concerns about mad cow disease. The worry is that these people may have eaten meat or meat products infected with mad cow disease, and could be at risk for getting and transmitting new variant Creutzfeldt-Jakob Disease (CJD), U.S. Food and Drug Administration (FDA) advisers said. The FDA will now decide whether to direct blood banks to follow the panel's advice. No American cattle have had mad cow disease.

The panelists said blood banks should survey donors to find out if they lived or spent up to a year in Britain or visited from 1980 to the present. After that data is gathered, a final decision on whom to block from donating blood in the U.S. can be made, the panel said.

Thirty-four people in Britain have come down with new variant CJD. Four donated blood at some point, said Jeremy Metters, deputy chief medical officer at the United Kingdom Department of Health.

The vote was 9 to consider blocking donations and six against. The panel voted unanimously that the recommendation should apply only to Britain.

"We have such an imperfect understanding about what's going on," said committee member Stanley Prusiner of the University of California, San Francisco. Prusiner won the Nobel Prize in Medicine for discovering the organism thought to cause diseases like bovine spongiform encephalopathy (BSE), or mad cow disease.

The American Red Cross estimated that 10.7 percent, or one million units, of the current blood supply would be lost if people who had lived or travelled in Britain could not make donations. "In a blood supply that is already marginal, a 10 percent deficit could be irremediable," said Steven Kleinman, a pathology professor at the University of British Columbia and chairman of the American Association of Blood Banks' transfusion transmitted diseases committee.

At least one million new donors would have to be recruited to replace the loss, said Richard Daly, chief medical officer of the American Red Cross. New donors are more likely to have infectious disease, he said. "It's likely therefore that taking this step in the face of a theoretical risk may actually decrease the safety of the blood supply," Daly said.

Open letter to Utah Bureau of Epidemiology

5 December 1998 open letter to Utah Bureau of Epidemiology from Mel Steiger
1

Mr. Craig Nichols
Director, Bureau of Epidemiology
288 North 1460 West
Salt Lake City, UT 84114-2104
12 Dec 98

Dear Mr. Nichols,

This is a request to make a disease called Creutzfeldt Jakob Disease (CJD) mandatorily reportable. This is a horrible disease. To watch a person die this way is devastating to the family, and I am sure to the victim as they know something is wrong and lose their ability to communicate to you early in the clinical symptom phase. It destroys the brain and the body functions to the extent they become comatose and then die. The clinical symptoms of the disease may be very long, some victims have suffered the clinical symptoms for as long as 12 years. Here in Utah, we have data that says the disease shows clinical symptoms from several weeks to at least one year.

Six Utahns have died of this Creutzfeldt Jakob in 1998, and a seventh victim has been diagnosed with the same disease. There are many indications that this disease is much more prevalent than the existing data shows, and the frequency appears to be going up. Many people that I have described my wife's (Ellie) symptoms to have said that sounds more like what their relatives died of than what the doctors diagnosed it as, primarily due to the speed with which the disease consumed their loved ones. CJD is known as 'fast Alzheimers'. To leave the disease unreported and allow the increases to continue without notice, is to respond in the same manner that the United Kingdom did in their continuing saga of Mad Cow Disease (BSE).

This disease is a member of the Transmissable Spongiform Encephalopathy family. The disease is believed to be transmissible by food, airborne particles, contact with infected tissue, blood, implants such as corneas and dura mattter, by medical instruments that have previously been used on an infected patient, and by heredity. A pro-active approach needs to be taken, as a passive approach could be considered as willful neglect.

The infectous agent for this disease, believed to be a mis-folded protein called a prion, cannot be killed. Current medical technology believes they can reduce the infectivity of the prion, but does not know how to render it completely harmless.

The reasons for making this disease reportable are:

1. Provide a more accurate count of CJD victims. The current status of non-reportable does not place any emphasis on identifying this disease, it does not require the doctor to make a thorough analysis or to report it even if it is suspected. Making the disease mandatorily reportable would stress the importance of the disease and hopefully cause the doctor to be very thorough in the diagnosis.

1.a Making CJD reportable will increase the importance of the disease occurring, and should cause the doctors to concentrate on a correct diagnosis. Hopefully those doctors that are tempted to report the cause of death as dementia, which is a symptom and not a cause, will concentrate on arriving at an assignable cause, and may find that CJD is the real cause of the many dementia cases and some Alzheimer's cases that are reported. The Utah records show that 16 people have died of CJD (code 046.1) from 1989 through early 1998, while 425 people have died of dementia (code 290.1). These 425 deaths should likely be reassigned to CJD, Alzheimer's, or some other disease.

1.b The Red Cross rules state that "all blood relatives" of CJD victims cannot donate blood. This currently is interpreted to mean children, and blood brothers, sisters, nephews and nieces. To what levels it should go beyond that is not defined.

1.c These same blood relatives should not be allowed to donate organs. Are any questions asked about CJD history in the family when organ donor is marked on the driver's license? I wasn't asked any such question when I checked the donor block on my drivers license.

2. Morticians in many cases may expose themselves to the risk of contracting the disease that their victims die of. The reportable cause of death should be available for morticians so they may exercise proper precautions in handling of the body. Exposure to the brain, spinal tissue, lymph organs and blood are believed to be a very serious health risk for anyone involved with CJD. The National Funeral Directors Association has recommended that CJD victims not be embalmed. Therefore, concerned morticians most likely will not embalm the body of a CJD victim, and may refuse, and rightly so, to dress a body which has been autopsied. The morticians should be given the same opportunities to protect themselves as other people have that work with hazardous materials.

2.a CJD victims will likely be offered only one or two options, either direct burial or cremation. Victims that have been autopsied will likely not be dressed or prepared for an open casket funeral due to the danger to their personnel. At least one funeral director in Utah will not even recommend cremation due to the inability to kill the infective agent and the unpredictability of what happens to the ashes, which are believed to still be infective. At least two of the Utah victims were not embalmed, while the family of a victim from some years ago was charged an extra $500 for embalming due to the risks involved.

2.b Embalming wastes are normally drained into the sanitary sewer. The sewage treatment process as it is today is not capable of sterilizing such waste. Neither are the culinary water treatment plants. Blood is known to be a carrier of the disease, but the mechanism of how it carries the disease is not known. Thus, the wastes will pollute our water supplies to an increasing degree, and we cannot sterilize for it. The medical expertise and culinary water facilities are not available to sterilize the water. Just how much of this material can we put in our water system and still safely drink it? To quote an esteemed individual, 'The solution to pollution is not dilution.'

2.c Identified CJD victims will not likely be embalmed, therefore no pollution potential. If they are embalmed, it must be with special fluids such as gluteraldehyde, since formaldehyde is not acceptable to a CJD victim. The waste materials can be designated as Hazardous Waste and sent to an incinerator or controlled burial. Tools and utensils used must also be treated as hazardous waste and incinerated.

3. The disease is frequently misdiagnosed as Alzheimer's disease by as many as 13% of the Alzheimer's cases. A study at Yale revealed that 6 of 46 Alzheimer victims had really died of CJD. Utah currently has 25,000 living victims of Alzheimer's. If only 10% are CJD, then we have 2,500 cases of CJD.

3.a. Alzheimer patients and their families can donate blood. A mis-diagnosed CJD victim can therefore donate blood and be placed into the system. There is a test reported to be able to identify Alzheimer's specifically. I believe that making CJD reportable, would encourage the use of this test to ascertain that is not CJD. Victims and relatives of Alzheimer's victims can donate blood. The family of a CJD victim who is mis-diagnosed as Alzheimer's can contribute blood and potentially contaminate the system further. We should make Alzheimer's reportable also to minimize the under-reporting of CJD.

3.b The families of CJD victims could have genetic testing done to verify the potential risk to blood relatives and marital partners. However, if mis-diagnosed as Alzheimer's, then the search may be for the wrong genetics

There are numerous forms of this disease. It has appeared in humans primarily as CJD and as New Variant CJD (nvCJD). There are approximately 21 different strains of this disease that have been identified. It also appears in deer and elk as Chronic Wasting Disease (CWD), in cattle as Bovine Spongiform Encephalopathy (BSE or Mad Cow Disease), in sheep as Scrappie, in mink as Transmissible Mink Encephalopathy (TME), and in pigs, cats, primates, most likely other animals including chickens and squirrels.

Colorado is believed to have had 40 deer taken in this year's hunt that have tested positive for CWD. South Dakota has tested 178 brains from animals which were kept on farms. These tests have shown 38 positive tests on elk and 2 on white tail deer in 1998. The mode of transmission from animal to animal is not known. It has been known to transmit merely by being placed in a pen which has previously been inhabited by an infected animal, even though all normal sterilization techniques were implemented in the pens. The pens were left vacant for 1 to 5 years.

CWD is mandatorily reportable in Utah, South Dakota, and some other Western states. Animals are also controlled and traced as to their movement from location to location. It seems strange that it is reportable and controlled in animals and not in humans?

It has been shown to be transmissible to humans by consumption (BSE and Kuru), contact with open cuts on the gums (Deadly Feasts by Richard Rhodes), injection of blood directly into the brain, consumption of contaminated vegetation, and merely by being in the proximity of other infected animals.

The gestation period is normally about 36 to 42 months for TSE in animals, same as scrappie in sheep.. In humans, CJD may take as long as 30 years to show visible signs of it.

Sterilization of contaminated instruments is not known to be possible; normal sterilization techniques are not effective in destroying the causative agent. The minimum conditions for sterilization of tools is thought to be 140 (C (288(F) for 30 minutes, and there are opinions that this is not adequate. The University of Nebraska medical laboratory requires that instruments used in surgery or autopsy on infected persons be destroyed. Some hospitals (one major hospital in SLC) will not take brain biopsies on a suspected victim for fear of the infectivity of the samples.

Canada will not allow persons that have had a blood transfusion donate blood for future transfusion. Neither can anyone who has lived in the United Kingdom donate in Canada.

Britian has decided to destroy all of their donated blood for fear of transmission of nvCJD to other people..

Information pamphlets which describe some of the variations of the disease are attached. Additional information is available for your review.

The British Government has gotten themselves in a horrible situation by denying that this disease ever existed for many years. They also denied the cause of nvCJD for fears of the consequences to their beef industry. They destroyed approximately 3.7 million head of cattle as a result. Their problems are still not over as they are now concerned about the effects of BSE on their sheep.

Britain's blood donation program is still limited by the effects of nvCJD as they will not allow blood from their people to be used for transfusion. Canada will not allow anyone who has lived in Great Britain to donate blood.

Eight countries, among them being Austria, Norway, Portugal, Malta, Ireland and recently Canada, have now decided to filter their blood that is donated for transfusion. They will filter out the white corpuscles which are believed to be the carriers of CJD. Canada is supposed to start filtering their blood in June 1999.

Is the risk of an epidemic over? No, the European community has just advised Portugal that they will not accept Portugese beef due to the current infestation of BSE in their cattle -- they have much higher rate of infection than the Portugese government admits to.

Bone meal used as animal food and rose bush fertilizer is considered infectous and cannot be fed to our animals per a recent FDA ruling. Neither should it be handled by gardeners with out proper personal protective equipment. Once used, that area of the garden should also be cordoned off and no one allowed to enter without proper protective clothing on.

I am happy to supply you with any additional data that I can find. Please call if there are questions on this request or any of the statements made herein.

Sincerely yours,

Mel J. Steiger

cc: Mr. Rod Betit, Executive Director, Utah Health Department
Dr, Chuck Brokopp, Division Director, Utah EpiLab
Mrs. Gerrie Dowdle, Manager, Communicable Disease Program
Mr. Mike Hansen, Consumer Affairs
Dr. Doug Lyon, EIS Officer, CDC
Dr. Diane Nielson, Executive Director, Utah Environmental Quality
Mr. Ted Stewart, Govenor's Chief of Staff
Utah Senate Health Committee
Utah House of Representatives Health Committee
Utah Science and Agriculture Committee

Hemophiliacs urge ban on blood donation by travelers to Britain

December 20, 1998  Nando Media  Agence France-Press
OTTAWA - A group of Canadian hemophiliacs has called for a ban on blood donations from people who have traveled to Great Britain over concerns about the transmission of mad cow disease, a report said Sunday. The society noted the apparent occurrence in Britain of a new form of Creutzfeldt-Jacob disease which is believed to be linked to bovine spongiform encephalopathy (BSE), or mad cow disease, the Montreal newspaper La Presse reported.

"We do not take this decision lightly," a Canadian Hemophiliac Society official was saying, adding that the group wanted to ensure the security of blood but also to avoid shortages of transfusable blood. On Saturday, Canadian health officials announced that they had asked hospitals not to use blood coming from an American donor who came down with Creutzfeldt-Jacob Disease.

No cases of blood transmission of the fatal neurological disease have yet been found but the Canadian Health Ministry has taken the precaution of asking for the recall of certain lots of blood products produced between February and November 1998 by the drug company Bayer. The hemophiliac group's demand comes after reports in Britain indicated that Creutzfeldt-Jakob disease could be transmitted by injections of growth hormones.

Foie gras to be outlawed

December 22, 1998  Reuters News Service
BRUSSELS (December 22, 1998 12:26 p.m. EST http://www.nandotimes.com) - European gourmets may be about to enjoy their last Christmas dinners starting with traditional foie gras if European Union scientists get their way.

A study into the production method of the rich delicacy -- made from the livers of ducks and geese which have had large amounts of grain crammed down their gullets through a tube twice a day -- concluded that "force-feeding as currently practiced is detrimental to the welfare of birds."

In a move likely to cause consternation, if not rage, in France and elsewhere, the scientists urged drastic changes to the rearing and feeding of the birds.

Their study is intended as non-binding advice for the European Commission, the EU's executive, which now must decide whether to use its recommendations as a basis for a legislative proposal.

The present method of producing foie gras causes the liver to be enlarged by up to 10 times that of a normal bird. The livers are then preserved and sold either whole or in pate form.

An "extreme" option, the scientists said, would be a complete ban on the production, importation and distribution of foie gras made under the force-feeding method. But they stopped just short of recommending this, acknowledging such a move would have disastrous consequences for the foie gras industry, mainly situated in southwestern France, where it employs almost 30,000 people, some part time.

"The irritation of the 30,000 people directly concerned with the production would also be shared by restaurant owners and the consumers themselves," the report said. But the study was welcomed by animal welfare groups, which are stepping up their calls for a ban in the only three EU countries -- France, Belgium and Spain -- which have yet to outlaw the process.

"The report is a catalog of welfare problems, which occur, in this much-criticized farming practice," said David Wilkins, director of the EU animal welfare lobby Eurogroup.

Canadian Health Department releases blood that had been quarantined

December 24, 1998 CP
Health Department releases blood that had been quarantined OTTAWA (CP) -- The Health Department has released thousands of vials of blood from quarantine after deciding there is no risk of infection from blood donated by a U.S. donor with Creutzfeld-Jakob Disease. The decision will avert the risk of shortages of crucial blood products in Canada over the holiday season.

The decision reverses a 1995 policy banning the use of blood products associated with donors diagnosed with Creutzfeld-Jakob Disease unless they are required in life threatening situations. Creutzfeld-Jakob Disease, also known as Mad Cow disease, is a serious neurological illness.

Keith Bailey, director of the federal Bureau of Biologics and Radiomedicals, told a news conference Thursday that federal officials consulted experts in Canada and abroad and are confident the blood poses no risk. The quarantine was imposed last week after officials learned a 29-year-old Utah man diagnosed with Creutzfeld-Jakob Disease had donated blood nearly 100 times in the past two years. Bailey said it has been established the Utah donor suffered from classic Creutzfeld-Jakob Disease, not from a new, less-understood variant of the disease.

There is no evidence the classic form of the disease can be transmitted by blood, said Bailey. [Absence of evidence is not evidence of absence -- webmaster] There is still uncertainty about whether the new variant of the disease can be transmitted by blood, and blood donated by someone diagnosed with the new variant will continue to be withheld. So far, new-variant Creutzfeld-Jakob Disease has not been diagnosed outside of the United Kingdom and France.

Bailey said a great deal of scientific evidence has accumulated since the introduction of the 1995 policy banning all blood associated with Creutzfeld-Jakob donors.

"All the evidence points to there being no transmissability of CJD (classic Creutzfeld-Jakob Disease) in blood products. That evidence was not available in 1995." [There is no such evidence -- webmaster]

Canadian Blood Services had been warning of possible shortages of blood products over the holiday period if the quarantined blood was not released.

Ministers clash over badger cull decision

December 30 1998  By Jill Sherman London Times
TWO Whitehall departments are heading for a clash over the fate of Britain's badgers.

In August the Ministry of Agriculture, Fisheries and Food decided to go ahead with a random cull of the animals to assess their role in spreading tuberculosis among cattle. But Michael Meacher, the Environment Minister, is determined to stop it, arguing that they should be protected.

Jeff Rooker, the Food Safety Minister, announced plans to kill 12,000 badgers over five years while Mr Meacher, who had opposed the scheme, was on holiday in August. The move was in response to a scientific report which, though inconclusive about the role of badgers in spreading TB in cattle, recommended a trial cull. Under the £6 million scheme, which started last month and is to cover about 30 areas in Britain, three different experiments are being carried out at each site.

The only trial to have gone ahead so far is in Cornwall and Devon. In the first experiment, badgers are culled at Putford, where a cattle herd has been infected; in the second, they are culled in Hartland, where there is no infection; and in the third, in Bude, none is killed. The badgers are lured into a cage by a poisoned bait, and their bodies collected and examined.

Mr Meacher wants the cull postponed pending a scientific review of its impact on the badgers. The all-party Select Committee on Agriculture is to hold its own inquiry into the trial's design and likely effectiveness next month. It is still unclear whether badgers originate TB or contract it from cattle. Mr Meacher argues that it is difficult to defend killing badgers where there is no evidence of disease. About 400 farms in England and Wales are under restrictions because of TB outbreaks in cattle. Farmers blame the badger population, which has risen to almost 400,000.

[MAFF's previous largest scandal was a coverup of bovine tuberculosis. Over 50,000 human deaths were attributed to this decision over a period of decades.. -- webmaster]

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