Another nvCJD Blood Recall
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Blood cells thought to transmit human BSE
Pattison fears CJD in blood reserves
Doctor warns of CJD risk in British blood supply
Report of the SEAC Meeting on 24 October 1997
Israeli fetuses may be tainted by 'mad cow' protein
Another nvCJD blood recall
World needs cross-species transplants?
Supreme Court denies Alzheimer feeding appeal
Public awareness study
WTO asked to back beef hormone ban
U.S. ``won't stand idly by'' if EU mad cow ban stands
First mad cow case surfaces in Belgium
Swiss detect another 'mad cow' case
BeefAmerica plant allowed to reopen
Ethical questions about Alzheimer's
S. Dealler asks: why are nvCJD victims ok as US blood donors?
Second nvCJD donor blood products recall

Blood cells thought to transmit human BSE

By Roger Highfield, Science Editor
Telegraph ... Friday 7 November 1997
The discovery led the Government yesterday to launch a study of the risk that transfusions and blood products may pass on infection. In addition, the National Blood Authority has been asked to consider the widespread introduction of a technique to remove white blood cells from donated blood by a process called leucodepletion, because studies suggest the cells may offer a route for infection.

The Spongiform Encephalopathy Advisory Committee recommended these actions, as a precaution, though there is, as yet, no evidence that any of the 22 cases of new variant disease arose after the receipt of blood. There is, however, evidence that circulating white blood cells called lymphocytes may play a more important role in the new variant of CJD - human BSE - than in the classic form of the disease, offering a route of infection from the gut to the brain .

"It is logical to seek to minimise any risk from blood or blood products by reducing the number of lymphocytes present," it said in its advice to ministers. The Government has accepted its recommendations.
Frank Dobson, the Health Secretary, said:
"The Government will continue to take whatever scientifically necessary action is practicable to protect the public from any risk of contracting new variant CJD. No one who needs treatment with blood or blood products should have any hesitation about accepting it; any risk of new variant CJD will be far outweighed by the risks of damaging health through not doing so."
He stressed that blood donors were not at any risk.

Blood filtering could be expensive. Some estimates say the cost will be at least £20 per donation. With 2.5 million samples per year, the overall cost would be at least £50 million.

The focus on blood has arisen from research which found that the tonsils of patients infected with new variant CJD contained the infectious agent, an abnormal version of a prion protein. Tonsils are part of the body's infection-fighting lymphatic system which exchanges cells with the blood supply, so the discovery by Prof John Collinge at St Mary's Hospital, London, raises the possibility that blood may be infectious.

This dovetails with work by Prof Adriano Aguzzi of Zurich University, Switzerland. The puzzle had been how eating food could cause a brain disease. In September, Prof Aguzzi reported in Nature a series of experiments on mice stripped of their immune systems which demonstrated how the agent needed the immune system to pass from the gut to the brain. His team revealed the "bridge" from gut to brain: first the agent passes to the lymph system, to a class of cells called follicular dendritic cells. From there it may pass to white blood cells, notably lymphocytes, and then to the peripheral nervous system that detects pain and moves muscles. From there it spreads to the brain.

The good news of this discovery is that this serial chain of infection, between gut and brain, offers the best place to block the process. The bad is that this again does not rule out the possibility that abnormal prion is indeed present in blood .

The committee also considered the theory that organophosphate was linked to the BSE epidemic but concluded that contaminated animal feed offered a more plausible explanation.

Pattison fears CJD in blood reserves

November 10 1997  by a correspondent London Times
A LEADING government health adviser believes there is a "significant risk" that CJD could be present in the national blood supply. John Pattison, chairman of the Spongiform Encephalopathy Advisory Body, says the Government, which received his report on recent discoveries about new variant CJD last week, should take preventive action. He tells Panorama on BBC1 tonight: "It's a significant risk for public health, one that we need to be concerned about." He advises that individuals might want to donate their own blood for their own use in order to minimise any possible risk of infection, and also urges the medical profession to give transfusions only to those who really need them. "I think the principle that's involved is to reduce the exposure of any individual to someone else's blood." However, the warnings have not convinced the National Blood Authority that blood transfusion patients need to be worried about possible infection. Sue Cunningham, a spokesman, said yesterday: "There is no evidence that CJD has passed through our blood supplies."

Doctor warns of CJD risk in British blood supply

 Reuters North America  Mon, Nov 10, 1997
LONDON - Britain's national blood supply could be infected with a new strain of the human equivalent of mad cow disease, a leading health official said Monday. Professor John Pattison urged the government to take action to minimize the threat from the variant of Creutzfeldt-Jakob disease (CJD), following recent discoveries about the brain-wasting illness.
"It's a significant risk for public health, one that we need to be concerned about and to take whatever measures we can to protect public health," he told the BBC's Panorama program, to be broadcast later Monday. "I think the principle that's involved is to reduce the exposure of any individual to someone else's blood, and there are a number of ways that you can achieve that."
Two recent studies have confirmed that bovine spongiform encephalopathy (BSE, or mad cow disease) causes the new strain of CJD, and that eating infected beef is the likely cause. Pattison, chairman of the government's Spongiform Encephalopathy Advisory Body, said screening procedures for blood donors should be tightened. He encouraged people to donate blood for their own use to reduce the risk of exposure. He stressed no one knew what percentage of the British population could have new variant CJD and might be donating blood.
"It's still impossible to say with any accuracy but there could be quite significant numbers of people incubating new variant CJD, raising the possibility that these people could be donating infected blood to the national stocks," he said.
British health officials said last month they had been searching for the blood donated by three confirmed CJD sufferers and one suspected patient since July. The government's chief medical officer, Kenneth Calman, said there was no evidence that CJD could be transmitted through blood transfusions, but he was not certain about the new variant of the disease.

He said it would take "some considerable time" before scientists have sufficient data on the new version of CJD to know for certain if it is transmissible through blood. But Professor Adriano Aguzzi, a leading CJD specialist in Switzerland, warned that a wait-and-see policy could be dangerous.

"If we wait until we see transmission of new variant CJD through blood than we may have waited 20 years too long because of the incubation," he told Panorama. "So I think it would be irresponsible just to wait and see. That has been done for BSE and we don't want to repeat it," he added.
The European Union imposed a ban on British beef in 1996 after scientists suspected a link between BSE infected cows and new variant CJD. According to the latest figures released by the Department of Health, 21 deaths have been caused by the new strain. CJD is an uncommon but rapidly progressive form of dementia in humans that normally occurs between the ages of 40 and 65. Scientists discovered the new variant that hits young people in 1996.

Report of the SEAC Meeting on 24 October 1997

24 October 1997
DEPARTMENT OF HEALTH 97/333 Thursday 6th November 1997 ... SEAC MEETING PUBLIC SUMMARY

The Spongiform Encephalopathy Advisory Committee (SEAC) met on 24 October 1997 at the offices of the Ministry ofAgriculture, Fisheries and Food, Tolworth. The Committee conducted its regular review of the emerging experimental data and of the epidemiology of BSE and nvCJD. The number of cases of BSE continues to be in line with predictions about the decay of the epidemic. No new confirmed cases of nvCJD in the UK had been notified by the CJD Surveillance Unit since the last meeting. Subsequent to the meeting, however, a single case has been confirmed taking the total to twenty-two. The Committee reviewed the safety of blood and blood products and has provided advice to Government on these matters (copy attached).

The Committee considered further papers relevant to the hypothesis that the organophosphate, Phosmet, is in some way causally linked to the BSE epidemic. It was noted that the epidemiological evidence is better accounted for by the view that the BSE epidemic is due to the widespread use of animal feed contaminated with the transmissible agent of BSE than by the OP theory. Central to the latter is the bio-accumulation of OP in treated animals however the available evidence does not support such accumulation. The Committee concluded that experimental evidence would be required to justify further consideration of a role for organophosphates in the epidemiology of BSE. Proponents of the theory were free to apply to funding agencies for resources to conduct such experiments. However, on the evidence to date the Committee did not feel that special priority should be given to this area of research.

The Committee reviewed the production and use of tallow. It noted the restrictions in the UK on the sources of raw material used in the production of tallow for food, feed, cosmetic, medical or pharmaceutical products and was impressed by UK tallow production controls. The Committee noted that imported tallow was not subject to the same restrictions nor required to reach the same standards but that the implementation of Commission Decision 97/534/EC would result in the exclusion of Specified Risk Materials from the production of tallow across all Member States from January 1998.

The Committee also reviewed the production and use of gelatin. It noted that plants in the UK manufacturing gelatin for food, feed, cosmetic, medical or pharmaceutical use have been brought under official control. The Committee also noted that all UK gelatin manufactured for these purposes from bovine raw material utilised only imported ingredients. They noted that implementation of Commission Decision 97/534/EC would exclude Specified Risk Materials from the source materials used for gelatin manufacture in all Member States. The Committee is due to meet again in December.

Spongiform encephalopathy committee - advice to ministers human blood and blood products

The Committee have recently concluded that the transmissible agent of nvCJD is indistinguishable from that of BSE but distinctly different from any of the forms of classical CJD. Recent research (some unpublished) suggests that the pathogenesis of nvCJD differs from that of classical CJD and the former may have more involvement of lymphoreticular tissues possibly involving circulating lymphocytes.

Therefore it is logical to seek to minimise any risk from blood or blood products by reducing the number of lymphocytes present. SEAC recommends that the Government should consider a precautionary policy of extending the use of leucodepleted blood and blood products as far as is practicable. It will be for the National Blood Authority to devise a strategy to implement such a policy. It will take time to achieve full implementation and SEAC recommends that planning begins soon while the risk assessments suggested below are carried out. It is not possible at present to estimate accurately the risk of transmitting nvCJD by blood transfusion. The magnitude of the risk will depend, inter alia, on the number of blood donors who are incubating nvCJD and this is not known. However, SEAC recommends that risk assessments, making assumptions of various possible incidences of nvCJD, be carried out to inform decisions on any measures which may be necessary to protect recipients.

BEEF

SEAC reviewed the safety of beef in the light of its discussion on human blood and blood products. Transmission experiments in mice have not found infectivity in the spleen, tonsil, lymph nodes or white blood cells of BSE infected cattle. The Committee conclude, therefore, that no further measures governing beef and beef products for human consumption, are necessary.

DoH 97/335 Thursday 6th November 1997: SEAC advice on safety of blood and blood products accepted

Health Secretary Frank Dobson announced today that he had accepted advice from the Spongiform Encephalopathy Advisory Committee (SEAC) on possible precautionary steps to protect recipients of blood and blood products from any possible risk of contracting new variant CJD (nvCJD). Mr Dobson, said:
"The Government will continue to take whatever scientifically necessary action is practicable to protect the public from any risk of contracting nvCJD.

"The Government accepts the advice it has received from SEAC and the MSBT and I have therefore asked the Department's Director of Research and Development, Professor Swales, to commission an assessment of the risks of human to human transmission of nvCJD through blood and blood products. Meantime, I have instructed the National Blood Authority (NBA) to start work towards the possible extension of leucodepletion of blood in order that they are prepared in the event that the risk assessment indicates that this would be a sensible precautionary measure.

" The Government will publish the results of the risk assessment and their response as soon as they are available." Mr Dobson added:

"These are purely precautionary measures. No-one who needs treatment with blood or blood products should have any hesitation about accepting it; any risk of nvCJD will be far outweighed by the risks of damaging health through not doing so.

"Blood donors are not at any risk. The gift of blood is a very precious one which is invaluable to the health service and to the health of patients."

SEAC's advice was also considered by the Advisory Committee on the Microbiological Safety of Blood and Tissues (MSBT) and the Government has taken account of their views in its response.

Commentary on the blood aspect

Dr Roger Highfield Electronic Telegraph  7 November 1997
HUMAN BSE" may be more likely than the classic form of Creutzfeldt-Jakob Disease to be transmitted by blood. The discovery led the Government yesterday to launch a study of the risk that transfusions and blood products may pass on infection. In addition, the National Blood Authority has been asked to consider the widespread introduction of a technique to remove white blood cells from donated blood by a process called leucodepletion, because studies suggest the cells may offer a route for infection.

The Spongiform Encephalopathy Advisory Committee recommended these actions, as a precaution, though there is, as yet, no evidence that any of the 22 cases of new variant disease arose after the receipt of blood. There is, however, evidence that circulating white blood cells called lymphocytes may play a more important role in the new variant of CJD - human BSE - than in the classic form of the disease, offering a route of infection from the gut to the brain.

"It is logical to seek to minimise any risk from blood or blood products by reducing the number of lymphocytes present," it said in its advice to ministers. The Government has accepted its recommendations.
Frank Dobson, the Health Secretary, said:
"The Government will continue to take whatever scientifically necessary action is practicable to protect the public from any risk of contracting new variant CJD. No one who needs treatment with blood or blood products should have any hesitation about accepting it; any risk of new variant CJD will be far outweighed by the risks of damaging health through not doing so."
He stressed that blood donors were not at any risk. Blood filtering could be expensive. Some estimates say the cost will be at least 20 pounds per donation. With 2.5 million samples per year, the overall cost would be at least 50 million pounds.

The focus on blood has arisen from research which found that the tonsils of patients infected with new variant CJD contained the infectious agent, an abnormal version of a prion protein. Tonsils are part of the body's infection-fighting lymphatic system which exchanges cells with the blood supply, so the discovery by Prof John Collinge at St Mary's Hospital, London, raises the possibility that blood may be infectious.

This dovetails with work by Prof Adriano Aguzzi of Zurich University, Switzerland. The puzzle had been how eating food could cause a brain disease. In September, Prof Aguzzi reported in Nature a series of experiments on mice stripped of their immune systems which demonstrated how the agent needed the immune system to pass from the gut to the brain. His team revealed the "bridge" from gut to brain: first the agent passes to the lymph system, to a class of cells called follicular dendritic cells. From there it may pass to white blood cells, notably lymphocytes, and then to the peripheral nervous system that detects pain and moves muscles. From there it spreads to the brain.

The good news of this discovery is that this serial chain of infection, between gut and brain, offers the best place to block the process. The bad is that this again does not rule out the possibility that abnormal prion is indeed present in blood.

Mad cow victim sparks blood donations alert

PA (PA News)
Thu, Oct 30, 1997
By John von Radowitz and Rachel Ellis
Blood products made with donations from victims of the new "Mad Cow" strain of CJD were ordered to be recalled today . The move by the Medicines Control Agency came after new recommendations from a European medicines advisory committee. News of the decision emerged when the National Blood Authority announced a recall of plasma products from 26 distribution sites in England.

Blood plasma donated by an unnamed victim of new variant CJD -- the brain condition believed to be triggered by eating beef infected with Mad Cow disease -- was traced to the products, which are used to treat burns and haemophilia. A hunt for the batch of albumin and Factor VIII was launched after officials were alerted to the 1995 blood donations by the father of the CJD victim, who is understood to have died.

The patient's condition was only diagnosed on Tuesday.

A statement from the National Blood Service said: "The recall is purely a precautionary measure since there is no epidemiological evidence to suggest that CJD can be transmitted between humans through blood transfusions or the use of blood products." However the recall notice only applies to new variant CJD -- not products derived from donations by people with the "classic" forms of the disease with no link to BSE.

The fact that nvCJD has been singled out reflects concern over the lack of knowledge about the new strain. Experts including Professor John Pattison, chairman of the Spongiform Encephalopathy Advisory Committee which helps shape Government policy on CJD and BSE, admit that although blood transmission of the disease is unlikely it cannot be ruled out.

Today's action was sparked by new advice received from the European Committee on Proprietary Medicinal Products. A National Blood Authority spokeswoman said the instruction specifically mentioned blood products, but not blood for transfusions. Presumably this is because by the time a CJD case is confirmed any donated blood would have been used up. Blood products are stored for much longer, but the spokeswoman said there was still a "large chance" that those ordered recalled have been used by now.

Earlier this month the Government's Chief Medical Officer, Sir Kenneth Calman, disclosed that three known victims of nvCJD and one suspected case had been blood donors. Scientists from the CJD Surveillance Unit in Edinburgh are tracing those donations as part of a study of the potential risk of transmission. This is quite different from today's action, where a general recall instruction was issued on public health grounds, albeit as a precautionary measure.

The NBA spokeswoman said the CJD victim at the centre of the recall was previously listed as "suspected". Attempts will now also be made to recall blood products linked to the other CJD-victim donors. However these have not yet been identified. Plasma from the blood donated by the latest confirmed victim was pooled with that from 2,000 other donors. The batch to be recalled had been available for use since September 1995. The Department of Health said the advice was that unused blood products derived from the blood of donors who subsequently develop nvCJD should be recalled and quarantined.

Today's move appears to have undermined an investigation by the CJD Surveillance Unit. In order to carry out the study it had been necessary to withhold the identities of blood donors. Blood service staff were given a number of donations to follow up without being told which were from the CJD victims. This removed any chance of bias when looking for signs of adverse effects in patients.

The matches were only to be made once all the data had been gathered by the scientists. But the confidentiality rule was dropped because of the recall instruction.

"In light of the new guidance we've had no option but to break confidentiality in all four cases," said the NBA spokeswoman.

CJD death toll reaches 22

PA News Nov 3, 1997 By Jo Butler, Consumer Affairs Correspondent, PA News
The death toll of people who are thought to have been victims of the brain disease linked to eating BSE-infected meat has reached 22, according to official figures published today. [data to 30 Sept, UK only, next posting 1 Dec 97] The monthly update on the death toll from CJD rose by one from 21 last month.

The latest victim of so-called new variant CJD was sports fanatic Chris Warne, from Ripley, Derbyshire.

Tests completed last month proved that the 36-year-old systems analyst died from the brain disease, which can only be officially confirmed after a post mortem. It brings the total number of people to have died from the strain so far this year to nine [extapolates to 12 for calendar year]. Last year the total was 10 [may have caught up on earlier undetected cases]

Public awareness study

September 18, 1997 Press Release
CMF&Z and Burson-Marsteller are owned by Young and Rubicam.  
Both PR firms work extensively on defusing food safety issues,
Y&R makes out the ads.
Editors and public address food safety concerns Fourth Annual Study Compares Media and Consumer Responses to Food Safety Issues DES MOINES, Iowa - - Consumers are becoming an increasingly concerned about the safety of the food, with their level of concern driven largely by food safety scares, a recent survey by CMF&Z Public Relations shows. The nationwide survey of consumers and editors who cover food and food safety issues was the fourth in as many years by CMF&Z, a Young and Rubicam affiliate. The 1997 survey was co-sponsored by the Industry Council on Food Safety, a restaurant and foodservice industry coalition.

Two-thirds, 67 percent, of editors who cover food safety and more than one-half, 52 percent, of consumers believe food safety is a more important consumer issue than it was a year ago. The rising importance consumers are placing on food safety issues was cited as a major factor in the Clinton Administration's $43 million plan to enhance food safety from the farm to the table.

The CMF&Z-Industry Council survey showed 79 percent of consumers had recently seen or heard media accounts of food safety issues including stories related to tainted strawberries, E-coli bacteria, salmonella, food handling and preparation and others. Mad cow disease was cited by only 3 percent in the 1997 study, compared with 33 percent in the 1996 survey when the disease and its perceived link to the food supply received considerable media publicity.

While 32 percent of consumers believe less than one-half of media stories on food safety issues, more than three-fourths of the consumers surveyed said they would take action in response to negative stories concerning safe drinking water, bacteria in food and food preparation. More than 60 percent would act on the basis of negative stories about pesticide residue, food handling, food processing and mad cow disease. However, the study showed sharp differences between consumers and editors on why food safety is becoming more important. While 43 percent of the editors said food safety's rising importance is a result of increased media information, only 18 percent of consumers cited media information as the reason food safety has become more important to them. Thirty-seven percent of editors cited continued food safety problems as a chief cause of the rising importance of the issue, compared with 19 percent of consumers who cited problems as responsible for their heightened concern about food safety. One-third of the consumers surveyed, 33 percent, compared with 21 percent of editors, cited increased public awareness as the leading cause for food safety's rise in importance.

The survey, conducted in April and May of 1997, questioned editors and the general public about a range of food safety issues. The survey was conducted via telephone interviews with 150 editors who represented newspapers >from across the United Sates, with circulations from under 25,000 to over 100,000. In addition, the survey contacted a random sample of 150 members of the general public. Additional survey highlights include:

Which food safety issues are of greatest concern? There were significant discrepancies between the issues editors felt were causing the public concern and what the public reported. In addition, the media underestimated the level of concern the public would feel about the issues. The media (81 percent) said the public would be most concerned about food handling. The next highest ranking issues in the editors minds were safe drinking water (78 percent), fat content and food preparation (77 percent), bacteria (75 percent), pesticides (62 percent), food processing (56 percent) and sodium content (56 percent). The public gave high rankings to several issues causing them the most concern: safe drinking water (86 percent); food handling (85 percent); food preparation (81 percent); bacteria (77 percent); pesticide residue (75 percent); food processing (73 percent); and fat content (62 percent).

Who do the public hold responsible for food safety? Nine in 10 respondents named meat and poultry packers, food processors and manufacturers, supermarkets and restaurants responsible for ensuring a safe food supply. Eight in 10 respondents said farmers and producers, and government agencies. The survey showed great consistency between consumers and editors on the issue, except in one area. Less than one-half of the editors said consumers hold themselves responsible for food safety, while 83 percent of consumers said they hold themselves responsible.

How credible is the media as a source of food safety information? The media retain high credibility with the public as an information source. More than three-fourths of the public respondents believe half or more than half of what they see in the media. Nine percent believe it all; nine percent believe less than half.

Who is doing a "good" job of ensuring food safety? On this subject as well, editors and the public were in general agreement. The top marks for doing a good job were given by both groups of respondents to producers/farmers and supermarkets. Consumers, food processors and restaurants also were ranked highly by both groups. Editors and consumers expressed less confidence in the job being done by meat and poultry packers and government agencies. These groups received votes of confidence from less than 40 percent of the respondents. However, a comparison of the four annual surveys shows a steady climb in consumer confidence in government agencies and meat and poultry packers.

Is it important to have a safe handling sticker on food? Two-thirds said such stickers on meat products are very important; 22 percent said the stickers are somewhat important; and only 9 percent said they were not very important. A majority, 57 percent, said safe handling labels would also be important for produce.

What are consumer perceptions of meat irradiation? Forty-five percent of consumers said they are somewhat or very aware of meat irradiation, up from 31 percent who were aware of the issue in the 1996 survey. Of those who are aware, 44 percent said they believe irradiation would be effective in improving the safety of meat and 50 percent said they believe it would enhance the safety of produce. Sixty-four percent of those aware of irradiation said they would likely purchase meat that has been irradiated and 66 percent said they likely would purchase irradiated produce.

The information generated by the survey provides useful insight into how closely the media are in sync with the attitudes of consumers about food safety and also give clues to how to work more effectively with the media, said Carol Bodensteiner, president of CMF&Z Public Relations.

"The survey confirmed some things we had suspected based on comparing our results from previous years' surveys to the results of surveys conducted by other organizations," said Bodensteiner. "The public is generally more aware of food safety issues and more concerned about a broad range of food safety topics than the media perceives."

"The media members cited fat content as among the most important food safety issues. Among the public, fat content ranked seventh on a list of food safety concerns. The public may believe they have more control over their consumption of fat and expressed greater concern with food safety issues over which they have little control."

"At the same time the public is concerned about a wide variety of food safety issues and appears to be looking for ways to increase their level of confidence in the food supply. Their responses indicate they see the safe handling stickers as an important way to be in control of the safety of the food they eat and serve."

An ongoing focus of the survey is to determine how the media view the various sources from whom they receive information on food safety to identify areas in which the food industry may improve its efforts.

The 1997 survey questioned the media on the communications practices of various groups, specifically asking which do the best job in the areas of amount of information provided, frequency of contact, accessibility and credibility. Overall, universities rated highest, receiving "good job" ratings from 59 percent of editors,. Government agencies, which received "good job" marks from only 31 percent of respondents to the 1996 survey, received similar marks from 48 percent of the respondents in the 1997 study. Consumer groups were rated as doing a "good job" by 44 percent of them media, and commodity groups received a good job rating from 37 percent of the media.

In conclusion, Bodensteiner commented that the food industry can use information such as that generated by this media/public survey to fine-tune their communication efforts.

"Linking food industry initiatives with research from credible organizations such as universities will assist the industry in moving important food safety issues forward in the media market place, doing a service to both the media and the public," Bodensteiner said.

Scientists say world needs cross-species transplants

October 30, 1997 By GEIR MOULSON, Associated Press Writer
GENEVA -- Transplanting animal organs into humans offers such promise that nations should cooperate to overcome scientific and ethical problems, experts said Thursday at a U.N.-sponsored meeting. Scientists have suggested in recent years that animals not only could ease the shortage of kidneys, hearts and livers for transplantation, but also supply brain tissue to treat diseases like Parkinson's and pancreatic tissue to treat diabetes.

Attention has focused on the pig, which has internal organs the right size for transplant to humans and breeds rapidly, meaning a large potential organ supply. There is concern, however, at the risk of infections crossing species barriers. Experiments so far have focused on limited transplantation of animal tissue rather than whole organs. The World Health Organization sponsored a two-day meeting ending Thursday to examine the possibilities and implications of "xenotransplantation."

British bioethics expert Dr. Rachel Bartlett said the starting point is the situation faced by people in need of transplants but unable to find donor organs. Professor Jeffrey L. Platt of Duke University said as little as 5 percent to 15 percent of the donor organs required may be available. About 2,000 heart transplants are carried out every year in the United States, while an estimated 40,000 hearts are needed. The problem is magnified in developing countries, where the resources are in far shorter supply. Platt said every conceivable way to increase the amount of organs available for transplant in the United States has been tried, but all have fallen well short of meeting requirements.

The use of nonhuman organs could solve the dilemma of how available organs are distributed, he said. He also denied that the need for organs could be met by using dialysis and other mechanical procedures. The experts said they also discussed the implications of transplants from pigs with scholars of Islam and Judaism, both of which forbid eating the animal as unclean, and had received a generally favorable response.

"The Koran and the Old Testament -- Leviticus particularly -- talk about the pig only in dietary terms," said Professor Abdallah S. Daar of Oman University. "Neither restrict the introduction of porcine material through other orifices or through surgical incisions," Daar said.
Some concerns have been raised over the development of "transgenic" animals, containing a human gene, to reduce the risks of patients rejecting organs. Such animals could be viewed as hybrids, but Bartlett said the human gene was "one gene of many" which would bring about only a "small and specific change." Discussion between countries is necessary, she said, "to make sure xenotransplantation goes ahead as safely as possible," especially as "viruses and bacteria do not carry passports."

WTO asked to back beef hormone ban

November 3, 1997  Reuters 
BRUSSELS - The European Union will make a last-bid effort on Tuesday to overturn a World Trade Organization decision that its ban on imports of hormone-treated meat violates free trade rules. The European Commission, the EU executive, will try to convince a WTO appellate body in Geneva that the EU had the right to impose the ban to protect public health.

The eight-year-old EU ban on imports of beef produced with the aid of synthetic growth hormones mainly affects exports from the United States, which won the ruling by a WTO dispute panel in July. Washington was backed by Australia, Canada, New Zealand and Norway. The U.S. meat industry says the ban has cut sales to EU countries by between $100 million and $250 million a year. However, the EU -- hit with a separate crisis over "mad cow disease" -- would find it politically impossible to relax the ban, which also applies to home-grown beef.

All 15 EU countries support the appeal.

The Commission expects a final ruling on the appeal before December, he added. If Brussels loses, but still declines to act, the WTO's Dispute Settlement Body (DSB) could request the EU to pay compensation to the United States for the amount of trade it says it has lost. If the EU refused, the DSB -- on which all the WTO's currently 131 members have a voice -- could authorise U.S. trade retaliation to the same amount.

Supreme court denies Alzheimer feeding appeal

November 3, 1997 By LAURIE ASSEO, The Associated Press
WASHINGTON -- The sister of an elderly Wisconsin woman who suffers advanced Alzheimer's disease lost a Supreme Court bid Monday to end her artificial feeding, days after doctors allowed removal of the feeding tube. The court, without comment, turned down Betty Spahn's argument that she should be allowed to have the feeding halted even though her sister at the time was not in a persistent vegetative state.

Edna M. Folz, 73, suffers from Alzheimer's disease, is bedridden and cannot eat, move or follow simple commands such as looking when her name is called. She was being kept alive with a feeding tube, but three doctors determined Thursday she was in a persistent vegetative state and allowed her feeding tube to be removed. Folz Monday was unconscious at St. Joseph's Hospice in Marshfield, Wis., according to hospice spokeswoman Carla David.

Spahn, Folz's sister and court-appointed guardian, asked the nursing home in October 1994 to end the artificial feeding. The nursing home said it would do so only under court order. In 1992, the Wisconsin Supreme Court ruled that when someone is in a persistent vegetative state, a guardian can decide to withdraw artificial feeding and other life-sustaining treatment. But a state judge would not allow Folz's feeding to be halted because she was not in a persistent vegetative state. The Wisconsin Supreme Court agreed last June, ruling that a guardian can decide to withhold life-sustaining treatment in such cases only when the patient had stated in advance that he or she would not want it.

Folz had not made such a clear statement of her desires, the state court said.

In the appeal acted on Monday, Spahn's lawyers said the Wisconsin ruling violated Folz's equal-protection rights because guardians of people in a persistent vegetative state can exercise their right to withhold treatment. People in Folz's condition must "remain in hopeless conditions of irreversible illness," Spahn's lawyers said. Howard Eisenberg, the Marquette University law dean appointed by the Wisconsin Supreme Court to defend the lower court's decision, said Folz was not in pain now but that ending the feeding would cause her pain.

"Some rights are personal and cannot be exercised by a guardian," Eisenberg added.

First mad cow case surfaces in Belgium

Reuters World Report Oct 31, 1997
BRUSSELS -- Traces of mad cow disease have been found in a Belgian beef cow in the first case to be reported in the country, a Belgian newspaper said on Friday. The debilitating illness had been found in the brain of an ailing cow analysed by the National Institute of Veterinary Research near Brussels, La Derniere Heure said.

In the past week samples of the brain had been sent for further analysis to a laboratory in Britain, where the disease, also known as bovine spongiform encephalopathy (BSE), was first discovered. The Belgian Agriculture Ministry said it would hold a news conference on Friday afternoon on the subject of the BSE story in the newspaper, but gave no details.

Belgian RTBF radio said the animal was from a farm in the southern Namur region. The exact location was not known, but once confirmation was obtained from Britain, all the farm's animals older than two years would be slaughtered.

Despite an 19-month-old worldwide ban on British beef exports imposed by the European Union, meat from Britain has been surfacing in other member states. Cases of suspected BSE have been found in the Netherlands and France. The ban was imposed during the consumer scare unleashed after the British government revealed that there could be a link between mad cow disease and Creutzfeld-Jakob disease, a similar brain-wasting affliction affecting humans.

BeefAmerica plant allowed to reopen

November 3, 1997 The Associated Press 
OMAHA, Neb. -- A BeefAmerica processing plant reopened Monday after being shut down because of repeated health violations and shortcomings in related paperwork. The U.S. Department of Agriculture inspectors were back Monday at the plant in Norfolk in northeastern Nebraska.
"The product we have is inspected by the USDA and approved by the USDA," said company spokeswoman Kim Essex.
The USDA withdrew its inspectors from the beef plant Friday -- effectively shutting down operations -- after it discovered repeated violations of sanitation rules, including contamination of meat with fecal matter and peeling paint coming into contact with meat.

The plant had been the subject of two meat recalls this year totaling more than 600,000 pounds of ground beef. No illnesses were reported, but the USDA said the company was not properly testing for contamination by E. coli bacteria.

BeefAmerica president Bob Norton said the sanitation problems pointed out by federal inspectors had been immediately corrected, but the company failed to provide enough paperwork showing that corrective action was taken.

New regulations implemented earlier this year require companies to document all corrective and preventive actions. Norton said that during the weekend the USDA helped the company improve its paperwork procedures.It was the second shutdown of a packing plant in Nebraska this year. A Hudson Foods Inc. plant in Columbus was shut down in August after 25 million pounds of beef were recalled; that plant has been sold to IBP Inc.

Israeli fetuses may be tainted by 'mad cow' protein

November 3, 1997  The Associated Press 
JERUSALEM -- Some women who underwent in-vitro fertilization in Israel recently may be carrying fetuses infected with the human variant of Mad Cow disease, a Health Ministry official said Monday. The Haaretz newspaper reported that hundreds of fetuses may be infected as a result of being grown on a protein from a donor who died of Creutzfeldt-Jakob disease.

Health Ministry spokesman Yair Amikam confirmed that hundreds of women were treated with the infected blood, but only some of them became pregnant. Even in those cases, Amikam said there was only a small risk the babies born would develop the condition.

"We told the couples not to halt their pregnancies, as there is only a very minimal chance of infection," Amikam told the AP.
He did not give exact numbers or identify the donor. According to Amikam, eight in-vitro fertilization labs used the man's blood. Amikam said they were informed by the company who provided the donor's blood that he had died of Mad Cow disease.

Eating meat from cattle tainted by the disease is believed to cause the brain-wasting Creutzfeldt-Jakob disease in humans, which has killed at least 20 people, mostly in Britain. The outbreak of the disease in Britain caused a crisis in the European Union last year. Beef exports from Britain were banned, and the EU had to pay farmers across the EU billions of dollars to prop up prices as consumers shunned beef.

Ethical questions about Alzheimer's

November 4, 1997  Scripps Howard 
(Bruce Hilton is director of the National Center for Bioethics
If you're over 40, you've probably felt that shadow pass over. The one that leaves you wondering, for just a second, after you've forgotten a name that should have been on the tip of your tongue. The shadow of a doubt: Alzheimer's? And then you laugh it off.

Alzheimer's disease. It has to be right up there among the cruelest and most frightening illnesses -- if only because we seem to fear bodily harm less than we fear losing our ability to reason and remember. There are about 4 million people in the United States with Alzheimer's disease (AD), and another 2 to 3 million who take care of them.

You probably know the wife who visits her husband every day, and has to tell him who she is each time. Or someone like the retired fireman who was diagnosed after he got lost walking the two blocks from his home to the firehouse. These and other AD patients are half of the nursing home residents in the country. It costs an average $45,000 a year to take care of each one, whether at home or in a home.

The physical and financial burdens are part of our fear. But there are other burdens less well known: the ethical quandaries that accompany AD. For example:

What does the testing mean?

There are two kinds of genetic test for AD. One, fairly clear and accurate, tells patients they are likely to develop the disease. But the gene it reveals is responsible for only 5 percent of all AD. The other test shows only a predisposition for AD. People with these genes apparently need some push from the environment to become AD patients -- and the test results, in percentages, are no more helpful than the weather person's "30 percent chance of rain for the weekend." How do you make crucial life decisions on such probabilities?

Should we test?

If there's a test, there will always be pressure to take it. Meanwhile, each participant will have a different view of testing -- the patient, the relative, the doctor, the insurance company, the drug company and the government policy maker. Do you agree that testing should take place only if it makes sense from the patient's point of view? And if the patient refuses, what about the right of a sister or son to know of their chances of developing AD? As of now, most experts advise against testing for AD except when there's a family history of AD. They say the odds are too long and the information too vague.

Home tests:

Suppose you just have to know. Surprisingly, the Food and Drug Administration doesn't regulate the advertising and marketing of AD tests. They may become available without the necessary counseling and explanations. Who will know? Suppose your daughter's test shows her susceptible to AD. How will the information be kept from the insurance companies and possible employers -- neither of whom is likely to want to sign her up.

Life-changing information.

Suppose your baby son is found to have an AD gene called APOE4. And you learn that a head injury may make people with the APOE4 gene more likely to have AD in later years. Would forbid your son to play contact sports? Would you advocate APOE4 testing for all children who sign up for contact sports?

Now or then?

AD begins with alternate periods of clarity and confusion. During the clear times, the patient may worry about becoming a burden to her family, and consider an early end to life. But she faces a Catch-22. She will be capable of planning and acting only while she is in full possession of her faculties -- and thus is neither sick nor dying. If she waits till she is clearly ill, she will no longer be able to make a decision or take drastic action.

One of Dr. Jack Kevorkian's earliest "clients" was an AD patient in this predicament. Critics pointed out that she had played tennis with her family just the day before her death. Few of them knew that she hadn't been able to score. This is not a suggestion that her solution was right for everybody. Only she could make that choice. But it is a reminder of the cruelty -- including the perplexing ethics dilemmas -- that Alzheimer's disease continues to bring to our world.

Swiss detects new 'mad cow' case

November 4, 1997  Agence France-Presse 
LAUSANNE, Switzerland - A new case of "mad cow" disease has been reported in Switzerland, bringing the total tally for the year to 32, Swiss authorities said Tuesday. The animal, which was due to be slaughtered, was born before the December 1990 ban on the use of animal carcasses in cattle feed.

Some 45 cattle in Switzerland have been detected with bovine spongiform encephalopathy (BSE), or "mad cow" disease last year. Recent research ponts to a possible link between BSE and Creutzfeldt-Jakob disease, a degenerative brain disorder in humans.

Why are nvCJD victims ok as US blood donors?

97-11-04  S. Dealler
"I can understand why blood transfusion risk from sporadic CJD are likely to be very low (calculated rate of people dying from catching CJD from blood and then living a further 20 years to incubate the disease: 2 cases per annum). But I cannot understand why nvCJD should be looked on in the same way. Calculated rates obviously depend on the rate of nvCJD in the donor population but this could be quite high. After a lot of mathematics the number of people dying from nvCJD from blood transfusion would be approximately 10% of the rate from eating BSE. This being the case from simple calculations would suggest that UK citizens should not be donors in the USA. Could you let me know why they are still accepted as donors in the USA?"
Eileen Church comments on 'tainted fetuses'
Am.Assoc.Blood Banks
5 Nov 97
"I believe that the AP article "Israeli fetuses may be tainted by "mad cow" protein, refers to the practice of using albumin as a stabilizer in in vitro fertilization.

At a late September meeting on research initiatives regarding the transmission of CJD by blood, held by the US National Heart, Lung and Blood Institute, Paul Brown, MD, presented data on infectivity of fractionated blood products. Dr. Brown stated that there is a good possibility that albumin is not infectious in "real life" situations.

At a subsequent Food and Drug Administration meeting on this issue, the FDA Transmissible Spongiform Encephalopathies Advisory Committee recommended that products that have an extremely low risk of carrying CJD, such as albumin, should be exempted from withdrawals of blood products associated with a donor who later develops CJD.

The Health and Human Services Committee on Blood Safety and Availability will probably have the final word on this issue. Current CJD policy will be on the Committee's agenda when they meet in January 1998, exact date to be determined.

Blood banks provide counseling to persons who have a family history of CJD and to those who have received units from a donor who subsequenly is diagnosed with CJD. A test for rogue prions would solve some of their problem, but advise is given to those with a positive test? "

Roland Heynkes comments:

There have been two CJD patients who had received albumin from people who later developed CJD. Although this does not prove an iatrogenic transmission with albumin, these cases should make Dr. Brown more careful.

CrČange,A.; Gray,F.; Cesaro,P.; Adlebiassette,H.; Duvoux,C.; Cherqui,D.;
Bell,J.; Parchi,P.; Gambetti,P.; Degos,J.D. - Creutzfeldt-Jakob-disease
after liver-transplantation - Annals of Neurology 1995 Aug; 38(2): 269-72

CrČange,A.; Parant,M.; Gray,F.; Cesaro,P.; Degos,J.D. - Pooled plasma
derivatives and Creutzfeldt-Jakob-disease - reply - The Lancet 1996;
347(N9006): 967

Ricketts,M.N.; Cashman,N.R.; Stratton,E.E.; ElSaadany,S. - Is
Creutzfeldt-Jakob Disease Transmitted in Blood? - Emerging Infectious
Diseases 1997 Apr-Jun; Vol 3(2) - Updated: 97/05/14

nvCJD donor blood products recalled

PA News Tue, Nov 4, 1997 By Rachel Ellis, Health Correspondents
A second batch of blood products made with donations from a victim of the human form of mad cow disease was recalled today. The National Blood Authority today sent out a notice to all major hospitals across the country recalling plasma products after it emerged the latest official case of new variant Creutzfeld Jacob Disease had given blood.

Blood plasma donated by an unnamed victim of new variant CJD - the brain condition believed to be triggered by eating beef infected with Mad Cow disease - was traced to the products after the case was confirmed at the end of last week. This is the second such recall in a week following new recommendations from the European Committee on Proprietary Medicinal Products.

Last week a hunt for a batch of albumin and Factor Eight, which are used to treat burns and haemophilia, was launched after officials were alerted to blood donations made in 1995 by another person who went on to develop CJD by the victim's father.

Both victims, among the 22 official cases of new variant CJD, are understood to have died. A statement from the National Blood humans through blood transfusions or the use of blood products. The recall notice only applies to new variant CJD, not products derived from donations by people with the "classic" forms of the disease with no link to BSE. The fact that new CJD has been singled out reflects concern over the lack of knowledge about the new strain.

Experts including Professor John Pattison, chairman of the Spongiform Encephalopathy Advisory Committee which helps shape Government policy on CJD and BSE, admit that although blood transmission of the disease is unlikely it cannot be ruled out. Plasma from the blood donated by the victims was pooled with that from 2,000 other donors. A spokeswoman for the NBA said there was a "large chance" that those ordered recalled have been used by now.

U.S. ``won't stand idly by'' if EU mad cow ban stands

Reuters World Report Wed, Nov 5, 1997 Nov 5 and Dow Jones
BRUSSELS - The United States urged the European Union on Wednesday to declare U.S. products free of mad cow disease risks and warned that it would retaliate if the EU insisted on rules that could shut out safe goods.
"We can't stand idly by while billions of dollars of pharmaceutical and cosmetic products which are absolutely, completely safe...cannot come in," said U.S. Under-Secretary of State for Trade Stuart Eizenstat after talks with EU officials. "We could simply not remain silent about the implications for EU exports coming into the United States," he said, declining to provide any example of what form retaliation might take.
The two-way trade in medicines, pharmaceuticals and cosmetic products which use cattle-derived tallow or gelatins is worth $14 billion a year, Eizenstat said at a news conference with senior EU official Hans Beseler. Eizenstat said the dispute over the EU's trade regulations concerning BSE (bovine spongiform encephalopathy or mad cow disease) was "the biggest problem on the trade front" at the moment. He said the best solution was to declare the United States free of BSE, "as in fact we are."
"There has never been a reported case of BSE to our knowledge in the United States...(but) we frankly did not get a terribly positive indication that" the EU would accept that as proof that there was no health risk, he said.
Washington has threatened to make a formal complaint to the Geneva-base World Trade Organisation (WTO) unless the EU changes the regulation before a ban on imports of products assessed to carry a BSE risk takes effect on January 1. "The clock is ticking away," Eizenstat said, noting that the two sides had less than two months to reach a solution.

Beseler agreed that "the money involved is enormous" but insisted that the EU must be guided by its scientific experts who say they cannot declare the United States free of BSE because "there are cases not of BSE but of TSE in the United States." TSE is a transmissible form of animal brain disease, such as scrapie, the illness found in sheep and transmitted to cattle fed with sheep brains and spinal offal.

A second reason for EU stand was that U.S. farmers practised "this process of feeding animals again with animals." Beseler said problems concerning products containing tallow were "more or less solved" but cases concerning goods with gelatin would have to be submitted to the case-by-case process which Eizenstat called unacceptable.

"This is more than a trade issue for the United States. This is a health issue for Europe," Eizenstat said, pointing out that European consumers and pharmaceutical industries producing vitally needed medicines would be deprived of base products if the regulations were enforced as they now stood. A case-by-case approach would have a devastating impact on the trade, he said, outweighing by light years the "infinitesimal" risk of BSE in American-made products.

Stuart Eizenstat, under-secretary for economic and business affairs at the State Department, said billions of dollars a year of U.S. pharmaceutical and cosmetics exports to the E.U. will be disrupted if the U.S. isn't exempted from the Jan. 1 ban.

Eizenstat said the U.S. will retaliate against the E.U. if the country isn't exempted from the ban. He declined to elaborate, but said the total value of U.S.-E.U. trade in the products in question is $14 billion a year.

Eizenstat was speaking at a press conference after meeting trade officials from the E.U. Commission, the executive of the 15-member E.U. The E.U. ban will be on products made from animal remains that could contain bovine spongiform encephalopathy, or "mad cow" disease. The remains - known as specified risk material - are the head and spine of cattle, sheep and goats over 12 months old and the spleen of all sheep and goats.

The ban affects tallow production. Tallow is generally made from whole cattle carcasses. Tallow derivatives are used in an estimated 80% of pharmaceuticals, as well as in cosmetics and other goods.

Nobelist cautious on mad cow-human link

Nobelist cautious on mad cow-human link

UPI US & World by Mara Bovsun  Thu, Oct 23, 1997
NEW YORK, Oct. 23 (UPI) -- Nobel prize winner Stanley B. Prusiner says he is not yet convinced that what causes mad cow disease is the culprit in the new human form of the brain destroying illness. Prusiner won the ultimate scientific prize as the pioneer of prion theory, that proposes that some proteins can mutate without genes and become infectious, causing deadly brain diseases. Prions have been implicated in mad cow disease and a human variant of the disease.

Prusiner says a lot of data is accumulating that mad cow disease is the cause of the fatal human disease that has now struck 23 people in Britain and France, called new variant Creutzfeldt-Jakob disease (nvCJD). But, he says, "all of this data is a little circumstantial." He said that if this were a viral disease, researchers would be able to use genetic detection tools to trace the virus from one host to another, something not possible with these diseases. That's because prions, malformed pathological versions of normal proteins, change as they move from one species to another.

He also says with only 23 cases, it would be hard to say for sure that tainted beef was the cause.

"The day there are 1,000 cases of new variant CJD, everyone will agree it came from the cow, or even 100 cases over the next year would convince everyone," he says. But, the fact that the disease is so rare "still makes us want to reserve judgment just a little bit," he says. "Now, the argument is 'What else would it be?' but I don't think that's a scientific argument. "
Prusiner, of the University of California, San Francisco, made his comments to an overflow audience of about 650 doctors, medical students and scientists at Columbia Presbyterian's College of Physicians and Surgeons.

He was in town to receive Columbia's Louisa Gross Horwitz Prize, which has been awarded by Columbia since l967 for research not recognized by other scientific awards. The decision to give the prize to Prusiner was made in May, before the Nobel Prize annoucements earlier this month.

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