News concerning BSE/nvCJD and Blood Transfusion/Pooled Plasma Products

The full details are now to be found at priondata.org
The details below are now out of date and will be kept up to date on the new site above.
 

July 2001.  Announcement that USA is no longer going to accept peope that have stayed in Europe for lengthy periods and visitors to the USA from Europe to donate any blood in the USA.  They are no longer going to accept European plasma products also.

March 2001.  I enclose an entire message from Linda Zambenini.  This basically shows that there is argument in the USA as to how long people might have been in Europe before their blood donation is banned:

"...In an incredible about face by the American Red Cross they are admitting that nvCJD "will
come to the US" and to protect the US blood supply from the human version of mad cow
disease they are going to go way beyond the weak new regulations that the FDA  proposes to
implement to ban donors who have spent TEN YEARS in France, Portugal or Ireland. Instead
this is what the ARC wants:
 
 

* The American Red Cross will soon announce a ban on all blood imports from
Western Europe - and on blood donations from anyone who has lived or traveled in
Western Europe for at least three months - in a bid to keep the U.S. blood supply safe
from the killer disease. (NB: NYC gets 25% of its blood supply from Europe now).

Red Cross officials believe the federal Food and Drug Administration's proposed ban
on blood from the United Kingdom, France, Portugal and Ireland isn't stiff enough
in the face of the growing spread of mad cow disease - or Bovine Spongiform
Encephalopathy (BSE) - in those countries. "It is undeniable that it will come to the
U.S.," said Dr. Rebecca Haley, a chief medical officer at the American Red Cross.

"We have to be very responsible and be extremely safety conscious and keep [blood]
donations as safe as possible even at the risk of depleting the blood supply," said
Haley, warning that mad cow disease could pose as great a threat to the blood supply
as AIDS if precautions aren't taken.
 

 January 2001. By this time it seems that blood from UK donors will not be accepted anywhere in the world if they are asked. Also, it now seems that large numbers of countries are refusing blood from people that have visited the UK on extended periods. This includes USA, Canada, Australia, New Zealand, Hong Kong, Belgium, Switzerland, Austria. 

 Brown writes that in this issue of The Lancet, F Houston and co-workers report convincing evidence that blood from a seemingly healthy sheep incubating BSE (infected by the oral route with brain from a diseased cow) was able to cause the disease when transfused into another sheep. This observation is entirely consistent with past experience in experimentallyinfected rodents. It extends current knowledge about blood infectivity in experimental models to a host/TSE strain pair that is closer to the human vCJD situation than the earlier rodent studies. It is also the first successful transfusion of BSE from blood taken during the all-important incubation period of infection. This result is part of a larger study (n=19)that includes both positive and negative control animals, all still healthy and in various early stages of the incubation period. Is it appropriate to publish an experimental result from a single animal in a study that is not far enough along even to have validated its positive controls? Brown says that the UK National Blood Transfusion Service has already implemented leucodepletion of donated blood, and imports all plasma and plasma derivatives from BSE-free countries. No further measures would seem possibleshort of a draconian decision to shut down the whole UK blood-donor system. What, therefore, is the rationale for this publishing urgency? The answer, evidently, is a perceived need to "defuse", by an immediate and accurate scientific report, public reaction to possibly inaccurate media accounts. The full study, when it appears, will be an important addition to our knowledge of TSEs, but science should not be driven to what in certain medical quarters might be termed a premature emission through fear of media misrepresentation.
Laboratory of Central Nervous System Studies, National Institutes of Health, Bethesda, MD 20892, USA
1 Ghani AC, Ferguson NM, Donnelly CA, Anderson RM. Predicted vCJD mortality in Great Britain. Nature 2000; 406: 583-84.
2 Brown P. Can Creutzfeldt-Jakob disease be transmitted by transfusion? Curr Opin Hematol 1995;2:472-77.
3 Brown P, Cervenáková L, McShane LM, Barber P, Rubenstein R, Drohan WN. Further studies of blood infectivity in an experimental model of transmissible spongiform encephalopathy, with an explanation of why blood components do not transmit Creutzfeldt-Jakob disease in humans.Transfusion 1999;39:1169-78.
4 Rohwer RG. Titer, distribution, and transmissibility of blood-borne TSE infectivity. Presented at Cambridge Healthtech Institute 6th Annual Meeting
"Blood Product Safety: TSE, Perception versus Reality", MacLean, VA, USA, Feb 13-15, 2000.
5 Hill AF, Butterworth RJ, Joiner S, et al. Investigation of variant Creutzfeldt-Jakob disease and other human prion diseases with tonsil biopsy samples. Lancet 1999; 353: 183-89.

Reuters/ PA News 15.9.00 BLOOD CAN TRANSMIT HUMAN MAD COW DISEASE-STUDY LONDON - Mad cow disease and its human equivalent can, according to these stories, be transmitted through blood transfusions, scientists in Scotland were cited as saying on Friday. Until now transmission of the deadly brain disorder, known as new variant Creutzfeldt-Jakob disease (vCJD), through contaminated blood has only been a theoretical risk. But researchers at the Institute of Animal Health in Edinburgh said they have infected a sheep with mad cow disease, or bovine spongiform encephalopathy (BSE), through a blood transfusion from another sheep carrying the disease but with none of the symptoms. Although there have been no reported cases of human transmission through blood or blood products, the Edinburgh scientists were cited as saying their research proves it is possible. Chris Bostock was quoted as writing in The Lancet medical journal that, "This report suggests that blood donated by symptom-free vCJD-infected human beings may represent a risk of spread of vCJD infection among the human population of the UK." Scientists have suspected that tainted blood could spread the infectious degenerative disease and the preliminary findings of the Scottish research,the story says, confirm their fears. In a commentary in The Lancet, Paul Brown of the National Institutes of Health in Bethesda, Maryland, said the study was "convincing evidence" that the illness can be transmitted through blood."It is also the first successful transfusion of BSE from blood taken duringthe all-important incubation period of infection," he added. 

Return to blood transfusion and BSE science page or the index page or the Phillips Inquiry news

New federal policy bans those at risk of brain disease

HALIFAX -- Canadians who have spent six months or more in Britain since 1980 must be banned from donating blood, according to a safety measure to be announced today by the federal government.

The donor deferral policy is a precaution to screen out people who have unknowingly contracted new variant Creutzfeldt-Jakob disease -- a fatal brain disorder associated with mad cow disease.

Officials at Health Canada will announce the regulatory requirements in Ottawa this morning. Under the plan, the six-month cutoff will be a minimum requirement that Canada's two blood agencies must follow.

The Canadian Blood Services, which collects and distributes blood everywhere except Quebec, will adopt the minimum standard. All donors who have cumulatively spent six months or more in Britain from 1980 through 1996 will be banned.

The blood agency's own survey has found the ban will cause a loss of at least three per cent of its 600,000 active donors, with the impact being felt hardest at blood banks in large cities such as Toronto and Vancouver.

Hema-Quebec is poised to go beyond the minimum regulatory standard. Because far fewer of its donors have visited Britain, the agency believes it can withstand a move in which donors who have spent one month or more in Britain are banned.

Health Canada is giving both agencies until Feb. 1, 2000, to implement the donor deferral policies, although it's expected they might have new programs in place as early as this fall.

Erma Chapman, president of the Canadian Hemophilia Society, said last night she was pleased with the decision by Canadian regulators. "We're very supportive of the policy. It's a step forward in safety for Canadians."

Ms. Chapman said now the blood agencies must implement a "very aggressive campaign" to recruit new donors to replace those who are lost.

There are no known cases of new variant Creutzfeldt-Jakob disease being transmitted through blood, but experts say there is a theoretical risk this can happen, especially since the strain is much more virulent than other forms of the disease.

Mad cow disease first appeared in British beef in 1980. In 1996, the human form, nvCJD, began appearing in Britons who had apparently eaten the beef.

Victims of the neurological disorder suffer memory loss, restlessness, seizures, loss of speech, dementia and usually within a year, death.

A foremost expert on the disease, Dr. Neil Cashman of the University of Toronto, wrote in a report to the federal government this year that: "CJD is a nightmare disease: clinically devastating, rapid, fatal and utterly untreatable."

Ms. Cashman added that nvCJD poses a significantly higher risk than the more common version, known as classical CJD.

The newer version is more virulent, hits victims at a younger age and spreads through the body instead of being concentrated in the brain.

As well, because nvCJD only surfaced in 1996 in Britain and infected people are still incubating the disease without showing symptoms, the risk of it being blood borne remains unknown.

Also today, the U.S. Food and Drug Administration will announce that blood banks in that country must "defer" donors who have spent six months or more in Britain.

For months, there has been pressure on Canadian regulators to move in tandem with the U.S. About half of all the plasma contained in blood products used by Canadians -- ranging from hemophiliacs to cancer victims -- comes from U.S. plasma donors. Tue, Aug 17, 1999 WASHINGTON --

Some Americans who traveled frequently to Britain during that country's mad cow disease crisis are being banned from donating blood back home

The Food and Drug Administration on Tuesday imposed the ban on blood donations by anyone who has traveled to, or lived in, Britain for a total of six months since 1980.

The average tourist who spent just a few weeks in Britain can still donate blood -- but people who went to Britain repeatedly between 1980 and 1997, the crisis years, will have to add up their trips to see if they're under the six-month limit.

Canada issued a similar restriction Tuesday.

The donor ban is strictly a precaution -- there is no evidence that any mad cow-type illness has been spread through blood transfusions. But the mad cow disease that swept through Britain's cattle has been linked to a human brain-destroying illness, and both illnesses are so mysterious that scientists simply can't rule out the possibility they could infect blood.

Still, the FDA's donor ban is controversial. It is sure to frighten Americans whose blood is refused.

Worse, the American Red Cross estimates the ban will cut U.S. blood donations by 2.2 percent at a critical time. Even before Tuesday's action, experts were predicting severe, nationwide blood shortages to hit as early as next year because blood donations already were falling.

As many as 200,000 to 250,000 blood donors could be turned away by the new ban, said James MacPherson of America's Blood Centers, which represents blood banks that provide half the nation's supply. Because people in the Northeast and large cities travel more than people from other parts of the country, areas such as New York could be hard hit.

"We certainly do not intend by this to scare people," said Mary Elizabeth Jacobs, the FDA scientist who coordinated the policy's development.

The FDA plans to work with blood banks to find ways to ease the donor loss, but MacPherson said the government also needs to help blood banks explain the issue to the confused or frightened donors they turn away. "It's going to be an extremely difficult issue for people to understand," he said.

At issue is an infection that kills by literally eating holes in brain tissue. In cattle, it's called mad cow disease, and it swept through British herds starting in the late 1980s.

About one in 1 million people around the world gets a similar brain disease called Creutzfeldt-Jakob disease, or CJD. Although CJD sometimes is hereditary, usually its cause is not known.

The worry about blood stems from Britain's discovery in the mid-1990s that some people apparently caught a new strain of CJD by eating beef infected with mad cow disease. Named "new variant CJD," it has killed 41 Britons.

There is no known mad cow disease in U.S. cattle. The United States has not allowed importation of British beef for over a decade and no American is known to have caught new variant CJD.

But because these brain diseases can incubate for years without causing symptoms, some scientists say the possibility exists that they'll one day discover a link between blood transfusions and infection.

Much is not known about the new human disease, including exactly how Britons were sickened. Theoretically, even a brief visit to Britain could have exposed someone to new variant CJD. But the FDA settled on the six-month limit to reduce the possible risk without slashing the U.S. blood supply; banning donors who spent less time in Britain would have had a far greater impact. The ban covers travel to or residence in England, Scotland, Wales, Northern Ireland, the Isle of Man and the Channel Islands.

 The advisers to the Food and Drug Administration expressed concern about a theoretical risk that a similar human brain disease might be able to spread through blood.

 Panel members stressed that their vote did not mean that frequent travelers to Britain are at risk of getting a fatal illness linked to mad cow disease -- or of spreading it through their blood.

 The problem is that scientists just don't know if the illness can be spread that way. There's never been a human case where that happened. But at issue is a new fatal disease that doctors don't yet understand -- and some scientists have successfully transmitted similar illnesses to animals through blood.

 ``The day you find out there is (human) transmission, you're years too late'' to protect the blood supply, warned Dr. Linda Detwiler of the U.S. Agriculture Department as the panel voted 12-9 that FDA should forbid some blood donations.

 The FDA is not bound by its advisers' recommendations, but typically follows them.

 If it does so in this case, it must decide how long someone had to stay in Britain to be deemed enough of a risk to refuse their blood.

 That's crucial because an American Red Cross study found almost 23 percent of recent blood donors had traveled to Britain at least once between 1980 and 1996. If the FDA barred them all, the United States would face a critical blood shortage.

 The advisory panel said the concern is not a typical week-long tourist trip. Instead, a majority said Americans must have spent a total of over six months in Britain between 1980 and 1996 before being blocked from donating blood. Some advisers wanted the time extended to over a year, excluding fewer people.

 Blood donations are dropping every year even as demand for blood increases, and every summer and during holidays parts of the country experience serious shortages.

 If the FDA blocks travelers who spent a total of six months in Britain, there will be a 2.2 percent drop in the U.S. blood supply, the Red Cross study said.

 A majority of FDA's advisers said even though the risk is only theoretical, it makes sense to be conservative in protecting the public. Some noted that critics say the AIDS epidemic might have been mitigated had doctors taken a more aggressive stand to protect the blood supply in the early 1980s.

 At issue this time is an infection that kills by literally eating holes in brain tissue. In cows, this condition is called mad cow disease -- and from the late 1980s through 1996, British cows suffered an epidemic. Mad cow disease also has been found in cattle in certain other countries, but Britain was hardest hit.

 About one in 1 million people around the world gets a similar brain disease called Creutzfeldt-Jakob disease, or CJD. Although CJD sometimes is hereditary, usually its cause is not known.

 The worry about blood stems from Britain's discovery in the mid-1990s that some people caught a new variety of CJD apparently by eating beef infected with mad cow disease. Named ``new variant CJD,'' it has claimed 39 British victims.

 There is no known mad cow disease in U.S. cattle, the United States has not allowed importation of British beef for over a decade and no American has caught new variant CJD.

 But because these brain diseases can incubate for years without causing symptoms, some scientists say the possibility exists that years from now they will discover a link between blood transfusions and infection. Indeed, doctors are closely watching Britain to see if that happens.

 The British government now imports drugs made from blood plasma from other countries, although British researchers told the FDA panel Wednesday that they simply cannot predict the risk, if any.

 Canadian health officials last month decided they, too, would determine how to block blood donations from certain Canadians who traveled to Britain.

 AP-NY-06-02-99 1814EDT Copyright 1998 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without prior written authority of The Associated Press.
 
 

This was followed by news articles such as the ones in the news section in June 1999. 

May 1999

December 1998

November 1998

Information concerning the banning of UK donors in Canada suggests that they have not carried this out yet but were considering it soon.

Express 16.11.98 How many more must be put in peril by blood products? Editorial. An aggressive article indicating that when they approached the officials concerning the risks from blood products, particularly gamma globulin against hepatitis A and anti-D. The argument put forward was perfectly reasonable and demanded to know why action was not taken that day rather than waiting. They were also unimpressed by Dobson's speech in the House of Commons last week in that he did not approach the hepatitis A subject. The author explains that the Committee on the Safety of Medicines, which had demanded that anti-D be considered a risk, had given rise to the replacement of UK plasma with USA plasma in its production at BPL. When it turned out that BPL could not do this in the time, the Department of Health said that they did not attempt to buy in foreign anti-D because the CSM had not asked them to. The editor is scathing at this. Just because committees do not demand something does not mean that departments cannot think for themselves. In the end the editor says "The Government needs to get its act together. At the very least, it needs to ban all further use of UK-sourced gamma globulin Hepatitis A. This day." (Ed - of course the Express editor is correct in this. The lack of information reaching the medical profession in the UK has led to little demand from them and the continuing use of the product). 

Information appeared indicating that the price of fresh frozen plasma was to drop to 13 pounds a unit from the National Blood Authority as a national price rather than many local ones of up to 52 pounds. The question as to whether the low price may get people to use more and use it in replacement of albumin (and hence put more risk of nvCJD as albumin is expected to carry little infection) is currently unclear. 

October 1998

September 1998

August 1998

The USA is now thinking of banning UK donors. This came out at the meeting in York and was quite a shock.
 
 

July 1998

Mail 17.7.98 CJD `almost certainly in the blood supply'. This explains that, as 3 of the cases of nvCJD were found to have been blood donors, and plenty of other people incubating the disease will also be donors, therefore the blood supply could not be looked on as being safe. Dealler `bitterly attacked the Government officials for acting too late. This is the news that a lot of people feared. Now we have firm evidence that probably thousands of people have possibly become infected while the experts have been aware of the seriousness of the situation' he said. (in fact Dealler had not spoken to the Mail at all). The National Blood Authority was secretly ordered weeks ago to submit plans and costings for a programme to remove white cells. It was clear that the slimming down of the NBA that has taken place will require that the technicians are re-hired to carry out the leucodepletion. It meant that while all this gets ready many of the 350,000 recipients of blood in the UK every year will continue to receive the blood from non-leucodepleted sources.

All TV and radio stations throughout the day 17.7.98. Major risks of nvCJD through blood transfusion. As the day went on, the initial data from Dealler indicating that the worst case scenario was unacceptably high in terms of risk from blood transfusion, was replaced by Dr. Jeremy Metters from the DofH indicating that the Government had decided to introduce leucodepletion to prevent nvCJD risk from transfusion. By the end of the day, the TV shows were putting out a lot of pictures of people donating blood and calming messages to show that blood will be made safe and that we can rely on the DofH. One of them made it clear that the DofH was more reliable and in the populus interest than MAFF had been. By around 2pm Dealler had stopped giving interviews to the press and other media and stopped putting out information concerning other methods that could be used to decrease blood transfusion risks. Early in the day the DofH press office had been saying that the risk from CJD in blood was less than one in 4 million and this was crushed rapidly by the press. 

June 1998

May 1998

April

Press Releases

 Specific blood press releases are:

• Committee on Safety of Medicines completes review of blood products (13.5.98)
• The British Council Health insight into diagnosing CJD and its significance for blood transfusion (6.3.98)
• Further precautionary measures on blood pruducts announced (26.2.98)
• Precau tionary measures announced for blood products (Scottish Office) (26.2.98)
• CJD and human transmission (Chief Medical Officer Statement) (this is dated 27.10.98 but I think that it is later - Ed)

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