- WWhat is the current policy with regards to vCJD?
- What is the current status or situation in the U.K. with the man who contracted vCJD through fractionated plasma-derived product?
- Should the vCJD policy be changed in wake of the new revelations in the U.K. concerning plasma products?
- What is the threat of vCJD to Canada's blood system?
- Have any Canadians received fractionated plasma-derived product from the U.K.?
- Are Canadians who received the U.K. plasma fractionator at risk for vCJD? What's being done about this given the latest revelations in the U.K.?
- Is there any evidence that Canadians have contracted vCJD from blood or blood products?
- Does Canada currently import blood products or plasma from the U.K. or countries in Western Europe that are deemed to be a risk for vCJD?
- How many haemophiliacs in the U.K. have been treated with U.K.-source plasma-derived clotting factor concentrates (CFCs) in the critical years of 1980 to 2000?
- How many haemophiliacs have been treated with concentrates made from plasma from a donor known to have developed vCJD?
- How many haemophiliac patients who have been treated with concentrates made from plasma they received from a donor who subsequently developed vCJD - have then died and had an autopsy that looked for prions performed?
- What is CJD and what is the difference between “classical CJD” and “variant” CJD?
- What is Canadian Blood Services’ policy on deferral for vCJD?
- Is the policy being expanded because the risk has increased?
- Why did you choose the period 1980 to now?
- Why not ban people who have spent any time in all of these countries since 1980?
- Has there been any public consultation on this issue?
- Shouldn’t Canadian Blood Services distinguish between people who eat beef and people who are vegetarians?
1. What is the current policy with regards to vCJD?
Over the past decade, it has been the policy of Canadian Blood Services to treat variant Creutzfeldt-Jakob Disease (vCJD) as a threat to the blood supply before there was scientific evidence that this disease could be passed through blood transfusions.
As there is currently no available test for vCJD in blood donors, blood components or plasma protein products, Canadian Blood Services has, since September 1999, refused to accept blood donations from people who have spent significant time in areas of the world where human cases of vCJD originated.
The current policy applies to anyone who has spent three months or more cumulatively in the United Kingdom (England, Northern Ireland, Scotland, Wales, the Isle of Man, or the Channel Islands) or France from January 1, 1980 through December 31, 1996.
The deferral policy also applies to anyone who has received a blood transfusion or received medical treatment with a product made from blood in the United Kingdom, France or Western Europe since January 1, 1980, and anyone who has spent five years or more cumulatively in countries of Western Europe since January 1, 1980.
The Western European countries are: Germany, Italy, Netherlands (Holland), Switzerland, Austria, Belgium, Spain, Republic of Ireland, Portugal, Denmark, Luxembourg, and Liechtenstein.
The period of time of three months spent in the United Kingdom or France is not based on a combination of time in either country.
The period of time of five years spent in Western Europe is calculated by either the time spent individually in each country or any combination of time spent in the various countries of Western Europe that amounts cumulatively to five years or more.
2. What is the current status or situation in the U.K. with the man who contracted vCJD through fractionated plasma-derived product?
On February 17, 2009, Britain's Health Protection Agency announced that a haemophiliac man was found, at autopsy, to have evidence of infection with the agent (prion) that causes vCJD, the human form of Bovine Spongiform Encephalopathy (BSE) - commonly known as mad cow disease.
A final conclusion as to how this haemophilia patient became infected with the vCJD prion has yet to be reached. However, at this point UK authorities consider that the infection most likely occurred through transfusion of a fractionated plasma-derived product (Factor VIII) eleven years ago, made from UK plasma that contained plasma from a donor who went on to develop vCJD after donation.
The vCJD infection was detected in the spleen of the deceased 70 year old haemophiliac during a post-mortem autopsy. The man died from causes unrelated to vCJD and did not display any symptoms of vCJD, or any neurological condition, when he was alive.
If confirmed, this will represent the first reported case of transmission of vCJD infection through a fractionated plasma-derived product. Since 2004 it has been known to the global medical community that it is possible for people to be infected with vCJD through blood transfusions, but no case of transmission by a fractionated plasma-derived product has previously been identified.
3. Should the vCJD policy be changed in wake of the new revelations in the U.K. concerning plasma products?
Canadian Blood Services will continue to monitor the situation in the U.K. and keep Canadians informed of all potential risks to the blood system. Canadian Blood Services' current policy effectively protects against the risk of vCJD being transferred through blood and blood products. Changes to the current vCJD policy will be made should they be deemed necessary.
Canadian Blood Services will carefully monitor the development of new technologies to either remove vCJD from blood, or test for the presence of the disease in blood.
4. What is the threat of vCJD to Canada's blood system?
The risk is extremely low. Canadian Blood Services has measures in place to protect the blood system from vCJD because we treated it as if it was a threat well before there was scientific proof. This new case in the U.K. involving plasma proves that the precautionary steps Canadian Blood Services took based on the theoretical risk of vCJD being transmissible through blood were correct.
While there have been over 180,000 cases of BSE identified in cattle in the U.K., France and Western Europe, to date there have been only fourteen cases that originated in Canadian cattle since 2004 (23,000 - 50,000 cattle tested per year). Two cattle have tested positive for BSE in the U.S. (over 100,000 cattle tested since September 2006).
There has never been a reported human case of vCJD in Canada or the U.S. that originated in North America. There has been one human case in Canada, but the person was considered to have contracted the disease in the U.K. The three cases of vCJD reported in the U.S. were considered to be acquired in the U.K. (2) and in Saudi Arabia (1).
5. Have any Canadians received fractionated plasma-derived product from the U.K.?
One product manufactured from U.K. Plasma from 1992 until mid-1998 was imported into Canada. This products was Factor XI (eleven) manufactured by BioProducts Laboratory (BPL). After mid-1998, BPL Factor XI was manufactured from plasma collected in the United States, where there have been no cases of endemic vCJD.
6. Are Canadians who received the U.K. plasma fractionator at risk for vCJD? What's being done about this given the latest revelations in the U.K.?
Canadian Blood Services is now in the process of notifying physicians of patients that received Factor XI manufactured from U.K. plasma (the BPL product over the period 1992 to mid-1998) to update them on the current situation so that they can communicate this information to their patients. Although the risk of vCJD is lower in France, physicians who treated their patients with Factor XI made from French plasma (a LFB product) will also be notified by Canadian Blood Services. These two products were issued to Canadian patients through the Special Access Programme (SAP).
This notification will concern approximately 70 Canadians who may have received Factor XI concentrates made from U.K.-source plasma or French-source plasma in the period 1992-1998.
In 2004, at the time that it was first confirmed that vCJD could be transmitted by blood transfusions, Canadian Blood Services notified physicians to who had requested, through SAP, the BPL FXI product prepared from U.K. plasma so that they could notify their patients who may have received these Factor XI concentrates of an estimated low risk of contracting vCJD from these products. Physicians who treated their patients with the LFB Factor XI made from French plasma were also notified.
7. Is there any evidence that Canadians have contracted vCJD from blood or blood products?
There is no evidence to suggest that these patients are at risk. Canadian Blood Services is disclosing new information about the risks as they relate to fractionated plasma-derived products.
8. Does Canada currently import blood products or plasma from the U.K. or countries in Western Europe that are deemed to be a risk for vCJD?
No. All products licensed by Health Canada (e.g. IVIG, albumin, coagulation factor concentrates) are manufactured from plasma collected in the United States or Canada.
9. How many haemophiliacs in the U.K. have been treated with U.K.-source plasma-derived clotting factor concentrates (CFCs) in the critical years of 1980 to 2000?
Almost all people with haemophilia A and B were treated with U.K.-source plasma-derived clotting factor concentrates between 1980 and 2000. This is because the U.K. widely used products made in U.K. fractionation plants from U.K. plasma. That would mean that up to 6,000 people were affected. The number of 6,000 people likely includes most haemophilia A and B patients treated between 1980 and 2000, as well as a handful of other bleeding disorders treated with BPL and SNBTS products.
10. How many haemophiliacs have been treated with concentrates made from plasma from a donor known to have developed vCJD?
Canadian Blood Services has heard that 200 haemophiliacs have been treated with concentrates made from plasma taken from a donor known to have developed vCJD. However, this number could be higher. Since patients have the choice to know their status, it is possible that an exact number has never been made public.
11. How many haemophiliac patients who have been treated with concentrates made from plasma they received from a donor who subsequently developed vCJD - have then died and had an autopsy that looked for prions performed?
A total of 17 patients have been biopsied. More than one, but not all, had received implicated batches, such as the person who died recently in the U.K. I believe we will have to wait for the publication of James Ironside's paper to know more details. So the denominator is more than one but not more than 17.
12. What is CJD and what is the difference between "classical CJD" and "variant CJD"?
Creutzfeldt Jakob Disease is a neurodegenerative disease that was first described in the 1920s. About one third of patients initially express vague feelings of fatigue, disordered sleep, or decreased appetite. Another third have neurologic symptoms such as memory loss, confusion or uncharacteristic behaviour. The final third have signs such as loss of vision, poor muscle coordination or problems with speech. It involves a loss of mental and physical abilities.
Classical CJD has always had sporadic occurrence in people with a mean age of 60 and incidence rate of one-in-one million worldwide.
Variant CJD has only been identified in the last few years. It is different in that it occurs in people with a mean age under 30. The risk factors are unknown, except that we do know that the prion agent causing Bovine Spongiform Encephalopathy (BSE) or "Mad Cow" disease is the same agent that causes variant CJD.
People in the U.K. and France were exposed to BSE through food in the mid-to-late 1980s when cattle were fed bovine offal. (Bovine offal contains animal parts such as sheep brains.) A ban on the use of offal in cattle food was put in place in 1989 and a slaughter of thousands of potentially infected cattle occurred, eliminating this potential source of infection.
It is believed that the more cases of BSE that have been found in a given country, the higher the risk of contracting variant CJD. Over the past year (2000/2001), BSE has been seen in many Western European countries, although the numbers are much lower than in the United Kingdom.
13. What is Canadian Blood Services policy on deferral for vCJD?
People are not eligible to donate blood or plasma if they have spent a cumulative total of three months or more in the United Kingdom (U.K.) between 1980, and 1996, or if they have spent a cumulative total of three months or more in France between 1980, and 1996, or if they have spent a cumulative total of five years or more in Western Europe outside the U.K. or France since 1980. In addition, people are not eligible to donate blood or plasma if they have had a blood transfusion or received medical treatment with a product made from blood in the U.K., France or Western Europe since 1980.
The U.K. includes England, Northern Ireland, Scotland, Isle of Man, Wales, Channel Islands. Western Europe includes: Belgium, Luxembourg, Spain, Germany, Italy, Switzerland, Republic of Ireland, Netherlands, Austria, Liechtenstien, Portugal, Denmark.
14. Is the policy being changed because there are now two possible cases of transfusion-transmitted vCJD in the U.K.?
We will be examining the impact of the news coming out of the U.K. and consulting with experts to determine if any changes need to be made to our policy. One should remember that we introduced our current vCJD deferral at a time when transmission of vCJD was considered a theoretical risk. This precautionary policy now appears to have been warranted. If needed we will continue to take measures to add protection to the blood system from vCJD. Any policy change will have to balance the risk of transfusion-transmitted vCJD versus a real risk of supply shortages.
15. Why did you choose the period 1980 to 1996?
The first cases of Bovine Spongiform Encephalopathy (BSE or "mad cow" disease) were first identified in 1986. Because scientists believe that the incubation period for the disease can be many years, it likely first appeared in cattle in 1980. Variant Creutzfeldt-Jakob disease is related to BSE. It is possible that people were exposed to BSE through food in the mid-to-late 1980s, when cattle were fed offal (animal parts, such as sheep brains).
Confirmed cases of BSE in these countries began declining in 1992, but the period between January 1980 and December 1996 was a time when the BSE epidemic was at its peak in the United Kingdom and France. Since that time, cases have continued to decline and BSE monitoring and control mechanisms have been implemented to stop the spread of the disease in the bovine population and thereby decrease the risk of transmission of vCJD to humans.
16. Why not ban people who have spent any time in these countries since 1980?
Protecting the safety of the blood supply also means ensuring that blood is available when patients need it. By turning away donors who had spent any time in all of those countries between 1980, and 1996, Canadian Blood Services would be losing a large portion of the existing donor base. This would place a great deal of strain on the blood supply, without significantly increasing blood safety.
17. Has there been any public consultation on this issue?
Health Canada held public and stakeholder meetings in 2000 and 2001 to discuss this issue. Canadian Blood Services and Héma Québec also held a joint consensus conference on vCJD of blood donors in March 2003.
18. Shouldn’t Canadian Blood Services distinguish between people who eat beef and people who are vegetarians?
Variant CJD has been found in people who have stated that they were vegetarians. As a result, they too are excluded under the policy.