Documents #2
documents continued
Below is a letter I received from BRAKES who supplied school meals during the 1980s and 1990s and still provide meals to schools and hospitals. I asked Brakes if they ever used MRM mechanically recovered meat in their school meal products. Below is their reply where they state ‘Brakes now do not allow its use (MRM) in our own brand products’.
FROM THIS I WOULD ASSUME AT ONE TIME THEY DID USE MRM IN THEIR OWN BRAND PRODUCTS.
Note the letter has been written and signed by Adrian Whitehead their Group Legal Director and the tone asking me why I needed to know this information is rather strong.
I wrote my letter as a concerned mum who wanted to know just what went into her sons school meals all those years ago.
I have since written to Brakes again requesting they supply me with the names of the ready meals, and products they supplied to schools across the UK during the 1980s and 1990s that contained MRM I have never received a reply to my request.
BRAKES were based not far from Ashford in Kent, where there was a cluster of cases of vCJD.
Below is a link to a letter from Leeds NHS Executive headquarters to all NHS Trust Medical Directors and NHS Chief Executives Health Authority Chief Executives written on February 1998 advising doctors not to tell Haemophiliac patients why their plasma products have been recalled. Donors who had supplied the blood products had gone on to develop and die of vCJD. The letter and its contents was kept from patients who had received the ‘risky’ blood products and states ‘there is no need to inform patients’. It wasn’t until September 2000 when this letter was leaked to campaigner Carol Grayson who informed the media, that GPs were forced to write to their patients asking them if they wished to be informed of their exposure to vCJD.
For ten years from July 1987 and July 1999 around 101 batches of BPLs Factor V111 and PFCs Z8 were gradually released to over 4,000 patients in the UK. A third of these were children most of these recipients were persons with haemophilia or bleeding disorders. The 101 batches were supplied by blood donated by individuals who had died of vCJD.
18 BLOOD DONORS HAVE DIED OF VCJD
There are 2 million blood transfusions in the UK every year.
“HAEMOPHILIA SOCIETY CONDEMNS GOVERNMENT ADVISORS’
CALL TO DENY AT RISK PATIENTS RIGHT TO vCJD TEST”
Below is information and regulations declared by the American Red Cross regarding the exclusion of UK blood donations. Followed by the Canadian Governments policy on exclusion of UK blood donations.
In-Depth Discussion of Variant Creutzfeld-Jacob Disease and Blood Donation
In some parts of the world, cattle can get an infectious, fatal brain disease called Mad Cow Disease. In these same locations, humans have started to get a new disease called variant Creutzfeld-Jacob Disease (vCJD) which is also a fatal brain disease. Scientists believe that vCJD is Mad Cow Disease that has somehow transferred to humans, possibly through the food chain.
There is now evidence from a small number of case reports involving patients and laboratory animal studies that vCJD can be transmitted through transfusion. There is no test for vCJD in humans that could be used to screen blood donors and to protect the blood supply. This means that blood programs must take special precautions to keep vCJD out of the blood supply by avoiding collections from those who have been where this disease is found.
At this time, the American Red Cross donor eligibility rules related to vCJD are as follows:
You are not eligible to donate if:
From January 1, 1980, through December 31, 1996, you spent (visited or lived) a cumulative time of 3 months or more, in the United Kingdom (UK), or
From January 1, 1980, to present, you had a blood transfusion in any country(ies) in the (UK). The UK includes any of the countries listed below.
Channel Islands
England
Falkland Islands
Gibraltar
Isle of Man
Northern Ireland
Scotland
Wales
You were a member of the of the U.S. military, a civilian military employee, or a dependent of a member of the U.S. military who spent a total time of 6 months on or associated with a military base in any of the following areas during the specified time frames
From 1980 through 1990 – Belgium, the Netherlands (Holland), or Germany
From 1980 through 1996 – Spain, Portugal, Turkey, Italy or Greece.
You spent (visited or lived) a cumulative time of 5 years or more from January 1, 1980, to present, in any combination of country(ies) in Europe, including
in the UK from 1980 through 1996 as listed in above
on or associated with military bases as described above, and
in other countries in Europe as listed below:
Albania
Austria
Montenegro (Federal Republic of Yugoslavia)
Belgium
Bosnia/Herzegovina
Bulgaria
Croatia
Norway
Poland
Czech Republic
Denmark
Romania
Finland
France
Slovak Republic (Slovakia)
Germany
Greece
Spain
Hungary
Ireland (Republic of)
Italy
Kosovo (Federal Republic of Yugoslavia)
Liechtenstein
Luxembourg
Macedonia
Netherlands (Holland)
Portugal
Serbia (Federal Republic of Yugoslavia)
Slovenia
Sweden
Switzerland
Turkey
Yugoslavia (Federal Republic includes Kosovo, Montenegro, and Serbia)
Below is the Canadian governments policy on Blood donations.
Donor Exclusion to Address Theoretical Risk of Transmission of variant Creutzfeldt-Jakob Disease (vCJD) through the Blood Supply
UNITED KINGDOM, FRANCE & WESTERN EUROPE
1. PURPOSE
The purpose of this Directive is to advise all licenced Canadian blood establishments to take further measures to reduce the theoretical risks of transmission of vCJD through the blood supply. This is to be accomplished by excluding from donating blood, all persons who:
have spent a cumulative period of time of 3 months or more in the United Kingdom(UK) consisting of England, Scotland, Wales, Northern Ireland, Isle of Man, the Channel Islands between the years 1980 to 1996; or
have spent a cumulative period of time of 3 months or more in France between the years 1980 to 1996; or
have spent a cumulative period of time of 5 years or more in countries of Western Europe(WE) consisting of Germany, Italy, Netherlands, Switzerland, Austria, Belgium, Spain, Republic of Ireland, Portugal, Denmark, Luxembourg, Liechtenstein between the years 1980 and ongoing; or
have received a transfusion of whole blood or blood components in the UK between the years 1980 and ongoing.
The period of time of three months or more spent in the UK or France is not based on a combination of time in either country. The period spent in the above noted WE countries considers either the time spent individually in each country or any combination of time spent in the various countries so that cumulatively, the residence period requiring deferral amounts to 5 years or more.
2. BACKGROUND
Variant Creutzfeldt-Jakob disease (vCJD), first described in 1996, is a “new” disease, linked with the outbreak of Bovine Spongiform Encephalopathy (BSE) in cattle.
While there have been no cases of vCJD attributable to the use of human blood or plasma derivatives to date, lack of experience with this condition and the causative agent, together with limited knowledge available on certain biological effects associated with this infection (e.g. the lack of information on the concentration and infectivity of the vCJD prion in blood), do not allow for conclusion that it can not occur. In addition, a report that BSE in sheep can be transmitted within that species through blood transfusion, suggests that theoretically, vCJD may have the potential to spread through human blood or blood derivatives. Scientific knowledge of the Transmissible Spongiform Encephalopathies (TSEs) has been hampered by the long incubation period of the known TSE infectious agents (e.g. vCJD and BSE) and the lack of diagnostic pr ocedures available for early detection. Consequently, Health Canada (HC) wishes to mitigate the risks of potential human to human transmission of vCJD with policies on blood donor deferral for persons who have spent time in the UK, or France or WE.
In considering this potential risk and measures to deal with it, the principle has been adopted that one must seek to apply measures which will reduce the targeted risk without jeopardizing the safety of the blood system in other ways. Using this rationale, Health Canada issued Directives on August 17, 1999 and August 20, 2000 requiring the exclusion from blood donation of all persons who had spent time amounting cumulatively, to a period of 6 months or more in the UK or France between the years 1980 to 1996, inclusive. Based on recent scientific knowledge available since the issuance of the 1999 and 2000 Directives, Health Canada, in consultation with stakeholders including Canadian Blood Services(CBS) and Héma-Québec(HQ), is directing industry to tighten the blood donor deferral for the UK and France to 3 months or more and to add a deferral based on 5 years or more spent in the above-noted countries of WE.
This new Directive is based on recent scientific knowledge available since the issuance of the 1999 and 2000 Directives and the following new information:
The total number of cases of vCJD is increasing, with a cumulative total that reached 110 in August, 2001, with 106 in the UK, France reporting 3 cases20and one case in the Republic of Ireland;
The number of observed BSE cases is increasing steadily in West European countries once thought to be free of the disease;
Brain tissue from BSE-infected primates, injected intravenously into other primates, has been shown to transmit disease;
Recent research has shown experimental sheep-to-sheep transmission of the BSE agent by blood transfusion.
Recent surveys conducted by CBS and HQ indicate that reducing the deferral period to three months or more for either France or the UK and the addition, of a deferral based on 5 years or more time spent in the above-noted countries of WE, will not jeopardize the blood supply. Health Canada’s Population and Public Health Branch has carried out a number of modeling studies to estimate the theoretical risk of acquiring vCJD for those persons who have spent time in the UK. Similar modeling studies have been done to estimate vCJD risk for persons spending time in France and the above noted countries of WE. These risks are not identical and consequently, HC would not require a deferral based on a combination of time in the UK with time spent in France; or a combination of times spent between the above-noted WE countries and either the UK or France. However, WE deferral does allow for a combination of times spent among the above-noted WE countries.
A theoretical risk reduction of 72% is achieved under the 1999 and 2000 Directives. With the implementation of the current Directive, there is expected to be an additional 16-18% reduction of the theoretical risk for an estimated overall risk reduction value of 88-90%. A blood donor loss of around 3% or less is estimated under the current Directive.
3. SCOPE
This Directive applies to all Canadian blood establishments that are licensed to fabricate blood and blood components for transfusion or for further manufacture. Products affected by the Directive include all blood components for transfusion with the exception of: autologous donations, peripheral blood stem cells collected for autologous transplants, rare blood types and products derived from USA-sourced plasma.
4. REGULATORY REQUIREMENTS
Blood establishments are required to submit a Licence Amendment Submission to the Blood and Tissues Division of the Biologics and Genetic Therapies Directorate (BGTD) for review.
An attachment must be included which indicates both the impacts that this measure will have on the donor base and plans to mitigate any such effects. Operators are also encouraged to develop materials to be used in explaining these deferral actions to affected donors in order to foster an appropriate understanding of these precautionary actions.
Regarding the withdrawal of prior donations by deferred donors, Health Canada, will require that all available components collected from these deferred donors, that have not been transfused or pooled for further manufacture, be retrieved.
5. COMPLIANCE DATE
The exclusion is to be introduced as soon as operationally feasible, but not later than three months from the date of this Directive.
6. ADDITIONAL INFORMATION
Blood operators will be required to report semi-annually on the impact of this policy on their donor bases and the supply of blood.
On an ongoing basis, Health Canada may update its guidance in response to new scientific knowledge. If other cases of vCJD are confirmed in a specific country, a risk assessment will be carried out to determine specifically what deferral measures will be required.
The Directive, with a list of supporting references on the Background science, will be posted on an HC website.
Questions concerning the ” Donor Exclusion to Address Theoretical Risk of Transmission of variant CJD through the Blood Supply” should be directed to:
Biologics and Genetic Therapies Directorate
Blood and Tissues Division
3rd Floor LCDC Building #6
Postal Locator 0603C
Tunney’s Pasture
Ottawa, Ontario
KIA 0L2 7. REFERENCES
Scientific references used in the development of the Directive’s “Background” Section:
Monthly statistics on the United Kingdom’s CJD cases http://www.doh.gov.uk/cjd/stats/aug01.htm
and EUROCJD and NEUROCJD: The European and Allied Countries Collaborative Study Group of CJD(EUROCJD) plus the Extended European Collab orative Study Group of CJD(NEUROCJD)EUROCJD
Monthly statistics on the cases of BSE determined through testing in the European countries. Monthly BSE testing – Cumulative table from January to May 2001 – BSE testing – May 2001
and Office International des Epizooties – Number of reported cases of BSE worldwide
Corinne Ida Lasmézas et al. PNAS, March 27, 2001, vol.98(7),4142-4147 “Adaptation of the bovine spongiform encephalopathy agent to primates and comparison with Creutzfeldt-Jakob disease: Implications for human health” www.pnas.org
Houston F, Foster J.D., Chong A, et al. Transmission of BSE by blood transfusion in sheep. Lancet 2000; 356:999-1000
Below is an excerpt from data presented by the USA Gov National Centre for Infectious Diseases (Feb 2001) it was supported by contributions from the same Ray Bradley (see profile whose to blame?) who kept life threatening documentation/evidence re BSE and its dangers to human health confidential from the UK public. Bradley covered up information and in a memo dated 1986 decided to ignore the warnings of at least three top pathologists regarding BSE and its implications to human health and put the export trade before lives.
Throughout BSE Bradley was well rewarded for putting the Beef industry before the British publics lives. He was consigned to many areas and departments within the UK government during the 1980s and 1990s which oversaw BSE and its implications to health. Bradley became a well paid and sought after BSE Consultant who could be relied upon to support government policy. If Ray Bradley had acted morally, correctly and appropriately when he was presented with three top scientists findings in 1985, then hundreds of lives lost due to vCJD would have been prevented and ‘one in a thousand of the UK population would not be at risk of carrying vCJD’ Members of the population that may be carrying vCJD could remain symptom free but could well infect other people through donated blood, cells, tissues, organs or other surgical procedures.
Bovine Spongiform Encephalopathy and Variant Creutzfeldt-Jakob Disease: Background, Evolution, and Current Concerns
Paul Brown,* Robert G. Will,† Raymond Bradley,‡ David M. Asher,§ and Linda Detwiler¶
*National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA; †National Creutzfeldt-Jakob Disease Surveillance Unit, Western General Hospital, Edinburgh, Scotland; ‡Central Veterinary Laboratory, New Haw, Addlestone, UK; Centre for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA; ¶Animal and Plant Health Inspection Service, U.S. Department of Agriculture, Robbinsville, New Jersey, USA.
Recent and Future Policy Decisions
Several governments have implemented policies to minimize the risk for human-to-human disease transmission through blood donations from apparently healthy persons who may be in the incubation phase of vCJD. In the UK, where whole blood or blood products from some persons who later died of vCJD have been administered to others, all plasma is imported and all blood from UK donors is filtered to eliminate leukocytes, which are the most likely carriers of infectivity in blood (38-40). In the United States, a blood donor policy excludes donations from anyone who has lived in or visit ed the UK for a cumulative period of 6 months or more during 1980 to 1996. The 6-month period was based on the fact that >80% of total US person-years in the UK would be excluded and that the 2%-3% deficit of blood donors resulting from the deferral could be absorbed by the blood banking industry without undue shortages. Several countries (Canada, Australia, New Zealand, Switzerland, Japan, and Germany) have since applied these criteria and formulated similar policies.
Because of the possibility of widespread infection in the UK, concern extends beyond blood and organ donors to the safe us e of medical and surgical instruments, particularly those used in neurosurgery and ophthalmic surgery. In the absence of a screening test, a zero-risk policy is untenable because it would require termination of the national organ donor program. A compromise might be the temporary deferral of organ donors–or perhaps only corneal donors–younger than 30 or 40 years of age. However, this measure might so diminish (and panic) the donor population as to be inadvisable. Similar considerations apply to invasive medical and surgical procedures: sound medical practice cannot be suspended on a basis of the theoretical risk for vCJD, and it would be unethical to deny needed procedures to persons suspected of having CJD. Under the circumstances, disposable instruments should be used whenever possible.
The modelling studies carried out by Health Canada’s Population and Public Health Branch to estimate the theoretical risk of acquiring vCJD under the conditions of the Directive can be found on the Health Canada website with URL