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December 19th, 2003
Possible vCJD transmission by blood reported in UK
On Wednesday 17th December, the UK Secretary of State for Health, John Reid, reported the death of a British man from variant Creutzfeldt-Jakob Disease (vCJD) and admitted there was a possibility that this was linked to a blood transfusion he received six yeras before his death.
This statement has immediately raised concern about the safety of the blood supply, especially in Britain where the majority of cases of vCJDhave occured. It has also raised new questions about the safety of plasma derivatives.
However, Commissioner for Health and Consumer Protection David Byrne said that all the circumstances surrounding this tragic death needed careful examination before any firm conclusion could be drawn. At a meeting of the EU's Communicable Disease Network yesterday the UK Representative was requested to provide detailed information so that all concerned could examine the issue.
With regard to the case reported this week, Mr Reid told the House of Commons "This is a single incident, so it is impossible to be sure which was the exact route of infection.However, the possibility of this being transfusion-related cannot be discounted."
The donor gave blood in March 1996, long before any signs of illness emerged. A few months later his blood was given to a man having surgery for a serious illness. Three years later the blood donor developed vCJD, the brain-wasting disease linked to eating BSE-infected beef, and died.
The recipient died in autumn this year and a post mortem examination revealed he also had vCJD.
Mr Reid said the blood link was "a possibility, not a proven causal connection". He added: "However, it is also possible that both individuals separately acquired vCJD by eating BSE-infected meat or meat products."
The question of vCJD transmission via blood or blood products is under constant review by scientific committees. Many EU Member States have precautionary measures in place to protect their blood supply. The British authorities informed that the incident happened before several protection and precautionary measures, like the removal of most of the white cells from blood donations, were implemented.
With regard to the risk of vCJD transmission by plasma derivatives, UK Department of Health officials this week stated: “because the products are derived from large pools of plasma donated by thousands of people, there is a significant dilution effect which leads us to believe that the risk is very low.”
This is in line with expert opinion expressed at the recent meeting on TSE risk and blood transfusion as reported in the Octapharma news on 28th November.
Despite the lack of scientific evidence in support of the theoretical risk of vCJD transmission through plasma protein therapies, Octapharma along with other PPTA member companies are committed to keeping this issue a high priority as we continue in our mission to ensure the safety and availability of the life-saving medicines we manufacture.
In the meantime it must be stressed :
- UK sourced plasma has not been used by PPTA members in the production of plasma derived medicinal products.
- More than 95% of all known cases of infection with vCJD have occurred in the UK. (By end of September 2003, there has been 6 cases of vCJD in France and 1 in Italy, whilst as of 1 December 2003 there had been a cumulative total of 143 cases in the UK).
- Residence in the UK for 6 months in the period 1980-1996 is an exclusion criteria for plasma donation in PPTA plasma collection centres
- Validated data has been published that demonstrates that the manufacturing process applied to plasma derived medicinal products is effective at removing infectious agents thought to be responsible for the transmission of vCJD
© Octapharma AG, 2003
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