The USA FDA (Food and Drug Administration) will now post a warning on human vaccines about the risk of vCJD transmission. The USA vaccines sourced from human albumen (blood donations) will have similar wording to those already used on blood bags/blood products in the USA. Though the FDA is playing down the risk as ‘remote’ this was the same wording used by the UK Department of Health during the BSE crisis here in the UK and since by government funded experts.

Two young men from Eastleigh near Southampton UK died of vCJD within weeks of each other both had been vaccinated from the same batch of polio vaccines. One of the young male victims was inoculated at school the other at a local college. Their families have been kept completely in the dark about the batch numbers and drug companies who produced these vaccines. The connection between the two young men’s deaths, their proximity to each other and the fact they had received vaccines from the same batch caused a press and public frenzy of concern. The UK Department of Health responded with Ray Bradley as their spokesperson who said ‘their was no connection between the two deaths’. This was the same Ray Bradley a scientist and head of the Central Vet Lab who kept secret the diagnosis of the first recorded case of BSE for nearly two years. See Bradley’s profile and expose on this website.

All victims who have died of vCJD received their childhood adolescent vaccinations; many did not eat school meals or commercially prepared baby food. The one common factor with all the victims were their exposure to vaccines sourced from BSE herds and produced using human material from blood donations.

With the FDA’s admission of this warning does this mean all recipients of vaccines will now be told about this ‘risk’ and choices they may have? Or is this wording on a very small vial of vaccine going to be missed by most patients about to receive their jabs?

When will this same warning be posted on vaccines here in the UK?

For more information about America’s FDA’s warning and information about vaccines check out this link:
www.vaccineriskawareness.com

The panel's report, published online, suggests conducting 'covert health surveillance' of around 30,000 patients known to have received a high number of blood transfusions.

Experts believe patients who have received more than 80 blood transfusions are most at risk of developing the fatal brain disease as it can be passed on through infected blood

But this has so far not been seen and may either mean the risk is lower than previously thought, or that it is taking longer for cases to develop.

The report acknowledges that following patients without their consent is 'ethically problematic'.

'Given the history of contaminated blood in the 1970s and 1980s, the maintenance of medical ethics is especially important to the haemophilia community.

Since the first vCJD cases emerged in the mid-1990s, 175 people in Britain have died from the brain wasting disease, which is linked to eating beef infected with BSE.

One theory is that some people have a genetic advantage and may only carry the disease without developing symptoms. However, they can still infect others if they give blood.

At the moment, patients are only informed that they are at increased risk of developing vCJD if they have been exposed to blood from more than 80 donors and if they are about to have brain, spinal or complex eye surgery.

'There is no grey area - if they are thinking about unconsented monitoring, then it is wrong.'

CJD occurs when nerve-tissue proteins called prions (illustration above) turn 'bad' and gradually destroy the brain

'But with that comes the moral question of whether patients should be informed or not, and this is the dilemma of the Health Protection Agency.'

A Department of Health spokesman said: 'No decisions have been taken on any unconsented follow-up of highly transfused patients.

'No unconsented follow-up has taken place and none would without appropriate ethical approval and on the basis of legal advice.'

Read more: http://www.dailymail.co.uk/news/article-2096643/Mad-Cow-Diesease-Plans-secretly-test-30-000-NHS-patients-CJD-fears-escalate.html#ixzz1lWd8FN2o

Variant Creutzfeldt-Jakob Blood Test on the Horizon?

By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network

The prospects for a practical blood test that quickly detects the presence of prions in blood, organs, and tissues became more encouraging with the results of two studies published earlier this year.

But until such screening and diagnostic tests become available, the greatest concern for U.S. officials is the deferment of blood and tissue donors who have spent substantial time in countries in which variant Creutzfeldt-Jakob disease (vCJD) is most prevalent, according to speakers at a meeting of the Food and Drug Administration’s Transmissible Spongiform Encephalopathies Advisory Committee in August.

One test from researchers at the National Institute of Allergy and Infectious Diseases uses an antibody-based technique to isolate abnormal prion proteins and detect them at levels 10,000 times more sensitive than in previous tests for detecting vCJD. Another test from researchers at University College London Institute of Neurology and the National Hospital for Neurology and Neurosurgery in London was able to detect vCJD prions in the presence of the normal prion protein with a sensitivity of 71% and specificity of 100%.

The safety of the blood supply is a concern, especially in places like the United Kingdom, because of five documented cases of transmission of vCJD via blood transfusions from donors with subclinical vCJD, NIAID study investigator Byron Caughey, Ph.D., said in an interview.

"The ability of [this assay] to detect prions in plasma samples raises the possibility that this assay could be used to improve prion disease diagnosis in humans and animals and to screen the blood supply for prion contamination," wrote Dr. Caughey and his coauthors at NIAID’s Rocky Mountain Laboratories in Hamilton, Mont. (mBio 2011 [doi:10.1128/mBio.00078-11]). Besides its sensitivity for detecting prions in human plasma spiked with brain tissue from patients with vCJD, the assay, called eQuIC, also accurately distinguished between hamsters infected with scrapie – including some that were in early preclinical phases of infection – and uninfected hamsters.

However, they pointed out that the test has not been studied in plasma or CSF from vCJD patients and that "further studies will be required to assess the diagnostic utility of eQuIC based on the detection of vCJD seeding activity that is endogenous to these and other specimens."

In addition to helping prevent infections through the screening of blood, blood products, and transplanted tissues, if the sensitivity is dramatically improved, the test might be used to catch the disease as early as possible, before irreversible brain damage occurs; at which point treatments, as they become available, could be used. Such a test might also be used to test medical instruments such as electrodes to prevent iatrogenic transmission, as well as to detect low levels of contamination in the food supply, such as bovine spongiform encephalopathy (BSE) in cattle and scrapie in sheep, Dr. Caughey said.

The test developed by English researchers was positive in 15 of 21 blood samples from patients with clinical vCJD and was negative in blood from 169 patients without vCJD. The authors said that the use of the test in the differential diagnosis of suspected vCJD would be studied further in large studies (Lancet 2011;377:487-93).

The Implications of a vCJD Blood Test

Dr. Brian Appleby, a neuropsychiatrist at the Cleveland Clinic Lou Ruvo Center for Brain Health, speculated that a blood test could have "huge implications" for screening the blood supply, largely in the United Kingdom, and for use in checking deer and elk for chronic wasting disease, the main acquired prion disease seen in the United States.

A better test could also help to expedite the diagnosis of vCJD in people, who often get diagnosed very late in the course of the disease – if at all – and usually survive for less than a month after diagnosis, he said in an interview. Currently, the only forms of Creutzfeldt-Jakob disease seen in the United States are the sporadic and familial types.

Of all the prion diseases, a better diagnostic test is needed for sporadic CJD, which accounts for about 85% of all human prion diseases, but there is no evidence that sporadic CJD is in the blood, Dr. Appleby said. vCJD, however, is present not only in the blood but also in lymphoreticular tissues such as the tonsils.

He added that sporadic CJD cases are being identified much earlier now with brain MRI, which has increasingly been used and has become very useful in making and expediting the diagnosis. Unique to vCJD is the "hockey stick" sign on brain MRI, which is a symmetrical hyperintensity in the pulvinar (posterior) nuclei of the thalamus.

Dr. Appleby is a member of the FDA’s advisory committee that in August discussed the implications of three cases of vCJD diagnosed in North America on current recommendations for vCJD screening of donors of blood, cell, and tissue-based products.

The three individuals were long-time residents of Saudi Arabia who were likely infected with the BSE agent in beef imported from the United Kingdom to Saudi Arabia during 1980-1996. After hearing data that included detailed descriptions of the cases from public health officials, the majority of the panel voted that the available data supported the FDA’s consideration to recommend deferring donors who had spent a cumulative of 6 months or more during 1980-1996 in Saudi Arabia as U.S. military personnel or who had spent more than 5 years cumulatively in Saudi Arabia during the same time period.

Having lived in the United Kingdom for at least 3 months during 1980-1996 (considered the highest risk period for dietary exposure to BSE) is among the reasons for donor deferral under current U.S. and Canadian blood donor deferral policies. Luisa Gregori, Ph.D., of the FDA’s division of emerging and transfusion-transmitted diseases said at the meeting that donor deferral is currently the only way to protect the U.S. blood supply from transfusion-transmitted CJD and vCJD and that the current donor deferral policy in the United States would not have deferred these three individuals.

The risk of CJD transmission via a blood transfusion is theoretical, but the risk of transfusion transmission of vCJD has been demonstrated, Dr. Gregori noted.