Screening Tests

Wednesday 2nd June 2010

Below is the latest  news from Amorfix the company who developed a blood screening test for vCJD. Their most recent trials using a  blood sample from a vCJD victim failed……totally…? WHY HAS THIS HAPPEND?

These  negative results have come as a  shock to the medics and scientists involved in these trials, also to campaigners like myself who have followed Amorfix  who were striving to develop and implement mass blood screening tests for vCJD.

This apparent wipe out of Amorfixs scientific/medical research into vCJD blood screening raises many significant questions and challenges. Not least the accessibility and availability of vCJD blood and other samples given to independent scientists outside the remit of the NHS and Department of Health. There is a complete lock down and ownership of vCJD human blood and body samples by the UK Government, which  echoes the travesty surrounding  BSE.
 Throughout the scandal  BSE infected material was owned by the government, this hampered any outside independent scientific support which helped to keep the source and originators of the infection protected and in-house.  This culture of secrecy and cover ups  killed my only  son. The lack of transparency and openness encouraged by the Uk governent which sourrounds all aspects of vCJD  including the Amorfix blood screening tests highlights the question......

 ‘DOES THE  GOVERNMENT REALLY WANT UK BLOOD DONORS TO BE INDIVIDUALLY SCREENED FOR VCJD?’

Was the Amorfix test viable?  Was its development scuppered by the UK Department of Health to protect the architects of BSE? Can the rogue prions that cause vCJD be detected in  human blood? Are blood screening tests already BEING USED SECRETLY in the UK? Why are the Government and its Whitehall cronies so determined to stop any individual blood screening test for vCJD? 

In October 2009 the Amorfix test ‘Detected prions in blood from non human primates, that had been infected orally with BSE’ this trial also ‘Detected prions in a clinical and pre clinical primate’ which means the test could evaluate the disease during its terminal as well as its incubation/carrying phase. Amorfix were considered to be the lead company in the world regarding their vCJD blood screening test with its high levels of ‘Specifity and hundred per cent sensitivity.’ It had success when it tested 39,000 blood donors in France and the support of the French Government. 

But when it came to testing human blood samples supplied from a secret source by the UKs DOH it has failed…and was not able to detect any rogue prions in the blood.supplied ...…something is not adding up…and something is very amiss……..

Before I discuss and answer the above questions, using my experiences, findings and the facts. I must qualify that I have no financial, political or corporate gain supporting any test or medical research in the field of vCJD. I am a mother, campaigner, journalist a educated and aware middle-aged woman. One of the campaigns goals is to prevent future and further deaths of vCJD via the UK and global blood supply. I and other families affected by vCJD have no other agenda…..so the facts and experiences that I am going to present to you now are truthful, honest and transparent. I have no one pulling my strings, no threat of loosing my career or funding if I speak the truth…..I cannot be bought or silenced….these are the facts..... and the truth ......

Qualities that have been continually compromised and besmirched by the Uk government and its Whitehall cronies who do not under any circumstances want blood donors individually screened for vCJD.

Amorifx is not the first or the last company who have been involved in the development of blood screening tests for vCJD. Here in the UK we face a ‘Secondary wave’ of victims of vCJD through blood, blood products and medical procedures, as people can ‘silently carry vCJD’ and pass it on through medical proceedures/iinterventions. It makes sense to be able to use a simple blood test to screen individuals every time they give blood, have a  invasive medical procedure, operation  or donate cells, tissues and other organs. So why  in 2010 isn’t this happening?

Why isn’t a test already in place and routinely used to screen our blood donors?  Politics and the need to keep a lid on evidence and the source of BSE/vCJD have always been paramount before the safety and health of the UK public. Approximately  81 million units of blood every year  is tested for HIV and Hep C. So a screening test for vCJD  is a must when at least 14,000 of the UK population could be silently carrying the disease. We exported BSE to every country in the world so our global blood supply is also at risk. The Uk spends tens of millions of pounds every year trying to keep our blood supply safe ( its not working one of the latest victims of vCJD is dying after receiving a blood transfusion in 2003), a blood screening test would be cost effective and simple to implement.  

I need to explain to you how tests that could be routinely used are being held back deliberately by the UK Government.

Over the last few years Amorfix has been at the forefront of cutting edge scientific research in the development of prion assay tests (screening tests) for vCJD and  diagnostic tools for forms of dementia, such as Alzheimer’s. During the trials for their vCJD test they have screened with the support of the French Government over 39,000 blood donors anonymously in Montpellier France; their test was successfully defined inside and outside the lab. As well as the backing of the French Government the UK Government also put Amorfix under contract….why? If the test was so poor and likely to fail? Once Amorfix signed this contract they were unable to speak openly to the media, they were effectively gagged, so were unable to complain openly about their dealings with the Department of Health. From various reputable sources  and my own experiences I discovered continual blocking, delays  and political intrigues  surrounding the validation of the vCJD test. Increasingly I heard of the frustrations and then fear that the test would never see the light of day from individuals within the Deaprtment of Health  who back Andrews campaign as well as  from scientists and medics involved. 

Again and again the test completed trials set by the UK Governments strict procedures and guidelines, so that the Amorfix test continually enhanced the specifity of their test…’99.95 percent exceeding the 99.85 percent recognised by the Blood Transfusion service’ The Canadian Company initially were led to believe it would only be a short time before the test would be validated and implemented within the UK blood transfusion service. 

Why would expectations be raised to such a level by the UK Department of Health if the test was not viable? Why did Amofix press releases show increasingly positive results declaring ‘Amorfix  has developed the most sensitive and specific test in the world’?

The biggest stumbling block seemed to be accessibility to human vCJD blood samples; Amorfix had proved inside the lab with spiked brain material and with their trial on blood donors in France that the test was successful. What they now needed for total  UK validation was human vCJD samples. 
This is where I and other families who have been affected by vCJD tried unsuccessfully to help……

Department of Health and its Whitehall cronies repeatedly stalled and blocked the validation of the test by withholding blood samples from vCJD victims. I tried without success to hand over some of my Andrews blood to Amorfix, as  did other UK families. We as families affected by vCJD were very aware of the scarcity of these samples but after reflection, consideration of many research papers and talking to experts not connected with Amorfix. We all believed that Amorfix test was well on the way to developing an individual blood screening test, that would eventually save many lives. We also knew that helping companies to develop such tests would also eventually lead to treatments and more understanding of the disease. Too many scientists involved in prion research in the UK are being funded by the very organisations/people and government departments that allowed vCJD to flourish in the first place. 

Too many companies involved in the BSE scandal  now hold the purse strings and  fund many of the top research scientists who are responsible for storing  human vCJD. blood, brain and body samples. 

 Familes  knew that if we  were involved in the handing over of our loved ones blood  that they would be bonafide samples and could be double checked for authenticity.  

After months of negotiation between victims families, Department of Health, Whitehall and Amorfix, myslf and  other families were ready to hand over those precious blood samples from our children to the company based in Canada. 
The next step would hopefully be validation and the rolling out of individual screening tests for the UK blood supply. No family member including myself had any financial political or corporate gain from this process. Remember these are the last physical remains of my beloved boy…I only considered giving these to Amorfix because I believed a blood screening test would result that could save lives and prevent further deaths.. no way would I have considered this option without talking, discussing and finding out at length everything I could about prion assays and screening tests.

I was about to sign the contract when I was informed by a Scientist that works and is funded by the Department of Health and those other shady companies that my Andrews blood was not stored correctly. My beloved sons blood couldn’t be used by Amorfix or any similar test. At the same time another family like me who had also worked for weeks to retrieve their son’s blood was told a similar story….. families who independently wanted to supply human vCJD blood samples…to Amorfix were suddenly told at the last minute that none of our loved ones blood would be suitable only blood  samples supplied by the Department of Health from a secret source would be?

For me this was a devastating blow…why was I not informed of this at the beginning of negotiations? Why waste months of talking, arguement with medics and government officials if my Andrews’s blood was not appropriate? I had spent long weeks and months talking and investigating every avenue of this procedure. I admit when I heard this devastating news I cried for  hours…..once again it appeared that a door had been slammed in my face. But I have bounced back and remain determined. 

Also I am not a scientist and have no idea how or in what manner my Andrews blood has been stored.? 

 I started to feel very worried about the Amorfix test and the likelihood that it would ever become validated! I also began to smell a rat………!. Lots of things were just not adding up.....?

During this time another family whose son was still alive but very ill with vCJD offered to help and agreed for him to give blood to Amorfix . This would mean the provenance and honesty of the sample would be without doubt and not compromised. I was going to be present and even planned to take my camera to film the victim and his family. I wanted to make sure this blood would be bonafide and there would be no more delays. The twenty one year old victims mum said to me ‘ Its too late to help my son but I want to make sure that other mums don’t loose their child to vCJD and I want to help our Canadian friends’. Over a period of days and then weeks I arranged for blood to be taken from this young man. Once again Whitehall’s cronies, stalled, prevaricated and brought every possible piece of bureaucracy into play. When an expert finally went to this young mans home to take blood he was dying, his veins had collapsed and no blood could be taken. These continued attempts to sabotage the Amorfix test, to waylay and disrupt grieving families from trying to protect the Uks blood supply…..stinks! It has convinced me that the UK government doesn’t want a blood screening test for individual blood donors…as they have over the last months and years done everything possible to prevent this occurring…..

I and other family members have no idea where the vCJD blood samples which were eventually given to Amorfix by the UK Government  came from? How were these samples stored? Can the provenance be verified? Why was these samples stored correctly and in sufficient quantities when my Andrews and other victims were not?

The intimidation I and other families experienced during these last months as we have tried to support  a blood screening test has been disgusting. I have personally been bullied by experts  who work for the Department of Health who  tried repeatedly to manipulate me and it has not be in the best interest of the UK publics health. I have been subjected to heated arguements, anger, dismissive comments about my intellect to hours of persuasive  claptrap from the most senior medics employed by the Government asking me not to hand over my Andrews blood samples to Amorfix for testing. 

Why?
 

When Whitehall found out that nothing they could do or say would prevent myself and other families from handing over our loved ones blood samples …we were suddenly told that all the samples had either been compromised, were not in sufficient quantities or stored correctly to be used by Amorfix.

Professor Richard Knight CJD Unit told one family ‘ I beleive from as early as  2000 the WHO has recommended that all vCJD  blood samples should be stored in a chemical called citrate so that is helps in the development of prion assays’ (screening tests for vcjd)

Most of the blood samples which are being taken  from UK vCJD victims are being stored in a powerful chemical called EDTA which compromises screening tests…..why?  This is not following WHO guidelines and means that screening tests will be invalid. 
I have discovered that when blood samples  taken from UK vCJD victims have been stored in citrate many are not in sufficient amounts or have been stored as whole blood and then frozen, both these procredures can hamper and compromise the future development of screening tests. Why is this happening?

BECAUSE IF OUR BLOOD SUPPLY WAS ROUTINELY SCREENED FOR vCJD THE SECRETS OF BSE/VCJD WOULD BE REVEALED, WE WOULD KNOW THE PREVALANCE OF VCJD IN THE POPULATION AND WE COULD ALSO TRACE BACK TO THE EXACT SOURCE OF THE INFECTION.

This is why filtering of blood is being pushed as the only option to safeguard our blood supply, THIS IS NOT TO PROITECT OUR FAMILIES BUT TO PROTECT THE ARCHITECTS OF BSE AND THE ESTABLISHMENT FIGURES WHO CREATED AND CONDONED THIS HORRIFIC DISEASE.... the cover up continues..... 

Once again political careers and the freedom of those named and shamed on this website are being put before the human health of not only the UK population but our global community.

Kenneth Clarke now sits at the head of our justice department, John Gummer has been made a Lord and now a blood screening test that could have saved lives has been suspended.

A test that had ‘unprecedented success’…totally failed when given secret blood samples from the Department of Health supplied by the same puppet masters who created and enabled BSE in the first place. Those that are culpable would be proved to be culpable by a blood screening test and the Government will do everything in its power to prevent such tests developing or being implemented. 

If there is no test currently available for vCJD why are family members, brothers, sisters, parents who have lost are loved ones to vCJD, encouraged to give blood for research at London hospitals?

I have given at least 6 vials of blood for this research. What use can my blood be if there is no blood test? I have filmed this process for a forthcoming documentary.

Why are haemophilliacs who have been exposed to vCJD through blood products made to give blood for research every couple of months? Some haemophilliacs have been threatened with their medicine being withdrawn if they don’t continue to give blood for this research. They are never told the results of this research which remains unpublished and secret.

Why is blood being taken every few weeks from current victims of vCJD to ‘TEST FOR THE LEVELS OF ROGUE PRIONS IN THE BLOOD?’, if there is no viable test and rogue prioins cannot be detected?  

I been told by experts and scientists that ‘Of course there are tests available which the government and department of health are using but these are being kept behind closed doors and the results top secret, they don’t want a mass screening test, it would topple many in the establishment’

A top medic in the UK has told me ‘We have a diagnostic test that can show a person has vCJD and we are using it.’

Once again the architects the enablers of BSE and its lethal pathogen vCJD have been working their particular poison, manipulating events, officials and government policy, in an effort to protect their rocky freedom and careers…once again more innocent people will die…..once again the lies and cover-ups that unlawfully killed so many people …..Is weaving its corruption through our cabinet and Government….

Unfortunately in the next weeks, months and years more people will die of vCJD through blood, blood products and medical procedures…if blood screening tests for vCJD had been allowed to openly openly flourish and develop….lives could and would have been saved…..

Kenneth Clarke, John Gummer and their cronies and also other individuals who I am also pursuing….will have more innocent deaths on their hands……..and it will not wash away or be forgotten by myself, other families, fellow campaigners and the UK public……

I and my supporters remain undefeated, determined and implacable…and  I with my coleagues will continue to expose those responsible ……..

AMORFIX

Billy and RoseCorporate update on vCJD test development

TSX: AMF

TORONTO, May 31 /CNW/ - Amorfix Life Sciences (TSX:AMF), a company focused on treatments and diagnostics for misfolded protein diseases, provides an update on the development of a blood test for vCJD, one of its six product development programs.

The company has been successful in developing versions 2 and 3 of the test, which differ in the sample preparation steps, and both are four times more sensitive than the first version which underwent testing with vCJD patient blood in December. The company has also been successful in obtaining a rare blood sample from a person in the clinical phase of vCJD. The new versions of the EP-vCJD tests were used to test this sample and it was scored negative by both versions of the test.

"Although we were able to achieve unprecedented sensitivity with brain prions diluted into blood, we have been unable to detect blood prions with the latest versions of the test," said Dr. Neil Cashman, CSO of Amorfix. "At this stage, we believe our other product development programs are a better use of our resources, although future research may prompt reevaluation of this assessment."

The Amorfix test and those of its competitors were developed using blood samples spiked with brain prions from vCJD patients. Amorfix successfully developed the most sensitive and specific test in the world and was the first to access human samples through the UK National Institute of Biological Standards and Control process. Subsequent significant improvements to the test in the last five months did not yield positive results, and the company has reached an impasse until scientific understanding improves or more vCJD patient blood is available. Accordingly the company will suspend the commercialization of the vCJD project allowing a more focussed effort on the development of novel therapeutics and diagnostics which include:

- Our ProMIS(TM) antibody program targeting disease specific epitopes for both therapeutics and companion diagnostics for cancer and other misfolded protein diseases;

- Growing the revenue from our A(4) amyloid testing service for cell culture, tissue and blood in animal models of Alzheimer's disease (AD);

- Development of a human Alzheimer's test adapting the A(4) test protocol to detect aggregated Abeta, the hallmark of the disease, in

human plasma and cerebro-spinal fluid;

- The advancement of our novel antibodies and vaccines for the treatment of ALS and AD; and

- The contract for the development of a liver cancer early detection assay, which is nearing completion.

About Amorfix

Amorfix Life Sciences Ltd. (TSX:AMF) is a theranostics company developing therapeutic products and diagnostic devices targeting misfolded protein diseases including ALS, cancers, and Alzheimer's Disease (AD). Amorfix utilizes its computational discovery platform, ProMIS(TM), to predict novel Disease Specific Epitopes ("DSE") on the molecular surface of misfolded proteins. Amorfix's lead programs include therapeutics and companion diagnostics for cancers and antibodies and vaccines to DSEs in ALS and AD. Amorfix's proprietary technology enables it to specifically identify very low levels of misfolded proteins in a normal sample. The Company's diagnostic programs include an ultrasensitive method for the detection of aggregated Beta-Amyloid in brain tissue and blood of animal models of AD, months prior to observable amyloid formation, and a blood screening test for liver cancer. For more information about Amorfix, visit www.amorfix.com

   

"One in a thousand of the UK population could be carrying vCJD." (Professor John Collinge,March 2008)

To watch the documentary please use this link

www.bbc.co.uk/mediaselector/check/england/realmedia/insideout/south/insideout?size=16x9&bgc=C0C0C0&nbram=1&bbram=1&nbwm=1&bbwm=1

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