Revealed - UK NHS tests for Transfusion related vCJD. US California new cases.

In More Bad news for purveyors of Bovine derived products and transfusion supporters, thousands of NHS patients could be secretly monitored by the Government for symptoms of the human form of mad cow disease amid concerns that there could be another wave of infections.

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

They say monitoring these patients could give vital clues about the way the disease develops and is transmitted from person to person and could help work out whether there are likely to be further deaths. 

Thousands of NHS patients could be secretly monitored by the Government for symptoms of the human form of mad cow disease amid concerns that there could be another wave of infections

It could also inform officials whether the risk from blood donations needs to be treated more seriously.

But they are considering conducting their surveillance secretly because they fear that informing patients they are at risk and are being monitored will cause unnecessary alarm.

The proposals have been discussed by a powerful panel of leading scientists and doctors, which advises the Government on the disease, known as variant CJD.

More...

• Blood test for mad cow disease used in UK for the first time
• Flesh-eating bug that you can catch on the bus or train is spreading in the UK

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 would expect to see at least 150 cases of vCJD in this group of patients, based on scientific evidence that between one in 4,000 and one in 20,000 of the population may be infected.

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 'highly transfused' group includes people suffering life-threatening illnesses including acute leukaemia, aplastic anaemia and the blood disorder thalassemia - as well as those with multiple injuries due to road accidents, or heavy blood loss from aneurysms. 

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

But the panel, a subcommittee of the Advisory Committee on Dangerous Pathogens, has asked the Health Protection Agency to set out the various options for monitoring these patients based on seeking their consent or not. 

Chris James, chief executive of the Haemophilia Society, said: 'We are shocked to learn there was ever any suggestion of non-consensual monitoring. 

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

'Any proposed framework must be reviewed by an ethics committee and open to challenge from individuals and organisations such as ourselves through a formal consultation process.' 

Latest official figures show seven NHS patients have died from vCJD after having blood transfusions.

Four are known to have been given blood from people who were infected with fatal vCJD, and the other three had previously had transfusions although it is not known whether the blood was contaminated.  

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.

Experts predicted that hundreds more could die after receiving blood infected with the disease. But they now admit they are baffled as to why these cases have failed to emerge. 

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.

In one case, a patient is known to have been exposed to vCJD in a blood transfusion and is still alive 24 years later. 

A memorial plaque to victims of Human BSE on the Riverside Walk near Westminster Bridge, London

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.

But this threshold may now be raised to only inform patients if they are exposed to 300 or more blood donors because the lack of vCJD cases so far may indicate that the risk of catching vCJD in blood may be lower than previously suspected. 

Judy Kenny, of the CJD Support Network, whose husband Deryck died aged 69 in 2003 after being given contaminated blood, said: 'If the authorities are going to do any monitoring, patients should be aware of it. 

'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

Professor Chris Bunce, science director of charity Leukaemia and Lymphoma Research, said: 'The extent of the risk [of vCJD] to patients who receive regular blood transfusions as part of their treatment is as yet uncertain. 

'One way to ascertain the risk would be to monitor the distribution of the pathogen among people in this group. 

'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.


Meanwhile Stateside...
(Sacramento, CA) 
Friday, February 10, 2012

The Marin County Public Health Officer, Dr. Craig Lindquist, says one person who was diagnosed with a brain disorder similar to Mad Cow Disease has passed away, but that the person did not contract the disease from contaminated beef.  That makes it the classic form of the disease and not the varient form.   

There is another resident still living with Creutzfeldt Jacob Disease or CJD.  Lindquist says there is no evidence it is of the varient variety either. 

CJD is very rare, but always fatal.  It attacks the memory, hand eye coordination and vision before killing the victim within a year. 

The Mad Cow variant of the disease can be spread only by contact with the brain tissue or nervous system tissue of someone or something that is afflicted.  Twenty five years ago, nearly 170 people died of the variant form of the disease in Europe.

Doctor Richard Breitmeyer runs the lab at UC Davis that  tests  Mad Cow disease in sheep and cattle.  

BREITMEYER:  "The current science believes in the United Kingdom that was the cause of Varient CJD in people in that they had consumed meat products that were contaminated with the bovine form."

Breitmeyer's lab is one of six in the nation.

Cattle fed with bovine bone meal was found to be a significant cause of the spread of the disease in Europe.  Of the 40,000 animals tested each year in the United States since, only two tested positive.

In humans, 85 percent of those afflicted with classic CJD had no known risk factors.  Five to ten percent had a genetic history of the disease.

Baxter Announces FDA Approval of Expanded Indication for TISSEEL

DEERFIELD, Ill., Jan 30, 2012 (BUSINESS WIRE) -- Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved TISSEEL [Fibrin Sealant] to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical. TISSEEL is effective in heparinized patients. TISSEEL mimics the final stages of the body's own blood clotting cascade, creating a clot that adheres to the wound surface and helps achieve hemostasis.

"The expanded indication for TISSEEL offers more surgeons an effective tool for controlling bleeding across a wider variety of surgical procedures," said Sibu Saha, M.D., Professor of Surgery, University of Kentucky. "This includes patients who have been treated with heparin who may have unique treatment challenges, which was the case for some of the patients involved in Baxter's clinical trials."
A Phase III clinical study assessed the safety and efficacy of TISSEEL in peripheral vascular surgery compared with manual compression, a standard of care, in 140 evaluable patients (70 patients per treatment arm). In the study, TISSEEL was shown to be statistically significantly better than manual compression in achieving hemostasis. These study results complement a clinical data package showing the safety and effectiveness of the use of TISSEEL as an adjunct to hemostasis.
"TISSEEL and its multiple application devices make it well-suited for a variety of surgical situations, such as open and laparoscopic procedures, reinforcing Baxter's commitment to supporting solutions to the surgical community," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience busines

Important Risk Information

For Topical Use Only. Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, may result in life-threatening thromboembolic events and may increase the likelihood of acute hypersensitivity reactions in susceptible patients. Exercise caution to minimize the risk of intravascular application when using TISSEEL in surgery.

Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.

Do not use TISSEEL for the treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.

Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of TISSEEL. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously.

Aprotonin is known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure.

Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Remove remaining product from the application site.

Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This may occur if a spray device is used at higher than recommended pressures and in close proximity to the tissue surface.

When using the EASYSPRAY device, or an equivalent spray device for open surgical procedures cleared by FDA, TISSEEL must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites.

TISSEEL is denatured when exposing to solutions containing alcohol, iodine or heavy metals. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL.

Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set. Excess clot thickness may negatively interfere with wound healing.

The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated; its use in this setting is not FDA approved.

TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Cryolife announce first patients enrolled for BioFoam (Bovine) trial.

ATLANTA, Oct. 24, 2011 /PRNewswire via COMTEX/ -- CryoLife, Inc., CRY +2.52% , a leading tissue processing and medical device Company focused on cardiac and vascular surgery, today announced that it has enrolled the first patient in its U.S. Investigational Device Exemption (IDE) clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology. In connection with the trial, BioFoam will be used as an adjunct to conservative measures of achieving hemostasis on newly resected liver parenchyma.
The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at up to three investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
"We are pleased to begin enrolling patients in our IDE study, which is a milestone in our efforts to obtain BioFoam approval for distribution in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed read more HERE.

Irish Budget cuts mean no CJD screening of donated blood

Ireland - THE MINISTER FOR Health has been advised not to introduce a new technology to screen donated blood for Creutzfeldt-Jakob disease because it would not be cost effective to do so.
Variant Creutzfeldt-Jakob disease (vCJD) is one of a group of rare, progressive fatal non-inflammatory degenerative diseases of the brain affecting humans and animals.
Also known as prion diseases, they are thought to be caused by an abnormal form of a naturally occurring protein in the brain (the prion protein) that has been acquired through infection.
Following a detailed health technology assessment (HTA) carried out by the Health Information and Quality Authority (HIQA), Dr Patricia Harrington, head of assessment with the Authority’s Health Technology Assessment Directorate, said: “The Authority’s HTA found that to filter red cell concentrates as proposed by the blood service would initially cost €11 million per year. It was estimated that such a measure would, over a 10-year period, potentially prevent two deaths from vCJD.”
The origin of vCJD is linked to the outbreak of a bovine form of the disease, bovine spongiform encephalitis (BSE), which occurred in the UK in the 1980s and 1990s.
The incidence of BSE and vCJD peaked in the Britain in 1992-1993 and 2000, respectively, and has been declining since.
However, there is an ongoing risk of vCJD transmission from transfusion of blood or blood products due to donations from carriers of the disease.
Worldwide, there have been five documented cases of transfusion- related vCJD infection, resulting in three deaths from clinical vCJD.
Emphasising HIQA’s increasingly important role as health budgets dwindle, the report states: “Given the likely number of clinical cases and, in the context of a finite healthcare budget, consideration must be given to the existing technologies and services that may need to be displaced should a decision be made to introduce prion filtration, at a cost of up to €11 million per annum.”

Public Increasingly Aware of Meat-Glue in Food - Health Industry Use Certain to be Debated?

As public awareness increases of the use of meat glue (animal derived thrombin) within the food industry, it seems inevitable that the use of similar products in surgery will become a discussion point. Particularly when perfectly viable alternatives are available, it will certainly impact the healthcare sector. Below is an excerpt of a commentary on this practice with further links below. We in the industry are fully aware of the risks associated with bovine thrombin... and this

Not to mention the public belief in regulatory protection

"There was...crap in that stuff. This stuff was manky, it was filthy, it was dirty ... but they still stuck it in the arms of children"

 

Meat what are you getting now?
The commercial meat packing industry and restaurants around the U.S. have found a new way to increase profits by using meat scraps to make filet mignons as well as hot dogs, sausages and stew meat.  Powdered meat glue binds scraps of beef, lamb, chicken or fish, that would normally be thrown out, into solid pieces of meat.  According to its manufacturer, meat glue can be used to produce new kinds of mixed meats (for example combining beef and fish seamlessly).
Meat glue permits restaurants and butchers to sell their meat scraps as premium meat.  Once you cook the glued meat, even a professional butcher or chef can’t tell the difference.
This Franken-food is sold as imitation crabmeat, ham, hot dogs, sausage, fish balls, for making milk, making noodles firmer and making yogurt (water loss) creamier.  It is also used for more expensive products such as filet mignons and veal steaks and products labeled as beef steak, chopped meat, shaped meat, frozen meat, pork or chicken as well as minute steak, formed meat, wafer sliced meat, frozen meat, beef added products, chopped meat, molded meat, cubed or frozen beef, chicken and pork as well as some Hydrolyzed plant protein.
So how do they glue meat together and make it look just like filet mignons?  Super glue?  No!  A new miracle glue from 3M?  No!  The industry uses a pseudo-coagulant called Thrombin or Fibrimex, which were initially banned in Europe but now sold in the EU, Australia, Canada and the U.S.
Thrombin is sold under the brand names Activa RM and Fibrimex.  The products derive from pig or bovine blood.  The active ingredient is called transglutaminase.  When sold in a store, products containing transglutaminase are labeled as “composite meat product”.  However there are no labeling or disclosure requirements placed on restaurants.
But meat glue sold as Thrombin and transglutaminase have a different enzyme makeup.  Transglutaminase is the enzyme that cross-links proteins in “meat glues.”  Thrombin is a different protein, a protease that causes increased transglutaminase activity.  Thrombin can be hazardous to use because if it enters a cut it can cause extensive blood clotting.
Thrombin contains Maltodextrin and sodium caseinate which contain (without disclosure) Ajinomoto’s MSG.  Blood carries bacterias, toxins and viruses causing infections and autoimmune responses in animals as they do in humans.
Factory farms also use growth hormones (steroids) that require daily doses of antibiotics in an effort to control or minimize illnesses.  Animal feed used in CAFOs contains pesticide residues that also contribute to illness.  The use of antibiotics signals an admission that factory farmed animals are sick or become sick.  Why would you give daily doses of antibiotics to an animal or human being unless they were sick?
The infectious agent that leads to mad cow disease can also be passed through animal blood meal.  As a result of mad cow’s disease cases in 2004, the Bush administration’s FDA said it “would ban animal blood in cattle feed, while dietary supplements and cosmetics would be kept free of materials from cattle too sick or hurt to walk.”  Consumer groups said the protections did not go far enough.  Why does the food industry and the USDA think animal blood meal is now safe for human consumption?  What has changed since 2004? 

Links

Full excerpt HERE.

Fibrimex website HERE and Ajinomoto HERE

U.S. FDA advisory meeting - TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE

On Oct. 28, the committee will discuss FDA's risk assessment for potential exposure to the variant Creutzfeldt-Jakob disease(vCJD) agent in U.S.-licensed plasma-derived Factor VIII and labeling of blood and blood components and plasma-derived products, including plasma-derived albumin and products containing plasma-derived albumin, to address the possible risk of transmission of vCJD.
On Oct. 29, the committee will hear informational presentations related to FDA's geographic donor deferral policy to reduce the possible risk of transmission of CJD and vCJD by blood and blood products and human cells, and tissue and cellular and tissue based products. The committee also will hear updates on the development of devices to remove transmissible spongiform encephalopathy agents from blood components and chronic wasting disease.

DATE: Oct 28-29, 0830/1230

LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: Bryan Emery or Rosanna Harvey, 301-827-0314

Animal Products

Following on from the Bleeding Calf Syndrome posting available HERE and other postings available Here regarding risks of animal sourced products.

I have provided further info above provided by DEFRA. To the best of my knowledge only the UK and Scotland are acting to investigate?

You can follow this link for further details also 'This intriguing disease captures the imagination. The VLA will be working with others to help discover the cause.'

I expect manufacturers will focus efforts on recombinant, plant-based technologies.

While our industry battles achieving financial success in the market with the ideal of creating an agent that is:

• of minimized risk
• efficaious
• cost effective,
• easily deliverable
• and applicable to multiple surgeries

The removal of King Pharmaceuticals crown as leader in the multi- $million Thrombin market by Zymogenetics is

a sure indicator as to market preference and acceptance of these benefits. J&J have a human sourced Thrombin following theirpurchase of Omrix.

Certainly reconstituted animal based technologies are facing severe threats currently as the link between zoonotic diseases (animal/human transfer) become more widely known. While BNP (Bleeding Calf Syndrome) transmission is far from clear it should be of concern. The lack of reporting and individual Government action highlight the inadequacies of public protection even with a cursory investigation.

While Bleeding Calf Syndrome may not pose infection risks via medical devices it exemplifies the public vulnerabilities to weak protection measures from their Governments. This is weak response and is exactly the response delivered that saw vCJD, and Prion borne infections escalate. Harvesting Bovine Materials HERE

Cow Products - Why ?

Bovine Neonatal Pancytopaenia (BNP) is a newly emerging disease syndrome of calves less than one-month-old which has recently been reported in Britain and Europe.
It is often referred to as calf haemorrhagic disease, haemorrhagic diathesis, bleeding calf syndrome or blood sweating disease.
The first cases of the condition were reported in Germany in 2007.Since then, reports of confirmed cases have slowly risen in a number of European countries while the first confirmed case was recently diagnosed in Ireland and there have been four cases confirmed in Northern Ireland to date.

Typically, the clinical signs in young calves can include excessive bleeding from small abrasions of the skin, or even from injection sites, and the passing of large clots of blood in the dung.

Temperature

Calves affected with the condition normally have a high temperature and become rapidly depressed. In the majority of cases, death follows within 24 to 48 hours (mortality of about 90% is commonly reported), with aggressive veterinary treatment, including blood transfusions, normally providing only a temporary respite for the animal.

The disease syndrome tends to affect single calves in a herd although multiple calves have been affected in some herds in Britain and Germany.

Affected calves tend to be found in larger well-managed herds with a large proportion of affected farms also keeping sheep as well as cattle.

Within countries that have identified cases, a geographical pattern to the occurrence of the disease has not been identified nor has any breed or gender association been established.

On post mortem examination of affected calves, significant damage to the bone marrow has been consistently reported.

The bone marrow is responsible for producing the blood cells. Red blood cells are responsible for transporting oxygen, while white blood cells play a role protecting against infection. Platelets are responsible for blood clotting.

Of these three, the platelets are most severely affected, giving rise to the typical clinical signs of poor clotting and widespread bleeding in the calf.

While the cause of the condition is unknown, there is no evidence that the condition is infectious or that it gives rise to food safety concerns.

The fact that apparently normal calves at birth can develop clinical signs rapidly after consuming colostrum has focused the attention of researchers on colostrum. It is possible that colostrum acts as a vehicle for the introduction into the calf of the agent which damages the bone marrow.

During the 24 hours that follow the birth of an animal, the intestine allows antibodies (a form of defence against disease) which are contained in the colostrum to pass from the gut into the blood stream. This is an important step in the transfer of immunity from the mother to her offspring and plays a vital role in preventing disease in the newborn calf.

It is possible that, in a very small percentage of calves, some of these antibodies target the bone marrow cells, leading to the clinical signs of the disease. Indeed, a similar mechanism is known to cause destruction of blood cells in some newborn foals and piglets. Researchers wish to ascertain whether this is the case in affected calves and, if so, to determine what has changed in the cow or her environment which has led to the occurrence of the condition.

The Department of Agriculture, Fisheries and Food's regional veterinary laboratories are available to assist herdowners and veterinary practitioners with laboratory diagnosis and investigation of any suspicious cases.

The Department has offered to provide free post mortem examinations of any young calf with clinical signs typical of the condition.

While the condition is rare, with minimal losses to date, the Department is always vigilant to the occurrence of novel diseases or novel presentations of existing diseases. Herd owners are asked to notify their veterinary practitioner of any young calves with apparent clotting difficulties.

Interesting article on bovine harvesting

Tachosil - Report Fails to Impress

A new product — a sponge-like patch — is now on the market to help decrease bleeding during cardiovascular surgery.
The sealing patch, called TachoSil, helps prevent bleeding and — better yet — never needs to be removed. It simply dissolves within the body over time.
“TachoSil is the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels when standard surgical techniques are ineffective or impractical,” said Dr. Michelle Yeboah.
The new product received approval in April from the Center for Biologics Evaluation and Research, the part of the Food and Drug Administration that regulates biological products for human use.
The absorbable fibrin sealant patch is unique. It is the first product of its kind available in the United States, said Laura Jacobs, corporate communications official with Baxter Pharmaceuticals.
Officially, the patch is considered an adjunctive hemostatic agent, used to control bleeding during surgery, Jacobs said.
TachoSil is a sponge-like material made up of naturally occurring proteins found in mammals. The product is covered with two proteins: fibrinogen and thrombin.
Together they cause chemical reactions that produce fibrin, which is a protein that brings about blood clots.
This sealant patch is biodegradable, which means that it breaks down within the body in less than six months.
TachoSil does not require preparation and can be applied directly to the bleeding area during both open and minimally invasive surgeries.
“In the presence of saline, blood or other bodily fluids, the coagulation factors in TachoSil dissolve to form a mechanical fibrin clot, which adheres the patch to the bleeding surface and achieves hemostatis,” Jacobs said.
It can be used in cardiovascular surgery when bleeding cannot be controlled by standard surgical techniques such as suture, ligature or cautery. It is not a replacement but rather an additional tool to what is currently available to surgeons.
The patch comes in various sizes. The surgeon can use scissors to cut the patch to a specific size or can overlap patches if the patch is not large enough.
In instances of heavy bleeding, excess blood is to be wiped away before TachoSil is applied.
One side of the patch is yellow, and that is the side that should cover the wound. It is dyed with riboflavin to indicate that the side contains active ingredients.
It is critical to apply pressure on the patch for three minutes.
After the surgery, imaging scans such as X-rays, ultrasounds and CT scans will show evidence that TachoSil was used. The clarity of the image depends on the specific site of application.
No product comes without risk, however.
It is not common, but some patients experience hypersensitivity or allergic reactions. In rare cases, it could turn into severe hypersensitive reaction. Those who are prone to having a systemic reaction to horse proteins or human blood products are not good candidates for use of TachoSil.
TachoSil comes in double packaging which makes it extra sterile. This allows someone to assist during surgery and open one layer of the package while leaving the inner package on the table with the other instruments ready for use.
The sealant patch is a significant advance for cardiologists and represents another tool surgeons can use to address the many types of bleeding challenges in cardiovascular surgery, Jacobs said.
TachoSil has more than 15 years of documented clinical experience and a strong safety record, Jacobs said.
The product, manufactured by Nycomed Austria, is available in more than 50 markets, in addition to the United States.

Source: Reporter News

Variant Creutzfeldt-Jakob Disease House of Commons debates, 18 March 2010, 5:27 pm

Insurance Company offers screened blood

ALC Health has signed an agreement with the Blood Care Foundation (BCF) to provide clients with screened blood, in the event of a medical emergency, from a network of blood banks around the world.
The service will be added as a new free benefit to all of the company's policies, including travel insurance, from 1 June 2010. ALC Health will be the only international medical provider offering the service across all of its policy products.
Andrew Apps, director at ALC Health commented:"The increase in incidences of people being given infected blood meant that many of our members were requesting a service of this type. We are delighted to be working with the BCF and now, at no extra cost to our customers, they can be assured that in the event of requiring a blood transfusion the blood will be available within a short space of time and will have been fully screened."
The BCF is a Sussex based charity that has been established since 1991 to provide a solution to the problems of sourcing and supplying screened blood in the case of emergencies. The BCF has built up a network of blood banks to overcome the demand where blood is in short supply, or the local blood does not meet US, UK and EU standards. All blood supplied by BCF is drawn from internationally recognised blood centres, which meet the highest international standard. BCF also supplies immunoglobulin and vaccine for the treatment of rabies.

Pathogen Safety of Evithrom

Irish HIQA will look at prion test for vCJD

Ireland - The Health Information and Quality Authority (HIQA) is to examine the introduction of prion testing and prion filtration to safeguard against the transmission of variant Creutzfeldt Jakob disease (vCJD) from blood donations.
Irish Medical Times has learned that the Chief Medical Officer of the Department of Health, Dr Tony Holohan, is due to discuss with HIQA the question of an ‘appropriate assessment with regard to the potential introduction of these technologies in the future’.
Such a review is likely to take the form of a Health Technology Assessment (HTA), designed to inform decision makers on safe and effective health policies that are patient-focused and achieve best value for money. The Irish Blood Transfusion Service (IBTS) has already estimated that introducing the technologies could cost up to E75 million over the next five years.
However, it believes applying formal evaluations to the cost of prion filtration and prion testing is ‘fraught with difficulty’.
IBTS Medical and Scientific Director Dr Willie Murphy told IMT that blood products had a ‘special status’, equivalent more to pharmaceuticals than healthcare interventions. “We don’t say to the pharmaceutical manufactures that we’ll leave out that safety step, or drop that quality control, to take 10 cent off the price.
“If a new, better test for HIV becomes available, of course we spend the money to do it. As a nation, we would be appalled if we didn’t,” Dr Murphy added.

New Strain of H.I.V. Is Discovered

European scientists have discovered a new strain of the virus that causes AIDS and linked it to gorillas, creating a mystery about when and how the first patient found to have the strain became infected.It is thought to be likely that this is the first time scientists have documented the jump of a simian immunodeficiency virus to humans from a gorilla. All three other known strains of the human immunodeficiency virus, H.I.V.-1, have been linked to chimpanzee's. But genetic tests showed that the new virus was closely related to a recently recognized gorilla virus. The most likely explanation for the new virus’s emergence is gorilla-to-human transmission, probably a result of humans slaughtering apes or handling or eating their meat. But the scientists said they could not dismiss the possibility that the chimpanzee virus linked to H.I.V.-1 was transmitted to gorillas and then to humans, or was directly transmitted to humans and then to gorillas. The new virus strain was isolated in 2004 from a 62-year-old woman upon her arrival in Paris from Cameroon in West Africa. She has not been treated for AIDS and has no signs of the syndrome, the scientists said. The woman had lost weight in 2003 and had been ill with number of times, the scientists said in reporting the discovery, in the Aug. 2 issue of the journal Her husband died in 1984 from complications of a stroke. It is not known if he was infected with H.I.V. The woman had six children, all born before 1980, a year before doctors first recognized AIDS; two of the children died of noninfectious causes, and none of the surviving children have H.I.V.

The authors of the report said they presumed that she had been infected through sex. The woman told her doctors that she had sexual partners in Cameroon after her husband’s death, but there was no information about whether any were infected — or, if they were, how they had contracted the virus. The amount of virus in her blood is high, reported the French and British scientific team, which was led by Jean-Christophe Plantier of the University of Rouen in France. But the number of CD-4 blood cells, a key laboratory measure of the progression of AIDS, is stable at about 300 per cubic millimeter. The scientists suspect that there are additional undetected cases because the patient lived in a semiurban area of Yaoundé, the capital of Cameroon, and she said she had no contact with apes or their meat. More studies are needed to determine how often the new virus infects people. The discovery was part of continued monitoring for new viruses. The goal is to identify a simian or other virus before it can cause another epidemic like AIDS, which has affected more than 33 million people worldwide. The new virus may escape detection by standard blood and laboratory tests for H.I.V.-1. New testing methods developed in recent years have allowed scientists to detect subtypes of H.I.V.-1. The three others are known as H.I.V.-1 Groups M, N and O. Dr. Plantier’s team calls the new one H.I.V.-1 Group P.

Sorry UK..........vCJD Filter to expensive!

A medical breakthrough that prevents the spread of the human form of mad cow disease via blood transfusions may be denied to NHS patients because it costs too much.

More than 60 adults having surgery have received blood free of the risk of variant CJD in trials overseen by the National Blood and Transplant Authority.

The advance centres on a filter that can remove the rogue vCJD protein, called a prion, from blood in just 30 minutes - eliminating the patient’s risk of catching the brain disease.

The filter could restore faith in British blood supplies which are proven to be tainted with vCJD after several deaths related to transfusions.

But documents reveal it has been branded ‘not cost-effective’ and experts warn it will double the price of producing red blood cells, leaving a bill for an extra £100million.

Donors who do not realise they are carrying the disease, which can have an incubation period of up to 50 years before showing symptoms, risk passing on vCJD when they give blood. It is feared as many as one in 4,000 could be carriers. There is no reliable way of testing stored blood to see if it is infected.

The filter simply clips on to the blood collection bag and red cells are slowly dripped through it into an empty bag underneath. Any prions are captured in a mesh containing resins that are designed to ‘attract’ amino acids found on the surface of vCJD proteins.

Animal studies have proved it prevents transmission of the deadly disease through blood transfusions.

FDA Reevaluates Safety of Plasma-derived Biologic Products

June 16, 2009 — The US Food and Drug Administration (FDA) Transmissible Spongiform Encephalopathies Advisory Committee has decided that no changes to blood-monitoring practices are required at this time. The committee met Friday to evaluate the risk for variant Creutzfeldt-Jakob disease (vCJD) in plasma-derived factor VIII products used for blood-clotting disorders.
Concern for patients was first sparked by a February announcement by health authorities in the United Kingdom reporting a vCJD infection in a person with hemophilia treated with a plasma product.
The FDA is now reevaluating whether current blood-donor policies are sufficient to maintain the safety of plasma-derived biologic products. The decision is anticipated to have international implications, because an estimated 50% of the world's plasma supply is provided by the United States.
Jay Epstein, director of the FDA's office of blood research and review, asked the committee if the UK announcement has "changed the landscape in a fundamental way" and should prompt changes in the United States.
The advisory committee voted unanimously that no changes are required at this time. The 15 voting members concluded that the risk for vCJD to patients who receive US-licensed plasma-derived coagulation factor VIII products is likely to be extremely small.
Committee chair Nick Hogan, MD, from the University of Texas Southwestern Medical School, in Dallas, said, "There is very little change to the modeling and epidemiological data, so there is very little reason to change this."
But during the open public hearing, some voiced concerns about the difficulty of reporting vCJD in many parts of the United States. Without thorough reporting, they question the accuracy of current data.

More Data Needed

The fatal neurodegenerative disease is acquired through infection with the agent that causes bovine spongiform encephalopathy. vCJD is typically acquired by consuming beef products from infected cattle. The first human cases of vCJD were reported in the United Kingdom in 1996. By May 2009, 211 definite or probable clinical cases of vCJD had been reported worldwide, with 168 of these in the United Kingdom.
At the open public hearing, some also raised concerns about inadequate animal surveillance. While countries such as Japan reportedly test every cow, this does not happen in many places, including the United States.
International health authorities have also been concerned about the risk for a secondary epidemic through human-to-human transmission. In the case that prompted the announcement in the United Kingdom, a 70 year-old man had been treated 11 years earlier with a plasma-derived factor VIII product. The product was reportedly developed from pooled plasma containing at least 1 donation from a person who later died of vCJD.
Postmortem examination of the 70-year-old's brain identified no neuropathological changes suggestive of Creutzfeldt-Jakob; however, his spleen revealed abnormal accumulations of prion protein typical of the disease.

Risk Likely Small

Mark Skinner, president of the World Federation of Hemophilia, said that he agrees with the advisory committee's decision. "While the risk may not be zero, it certainly is very small," he said at the meeting.
He suggests that current donor-deferral measures appear to be effective, but a donor screening test could still be useful. Mr. Skinner recommended that product warning labels should be updated to include vCJD among risk factors.
The committee discussed donor-deferral measures and product labeling at length but did not vote on these issues.
The FDA is considering the input from the advisory committee and will issue a final decision after its review.