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

Hemostat Companies Persist With Animal Derived Production Despite Risks

Despite the World Health Organisation (WHO) recommending....."The pharmaceutical industry should ideally avoid the use of bovine materials and materials from other animal species in which TSEs naturally occur. If their use is absolutely necessary, bovine materials should be obtained from countries which have a surveillance system for BSE in place and which report either zero or only sporadic cases of BSE. These precautions apply to the manufacture of cosmetics as well."
Some Medical Device companies are seeming to blithely plunge onward commercialising animal derived hemostatic products. There does seem adequate reason for concern for this along with other technologies from safer sources.

Interested in Human-Horse Diseases? ClickHERE and HERE

Researchers have found new evidence for the existence of a subclinical form of bovine spongiform encephalopathy (BSE). Cattle, sheep, and other animals that are outwardly healthy may be harbouring the infection, with the risk that BSE could still be getting into the food chain.
In a new study based on a mouse model, researchers at the Medical Research Council Prion Unit took a closer look at the species barrier, which limits the ability of prions to jump from one species to another (Proceedings of the National Academy of Sciences 2000;97:10248-53).
In the study, scientists tried to infect laboratory mice with hamster prions and saw no apparent signs of disease. But when they looked more closely they found that the mice had high levels of prion in their brains.
"Previously scientists have injected mice with the hamster disease, found no clinical signs of infection, and concluded it cannot jump the species barrier," said Dr Andrew Hill of the University of Melbourne, one of the authors of the study.
The team, led by Professor John Collinge, director of the MRC Prion Unit, also found that the new subinfection could be easily passed on when injected into healthy mice and hamsters.
"These results have a number of important implications. They suggest that we should rethink how we measure species barriers in the laboratory and that we should not assume that just because one species appears resistant to a strain of prions they have been exposed to, that they do not silently carry the infection," said Professor Collinge.
He continued: "These new findings have important implications for those researching prion disease, those responsible for preventing infected material getting into the food chain, and those considering how best to safeguard health and reduce the risk that, theoretically, prion disease could be contracted through medical and surgical procedures."

Countries or regions with a controlled BSE risk

EU Member States — Belgium, Bulgaria, the Czech Republic, Denmark, Germany, Estonia, Ireland, Greece, Spain, France, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, the Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, the United Kingdom

EFTA countries — Switzerland, Liechtenstein

Third countries— Brazil, Canada, Chile, Taiwan, Mexico, United States

Tachosil - IFU and FDA info

Horse tendons for production of Collagen Sponge are collected from slaughterhouses. ---(b)(4)-- (horse–(b)(4)) slaughterhouses are certified by authorities of the European Union. -----(b)(4)---- slaughterhouses possess an approval of the EU veterinary authorities and are listed on the FSIS (USDA) list as certified facilities. All slaughterhouses are regularly inspected and approved by the national veterinary authorities and are audited by Nycomed. Each batch of horse tendons supplied to Nycomed is accompanied by a veterinary certificate and by a QA certificate issued by a quality responsible person at the slaughterhouse.

Transmissible Spongiform Encephalopathy

TachoSil has an acceptable safety profile with regard to prions. TachoSil does not contain any bovine ingredients. According to current knowledge, horses do not develop prion disease. Measures to avoid cross contamination of the equine tendons are in place at the slaughterhouses. For the Active Substances - Human Fibrinogen and Human Thrombin - strict plasma donor selection criteria are employed by the manufacturer.........Full FDA document with IFU available below.....

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

Lawyer calls drug vials 'weapons of mass infection'

The drug companies that produced and sold the sedative linked to Southern Nevada's hepatitis C outbreak provided large vials of medication to endoscopy centers despite their risk to public safety, a lawyer charged Friday.

"These drug companies knew that these were weapons of mass infection. They knew what was going on in these endoscopy centers. ... They knew it for years and years and years, and they did nothing to stop it," Robert Eglet told a jury during closing arguments in the first trial stemming from the outbreak.

Eglet represents Henry Chanin, 62, who was infected with hepatitis C during a 2006 colonoscopy at the Desert Shadow Endoscopy Center, one of two clinics linked to Southern Nevada's hepatitis C outbreak.

Chanin, headmaster at The Meadows School, and his wife, Lorraine, are suing Teva Parenteral Medicine and Baxter Healthcare Services, which made and sold the drug propofol, on several product liability claims.

After hearing two weeks of trial testimony, the jury began deliberations late Friday afternoon to decide whether the companies should he held liable for Henry Chanin's infection.

His case was one of nine linked to two Las Vegas endoscopy clinics by health officials, who in 2008 notified 50,000 patients about possible exposure to hepatitis, HIV and other blood-borne diseases because of unsafe injection practices at the clinics. Hundreds of patients have filed lawsuits as a result of the outbreak.

Officials blamed the local outbreak on nurse anesthetists reusing single-dose drug vials between patients after the vials had become contaminated by the nurses reusing syringes on the same patient.

Eglet said the companies knew of the temptation to reuse the large 50 milliliter vials of propofol, which contained four to five times the amount needed for a typical 10-minute colonoscopy.

"They knew they were going to be 'double dipping' on this between patients," he said.

Teva and Baxter should have known about the dangers because propofol was associated with seven previous hepatitis C outbreaks that infected 148 people, he said.

Eglet also pointed to a report Teva wrote to the U.S. Food and Drug Administration in 2000 to get approval to make 10 milliliter vials of propofol. The report acknowledged that some medical workers were reusing the larger vials among patients to avoid throwing away unused anesthetic.

The smaller vials would improve patient safety undergoing endoscopic procedures because there would be less leftover anesthetic to tempt medical workers to reuse the vials, the report stated.

Teva made the 10 milliliter vials until 2007, when it stopped production in part because the smaller vials cost more to make than the larger vials, Teva executive Craig Lea testified at trial.

Based on their knowledge of previous misuse of the larger vials, the drug companies should be held liable because the misuse was "reasonably foreseeable," Eglet said.

The lawsuit originally named the doctor and nurses who performed Henry Chanin's colonoscopy, but their insurance company settled the medical malpractice claim last month, preventing the drug companies from shifting blame.

"They cannot point the finger at somebody who is not here," Eglet said.

The Chanins' suit also claims warning labels on propofol inadequately warned of the dangers of reusing the vials.

Drug company lawyer Mark Tully defended his clients, saying there was nothing defective about the propofol, which worked exactly as it was supposed to during Chanin's colonoscopy.

He said Teva made the 10 milliliter vials until 2007, when they were discontinued because doctors preferred to buy 20 and 50 milliliter vials. It was up to the medical professionals to decide which size was appropriate because the amount of propofol needed varies by procedure length and patient size, he said.

"There are uses for 20s and 50s that are entirely acceptable," Tully said.

He also dismissed the 148 hepatitis C cases Chanins' lawyers connected to propofol, pointing out that all of those infections were blamed on poor techniques for maintaining a sterile environment, such as reusing syringes and improperly cleaning scopes, which were warned against in the drug packaging.

"There are risks with using propofol, and the way to avoid those risks is to use proper aseptic technique and only use the vial on one patient," Tully said, noting that every propofol vial had "single-patient use" written in red letters.

Since being infected with the hepatitis C virus, which makes the liver swell and stops it from working correctly, Henry Chanin has lived with the constant worry of infecting his wife. The couple have stopped doing anything that might spread bodily fluids, from sharing a glass of wine to having sex. He also deals with lingering side effects of fatigue and joint pain two years after undergoing chemotherapy-like treatment for hepatitis C.

Eglet asked the jury to award him $8.5 million in damages to account for economic losses and his suffering. Lorraine Chanin's lawyer, Will Kemp, asked the jury to award her between $1.6 million and $2.3 million.

Eglet also encouraged the jury to levy punitive damages against the drug companies because of their conscious disregard for public safety in the name of profits.

"You can't put them in jail. We can't do other things," Eglet said. "The only thing we can do, quite frankly, is hit them where they take notice ... with money."

vCJD Families Protest outside Downing Street, London

The government has recorded 168 deaths due to variant CJD - caught from infected bovine material - but this figure is contested as being inaccurate by the families of victims because many of the families who have lost a loved one to this devastating brain disease say that they were never recorded in the official statistics.

Victims are also recorded as 'sporadic CJD', which was the original and very rare form of CJD that can occur in anybody and is not related to infected cattle.

Some cases, even in people in their teens and twenties, are put down to 'early onset alzheimer's disease'. Those left to nurse their husband's, son's, daughter's and wives through the terminal illness say that this is part of a cover up to protect pharmaceutical industries, who use bovine products widely in medicines and vaccines.

Unsafe Blood Donations

Eighteen UK blood donors later died of vCJD and their blood was used to make vaccines and medicines such as factor 8 which is given to haemophiliacs. Some haemophiliacs have since died of vCJD after being given infected blood. Despite this, the government refuse to screen donated blood. An effective test is available but they will not use it. Why not? Christine Lord, Grahame Bell and other members of the protest think it's maybe because screening people's blood would reveal the true magitude of the problem, which would be a disaster of epic proportions for government, the pharmaceutical and agricultural industries.

UK blood bags have warning labels on them due to being possibly contaminated with vCJD and they are not allowed for donation in any other country in the world apart from the UK.

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

Pathogen Safety of Evithrom

UK - vCJD Testing by Coroners called for...

Coroners are refusing to carry out post-mortem tests for an infection that

causes the human form of mad cow disease, despite pleas that they could help to monitor the disease.

Professor John Collinge, a leading expert on variant Creutzfeldt-Jakob Disease (vCJD), warned that systematic testing was vital to find out whether many people were “silently infected” with the potentially fatal condition.So far 164 people are confirmed to have died of the disease but scientists say that there is no accurate indication of how many people may be carrying it.“There is a concern that what we have seen so far may be the first wave, occurring in individuals who are particularly genetically susceptible, but there may be more people who are silently infected in the community than the number of clinical cases we have seen would suggest,” Professor Collinge told BBC Radio 4’sToday programme. But experts in the law governing coroners courts say that the tests can be ordered only if the Government changes the law. The Spongiform Encepalopathy Advisory Committee (SEAC), whose job is to monitor the progress of the disease and advise the Government, has been warning for two years that it was important to find out how many people were carrying the infection. The only reliable way of doing that, SEAC says, would be to ask coroners to test the brain and spleen of young people during post-mortem examinations so that they could be tested for the presence of the infectious agent, a protein known as a prion. Professor Collinge, a member of SEAC, said that systematic testing was needed to establish how many more people were likely to get the disease and whether the current measures to protect the spread of infection were appropriate. He urged coroners to request the test when ordering post-mortem examinations. “I would hope that they would be able to help with this because I don’t see any other way for us to get this information at the moment,” he said. “We have been very vocal in terms of saying these data are absolutely vital if we really want to manage the process properly," said Professor Graham Medley, another member of SEAC. “My understanding is the Department of Health is very keen to push this forward, it’s really just using coroners as an opportunity to do some sampling. I’m not sure why there has been some apparent reluctance on behalf of coroners.” In response, Dr Michael Powers, QC, an expert in coronial law, said that coroners would be happy to order the test if the Government changed the law. He told Today that at present they are able to order a post-mortem examination only to find the cause of death, and not test for other infections that may have been present. Dr Powers said: “This is a function which is outside the coroners’ statutory authority. Because they are not, those tests, directed to ascertaining the death in an individual case.” The Coroners and Justice Bill going through Parliament could be altered to put a duty on coroners to order the test, he said. “That would completely solve the problem,” he said. Christine Lord, whose son Andy Black died of vCJD, told Today: “This is a public health issue. I, as a mum, have lost a child, a very dear, loved child, through an avoidable disease. “The coroners, by actually blocking this, are actually not protecting public health. They just seem to be protecting their particular role in Government. “At the end of the day, they are public servants and their job is to protect us.” A Department of Health spokesman said that a pilot study will take place later this year, with the co-operation of some coroners, to obtain tissue samples from post-mortem examinations. “It is important to obtain a better understanding of the prevalence of vCJD so that we can prevent secondary transmission from person to person,” the spokesman said. “SEAC has recommended that studies of tissues, such as spleen, collected at post-mortem would provide important data on the prevalence of vCJD infection in the population. “The Health Protection Agency is running the pilot with the co-operation of NHS Bereavement Services and NHS Blood and Transplant’s consent team. “Some coroners have agreed to participate in the pilot study and appropriate funding will be made to them and to the other organisations incurring additional costs.”

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.

Poll Results - Will the Feb. '09 vCJD scare in the UK affect your consideration of using a human or bovine sourced hemostat or sealant?

We asked "Will the Feb. '09 vCJD scare in the UK affect your consideration of using a human or bovine sourced hemostat or sealant?"

50% said YES

20% said NO

13% said DEPENDS ON THE COUNTRY OF ORIGIN OF PRODUCT

16% said MAYBE

Obviously human and animal sourced products do exhibit some concerns for many.

802 haemophilia patients at risk from vCJD

Figures released by the Department of Health state that 802 haemophiliacs received blood from patients who went on to develop variant Creutzfeldt-Jackob Disease (vCJD).

It comes after a haemophiliac in his 70s was found to be infected with vCJD after his death. Although the infection was not the cause of his death, he had been treated with blood from a donor who later died from vCJD.

The disease, which destroyed Britain's beef industry in the mid 1990s, is believed to have been responsible for an estimated 164 deaths since 1995.

The Haemophilia Society has now called on the Government to test the patients at risk as soon as possible to determine whether they had contracted the disease.

Health officials released the figures in response to calls from Lord Morris of Manchester, who demanded to know whether the Government had revised its assessment of the risk presented by contaminated blood following the death of the haemophiliac who was found to be infected with vCJD.

Lord Darzi, Labour's health minister in the Lords, stated in a written answer to Lord Morris: "To date, 802 haemophilia patients are registered on the UK Haemophilia Centre Doctors' Organisation database as receiving clotting factors made from UK plasma pools containing a donation from a donor who went on to develop vCJD."

The Department of Health also revealed that 66 people who are not haemophiliacs have received blood components from donors who later went onto develop vCJD. Of these, 22 are still living, three died after contracting vCJD, and the others died from unrelated causes.

Chris James, chief executive of the Haemophilia Society, said: "We now know a much larger number of people have been exposed to higher-risk blood and blood product than was previously thought. vCJD remains an illness for which there is no test and no cure.

"It is just the latest in an increasingly long line of infections that people affected by bleeding disorders have been exposed to."

Haemophilia is a blood condition in which an essential clotting factor is missing and sufferers bleed for longer than normal. Around 6,000 people are affected by the condition within the UK.

Almost 4,700 haemophilia patients were infected with hepatitis C after receiving contaminated blood products that were given during the 1970s and 1980s. Campaigners have been fighting for compensation from the Government over the scandal.

The brain-wasting disease vCJD was first detected in the mid 1990s and since then most vCJD patients are thought to have been infected after eating BSE-contaminated meat.

The number of vCJD deaths peaked in 2000, when there were 28. That number has dropped to about five a year since 2005.

The epidemic of BSE in the 1980s and 1990s was caused by cattle being fed the remains of other cattle in the form of meat and bone meal, causing an infectious agent to spread.

More than four million cattle were slaughtered after almost 200,000 were infected with the fatal neurodegenerative disease.

Scientists recently warned that Britain could see a second wave of vCJD, affecting as many as 300 people, after discovering that genetic differences can affect how long it takes a person to incubate the disease.