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From: TSS ()
Subject: Potential Variant Creutzfeldt-Jakob Disease (vCJD) Risk From US Licensed Plasma-Derived Factor VIII (PdFVIII, Antihemophilic Factor) Products
Date: May 31, 2007 at 7:16 am PST

Thursday, May 31, 2007
Potential Variant Creutzfeldt-Jakob Disease (vCJD) Risk
From US Licensed Plasma-Derived Factor VIII (PdFVIII, Antihemophilic Factor) Products
Summary Information

Key Points:

In recent years, questions have been raised concerning the risk of variant Creutzfeldt-Jakob disease (vCJD) (a rare but fatal brain infection) to hemophilia A and von Willebrand disease patients who receive US licensed plasma-derived Factor Eight (pdFVIII, Antihemophilic Factor) products.
Based on a risk assessment, the US Public Health Service (PHS), including FDA, CDC, and NIH, believes that the risk of vCJD to hemophilia A and von Willebrand disease patients who receive US licensed pdFVIII products is most likely to be extremely small, although we do not know the risk with certainty. vCJD risk from other plasma derived products, including Factor IX, is likely to be as small or smaller.
Contacting a specialist in hemophilia or von Willebrand disease at a Hemophilia Treatment Center is a good way to learn about new information as it becomes available.
Additional Information:

Between December 2003 and April 2007, there have been four reports of people, all in the UK, who probably acquired the vCJD agent through red blood cell transfusions. This has increased concern about the potential transmission of vCJD by blood products.
Principal concerns are whether persons infected with vCJD could donate plasma in the U.S., and whether clotting factor products made from their plasma donations might transmit the disease.
To address these concerns FDA recommends the deferral of donors who may have lived in or traveled extensively to countries with a higher prevalence of vCJD and bovine spongiform encephalopathy (BSE) than in the U.S.
In the United States, pdFVIII products have not been made from the plasma of anyone known to have developed vCJD, and no one who received any of these products is known to have developed vCJD.
FDA conducted a risk assessment for pdFVIII because the plasma fraction from which it is made is likely to contain more of the vCJD infectious agent, if present, than plasma fractions from which other plasma-derived products are made, such as Factor IX, (used to treat hemophilia B), albumin, and immune globulins. The FVIII-containing fraction is further processed using a variety of methods that are likely to reduce or potentially eliminate vCJD from the final pdFVIII product. Methods likely to reduce or potentially eliminate vCJD are also used in the manufacture of other plasma-derived products.
FDA, CDC, and NIH are not aware of any cases of vCJD having been reported worldwide in patients with hemophilia, von Willebrand disease, or other blood clotting disorders. This includes those who have received, over a long period of time, large amounts of blood clotting factor products manufactured from plasma donations from the UK where the risk of vCJD is highest because of a previous higher risk of potential exposure to BSE- infected beef in the UK diet.
The FDA has taken a number of steps to further reduce the potential vCJD risk from blood components. These steps include donor deferral recommendations, and quarantine and withdrawal of products at increased vCJD risk. Donor deferral guidance, first issued in August 1999 and subsequently updated, includes, among other things, deferral of donors who visited or resided in Europe where BSE prevalence is higher than in the US. Also, blood components and plasma derivatives are to be withdrawn if a donor is later diagnosed with vCJD. The potential spread of vCJD through red blood cell or plasma transfusion is limited by these deferral and quarantine measures that are in place.
Additional steps FDA is taking to reduce potential vCJD risk from plasma derivatives include gathering, evaluating, and disseminating information about manufacturing processes that potentially could reduce the vCJD infectious agent in blood products. FDA is helping to develop donor screening and diagnostic tests for vCJD, and to inform patients and physicians about the current scientific understanding of vCJD risk from blood products.
Using a computer model, FDA assessed the potential risk of vCJD infection from the current use of pdFVIII products. However, because so much is unknown about vCJD and its prevalence, the risk assessment performed by FDA has a lot of uncertainty, making it impossible to precisely estimate the risk of vCJD in general, or of the actual risk to individual hemophilia A or von Willebrand disease patients. Meaningful distinctions also could not be made among specific products. There is no test yet available to detect vCJD infection in healthy donors or recipients.
Although the risk of vCJD exposure from US pdFVIII products is most likely to be extremely small, it may not be zero, and FDA is encouraging physicians and patients to consider this risk, in the context of all remaining real or potential risks and the known benefits of product use, when making treatment decisions.
At this time, the PHS does not believe there is a need for hemophilia A and von Willebrand disease patients who receive pdFVIII to inform their surgeons or dentists about their potential exposure to vCJD. Also, there is no recommendation for surgeons and dentists to take any special precautions based on such potential exposures. This belief is based on the results of the FDA risk assessment, as well as on the lack of known cases of vCJD transmitted by plasma-derived clotting factor products in the UK or anywhere else in the world. PHS agencies will continue to monitor and reevaluate the situation as new information becomes available.
vCJD originally came from a disease in cattle called “mad cow disease” or BSE (bovine spongiform encephalopathy) . Transmission of the BSE agent to humans, leading to vCJD, is believed to occur primarily from eating beef and beef products contaminated with the BSE agent. Both BSE and vCJD are invariably fatal brain diseases with incubation periods typically measured in years.
From 1995 through April 2007, 202 individuals with vCJD were reported worldwide, with 165 in the United Kingdom (UK), and three in the United States. Two of the individuals in the United States had lived in the UK from 1980-1996 during a key exposure period to the BSE agent. The third US individual with vCJD most likely acquired the disease in Saudi Arabia. The reported incidence of vCJD in the UK based on disease onset peaked in 1999 and has been declining thereafter. In the UK, where most cases of vCJD have occurred, the current risk of acquiring vCJD from eating beef and beef products appears to be negligible.
More information about vCJD is available on these government websites:
FDA: Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products
Centers for Disease Control and Prevention: vCJD (Variant Creutzfeldt-Jakob Disease)
US Department of Agriculture
Information also may be obtained from these non-government sources:
Committee of Ten Thousand
Hemophilia Federation of America
National Hemophilia Foundation and/or HANDI
World Federation of Hemophilia


http://www.fda.gov/cber/blood/vcjdplasma.htm


DRAFT Draft Quantitative Risk Assessment of vCJD Risk Potentially Associated with the Use of Human Plasma-Derived Factor VIII Manufactured Under United States (US) License From Plasma Collected in the US November 27, 2006

http://www.fda.gov/cber/blood/vcjdassess.pdf


APPENDIX A Supplemental technical information for the FDA Risk Assessment The sections in this appendix provide additional technical information and details of data and modeling approaches used in specific sections (but not all sections) of Section IV. The heading and numbering of each section in this appendix mirrors the sections in “Section IV. Exposure Assessment” portion of the risk assessment. A- IV. A. Estimation of vCJD Prevalence in the United Kingdom (Module 1) A-IV. A. 3. Estimation of age-specific vCJD prevalence based on the age distribution of diagnosed vCJD cases in the UK Cases of vCJD occur in relatively young individuals (median age of 28 years) compared to classic CJD. Blood and plasma donors are usually at the age 18-40, among whom the vCJD prevalence would be expected to be higher than the prevalence among general population. Because age specific rates of donation and vCJD infection would likely have a large effect on the final risk estimate the FDA model carefully characterizes the age specific prevalence of vCJD and donation rate. Throughout the FDA model, age specific vCJD prevalence rates are calculated for each five year age group beginning at age group of 10 – 14 yrs, 15-19 yrs and so on – and applied in estimating vCJD risk and prevalence for the residents of different geographic regions and the US blood and plasma donors who traveled to those regions. The percentage of reported vCJD cases by age is shown in Table A-4.3. The model assumes that the age-specific percentage and prevalence of incubating asymptomatic cases reflects the same age-specific trend as for reported cases of symptomatic vCJD and deaths from vCJD. Table A-4.3. Reported vCJD cases in the UK and percent of US Source Plasma and blood (recovered plasma) donors by age groups

snip... full text 85 pages ;


http://www.fda.gov/cber/blood/vcjdappa.pdf


Q and A ???

http://www.fda.gov/cber/blood/vcjdahf.htm


Thursday, May 31, 2007
Questions and Answers
Variant Creutzfeldt-Jakob Disease (vCJD) and Plasma Derivatives Other than Factor VIII (pdFVIII)
Q. What is the risk of vCJD for a patient who receives a US licensed plasma-derived product other than plasma-derived Factor VIII (pdFVIII)?

A. The US Public Health Service, including FDA, CDC, and NIH, believes that vCJD risk from US licensed pdFVIII products is most likely to be extremely small, although we do not know the risk with certainty. We believe that the risk of other plasma derived products including plasma derived Factor IX, is likely to be as small as or smaller than for pdFVIII.

FDA conducted a risk assessment for pdFVIII because the plasma fraction from which it is made is likely to contain more of the vCJD infectious agent, if present, than plasma fractions from which other plasma-derived products are made, such as Factor IX, (used to treat hemophilia B), albumin, and immune globulins. The FVIII-containing fraction is further processed using a variety of methods that are likely to reduce or potentially eliminate vCJD from the final pdFVIII product. Methods likely to reduce or potentially eliminate vCJD are also used in the manufacture of other plasma-derived products, including Factor IX, albumin, and immune globulins.


http://www.fda.gov/cber/blood/vcjdother.htm


MAD COW nvCJD blood recalls May 2007 FDA


PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1221-07
CODE
Unit: 7113661
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on April 5, 2005. Firm
initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1222-07;
b) Recovered Plasma, Recall # B-1223-07
CODE
a) and b) Units: 5587539, 9710079
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile, and e-mail
beginning August 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
LA and Switzerland

___________________________________

http://www.fda.gov/bbs/topics/enforce/2007/ENF01002.html


PRODUCT
Source Plasma, Recall # B-1239-07
CODE
Units: 90002025 and 90003068
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., dba Biomat USA, Inc., Clarksville, TN, by
facsimile on December 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Spain

___________________________________


http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01003.html


PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1085-07;
b) Fresh Frozen Plasma, Cryoprecipitate Reduced, Recall # B-1086-07;
c) Cryoprecipitated AHF, Recall # B-1087-07;
d) Recovered Plasma, Recall # B-1088-07
CODE
a) and c) Units: 7114289, 9703931;
b) Unit: 9703931;
d) Unit: 7114289
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile
transmissions and e-mails beginning on October 25, 2005. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor who had risk factors for variant
Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
LA, MI, WA, and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1089-07;
b) Recovered Plasma, Recall # B-1090-07
CODE
a) and b) Unit: 026FW04563
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Alabama Region, Birmingham, AL, by
telephone on February 9, 2006 and by letters dated February 9, 2006. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor who had risk factors for variant
Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL and Switzerland

___________________________________
PRODUCT
Recovered Plasma, Recall # B-1240-07
CODE
Units: 203121278 and 207272514
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by email on January 3,
2006.
Manufacturing Firm: Blood Systems, Inc., Lafayette, LA. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland
___________________________________


http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01004.html

USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN

18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.

Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...

http://www.seac.gov.uk/minutes/95.pdf


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western
Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.

***These results indicate that BASE is transmissible to humans and suggest
that BASE is more virulent than
classical BSE in humans.***


6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html

There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Singeltary, Sr et al. JAMA.2001; 285: 733-734.

http://jama.ama-assn.org/http://www.neurology.org/cgi/eletters/60/2/176#535

BRITISH MEDICAL JOURNAL


BMJ


vCJD in the USA * BSE in U.S.
15 November 1999


http://www.bmj.com/cgi/eletters/319/7220/1312/b#5406


BMJ


U.S. Scientist should be concerned with a CJD epidemic in the U.S., as
well...
2 January 2000


http://www.bmj.com/cgi/eletters/320/7226/8/b#6117

JOURNAL OF NEUROLOGY

MARCH 26, 2003

RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States

Email Terry S. Singeltary:

flounder@wt.net

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to

comment on the CDC's attempts to monitor the occurrence of emerging

forms of CJD. Asante, Collinge et al [1] have reported that BSE

transmission to the 129-methionine genotype can lead to an alternate

phenotype that is indistinguishable from type 2 PrPSc, the commonest

sporadic CJD. However, CJD and all human TSEs are not reportable

nationally. CJD and all human TSEs must be made reportable in every

state and internationally. I hope that the CDC does not continue to

expect us to still believe that the 85%+ of all CJD cases which are

sporadic are all spontaneous, without route/source. We have many TSEs in

the USA in both animal and man. CWD in deer/elk is spreading rapidly and

CWD does transmit to mink, ferret, cattle, and squirrel monkey by

intracerebral inoculation. With the known incubation periods in other

TSEs, oral transmission studies of CWD may take much longer. Every

victim/family of CJD/TSEs should be asked about route and source of this

agent. To prolong this will only spread the agent and needlessly expose

others. In light of the findings of Asante and Collinge et al, there

should be drastic measures to safeguard the medical and surgical arena

from sporadic CJDs and all human TSEs. I only ponder how many sporadic

CJDs in the USA are type 2 PrPSc?

http://www.neurology.org/cgi/eletters/60/2/176#535


doi:10.1016/S1473-3099(03)00715-1
Copyright © 2003 Published by Elsevier Ltd.
Newsdesk

Tracking spongiform encephalopathies in North America

Xavier Bosch

Available online 29 July 2003.


Volume 3, Issue 8, August 2003, Page 463


“My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my
mom to hvCJD (Heidenhain variant CJD)
and have been searching for answers ever since. What I have found is that we
have not been told the truth. CWD
in deer and elk is a small portion of a much bigger problem.”
............................


http://www.thelancet.com/journals/laninf/article/PIIS1473309903007151/fulltext

http://download.thelancet.com/pdfs/journals/1473-3099/PIIS1473309903007151.pdf


4th CASE VCJD VIA BLOOD TRANSFUSION, BSE, BASE, AND SPORADIC CJD
By Terry S Singeltary


Bacliff, Texas USA Jan 24, 07


http://www.bloodindex.com/view_news_zone.php?id=206


http://www.bloodindex.com/view_news_zone.php?id=207


Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518



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