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From: TSS ()
Subject: Re: TSE ADVISORY COMMITTEE DECEMBER 15, 2006
Date: November 28, 2006 at 9:01 am PST

In Reply to: TSE ADVISORY COMMITTEE DECEMBER 15, 2006 posted by TSS on November 27, 2006 at 3:06 pm:

DRAFFT ( ((1 111 11/ //2 221 11/ //0 006 66) ))

AGENDA

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

Crown Plaza, 8777 Georgia Avenue, Silver Spring, MD

December 15, 2006

Friday, December 15, 2006

8:00 a.m. Administrative Remarks, TSEAC Executive Secretary

8:05 a.m. Opening Remarks, Glen Telling, Ph.D. Chairperson, TSEAC

8:10 a.m. Committee Update


- Status of FDA’s initiative on communication of the potential exposure to vCJD risk from an investigational product, plasma derived Factor XI that was manufactured from UK donor plasma (15’) (M. Weinstein, Ph.D., FDA)

8:25 a.m Topic I. FDA’s risk assessment for potential exposure to vCJD in human plasma-derived

antihemophilic factor (FVIII) products and communication materials.


A. Introduction: FDA risk management strategy for potential exposure to vCJD in plasma derivatives (D. Scott, M.D., FDA) (10’)


B. Risk assessment and interpretation (S. Anderson, Ph.D., FDA) (40’)

C. Overall risk communication approach

(M. Weinstein, Ph.D., FDA) (15’)

D. Advocacy organization perspectives (30’)


i. National Hemophilia Foundation (Val Bias) (5’)


ii. Hemophilia Federation of America (Janice Hamilton) (5’)


iii. Committee of Ten Thousand (Richard Colvin, M.D., Ph.D.) (5’)


iv. World Federation of Hemophilia (Mark Skinner) (5’)

10:10 a.m. Break

10:25 a.m. Open Public Hearing

.

10:55 a.m. FDA Questions for the Committee

11:05 p.m. Open Committee Discussion and Recommendations

12:00 p.m. Lunch

2

1:00 p.m. Topic II. Levels of TSE clearance in the manufacture of plasma-derived FVIII


A. Summary of 18 September 2006 TSEAC discussion (D. Scott, M.D., FDA) (15’)


B. Updated information from manufacturers (T. Kreil, Ph.D., PPTA Baxter Bioscience) (20’)

1:35 p.m. Open Public Hearing

2:05 p.m. FDA Questions for the Committee (10’)

2:15 p.m. Discussion (45’)

3:00 p.m. Adjourn

http://www.fda.gov/ohrms/dockets/ac/06/agenda/2006-4271A(draft)%20.pdf

Greetings,

i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;


http://www.newsday.com/news/health/ats-ap_health14nov27,0,7955259.story?coll=ny-leadhealthnews-headlines


however, i seem to disagree. from my primitive ciphering, i see it another way. this is a huge catastrophic risk. 3 in 160 is 1.9%. so call that 2% which is 1 in 50 or twenty per thousand or 20,000 per million. also, what about the mixed genotypes/mixed susceptibility? what about the silent carriers that donated tainted blood? what about the sporadic CJDs of UNKNOWN strain or phenotype? this risk assessment is just more BSe to me. just another in a long line of industry fed crap. i pray that my assessment is the one that is wrong. but it is THEY who roll the dice with your life. it is THEY who refuse to regulate an industry that has run amok...

PRODUCT
Source Plasma, Recall # B-0054-7
CODE
Units: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891, 03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969, 03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588, 03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228, 03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628, 03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707, 03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189, 03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979, 03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707, 04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719, 04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816, 04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063, 04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485, 04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930, 04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004. 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
89 units
DISTRIBUTION
CA and Austria


END OF ENFORCEMENT REPORT FOR October 25, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00975.html


USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
______________________________
PRODUCT
Source Plasma, Recall # B-1708-6
CODE
Units: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140,
MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855,
MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136,
MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343,
04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504,
05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874,
05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236,
05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336,
05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907,
05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277,
05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355,
05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892,
05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.
Firm initiated recall is complete.
REASON
Blood products, collected from unsuitable donors based on risk factors for
Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
CA, NC, and MD

______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;
b) Fresh Frozen Plasma, Recall # B-1715-6;
c) Platelets, Recall # B-1716-6
CODE
a), b), and c) Unit: 2443732
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by letters dated
November 11, 2003 and December 18, 2003. 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
3 units
DISTRIBUTION
TX and WI

END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.html

PRODUCT
Fresh Frozen Plasma, Recall # B-1751-6
CODE
Unit: 4936623
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated September
16, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk
factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html


Mon Aug 7, 2006 10:24
71.248.132.189

PRODUCT
a) Red Blood Cells, Recall # B-1587-6;
b) Cryoprecipitated AHF, Recall # B-1588-6;
c) Recovered Plasma, Recal # B-1589-6
CODE
a), b) and c) Unit: 2016719
RECALLING FIRM/MANUFACTURER
Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on
March 13, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA and Germany

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;
b) Fresh Frozen Plasma, Recall # B-1591-6
CODE
a) and b) Unit: 2443595
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June
30, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;
b) Fresh Frozen Plasma, Recall # B-1593-6
CODE
a) and b) Unit: 2545596
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
December 14, 2004 and January 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html



PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;
b) Fresh Frozen Plasma, Recall # B-1551-6
CODE
a) and b) Unit 2395371
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6;
b) Platelets, Recall # B-1553-6;
c) Fresh Frozen Plasma, Recall # B-1554-6
CODE
a), b) and c) Unit 2438702
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6;
b) Fresh Frozen Plasma, Recall # B-1556-6
CODE
a) and b) Unit 2454970
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 and December 11. 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1494-6
b) Cryoprecipitated AHF, Recall # B-1495-6
CODE
a) and b) Unit 5013100
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

______________________________
PRODUCT
Source Plasma, Recall # B-1450-6
CODE
Unit numbers ST0824313 and ST0824764
RECALLING FIRM/MANUFACTURER
Stillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UK

______________________________
PRODUCT
Plasma Frozen, Recall # B-1422-6;
Recovered Plasma, Recall # B-1423-6
CODE
a) Unit 03E42218;
b) Unit 03E38153
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by telephone, e-mail or letter on February 20 or 21, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and Switzerland

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6;
b) Recovered Plasma, Recall # B-1375-6
CODE
a) and b) unit 2453906
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31 and November 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Austria

______________________________
PRODUCT
Source Plasma. Recall # B-1295-6
CODE
Units: NG0046551, NG0045950
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002, Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire appropriately, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY

______________________________
PRODUCT
Source Plasma. Recall # B-1296-6
CODE
Unit: NG 0044520
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 12, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

______________________________
PRODUCT
Source Plasma. Recall # B-1297-6
CODE
Units: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020, NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
KY

______________________________
PRODUCT
Source Plasma, Recall # B-1298-6
CODE
Units: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG 0042525, NG 0042341
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who answered questions on the variant Creutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
KY

______________________________
PRODUCT
Recovered Plasma, Recall # B-1299-6
CODE
Unit: 4357117
RECALLING FIRM/MANUFACTURER
Department of the Navy, Naval Medical Center, San Diego, CA, by fax and letter on September 25, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at risk of exposure to Creutzfeldt-Jacob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany

END OF ENFORCEMENT REPORT FOR July 12, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html


CJD WATCH MESSAGE BOARD
TSS
FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY
Fri Jul 7, 2006 09:37
70.110.83.160


FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY

PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1379-6;
b) Platelets, Recall # B-1380-6;
c) Fresh Frozen Plasma, Recall # 1381-6;
d) Recovered Plasma, Recall # B-1382-6
CODE
a) Unit numbers: 2343106, 2377779, and 2403533;
b) and c) Unit numbers: 2377779;
d) Unit numbers: 2343106 and 2403533
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 12, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
TX and Austria
______________________________


PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6;
b) Recovered Plasma, Recall # B-1468-6
CODE
a) and b) Unit numbers: 2329380
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland

______________________________

PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6;
b) Cryoprecipitated AHF, Recall # B-1480-6;
c) Recovered Plasma, Recall # B-1481-6
CODE
a), b), and c) Unit numbers: 2383280
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 23 and 29, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Switzerland

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6;
b) Fresh Frozen Plasma, Recall # B-1483-6
CODE
a) and b) Unit number: 2501452
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 5, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and NY

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6;
b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6;
c) Recovered Plasma, Recall # B-1486-6
CODE
a) and c) Unit number: 2554077;
b) Unit number: 2415708
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Austria

_____________________________________

END OF ENFORCEMENT REPORT FOR July 5, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00959.html

with new atypical TSE in the bovine, in the sheep, goat, and humans, and the fact that the new BASE TSE in cattle being very very similar to sporadic CJD, rather than the nvCJD, the fact that now science showing the TSE agent of the atypical cattle in Japan showing infectivity other than CNS tissue, the fact that the latest Texas mad cow and the recent Alabama mad cow both being of the atypical strain, it would seem prudent to include all human TSE in the blood ban, in my opinion. ...

TSS

Prion infections, blood and transfusions

Adriano Aguzzi* and Markus Glatzel

Prion infections lead to invariably fatal diseases of the CNS, including

Creutzfeldt-Jakob disease (CJD) in humans, bovine spongiform

encephalopathy (BSE), and scrapie in sheep. There have been hundreds

of instances in which prions have been transmitted iatrogenically among

humans, usually through neurosurgical procedures or administration of

pituitary tissue extracts. Prions have not generally been regarded as bloodborne

infectious agents, and case-control studies have failed to identify

CJD in transfusion recipients. Previous understanding was, however,

questioned by reports of prion infections in three recipients of blood

donated by individuals who subsequently developed variant CJD. On

reflection, hematogenic prion transmission does not come as a surprise, as

involvement of extracerebral compartments such as lymphoid organs and

skeletal muscle is common in most prion infections, and prions have been

recovered from the blood of rodents and sheep. Novel diagnostic strategies,

which might include the use of surrogate markers of prion infection, along

with prion removal strategies, might help to control the risk of iatrogenic

prion spread through blood transfusions. ...

snip...


Last, despite all epidemiological evidence to

the contrary, patients who are methionine/valine

heterozygous at codon 129 of the PRNP gene are

susceptible to infection with vCJD prions, which

raises several important questions. Is the virulence

of BSE prions enhanced when passaged

from human to human, as opposed to the

original bovine to human situation? Passaging

experiments of scrapie infectivity between mice

and hamsters indicate that this scenario is highly

plausible.6 Even more importantly, can vCJD

infection of heterozygous individuals establish

a permanent subclinical carrier state? Although

this situation might constitute a best-case

scenario for the infected individuals, it could be

disastrous from an epidemiological viewpoint,

as it might lead to an unrecognized and possibly

self-sustaining epidemic. ...

snip... full text ;

JUNE 2006 VOL 2 NO 6 AGUZZI AND GLATZEL NATURE CLINICAL PRACTICE NEUROLOGY 329

www.nature.com/clinicalpractice/neuro


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2004. SPORADIC CJD CASES TRIPLED, and that is
with a human TSE surveillance system that is terrible
flawed. in 1997 cases of the _reported_ cases of cjd
were at 54, to 163 _reported_ cases in 2004. see stats
here;

p.s. please note the 47 PENDING CASES to Sept. 2005

p.s. please note the 2005 Prion D. total 120(8)
8=includes 51 type pending, 1 TYPE UNKNOWN ???

p.s. please note sporadic CJD 2002(1) 1=3 TYPE UNKNOWN???

p.s. please note 2004 prion disease (6) 6=7 TYPE
UNKNOWN???


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

FDA Fines American Red Cross $4.2 Million (BLOOD CJD)
Fri Sep 8, 2006 20:01
71.248.154.242


FDA Statement
FOR IMMEDIATE RELEASE
Statement
September 8, 2006
Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Fines American Red Cross $4.2 Million for Failure to Meet Established
Blood Safety Laws

The U.S. Food and Drug Administration (FDA) announced today that the
American Red Cross (ARC) is being fined $4.2 million for failure to comply
with requirements under Federal laws and FDA regulations relating to the
collection of blood products. These fines were assessed under an amended
2003 consent decree that calls for significant financial penalties when ARC
fails to comply with FDA regulations and consent decree provisions designed
to ensure the safety of the nation's blood supply.

The fines stem from a recently completed FDA review of recalls conducted by
ARC between 2003 and 2005 that found these events were preventable by ARC.
The violations include breaches of Good Manufacturing Practice (GMP) such as
a failure to ask appropriate donor screening questions and failure to follow
manufacturer test protocols. We have no evidence that these violations
resulted in serious health consequences.

Because receiving blood products always carries a degree of risk, it is
important that the blood industry complies with the full set of safeguards
in Federal laws and FDA regulations to minimize that risk. However, any
particular breach of the safeguards does not necessarily translate into
unsafe blood products, because the safeguards designed to protect the blood
supply are to some extent overlapping. The FDA continues to advise care
providers and consumers that rigorous protections are in place and that the
blood supply is safe. Patients in need of a transfusion should continue to
follow the advice of their physicians. The risks of receiving a transfusion
are far less than the risk of failing to receive a transfusion when blood
treatment is indicated.

Improvements in donor screening procedures and the use of a variety of new
tests in the last few years have made the national blood supply safer from
infectious diseases and other risks than it has been at any other time.
However, because there is always some degree of risk in receiving blood
products, each individual safeguard is considered critical to minimizing
that risk. Although the failure of an individual safeguard does not
automatically translate into the release of unsafe products, it may increase
the potential for risk. It is the potential risk that FDA insists the Red
Cross Board of Directors prioritize and support its new management's ability
to immediately address and work to improve its approach to quality.

The amended consent decree requires ARC to:

Establish clear lines of managerial control over a newly established
comprehensive quality assurance system in all regions;
To enhance training programs; and
To improve computer systems, records management, and policies for
investigating and reporting problems, including adverse reactions
Since entry of the 2003 consent decree and prior to this action, FDA has
issued the American Red Cross seven similar letters and assessed a total of
$5.7 million in penalties.

While achieving a blood supply with zero risk of transmitting infectious
disease is the ultimate objective, we recognize based on the available
science that this may not be realistic. Therefore, the FDA requires blood
processors to adopt and strictly follow a multi-layered safety program to
protect and enhance the safety of blood products at each stage of their
manufacture. At the blood collection stage, these measures generally
include:

Accurate and complete educational material for donors so that they can
assess their risk and decline to donate if that is appropriate;
Administration of donor screening questions to identify safety risks;
Checking of lists to prevent use of blood from persons known to be
ineligible to donate;
Quality controlled infectious disease testing procedures;
Inventory controls to prevent the release of units that are unsuitable;
Appropriate handling and distribution of blood and blood products for
patient use; and
Investigation and correction of deviations from standards
ARC is responsible for approximately 45% of the nation's blood supply; other
independent community-based blood centers together provide another 45%, and
hospitals collect most of the remaining 10%.

Blood donations are critically needed every day to save lives, and blood
donation is a safe procedure. FDA encourages persons who are in good health
to donate blood and to become regular blood donors.

####

http://www.fda.gov/cber/talkpapers.htm#arc

Red Cross fined $4.2 mln over blood safety

By Lisa Richwine

WASHINGTON (Reuters) - The U.S. government fined the American Red Cross $4.2
million for failing to ask blood donors proper screening questions and
skipping other steps meant to keep the blood supply safe, officials said on
Friday.

The fine, the largest ever levied by the Food and Drug Administration for a
blood safety violation, follows a multiyear battle between the FDA and the
Red Cross, which collects about 45 percent of the blood donated in the
United States each year for transfusions.

The agency said it had no evidence that any blood collected by the Red Cross
harmed people who got transfusions.


But FDA officials said the failure to follow multiple safeguards increased
the risk that patients could receive blood tainted by an infectious disease.

"It is not acceptable that the quality systems failed in this way," Margaret
O'K. Glavin, FDA associate commissioner for regulatory affairs, told
reporters.

The FDA said its investigation found that several Red Cross recalls of blood
between 2003 and 2005 could have been prevented if it had taken a series of
mandatory steps to ensure donations are free of HIV or other infectious
agents.

One way the Red Cross erred was by failing to ask donors about travel
history that could increase the chances of having malaria or the human
version of mad cow disease, FDA officials said.

The problems involved 12,000 units of blood and blood components, FDA
officials said. None of the units was found to be contaminated after they
were recalled.

The latest fine was issued as part of a legally binding consent decree
reached in 2003 in which the Red Cross promised to improve its blood safety
system. Previously, the FDA had fined the organization a total of $5.7
million.

The 2003 deal revised a 1993 agreement that allowed the FDA to fine the Red
Cross for blood collection lapses.

The Red Cross said it would review the FDA's letter outlining its new
concerns and respond within 20 days.

"American Red Cross's senior management takes (the letter) seriously and is
committed to full compliance with the amended consent decree and all
applicable federal regulations," the organization said in a statement.


The FDA said the blood supply remained very safe.

http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-09-08T224834Z_01_N08403053_RTRIDST_0_HEALTH-REDCROSS-DC.XML

http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-09-08T224834Z_01_N08403053_RTRIDST_0_HEALTH-REDCROSS-DC.XML&pageNumber=1&imageid=&cap=&sz=13&WTModLoc=NewsArt-C1-ArticlePage1

TSS



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