Subject: FDA DHHS TSE ADVISORY COMMITTEE September 18 and 19 2006 ''There is a growing number of human CJD cases, Gambetti''
Date: November 4, 2006 at 7:41 pm PST
Meeting of:
TRANSMISSIBLE
SPONGIFORM ENCEPHALOPATHIES
ADVISORY COMMITTEE
September 18, 2006
Holiday Inn Gaithersburg
Gaithersburg,Maryland
TABLE OF CONTENTS
Page
Administrative Remarks - Executive Secretary 1
Opening Remarks, Glenn Telling 8
Committee Updates:
- US and Worldwide BSE 8
- vCJD epidemiology and transfusion transmission 26
- Draft Guidance for Industry: Amendment (donor 32
deferral for transfusion in France Since 1980)
- Critical Factors Influencing Prion 39
Decontamination Using Sodium Hydroxide
- Human Prions: Clearance and Plasma Lipoproteins 53
TOPIC I: Experimental Clearance of Transmissible
Spongiform Encephalopathy Infectivity on
Plasma Derived FVIII Products 69
TSE Clearance studies for pdFVIII: Study Methods and 70
Clearance Levels
Industry TSE Clearance Studies for pdFVIII 95
Open Public Hearing 116
- Statement by Dave Cavenaugh 118
Open Committee Discussion, Questions for the Committee 122
Committee Updates:
Status of FDA's Initiative on Communication of the 177
Potential Exposure to vCJD Risk
Summary of WHO Consultation on Distribution of 184
Infectivity in Tissues
Open Public Hearing 201
- Statement by Charles Sims 203
- Statement by Paul Brown 209
snip...
I went through the proceedings and I selected some points that I thought were of particular interest to this group today, and I list them on the next three or four slides:
Naturally affected cattle, infectivity detected by mouse assay demonstrated only in brain, spinal cord, retina and a pool of nictitating membranes, but not in pools of lymph nodes.
Infectivity was detected in some peripheral nerves, and a solitary muscle of a single case of BSE in a German cow. That is a greater concern in Europe where there is more BSE than the maximum of one case per million, we hope, that USDA estimates here. There was only infectivity found in a semi-tendonoisis muscle using only an extremely sensitive transgenic mouse that Martin Groship(?) has developed.
Still, it would be disturbing if meat itself was intrinsically infected rather than neural tissue, because
192
full text 223 pages ;
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf
Meeting of:
TRANSMISSIBLE
SPONGIFORM ENCEPHALOPATHIES
ADVISORY COMMITTEE
September 19, 2006
Holiday Inn Gaithersburg
Gaithersburg, Maryland
TABLE OF CONTENTS
Page
Opening Remarks 1
Topic II: Possible Criteria for Approval of
a Donor Screening Test for vCJD
Donor Screening Test Issues: Sensitivity, Specificity 4
and Confirmatory Testing
Algorithm for Approval of Human TSE Tests in Europe 13
Available Reference Materials 35
Research Updates from Test Developers: 69
- Prionics - A. Raeber 70
- University of Texas - C. Soto 78
- Microsens Biotechnologies - S. Wilson 88
- BioMerieux - Dr. Van Driesische 94
- Adlyfe - K. Lohman 98
- Chiron - D. Peretz 109
- UC San Francisco - J. Safar 117
Questions for Presenters from Committee 128
Open Public Hearing 144
- Arllene Carr-Greer 145
Open Committee Discussion 148
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t2.pdf
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t2.htm
TSS
Date: November 4, 2006 at 7:41 pm PST
Meeting of:
TRANSMISSIBLE
SPONGIFORM ENCEPHALOPATHIES
ADVISORY COMMITTEE
September 18, 2006
Holiday Inn Gaithersburg
Gaithersburg,Maryland
TABLE OF CONTENTS
Page
Administrative Remarks - Executive Secretary 1
Opening Remarks, Glenn Telling 8
Committee Updates:
- US and Worldwide BSE 8
- vCJD epidemiology and transfusion transmission 26
- Draft Guidance for Industry: Amendment (donor 32
deferral for transfusion in France Since 1980)
- Critical Factors Influencing Prion 39
Decontamination Using Sodium Hydroxide
- Human Prions: Clearance and Plasma Lipoproteins 53
TOPIC I: Experimental Clearance of Transmissible
Spongiform Encephalopathy Infectivity on
Plasma Derived FVIII Products 69
TSE Clearance studies for pdFVIII: Study Methods and 70
Clearance Levels
Industry TSE Clearance Studies for pdFVIII 95
Open Public Hearing 116
- Statement by Dave Cavenaugh 118
Open Committee Discussion, Questions for the Committee 122
Committee Updates:
Status of FDA's Initiative on Communication of the 177
Potential Exposure to vCJD Risk
Summary of WHO Consultation on Distribution of 184
Infectivity in Tissues
Open Public Hearing 201
- Statement by Charles Sims 203
- Statement by Paul Brown 209
snip...
I went through the proceedings and I selected some points that I thought were of particular interest to this group today, and I list them on the next three or four slides:
Naturally affected cattle, infectivity detected by mouse assay demonstrated only in brain, spinal cord, retina and a pool of nictitating membranes, but not in pools of lymph nodes.
Infectivity was detected in some peripheral nerves, and a solitary muscle of a single case of BSE in a German cow. That is a greater concern in Europe where there is more BSE than the maximum of one case per million, we hope, that USDA estimates here. There was only infectivity found in a semi-tendonoisis muscle using only an extremely sensitive transgenic mouse that Martin Groship(?) has developed.
Still, it would be disturbing if meat itself was intrinsically infected rather than neural tissue, because
192
full text 223 pages ;
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf
Meeting of:
TRANSMISSIBLE
SPONGIFORM ENCEPHALOPATHIES
ADVISORY COMMITTEE
September 19, 2006
Holiday Inn Gaithersburg
Gaithersburg, Maryland
TABLE OF CONTENTS
Page
Opening Remarks 1
Topic II: Possible Criteria for Approval of
a Donor Screening Test for vCJD
Donor Screening Test Issues: Sensitivity, Specificity 4
and Confirmatory Testing
Algorithm for Approval of Human TSE Tests in Europe 13
Available Reference Materials 35
Research Updates from Test Developers: 69
- Prionics - A. Raeber 70
- University of Texas - C. Soto 78
- Microsens Biotechnologies - S. Wilson 88
- BioMerieux - Dr. Van Driesische 94
- Adlyfe - K. Lohman 98
- Chiron - D. Peretz 109
- UC San Francisco - J. Safar 117
Questions for Presenters from Committee 128
Open Public Hearing 144
- Arllene Carr-Greer 145
Open Committee Discussion 148
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t2.pdf
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t2.htm
TSS