TSE ADVISORY COMMITTEE MEETING SEPTEMBER 18-19 2006
Wed Aug 30, 2006 08:11
70.110.86.159
Transmissible Spongiform Encephalopathies Advisory Committee
September 18-19, 2006 Meeting
Date and Time:
The meeting will be held on September 18, 2006, 8 a.m. to 4:30 p.m. and September 19, 2006, 8 a.m. to 1 p.m.
Location:
Holiday Inn Gaithersburg, MD, 2 Montgomery Village Avenue, Gaithersburg, MD 20879
Contact Person:
William Freas, or Rosanna L. Harvey, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512392. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On September 18, 2006 the Committee will hear updates on the following topics: United States and worldwide bovine spongiform encephalopathies (BSE); variant Creutzfeldt-Jakob disease (vCJD) epidemiology and transfusion-transmission; blood and plasma donor deferral for transfusion in France since 1980, guidance; FDA’s current assessment and plans regarding the potential exposure to vCJD from an investigational product, FXI, that was manufactured from UK donor plasma; and a summary of World Heath Organization Consultation on distribution of infectivity in tissues of animals and humans with transmissible spongiform encephalopathies. The Committee will then discuss experimental clearance of transmissible spongiform encephalopathy infectivity in plasma-derived Factor VIII products. In the afternoon, the Committee will discuss FDA’s risk assessment for potential exposure to vCJD from human plasma-derived antihemophilic factor (FVIII) products and potential responses. On September 19, 2006 the Committee will discuss possible criteria for approval of donor screening tests for vCJD.
Oral presentations from the public will be scheduled between approximately 10:45 a.m. and 11:15 p.m. and 2:30 p.m. and 3:00 p.m. on September 18, 2006 and between approximately 10:15 a.m. and 11:45 a.m. on September 19, 2006. Those desiring to make formal oral presentations should notify the contact person on or before September 11, 2006.
http://www.fda.gov/cber/advisory/tse/tse0906.htm
CJD WATCH MESSAGE BOARD
TSS
Prion infections, blood and transfusions Aguzzi and Glatzel
Sat Jul 8, 2006 12:18
68.238.108.213
Prion infections, blood and transfusions
Adriano Aguzzi* and Markus Glatzel
http://disc.server.com/discussion.cgi?disc=167318;article=2948;title=CJD%20WATCH;pagemark=60
Freas, William
From:
Sent:
To:
Subject:
Terry S. Singeltary Sr. [
[email protected]]
Monday, January 08,200l 3:03 PM
[email protected]
CJDIBSE (aka madcow) Human/Animal TSE’s--U.S.--Submission To Scientific Advisors and
Consultants Staff January 2001 Meeting (short version)
Greetings again Dr. Freas and Committee Members,
I wish to submit the following information to the
Scientific Advisors and Consultants Staff
2001 Advisory Committee (short version).
snip...
I am beginning to think that the endless attempt to track
down and ban, potential victims from known BSE Countries
from giving blood will be futile. You would have to ban
everyone on the globe eventually? AS well, I think we
MUST ACT SWIFTLY to find blood test for TSE's,
whether it be blood test, urine test, eyelid test,
anything at whatever cost, we need a test FAST. ,
DO NOT let the incubation time period of these TSEs fool you.
To think of Scrapie as the prime agent to compare CJD,
but yet overlook the Louping-ill vaccine event in 1930's
of which 1000's of sheep where infected by scrapie
from a vaccine made of scrapie infected sheep brains,
would be foolish. I acquired this full text version of the
event which was recorded in the Annual Congress of 1946
National Vet. Med. Ass. of Great Britain and Ireland.
From the BVA and the URL is posted in my (long version).
U.S.A. should make all human/animal TSE's notifiable at all ages,
with requirements for a thorough surveillance and post-mortem
examinations free of charge, if you are serious about eradicating
this horrible disease in man and animal.
There is histopathology reports describing o florid plaques"
in CJD victims in the USA and some of these victims are getting
younger. I have copies of such autopsies, there has to
be more. PLUS, sub-clinical human TSE's will most definitely
be a problem.
THEN think of vaccineCJD in children and the bovine tissues
used in the manufacturing process, think of the FACT that
this agent surviving 6OO*C.
PNAS -- Brown et al. 97 (7): 3418 scrapie agent live at 600*C
Then think of the CONFIDENTIAL documents of what was known of
human/animal TSE and vaccines in the mid to late 8Os, it was all about
depletion of stock, to hell with the kids, BUT yet they knew.
snip...
full text ;
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Last updated: 19 July 2005
Adopted July 2004 (Question N° EFSA-Q-2003-083)
Report
Summary
Summary of the Scientific Report
The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.
A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.
EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.
Publication date: 20 August 2004
EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Adopted July 2004 (Question N° EFSA-Q-2003-083)
[Last updated 08 September 2004]
[Publication Date 20 August 2004]
http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf
THE SEVEN 1/2 SCIENTIST REPORT *** ;-)
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf
Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)
https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument
03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf
Specified Risk Materials (SRMs)
I am in full support of the interim final rule which prohibits SRMs from
being included in food for human consumption. In addition to the list of
tissues published in this rule, I am requesting that additional tissues be
added to the list. These would include dura
("sheath") covering the spinal cord and the ENTIRE INTESTINE (from pylorus
to rectum). The scientific justification is provided below. THESE SRMs
should also be prohibited from ANY FDA regulated food or product intended
for human consumption, including but not limited to flavorings, extracts,
etc. ...
Dr. Linda Detwiler comments in full;
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf
TIP740203/l 0424 CONFIDENTIAL
http://www.mad-cow.org/00/may00_news.html#aaa
TWA LITTLE minute
http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf
COMMERCIAL IN CONFIDENCE
http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf
NOT FOR PUBLICATION
http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf
NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE snip... I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use. snip... The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out...
http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf
more on the 1968 medicine act, they forgot to follow
http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf
Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)
http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf
(It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.)
http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf
http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf
TWA LITTLE STATEMENT 331
http://www.bseinquiry.gov.uk/files/ws/s331.pdf
snip...
http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm
8. The Secretary of State has a number of licences. We understand that
the inactivated polio vaccine is no longer being used. There is a stock
of smallpox vaccine. We have not been able to determine the source
material. (Made in sheep very unlikely to contain bovine ingredients).
http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf
although 176 products do _not_ conform to the CSM/VPC
guidelines.
http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf
TSS