Transmissible Spongiform Encephalopathies Advisory Committee September 18-19, 2006 Meeting

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



Transmissible Spongiform Encephalopathies Advisory Committee December 15, 2006 Meeting

Date and Time: The meeting will be held on December 15, 2006, 8 a.m. to 3:30 p.m.

Location:Crown Plaza Silver Spring, 8777 Georgia Ave., Silver Spring, MD 20910, 301-589-0800.

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 December 15, 2006, the Committee will discuss FDA's risk assessment for potential exposure to vCJD in human plasma-derived antihemophilic factor (FVIII) products manufactured from US plasma donors and related communication materials. In the afternoon, the Committee will discuss levels of transmissible spongiform encephalopathy clearance in the manufacture of plasma-derived Factor VIII products.

Oral Presentations: Oral presentations from the public will be scheduled between approximately 10:25 and 10:55 a.m. and 1:35 and 2:05 p.m. on December 15, 2006. Those desiring to make formal oral presentations should notify the contact person on or before December 7, 2006.

Unofficial Summary

for the

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE Meeting on

December 15, 2006



http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4271t-unofficial.htm

http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4271t1.pdf

http://www.fda.gov/ohrms/dockets/ac/cber06.html#TransmissibleSpongiform

http://www.fda.gov/cber/advisory/tse/tse1206.htm



TSE advisory committee for the meeting December 15, 2006

(MICROSOFT WORD FILE)


please note, the beginning starts on page 13.

page 1 - 13 are parts II and Parts III that were added later. ...tss


----- Original Message -----

From: Terry S. Singeltary Sr.

To: FREAS@CBER.FDA.GOV

Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov

Sent: Wednesday, November 29, 2006 1:24 PM

Subject: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION]

November 29, 2006

Greetings FDA, DHH, Dr. Freas, and Dr. Harvey et al,

a kind and warm Holiday Greetings to you all. i kindly wish to submit the following to the TSE advisory committee for the meeting December 15, 2006, about the assessment for potential exposure to vCJD in human plasma-derived antihemophilic factor (FVIII) products manufactured from U.S. plasma donors and related communication material ;


http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-20251.htm

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. just from a recall aspect of potentially tainted blood, and these are just recent recalls ;


snip.. please see full text 48 pages @ ;

http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8



DER SPIEGEL (9/2001) - 24.02.2001 (9397 Zeichen)USA: Loch in der MauerDieBSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte inTexasverbotenes Tiermehl ins Rinderfutter - die Kontrollen derAufsichtsbehördensind lax. Link auf diesen Artikel im Archiv:

http://service.spiegel.de/digas/find?DID=18578755


"Its as full of holes as Swiss Cheese" says Terry Singeltary of the FDA regulations. ...

http://service.spiegel.de/digas/servlet/find/DID=18578755


Thu Dec 6, 2007 11:38

FDA IN CRISIS MODE, AMERICAN LIVES AT RISK

http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/dec0407fda.html


FDA SCIENCE AND MISSION AT RISK

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf


2 January 2000

British Medical Journal

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

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


15 November 1999

British Medical JournalvCJD in the USA * BSE in U.S.

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


BSE (Mad Cow) Update: Do Reports of sCJD Clusters Matter?

snip...

see full text ;

http://cjdtexas.blogspot.com/


16 January 2008 - The final minutes of the 98th SEAC meeting have been published.

PUBLIC QUESTION AND ANSWER SESSION 2© SEAC 2007

SEAC considered a question about possible links between CJD cases and animal TSEs in the United States of America (USA).

http://www.seac.gov.uk/summaries/seac99_summary.pdf


SEAC 99th meeting on Friday 14th December 2007

http://seac992007.blogspot.com/



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