Blood Products Advisory Committee FDA (VS):

agenda vergadering 14 december 2010

 

 

 

 


 

Op 14 december vergadert een speciale FDA-kommissie over XMRV en de bloedbanken.

 

Het standpunt en de besluiten van deze kommissie is van groot politiek belang,

omdat zij daarmee namens de Amerikaanse overheid een formele uitspraak doet over XMRV.

 

Op de agenda staan onder meer presentaties van drie studies die momenteel "lopen".

 

Voor een boeiende voorbeschouwing op deze vergadering, klik op onderstaand logo:

 

 

 

Voor een overzicht van de studies tot op heden (bron: FDA), klik op onderstaand logo:

 

 

 


 

 

 

December 14-15, 2010:

Blood Products Advisory Committee Meeting Draft Agenda

99th Meeting, December 14-15, 2010

 

 

Tuesday, December 14, 2010, 1:00 p.m.

 

Topic II: MLV-related Human Retroviruses and Blood Safety

 

A. Introduction and Background, Indira Hewlett, Ph.D., DETTD, OBRR, FDA (10)
B. Summary of Current Research on MLV-related Human Retroviruses and Disease Association, Jonathan Stoye, Ph.D., NIMR, UK ( 25)
C. Recent Studies of Epidemiology of MLV-related Human Retroviruses:
    U.S. Study, Shyh-Ching Lo, M.D., OCTGT, FDA (15)
    U.S. Study, Maureen Hanson, Ph.D., Cornell University (15)
    UK Study, Judy Mikovits, Ph..D. Whitmore Peterson Institute (15)
D. Animal Studies: Potential Transfusion Transmission of MLV-related Human Retroviruses, Francois Villinger, Emory University (20)
E. Update of Blood XMRV Working Group Activities, Graham Simmons, Ph.D., BSRI (15)
F. Prospective and Retrospective U.S. Donor Surveillance Studies, Michael Busch, M.D., Ph.D., Blood Systems Research Institute (15)
G. Assay Development Efforts on MLV-related Human Retroviruses, Rachel Bagni, Ph.D., National Cancer Institute (20)

 

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/

BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm234882.htm

 

 

Questions for the Committee

  1. Do the scientific data support asking donors about a medical history and/or diagnosis of CFS as a basis for indefinite deferral?
  2. Please discuss whether the scientific data support asking donors about a medical history and/or diagnosis of prostate cancer as a basis for indefinite deferral.
  3. Please comment on the scientific evidence that would be needed to justify a policy of donor testing for infection with MLV-related human retroviruses. In particular, should donor testing be considered in the absence of confirmed disease causation?
  4. Assuming that testing is warranted, please comment on the potential utility of NAT and/or serologic testing of blood donations to ensure safety of the blood supply from transmission of MLV-related human retroviruses.

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/

BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm234884.htm