| December 14-15, 2010: Blood Products Advisory Committee Meeting Draft Agenda 99th Meeting, December 14-15, 2010 The Hilton Washington DC North/Gaithersburg 620 Perry Parkway Gaithersburg, MD 20877 |
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 Tuesday, December 14, 2010 1:00 p.m. Topic II: MLV-related Human Retroviruses and Blood Safety 1. Introduction and Background, Indira Hewlett, Ph.D., DETTD, OBRR, FDA (10’) 2. Summary of Current Research on MLV-related Human Retroviruses and Disease Association, Jonathan Stoye, Ph.D., NIMR, UK ( 25’) 3. Recent Studies of Epidemiology of MLV-related Human Retroviruses: 1. U.S. Study, Shyh-Ching Lo, M.D., OCTGT, FDA (15’) 2. U.S. Study. Maureen Hanson, Ph.D., Cornell University (15’) 3. UK Study, Judy Mikovits, Ph.D. Whitmore Peterson Institute (15’) 4. Animal Studies: Potential Transfusion Transmission of MLV-related Human Retroviruses, Francois Villinger, Emory University (20’) 5. Update of Blood XMRV Working Group Activities, Graham Simmons, Ph.D., BSRI (15’) 6. Prospective and Retrospective U.S. Donor Surveillance Studies, Michael Busch, M.D., Ph.D., Blood Systems Research Institute (15’) 7. Assay Development Efforts on MLV-related Human Retroviruses, Rachel Bagni, Ph.D., National Cancer Institute (20’) 3:30 p.m. Break 3:45 p.m. Open Public Hearing 4:30 p.m. Open Committee Discussion Questions for the Committee 5:30 p.m. Adjournment Wednesday, December 15, 2010 |
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Opening Remarks, Blaine Hollinger, M.D., Chair Statement of Conflicts of Interest, Announcements 8:10 a.m. Committee Updates * Update from the HHS Advisory Committee on Blood Safety and Availability and Summary of November 4-5, 2010 Meeting, CDR Richard Henry, Deputy Executive Secretary for the Advisory Committee on Blood Safety and Availability | |||
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| CDC and ME/CFS/XMRV History for New Readers ♥ | |||
The following note just arrived from Heidi Bauer, via the "Blood Products Advisory Committee Meeting" being held today, in Bethesda Maryland, December 14, 2010. Heidi received the WPI "Patient Advocate of the Year Award for 2010" Thank you, AGAIN ~Heidi.
This was provided as pre-meeting background info~ from the FDA.
“The Blood Products Advisory Committee has been asked to consider the issue of donor testing for MLV-related retroviruses even in the absence of confirmed disease causation. Absent evidence that these viruses have a causal role in any human disease it seems reasonable that the following criteria be met prior to the implementation of donor screening:
1. evidence of transfusion transmission of these viruses
2. consistent evidence of association of these viruses with disease, and
3. development of validated assays for these agents that detect infected individuals but do not implicate non-infected individuals.
“The presence of a virus, and even transfusion transmission of an agent, is not, in and of itself a reason to implement donor deferral or screening. Since no causal association of XMRV with human disease has been demonstrated, a decision to introduce a blood donor screening assay, were one to become available, would appear premature. Many commensal viruses, for example Anellovirus species, are known to be transmitted by transfusion but despite extensive study have not been associated with disease. In the absence of direct evidence of causation, a decision to implement testing should be based on an assessment of recipient risk that includes the prevalence of the infection in the donor population, the transmission rate to recipients and the current best assessment of the risk of recipient harm, compared to currently accepted risks of transfusion.
“Members of the blood transfusion community are concerned about the potential threat to the blood supply posed by XMRV/MLV and are actively involved in efforts to validate quality control panels and develop tests for the detection of MLV-related retroviruses. However we believe that current evidence does not support introducing any test methodology at this time.”
Guest Speakers today:
Bagni, Rachel K., Ph.D., Busch, Michael P., M.D., Ph.D., Hanson, Maureen, Ph.D., Holmberg, Jerry A., Ph.D., Mikovits, Judy A., Ph.D., Monroe, Stephan S., PhD, Petersen, Lyle R. M.D, M.P.H., Simmons, Graham, Ph.D., Stoye, Jonathan, PhD, Stramer, Susan L...., Ph.D., Villinger, Francois, DVM, PhD
Text messages sent form Heidi ♥
-> XMRV section of FDA meeting starting now.
-> Overall, same old, same old. Presentations are of all the papers that have been published. Committee was presented with questions to consider while listening to presentations.
-> Coffin is telling Lo his mitochondrial tests are not as sensitive as what he uses to detect contamination. Coffin has two papers coming out in Retroviral by the end of the month. Lo is giving his rebuttal.
-> If I am not mistaken, and I could be, Coffin was one of the reviewer who forced Alter and Lo back to the lab before their paper would be released. Lo said in his response to Coffin "we did as you suggested". ?????
-> Lo and Coffin agree though that standards with contamination detection have to be incredible high.
-> Hanson did great! Judy is up next with UK study. Hanson is mainly finding PMRV btw.
-> Can see now why Dr. Mikovits says they learned so much on the UK study. 48/50 positive.
-> UK patients had XMRV. Hard to find polytropic.
-> There is someone on MECFS forum sending copious notes I am told. Just FYI.
-> Way too many heads nodding in agreement with Stoye regarding contamination, etc.
-> All I can say is Stoye is not worth reporting on. Yawn!!
-> Even committee members find Stoye's ideas and talk laughable I think.
-> It is not all that comforting. He is just not up to par intellectually with the other speakers really. He was part of the negative UK study and a pain in the butt.
-> Abbott study on monkey infected with XMRV is up. Compelling stuff if people are listening. Even the researchers were not anticipating the amount of viral response that was there.
-> Meeting is running WAY over time.
-> BWG report. No advantage to delayed testing. Run serology along with NAT. NAT though sensitive was unable to detect positives.
My comment: What the neck is the NAT Test? We have been able to order the PCR/culture and serology, but have not been told about any NAT test.. Please advise BWG, OK?
-> Dr. Bagni up. Talking about development of seroassay development for labs.
***Brain is drooping guys. Signing off. Will have to leave soon. Thanks!
~ ALL of our Loving Thanks to Heidi for exerting the Precious Energy to attend and Cover this meeting for the Public and the ME/CFS patients of the world. You definitely ARE on our list of Patient Heroes. ♥Hugs♥
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This has been a VERY Informative yet disappointing as "usual meeting", as we have unfortunately become accustomed to dealing with. It's OBVIOUS that even tho XMRV and MRV/MLV are being found in labs and people ALL over the world, including Belgium, Spain, Norway, Sweden, Australia and the U.K.~ this does not seem ENOUGH to Budge the Lazy Arses that have never found a Retrovirus that "Promotes Health" so far ONLY disease, yet they don't seem to want to protect any of the blood supply YET. Maybe one of THEM will need to be infected FIRST before they will BELIEVE? Thus has been the case with MANY Drs/Nurses~ until THEY or a Family member gets this they play ostrich.
To anyone that is reading THIS for the 1st time that is unfamiliar with the history of this illness, please let us remind you that our Worldwide Awareness day is May 12th that is the Birthday of Florence Nightengale, as she also had this illness for MANY Years after caring for soldiers after the Crimean War.
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| http://rescindinc.org/history.htm |
Please know that there have been links shown that XMRV is linked to not only ME/CFS, but also Autism, MS, FMS, and cancers such a Leukemia, Lymphoma, an Agresive for of Prostate Cancer, and if a current study bears fruit~ thenit could also be linked to breast cancer and transmitted by saliva... Even a German study has found:
They found XMRV in:
- 3.2% of controls
- 2.3% of those with RTIs & no underlying conditions
- 2.3% of those with RTIs & COPD
- 9.9% of those on immunosuppressive drugs IF it's in COPD Respiratory patients then Hello it might be in their respiratory fluids and transmitted that way...Can you say COUGH?
Please STAY TUNED.. This is an URGENT Health Issue for the HUMAN RACE. Yet no one seems to be paying attention YET.
Will YOU or your child be NEXT ?
I sincerely HOPE that the NIH/BWG "will indeed' be MORE forthcoming "with details" as the PROMISED after the Oct CFSAC meeting OR it WILL be time to start contacting Dr.s Collins and Fauci and Magnan AGAIN~ SOON !
With this brief tidbit today they had Better contact us BEFORE the Holidays with some coherent results from the BWG~ IMHO.
We MAY have Brainfog, but we are NOT Stupid and we also CAN Have the memory of Elephants and DO remember what you promised.
"KEEP your WORD" or we will know that your word is the same as Trustworthy as the CDC.
...And you WILL be hearing from us..
DO NOT RECESS FOR THE HOLIDAYS W/O CONTACTING US~
ARE YOU LISTENING?Should you and the Government FAIL to ACT and HELP us and the millions ALREADY infected.. WE WILL be hiring a lawyer. Suing the government worked for the AIDS project. THIS is a Retrovirus ALSO~
..."And the Band Played ON" has alredy been made
MUST YOU REPEAT History ??
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