* Each of the 52 rabbits shipped the week of September 24, 2001 to USAMRIID Building 1425 to join Dr. Ivins in the Biolevel 3 lab had a unique identifying microchip.
Posted by DXer on December 26, 2011
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CASE CLOSED ... what really happened in the 2001 anthrax attacks? 
DXer said
Dr. Ivins explained his past work under the protocol in a submission February 11, 2002. (The explanation was produced to me under FOIA on November 13, 2013 and will be uploaded to the USAMRIID FOIA Reading Room under Protocols, toward the end of the file labeled B01-11.)
“This protocol was originally approved for 52 rabbits. We are requesting an additional 52 animals in this addendum. The ultimate objective of the study was to determine whether formaldehyde should be included in a new recombinant PA (rPA) anthrax vaccine. The specific objective was to determine if there was any potency difference in rPA/Alhydrogel anthrax vaccines (+/- formaldehyde) prepared in 1996 for protocol B96-08 and stored since then at 4 [degrees] C. The hypothesis was that we would find that formaldehyde was not required for preservation of potency upon storage of an rPA/Alhydrogel anthrax vaccine.
2. Results of the study: 1) As determined by SDS-PAGE, there was little or no degradation of rPA bound to Alhydrogel in the absence of formaldehyde; 2) There was an increase in survival (not statistically significant) in the group receiving vaccine containing formaldehyde (16/24) compared to the group receiving vaccine without formaldehyde (11/24).
3. The results suggest that formaldehyde may increase survival by acting as an adjuvant (stimulating inflammation at the injection site) rather than by preventing degradation of antigen in the vaccine. We have been informed by the FDA that formaldehyde may NOT be included in a vaccine if its beneficial effect on potency is by acting as an adjuvant rather than a stabilizer. Thus, even though formaldehyde may substantially (significantly) increase the new anthrax vaccine’s protective efficacy, we may not be permitted to include it.”
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5. This is a “tech-base” study designed to support phase 1 testing of a new anthrax vaccine in humans. It is not a GLP/GMP study. If a GLP/GMP study is needed to support INCLUSION of a formaldehyde in a new anthrax vaccine, it will be contracted to an appropriate facility (such as Battelle Memorial Institute). If we find there is no justification for including formaldehyde in the vaccine, then we will not need to perform such a study. The FDA does not require a study to demonstrate to them that formaldehyde should NOT be in a vaccine.”
Comment: Dr. Vahid Majidi wrote me stating his supposition that the September/October 2001 study I pointed to was done at some other facility. He was wrong. By now, he should have read enough of the uploaded documents to know that. There simply is no excuse given the importance of the matter for him not to have learned that the 52 rabbits were shipped from Covance to USAMRIID on September 24, 2001. There simply is no excuse for him not to have corrected and re-uploaded the e-book he is selling.
(Under the controlling SOP, they needed to be put in the B3 one week prior to challenge so that they were acclimatized to the environment.)
It is never too late to be right — untii it is. But there is always an obligation to correct mistakes.
Let’s hope he corrects his mistake before it is too late.
Dr. Ayman Zawahiri and my one-time Facebook friend Yazid Sufaat are counting on him that Vahid doesn’t.
I cannot praise enough USAMRIID’s responsiveness in working through the issues.
If litigation is necessary this Fall over yet additional documents, it will only be because their counsel does not understand the legal precedent.
There simply is nothing more fun than FOIA litigation (which typically is resolved on motion for summary judgment) — no one should stand in the way of the very best evidence available in reconstructing the truth. We all have a moral obligation to do our utmost in avoiding the next 9/11.
http://www.amerithrax.wordpress.com
DXer said
The rabbits were shipped in Week 5. Elsewhere a year or two ago I mistakenly said that they were shipped Week 9, relying on a less pertinent document.
In addition to the person who signed for receipt of the 52 rabbits from the shipper, GAO should interview the technician or scientist who inserted the identifying microchip. We even know (from the SOP) the model microchip used. (Maybe the microchips were retained which evidence through data when they were inserted.)