141122: SUBMITTED IN
COMMENTS FOR THE NIH RULE PROPOSAL RE FDA VALIDATED TESTING FOR CLINICAL TRIALS (see link at the end):
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We in the Lyme Cryme Victim community
would like to know if any of these rules related to FDA validations requirements (see "Guidelines on the Validation of Bioanalytical Methods," by the FDA; ie., specificity, linearity, accuracy, limit of detection, precision, ruggedness, where Yale's patented flagellin method, US Patent 5, 618, 533 is the only method that meets the FDA's criteria for a Validation)
will be retroactively applicable to previous bogus Clinical Trials such as Mark Klempner's 2001 research fraud report on the non-retreatment of 2/3rds of his victims with IV ceftriaxone (2/3rds never had IV ceftriaxone before, yet this was called a re-treatment study);
the criteria [for Klempner’s bogus clinical trial] was the falsified CDC Dearborn case definition:
http://content.nejm.org/cgi/reprint/345/2/85.pdf
or [will it apply to] the 2 bogus Lyme vaccine trials:
LYMErix results (76% "safe and effective"):
http://content.nejm.org/cgi/content/abstract/339/4/209
ImmuLyme results (92% "safe and effective"):
http://content.nejm.org/cgi/content/abstract/339/4/216
Dearborn Falsified case definition (as you can see, there was no consensus, and nowhere will you find evidence that the FDA approved this new criteria, since at the FDA meetings in 1994 and 1998, participants objected the entire time and said "HLA-linked Lyme arthritis was the exception rather than the rule," and that "seronegative patients were the sickest (Dattwyler).
http://www.actionlyme.org/DEARBORN_PDF.pdf
The seronegative and neurological cases were excluded by Allen Steere in Europe and also at the 1994 CDC Dearborn meeting where the average consensus from all the invited labs was 15% accuracy. The FDA says your testing should detect ALL the cases or be 100% accurate. The current case definition for Lyme Disease was not valid and it was far from a consensus.
Recently Senators Blumenthal, Gibson, et al requested that the OBM.gov ask the FDA to enforce their Guidelines on Validations regarding the Lyme Disease testing schema falsified by Allen Steere in Europe in 1992
http://www.actionlyme.org/STEERE_IN_EUROPE.htm
where he fraudulently left OspA and B out of the case definition to satisfy a later intended monopoly on post-FDA "approval" of the Yale OspA vaccine, in grants, national testing for vector borne diseases, patents for new vector borne diseases vaccines and test kits, and for all the HLA-related disease susceptibility data from the human population... intended to OWN all personal, private, proprietary data exclusively by the 3 labs who orchestrated the scam: Corixa (later purchased by SmithKline to take evidence of the LYMErix/Dearborn cryme out of the country), Yale's L2 Diagnostics, and Imugen (Norwood, Mass), and never approved by anyone at the CDC's bogus Dearborn Meeting on the "standardization of testing" for Lyme, as previously mentioned.
The 3 RICO monopoly labs who intended to use this patent (you can see it is related to the Dearborn case definition because there is no OspA-B plasmid, which interferes with the reading of Western Blots)
http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6045804.PN.&OS=PN/6045804&RS=PN/6045804
No one knows the exact relationship between Allen Steere and Imugen but it was whispered that he was part-owner of Imugen. I myself cannot find that information to confirm. Here is what was posted by Corixa years ago demonstrating that Yale's L2 Diagnostics and Imugen were officially listed as "partners" (even with the SEC). (Yale's and L2 Diagnostics Robert Schoen worked on the development of the OspA-B-plasmid-absent strain as a method to test for post-LYMErix victims. That fact does not come up in that US # 6,405, 804 RICO patent):
https://groups.google.com/forum/?hl=en#!original/sci.med.diseases.lyme/D6v-QHQdMbc/WupHjKwFilIJ
So, the whole thing was total corruption for personal gain by CDC officers, many of whom own multiple patents, in particular Alan Barbour and Barbara Johnson - the same people who "approved" this falsified Dearborn case definition.
We're also wondering how we all will be compensated for this crime, that mainly seemed to have the intention of benefiting Yale since they owned the LYMErix patent, and were conspiring with Corixa and Imugen for a later monopoly on testing of people who had been unfortunately vaccinated with this Pam3Cys vaccine which of course was never a vaccine since it is a fungal antigen and TLR2/1-agonist, well known to be of the fungal type, causing T cell anergy.
Thank you. We all want to know when this will be prosecuted. We won't be backing down until it is. This was an international cryme affecting thousands of our personal friends in Europe as well. We look bad. We look like the Germans during the NAZI regime... it looks like we aren't standing up to these war criminals.
Kathleen M. Dickson
Analytical Chemist, formerly with Pfizer
Whistleblower for Dearborn and OspA as immunosuppressive:
http://www.fda.gov/ohrms/dockets/ac/01/slides/3680s2_11.pdf
RICO Complaint filed with the USDOJ July, 2003
http://www.actionlyme.org/index.htm
Clinical Trials Registration and Results Submission
http://www.regulations.gov/#!documentDetail;D=NIH-2011-0003-0003
