$57 million claim against the CDC on Lyme test
Jul 20, 2017 — In 2013 the CDC provided 52 blind-coded archived serum samples including 12 from posttreatment and 20 pretreatment clinically suspect Lyme disease patients, and 20 negative serum samples to Milford Molecular Diagnostics for the purpose of evaluating the accuracy of a new diagnostic test for Lyme disease by Nested PCR and DNA Sequencing, under CDC MTA Reference: NCEZID-R137154-00 and NCEZID-R147284-00.
Dr. Lee’s technology uncovered a novel Borrelia in one of the serum samples tied to a patient in the Hudson Valley, who had been previously treated for neurologic Lyme disease (DNA sequence deposited in GenBank under accession number KM052618) Dr. Lee also found Borrelia miyamotoi in one of the CDC’s serum samples.
NOTE: “Serum is a very poor sample for routine detection of Lyme disease bacteria because most of the spirochetes in the blood are trapped in the blood clot and lost in high-speed centrifugation during preparation of the serum sample for serology tests.” Milford Molecular Diagnostics was still able to detect Borrelia pathogens in the CDC’s blind coded serum samples!
When Dr. Lee published his findings all communication stopped with the CDC as they refused to respond.
Detection of Borreliae in Archived Sera from Patients with Clinically Suspect Lyme Disease
This work had been started by Dr. Lee and David Shearer as they contacted the CDC for collaboration. Marty Schriefer of the CDC agreed to assist and sent archived sera from the CDC’s Lyme disease repository for testing using Dr. Lee’s CLIA-certified PCR/sequencing technology.
Dr Gary Wormser of New York Medical College supplied the blind coded serum samples that were incorrectly coded as they were missing infections identified by PCR/DNA testing out of Milford Molecular Diagnostics.
This is a serious problem and clearly identifies that there is no accountability at the CDC. It would appear that the serum repository for Lyme disease has many problems with samples wrongly coded. Using these samples to determine the validity of future test kits is highly questionable.
Early detection and treatment of Lyme disease is of utmost importance but we know that antibodies are not produced for 4-6 weeks after a tick bite. The lack of early diagnostic tests for Lyme disease has caused untold pain and suffering worldwide as delayed diagnosis and treatment often leads to "chronic Lyme disease" or "Post Lyme Treatment Syndrome".
Nested PCR and Sequencing through Milford Molecular Diagnostics can detect early infection with as few as 25 bacteria per mL of blood.
There is a double standard for Lyme disease in reference to DNA testing:
1. CDC Lauds New DNA Test for Zika in Blood
“Frieden emphasized the distinction between this molecular test for Zika DNA versus serology tests. The latter can indicate any exposure to the virus over time, and also may not give a positive result in a person recently infected. In contrast, a positive molecular test result indicates a current, active infection.”
2. In May of 2012 the CDC announced the Development of a Novel Genus-specific Real-time PCR Assay for Detection and Differentiation of Bartonella Species and Genotypes http://www.ncbi.nlm.nih.gov/pubmed/22378904
“The genus Bartonella includes numerous species with varied host associations, including several that infect humans. Development of a molecular diagnostic method capable of detecting the diverse repertoire of Bartonella species while maintaining genus specificity has been a challenge. We developed a novel real-time PCR assay targeting a 301-bp region of the ssrA gene of Bartonella and demonstrated specific amplification in over 30 Bartonella species, subspecies, and strains…this assay may be an effective diagnostic method for identification of Bartonella infections in humans and have utility in Bartonella surveillance studies”
I would like to point out that there is no mention of “live vs dead” bacteria/virus in the Zika or Bartonella DNA tests but for some strange reason when Lyme is involved suddenly DNA testing is in question. Why the double standard for Lyme disease????
Was the CDC's suppression of well-established 16S rRNA sequence analysis for diagnosis of Lyme disease done so to protect its own patented technology in order to promote the unproven BbHtra protease metabolomics tests patented by Russell and Johnson?
1. Lyme disease spirochaetes possess an aggrecan-binding protease with aggrecanase activity
First published: 10 June 2013 Authors Theresa M. Russell, Barbara J. B. Johnson
2. Compositions and methods relating to lyme disease https://www.google.com/patents/EP2805168A1?cl=en
Patent filing date: Jan 21, 2013
Inventors: Theresa M. RUSSELL, Barbara J.B. JOHNSON
Applicant: The Goverment Of The United States Of America As Represented By The Secretary Of Health And Human Services, Centers For Disease Control And, Russell, Theresa, M., Johnson, Barbara, J.b.
EP 2805168 A1
Compositions and methods of the present invention relating to B. burgdorferi HtrA sensu lato (BbHtrA) protease activity, its substrates, cleavage products, biological effects and use in detection, diagnosis and/or treatment of Lyme disease are provided.
Through the law firm of Moore Leonhardt & Associates LLC, Dr. Sin Lee of Milford Molecular Diagnostics has submitted the SF-59 form with documents to support the $57 million damage claimed:
SF-59 Form: https://www.dropbox.com/s/g94774ielt0e6ok/Lee-CDC%20SF-95.pdf?dl=0
Letter to Heather Huntley Office of General Counsel: https://www.dropbox.com/s/ggdqd2rm1er3uwx/Lee%20-CDC%20Huntley%207-19-17.pdf?dl=0
Letter to the office of Inspector General Daniel Levinson: https://www.dropbox.com/s/p78vepr4uo0mrdj/Lee%20-%20CDC%20OIG%207-19-17.pdf?dl=0
File of Exibits: https://www.dropbox.com/s/i66q1c863fyhh2b/Exhibits%20Combined.pdf?dl=0
Lyme disease belongs in the same health threat category as AIDS and Zika and with over 300,000 cases annually Lyme is now six times the AIDS epidemic and twice as prevalent as breast cancer.
The Centers for Disease Control is 100% responsible for this runaway plague with unacceptable testing, inadequate treatment, lack of medical training and absolutely no disease control. This is an epic forty year failure of the nation’s health protection agency responsible for the health and wellbeing of all Americans.
MOVE LYME DISEASE TO HIGHEST ALERT LEVEL
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