|NEW STUDY OF GARDASIL RAISES MORE SAFETY QUESTIONS|
By Norma Erickson, President www.sanevax.org Posted 17 March 2013
Why were HPV-16 L1 DNA fragments detected in post mortem samples taken six months after Gardasil vaccination and not the other vaccine-relevant types? Dr. Sin Hang Lee, of Milford Hospital and Milford Molecular Laboratory, may have provided an answer in his most recently published paper entitled, Topological conformational changes of human papillomavirus (HPV) DNA bound to an insoluble aluminum salt – A study by low temperature PCR. His findings suggest that non-B-conformational changes in HPV L1 gene DNA fragments bound to the AAHS adjuvant may be genotype related, in other words specific to HPV-16.
In September 2011, SaneVax Inc. informed the FDA that despite all claims stating Gardasil contained ‘no viral DNA’ Dr. Lee had discovered there were indeed fragments of HPV-11, HPV-16 and HPV-18 L1 DNA firmly attached to Merck’s proprietary aluminum adjuvant in 100% of the samples he tested, but all were lacking a region amplifiable by an MY09 degenerate primer.
The FDA was quick to confirm that Gardasil does contain residual HPV L1 gene DNA fragments, but that these fragments posed no health risk. The FDA completely ignored a request for further investigations put forth by the SaneVax Team.
In light of the FDA statement corroborating Dr. Lee’s previous findings, the presence of HPV DNA fragments of vaccine origin in the bodies of recipients might be anticipated after intramuscular injections of Gardasil. However, finding HPV-16 L1 DNA fragments in post-mortem blood samples of a teenager who died six months after completion of 3 Gardasil injections without finding any other vaccine-relevant fragments was a surprise. Obviously, further investigations were necessary.
At the request of SaneVax Inc., Dr. Lee agreed to use PCR amplification followed by direct DNA sequencing to try and determine what was going on. What he discovered is stated clearly in the conclusion of the above referenced paper. It says:
“Naked HPV L1 gene DNA fragments bound to Al3+ in solid phase by ligand exchange have acquired a non-B-conformation. The resulting topological conformational changes may affect a region shared by many HPV genotypes, for example at the primer-binding site for the degenerate MY09 primer, or may affect a region of a specific genotype, for example at the degenerate MY11 primer-binding site of the HPV-16 L1 gene DNA. DNA conformational changes induced by a particulate aluminum-based adjuvant may have stabilized the residual HPV-16 L1 gene DNA fragments in an injectable vaccine and prevented their enzymatic degradation in a vaccine recipient.”
The term ‘non-B conformation’ refers to any DNA conformations other than the orthodox B-conformation right-handed Watson-Crick structure pictured on the left. Conformational change may be induced by many factors such as a change in temperature, pH, voltage, ion concentration, phosphorylation, or the binding of a ligand. Conformational change can be something as simple as a slight twisting, kinking, or knotting. Non-B DNA conformations also include some of the more complex structures referred to in the quotes below. Scientists have been studying non-B conformation DNA as related to genetic disorders since the mid 1960s.
Consider the following quotes from various peer-reviewed scientific papers (emphasis added):
Where does this leave the average medical consumer? Unfortunately, it leaves them with the following unanswered questions:
The scientific community needs to investigate these potential risks immediately. Medical consumers need to know the risks as well as any potential benefits before they decide if Gardasil is right for them.
In the interest of public health and safety, the FDA needs to rescind approval for Gardasil until satisfactory answers are provided to the four questions above. The time for poke and hope is long since passed. Medical consumers need proof this vaccine is safe.
 Lee, S.H. (2012) Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil®. Journal of Inorganic Biochemistry, 117, 85-92. doi:10.1016/j.jinorgbio.2012.08.015
 Lee, S.H. (2012) Detection of human papillomavirus L1 gene DNA fragments in postmortem blood and spleen after Gardasil® vaccination—A case report. Advances in Bioscience and Biotechnology, 3, 1214-1224.
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