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Continued from page 7 – SANE Vax Inc. Discovers Potential<br />

Bio-hazard Contaminant in Merck’s Gardasil HPV 4<br />

Vaccine<br />

as environmental hazard has been a concern since rDNA<br />

technology was invented in 1973. Thus, rDNA is<br />

considered a potential biohazard, and NIH has mandated<br />

that research institutions monitor and regulate its use. 2.<br />

All re<strong>com</strong>binant or genetically engineered DNAs are<br />

considered potential biohazards if injected intramuscularly<br />

into the body. Merck’s Gardasil HPV4 vaccine is<br />

administered intramuscularly – as are many other vaccines.<br />

However, Gardasil is the first vaccine found to be<br />

contaminated by a genetically engineered DNA used to<br />

manufacture virus-like particle proteins for the vaccine.<br />

SANE Vax Inc. believes the FDA should have required<br />

Merck to test for, evaluate and quantify the risks of<br />

residual re<strong>com</strong>binant HPV DNA in Gardasil before<br />

granting approval for marketing the vaccine. SANE Vax<br />

Inc. believes the FDA should require every lot of<br />

Gardasil be tested for residual HPV DNA prior to<br />

shipment.<br />

Gardasil Patient Product Insert Stated No Viral DNA’s<br />

in the Vaccine.<br />

The European Medicines Agency on line literature still<br />

states: ‘Gardasil is an adjuvanted non-infectious<br />

re<strong>com</strong>binant quadrivalent vaccine prepared from the highly<br />

purified virus-like particles (VLP’s) of the major capsid L1<br />

protein of HPV types 6, 11, 16 and 18. The VLP’s contain<br />

no viral DNA; they cannot infect cells, reproduce or cause<br />

the disease.’ 4.<br />

SANE Vax Inc.’s research found that 100% of the 13<br />

samples tested were contaminated with viral HPV DNA<br />

residue, including a synthetic construct for HPV11 major<br />

capsid protein L1 gene, a re<strong>com</strong>binant DNA genetically<br />

engineered specifically for manufacturing of the Gardasil<br />

vaccine. All DNA residue discovered was firmly attached<br />

to the insoluble aluminum adjuvant in the vaccine,<br />

requiring a new protocol for detection. 5<br />

Dr. Lee firmly stated: “Based on medical literature and<br />

some of the FDA/Merck’s own publications, adventitious<br />

(<strong>com</strong>ing from an outside source) DNA in an injectable<br />

protein-based vaccine may increase the risk of autoimmune<br />

disorders and gene mutation which may lead to<br />

malignancies.”<br />

Merck, the FDA, CDC and the NCI Owe Medical<br />

Consumers Answers<br />

SANE Vax Inc. wants to know how many adolescents who<br />

have suffered adverse reactions post Gardasil vaccination<br />

have HPV DNA in their blood. What are the medical<br />

ramifications should HPV DNA remain in the bloodstream<br />

for an extended period of time<br />

Does the aluminum adjuvant be<strong>com</strong>e the carrier for HPV<br />

DNA causing said DNA to remain in the blood and/or<br />

organs for an extended length of time<br />

Since viral DNA cannot replicate by itself (it needs a host<br />

cell) what happens if genetically engineered viral DNA<br />

enters a human host cell<br />

How will this now ‘genetically-engineered cell’ replicate<br />

Will it mutate the host cell leading towards cancer<br />

How will genetically engineered cells affect the<br />

reproductive health of future generations<br />

How does the immune system react to the detection of a<br />

<strong>com</strong>bination viral DNA and human DNA in what was once<br />

a ‘normal’ cell Will the immune system fight the now<br />

genetically engineered human cell<br />

Medical consumers need to have these questions answered<br />

by Merck, the FDA, CDC, and NCI.<br />

SANE Vax Inc.’s Position<br />

SANE Vax Inc. believes the FDA and Merck should be<br />

transparent and tell medical consumers the potential health<br />

impacts the contaminant HPV DNA has brought upon the<br />

vaccinated children of the world. High rates of<br />

autoimmune disorders, 380 reports of abnormal pap tests,<br />

137 reports of cervical dysplasia, and 41 reports of cervical<br />

cancer including Carcinoma in situ or Cervix carcinoma or<br />

Cervix carcinoma stage 0 or Cervix carcinoma stage I or<br />

Cervix carcinoma stage III<br />

6 warrants an immediate<br />

investigation into Gardasil’s safety and efficacy.<br />

SANE Vax Inc. believes the FDA and Merck should have<br />

tested, evaluated and quantified the risk of the residual<br />

re<strong>com</strong>binant HPV DNA in Gardasil before vaccine<br />

approval.<br />

SANE Vax Inc. believes that both the FDA and Merck<br />

were at least negligent and perhaps fraudulent when<br />

claiming there was ‘no HPV (viral) DNA’ in the<br />

Gardasil vaccine.<br />

Sources:<br />

1. SANE Vax Inc. Letter to FDA Requesting Investigation into<br />

Gardasil Contamination<br />

2. Policy on the use of Bio-hazardous Agents and Re<strong>com</strong>binant<br />

DNA in <strong>Research</strong> and Teaching Laboratories at the University<br />

of North Carolina at Greensboro<br />

3. Gardasil Patient Product Insert<br />

4. EMEA Scientific Discussion on Gardasil<br />

5. Gardasil Contaminants by Country<br />

6. VAERS Data<br />

http://sanevax.org/sane-vax-inc-discovers-potential-bio-hazard-<br />

contaminant-in-merck%E2%80%99s-gardasil%E2%84%A2-<br />

hpv-4-vaccine/<br />

☻☻☻☻☻☻<br />

-19- <strong>Traditional</strong> <strong>African</strong> <strong>Clinic</strong> October 2011

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