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Hilary's Desk

FDA questioned about genetically engineered HPV DNA in Gardasil worldwide.

Hilary Butler - Monday, September 05, 2011

All New Zealand samples contaminated.


A few days ago, an American organisation put on their website a copy of a letter sent to the FDA, in which they stated that thirteen samples of Gardasil from Poland, France, Spain, USA, New Zealand and Australiamade in four different Merck factories (USA, Holland, France and CSL Australia) had been tested, and found to contain genetically engineered dna fragments which the purification process failed to remove.  Yesterday, a more detailed press release was put onto SANE-Vax's site, which showed samples contaminated with HPV DNA 11 and 18.  The New Zealand results can be seen here.

One of the genetically engineered particles found is said to be  a genetically engineered syntheticaly constructed gene designed to instruct the yeast or baculovirus cells, to make the HPV-11 outer capsid protein (virus-like particles) for the Gardasil vaccine.  

This is the Pubmed site for GenBank Locus SCU55993, which is the picture below, of ONE of the alleged contaminants:




Wavy lines mean nothing to me, and probably nothing to you.  

SANE-vax's letter doesn't specifically say what the other contaminants are, but say that the rest of their proof is available for review provided that FDA provides " appropriate safeguards ... to protect the proprietary processes and information utilized by our laboratory to test the samples."

To me, no platitudes and fob-offs on this issue are acceptable.

The first question that comes to mind is,

"Is  this  a  big  deal?"


This isn't a quality issue in one factory.

The problem, according to the testing done by SANE-vax shows;

A global manufacturing fault.

 

A global manufacturing issue relating to vaccine design, process and purity - IS - a big deal.

The next question is:

Are  the  "genetically  altered  HPV  DNA  fragments"  a  big  deal?

I don't know, since this is going where no-one has gone before.

This is not like the situation recently when porcine viruses were found, as a contaminant of tripsin in the Rotavirus vaccine.

We are talking about the alleged laboratory identification of ONE specific genetically modified viral sequence (GenBank Locus SCU55993) spliced into the DNA of another species, for the manufacture of Gardasil, plus other so far unspecified "contaminants".

"Do  the  manufacturers  of  Gardasil  claim  there  is  no  DNA  in  Gardasil?"

 

Yes they do!

During the licensure process Merck assured the FDA that Gardasil had no DNA in it, but nowhere on the FDA website are there any tests which proved that.  And this is the first ever vaccine which specifically claims there is no DNA in the vaccine.

As a matter of historical interest, Dr Maurice Hilleman, whose name is synonymous with Merck said in this article about mammalian cell cultures:

"The principal concern for safety lies with retention of residual DNA in the vaccine, especially since induction of cancer is a single-cell phenomenon, and a single functional unit of foreign DNA integrated into the host cell genome might serve to induce cell transformation as a single event or part of a series of multifactorial events. Current proposed standards for vaccines would permit contamination with up to 100 pg of heterologous DNA per dose. This is equivalent to about 10(8) "functional lengths" of DNA. Total safety would seem to require complete absence of DNA from the product."

However, the next sentence indicates that it didn't seem to occur to him that vaccines made in bacteria or yeast might also potentially contain DNA fragments.

(Out of interest for those who want more detail, here is a copy of the FDA regulations for "safety" and the regulation for "contaminants" as well as their Guidelines to Industry.)

So the next question is:

"What  does  worldwide  information  say  about  DNA  in  Gardasil?"

Since Gardasil was brought into New Zealand, Medsafe has consistently had this comment on their website:

"Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce." 

This is stated in the CSL 2008 and CSL 2011

It's also stated in a product sheet I obtained in 2009 (scan here).

The UK Government goes further and says that:

"HPV vaccines are sub-unit vaccines made from the major protein of the viral-coat or capsid of HPV.Virus-like particles (VLPs) are prepared as recombinant proteins from either yeast or baculovirus infected cells that are derived from a type of moth. VLPs mimic the structure of the natural virus but do not contain any viral DNA." (end of page 1, beginning of page 2)  (pdf here)

HOWEVER, I note the most recent American patient information and product information does not contain any comment of this type, which is interesting and leads to this question:

Why  have the words  "NO viral DNA" been  removed  from  USA materials?

They used to be there...    Um, er,... ??

The next question is....

"Does  the  vaccine  manufacturer  CHEck  to  make  sure  that  there  is  no  genetically  engineered  HPV DNA fragments  in  the  final  product ?"

Here are OIA copies of the New Zealand Gardasil application by Merck, with masses of text "blacked out".

Medsafe did ask Merck questions, because they were concerned there were:

 no "filter integrity tests" neither were there any "impurity tests".  (See underscorings in application)

The answers Merck came back with appeared to convince Medsafe that neither tests were necessary, so Medsafe approved a vaccine for which a final purity test did not exist - as per their own documents.

The next question is:

Has  there  been  discussion  about  the  dangers  of  residual  DNA  in  medical  products,  in  the  medical  literature  in  the  past ?

Yes.  These medical articles expressing concern about residual DNA were published in medical journals in:  1974, 1982, and 1991.

This 2010 article though, takes a very blase stance on DNA contamination considering it no big deal.

In this recent document pdf'd from their website, FDA said that the technology they use is inadequate to detect vaccine culture contaminants in vaccine made on the new tumor cell cultures. This also applies to normal vaccines.

The shortcomings of the technology has been a subject of discussion for years.  This 2008 medical article states, "tests that are used to rule out the presence of adventitious agents have been recognized as areas that could benefit greatly from studies using state-of-the-art techniques." 

This medical article by Pawlita in 1996, is very interesting, because it shows that virus-like particles assembled in nuclei of insect cells have been shown in the past, to be sufficient to unspecifically encapsidate DNA.

(Extra general information: the Office of Environmental Health and Safety published this document in 2006, relating to recombinant - or genetically engineered DNA in general.

The next question is:

If  there  IS  genetically  engineered  HPV  DNA  in  GARDASIL,  how  is  it  presented  to  the  body ?

Medsafe data sheets say that the "virus-like particles are adsorbed onto ... aluminum hydroxyphosphate sulfate".  According to SANE-vax's press release yesterday, the testing laboratory found that the DNA fragments were tightly bound to the aluminum hydroxyphosphate sulfate!!

The next question is:

What  might  an  aluminium/DNA/antigen  complex  do  in  the  body ?

Short answer - the medical literature doesn't say specifically.

If this finding is accurate, Gardasil is an aluminium adjuvanted genetically engineered DNA vaccine, not just a virus-like particle vaccine.  Given that the vaccine also has polysorbate as an ingredient, which makes the blood brain barrier more accessible, polysorbate increases the ability for DNA fragments, bound tightly to aluminium, to gain access to the brain, and set up inflammation.

There are several issues here, the first being what aluminium adjuvants do in the body and how they work.  The most recent medical papers on these issues are a 2011 paper by Marichall, which says that aluminium appears to work by releasing large amounts of human DNA into the body. What the body does with that, is unstated. We already know that repeat vaccination can result in autoimmunity. 

Other medical authors - Shoenfeld 2010, 2011, and Tomljenovic 2011 discuss worrying issues surrounding aluminium as an adjuvant. Exley 2009 has also suggested that aluminium adjuvant is related to chronic fatigue syndrome.

But what about aluminium + genetically engineered DNA?

Other than what is suggested in Wills 1982, regarding recombinant hepatitis B DNA in chimps, no-one knows, because it's not been studied since, ...  that I can see. 

The next question is:

What  are  the  known  unwanted  effects  from  Gardasil  in  New  Zealand ?

Officially this is what CARM has to say.  Unofficially, I continue to get reports like this one I got yesterday which is altered, redacted and rewritten for clarity:

"My daughter is 12 and was given Gardasil in March 2011. Initially she felt faint, had a red arm with a hard lump at the site for a month. She had a fever of over 38 + that evening and slept. Her muscles have ached since then.  She also had abdominal pain after the vacine that was diagnosed as ovarian cyct ?? or an inflamed appendicitis that ? burst and she had ? peritonitis and was given a lot of antibiotics. Gluten intolerance was diagnosed after that.

Since then these symptoms have got worse: She has not been sleeping well, constant fatigue, muscle and joint aches, blacking outs, fainting, twitching, seizures of a type, stuttering, and rash behind her ears, headaches, migraines etc. She can't go to school."

Let's take three of the problems mentioned in the case above:

Fainting, or repeated blacking out.  This is considered by the FDA and the medical system, to be typical female hysterics. However, fainting might also be explained as a symptom of POTS syndrome, which is what most Gardasil Girls I talk to have appear to be suffering.  Potts syndrome, is a defined medical entity and not a result of needle hysteria.

Seizures. There has been a case of myoclonic seizures reported, but the fact is that brain inflammation can cause seizures. Polysorbate makes the blood brain barrier more accessible, so theoretically can take the aluminium/antigen across the brain barrier, making inflammation more of a possibility.

Joint pain.  This is a "constant" amongst many of the girls who have serious reactions to Gardasil.  But if there is DNA in the vaccine Zhong 2007 shows that antibody bound DNA can indeed cause "joint pain". Problem being, that no-one's looking at the "Gardasil Unwanted Effects" elephant in the room.

Parents are always told that joint pain, blacking out and seizures are nothing to do with Gardasil. However, pain at site is sometimes admitted to. After all, that's "no big deal".  

The next question is:

What  unwanted  effects,  have  been  reported  overseas ?

The UK produced this document in June 2010, but doesn't specify the vaccine.  Cervarix is mainly used in UK, and is made using the same process as Gardasil, but using a different adjuvant. As you see, the list is very long indeed, but again, most of these aren't considered "causal". You will find USA reported side effects, such as Judicial Watch, by doing a Google search.

A US consumer driven survey can be found here.

Given that both HPV vaccines (Cervarix and Gardasil) are causing an outcry world wide with large numbers of girls coming down with what looks like autoimmunity and other serious neurological and immunological reactions after vaccination, another question comes to mind:

are  genetically  engineered  HPV  DNA  fragments  used  during manufacture,  also  in  Cervarix  VAccine ?

 

If so, Gardasil and cervarix should be recalled immediately.

 

The same question could be asked about the Hepatitis B vaccine!

 

 

SUMMARY  AS  I  SEE  IT :

 

  • Gardasil is the first vaccine to be marketed specifically stating that the vaccine contains no HPV DNA.

 

  • If the findings of SANE-vax are correct, then Merck's licensure information and assurances to Medsafe mean nothing

 

  • It is of interest to me that the three vaccines made using the same method are Recombinant Hepatitis B vaccine, Gardasil and Cervarix

 

  • All of these vaccines, have generated the most parent-reported case histories relating to demyelination, neurological disorders, chronic ill health of many kinds, and autoimmunity.

 

  • All medical authorities have stated that all unwanted health issues after Hepatitis B vaccine, gardasil and cervarix are coincidental, and due to idiosyncracies in the vaccine recipient.  In other words, these "events" would have happened anyway, because the person had a genetic susceptibility to that problem. This 2011 article looking at this issue in drugs, doesn't mention vaccines.

 

Conclusion:

 

As I see it, FDA must ask SANE-vax to be given access to the information provided by the laboratory, describing what they found and with the necessary protection requested, regarding the testing procedures. 

 

What will happen now?

Merck has it's back to the wall with this issue.  What strategies will Merck employ?

Gardasil was to be their saviour to help pay off the Vioxx lawsuits, and the "vaccination sacred cow" is much too large an industry to allow such a possible finding to get any real "traction".

Will:

  • FDA call a committee to review the evidence, and involve the ACIP (FDA Advisory Committee on Immunization Practices)?
  • FDA challenge the results of SANE-vax's laboratory findings?
  • FDA, if genetically engineered DNA is confirmed, deny the significance of that DNA?
  • FDA and vaccine defenders then accuse SANEvax of spreading FUD (fear and unwarranted dread)?

 

Why have I asked these questions?

When the Polio vaccine was found to be globally contaminated with SV40, a decision was made by the FDA to whitewash, bluster, and downplay the significance of the vaccine contaminants (which continues to this day!) for the reasons mentioned in these 1984 regulation, - that:

"any possible doubts, whether or not well founded, about the safety of the vaccine cannot be allowed to exist in view of the need to assure that the vaccine will continue to be used to the maximum extent consistent with the nation's public health objectives."

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