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dodgy experts & gardasil - further questions

Perhaps the greatest fear for any parent is that their child will die before they do. Such events must be incredibly hard to bear, particularly if the death is unexplained and unexpected,  & my heart goes out to any parents in such a situation.

Sometimes, particularly where the death is unexplained, all sorts of alternative hypotheses can be put up, perhaps as a way of dealing with the grief. And unfortunately, sometimes those hypotheses can offer fertile ground for proponents of pseudoscience to put down roots. Grant and Orac have both posted on one such case, a young New Zealand woman whose untimely death has been attributed by her mother to the Gardasil vaccine that she received 6 months prior (despite the fact that other causes - some potentially heritable - may have come into play).

This death is currently the subject of a coroner's inquiry, during which a couple of overseas 'experts' have had the opportunity to present their views to the coronial court. Expertise, and views, that require rather closer scrutiny than has yet been afforded by the media. Orac has already done his usual very thorough job but I wanted to add a couple of points.

In the Otago Daily Times* we read that

Neuroscientist Profefssor Christopher Shaw of the University of Columbia in Vancouver told the inquest ... that he was sent Ms Renata's brain tissue to test. He said there was aluminium in all the samples he tested and there were some abnrmalities in the samples. The human papillomavirus (HPV16) was found in her brain, which could only have got there through the vaccine, Prof Shaw said...He said there was a "biological plausibility" that [the vaccine caused her death] because of the abnormalities in her brain he had examined.

In addition,  

Dr San Hang Lee, a pathologist at Milford Hospital in Connecticut, told the inquest ... that he tested samples from Ms Renata's blood and spleen. He also found aluminium and HPV in her system, from the vaccine. Dr Lee could not say for sure what caused Ms Renata's death, but said the results he found from testing samples from her were "unnatural". 

Aluminium is the third most abundant element on Earth. It's present in the food we eat and the liquids we drink. So it's hardly surprising that either 'expert'** would find aluminium in the dead woman's tissues. (We're not told whether either of them used control samples when doing their analyses.) Aluminium is used as an adjuvant in some vaccines - but there's no way of distinguishing the various sources of Al in someone's tissues and in addition, the quanitity of Al used as an adjuvant in Gardasil is comparable to that ingested daily via food and drink*** (& vaccines are not delivered on a daily basis). 

Both men said that they found abnormal or "unnatural" results, but we're not told (in this article anyway) what "unnatural" actually means. How does it compare with 'normal'? Who knows?

And HPV in the brain, 'which could only have got there through the vaccine'? First up, you'd want to know how the virus was detected: the amount of HPV DNA in Gardasil is tiny, and only a fraction of that would make it into the bloodstream, and a fraction of that again into the brain. Any testing regime would need to be extremelysensitive and also extremely robust, with suitable controls. Was this the case? We don't know; certainly neither 'expert' is reported as giving this information. In addition, human papilloma virus isn't spread only via intercourse. In fact, HPV - including the HPV16 strain - is also found in dermal warts. So there are other potential sources of HPV virus particles. 

And as one of Orac's regular commenters noted:

If tiny traces of HPV DNA cause sudden death, I would expect most warts (which are essentially HPV DNA factories) to be fatal.

Again, this is a very sad story - made even sadder by the fact that the focus on a vaccine as a potential cause of death is obscuring other possible causes.

 

* The ODT story also gives a more measured response from a pathologist, further down the page. 

** A search of the staff at Milford Hospital, Connecticut, does not bring up Dr Lee's name.

*** someone using antacid tablets would receive a much higher dose.

There's a lot of information on the development and testing of the Gardasil vaccine here, and the US National Cancer Institute provides more general information.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

11/08/2012  Something else (courtesy of another of Orac's commenters: the HPV virus infects squamous cells - the type you find in skin & other eplthelia. It does this by locking onto receptors that are peculiar to squamous cells. Neurons (the type of cell found in the brain & nervous system) are not squamous cells. (Which should be a case of 'nuff said.)

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I don’t know if the target specificity of HPV is going to convince anyone. Obviously the anti-Gardasil crowd have been careful to remain vague, avoiding particulars about the nature of the threat posed by the purported trace contaminants of HPV-DNA in the vaccine… they may give the impression that the DNA is actively infecting the recipient of vaccination, but you would be hard-pressed finding someone who says that explicitly.

Dr Lee’s own assertion is that (1) these are DNA fragments, not the intact HPV genome; (2) the fragments are not the native infective HPV, but rather the recombinant DNA used to produce antigenic proteins (and his magic test is fine-tuned just to pick up the rDNA, not the native form from warts), and (3) the DNA is bound somehow to colloidal microparticles of aluminium hydroxide from the adjuvant, so it can’t enter cells, and remains in the bloodstream indefinitely — because his test finds it in blood samples.

Why this otherwise-invisible DNA/Al chimera should be a bad thing as it sloshes around through the circulation for six months is never explained.

I say again, there is the *implication* that the DNA is being expressed (despite being bound to Al particles, and outside cells), and is multiplying (despite the absence of fresh sources of Al to make new copies of the DNA/Al chimera), but you won’t catch anyone saying so in as many words.

the amount of HPV DNA in Gardasil is tiny,
I think you concede too much there. There is no evidence for *any* HPV DNA in Gardasil, apart from Dr Lee's untested and detail-free magical claims.

The human papillomavirus (HPV16) was found in her brain, which could only have got there through the vaccine, Prof Shaw said
Like Grant, I am wondering whether Shaw mentioned DNA at all, or whether this was a reporter's conflation of separate testimonies. Shaw is not set up to run nested PCR, and in his e-mailed exchanges with the Renata family, he does not mention any such analysis -- all his proposed tests are for detecting aluminium (of whatever source) and metabolic responses to aluminium.

In other news, I was looking at the chronology of the SaneVax / Lee claims. I'm calling them that because SaneVax apparently paid for Lee's tests of Ms Renata's blood and claim ownership of the IP rights for the results:
http://www.activistpost.com/2012/08/gardasil-vaccine-rdna-introduced-at.html

So the announcements that Lee’s special nested-PCR reagents could detect HPV rDNA in Gardasil samples appeared in September 2011:
http://scienceblogs.com/insolence/2011/09/06/oh-no-theres-dna-in-my-gardasil/

At that point, all Lee’s work was with fresh vials of straight vaccine. In related press releases from SaneVax in September 2011, Lee is *talking* about rDNA staying in the bloodstream and being a potential threat, but he is not testing for it himself… instead, there is a reference to another case of a woman going “to an MD practicing naturopath who conducted a toxicity test that eventually found HPV DNA in the girl’s blood”. Of course the kinds of ‘toxicity tests’ conducted by naturopaths are a whole source of hilarity in themselves.
http://healthimpactnews.com/2011/sane-vax-inc-discovers-potential-bio-hazard-contaminant-in-merck%E2%80%99s-gardasil%E2%84%A2-hpv-4-vaccine/

Going back to that first link -- Erickson from SaneVax explains that the September 2011 press releases led to a flood of requests to test blood samples, “Dr. Lee’s lab was not set up to work with blood samples and no protocol had been developed to try and detect HPV DNA particles attached to aluminum in human samples.”
Presumably one of those requests being from the Renata family, to test Ms Renata’s blood samples.

So when Erickson says “The tests were done in June to August of 2011″, she is evidently describing referring to the analyses of Gardasil vials.

Some time after that, Dr Lee — working without a laboratory — refined his reagents to work in a different liquid environment, and increased their sensitivity umpteen orders of magnitude to adjust for the dilution of a few millilitres of vaccine within three or four litres of blood (we agree that the fragments of rDNA are not replicating).

Yeah right.
-----------------------
I only just got around to pursuing all the links on an Orac-post link-farm, and found this one:
http://www.naturalnews.com/031535_HPV_screening.html

The SaneVax / Lee collaboration turns out to be far, far sleazier than I had previously realised. Not only do they claim that Gardasil has *side-effects*, but they claim that it *doesn't work*, because all the researchers who have specialised in HPV are wrong about the dangerous varieties.

Apparently there are "13 high-risk HPV genotypes" -- not just the two singled out by the NCI -- and it has taken a non-specialist in the form of the Nobel-Prize-worthy Dr Lee to work this out. But fret no longer, you can send a tissue sample plus $50 ("Most health insurance companies will reimburse this cost") to SaneVax and Lee for his special "short-target DNA sequencing PCR", and they will tell you whether you in danger!

Do not trust the HPV-genotyping offered by the NCI! What do *they* know?

In the same post, Orac asks Which vaccines are “necessary” and “effective”? The answer, it is increasingly clear, is "ones developed and sold by SaneVax and Lee".

here's hoping the NZ media pick up n all this. (Do you have a spot lined up on Campbell Live?)

I've been seeing much of the same from my reading, just not saying as much as I should, I guess.

From memory there are more than 4 strains of HPV that can cause trouble, but what they've done with the vaccine is to select the most common strains, so that the can cover the vast majority of cases (the ones not covered are rare). It does look like Lee is exaggerating though - making this out to be a huge issue (the anti-vaccine nonsense pleading for perfection trope, etc.)

One thing I'm still concerned about is why Rhonda didn't present Jasmine's symptoms to a doctor - and if the anti-vaccine community or other material on-line had an influence on that. (The issue with the "experts" is important, but this precedes them in time, etc.)

Going further into the Google, it does look as if Dr Sin Hang Lee's genotype test for the different HPV strains is an important part of the backstory behind his issues with the virology mainstream that has failed to recognise his genius.

In 2008 he was suing the FDA (through his company HiFi DNA Tech) because they refused to endorse his test. The FDA argued that Lee had showed them insufficient evidence that his test was any more specific or reliable than existing tests, what with extravagant claims not being enough on their own. Evidently their argument was convincing since the court found for the FDA, and in 2009 we find Lee appealing to the 2nd Circuit Court, amid a flurry of accusations of conspiracies and conflicts-of-interest between FDA officials and the suppliers of tests that are endorsed.

Conspiracy is also responsible for the NEJM declining to publish a manuscript from Lee on the economics of HPV screening (and how much better it would be with his test). We find him harassing the editorial board here, and appealing to a professional group that he believes can over-rule them

There was a Dr Sin Hang Lee, of Connecticut, sacked from a shared pathology practice in 2003. In 2006-2010 he was (unsuccessfully) suing the employment lawyers of that practice for allowing him to sign a revised employment agreement. Of course there might be *multiple* pathologists of that name in CT with the habit of employment-loss-related litigation.

There *might* be...

You'll have seen the ongoing 'discussion' around this on the Sciblogs syndication of this post?

I hadn't. Checking there now.

Oh goodness me.
I get the impression that RonL on the Sciblogs thread is not a devotee of Dr Lee who has wandered in from outside and has a party line to follow, but is a regular on Sciblogs who is manufacturing ad hoc bovine excrement in order to produce a reaction.

You might like to think so; I couldn't possibly comment...

Feel free to refer RonL to Riddled. We insist, however, that making up nonsense is the purview of the bloggers, not the commenters.

Reprising a comment I just left at Grant's blog:

The aluminium in Gardasil is in the form of insoluble, colloidal particles of aluminium hydroxyphosphate sulfate. The antigen part of the vaccine (capsin proteins) are attracted to the surface of the particles, so that immune cells can find them when they are fussing around the particles wondering what to do. So the 'insoluble' and 'particulate' aspects of the aluminium compound are crucial for it to work.

Dr Lee reckons that these particles bind with the rDNA fragments that only he can detect, migrate from the injection site into the bloodstream, and hang around there indefinitely, simultaneously particulate and soluble, to be found months or years later.

Dr Shaw reckons that they migrate from the injection site to the brain, where they find their way inside neurons and change into charged atomic aluminium, in order to be detected by the Morin stain (it is unclear how he distinguishes between aluminium from Gardasil and aluminium from other exposures).

Ms Renata's expert witnesses cannot both be right.

Please can you also put it on my Sciblogs syndication - the comments here don't transfer across and I have another reader who could benefit from your wisdom...

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  • Alison Campbell: Please can you also put it on my Sciblogs syndication read more
  • herr doktor bimler: Reprising a comment I just left at Grant's blog: The read more
  • herr doktor bimler: Feel free to refer RonL to Riddled. We insist, however, read more
  • Alison Campbell: You might like to think so; I couldn't possibly comment... read more
  • herr doktor bimler: Oh goodness me. I get the impression that RonL on read more
  • herr doktor bimler: I hadn't. Checking there now. read more
  • Alison Campbell: There *might* be... You'll have seen the ongoing 'discussion' around read more
  • herr doktor bimler: Going further into the Google, it does look as if read more
  • Grant: I've been seeing much of the same from my reading, read more
  • Alison Campbell: here's hoping the NZ media pick up n all this. read more