Here we go again. Anti-Gardasil activists and other vaccine deniers are attempting, once again, to make specious claims about the HPV anti-cancer vaccine. This time claiming that Gardasil DNA and aluminum somehow interacted to kill a young child.
This time, it’s a claim filed in United States Court of Federal Claims Office of Special Masters, as a part of the National Vaccine Injury Compensation Program (NVICP), that an injection of the Gardasil vaccine lead to the death of a young male the next day.
As tragic as that death is, and all children’s deaths are tragic, let’s take a look at the evidence being used here. Of course, I’m not a Special Master in the Federal Court System (admittedly, I want that title), I’m not an attorney (nor do I pretend to be one on the internet), and the NVICP has some complex rules and decisions processes. It’s never simple, and remember, the NVICP, or any court for that matter, lacks the privilege of deciding what is good science.
So what did Gardasil do this time?
Well, if you believe in anti-vaccine websites, Gardasil (see this article for a large breadth of Gardasil myth debunking) caused a myocardial infarction in young male, Joel Gomez, the day after the vaccine was given to Gomez. According to the vaccine denying website, Gomez was a:
[infobox icon=”quote-left”]healthy boy who had regular visits to the pediatrician’s office for periodic check-ups since birth showed no evidence of any pre-existing health issues, specifically no evidence of cardiac abnormalities, psychological disorders or substance abuse. The teenager had been training for the high school football team from four to five hours a day for the two months prior to his death without incident.[/infobox]
At this point, I’d wonder if Gardasil was the causal factor, but, as I mention frequently, one has to show a high level of biological plausibility before we can even determine correlation, let alone causation. And this is just one case, which makes any determination of causality pretty much impossible.
However, the autopsy report, from the medical examiner (coroner) of Los Angeles County, seems to come to another conclusion:
[infobox icon=”quote-left”]…a long narrow band of dark reddish discoloration which is somewhat darker than the rest of the myocardium, extends over a length of 6 cm and has a width of 0.4 cm extending from the anterior base of the heart almost to the apex. ..this lesion is limited to the anterior free wall. Both lungs are extremely heavy. The lung parenchyma is dark-purple-red and completely soaked with edema fluid and blood. Microscopically, a localized lesion was found in the left ventricle of the heart.
The Decedent died of myocarditis, which apparently was completely asymptomatic. By histology, the disease had been present for at least several days or weeks. The cause is unknown.[/infobox]
So, the medical examiner, someone who actually trained in determining cause of death, when they can, said it was caused by myocarditis.
Myocarditis is an inflammation of the heart muscle, caused usually by an infection. There are many signs and symptoms of the disease, some of which are obvious, such as arrhythmias, and some so nonspecific that they are probably ignored by an outwardly healthy young man. Some symptoms could even be confused for the flu.
Many times the disease is asymptomatic for a long period of time, occasionally leading to sudden death. Surprisingly, myocarditis is the cause of approximately 20% of sudden deaths in young adults.
In other words, the simplest and best explanation of his death is an underlying myocarditis, which lead to a sudden myocardial infarction. And that’s not me claiming that, but an expert, someone who actually did the autopsy, a trained medical examiner.
The story should just end there, the myocardial infarction was almost certainly not related to the vaccine. But for the anti-vaccination cult, stories never just end, they go on with the lamest of evidence.
The lame evidence
A Southern California law firm took the case to present it to the NVICP, which is how the system should work to ascertain whether there is a vaccine-related injury. I have no problem with that.
The law firm then hired an “expert witness” to perform an independent examination of the medical examiner’s report. Further, the “expert witness” performed additional tests to “prove” that the HPV vaccine was responsible.
The expert witness, Sin Hang Lee, MD, F.R.C.P.(C), FCAP, Director Milford Molecular Diagnostics Laboratory, has an interesting background. He’s done significant research into Lyme disease, and, as far as I can tell, has not fallen into the black hole called “chronic Lyme disease,” a malady that lacks any supporting evidence. However, his DNA testing for Lyme disease bacterium, Borrelia burgdorferi and and Borrelia miyamotoi, seems to be based on his own research rather than a broad base of clinical research. I might look into his Lyme disease research at a later time, but Lyme disease is not the point of this article.
Dr. Lee has written several articles about HPV and DNA testing. Of those published articles, only two are specifically about Gardasil and his testing procedures. The first one attempts to claim that the HPV fragments in the vaccine bind to the aluminum adjuvant. If this were true, it really has no meaning, since the amount is biologically unimportant, and is cleared quickly. Moreover, the study is published in a minor journal with a low impact factor, and his “research” has not been cited or repeated by anyone in the last two years. It’s difficult for me to see clinical significance of his research.
His second article, also published in a low impact journal, is very similar to the article discussed above. It has not been repeated, but has been used by anti-vaccination researchers as “evidence” that, without any biological plausibility, somehow the antigen-aluminum complex has some clinical importance. Which, of course, has never been shown, but that’s how these people roll.
But there are bigger issues. Neither of those papers give us a detailed description of how these tests are done, and how he got the results. There are some pretty graphs, but no controls, no anything that would provide the reader with the methods behind his results. This probably is why it’s not been repeated.
Dr. Lee makes an incredible claim that,
[infobox icon=”quote-left”]Natural HPV DNA does not remain in the bloodstream for very long. However, the HPV DNA in Gardasil is not ‘natural’ DNA. It is a recombinant HPV DNA (rDNA) – genetically engineered – to be inserted into yeast cells for VLP (virus-like-particle) protein production. rDNA is known to behave differently from natural DNA. It may enter a human cell, especially in an inflammatory lesion caused by the effects of the aluminum adjuvant, via poorly understood mechanisms.
Once a segment of recombinant DNA is inserted into a human cell, the consequences are hard to predict. It may be in the cell temporarily or stay there forever, with or without causing a mutation. Now the host cell contains human DNA as well as genetically engineered viral DNA.[/infobox]
I’m sorry, but that’s utter bullshit (oh, I mean nonsense, ignorant nonsense). If Dr. Lee actually knew anything about DNA, he would understand that it is incredibly difficult to insert DNA into human cells just from the blood. If it were so easy, gene therapy would be a miracle medical treatment today. But there’s that issue that we eat DNA all day long, and it never gets inserted into human DNA.
More than that, the HPV antigen used is…hold on…a protein. And unless somehow I missed something in biochemistry during my undergraduate and graduate education proteins are not DNA.
But it gets worse. The mysterious purveyor of real science, Orac, closely examined Lee’s DNA work, and found it wanting. For example, Orac pointed out that Lee found only one fragment of the rDNA sequence. That would be incredible, except if the whole sequence contaminated the vaccine, then Lee should have found hundreds, if not thousands, of different fragments. It stretches the imagination to think that one tiny fragment was the ONLY contamination.
All of these claims are so ridiculous that I can’t believe I’m wasting a nanosecond in refuting it. I guess he took his cue from the ridiculous pseudoscience foisted on us by the anti-GMO crowd.
So the whole basis of his “Danger Will Robinson” attitude about HPV recombinant DNA fragment being attached to aluminum is utter nonsense. It frustrates me how so called scientists want to oversimplify very complex ideas so that it fits their narrative.
But there’s more. Dr. Lee is associated with SANEVax, possibly one of the most irresponsible anti-vaccination groups on this planet (and there are so many choices). And they have been pushing this HPV DNA trope for at least 5 years. If Dr. Lee were really an expert in HPV DNA, he’d disassociate himself from INSANEVax, run large scale clinical trials, and then publish peer reviewed articles that establish a correlation, along with biological causation between something and this DNA observation.
Let me make this simple – until Dr. Lee actually shows us his results, his methods, and someone else repeats his results, no credible scientist is going to accept his SANEVax claims. They just don’t qualify as good science.
Refuting Dr. Lee’s refuting of ME report
But back to case of Joel Gomez. Dr. Lee makes several claims, based on really limited evidence:
- Gardasil causes hypotension. No it doesn’t. And relying upon the package insert is amateurish at best, deceitful at worse. Package inserts do not establish causality.
- Molecular mechanism of Gardasil-induced hypotension and sudden unexpected death. Once again, he bases his claims on unproven claims about the aluminum adjuvant. It’s like he took his wild beliefs right out of the anti-vaccination playbook. The whole aluminum “manufactroversy” has been debunked. And where is the scientific consensus about Dr. Lee’s claims? Why is it that no other immunologist, virologist, epidemiologist has observed this? And taking quotes out of context from the CDC and a package insert is amusing.
- Gardasil vaccination was the most likely cause of the decedent’s death. This is the crux of the matter. Dr. Lee disputes the conclusions of a well-trained medical examiner (Dr. Lee is NOT a medical examiner by training), without first-hand observation. Dr. Lee utterly dismisses the presence of observations of pre-existing myocardial infarctions, long before the vaccine was delivered. Yes, some myocardial infarctions can be tolerated, especially in a child – if the underlying cause is ignored, then causes a fatal and sudden death, we’re supposed to overlook the evidence that Joel Gomez might have had a lingering case of myocarditis. Especially when there’s evidence of that myocarditis?
I am not a medical examiner, nor do I play one on TV. And his analysis probably would be close to one I’d see on TV.
Gardasil DNA and aluminum – TL;DR
- The Los Angeles County medical examiner, who actually did the autopsy, found that Joel Gomez had an underlying and undiagnosed case of myocarditis.
- Myocarditis can lead to sudden death in teens and young adults. In fact, 20% of cases of sudden death in that age group is related to myocarditis.
- Myocarditis is generally caused by an infectious diseases. There is NO published evidence that it’s related to any vaccination, especially HPV.
- Dr. Lee’s hypothesis that some HPV DNA particle links to aluminum lacks two things: repetition by another, independent, researcher, and clinical importance. Who cares if the DNA is linked to aluminum, it’s just using big words to scare us. Unless someone says “hey this is why we are concerned, and here’s 2000 data points from a double blind, randomized clinical trial,” this barely rises to the level of observation.
- Dr. Lee is supported by SANEVax, a notorious anti-vaccine gang. This, itself, doesn’t negate Dr. Lee’s work, but when added to his biases and lack of clinical research, it does point me in a direction of “this doesn’t smell right.”
SANEVax and Dr. Lee have been in bed together for a long time. David Gorski took on this nonsense 5 years ago (please read the article, it goes into more detail about Dr. Lee’s nonsense about HPV DNA). And here’s what Dr. Gorski had to say about HPV DNA and aluminum:
[infobox icon=”quote-left”]Wow. Sounds pretty scary, doesn’t it? Actual HPV DNA! But not just any HPV DNA. Oh, no. We’re talking recombinant HPV-11 and HPV-18 residues, which–horror of horrors!–were attached to the dreaded aluminum adjuvant! Stop the factories! Stop injecting our little girls with that evil vaccine whose only purpose is to encourage them to go out and have unprotected sex, knowing that they won’t get HPV!
Now hold on just a minute. I got a little carried away.[/infobox]
Snark and sarcasm. Makes my day.
It’s not up to me to determine if Dr. Lee’s “review” has the authority of an expert witness. The Special Masters will do that, and they might bring in better trained experts to refute the claims. My guess is that the Special Masters are going to question Dr. Lee’s credentials and “research.”
And once again, a laughable anti-vaccination claim bites the dust.
- Eckart RE, Scoville SL, Campbell CL, Shry EA, Stajduhar KC, Potter RN, Pearse LA, Virmani R. Sudden death in young adults: a 25-year review of autopsies in military recruits. Ann Intern Med. 2004 Dec 7;141(11):829-34. PubMed PMID: 15583223.
- Lee SH, Vigliotti JS, Vigliotti VS, Jones W, Moorcroft TA, Lantsman K. DNA sequencing diagnosis of off-season spirochetemia with low bacterial density in Borrelia burgdorferi and Borrelia miyamotoi infections. Int J Mol Sci. 2014 Jun 25;15(7):11364-86. doi: 10.3390/ijms150711364. PubMed PMID: 24968274; PubMed Central PMCID: PMC4139787.
- Lee SH. Melting profiles may affect detection of residual HPV L1 gene DNA fragments in Gardasil®. Curr Med Chem. 2014 Mar;21(7):932-40. PubMed PMID: 24083601.
- Lee SH. Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil. J Inorg Biochem. 2012 Dec;117:85-92. doi: 10.1016/j.jinorgbio.2012.08.015. Epub 2012 Aug 30. PubMed PMID: 23078778.
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