Thursday, November 30, 2017

Christopher Exley has Become the New Face of the Anti-Vaxx Aluminium Grift

A new study by Mold et al. Aluminium in brain tissue in autism is not Exley's (corresponding author) first foray into aluminium as the cause of name-that-disorder by any stretch.  His publications vilify aluminium for a sundry of unrelated observations such as impaired sperm counts and quality, Alzheimer's Disease, "vaccine-induced" macrophagic myofaciitis and chronic fatigue syndrome along with fellow aluminium grifter Gherardi, breast cancer and of course vaccines.

The study Aluminium in brain tissue in autism is problematic from the start.  As Orac and The Blood-Brain Barrier Scientist note, Christopher Exley sits on the editorial board of the “Journal of Trace Elements in Medicine and Biology“ where the study was published.  The study also had an extremely rapid submission to acceptance time frame which was 26 October for submission, 21 November for a submitted revision, 23 November for acceptance and 26 November for online publication.  The sole funding source for this study was the Child Medical Safety Research Institute (CMSRI) which is a Dwoskin family foundation.  CMSRI is the funding source for the duo of Shaw and Tomljenovic to the tune of $900,000.00.  Clare Dwoskin is very very anti-vaccine which is evidenced by her statement to journalist John Stossel:
What his daughter went through is NOTHING compared to what the families of autistic children go through every day of their lives. No disease can match this record of human devastation. Vaccines are a holocaust of poison on our children’s brains and immune systems. Shame on you all.
More on what kind of "research" the Dwoskins finance can be found here and here.  The Dwoskins' latest study (prior to this one) with Christopher Shaw as the corresponding author was retracted due to image manipulation and dodgy methods.

While these issues individually don't disqualify the merits of a study, taken together they do cast serious doubt on the scientific rigour, review and impartiality of the study.  More importantly, the methods and results are the issues which ultimately render this study completely meaningless.

The thrust of this study is laid out in the abstract and introduction that state:
Human exposure to the environmental toxin aluminium has been linked, if tentatively, to autism spectrum disorder.
And
Paediatric vaccines that include an aluminium adjuvant are an indirect measure of infant exposure to aluminium and their burgeoning use has been directly correlated with increasing prevalence of ASD [11].
No it hasn't and is based upon some cherry-picked, weak studies.  The authors obtained five samples of brain tissue from people with confirmed autism spectrum disorder (ASD) for aluminium measurement.  They also obtained ten paraffin-embedded brain tissue samples from ASD individuals for fluorescent microscopy.

There were no controls.  Yes you read that correctly.  Not a single control for any aspect of this study; I'll elaborate.  The authors state:
Total aluminium was measured in each sample by transversely heated graphite furnace atomic absorption spectrometry (TH GFAAS) using matrix-matched standards and an established analytical programme alongside previously validated quality assurance data [13].
The "established analytical programme alongside previously validated quality assurance data" is their own protocol which is from these two studies, Brain burdens of aluminum, iron, and copper and their relationships with amyloid-β pathology in 60 human brains and The Identification of Aluminum in Human Brain Tissue Using Lumogallion and Fluorescence Microscopy.  I don't think validation means what they think it means.  This was internally-validated and not a recognised method for TH GFAAS by having been actually validated independently.

In the recent study two technical things (among many) stand out for the recently published "Aluminium in brain tissue in autism", first there was no mention of blanks used.  Granted it was an abbreviated description given the protracted version was explained in "Brain burdens of aluminum, iron and copper and their relationships with amyloid-β pathology in 60 human brains" (House, Exley et al. 2012), however there is no mention of an aluminium blank used to correct for contamination in either the body of the text nor in the description of Table 1 (Mold, Exley et al. 2017) where the values for aluminium content appear.  But this does appear in the cited study in both the body of the text and the description for it's Table 3 (House, Exley et al. 2012) aluminium content of brain samples.  It's worth mentioning that in the cited study (House, Exley et al. 2012), several samples have negative values and a high degree of intra-sample variation.  This is a problem with with their validation and they weakened this further by not including blanks in the autism study (Mold, Exley et al. 2017) as evidenced by the higher degree of intra-sample variation.

The second technical issue was the use of mean in the aluminium autism study.  Exley stated in his own cited brain aluminium study that due to non-normal distribution of intra-sample values, median with standard deviation was calculated.  This is correct but this was not done for the autism aluminium study, instead they used mean with standard deviation which skewed the means much higher because the outlier values were captured.  These values are further meaningless since the standard deviations are higher than the mean values for 3 of the four lobes sampled.
The mean (SD) aluminium content across all 5 individuals for each lobe were 3.82(5.42), 2.30(2.00), 2.79(4.05) and 3.82(5.17) μg/g dry wt. for the occipital, frontal, temporal and parietal lobes respectively.
Another huge problem for this study is both lack of controls and their own scale of pathology:
Previous measurements of brain aluminium, including our 60 brain study [15], have allowed us to define loose categories of brain aluminium content beginning with ≤1.00 μg/g dry wt. as pathologically benign (as opposed to ‘normal’). Approximately 40% of tissues (24/59) had an aluminium content considered as pathologically-concerning (≥2.00 μg/g dry wt.) while approximately 67% of these tissues had an aluminium content considered as pathologically- significant (≥3.00 μg/g dry wt.). The brains of all 5 individuals had at least one tissue with a pathologically-significant content of aluminium.
They cited The Identification of Aluminum in Human Brain Tissue Using Lumogallion and Fluorescence Microscopy (Mirza, Exley 2016) but it was not developed from samples of 60 brains; it was developed from multiple samples of one brain.  They rated the wildly variable observed aluminium levels in the Mold, Exley et al. 2017 study using a scale they developed in Mirza, Exley 2016 based on one single brain donation.  The authors must have a lot of contempt for their target audience and benefactors or are woefully inept to try and pass this stratification off as valid.  But more importantly, the results are meaningless because they did not include any controls, nor did they include any information on medical and dietary history nor causes of deaths of the individuals whose samples were donated.

The microscopy isn't any better.  There is no validation of the stain specificity nor control for contamination.  The Blood-Brain Barrier Scientist discusses the problems with the microscopy in detail.  Futhermore, they use Photoshop for visualising and enhancing images:
The subsequent merging of fluorescence and bright-field channels was achieved using Photoshop (Adobe Systems Inc. US).
This is not standard practice, in fact it's rather amateurish.  There are dedicated software packages available for fluorescent microscopes that track image capture and enhancements.  There is also no randomisation of microscopy sections nor blinding of the reader.  Presumably (or should be) there are several images taken and randomly selected for results discussion.  This was not done so for all we know, images are cherry-picked for maximum effect.  The fact that the microscopy suddenly had ten different samples (instead of the five previously noted) begs the question of IRB approval not to mention their Table S1 does not appear in the published study.

They make very far-reaching conclusions about their findings but fail to qualify any clinical relevance.  No histology was done so actual pathology of tissues samples is lacking.  The discussion is loaded with supposition with no evidence to support their claims.
A limitation of our study is the small number of cases that were available to study and the limited availability of tissue. Regarding the latter, having access to only 1g of frozen tissue and just 3 serial sections of fixed tissue per lobe would normally be perceived as a significant limitation. Certainly if we had not identified any significant deposits of aluminium in such a small (the average brain weighs between 1500 and 2000g) sample of brain tissue then such a finding would be equivocal. However, the fact that we found aluminium in every sample of brain tissue, frozen or fixed, does suggest very strongly that individuals with a diagnosis of ASD have extraordinarily high levels of aluminium in their brain tissue and that this aluminium is pre-eminently associated with non-neuronal cells including microglia and other inflammatory monocytes.
No the actual limitations of this study are the utter lack of controls, validation and rigour at every step of the way.  Non ASD people and with no pathology are going to also have aluminium deposits in their brain tissue.  Brain tissue banks are precious resources for neuroscience investigators.  It's a gross violation of the scientific method to be wasted on rubbish studies such as this to satisfy a rich matron with a hatred for vaccines.



Monday, April 17, 2017

Andrew Wakefield is the Anti-Vaxx Gift That Keeps Giving

The Minnesota Department of Health has confirmed that at least eight children have measles.  They are all between the ages of 1 year and 4 years old and NONE have been vaccinated against measles although they are age-eligible.  Seven of the eight children belong to the large Somali community in Hennepin County and six have been hospitalised.  There may be more cases given the low MMR vaccine uptake among those in that community and only one case could be traced to a contact.

Andrew Wakefield, professional fraud made at least three trips to the Minnesota Somali community between 2010 and 2011 to pimp his faux concern about autism and measles jabs.  The result was a 50% uptake in the MMR jab as of 2013.  Even before his visits, Wakefield's fraudulent 1998 study linking MMR jabs to autism and visits from other anti-vaxx groups impacted this community and decreased the MMR vaccine uptake from ~90% to 54% sparking an outbreak in 2011 after his visits there.

Andrew Wakefield promised this community he would investigate their autism rate; he never did.  Instead he convinced them to eschew vaccination and gave them measles outbreaks.  That's the Wakefield Touch.

Update 18 April 2017:  The Minnesota Department of Health has confirmed a ninth measles case in Hennepin County in an unvaccinated child.

Update 20 April 2017:  The Minnesota Department of Health has confirmed  eleven cases of measles in Hennepin County all in children ages 1-5 years old, nine confirmed in unvaccinated children and nine in the Somali community.

Update 22 April 2017:  The Minnesota Department of Health has confirmed twelve cases of measles in Hennepin County all in children under 5 years old and all unvaccinated.  The uptake of MMR in the Somali community there is 42% in children under the age of two years old.

Update 25 April 2017:  The Minnesota Department of Health has confirmed twenty cases of measles in Hennepin County now.  One child less than one year old has been infected and 50% of infected children have been hospitalised.  Sixteen children have been confirmed unvaccinated.

Update 27 April 2017:  The Minnesota Department of Health has confirmed 24 cases of measles in Hennepin County.  Twenty-three of the 24 cases have been confirmed UNVACCINATED.  All children infected are five years old and younger. It has been confirmed that NONE of the infected children were vaccinated, 50% have been hospitalised and the infected children are between 10 months and 5 years old.  The outbreak may have emanated from a daycare.

Update 1 May 2017:  The Minnesota Department of Health has confirmed 32 cases of measles, 30 in Hennepin County and has spread with one in Ramsey County and one in Stearns County.  Of the 32 measles cases, only one child has received a single MMR jab, all others are UNVACCINATED.

Update 5 May 2017:  The Minnesota Department of Health has confirmed 41 cases of measles which has spread to Crow Wing County involving another unvaccinated child.  The stats of this outbreak are:
• 1 involves an adult and the rest are children age 10 or younger
• 39 involve people who were not vaccinated against the disease
• 34 are from Minnesota's Somali community
The case previously reported from Stearns County was ruled out as measles with confirmatory testing.
Anti-vaxx groups continue to stoke unfounded fears of vaccines causing autism among the Somali community in Hennepin County.

Update 8 May 2017:  The Minnesota Department of Health has confirmed the measles outbreak is up to 48 cases.
  • 45 in Hennepin County
  • 2 in Ramsey County
  • 1 in Crow Wing County
  • 45 confirmed to be unvaccinated
  • 1 had 1 dose of MMR
  • 2 had 2 doses of MMR
  • 41 of the cases are Somali Minnesotan 
Update 11 May 2017:  The Minnesota Department of Health has confirmed the measles outbreak is up to 51 cases:
  • 47 confirmed to be unvaccinated
  • 1 had 1 dose of MMR
  • 2 had 2 doses of MMR
  • 1 case has unknown vaccination status
  • 48 in children (ages 0-17 years)
  • 3 cases in adults
  • 46 of the cases are Somali Minnesotan 
Update 15 May 2017:  The Minnesota Department of Health has confirmed the measles outbreak is up to 58 cases:
  • 49 in Hennepin County
  • 3 in Ramsey County
  • 4 in Crow Wing County
  • 2 in Le Sueur County
  • 55 confirmed to be unvaccinated
  • 1 had 1 dose of MMR
  • 2 had 2 doses of MMR
  • 55 in children (ages 0-17 years)
  • 3 cases in adults
  • 49 of the cases are Somali Minnesotan
Additionally, the cost of this outbreak is estimated to be ~$1 Million Dollars.

Update 22 May 2017:  The Minnesota Department of Health has confirmed the measles outbreak is up to 66 cases:
  • 56 in Hennepin County
  • 4 in Ramsey County
  • 4 in Crow Wing County
  • 2 in Le Sueur County
  • 62 confirmed to be unvaccinated
  • 1 had 1 dose of MMR
  • 3 had 2 doses of MMR
  • 63 in children (ages 0-17 years)
  • 3 cases in adults
  • 57 of the cases are Somali Minnesotan 
Update 2 June 2017:  The Minnesota Department of Health has confirmed the measles outbreak is up to 73 cases.
  • 64 in Hennepin County
  • 3 in Ramsey County
  • 4 in Crow Wing County
  • 2 in Le Sueur County
  • 68 confirmed to be unvaccinated
  • 2 had 1 dose of MMR
  • 3 had 2 doses of MMR
  • 70 in children (ages 0-17 years)
  • 3 cases in adults
  • 60 of the cases are Somali Minnesotan

Tuesday, January 10, 2017

Anti-Vaxxer Robert F. Kennedy, Jr. to Chair a Vaccine Commission

U.S. President-Elect Donald Trump has met with anti-vaxxer RFK, Jr. to solicit him for a committee on vaccine safety and research integrity.  Sadly but not surprisingly such an appointment is on par with Trump's other picks for cabinet positions (although this isn't a cabinet position).  RFK, Jr.'s monomania regarding thiomersal has been debunked by the scientific community repeatedly.  Which leads me to believe that failure on that front will lead RFK, Jr. to turn his sights on "too many too soon" which Trump fervently believes.

It is unclear whether Trump is unaware of the CDC's Immunization Safety Office and the Vaccine Safety Datalink or simply doing an end run around them because he can't exert any direct control over them.  In any event, Trump is feeding his own anti-vaxx proclivities at the U.S. taxpayers' expense. Ultimately it is doubtful that anything meaningful will emerge from such a committee but that doesn't mean that RFK, Jr. can't cause a lot of trouble, not to mention the new life which will be breathed into the anti-vaxx movement.  How long before Andrew Wakefield is announced as a co-chair or committee member?

RFK, Jr. admits in an interview with ScienceMag that he has no expertise in science and will place "science people and prominent Americans".
How many people will be on the commission?
A dozen people -- a mix between science people and prominent Americans.
Who will you ask to serve?
I couldn’t tell you. I just finished meeting with the President-elect an hour ago.
When you say “science people,” do you mean experts from the scientific establishment?
Prominent scientists.
Do you mean prominent vaccinologists who believe in the safety and efficacy of today’s vaccines?
We are going to look for people who have expertise in toxicology, epidemiology and in public health.
Do you have scientific training?
No.  My background is I’m an environmental lawyer.  I’m not a scientist. But I have an expertise, I would say in reading science and spotting junk science because that’s what I do with most of my time.

Translation: He is going to look for people who might know a little bit more on the subject of vaccinology who are just as anti-vaccine as he is to launch a performance art showing.  Somehow I suspect that RFK, Jr. and his future committee members aren't exactly qualified to evaluate the science coming out of the CDC.  If it wasn't for the momentary pain in the arse RFK, Jr. and his little band of anti-vaxx warriors will cause for hard-working ethical people, it would be rather entertaining.

I am going to choose to look at the bright side of this which is another Trump rock will be turned over and we will get to see who crawls out.  Just as foisting Breitbart into the spotlight emboldened racists and let us see who they really are, this committee will undoubtedly have the same effect by emboldening anti-vaxx politicians and others who have cravenly kept to the shadows on the subject.  We will get to see who they are and may they have the same backlash inflicted upon them as the racist, bigoted Breitbart fake news site has.

Had organisations such as the Centers for Disease Control, the American Medical Association and the American Academy of Pediatrics been more proactive and damning of anti-vaxx quack physicians and activities, perhaps the creation of a committee such as this would have been more politically unsavoury.  It's time for these organisations, physicians and scientists to step up and push back against pseudo-scientific claims and those who make them and stop relying upon lightning-rods like Dr. Offit to be the only one doing their dirty work for them.

Robert F. Kennedy, Jr., Andrew Wakefield, Dr. Bob Sears and all their other associates are inexpert has-beens and wannbes but that doesn't mean their activities haven't done substantial damage to public health and public trust in our healthcare agencies.  It's time for all of us who are interested in public health and the well-being of our children to send a clear, organised message to these anti-science predators that their meddling in affairs that are way over their heads will not be tolerated.