Vaccination: response to article in “the Atlantic”

I became intrigued by discussions about an article in “The Atlantic” which detailed the ongoing negative depiction of folks who question vaccination(s) as a medical strategy.  The first paragraph of the article depicted results from court case where religious fringe anti-medical zealots were held liable for causing the death of their diabetic daughter by witholding vaccinations and medical treatment.  By extension then, the article depicted a well known celebrity, Jenny McCarthy, who had withheld further vaccinations from her autistic son, as someone who should not be on TV or hold some ‘responsible reporting job ‘ on a reasonably well known TV show.  The reasoning became that this provides the celebrity a highly visible platform from which to spout some seemingly unscientific or dangerous rhetoric.  Barbara Lowe Fisher weighed in with an appropriate defense of McCarthy with some first rate vaccine statistics, solid references and a good synopsis of the recent history/court settlements/etc of vaccine-caused adverse events.

First of all, in this day and age, although I am hard pressed to take much of anything that a celebrity says about any subject with much more than a grain of salt, I thought that McCarthy has been right about her right and purview to morally and ethically question “this $126 billion dollar a year^citation public health disaster doctors call autism but still can’t agree on how to define it or how often it happens”.  The fact that journalists and the medical establishment seem to engage in a high tech witch hunt is deplorable, IMHO.

 Further, I long ago realized, discovered and evaluated that much of the ‘science’ which medical / research community produces also requires a good deal of critical evaluation and understanding in order to understand properly and put in dynamic context.  Despite what the medical community might have us believe about vaccinations, there’s considerable evidence to the contrary about the necessity for the number and breadth of vaccinations given to children and adults today. Some of the reasoning was laid out nearly 30 years previously by Moskowitz.  The fundamental question remains: if vaccines are so safe, please explain why the US government has been settling lawsuits about vaccine-caused injuries for the last 20 years. 

CBS News has found that since 1988, the vaccine court has awarded money judgments, often in the millions of dollars, to thirteen hundred and twenty two families whose children suffered brain damage from vaccines. In many … cases, the government paid out awards following a judicial finding that vaccine injury lead to the child’s autism spectrum disorder. In each of these cases, the plaintiffs’ attorneys made the same tactical decision made by Bailey Bank’s lawyer, electing to opt out of the highly charged Omnibus Autism Proceedings and argue their autism cases in the regular vaccine court. In many other successful cases, attorneys elected to steer clear of the hot button autism issue altogether and seek recovery instead for the underlying brain damage that caused their client’s autism.”: [Vaccine Court: Autism Debate Continues – Robert F. Kennedy, Jr. and David Kirby Huffington Post 24 Feb 2009] 

Because of contrary evidence about vaccine safety and vaccination against rather benign pathogens (ie, measles, mumps and rubella), many vaccine-related reports or studies require additional papers or citations to digest, criticisms and supporting evidence to evaluate, and a careful weighing of the scientific facts or validity for each study.  The fundamental intellectual laziness and blind acceptance on the part of the public to accept oftimes flawed research as gospel or the strident promptings of the medical community to vaccinate  at all costs remains, frankly galling.  Finally, the science that vaccine supporters want has been deconstructed to reveal the lack of robustness, flawed design, and fundamental duplicetousness- links to peer reviewdd articles are provided in the body of the blog report.

The Atlantic article cites a CDC report by Stefano (CDC DeStefano 2013 link, http://jpeds.com/webfiles/images/journals/ympd/JPEDSDeStefano.pdf )

A number of comments and critiques about the DeStefano study have been written:
cdc report  http://vran.org/in-the-news/cdc-autism-studies-flawed/
Basis for DeStefano CDC article:  Price et al 2010 link http://pediatrics.aappublications.org/content/126/4/656.long
  Price 2009 grey literature articles (link vol I) and (link vol II) [methodology outlined]

Comments about the studies are interesting. Alberto Tommasini MD and Aldo  Scabar were supportive, saying, “Environmental factors such as vaccines or some foods, which  are produced by human activity, are often perceived as non-natural. Large epidemiological studies  are very important to demonstrate the safety of these human interventions”. But pharmacologist,  Richard Deth and Edward Calabrese of the U of Massachusetts addressed the finding that “an  increase in ethylmercury exposure…was associated with decreased risk of each of the 3 ASD  outcomes [ASD, autistic disorder, and ASD with regression].” They advised, “the findings of this  study strongly suggest a hormetic response to thimerosal…Hormesis is a dose-response phenomenon  characterized by low-dose stimulation and high-dose inhibition…exposure to a toxin such as ethylmercury  might lead to a protective hormetic response in most individuals, but this response would be less  robust or absent in other individuals, increasing their risk.”

 Moreover, Raymond Palmer of U of Texas  Health Science Center was “disappointed that the conclusions put forth by the authors did not mention  the important caveat that the case-control design they used, would not be sufficient to investigate the  prevailing consensus of GxE [gene/environment interaction] in the development of ASD.” John Stone, father  of an autistic boy, groaned, “It is as if Sir Richard Doll had tried to lay the smoking controversy to rest  by concluding that, as not all smokers get lung cancer, smoking does not cause lung cancer… it is surprising that a study itself many years in the pipeline should be open to such basic criticisms.”  

The Price and DeStefano CDC studies failed to properly develop adequate controls for the studies: DeSoto & Hinjen chapter (2013) on Price et al 2010 http://cdn.intechopen.com/pdfs/41866/InTech-Vaccine_safety_study_as_an_interesti ng_case_of_over_matching_.pdf
 This article outlines how the CDC studies (Price in 2009 & 2010, and DeStefano, 2013) were fundamentally flawed,  unusually biased towards finding no relationship between vaccination and autism and basically was uninformative  towards providing any insight towards answering the basic question of “vaccine-caused autism”.  The reason that  all three studies (Price and Stefano) are mentioned by DeSoto relates to the fact they used the same data sets  and flawed collection/screening methodologies.

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Hooker Criticism of DeStefano et al study Critique of Destefano et al. 2013 J Peds. Study By Brian S. Hooker, Ph.D., P.E. in: http://healthimpactnews.com/2013/can-we-trust-the-cdc-claim-that-there-is-no-lin k-between-vaccines-and-autism/   The recent CDC study “Increasing Exposure to Antibody-Stimulating Proteins and Polysaccharides in Vaccines Is Not Associated with Risk of Autism” by Destefano et al. 2013 was released in the Journal of Pediatrics last week.  This study purports that “increasing exposure to antibody-stimulating proteins and polysaccharides in vaccines during the first 2 years of life was not related to the risk of developing an ASD (Autism Spectrum Disorder).”  Of all of the papers I have reviewed over my 26-year career as a research scientist, this is perhaps the most flawed and disingenuous study I have encountered.  The Destefano et al. 2013 study is to science what the movie Ishtar was to cinema.
  No New Data The basis for the study is essentially a rehash of the data that was used to generate the fraudulent Price et al.  2010 Pediatrics study.  This research, (Price et al. 2010 “Prenatal and Infant Exposure to Thimerosal From  Vaccines and Immunoglobulins and Risk of Autism” Pediatrics 126:656) was supposed to be the CDC’s “final  word” stating that thimerosal, the mercury-containing preservative in some vaccines, was in no way causally  linked to autism. 

Not only was this original study fatally flawed due to a statistical error called “overmatching”  but also the study authors hid data regarding the only valid part of the study (i.e., prenatal thimerosal exposure)  which showed that children exposed to just 16 microgram mercury in thimerosal in utero were up to 8 times more  likely to receive a diagnosis of regressive autism (Price C, et al.Thimerosal and Autism. Technical report.  Vol I. Bethesda, MD: Abt Associates Inc; 2009). The study authors instead falsely reported no risk of autism associated with prenatal thimerosal exposure.

No True Controls in the Study
Within the Destefano study released last week, with the help of multimillionaire vaccine industrialist Dr. Paul  Offit, CDC researchers merely added up the number of vaccine antigens that the case (autism) and control  (neurotypical) children were exposed to through the infant vaccination schedule.  The theory that they were  trying to refute essentially was “children exposed to a greater total number of antigens had a greater risk of  autism.”

 Given this train wreck of a study, it is very difficult to know where to start my critique. However, the following statement stood out from the rest as the study authors described the control group:  “    Of the remaining 752 controls included in the analysis, 186 had an SCQ (Social Communication Questionaire) score <16 but had indications of speech delay or language delay, learning disability, attention deficit hyperactivity disorder or attention deficit disorder, or tics, or had an individual education plan.  This clearly shows that the 186 aforementioned controls (25% of the control group) were not controls at all but instead had some underlying developmental deficit (all of which are features of autism or autism spectrum disorder).  Unlike the study design described (i.e., where autism cases were matched to neurotypical controls), autism cases were matched with “cases” of other, similar neurodevelopmental maladies.  Thus, you would expect to see no difference between the two groups.  

Antigen Correlation is Meaningless
  Next, the basis of the study was to confirm or deny a correlation between the “number of antigens received”  and the incidence of autism.  The possible number of antigens per given vaccine was reported in Table 1 of  the study.  However, the term “number of antigens” is a complete white-wash of what is actually in these vaccines,  their concentrations and their relative strengths in terms of inflammatory response, and is not an accurate predictor  of how the body will respond to specific antigens.  For example, “antigens” for the five antigen DTaP vaccines (e.g., Infanrix) include diphtheria toxoid, tetanus  toxoid, pertussis toxoid, filamentous hemagglutinin and pertactin.  The number “5” assigned in this category is  merely the number of different antigens and doesn’t account for each antigen’s amount or relative strength. Neither does this account for the fact that Infanrix also contains aluminum (an adjuvant – designed to elicit a  non-specific immune response), formaldehyde and polysorbate 80, all which could also elicit some form of  inflammatory reaction.  Thus, the main “independent” variable of “number of antigens” within the Destefano et al.  2013 study is essentially completely meaningless.

High Participant Refusal Rate Creates Selection Bias     The high participant refusal rate in this study is also problematic.  Out of 668 cases and 2444 controls originally  selected for the study, only 321 cases (48.1%) and 774 controls (31.7%) chose to participate in the research.   In other words, 65% of the individuals contacted as potential participants flat-out refused to participate in the study.  Who could blame them?!  The CDC has been producing junk science regarding vaccines and autism since 2002  and the public knows.  This indeed could produce selection bias in that  the 35% of individuals that did participate  were less likely to believe that vaccines were responsible for neurodevelopmental sequelae including autism.       

Overmatching Statistical Error   Also, the analysis is plagued with a statistical error called “overmatching.”  For a comprehensive analysis of the previous CDC study completed on the same data set  (Price et al. 2010 Pediatrics), regarding thimerosal exposure rather than the number of vaccine antigens, please see Chapter 6, “Vaccine Safety Study as an Interesting Case of ‘Over-Matching’” by M. Catherine DeSoto and Robert Hitlan
(http://www.intechopen.com/books/recent-advances-in-autism-spectrum-disorders-vol ume-i/vaccine-safety-study-as-an-interesting-case-of-over-matching-) 

in the book “Recent Advances in Autism Spectrum Disorders – Volume I”, edited by Michael Fitzgerald, ISBN 978-953-51-1021-7.
   The point made by Dr. DeSoto and Dr. Hitlan is that the cases and the controls in this study are too closely matched to each other.  Cases were matched with controls of the same age, sex, within the same HMO and essentially the same vaccination schedule using the same vaccine manufacturers.  This may be seen in Figures 1 and 2 of the Destefano et al. 2013 paper which indicated that there are almost no differences between the exposure to antigens between the case (autism) and control groups in every exposure group tested. This holds for cumulative antigen levels (Figure 1) as well as single day antigen exposure levels (Figure 2). 

              This type of error of course precludes “finding
a difference” between cases and controls because all differences were matched
out case-by-case.   This would be akin to analyzing radiation workers that
got the same dosage of gamma radiation within cases and control groups to
determine the relationship between gamma radiation and cancer incidence. 
Of course, since cases and controls got the same dosage, no effect would be
seen.  However, this is an unfair study.  To see the true effect,
cases would need to be matched with controls with variable levels of gamma
radiation exposure and perhaps a “no exposure” group would be included as a
baseline comparison to cancer rates within higher exposure groups.   In
the same way, the CDC study by Price et al (2009 & 2010), and DeStefano
(2013)[because they used the same data/methods]has used these overmatched data
to obfuscate any true effect between vaccine antigen exposure and autism
incidence.    

OREGON undervaccination study– Glanz et al 2013
http://archpedi.jamanetwork.com/article.aspx?articleID=1558057#qundefined
Glanz et al in the Journal of the American Medical Association (Pediatrics discipline) which states that “children who were undervaccinated because of parental choice had lower rates of outpatient visits and emergency department encounters than age-appropriately vaccinated children.”

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One of the ongoing criticisms about vaccination has been the drumbeat mantra that the ‘science’ is lacking.  With the above paragraphs and peer-reviewed articles, it should be clear or self-evident that a significant amount of evidence exists for questioning the efficacy and reliability for large scale public vaccinations as a public health strategy.  Further, there exists more than a century of data (http://childhealthsafety.wordpress.com/graphs/) which have been collated from existing articles, disease statistics websites, and talks (Rosling).  Further, Blaylock wrote an article showing potential dangers from excess vaccinations and the likely immune/neurological responses? Blaylock 2008 article with 105 references.  

Finally, there remains a good deal of skepticism within the developing world about Western Medicine, vaccinations, and disease.  The refusal by states within Northern Nigeria, Pakistan and India to allow polio eradication programs and large scale vaccination efforts requires some understanding.  Primarily, the refusal had more to do with an abject misconceptions about health care implementation, sociopolitical dynamics, and outright deceit by Western Powers to enforce the programs.  The latter reasons- a ruse concocted by the CIA to obtain Osama Bin Laden’s DNA to firmly establish his location before a targeted assassination operation has been documented to have done more harm to large scale, long term public health programs than good.