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Hilary's Desk

Ministry of Health seriously misled the Immunisation Select Committee

Hilary Butler - Wednesday, April 06, 2011

This is the first in a series of blogs on this topic. This one is a long blog but you need to read it very carefully.  You need to understand exactly how the information provided by the MOH to Dr Hutchison is so misleading and the implications of that for the whole debate. 

In December 2010, the Ministry of Health (MOH) replied to other submitters, and my written and oral presentation of March and June 2010, in which I stated that there had never been a scientifically valid vaccinated unvaccinated study.  On page 42 of their 102 page submission, the MOH stated:  A recently published study showed that vaccinating children on time (according to the immunisation schedule) during infancy had no effect on neuropsychological outcomes 7 to 10 years later, compared to children who had were vaccinated late or not at all (Smith and Woods 2010). The study used publicly available data on 1,047 children from the United States’ Vaccine Safety Datalink project, and analysed 42 neuropsychological outcomes. For some outcomes, vaccination on time was associated with better performance; no statistically significant differences favoured late or no vaccination.

The next paragraph said:

With respect to specific diseases, there are claims that atopy (the asthma, eczema and hay fever triad) is more common in children who are immunised than those who are not. There is conflicting evidence from a small number of studies on this topic. Many of the studies use sampling methods with a high probability of bias, such as parent recall in groups of parents who choose not to immunise their children. One of the largest and best conducted studies was a longitudinal cohort study of 167,240 children followed up prospectively (DeStefano 2002). In this group there was no evidence of a relationship between asthma and immunisation status.

This multiple asthma porkie will be dealt with in another blog, but note the highlighted portion above, about sampling methods with a high probability of bias

So let’s look at this Smith 2010 study which the MOH uses to counter my allegations.

If you just want a ten-second soundbite, here it is.

The Smith 2010 study is not valid science, because there were too many exclusions, and too few never vaccinated children. Furthermore, this study can't prove that vaccinated children were healthier than unvaccinated children, because as the authors admit, there were too few never vaccinated children to do the required analyses. 

If that's enough to convince you, then read no further.

But if you really want to understand exactly why this study cannot be seriously misrepresented the way the Ministry of Health did to the Parliamentary Select Committee, you will have to wade through the rest of this blog to understand EXACTLY why the Ministry of Health is wrong.

Here are extracts from a previous blog on this study:

Note the underlining where the study authors say;

 "This cohort did not have enough children who were fully unvaccinated in the first year of life to form robust estimates of neuropsychological outcomes as compared with children with other patterns of receipt.  This is an inherent limitation of any VSD-based study given the generally high immunization rates of children within the member health maintenance organizations." 

 But even more odd was this next sentence: "We did not attempt to control statistically for potential differences between completely unvaccinated children and those with later receipt."

Yet the Ministry of Health stated to the select committe in December 2010, that there were: “... no statistically significant differences favoured late or no vaccination.”

There were 9 (yes - NINE) never vaccinated children ('fully unvaccinated' is a stupid expression), compared with 1038 children, who were fully (early or late) vaccinated.

 

So just how “scientific” was this study?  It wasn’t for many reasons, two of which are below:

1)  The Smith 2010 study omitted the Boniferri adjustment, mentioned in a previous blog.

A community board contributor who appears to be in charge of undergraduate honors students at University, stated in her first post on a community board thread:

“I read the study quickly last night.

Two words: Bonferroni adjustment.”

Later in the same thread she explained:

“Basically, it means that when you run a lot of tests (like the 42+ they ran), you have to adjust the p-value to account for that. The p-value is typically set at .05, which means that for something (a difference between the 2 groups) to be accepted as statistically significant, the probability of that difference being due to chance is less than 5 in 100. Well, if you run 42+ tests, SOMEthing will come up significant, just because you've run that many tests. (and, with a p-value of .05, 5 tests out of 100 would come up significant, just due to chance). So, a Bonferroni adjustment, you divide the p-value by the number of tests you run.

.05/42 = .0011

None of their results would be significant if they had done a Bonferroni adjustment.

A good peer review should have stopped that paper right there. We make our undergraduate honors candidates use Bonferroni adjustments when they run more than 4 or 5 tests!

Although one might argue that it would still be publishable withOUT finding any differences between the lesser vaxed group and the most vaxed group, as this is the type of finding that the CDC would use as "evidence" that vaccines are "safe."

As the study stands now, the 2 groups - lesser-vaxed and more vaxed - were different on SES and mother's education (favoring the more vaxed group), and the differences on the neuropsy tests that favored the vaxed group all but disappeared when they statistically accounted for SES and income. The ONE difference that is left is the one they should not have accepted had they done a Bonferroni adjustment.

HOWEVER, the fact that the lesser-vaxed group had lower SES and lower mother's education means that it is NOT a good comparison group to the lesser-vaxed children of today.”

(underlining above, is mine) 

However, the lack of good solid "scientific evidence" doesn’t stop at just ignoring the Bonferroni adjustment.  

2)   The fundamental problem is gross selection bias in the study group itself, and extrapolating that “bias” to the great unselected, unwashed masses of children in the world, as did the MOH.... 

So, who were the children studied?

First up, the Smith 2010 study was simply a rework of the same CDC based population data from Thompson, Price, Goodson et al (2007).  

Thompson, Price, Goodson et al (2007) (pdf uploaded onto blog) said

“We enrolled 1047 children between the ages of 7 and 10 years and administered standardized tests assessing 42 neuropsychological outcomes. (We did not assess autism-spectrum disorders.)”

Smith and Woods (2010) (pdf uploaded onto blog) said:

“Publicly available data, including age at vaccination, from a previous VaccineSafety Datalink study of thimerosal exposure and 42 neuropsychological outcomes were analyzed.

In summary, these include assessments of speech and language, verbal memory, achievement, fine motor coordination, visuospatial ability, attention and executive-functioning tasks, behavior regulation, tics, and general intellectual functioning. (Page 1135.)

Easy.  That cuts down the research work.

 

 

So how was this same study population, which was used in both studies, selected?

  

 

 

Wouldn’t you want the Ministry of health, to know whether or not both the Thompson - and Smith study cohorts - had “sampling methods with a high probability of bias”?

The selection process for the group of children used in both the THOMPSON 2007and SMITH 2010 study cohort is contained in a technical pdf on the CDC website:  (pdf uploaded onto blog) 

On Page 1 Chapter one, (which is page 9 and 10 of the 179 page CDC pdf), we read this relating to the first THOMPSON 2007 study:

“The primary weakness of the current study is that exposure levels were not determined in a randomized controlled trial (RCT) design. Although the study measured and controlled for a wide range of potential confounders, it is impossible to know with certainty whether the threat of selection bias has been eliminated. Selection bias will have affected the results if one or more unmeasured factors have causal effects on both the amount of exposure that children receive, and outcome measures. Given this important limitation of the design of the study, results can only be judged as informative, not conclusive. The study was intended to be an important contribution to a growing literature regarding the possible effects of ethylmercury, and was not intended to be a definitive concluding statement of whether the ethylmercury in thimerosal-containing vaccine sand immune globulins does or does not cause harm.”

Okay, now move on to page 18, (page 26 in the pdf), where you see HOW these 1047 children eventually used in both studies were chosen: 

The sample frame included 27, 240 children, okay?

Of those 27, 240 children 7,982 were selected, okay?

Out of those 7,982 children 3,648 had records scrutinised, to see if they met the criteria to be included in the Thompson 2007 study.  Okay?

This is what the Thompson 2007 says about these children:

"Of 3648 children selected for recruitment, 1107 (30.3%) were tested. Among children who were not tested, 512 did not meet one or more of the eligibility criteria, 1026 could not be located, and 44 had scheduling difficulties; in addition, the mothers of 959 children declined to participate. Most of the mothers (68%) who declined to participate in the study and provided reasons for nonparticipation cited a lack of time; 13% reported distrust of or ambivalence toward research. Of the 1107 children who were tested, 60 were excluded from the final analysis for the following reasons: missing vaccination records, 1 child; missing prenatal records, 5; missing data regarding weight, 7; and discovery of an exclusionary medical condition during record abstraction, 47. Thus, 1047 children were included in the final analyses. The exposure distribution of the final sample was similar to the exposure distribution of the initial 3648 children selected for recruitment in the study.

Our study had several limitations. A majority of the selected families declined to participate or could not be located, and we were able to enroll only 30% of the subjects included for recruitment. Therefore, our findings may have been influenced by selection bias. In addition, we were not able to control for interventions, such as speech therapy, that may have ameliorated the potential negative effects of thimerosal exposure and could have biased the results toward the null hypothesis. Given that parents were not trained to assess tics, the parental ratings of tics may have been less reliable than the ratings by trained evaluators. We did not assess exposure to thimerosal beyond 214 days. Finally, the information available for some potential confounding factors, such as family income, which may have resulted in unmeasured residual confounding, was imprecise. Our study did not examine the possible association between autism and exposure to mercury from vaccines and immune globulins."

Page 18 (26 in the CDC technical pdf) lists these 60 excluded mentioned above, as:

Excluded (n=60)

1 – Year 1 care not in HMO;

24 low birth weight, (exclusionary Medical condition.)

7 no weight data,

5 No prenatal exposure data,

23 Exclusionary medical condition  (total 47 exclusionary medical condition.)

= 60 excluded.)

(The red above is added to match with the Thompson 2007 exclusionary criteria)

So.... 512 were eliminated because they didn’t meet the INCLUSION criteria.  After they got to 1,107 children, 60 more were excluded with 47 of those removed, because they had a medical condition listed in the EXCLUSION criteria. 

It also says  in the first appendix, that they found seven more children who were included in the study, but who were then excluded when it was found that they ALSO had one or another of the medical problems for which they were excluding kids.

Now, please go and  study pages 19 – 25 of the CDC technical report and READ the two Inclusion and Exclusion criteria LISTS very carefully.

This was the cohort used in BOTH studies.  

Supposedly "evidence-based scientists" removed a large proportion of people they would routinely vaccinate, thereby WEEDING OUT all child who already had a neurological or a history of other health problems, ...  which then leaves just super-healthy children to study. 

Those children tossed out and not studied, are the very children for whom the study vaccines are potentially the most dangerous.  And parents of these children are told routinely by doctors that their child needs these vaccines EVEN MORE than normal children. 

These are the very children they need to include, as part of a typical population, because THEY are the ones who will be most at risk for develop neurological issues following vaccines.  Most children with ASD or autistic disorders will also be removed under both inclusion and exclusion criteria,  which is why neither Thompson, nor Smith could effectively examine any possible association between autism or neurological disorders, with exposure to mercury from either vaccines or immunoglobulins.

So - Smith 2010, used Thompson 2007 cohort of 1047 "very healthy/ all sick children removed”, as well as the same test results taken from Thompson’s 42 tests. Of course, you will find nothing.  That was the purpose.  The desired end result just needed the right "method". 

All Smith 2010 did, was recrunch other numbers.

So let’s look more closely at these 1,047 children.

1,038 children were fully vaccinated, some early, some later.

NINE children had never been vaccinated.

Let’s look at these nine children.

 

 

 Page 1139 states: 

"In contrast, only 1 of the 9 children who had not received any vaccines resided in a single-parent household, and 6 had mothers with college degrees. This is consistent with a previous study that demonstrated that children who received no vaccines are more likely to come from affluent, well-educated families.5 This cohort did not have enough children who were fully unvaccinated in the first year of life to form robust estimates of neuropsychological outcomes as compared with children with other patterns of receipt. This is an inherent limitation of any VSD-based study given the  generally high immunization rates of children within the member health maintenance organizations.26 We did not attempt to control statistically for potential differences between completely unvaccinated children and those with late receipt.”

And yet, the Ministry of Health tells us no statistically significant differences favoured late or no vaccination.

Some might call this "misrepresentation". I'd prefer to call it as I see it... a blatant LIE.

Maybe the MOH submission writer didn't read the article and cohort selection process to see if it met the criteria for “science”.  Maybe they just assumed it would be "scientific"?

As the CDC technical document says:

Given this important limitation of the design of the study, results can only be judged as informative, not conclusive.

As we know, there is information and there is information.

No doubt, the MOH also presumed that no-one would bother to go and check up the facts for themselves.  Dr Hutchison certainly didn’t!  Why would he not believe the Ministry of Health?

However, I had checked these facts LONG ago.

***This study doesn’t and can’t prove that vaccinated children were healthier than unvaccinated children, because as the authors admit, there weren’t enough never vaccinated children to do the required analyses. ***

 

Here’s the crunch question:

 

Do any of you know of one supposedly "large" drug study in which a similar non-treatment “control”group of nine people, who couldn't be statistically analysed, would be considered “valid” science?

 

Why did the Ministry of Health not state that in the study there were only 9 never vaccinated children, and that the authors didn't attempt stastical analyses compared with the others?

 

 

What say?.... 

 

 

... we turned this around, and did a study of vaccinated and unvaccinated children,  ....

....and deliberately removed all the healthy children, leaving only the children excluded by the THOMPSON/SMITH inclusion and exclusion criteria, the sick ones?

.... and what say that using sick children only, we extrapolated those results to the whole of the rest of the world?

?????

 

 

If you or I even attempted to massage the composition of a study cohort in the way the CDC/Smith/Thompson did, we would be hung by the media and the MOH.

If we never used the Bonferroni adjustment, ---“peer reviewer”, and the MOH, would accuse us of being statistically ignorant - or worse. 

Yet according to the Ministry of Health, Smith 2010 is supposedly “evidence based science” ! ...

....  and was used to inform theParliamentary Select Committee that:

.... everyone who says there is no scientifically valid vaccinated/never vaccinated study doesn't know what they are talking about.

Presumably the MOH also consider that Thompson 2007, and Smith 2010 have no conflicts of interest either:

Thompson, Price, Goodson et al (2007):

Dr. Thompson reports being a former employee of Merck; Dr. Marcy, receiving consulting fees from Merck, Sanofi Pasteur, GlaxoSmithKline, and MedImmune; Dr. Jackson, receiving grant support from Wyeth, Sanofi Pasteur, GlaxoSmithKline, and Novartis, lecture fees from Sanofi Pasteur, and consulting fees from Wyeth and Abbott and serving as a consultant to the FDA Vaccines and Related Biological Products Advisory Committee; Dr. Lieu, serving as a consultant to the CDC Advisory Committee on Immunization Practices; Dr. Black, receiving consulting fees from MedImmune, GlaxoSmithKline, Novartis, and Merck and grant support from MedImmune, GlaxoSmithKline, Aventis, Merck, and Novartis; and Dr. Davis receiving consulting fees from Merck and grant support from Merck and GlaxoSmith-Kline. No other potential conflict of interest relevant to this article was reported. 

 

Smith and Woods (2010):

Drs Smith and Woods are or have been unfunded subinvestigators for cross-coverage purposes on vaccine clinical trials for which their colleagues receive funding from Wyeth, Sanofi Pasteur, GSK, MedImmune, and Novartis; and Dr Woods has received honoraria for speaking engagements from Merck, Sanofi Pasteur, Pfizer, and MedImmune and has received research funding from Wyeth and Sanofi Pasteur.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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