Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases

A study so fraudulent it inspired a 400 page New York Times bestseller for which CDC had no answer.

Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases

Thomas Verstraeten  1 , Robert L Davis, Frank DeStefano, Tracy A Lieu, Philip H Rhodes, Steven B Black, Henry Shinefield, Robert T Chen; Vaccine Safety Datalink Team

Abstract

Objective: To assess the possible toxicity of thimerosal-containing vaccines (TCVs) among infants.

Methods: A 2-phased retrospective cohort study was conducted using computerized health maintenance organization (HMO) databases. Phase I screened for associations between neurodevelopmental disorders and thimerosal exposure among 124 170 infants who were born during 1992 to 1999 at 2 HMOs (A and B). In phase II, the most common disorders associated with exposure in phase I were reevaluated among 16 717 children who were born during 1991 to 1997 in another HMO (C). Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 micro g of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life.

Results: In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.05-3.38). At HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13; 95% CI: 1.01-1.27) and 7 months (RR: 1.07; 95% CI: 1.01-1.13). In phase II at HMO C, no significant associations were found. In no analyses were significant increased risks found for autism or attention-deficit disorder.

Conclusions: No consistent significant associations were found between TCVs and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes. For resolving the conflicting findings, studies with uniform neurodevelopmental assessments of children with a range of cumulative thimerosal exposures are needed.

ERRATUM

Pediatrics (2004) 113 (1): 184. https://doi.org/10.1542/peds.113.1.184b

Connected Content

This is a correction to: Standards for Child and Adolescent Immunization Practices

Topics:

immunization,national vaccine advisory committee,vaccines

Two errors occurred in the article by the National Vaccine Advisory Committee, titled “Standards for Child and Adolescent Immunization Practices,” that was published in the October 2003 issue of Pediatrics (2003;112:958–963). On page 958, left column (first footnote), the National Vaccine Advisory Committee is based in Washington, DC. On page 963, left column (second paragraph of the “National Vaccine Advisory Committee (NVAC)” section), the correct affiliation for Peter R. Paradiso, PhD, is Wyeth Vaccines.

CDC – https://www.cdc.gov/autism/media/pdfs/cdcstudiesonvaccinesandautism-508.pdfWritten by the Centers for Disease Control, the federal agency in charge of the vaccine program. The lead author, Thomas Verstraeten, left to take a job with Glaxo SmithKline — a vaccine manufacturer — after the study was written and before it was published. The U.S. Congress later cited this as an ethical violation.

GENERATION ZERO
Thomas Verstraeten’s First Analyses of the Link Between Vaccine Mercury Exposure and the Risk of Diagnosis of Selected Neuro-Developmental Disorders Based on Data from the Vaccine Safety Datalink: November-December 1999


Safe Minds
September 2004
Generation Zero.ppt – 1 –
“THIMEROSAL ANALYSIS”
From: Verstraeten, Thomas
Sent: Monday, November 29, 1999 11:45 AM
To: ‘Robert Davis’
Cc: ‘Frank Destefano’
Subject: Thimerosal analysis
Hi Bob,
After running, re-thinking, re-running, re-thinking….for about two weeks
now I should touch base with you, I think, to see whether you can agree
with what I came up with so far. I’ll attach the SAS programs hoping you or
one of your statisticians can detect major flaws before I jump to conclusions.
I’ll try to structure my findings….
Thomas Verstraeten, M.D.
Generation Zero.ppt – 2 –
SUMMARY (I)
Between February 2000 and November 2003 Thomas Verstraeten and his supervisors at
the National Immunization Program produced four separate generations of an analysis
designed to assess the impact of vaccine mercury exposures on neuro-developmental
disorders in children. With each generation, elevated and statistically significant risks
were reduced and/or eliminated.
But before these four generations of report were produced, Verstraeten conducted an
earlier analysis of these issues in November and December of 1999. He never prepared
a formal report on this work, but statistical tables obtained by Safe Minds in a FOIA
request (and not previously analyzed) demonstrate large and statistically significant
mercury exposure effects that in many cases exceeded the findings of the later reports.
These “Generation Zero” analyses followed a straightforward methodology that was
relatively unaffected by biases applied later and was considerably more sensitive with
respect to detecting mercury exposure effects than the later reports.

Ginger Taylor, MS, Autism mom, 2005

I have been looking at these studies with two basic questions in mind:

Can this study be applied to entire population of children in the U.S. and thereby be useful for guidance in setting vaccine policy? If so, how?

Can I use this study to make a determination as to the safety of vaccinating my sons, one who is autistic and one who is neurotypical. If so, how?

I want to start first with what an epidemiological study is and what it can do.

Any question like this starts with case studies. Some one notices two things occurring together (smoking and lung cancer, vaccine reaction and autism) and they look at the plausibility of a relationship (smoke filling the lungs could cause damage, neurotoxic mercury in vaccines could cause brain damage).

Next they want to see if what they are observing in their setting could be happening else where and after conferring with associates and finding that others see the possibility of a link as well, they commission a large population study.

Epidemiological studies are limited in their use. They can be used to spot patterns and trends, but they can almost never be used to prove or disprove anything. They are one of the first stages of a medical inquiry and act as a divining rod to tell researchers where to start digging.

They are very vulnerable to confounders, because they are asking broad questions over huge numbers of people; so they should not be used to make definitive statements as much as to help researchers shape the next question that should be asked.

Those next questions are taken to smaller population studies (where confounders can be more easily controlled), lab studies (in vitro), and actual case studies (in vivo). The results of those studies, helps to further refine the questions being asked, which can be sent back up to large population studies, and so on, and so on until, (hopefully) the results of your epidemiological, in vitro and in vivo studies all line up like tumblers in a lock and the lock opens with one key.

This is not what we are seeing yet when we look at totality of autism/thimerosal research, as the IOM report shows. In fact the large epidemiological studies relied on for the conclusions in the report are at odds with other in vitro and in vivo research also in the report. The tumblers do not line up and therefore all of the research should be scrutinized to see what is throwing things off.

The scrutiny of the epidemiological studies has shown that they do not measure what they purport to measure, and even if they did, they cannot be applied in the way that they are being applied.

Your example of how epidemiological studies were used in the 50’s a nice example of how they can be used well and lead researchers to determine the source of a terrible illness like lung cancer, unfortunately it seems that what is going on today in this inquiry is a very different scenario.

What we know so far about autism tells us that it is not as straight forward as, smoke cigarettes get lung cancer. The thimerosal studies seem to have multiple confounders (genetic, environmental, etc) that cut into the reliability of epidemiological studies.

The two studies that are relied upon the most heavily are the Danish Study and the Verstraten Study. Both of these studies were designed and carried out very poorly and are being used very badly.

Here is why I treat them with such skepticism. (Quoting myself in part from an earlier post that responded to a piece by Dr. Laidler)

One of the problems that complicates the search for the causes and cures of autism is the assumption that it is a single disorder and that all cases are caused by the same thing. This is in contrast to a disease like AIDS in which all cases are brought on by the HIV virus.

What is diagnosed as ‘Autism’ is actually likely to be more than one physical syndrome. Because Autism is a DSM diagnosis and based solely on behavioral criteria, the diagnosis does not address the different sets of physical anomaly clusters that researchers are finding when they look at the biology of ‘autistic’ patients.

One research group has recently made a distinction between two types of autistic profiles. One, labeled complex autism and occurring in about 30% of autism cases, presents with smaller head size, greater chance of low IQ, lower rate of siblings with the disorder and seems to have close to a 1:1 ratio of occurrence between boys and girls.

The other, essential autism, presents with larger head size, few structural brain abnormalities and has a ratio of 7:1 boys to girls.

This is a huge confounder to any epidemiological study, even a well designed one, that looks at all cases of diagnosed autism with out differentiating between groups with different phenotypes.

In discussing research into the causes of autism (in this case the genetic cause), one of the researchers commented, “…Studies haven’t found anything because they’re looking at a big heterogeneous group — a mishmash of people with different etiologies,” Takahashi said.”

One could postulate that only the larger head size group displays autistic symptoms because of mercury poisoning, as mercury toxicity does not always present with impaired IQ; and because in vitro thimerosal toxicity studies preformed at the University of Kentucky showed that estrogen has a protective effect against, and testosterone exacerbates the damage of, ethlymercury as a neurotoxin.

In light of this new information it seems that a better question than, “is autism is caused by mercury toxicity” which is the question largely being asked in these epidemiological studies, would be, “are cases of mercury toxicity being misdiagnosed as autism”.

The answer to that question cannot be found in a large epidemiological study.

The authors of the the final IOM report on the thimerosal/autism relationship in 2004 stated themselves that the epidemiological research it was relying on to clear thimerosal as a cause of autism would not pick up on a sub-set of the population that was genetically vulnerable to mercury poisoning.

If that is the case, then how much more so to these studies fail to give us meaningful data if the children who may be mercury poisoned are members of two different subsets being confused with one another?

Since the working theory in biomedical treatment of autism is that many of the children diagnosed with autism are genetically vulnerable sub set who cannot excrete heavy metals, and since this treatment is bringing about successes in the abatement of many children’s autistic symptoms, does that not throw into question the use of these large scale studies to find the correlation between thimerosal and autism as easily as they would between smoking and cancer?

What causes further problems for people who want to use these studies to show that the case is closed on thimerosal and NDDs (as the conclusion in the IOM study does) is that these studies are not well designed and are very poorly applied.

The problems with the Verstraten study, the only epidemiological study that the CDC has done in the U.S. to examine the possible link between thimerosal containing vaccines and neurodevelopmental disorders, are severe. It is such a badly designed and executed study that I can hardly do it justice in a blog post.

I will try to do a quick review of my ‘distain’ for it, as I actually think the harshness of the term might apply to my attitude in this case.

Verstraten started with a nice, simple study. He had medical records of about 180,000 kids in California, a good sized sample. He broke them up into four main groups, kids who received no thimerosal, a little thimerosal, a moderate amount, and a high amount. He checked to see if the amount of thimerosal that they got, and when they got it (two months of age, six months of age, etc) corresponded to an increased risk for different types of neurodevelopmental disorders, and NDDs in general.

The study began in November of 1999 and was supposed to be finished in 4 months.

What he found was that the more thimerosal a child got, the higher their chance of an NDD, with children who got the highest doses had a huge risk of having a disorder, more than 600% in one case. He also found that the age at which it was administered determined the type of disorder that a child would develop.

Verstraten sent an email to another CDC employee, Dr. Davis, and said that no matter what he tried, could not make the relationship go away.

In December the two men, and additional researchers at the CDC, began to change the parameters of the study. When you do this, you are supposed to document all the changes and justify why they are needed to properly answer the question you are asking. They did not.

The changes they began to make to the statistical analysis of the study are now described by the CDC as “improvements”. How they could see some of these changes as improvements is unbelievable to me. Here are some of the changes:

They took the zero thimerosal group, and tucked them into the low thimerosal group. Now they only have three groups and in effect they have brought up the bottom, so the top does not seem as high.

That did not bring down the risk enough, so they decided to get rid of the no thimerosal group all together, so now you are only comparing the low, middle and high groups, bring up the bottom further.

They got rid of a catch all group of NDDs so the study no longer addressed the question, ‘does an increase thimerosal increase the risk of a neurodevelopmental disorder’. Now it only looked at each disorder separately.

Still not dampening the signal enough, the decided to go into and change some of the actual medical records of the patients they were studying. The CDC reports that these were correcting errors in patient records, but will not offer any proof of this claim, saying instead that the data that would confirm their claim was ‘lost’.

This brought the risk down, but still showed a link between thimerosal and NDDs, so they then started dropping children from the study. They used about 20 different ICD9 codes to exclude any child from the study that had almost any birth complication or whose mother had almost any pregnancy complication. This included serious problems like premature birth and birth defects, but went all the way down to moms who took an antibiotic while pregnant. In effect this removes from the study many children who are likely to go on to develop NDDs.

This is fine to do in your study if you want, but it renders it almost completely useless for application to vaccine policy. This policy covers all U.S. children, and lots and lots of those children were subject to pregnancy and birth complications.

This study now no longer applies to my children as both of my pregnancies had complications.

At this point it is safe to say that this study no longer addressed the question of whether or not an increase in the dose of thimerosal increases the chance of an NDD in American children. But the ‘improvements’ don’t stop there.

Many more people are given a chance to make suggestions, the Simpsonwood meeting was held, comments are made that the study never should have been done in the first place, and the research is further bastardized.

A stop date was put in place so that children who were initially diagnosed with something like a speech delay, were then always considered to be speech delayed, even if they went on to be diagnosed with a more serious disorder like full blown autism. This is important as a large number of kids diagnosed with autism at ages 3 and 4 are diagnosed with some milder developmental delay at 18 months or two years of age. Doctors don’t like giving the autism diagnosis early, and the state of California (where the study was done) won’t even formally evaluate children for autism, or diagnose it before the age of 3.

I live in California. My son was evaluated at 2 and found to have ‘speech delays’ and offered early start services. To all involved in his treatment, he was autistic, but he did not become officially “Autistic” according to the state and his own records until age 3. Chandler would not have been considered Autistic for the purposes of the Verstraeten study.

My favorite ‘improvement’ was to add into the study children who were only a year or so old at the cut off date of the study. No child is diagnosed with autism, or indeed much of anything, this early. They all could have gone on to be diagnosed with a neurodevelopmental disorder but in the Verstraeten study, they are all considered healthy and unaffected by thimerosal.

Even with all these shenanigans, they STILL could not completely get rid of the relationship between thimerosal and NDDs. They then employed a tactic that served to make their own findings in the study irrelevant.

They split the whole group up into two, one large one from one HMO and one smaller group from another HMO (I think it was around 16,000). The small group was now too small to be of any statistical power. They used that group to say that the results in the first group could not be replicated in the second.

Then they bought another database from an HMO in New England, which was odd because they already owned dozens of them at the cost of millions of dollars in tax payer money. The HMO had failed and was in receivership due in part to poor record keeping on out of date computers. The HMO also used their own diagnostic system that didn’t even implement ICD9 codes and the researchers used completely different parameters to study this database than they did in the first. They used this third group of only 12,000 or so patients, as yet another example of how they could not replicate the results of the first, large group, which they were now referring to as ‘the screening study’.

The 4 month study took 4 years and, in my opinion, came out looking like something akin to Frankenstein’s Monster.

This study does not offer a meaningful measure of anything and cannot be applied to any group that I can think of.

Add to this the fact Verstraten himself became an employee of Glaxo (currently being sued by parents of autistic children) half way through the study, which was not disclosed when the study was published, and it becomes easy to see why where the distain comes from.

When asked to justify all the changes and publish the data so that the study could be confirmed and replicated, the CDC repeated the claim that the original data was ‘lost’. A private contractor testified before congress that he had been ordered to destroy the data sets, “to insure patient confidentiality”. This is a violation of federal law and is what sparked the congressional investigation currently underway.

It is practice in the scientific community that if a study can not be confirmed or replicated, that it should be withdrawn. Despite parent requests for such action, the CDC stands by this study and refuses to pull it.

As a parent who is looking at this issue as hard as I can, I am upset that the IOM, who should know better, keeps calling these studies ‘well designed’ and has used them to show that the case is closed on thimerosal and autism.

Verstraeten himself says that the study is a ‘neutral study’ and does not find for or against thimerosal in the implication that it is involved with NDDs.

In grad school, in order to pass statistics we had to take studies and break them down, justifying if and how they could be used for us to make treatment decisions. The Institute of Medicine would have failed my 600 level stats courses.

ADDENDUM:

People have asked for citations. What hasn’t been referenced above can be found in David Kirby’s book, Evidence Of Harm as this post just attempts to squish his big fat book into a blog post.

Additional addendum:

Julie Gerberding was asked by Congress to defend Verstraeten and had to reply that it was a useless study.  She did so in secret, but the document was leaked by a congressional staffer.  Even though everyone knows it is garbage, Pediatrics has not retracted it, and some still claim it clears the vaccine/autism theory.  However CDC removed it from their list of research that refutes the theory in by the end of 2008 when news of the Congressional/CDC exchange went public.

14Studies.org

Fourteenstudies.org: Study Analysis

score
3		 “Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintance Organization Database”
Pediatrics, Thomas Verstraeten, MD (November 2003)

Headline:

A disaster. The most widely quoted study, and the only study ever done with American data on American children, reached a neutral conclusion, asked the wrong question, and the author left to join a vaccine company before its publication. And, the world’s most incriminating and public “secret meeting” calls the entire study into question. If this is the CDC’s best work, we’re all in trouble. Recently, the former CDC Director called this study “unhelpful and potentially misleading.”

Actual Question This Study Asked & Answered:

Q: Do children receiving more thimerosal in their vaccines have different neurological outcomes from children receiving less thimerosal in their vaccines?

A: Additional investigation is required, an answer could not be found. Nuetral outcome.

Did the study look at unvaccinated children?

No.

Conflict of Interest:

Written by the Centers for Disease Control, the federal agency in charge of the vaccine program. The lead author, Thomas Verstraeten, left to take a job with Glaxo SmithKline — a vaccine manufacturer — after the study was written and before it was published. The U.S. Congress later cited this as an ethical violation.

Ability to Generalize:

The study had a robust dataset, with more than 140,000 children analyzed. But, the original data has apparently been lost by the CDC, and the Vaccine Safety Datalink data that the CDC used is unavailable to other researchers, so its impossible to confirm using neutral researchers.

Post-Publication Criticism:

Extreme, the most of any study, including criticism from the study’s author for how the study has been mischaracterized in the media.

Scoring (Out of 40 possible points):

Asked the Right Question: 1

Ability to Generalize: 2

Conflict of Interest: 0

Post-Publication Criticism: 0

Total Score: 3

Choice Excerpt from the Study:

“The biological plausibility of the small doses of ethylmercury present in vaccines leading to increased risks of neurodevelopmental disorders is uncertain.”

Guest Critic #1: Julie Gerberding, Former Director of the CDC

CDC: Vaccine Study Design “Uninformative and Potentially Misleading” By David Kirby, The Huffington Post

Excerpt from this great article:

“CDC Director Dr. Julie Gerberding has delivered a potentially explosive report to the powerful House Appropriations Committee, in which she admits to a startling string of errors in the design and methods used in the CDC’s landmark 2003 study that found no link between mercury in vaccines and autism, ADHD, speech delay or tics.”

Guest Critic #2: Dr. Guest Critic: Dr. Mark Geier (re-printed from a letter published in Pediatrics)

Study Misses Link Between Thimerosal and Neurodevelopmental Disorders

Letter to the Editor:

The recent article, “Safety of Thimerosal-Containing Vaccines: A Two- Phased Study of Computerized Health Maintenance Organization Databases,” by Verstraeteten et al. [1], which failed to find a consistent association between thimerosal in childhood vaccines and neurodevelopmental disorders, has a number of issues that need to be further addressed.

First, the head author, Dr. Thomas Verstraeten, has for the past several years worked for GlaxoSmithKline, a vaccine manufacturer of thimerosal-containing vaccines. In addition, Nancy Pekarek, a company spokeswoman for GlaxoSmithKline, has written that Verstraeten, since leaving the Centers for Disease Control and Prevention (CDC), has worked as an adviser as the study was finalized and prepared for publication. Presently, GlaxoSmithKline, potentially, faces a large number of lawsuits on the very issue that the paper discusses.

Second, this very study was the topic of secrete-closed meetings between members of the CDC and other government organizations, as well as members of the vaccine manufacturers held at Simpsonwood, Georgia from 7-8 June 2000. The transcript of this meeting has been obtained under the Freedom of Information Act. This transcript reveals that the study initially found statistically significant dose-response effects between increasing doses of mercury from thimerosal-containing childhood vaccines and various types of neurodevelopmental disorders. The transcript documents that the data was real and statistically significant for many types of neurodevelopmental disorders, but that the meeting participants expressed that the data had to be “handled.” Despite, discussion about how to “handle” the data, some participants expressed concern that the work that had already been done would be obtained by others through the Freedom of Information Act. In this event, even if professional bodies expressed the opinion that there was no association between thimerosal and neurodevelopmental disorders, it was already too late to do anything. In addition, other participants expressed that the vaccine manufacturers were in a horrible position to be able to defend any lawsuits alleging a relationship between thimerosal and neurodevelopmental disorders, since no one would say with the available data that there was no relationship between thimerosal and neurodevelopmental disorders. Even Verstraeten, in an email following the Simpsonwood meeting, expressed surprise that the data was to be manipulated, stating that ones desire to disprove an unpleasant theory should not interfere with sound scientific methods to evaluate the relationship between thimerosal and neurodevelopmental disorders.

Third, there are also significant issues about the methods used to determine the mercury dose that children received from thimerosal- containing vaccines. The authors, in Table 1 of their manuscript, completely fail to mention that there were large numbers of thimerosal- free Diphtheria-Tetanus-acellular-Pertussis (DTaP) vaccines administered to children in the Health Management Organizations (HMOs) analyzed. Thimerosal-free DTaP vaccine has been produced by GlaxoSmithKline since 1997. We have personally analyzed the Vaccine Safety Datalink (VSD) database determining that approximately one-third of the children receiving DTaP in the VSD from 1997 through 2000 were immunized with this vaccine, and that the children received thimerosal-free DTaP vaccines in various combinations, with some receiving four doses of thimerosal-free DTaP, some receiving three doses of thimerosal free DTaP and one dose of thimerosal-containing DTaP, some receiving two doses with and two doses without thimerosal, some receiving three with and one without thimerosal, and some receiving all four doses of thimerosal-containing DTaP. In order to evaluate whether Verstraeteten et al., did or did not take this into account, we analyzed Table 1 from their study for the possible cumulative mercury exposures at the various ages of immunization. At one month, the possible mercury exposure was 12.5 micrograms of mercury according to the authors, which is appropriate because there was no potential thimerosal- free DTaP vaccine to take into account. At 2-3 months, the possible cumulative mercury exposure was 37.5-75 micrograms of mercury according to the authors. These potential possible cumulative mercury exposures could be generated by DTP and Hib vaccine separated or combined, or by thimerosal-free DTaP vaccine and Hib (i.e. both DTPH or thimerosal-free DTaP vaccine and Hib vaccine, resulted in children being exposed to 25 micrograms of mercury). At 5-6 months, the possible cumulative mercury exposure was 75 or 125 micrograms according to the authors. The fact that the authors only list these two potential possible cumulative mercury exposure doses show that the authors failed to take into account the thimerosal-free DTaP vaccine made by GlaxoSmithKline, since children receiving one thimerosal-containing DTaP followed by one thimerosal-free DTaP vaccine, in addition to their two doses of hepatitis B vaccine and two doses of Hib vaccine received 100 micrograms of mercury, a mercury dose not mentioned in the table. At 6-7 months, the possible cumulative mercury exposure was 112.5 micrograms of mercury or 187.5 micrograms of mercury according to the authors. These potential possible cumulative mercury exposures show overwhelmingly that there is a significant error in the study. The intermediate mercury values children were exposed to also included: two thimerosal-containing and one thimerosal-free DTaP vaccine, with three doses of hepatitis B vaccine and three doses of Hib vaccine, for a total of 162.5 micrograms of mercury; and two thimerosal-free DTaP and one thimerosal-containing DTaP vaccine, with three doses of hepatitis B vaccine and three doses of Hib vaccine, for a total of 137.5 micrograms of mercury. These calculations indicate that Verstraeteten et al. did not take thimerosal-free DTaP vaccine into account in their study, or if they did, then their paper, as it stands, is replete with inaccurate information.

Additionally, the fact that the VSD data contained large numbers of children who took thimerosal-free DTaP vaccine and large numbers of children who took thimerosal-containing DTaP vaccine allows a much more direct and powerful way to do the study by comparing these two groups, since this type of analysis would allow for overall evaluation of the effects of increasing doses of mercury from thimerosal in comparison to considerably lesser doses of mercury from thimerosal. We have done just such a study in VSD and found an association between increasing doses of thimerosal and neurodevelopmental disorders. We have previously epidemiologically examined the Vaccine Adverse Event Reporting System (VAERS) for children receiving thimerosal-containing DTaP vaccines in comparison to thimerosal-free DTaP vaccines and the US Department of Education dataset, and both showed an overall and dose-response statistically significant link between increasing doses of thimerosal and neurodevelopmental disorders [2-5]. It also has been observed that children with autism fail to excrete mercury in their hair and show large increases in the amount of mercury in their urine following chelation therapy in comparison to controls [6,7]. These finding are particularly troubling in light of the fact that many authors including Slikker [8] from the Food and Drug Administration have published that thimerosal crosses the blood-brain and placental barriers and results in appreciable mercury content in tissues including the brain, and because it has been shown by Baskin et al. [9] that micromolar concentrations of thimerosal are capable of causing significant damage to neurons. A recently published report from Northeastern University, the University of Nebraska, the USDA, and the Johns Hopkins University has found that thimerosal at picomolar concentrations is a potent neurotoxin since it inhibits the insulin growth factor-1 and the dopamine-stimulated methlyation synthase pathways providing a potential molecular mechanism of how the link between thimerosal in vaccines and neurodevelpmental disorders, reported in our studies, actually increased the incidence of autism and how thimerosal in vaccines through its interaction with the D4 receptor gene may even account for the increase in ADHD as well [10]. It also is in keeping with the many hundreds of peer-reviewed articles published over many decades and from many fields of medicine and science reporting on the harmful effects of thimerosal in humans, animals, isolated neurons, and other systems.

Fourth, there is also a significant issue regarding the inclusion of children who received whole-cell Diphtheria-Tetanus-Pertussis (DTP) vaccine and DTaP vaccine. The Institute of Medicine of the United States’ National Academy of Sciences has determined that the evidence is consistent with a causal relationship between whole-cell DTP vaccine and permanent brain damage [11, 12]. In addition, despite the claim by Verstraeteten et al. that encephalopathies following whole-cell DTP occur only rarely, and therefore, this would be unlikely to have influenced the results of the study, some authors, such as Strom [13] reported that 1 in 6,000 children developed a neurological reaction and 1 in 17,000 children died or were left with a permanent neurological defect, and Pollock and Morris [14] who reported that 1 in 8,500 children died or had a neurological disorder following whole-cell pertussis vaccination. Therefore, it is clear that the assumption by Verstraeteten et al. that whole-cell DTP vaccine would have limited effects upon the results of their study seems incorrect, but rather points to a serious confounder present in their study that makes evaluation of the effect of thimerosal more difficult to discern.

In conclusion, because of a number of very serious issues have been raised and the critical importance of the issue as to whether thimerosal causes neurodevelopmental disorders, we respectfully request that Verstraeten et al. consider withdrawing this study. In order to restore the badly damaged confidence in our much needed vaccine program, it is necessity that past errors be admitted, and that open investigations be conducted on vaccines issues. It is also essential that future vaccine decisions are made by physicians and scientists without even the appearance of conflicts of interest.

Dr. Mark R. Geier has been a consultant and expert witness in cases involving vaccine adverse reactions before the National Vaccine Injury Compensation Program and in civil litigation.

David A. Geier has been a consultant in cases involving vaccine adverse reactions before the National Vaccine Injury Compensation Program and in civil litigation.

Additional History:

This lengthy but thorough history was reprinted with permission from www.putchildrenfirst.org:

At 4:15 pm Eastern time on a Friday afternoon in July 1999, a joint statement by the AAP and Public Health Service was released to the press advising Americans that the amount of mercury in vaccines administered to children, through a preservative called Thimerosal, exceeded Federal Health guidelines. This statement did not reveal the amount of panic, backdoor negotiating, and concern federal health officials had been engaged in for the past few weeks, after the levels of mercury had been calculated by dumbfounded federal officials reviewing submissions from vaccine manufacturers responding to a broad FDA inquiry regarding mercury in consumer products. While this article from Pediatrics ultimately looks at the policy makers favorably, it does help explain how frenetic the process was.

How could July 1999 be the first time Federal Officials realized there was mercury in vaccines exceeding our own safety standards? There are many answers to this question. For some officials, this was the first time they had learned mercury was even in vaccines. Others clearly knew and had been concerned for some time, and at least one vaccine manufacturer realized the levels were high eight years earlier, in 1991.

Thimerosal was first used as a preservative in vaccines in the late 1930s, long before we understood the extreme neurotoxicity of mercury. As the FDA ratcheted up safety standards, Thimerosal was grandfathered through due to its history without ever having to undergo any safety testing. We may not be reading so much about Thimerosal today if the CDC hadn’t embarked upon an aggressive plan to add vaccines to the Recommended Childhood and Adolescent Immunization Schedule in the late 1980’s. In 1988, the Haemophilus Influenzae type B (Hib) vaccine was added to the schedule, followed by the Hepatitis B (HepB) vaccine in 1991. Together, these two vaccines added six shots to the schedule, and tripled the amount of mercury children born after 1991 received compared to the previous generation.

The joint statement above downplayed the risk of mercury injected in newborns, and it downplayed the degree to which mercury exceeded federal safety standards. Doing the simple math, a child following the recommend schedule and receiving vaccines at birth, 2 months, 4 months, and 6 months was receiving mercury in excess of the EPA safe standards by a factor of 36x, 120x, 77x, and 66x, respectively. That’s 120 times the safe Federal standard!! (See chart).

The start of the sharp increase in autism and other neurodevelopmental disorders matches the change in the vaccine schedule. In the 1980s the incidence of autism was somewhere between 1 in 10,000 and 1 in 5,000, today it is 1 in 150. (See chart).

“The Food and Drug Administration (FDA) Modernization Act of 1997 called for the FDA to review and assess the risk of all mercury containing food and drugs. In line with this review, U.S. vaccine manufacturers responded to a December 1998 and April 1999 FDA request to provide more detailed information about the thimerosal content of their preparations which include this compound as a preservative,” said the statement.

The Federal Health authorities were well aware of the potential damage their public announcement could cause to the National Immunization Program, and they did their best to downplay risks, slow down change, and avoid blame or liability. Perhaps most astonishing of all, there is still Thimerosal, at high levels, being injected in our children before their first birthday, 7 years after this joint statement was released.

“The number of dose related relationships [between mercury and autism] are linear and statistically significant. You can play with this all you want. They are linear. They are statistically significant.” – Dr. William Weil, American Academy of Pediatrics. Simpsonwood, GA, June 7, 2000

“The issue is that it is impossible, unethical to leave kids unimmunized, so you will never, ever resolve that issue [regarding the impact of mercury].” – Dr. Robert Chen, Chief of Vaccine Safety and Development, Centers For Disease Control, Simpsonwood, GA, June 7, 2000

“Forgive this personal comment, but I got called out at eight o’clock for an emergency call and my daughter-in-law delivered a son by c-section. Our first male in the line of the next generation and I do not want that grandson to get a Thimerosal containing vaccine until we know better what is going on. It will probably take a long time. In the meantime, and I know there are probably implications for this internationally, but in the meanwhile I think I want that grandson to only be given Thimerosal-free vaccines.” – Dr. Robert Johnson, Immunologist, University of Colorado, Simpsonwood, GA, June 7, 2000

“But there is now the point at which the research results have to be handled, and even if this committee decides that there is no association and that information gets out, the work has been done and through the freedom of information that will be taken by others and will be used in other ways beyond the control of this group. And I am very concerned about that as I suspect that it is already too late to do anything regardless of any professional body and what they sayÂ…My mandate as I sit here in this group is to make sure at the end of the day that 100,000,000 are immunized with DTP, Hepatitis B and if possible Hib, this year, next year and for many years to come, and that will have to be with thimerosal containing vaccines unless a miracle occurs and an alternative is found quickly and is tried and found to be safe.” – Dr. John Clements, World Health Organization, Simpsonwood, GA, June 7, 2000

Soon after the joint statement by the AAP and Public Health Service was released, all hell broke loose, and the CDC moved into damage control mode, where they remain today, seven years later. (Here’s a great article from the Hepatitis Control Report on the panic.) Parents of autistic children began to compare the symptoms of autism to the symptoms of mercury poisoning, and a feisty Congressman from Indiana with an autistic grandson, Dan Burton, started using his pulpit as head of the Committee on Government Reform to ask very tough questions. By August, two months after the joint statement, his committee was in a full-scale investigation of conflict in vaccine policy, which the CDC knew.

Shockingly, CDC received letters in July and September 1999 from Merck and SmithKline Beecham, respectively, letting CDC know that full production of Thimerosal-free vaccines for Hepatitis B and DTaP could be made available almost immediately. To SmithKline, CDC responded with a tepid letter thanking them for the offer, but not taking them up on it. Thimerosal would remain in the vaccines on the Childhood Immunization Schedule for three more years, into late 2002, before Thimerosal-free vaccines were finally available for all vaccines, as this letter from FDA to Congressman Dave Weldon demonstrates. CDC’s inexplicable complacency in the face of the July 1999 statement to switch over to Thimerosal-free vaccines was highlighted in this March 2006 article by Robert F. Kennedy, Jr in the Huffington Post.

As part of the FDA Modernization act that spurred the joint statement, FDA was required to commission the Institute of Medicine to review the impact of mercury in vaccines. The IOM’s study began in late 1999 with an expected publication date in 2001. For the CDC, the walls were starting to close in, particularly for the man responsible for both vaccine development and vaccine safety, Dr. Robert Chen. The knowledge of a looming IOM review spurred CDC to take matter into their own hands.

Soon after the AAP statement a young CDC epidemiologist, Dr. Thomas Verstraeten, was given the task of comparing neurodevelopmental outcomes of children exposed to Thimerosal using the CDC’s internal database, the Vaccine Safety Datalink (VSD). CDC hoped to run their own analysis, establish no relationship between Thimerosal and autism, give the analysis to the IOM, and close this chapter for good. By November of 1999, just 5 months after the joint statement, Dr. Verstraeten was in a near panic as the data he was analyzing was showing a clear, unassailable, ugly truth: there was a statistically significant relationship between the amount of mercury children were receiving through their vaccines and autism. No matter how he tried to run the numbers, he wrote, the association “just won’t go away.”

In June of 2000, six months after Dr. Verstraeten’s analysis revealed a clear correlation, the CDC commissioned a private meeting at the Simpsonwood Conference Center in Atlanta, GA, with representatives from the CDC, other health organization (WHO, FDA) and representatives of vaccine manufacturers to share some startling news: despite six full months of trying to dumb down the data, CDC’s analysis was still showing a statistically significant relationship between neurodevlopmental disorders, especially autism, and Thimerosal children received through their vaccines.

The Simpsonwood meeting set that stage for the way the CDC has conducted themselves ever since: control the damage, bury the data, and ensure that the National Immunization Program never misses a beat. The candor and incriminating statements of the Simpsonwood attendees is at times breathtaking, as some of the above quotes demonstrate, and a whole website could be devoted to analyzing the words of the participants. A great summary of the Simpsonwood meeting is available through this excellent article written by Dr. Russell Blaylock. The transcript from the meeting was stamped with the words “Do Not Copy or Release” and “Confidential”, but was obtained by parents through FOIA.

Late 2000 and 2001 was a rough time for the CDC. Simpsonwood had already highlighted the challenges CDC faced with the data they were sitting on. In August of 2000, two months after Simpsonwood, Dan Burton’s Government Reform Committee released a highly critical document on the conflicts of interest at CDC and FDA for decision made on the Rotavirus vaccine, recently recalled due to intussusception in children (a severe bowel disorder), and critical of vaccine policy making in general.

In January 2001, parents associated with the nonprofit group SafeMinds published an article in a peer-reviewed journal titled Autism: A Novel Form of Mercury Poisoning. Chairman Burton continued to hold hearings, browbeating public health officials over the lapse on thimerosal and what was being done about it. This was followed up that May by a speech by Chairman Burton demanding FDA recall any vaccine containing thimerosal at once (they didn’t).

Once it was clear that unsafe levels of mercury were in the vaccine supply, FDA was required to hire the Institute of Medicine to review thimerosal and any role it may play in damaging children. With the weight IOM carried with the scientific community, IOM’s conclusions, expected to be published in late 2001, were of grave concern to CDC. By the summer of 2001, CDC was aware of IOM’s likely conclusion, which was not particularly favorable to CDC: they were going to say that the notion that thimerosal created neurological disorders was “biologically plausible” and merited further study. CDC had already given IOM their data from the VSD, which had been manipulated enough to neither prove nor disprove an association.

Perhaps most frustrating about the recommendations of the IOM in October 2001 is that CDC did not pursue any of them. Where IOM recommended further work to assess biologically plausibility (like measuring mercury levels in autistic children), CDC would focus exclusively on epidemiology, a statistical science easily manipulated. Where IOM encouraged CDC to explore the growing reports of autistic children recovering after chelation therapy, a treatment to remove mercury and other metals from the body, CDC never did anything to explore the reports further. Where IOM encouraged CDC to replace any thimerosal containing vaccines immediately, CDC still has vaccines with thimerosal targeted at infants today, five years later.

Luckily for the children, what CDC did not realize was that parents would dig into their own pockets to fund biological research to prove what had been done to their children, as we will discuss in Chapter 5.

CDC was in a bind. They knew what the Generation Zero data had shown and how explosive that information, if released, would be to the National Immunization Program, their jobs, and vaccine manufacturer liability. They also knew IOM was not going to let them off the hook, and that more work and analysis would be recommended. It left only two alternatives for CDC, both of which they continue to follow today:

  1. Never, ever let anyone else see the Generation Zero data nor any of CDC’s other internal data. Given all the shortcuts and assumptions CDC made to manage down the risks, independent researchers would most assuredly come to a different conclusion. Even though laws required CDC to share this data publicly, they would become experts at buying time and “losing” data when pressured.
  2. Since the U.S. data shows a high correlation, go to other countries and find willing participants to manufacture data that will “prove” thimerosal and autism are unrelated.

With that strategy in place, a few months prior to the release of the IOM study, CDC employees, under the guidance of their bosses, Dr. Walter Orenstein, Director of the NIP and Dr. Roger Bernier, Associate Director of Science for the NIP, began a world-wide inquiry to find data from other countries that would be used bail them out. Not only would CDC initiate, fund, and structure these studies, but their own employees would also end up as published authors in the studies exonerating thimerosal’s role in autism.

Dr. Vestraeten’s data, which began with a panic in late 1999 (“It just won’t go away”), was published in Pediatrics titled Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organizations. Perhaps most frustrating about this study is that it is often referenced as “proof” that vaccines do not cause autism when it was actually a neutral-outcome study, as Dr. Verstraeten himself noted, in a letter to Pediatrics:

“Surprisingly, however, the study is being interpreted now as negative [where ‘negative’ implies no association was shown between Thimerosal and autism] by many…The article does not state that we found evidence against an association, as a negative study would. It does state, on the contrary, that additional study is recommended, which is the conclusion to which a neutral study must come…A neutral study carries a very distinct message: the investigators could neither confirm nor exclude an association, and therefore more study is required.”

This study was highly flawed for the following reasons (read SafeMinds’ critique here):

The data was manipulated to remove the strong correlation between mercury and autism. As Chapter II discussed, the initial analysis using Vaccine Safety Datalink data (VSD) showed a high correlation between Thimerosal and autism, called “Generation Zero.” The CDC used many techniques to dumb-down the numbers including removing comparisons to children who had received no Thimerosal, lowering the age of children available for the analysis, and including a bankrupt HMO, with notoriously faulty data systems, in their final round of analysis. This HMO helped neutralize the findings reviewed at Simpsonwood. As SafeMinds reported:

“The general drift of their design changes was clear, to reduce the statistical power through conscious manipulation of statistical methods, data classifications, and samples.”

Dr. Verstraeten, the study’s author, had been an employee of Glaxo SmithKline for more than 2 years by the time the study was published. This blatant conflict, with a study author employed by a company being sued by parents for Thimerosal in vaccines, was never noted in the Pediatrics study.

Even with all the manipulation, the study was still a neutral outcome study. Many people would be surprised to know that the study itself cites a correlation between Thimerosal-containing vaccines and both “tics” and “language delay.” Beyond that, the study neither proves nor disproves an association between Thimerosal and autism and recommends that more work needs to be done.

A “SIGNAL” DISAPPEARS ACROSS FIVE GENERATIONS OF STUDY

Critics of the Verstraeten paper question the process under which the data were managed across at least five different generations of analysis that lasted more than four years before the official version was published in Pediatrics. They charge that the data were put through a rather torturous process of statistical manipulation designed to get the results so badly desired by CDC: Namely, no association between thimerosal and negative outcomes.

Whether done intentionally or not, the various generations of analysis clearly show how an extremely strong “signal” between thimerosal and autism, ADD and other NDDs in the first generation was reduced to almost nothing in the fifth and final published version.

It is important to note that the first four analyses would never have come to light without documents obtained by SafeMinds through the FOIA. The group’s FOIA efforts likewise yielded unpublished minutes from a secret, two-day conference held in June 2000 near CDC headquarters outside Atlanta, known as the Simpsonwood Meeting. It is clear from the transcript that many industry and public health experts at Simpsonwood were alarmed by the possible harm being caused by thimerosal – but even more worried about the possible damage that any bad publicity would have on the national and global vaccine programs. Participants voted to keep the meeting secret, and it remained so for two years, when the minutes were delivered to SafeMinds. (See Below).

It is also important to note that Verstraeten himself presented results from some of the earlier VSD analyses – in which the thimerosal signal was still quite significant – to the CDC’s Advisory Committee on Immunization Practices Institute (ACIP) in 2000 and to the Institute of Medicine in 2001 without dismissing the data as being “preliminary” and therefore unreliable (also discussed below)

FIRST ANALYSIS – December, 1999 — Autism Relative Risk = 7.62

In the very first run of the VSD data on thimerosal, lead author Thomas Verstraeten divided all of the children in HMO A and B into four groups: Those who had received zero micrograms of mercury in vaccines by one month of age, those who had received 12.5mcg, those who received 25mcg, and those exposed to more than 25mcg by one month of age.

The results were astonishing. The children exposed to more than 25mcg had extremely elevated relative risks for:

● ADHD: 11.35 times more likely

● Autism: 7.62 times more likely

● ADD: 6.38

● Tics: 5.65

● Speech and Language Delay: 2.08

SECOND ANALYSIS – February, 2000 — Autism Relative Risk = 2.48

Within two months, Verstraeten had reanalyzed the data, incorporating methodological changes suggested by colleagues at the CDC. In the second version, completed in February 2000, the estimated relative risk for autism had fallen considerably – though it was still worryingly high. Children in the two HMOs exposed to the most mercury (62.5mcg) at three months of age were almost two and half times more likely to develop autism (RR=2.48). This calculation was just short of statistical significance because the low end of the margin of error fell slightly below the risk of 1.0. It’s worth noting that Verstraeten excluded children who had been treated with hepatitis B immune globulins “as these were more likely to have high exposures and high outcomes.” Most formulations of immune globulins were preserved with thimerosal at that time. These infants were among the most heavily exposed patients and also had dramatically higher rates of autism and other disorders, and yet they were excluded from the analysis at this stage.

Relative risk of Autism from thimerosal exposure at 3 months of age:  

SOURCE: Internal CDC report, February 2000 – Obtained through the Freedom of Information Act (FOIA).

Verstraeten was nonetheless alarmed. On December 17, 1999 he sent an email to colleagues Robert Davis and Frank DeStefano under the subject line “It just won’t go away,” by which one presumes he meant the association between thimerosal and NDDs. “Some of the relative risks increase over the categories, and I haven’t yet found an alternative explanation,” he said. “Please let me know if you can think of one.” 

In this second analysis, Verstraeten, Davis and DeStefano candidly wrote that they had associated “increasing risks of neurological developmental disorders with increasing cumulative exposure to thimerosal.” They also found “similar increases” for the risk of developmental speech disorder, autism, stuttering and attention deficit disorder, though these increases were not statistically significant. “We can state that this analysis does not rule out that receipt of thimerosal containing vaccine in children under three months of age may be related to an increased risk of neurological developmental disorders.”

THIRD ANALYSIS – June, 2000 — Autism Relative Risk = 1.69

On March 9, 2000, Verstraeten sent another email, obtained through FOIA, about his work on the third generation of analyses. He wrote that the risk of developmental delay began to drop among children who missed their first thimerosal-containing HiB and DTP shots before three months of age. This confirmed his “hypothesis” that “What matters is not getting it before the third month, after which the implications gradually diminish.”

Verstraeten also looked at exposure rates and outcomes among 10 premature infants and found that those exposed to 200mcg mercury were five times more likely to have an NDD than preemies exposed to 100mcg. “These findings are very extreme and warrant closer examination,” he wrote.

By this time, Verstraeten et al. were preparing a third analysis of the VSD data, incorporating even more changes (i.e. entry criteria, stratification of population groups, etc) to their methodology. Critics say these changes were made deliberately to eliminate the “signal” that would “not go away” (discussed below) while CDC officials have insisted they were just trying to get the “cleanest” and most reliable data possible.

In June, 2000, Verstraeten presented the third analyses at a meeting of the CDC’s Advisory Counsel on Immunization Practices (ACIP) and at the Simpsonwood conference. This time, the relative risk for autism among children given more than 62.5 mcg by three months of age had fallen – from 2.48 to 1.69:

This still-elevated autism finding was not considered statistically significant because the margin of error dipped below a relative risk of 1.0. But the team did find “statistically significant associations between thimerosal and neurodevelopmental disorders” other than autism. These included:

Relative Risk for All NDDs Combined: The RR for this umbrella category of outcomes among children exposed to 62.5mcg at three months was 1.64, meaning these children were 64% more likely to have any NDD than children exposed to 0mcg. The risk was considered statistically significant because the margin of error remained above 1.0. And increased risk was completely linear and dose-dependent: It increased by 0.7% for every microgram of mercury exposure:

Relative Risk for Developmental Language Disorder: Statistically significant increased risks for language disorder were found at 3 months (2.1% per mcg). The RR for children receiving 50mcg mercury or more by 3 months of age was especially high. Children who received 62.5mcg had a relative risk of 2.10 compared with children who received 12.5 mcg.

 Relative Risk for Attention Deficit Disorder: There was a statistically significant, dose-dependent response at six months of age of 0.6% for each microgram of exposure. At 62.5mcg, the RR was 1:30, or 30% more likely to develop ADD.

Other Elevated risks: Increased risks per mcg of exposure were found for:

Speech delay: 1 month (RR: 1.011), 3 months (RR:1.008), 6 months (RR:1.002)

Unspecified Delays: 2 months (RR: 1.005), and 3 months (RR:1.007)

Tics: 3 months: (RR: 1.021)

“Some of these are borderline statistically significant,” Verstraeten told the ACIP meeting. “Some of them are highly statistically significant. What these estimates suggest is that there seems to be an increasing trend, an increasing risk for any of these neurological developmental outcomes, with increasing thimerosal exposure.”

THE SIMPSONWOOD CONFERENCE – June 2000

The same month as the ACIP meeting – June, 2000 – the CDC convened an invitation-only conference at a retreat outside Atlanta called Simpsonwood, where dozens of public health officials, physicians, scientists, and industry executives gathered for a two-day, supposedly off-the-record discussion of the Verstraeten findings. The meeting was not announced to the public, and the transcript was not meant for public consumption. It was, however, included in a FOIA request packet that was delivered to SafeMinds. Members of the public were patently excluded at Simpsonwood, and industry representatives outnumbered panel members.

The task at hand was to review the VSD analysis and determine if a “signal” between TCVs and developmental disorders was there. Participants were also asked for ideas on how to proceed in the ongoing investigation, which was in its first year of what would become four years of analysis and reanalysis. Among the revelations:[57]

● Troubling data – Many attendees knew they had a problem. “What if the lawyers get hold of this?” asked one. “There’s not a scientist in the world who can refute these findings.”

● Deference to industry – It is clear that the CDC would not recall any mercury containing vaccines, regardless of the risks, out of concern for the financial interests of the vaccine industry. “CDC is not in favor of expressing a preference for a particular vaccine (i.e. thimerosal-free) for fear of alienating the other manufacturers and disrupting a free market economy,” one participant wrote to colleagues after the meeting.

● Dr. Paul Stehr-Green, an associate professor of epidemiology at the University of Washington and lead author of the Danish-Swedish thimerosal study, summarized the meeting in a memo obtained through FOIA. He wrote that, despite a prolonged “re-analyses,” the data still showed a “slight tendency for groups with higher exposure to thimerosal-containing vaccines to have higher rates of the same neurobehavioral outcomes.” But, he insisted, the level and consistency of statistical significance of these findings was “unimpressive.” The results did not “offer adequate evidence to support or refute the existence of causal relationship.          

● Dr. Philip Rhodes (a CDC statistician) spoke of a certain way that researchers could suppress the signal through changing the exclusion criteria: Restore thousands of children with congenital disorders who were excluded from the study, “which would serve to add ‘noise’ that could obscure the signal. All those kids that Tom (Verstraeten) has excluded, I have thrown them in. I think there is a clear argument that is going too far, but that further brings things down,” Rhodes said. “So you can push, I can pull. But there has been substantial movement from this very highly significant result, down to a fairly marginal result.”

Eventually, those previously excluded children with congenital disorders would indeed be added back into the patient population under study.

● Dr. Thomas Verstraeten discussed many of the study’s flaws, including the large number of young children. “One thing that is for sure, there is certainly an under-ascertainment of all of these cases,” he said. “Some children are just not old enough to be diagnosed. So the crude incidence rates are probably much lower that what you would expect, because the cohort is still very young.” As for the most common disorder found, speech delay, Verstraeten said the trend had been “highly statistically significant.” He added that the hypothesis was “biologically plausible.”

Verstraeten was very clear on one central point, however. Despite the changes in methodology and stratification of the data, the signal between thimerosal and NDDs simply would not vanish. “You can look at this data and turn it around,” he said, “and look at this, and add this stratum, and I can come up with very high risks. And I can come up with very low risks, depending on how you turn everything around. You can make it go away for some and then it comes back for others,” he concluded. “So the bottom line is, okay, our signal will simply not just go away.”

● Dr. William Weil, who represented the American Academy of Pediatrics, lectured his colleagues for believing that the signal was weak and not significant:

The number of dose related relationships are linear and statistically significant. You can play with this all you want. They are linear. They are statistically significant. The increased incidence of neurobehavioral problems in children in the past few decades is probably real. Like many repeated acute exposures, if you consider a dose of 25 mcg on one day, then you are above threshold. And then you do that over and over to the same neurons. It is conceivable that the more mercury you get, the more effect you are going to get. The brain and central nervous system are not fully developed at birth. The earlier you work with the central nervous system, the more likely you are to run into a sensitive period for one of these effects. It changes enormously the potential for toxicity. There’s a host of neurodevelopmental data that would suggest that we’ve got a serious problem. To think there isn’t some possible problem here is unreal. The number of kids getting help in special education is growing nationally and state by state at a rate we have not seen before. The rise in the frequency of neurobehavioral disorders is much too graphic. We don’t see that kind of genetic change in 30 years.
      
● After the meeting, Verstraeten sent an email to colleagues complaining of the indifferent stance that most of the participants took toward the thimerosal signal that “won’t go away.” Their attitude seemed to be that, “if nothing is happening in these studies, then nothing should be feared of thimerosal,” he wrote. “I do not wish to be the advocate of the anti-vaccine lobby and sound like being convinced that thimerosal is or was harmful, but at least I feel we should use sound scientific argumentation and not let our standards be dictated by our desire to disprove and unpleasant theory.”

FOURTH ANALYSIS – July, 2001 — Autism Relative Risk = 1.58

In this fourth analysis, presented at the July 2001 meeting of the IOM’s Immunization Safety Review Committee, the VSD team had decided to divide HMO A and B and examine their data separately.

But HMO B, with some 15,000 patients studied, was considerably smaller than HMO A, which had 115,000 patients. After breaking them into two subpopulations, they found that data from the smaller HMO were no longer statistically significant. The smaller HMO simply lacked the “statistical power” of the larger HMO and therefore, results from the two HMOs were no longer “consistent.” The same was true for speech and language delays.

Even so, for some of the estimates, “we found high statistical significance,” Vertraeten told the IOM. “Some of these associations are biologically plausible, and for some, we saw a dose response.”

By now, the team had also completed Phase II of the study, which was to compare results from HMOs A and B with a third, independent HMO, in this case, Harvard Pilgrim of Massachusetts. And though Phase I had found “several significant associations between thimerosal and neurodevelopmental disorders,” Verstraeten said, “in an analysis in a smaller and independent data set, we could not confirm those associations for speech or language delay and ADHD.” And given the lack of statistically significant risk for autism, the team had stopped looking at that outcome altogether in the Harvard Pilgrim data.

The reliance on HMO C to discount the entire study was criticized by Neal Halsey (title here) “Some people who have seen the third HMO, which is Harvard Pilgrim, have said there is no effect there, therefore that disproves the hypothesis,” he testified at IOM. “Well, that is really not true. I don’t know what the real power is of that study to say that there really isn’t an effect there. Power is a very important factor in studies that don’t show an effect.”

The data were inconclusive, but “still suggestive of an effect from thimerosal,” he said.

FINAL ANALYSIS – November, 2003 — Autism Relative Risk = N/A

By the time the study was published in 2003, the authors found just one increased risk for tics in phase I: At HMO A, exposure at 3 months the relative risk was 1.89. At HMO B, B, there was an increased risk of language delay for exposure at 3 months (RR: 1.13) and 7 months (RR: 1.07). But in Phase II at HMO C, “no significant associations were found.” And “in no analyses were significant increased risks found for autism or attention-deficit disorder.”

This was untrue. In the first analysis, there were significant increased risks for autism and ADD, and in the second analysis, there was a significant increased risk for ADD.

CRITIQUES OF THE STUDY

How did the relative risk for autism tumble from 11.35 to null? The four-year, five-generation analysis has been examined closely by many critics, both inside the autism community and among respected scientists, physicians and members of Congress. The many methodological flaws they have identified include:

■ Inclusion of Young Children – Researchers included young children, from 0-3 years old, even though the average age of an autism diagnosis was 4.4 years. A diagnosis in the first years of life was rare, so including these children would tend to drive down the overall relative risk. Because they were not yet diagnosed, all of them would have been misclassified under the normal group. But the CDC assumed that autism is diagnosed as frequently in 1-year-olds as five-year-olds. 

■ No Autism Diagnoses Among Youngest Children – Among the youngest children, who made up 40% percent of all kids in the study, not a single case of autism was reported, which means that 40% of the sample was misclassified.

■ Underreporting of Autism Cases – The researchers identified relatively few kids with autism compared to what one would expect to find in the general population. In California at the time, the autism rate (excluding PDD and Aspergers) was around 50-100 per 10,000 children. But the average rate at the two California HMOs was just 11.5 per 10,000. Had they missed, or somehow eliminated four out of five cases? What else could explain this dramatic under-ascertainment? This undercount clearly also means that these cases were misclassified.

■ Exclusion of ASD cases other than “autism” – The researchers did not look for outcomes like PDD-NOS and Asperger’s Syndromes, even though they are autism spectrum disorders. This meant that higher-functioning children were not included in the risk ratios.■ Stratification of Data – The authors not only separated HMO A and B to find that data from the smaller HMO alone lost statistical power, they even broke up the larger HMO into subgroups comprised of individual clinics in the network. This “stratification” helped eliminate any consistent statistically significant risk of ADHD or speech disorders that were found within the larger HMO as a whole. Smaller population subgroups have less “statistical power,” and increase the possibility that statistical significance will not be attained.

■ Elimination of the combined “NDD” Outcome – By breaking this generalized umbrella outcome into individual categories like ADHD, speech delay and tics, the relative risks and statistical significance of most outcomes were reduced or eliminated. Again, the smaller the stratified subgroup, the greater the chance of reducing statistical power and thus statistical significance.

■ Elimination of cases diagnosed outside the HMOs – The authors chose to include only those cases confirmed by a behavioral specialist. But if that specialist was outside the HMO, the diagnosis was not counted. This provided the opportunity to “cherry pick” cases out of the original data set. Among the ADD/ADHD cases, 60% were eliminated because they were not made by an in-network specialist. For speech and language delay, 50% were excluded and for autism, 20% were eliminated.

■ Higher risk with increased vaccination – Generally speaking, among the three HMOs studied, the higher the vaccination rate, the greater the risk of adverse outcomes. During the third generation of analysis, for example, HMO C had the highest full vaccination rate, at 65%, and also the highest speech delay rate. Meanwhile, at HMO A, the fully vaccinated rate was 60%, or four times greater than compliance at HMO B (15%), while the rate of all NDDs at HMO A was 5.7%, four times greater than the 1.3% rate found at HMO B.

 HMO AHMO BHMO C
Full Vaccination Rate60%15%65%
NDD Rate5.7%1.3%n/a
Speech Delay Rate3.9%2.6%4.5%

■ Problems at Harvard Pilgrim – There were questionable record keeping practices at Harvard Pilgrim (HMO C), and Massachusetts had been forced to take over after it declared bankruptcy. Even worse, the HMO used different diagnostic codes than the other two HMOs in Phase I. It wasn’t surprising that the Harvard Pilgrim data was inconsistent. Also, the study population at Harvard Pilgrim was significantly smaller (15,000 kids). The smaller the population studied, the greater the margin of error, which lowers the study’s “statistical power” and weakens the signal for outcomes.

■ Undeclared conflict of interest. After Verstraeten began work at GlaxoSmithKline, “the data, sampling and methodology of the study were altered, so that results would point to enough inconsistencies to cast doubt that mercury in vaccines causes autism,” critics alleged. Verstraeten had not been named as a GSK employee in the study and was misidentified as an employee of the CDC. It must be noted that GSK made thimerosal- containing vaccines included in the study, such as Hepatitis B and DTaP vaccines.

■ Unavailability of data – “The current practice of restricting access to the database to a limited group of possibly biased individuals is not acceptable,” SafeMinds declared. Their statement added that the Pediatrics report “cannot be accepted as final.” CDC rules had made the approval process long and arduous. Those who did gain access (the Geiers) could only “utilize a limited portion of the VSD data set, and their examination of the data is subject to constant monitoring by CDC staff.”

WHAT THE MEDIA SAID

Associated Press – Co-author Frank DeStefano “acknowledged that the early results suggested stronger links with some disorders, though not autism, but denied that there had been pressure or a cover-up. He said the final data reflect a more thorough recent analysis. Verstraeten, who left the CDC in July 2001, did not respond to an email request seeking a response, and company spokeswoman Nancy Pekarek said he did not wish to discuss the results, but provided a statement in which Verstraeten said that ‘since leaving the CDC he was only an adviser as the study was finalized and prepared for publication.’” [58]

WHAT THE CDC SAID

CDC spokesman Von Roebuck told Insight on the News magazine that, “We pretty much looked into that [the manipulation of data] in the sense of how the information was presented, and we do stand behind it.” As for Verstraeten’s undisclosed employment at vaccine maker GSK, he said. “The one thing that we would want to happen differently is that would have been known before. But the work that Dr. Verstraeten did was for the CDC at the time the work was produced – the work that he did for the study was done when he worked for the CDC.”

WHAT LEADING VACCINE EXPERTS SAID

Dr. Neal Halsey, the national vaccine expert, along with colleagues Daniel A. Salmon and Lawrence H. Moulton, published a letter in the journal Pediatrics calling for further analysis of the data which included the following critiques:[59]

■ Changing Criteria – By eliminating the combined umbrella outcome of NDDs, and dividing it into separate diagnoses, the authors “may have substantially reduced the power to find important relationships,” Halsey et al. said, adding that the later entry criteria “appear to have been more lax” than in a previous version.

■ Excluding Diagnoses – The requirement that diagnoses be made by an in-network specialist was also questioned. “Were diagnoses that were not made by a specialist excluded from analyses?” they asked, noting that primary care doctors are quite “capable of diagnosing ADD without input from a sub-specialist.”

■ Unequal Population Sizes – Halsey et al. also criticized the comparing of data from a large HMO with two much smaller ones.

WHAT VERSTRAETEN SAID

In a letter published in the April, 2004 issue of Pediatrics, Verstraeten wrote that, while his team had found a positive association between thimerosal and certain outcomes in Phase I, these findings could not be replicated in the second phase.[60]

But this in no way disproved an association (at least for NDDs other than autism), he insisted in a declaration that is seldom, if ever quoted today. “The perception of the study changed from a positive to a neutral study,” he said. “Surprisingly, however, the study is being interpreted now as negative by many, including the anti-vaccine lobbyists. The article does not state that we found evidence against an association, as a negative study would. It does state, on the contrary, that additional study is recommended, which is the conclusion to which a neutral study must come.”

“Did the CDC water down the original results?” Verstraeten asked, and then answered: “It did not.” Despite the fact that vaccine safety activists were charging that a “positive” study had been manipulated into a “negative” one, the study results were neutral; they proved nothing for either side of the debate. Presumably, the point he was making is that a deliberately manipulated study would have yielded a negative result, and not a neutral one

“Did the CDC purposefully select a second phase that would contradict the first phase?” Verstraeten also asked. “Certainly not. The push to urgently perform the second phase at (Harvard Pilgrim) came entirely from myself, because I felt that the first-phase results were too prone to potential biases to be the basis for important public health decisions. (It) was the only site known to myself and my coauthors that could rapidly provide sufficient data that would enable a check of the major findings of the first phase in a timely manner.

And he added this:

The bottom line is and has always been the same: an association between thimerosal and neurological outcomes could neither be confirmed nor refuted, and more study is required.

WHAT A SPECIAL PANEL OF THE NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES SAID

On August 24, 2006, a special panel appointed by the NIEHS issued a report titled “Thimerosal Exposure in Pediatric Vaccines: Feasibility of Studies Using the Vaccine Safety Datalink.”[61] Among other things, the panel was asked to “Identify the strengths and weaknesses of the VSD for evaluating the possible association between exposures to thimerosal-containing vaccines and AD/ASD”

According to the panel, “a number of gaps were identified in the information available at the meeting. These involved business and medical practices at the MCOs that might impact data quality and interpretation of study results, and more generally, the completeness and validity of exposure and diagnostic data in the VSD and the ability to link across family members.” The panel recommended that these gaps be addressed prior to consideration of further studies of ASD and thimerosal using the VSD.

The panel also “identified several areas of weakness,” the report said. “The cumulative effect of these weaknesses was judged to reduce the usefulness of the VSD for addressing the potential association between exposure to the vaccine preservative thimerosal and risk of AD/ASD.”

The weaknesses of primary importance are summarized below.

Case ascertainment –“Of particular interest to the panel was the large proportion, around 25%, of births excluded from the analyses in the Verstraten study. These exclusions were intended to decrease confounding. The panel noted that these children may represent a susceptible population whose removal from the analysis might have had the unintended consequence of reducing the ability to detect an effect of thimerosal. A VSD study that relies exclusively on administrative data to identify cases of ASD is subject to both false positives and missed cases. This stems in part from the original design of the data systems that support the VSD; these systems were designed for administrative rather than research purposes. For example, the administrative record created for an outpatient visit of a child with AD/ASD who is being treated for another medical condition will reflect that other condition rather than the presence of autism. Entries of this type would lead to under-ascertainment of cases.”

Heterogeneity in business practices across and within MCOs (HMOs) – “Eight MCOs currently participate in the VSD and each relies on data systems designed to meet the specific business requirements of the MCO. In addition to obvious differences among MCOs in enrollment size and geographic location of the populations served, many other aspects of service delivery and tracking vary (e.g., developmental screening practices and specialist referral guidelines). Differences across clinics and other service providers affiliated with an individual MCO occur as well. The panel noted that these variations within and among VSD sites would complicate interpretation of a VSD study that combined data across clinics and sites by introducing heterogeneity in the completeness and quality of case ascertainment. Moreover, membership in an MCO might be influenced by an AD/ASD diagnosis. This could occur, for example, if children presenting with problems predictive of the development of AD/ASD (e.g., speech delay) are more likely to leave a MCO-administered plan because the parents believed that another model of service delivery would be more beneficial.”

Systematic changes over time – “The systems for creating medical records at the VSD sites are dynamic and change frequently in response to the evolution of the individual MCO business model. The panel noted that at least some of these changes would be expected to affect the observed rate of autism and could confound a trend analysis. One such change was the transition from paper to electronic medical records. This change occurred at different times for each of the participating MCOs.”

Estimation of mercury burden. “Panel members expressed a concern that thimerosal dose, administered through a series of vaccinations, may provide a poor surrogate measure of the cumulative exposure of a child to organic mercurials. Exposures through diet or other environmental sources would not be documented reliably in either the VSD administrative data or medical charts.”

Transparency and Public Access – “The panel recognized the perception by some members of the public and the advocacy community that previous VSD analyses have not been conducted in an open manner. The panel recommended that the AD/ASD advocacy community participate meaningfully in all aspects of any future VSD study of AD/ASD, including design, analysis and interpretation.”

CRITIQUE BY IRVA HERTZ-PICCIOTTO, PHD, MPH, CHIEF OF THE DIVISION OF ENVIRONMENTAL AND OCCUPATIONAL HEALTH, UNIVERSITY OF CALIFORNIA, DAVIS SCHOOL OF MEDICINE

“The appropriateness of exclusions that amounted to nearly 25% of the birth cohort in the investigation by Verstraeten et al. (2003) was questioned in the NIEHS expert panel report, and (CDC Director) Dr. Julie Gerberding concurred that further work should be done using the VSD to address this weakness.”[62] The VSD study “was not the last word… things need to be looked at again, perhaps with different methodology.”[63]

WHAT A LEADING CRITIC IN CONGRESS SAID

Former Rep. Dave Weldon, MD (R-FL), who served as only one of two physician members of Congress, wrote to CDC Director Dr. Julie Gerberding about his “serious reservations about the four-year evolution and conclusions of this study.”[64]

“I have read various emails from Dr. Verstraeten and coauthors. I have reviewed the transcripts of a discussion at Simpsonwood. I found a disturbing pattern which merits a thorough, open, timely and independent review by researchers outside of the CDC, HHS, the vaccine industry, and others with a conflict of interest in vaccine related issues (including many in University settings who may have conflicts), he wrote.

Instead of a “good faith effort” to investigate potential harm from thimerosal, “there may have been a selective use of the data to make the associations in the earliest study disappear,” he charged. “I cannot say it was the author’s intent to eliminate the earlier findings of an association. Nonetheless, the elimination of this association is exactly what happened and the manner in which this was achieved raises speculation.” The Simpsonwood transcripts, he added, “clearly indicated how easily the authors could manipulate the data and have reasonable sounding justifications for many of their decisions.”

WHAT THE IOM SAID

The IOM vaccine safety committee was not troubled by the changing criteria for entry and outcomes, nor did the total disappearance of an autism signal concern them.

“The difference in preliminary results can be attributed to three major reasons,” they said:

■ “Investigators updated datasets with extended follow-up periods, which allowed for additional cases to be identified.”

■ “They modified exclusion criteria based on scientific input from the (2001) IOM report and CDC and VSD investigators

■ “They improved adjustments for health-care-seeking behavior.

■ “Other reasons cited for the differences were a modification to the time of exposure, and inclusion of additional variables in the model.

The panel added this:

The committee notes that it is commonplace for large and important studies to be reviewed along the way, with adjustments often made to improve the eventual validity of the results; thus, it finds nothing inherently troubling in the fact that the VSD study underwent this process. The committee also notes that preliminary results are often misleading and can change substantially as methods are adjusted and more cases and controls are assembled. Indeed, the fact that a conference was held to discuss preliminary findings (Simpsonwood) would typically be interpreted as an attempt by researchers and their sponsors to “get it right,” given the high level of interest in the findings.

Under-ascertainment of cases? The IOM panel wrote that, for HMO A, the autism rate was 1 in 635, or 15.7-per-10,000, and HMO B had 1 in 523, or 19-per-10,000). “Several concerns were raised about the possibility of misclassification of cases with autism because of the way the age of the child was handled in the analyses,” they wrote. One worry was that “some cases of autism may have been missed with shorter follow-up.” But, the data “were adjusted for month and year of birth and time of follow-up,” a “statistical-analysis technique” that “should therefore take care of this concern,” the panel said, without explaining how.

Inclusion of younger children – “Another related concern was that inclusion of a younger group (who are less likely to be diagnosed with autism) in the study would bias the thimerosal effect toward zero,” the panel wrote. “Adjusting for age would reduce, but not eliminate, this tendency. However, if there were an effect of thimerosal, one still would anticipate a trend of increasing effect with age. In this study, there was no such association, even in the older age groups.”

Misdiagnosis of younger children – “The authors attempted to address this by determining the association between thimerosal and neurodevelopmental outcomes and found no consistent significant associations,” the panel said. But it conceded this very important point, often overlooked by the media: “If there are multiple pathways leading to these disorders, it would be difficult to detect the effect of any one cause—unless it occurred with high frequency and the sample size was large—because the tendency of misclassification of outcome is to dilute measures of effect.”

General Limitations cited by the IOM

■ “The authors were unable to control completely for other potential confounding factors. In HMO B, the clinic that a child attended may have acted as a confounder.” In other words, inconsistencies between record keeping practices – even within the same HMO – render the data less reliable.

■ “The HMO databases did not provide information on other possible confounders, such as maternal smoking, lead exposure, or fish consumption.” Total accumulated toxic exposure is probably more important that a single type of exposure from a single source (ie, mercury in vaccines). Background exposures should also be included.

■ “Limitations include the study’s ability to answer whether thimerosal in vaccines causes autism because the study tests a dose-response gradient, not exposure versus non-exposure.” This study compared children who received the highest doses of thimerosal with children who received lower doses. Studying exposed versus non-exposed children might yield clearer data.

■ “The small number of cases and instability of some of the risk estimates may affect the findings.” The number of autism cases found was quite low – far lower than what would be expected for such large HMOs.

SUMMARY: This highly controversial study is considered the most important by people who reject any link between thimerosal and ASD, yet it is fraught with severe limitations, methodological weaknesses and questionable analyses. Data collected from the HMO’s was repeatedly re-analyzed – at least five times across three years of study. During that time, entry criteria were changed, children too young to have an ASD diagnosis were added, and other questionable methods of analysis were used. The relative risk for autism fell from 11.35 to zero during that time. As for other NDDs, even the lead author wrote that this was a “neutral” study and could not be used to support or refute a link.

Ken Stoller’s Letter to Pediatrics on the Verstraeten Study

Thimerosal Mea Culpa from the CDC
Kenneth Stoller,Pediatrician
International Hyperbaric Medical Association

Letter sent to Pediatrics:

In 2003, Dr. Eric Coleman (LETTERS TO THE EDITOR: Ethylmercury in Vaccines
Pediatrics, Apr 2003; 111: 922 – 923.) was able to have a letter printed in Pediatrics, undoubtedly because of his affiliation with the FDA, defending the decision to pull the Hep B vaccine until a Thimerosal or ethylmercury free version became available. He said the AAP and USPHS should be commended for this proactive decision for “the fact is, no preclinical or clinical studies were ever conducted to specifically examine the safety of thimerosal (ethylmercury) at the doses found when used in multiple infant and childhood vaccines. Thus, there was no conclusive evidence because there were no studies.”

The Coleman letter is of historical importance because of what what took place next.
What followed was insanity. The CDC forced flawed and perhaps fabricated ecological
studies down the throats of pediatricians and the AAP. Pediatrics published the
Verstarten and Madsen studies, to name two, despite glaring methodological errors.

The CDC then used this planted intelligence, if you will, to not only defend the continued presence of Thimerosal, but to obfuscate the rising numbers of children with neurobehavioral disorders, including Autism, and controlled the IOM in the process to make it all but impossible for any one in academic medicine to point out the obvious and still be taken seriously.

Valuable time was lost for affected children and families were destroyed in the ensuing years when legitimate interventions and research could have been taking place.

Thimerosal continues to this day to be given to 3rd world children with the blessing of the WHO and without protest from those that know better within the USA. Meanwhile
the CDC line was all the “new” cases of affected children were but do to better diagnosis.

After numerous unanswered Data Quality Act complaints filed with the the CDC, Director Dr. Julie Gerberding has produced a report delivered to the House Appropriations Committee, in which she admits to a startling string of errors in the design and methods used in the CDC’s landmark 2003 study that found no link between mercury in vaccines and autism, ADHD, speech delay or tics.

A 2006 report from the National Institute of Environmental Health Sciences (NIEHS),
concluded that the CDC’s infamous Verstarten Thimerosal safety study publish in this journal was riddled with “several areas of weaknesses” that combined to “reduce the usefulness” of the study.

“CDC concurs,” Dr. Gerberding wrote in an undated confession (see above link) to Congress, (provided to journalist David Kirby through a Capital Hill staffer) adding that her agency “does not plan to use” the database in question, the Vaccine Safety Datalink, (VSD) for any future “ecological studies” of autism.

In fact, Gerberding’s report said, any continued use of the VSD for similar ecological studies of vaccines and autism “would be uninformative and potentially misleading.”

After Verstarten revealed the link between Thimerosal and neurobehvioral disorders in the report presented to the secret Simpsonwood meeting in June of 2000 (http://www.putchildrenfirst.org/media/2.9.pdf) CDC officials conducted at least five separate analyses of the data. The first analysis revealed at Simpsonwood showed that children exposed to the most Thimerosal by one month of age had extremely high relative risks for a number of outcomes, compared with children who got little or no mercury: The relative risk for ADHD was 8.29 times higher; for autism, it was 7.62 times higher; ADD, 6.38 times higher; tics, 5.65 times; and speech and language delays were 2.09 more likely among kids who got the most mercury.

Verstarten, who did NOT disclose to this journal that he was now an employee of vaccine maker GlaxoSmithKline (not the CDC) diluted his data five times The relative risk for autism plummeted from 7.62 in the first analysis, to 2.48 in the second version, to 1.69 in the third round, to 1.52 in the fourth, and down to nothing at all in the fifth, final, and this was what was published in November of 2003 (Pediatrics 2003; 112:1039-1048).

The new and improved Verstarten VSD study was the main pillar of a hugely influential 2004 report by the Institute of Medicine, which was essentially ordered to conclude that there was no evidence of link between mercury, vaccines and autism.

The AAP published VSD study has long been held up as the best and brightest of all epidemiology studies(the others were in Sweden, the UK, and two in Denmark).

There is now not a single pediatrician in the USA who can not quote from at least the AAP (Verstarten) study.

In 2005, a group of Senators and Representatives headed by Sen. Joe Lieberman wrote to the NIEHS (an agency of the National Institutes of Health) saying that many parents no longer trusted the CDC to conduct independent minded studies of its own vaccine program. Lieberman et al asked NIEHS to review the CDC’s work on the vaccine database and report back with critiques and suggestions.

The final NIEHS report detailed where the CDC went wrong in its design, conduct and analysis of the study. The NIEHS panel “identified several serious problems,” with the CDC’s effort, criticism to which the agency had not responded until Dr. Gerberding delived her undated report referenced above.

The NIEHS had criticized CDC for failing to account for other mercury exposures, including maternal sources from flu shots and immune globulin, as well as mercury in food and the environment.

“CDC acknowledges this concern and recognizes this limitation,” the Gerberding reply
says.

The NIEHS also took CDC to task for eliminating 25% of the study population for a variety of reasons, even though this represented, “a susceptible population whose removal from the analysis might unintentionally reduce the ability to detect an effect of thimerosal.” This strict entry criteria likely led to an under-ascertainment” of autism ases, the NIEHS reported.

“CDC concurs,” Gerberding wrote, again noting that its study design was “not appropriate for studying this vaccine safety topic. The data are intended for administrative purposes and may not be predictive of the outcomes studied.”

Another serious problem was that the HMOs changed the way they tracked and recorded autism diagnoses over time, including during the period when vaccine mercury levels were in decline. Such changes could “affect the observed rate of autism and could confound or distort trends in autism rates,” the NIEHS warned.

“CDC concurs,” Dr. Gerberding wrote again, “that conducting an ecologic analysis using VSD administrative data to address potential associations between thimerosal exposure and risk of ASD is not useful.”

So, the Director of the CDC is now saying that its most powerful and convincing piece of exonerating evidence for Thimerosal is, in effect, “useless.” This after years of
propagandizing the American public in violation of the law, after holding the illegal secret Simpsonwood meeting when all of this was revealed – including to a representative of the AAP!

Now we have a generation of pediatricians, who face perhaps the greatest iatrogenic accident in the history of pediatrics, who actually need to be deprogrammed to understand what the true nature of all the neuro-behvioral problems are that they confront without any understanding of etiology or potential interventions.

The most serious message that affected children have sacrificed themselves for still goes unheeded. The message is that the level of industrial pollution we are exposing ourselves to is so great now, that just a little more toxic load will push us over the edge.

It pushed a generation of children over the edge and so while we ponder who is going to pay for the many who will go on full disability, we should ponder the fate of our species as well.

(Special thanks to the journalist David Kirby.)

Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy Hardcover – April 1, 2005

by David Kirby (Author)

In the 1990s reported autism cases among American children began spiking, from about 1 in 10,000 in 1987 to a shocking 1 in 166 today. This trend coincided with the addition of several new shots to the nation’s already crowded vaccination schedule, grouped together and given soon after birth or in the early months of infancy. Most of these shots contained a little-known preservative called thimerosal, which includes a quantity of the toxin mercury.

Evidence of Harm explores the heated controversy over what many parents, physicians, public officials, and educators have called an “epidemic” of afflicted children. Following several families, David Kirby traces their struggle to understand how and why their once-healthy kids rapidly descended into silence or disturbed behavior, often accompanied by severe physical illness. Alarmed by the levels of mercury in the vaccine schedule, these families sought answers from their doctors, from science, from pharmaceutical companies that manufacture vaccines, and finally from the Center for Disease Control and the Food and Drug Administration-to no avail. But as they dug deeper, the families also found powerful allies in Congress and in the small community of physicians and researchers who believe that the rise of autism and other disorders is linked to toxic levels of mercury that accumulate in the systems of some children.

An important and troubling book, Evidence of Harm reveals both the public and unsung obstacles faced by desperate families who have been opposed by the combined power of the federal government, health agencies, and pharmaceutical giants. From closed meetings of the FDA, CDC, and drug companies, to the mysterious rider inserted into the 2002 Homeland Security Bill that would bar thimerosal litigation, to open hearings held by Congress, this book shows a medical establishment determined to deny “evidence of harm” that might be connected with thimerosal and mercury in vaccines. In the end, as research is beginning to demonstrate, the questions raised by these families have significant implications for all children, and for those entrusted to oversee our national health.

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