One Thing We Know About Autism: Vaccines Aren't to Blame
...The original research began to be discredited as early as 1999, when two studies commissioned by the U.K. Department of Health found no evidence that immunizations were associated with autism. In 2001, a panel of 15 experts from the Institute of Medicine, which advises Congress, found no connection between the measles, mumps, and rubella (MMR) vaccine and autism. In 2004, a comprehensive review by the Institute of Medicine found no causal relationship between vaccines and autism.
But it would take almost another decade for the furor to even begin to die down. A study this year in The Journal of Pediatrics may at last put the final nail in the coffin of the discredited research. In April, researchers published a study that looked at nearly 1,000 children and concluded that exposure to vaccines during the first two years of life was not associated with an increased risk of developing autism.
Increasing Exposure to Antibody-Stimulating Proteins and Polysaccharides in Vaccines Is Not Associated with Risk of Autism - Frank DeStefano, MD, MPH1, Cristofer S. Price, ScM2, and Eric S. Weintraub, MPH1
http://jpeds.com/webfiles/images/journals/ympd/JPEDSDeStefano.pdf
Critique of Destefano et al. 2013 J Peds. Study
February 15, 2014 Can We Trust the CDC Claim that There is No Link Between Vaccines and Autism?
The
CDC released a “new” study on “Good Friday” just before the Easter holiday
weekend that supposedly showed there was no connection between vaccines and
autism. One has to wonder on the timing of the announcement of this study,
considering the fact that the CDC just released statistics about two weeks
ago stating that the rate
of autism among school children in the U.S. has now risen to one out of 50.
So I contacted Dr. Brian Hooker and asked him to respond to this “new” study that the mainstream media is reporting has ended the vaccine-autism debate. According to Dr. Hooker, the study is not so new, as it is based on data from 2010 and is basically a rehash of a “fraudulent” study published then.
Why did we ask Dr. Hooker to comment? There are probably very few people in the world who have spent as much time looking at CDC studies related to vaccines and autism as Dr. Hooker. Dr. Brian Hooker, a PhD scientist, has been fighting the CDC since 2004 in trying to get them to comply with Freedom of Information Acts to see the CDC research that supposedly shows there is no link between mercury in vaccines and autism. The CDC apparently believes they are above the law regarding the Freedom of Information Act, and have fought to withhold most of the information Dr. Hooker has requested. But as you will see from Dr. Hooker’s critique below, even what the CDC does publish and make public doesn’t amount to much of anything that will help us understand the problem of the rising rates of autism, let alone solve it.
Here are Dr. Hooker’s comments on the CDC study just published in The Journal of Pediatrics.
Critique of Destefano et al. 2013 J Peds. Study By Brian S. Hooker, Ph.D., P.E.
The recent CDC study “Increasing Exposure to Antibody-Stimulating Proteins and Polysaccharides in Vaccines Is Not Associated with Risk of Autism” by Destefano et al. 2013 was released in the Journal of Pediatrics last week. This study purports that “increasing exposure to antibody-stimulating proteins and polysaccharides in vaccines during the first 2 years of life was not related to the risk of developing an ASD (Autism Spectrum Disorder).” Of all of the papers I have reviewed over my 26-year career as a research scientist, this is perhaps the most flawed and disingenuous study I have encountered. The Destefano et al. 2013 study is to science what the movie Ishtar was to cinema.
The basis for the study is essentially a rehash of the data that was used to generate the fraudulent Price et al. 2010 Pediatrics study (Price et al. 2010 “Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism” Pediatrics 126:656) that was supposed to be the CDC’s “final word” stating that thimerosal, the mercury-containing preservative in some vaccines, was in no way causally linked to autism. Not only was this original study fatally flawed due to a statistical error called “overmatching” (which I’ll discuss further below) but also the study authors hid data regarding the only valid part of the study (i.e., prenatal thimerosal exposure) which showed that children exposed to just 16 microgram mercury in thimerosal in utero were up to 8 times more likely to receive a diagnosis of regressive autism (Price C, et al. Thimerosal and Autism. Technical report. Vol I. Bethesda, MD: Abt Associates Inc; 2009). The study authors instead falsely reported no risk of autism associated with prenatal thimerosal exposure.
Within the Destefano study released last week, with the help of multimillionaire vaccine industrialist Dr. Paul Offit, CDC researchers merely added up the number of vaccine antigens that the case (autism) and control (neurotypical) children were exposed to through the infant vaccination schedule. The theory that they were trying to refute essentially was “children exposed to a greater total number of antigens had a greater risk of autism.” Given this train wreck of a study, it is very difficult to know where to start my critique. However, the following statement stood out from the rest as the study authors described the control group:
Of the remaining 752 controls included in the analysis, 186 had an SCQ
(Social Communication Questionaire) score <16 but had indications of speech
delay or language delay, learning disability, attention deficit
hyperactivity disorder or attention deficit disorder, or tics, or had an
individual education plan.
This clearly shows that the 186 aforementioned controls (25% of the
control group) were not controls at all but instead had some
underlying developmental deficit (all of which are features of autism or
autism spectrum disorder). Unlike the study design described (i.e.,
where autism cases were matched to neurotypical controls), autism cases were
matched with “cases” of other, similar neurodevelopmental maladies. Thus,
you would expect to see no difference between the two groups.
Next, the basis of the study was to confirm or deny a correlation between the “number of antigens received” and the incidence of autism. The possible number of antigens per given vaccine was reported in Table 1 of the study. However, the term “number of antigens” is a complete white-wash of what is actually in these vaccines, their concentrations and their relative strengths in terms of inflammatory response, and is not an accurate predictor of how the body will respond to specific antigens.
For example, “antigens” for the five antigen DTaP vaccines (e.g., Infanrix) include diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous hemagglutinin and pertactin. The number “5” assigned in this category is merely the number of different antigens and doesn’t account for each antigen’s amount or relative strength.
Neither does this account for the fact that Infanrix also contains aluminum (an adjuvant – designed to elicit a non-specific immune response), formaldehyde and polysorbate 80, all which could also elicit some form of inflammatory reaction.
Thus, the main “independent” variable of “number of antigens” within the
Destefano et al. 2013 study is essentially completely meaningless.
High Participant Refusal Rate Creates Selection Bias
The high participant refusal rate in this study is also problematic. Out of 668 cases and 2444 controls originally selected for the study, only 321 cases (48.1%) and 774 controls (31.7%) chose to participate in the research. In other words, 65% of the individuals contacted as potential participants flat-out refused to participate in the study.
Who could blame them?! The CDC has been producing junk science regarding vaccines and autism since 2002 and the public knows. This indeed could produce selection bias in that the 35% of individuals that did participate were less likely to believe that vaccines were responsible for neurodevelopmental sequelae including autism.
Also, the analysis is plagued with a statistical error called “overmatching.” For a comprehensive analysis of the previous CDC study completed on the same data set (Price et al. 2010 Pediatrics), regarding thimerosal exposure rather than the number of vaccine antigens, please see Chapter 6, “Vaccine Safety Study as an Interesting Case of ‘Over-Matching’” by M. Catherine DeSoto and Robert Hitlan (http://www.intechopen.com/books/recent-advances-in-autism-spectrum-disorders-volume-i/vaccine-safety-study-as-an-interesting-case-of-over-matching-) in the book “Recent Advances in Autism Spectrum Disorders – Volume I”, edited by Michael Fitzgerald, ISBN 978-953-51-1021-7.
The point made by Dr. DeSoto and Dr. Hitlan is that the cases and the controls in this study are too closely matched to each other. Cases were matched with controls of the same age, sex, within the same HMO and essentially the same vaccination schedule using the same vaccine manufacturers. This may be seen in Figures 1 and 2 of the Destefano et al. 2013 paper which indicated that there are almost no differences between the exposure to antigens between the case (autism) and control groups in every exposure group tested. This holds for cumulative antigen levels (Figure 1) as well as single day antigen exposure levels (Figure 2).
This type of error of course precludes “finding a difference” between
cases and controls because all differences were matched out case-by-case.
This would be akin to analyzing radiation workers that got the same dosage
of gamma radiation within cases and control groups to determine the
relationship between gamma radiation and cancer incidence. Of course,
since cases and controls got the same dosage, no effect would be seen.
However, this is an unfair study. To see the true
effect, cases would need to be matched with controls with variable levels of
gamma radiation exposure and perhaps a “no exposure” group would be included
as a baseline comparison to cancer rates within higher exposure groups.
In the same way, the CDC has used these overmatched data to obfuscate any true effect between vaccine antigen exposure and autism incidence.
This points back to the study that the CDC refuses to do: Health
outcomes between vaccinated and unvaccinated populations.
What is the CDC’s point?
Ethics – i.e., we don’t believe that is ethical NOT to vaccination
children?… Nonsense – there are portions of the United States’
population that choose not to vaccinate regardless of what CDC believes;
Lack of “blinding” within the study design?… again, Nonsense – all current
vaccine safety studies are retrospective anyway without any type of blinding
to the subjects.
The CDC is simply afraid of what they already know – vaccines cause chronic disease and an unvaccinated population will be much healthier, period (as evidenced in the Glanz et al. 2013 study within the Journal of the American Medical Association which stated that unvaccinated children were seen at a lower rate of frequency in emergency room and outpatient visits).
(Editor’s note: See our commentary on the JAMA study here: JAMA Study: Kids With Fewer Vaccines Have Fewer Doctor and Emergency Room Visits)
Finally, this type of study misses the point entirely that children with autism are physiologically different than neurotypical children. Numerous studies have shown genetic (e.g., James et al. 2006), morphological (e.g., Herbert et al. 2005) and biochemical differences (e.g., Waly et al. 2004) between these two populations. To perform a case-control study such as that presented in the Destefano et al. 2013 paper assumes a genetically, morphologically and physiologically homogeneous population, which is simply not the case.
No one is claiming that children with autism or ASD got higher doses of vaccine antigens, thimerosal, MMR or whatever. What we know instead is that when our children received the same vaccines within the ACIP recommended schedule, they reacted differently. The scientists at the CDC are trained in managing infectious diseases with progressions that may be predicted with reasonable certainty. However, these neurological sequelae to vaccines are chronic, multifactorial conditions that cannot be put into the same tiny box as the common cold, influenza or chicken pox.
It also needs to be pointed out the CDC is responsible for vaccine uptake in the United States. By their own standards, they believe that vaccine compliance should be at 90% for “herd immunity” to prevent infectious disease outbreaks.
Without going into the flawed logic behind this assertion, my point is that the CDC (and the DHHS as a whole) should not be conducting ANY type of vaccine safety study, based on their primary mandate of maximizing vaccine uptake. Their role is conflicted at best.
This has led to a long list of studies on vaccines and neurological disorders in children that are at a minimum fatally flawed but more often complete misrepresentations of the truth. Starting in 1999, when the CDC buried strong associations between thimerosal exposure early in life (0 to 1 month), where infants exposed to the highest levels of thimerosal possible were at least 7.6 times more likely to receive an autism diagnosis through this current study, there has been developed a full body of “tobacco science” designed to hide the truth of what has been found behind closed doors.
It is time for the CDC to come clean. Their own data show that vaccines cause neurodevelopmental disorders in children including autism.
Brian
S. Hooker, PhD, PE, is an Associate Professor of Biology at Simpson
University in Redding California where he specializes in chemistry and
biology. Additionally, Hooker is the Senior Process Consultant at ARES
Corporation, working closely on process design for the environment
restoration industry. His design efforts focus on industrial biotechnology
and chemical engineering principles. Brian dedicated over 15 years as a
bioengineer and the team leader for the High Throughput Biology Team and
Operations Manager of the DOE Genomics: Genomes to Life (GTL) Center for
Molecular and Cellular Systems at the Pacific Northwest National Laboratory
(PNNL). Dr. Hooker managed applied plant and fungal molecular biology
research projects at the Pacific Northwest National Laboratory,
where systems biology researchers are focused on understanding gene and
protein networks involved in individual cell signaling, communication
between cells in communities, and cellular metabolic pathways. In 1985, Dr.
Hooker earned his Bachelor of Science degree in chemical engineering, from
California State Polytechnic University, Pomona, California. He earned his
Masters of Science degree in 1988 and his doctorate in 1990, both in
biochemical engineering, from Washington State University, in Pullman,
Washington.
Brian Hooker has many accomplishments to his credit including: co-inventor for five patents, recipient of the Battelle Entrepreneurial Award in 2001, and a Federal Laboratory Consortium Recognition Award in 1999, for his work on “Reactive Transport in 3-Dimensions.” The breadth of Hooker’s 50 science and engineering papers have been published in internationally recognized, peer reviewed journals. He has a 15-year old son with autism and has been active in the autism community since 2004.
Contact Dr. Hooker via Health Impact News here.
Copyright 2013 Health Impact News. Health Impact News and Dr. Brian Hooker grant full permission to republish this article. Citiation for original source is appreciated.
Critique of the 6 epidemiological studies used to exonerate thimerosal containing vaccines
http://www.bolenreport.com/Mark%20Geier/critique_of_the_6_epidemiologica.htm
Brian Hooker PhD
Six epidemiological studies have been used to “refute” the link between thimerosal and autism. These are:
- “Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data” by Kreesten Madsen et al. 2003, published in the journal Pediatrics
- “Autism and thimerosal-containing vaccines: lack of consistent evidence for an association” by Paul Stehr-Green et al., 2003, published in the American Journal of Preventative Medicine
- “Association between thimerosal-containing vaccine and autism” by Anders Hviid et al., 2003, published in the Journal of the American Medical Association
- “Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases” by Thomas Verstraeten et al., 2003, published in the journal Pediatrics
- “Thimerosal exposure in infants and developmental disorders: a retrospective cohort study in the United kingdom does not support a causal association” by Nick Andrews et al., 2004, published in the journal Pediatrics
- “Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism” by CS Price et al., 2010, published in the journal Pediatrics
This critique will consider each publication from two perspectives: (1) the scientific quality and (2) any anomalies based on information obtained from the Centers for Disease Control and Prevention via the Freedom of Information Act.
The publication reports an ecological study based on the reported autism incidence in Denmark as recorded in the Denmark National Center for Registry-based Research (NCRR) database. Denmark phased thimerosal containing vaccines out of circulation in 1992. The authors’ premise is that if there is a causal relationship between autism and thimerosal containing vaccines, then the prevalence of autism should decrease in subsequent years. Instead, the study showed a dramatic increase in the number of new autism diagnoses in the years following thimerosal removal, in age groups 2-4, 5-6 and 7-9 years old.
This paper has two severe methodological flaws. First, the Denmark NCRR database changed diagnostic criteria for autism diagnoses in 1994 from ICD8 to ICD10. This led to a greater number of autism diagnoses overall. Second, the Denmark NCRR database changed the accounting of autism based on outpatient visits in 1995, whereas up to 1995, only inpatient (i.e., Hospital) visits were accounted. This led to a significant increase in autism cases counted beyond 1994. In a separate publication, the ratio of inpatients to outpatients accounted for by the NCRR database has been reported to be 13.5:1 (Madsen et al. 2002). These two data artifacts (changing diagnostic criteria and inpatient/outpatient reporting) show a misleading jump in the prevalence of autism after 1995. However, when these are corrected for, the actual autism rates in Denmark decreased by as much as 4 times upon the phase out of thimerosal-containing vaccines (Trelka et al. 2004). Although the raw data from the Madsen et al. 2003 publication has been requested, the authors chose not to release it, creating significant difficulty in confirming this decrease.
It is apparent from emails released by the CDC via the FOIA, that the lead
author of the study, Dr. Kreesten Madsen, was well aware of the issues with
the Denmark NCRR database. In fact, in a June 2001 email to then
acting Deputy Director of the National Immunization Program (NIP) of the
CDC, Diane Simpson, Dr. Madsen stated of the increases in autism rates after
1993, “Yes, but not very dramatically and there could be more reasons for
that. First of all we had a change from ICD8 to ICD10 in 1994 and
furthermore our outpatient clinics were registered in our surveillance from
1995.” It wasn’t until after Dr. Diane Simpson visited Denmark to
forge a collaboration with Madsen’s supervisor at Aarhus University that
this publication went forward.
In addition, an additional email obtained from the CDC indicates that the
autism rates in Denmark decreased between 1999-2001: from Dr. Marlene
Lauritsen a coauthor from Aarhus University to Dr. Diana Schendel, a
scientist in the National Center for Birth Defects and Developmental
Disabilities (NCBDDD) of the CDC, “I need to tell you that the figures in
the manuscript do not include the latest data from 2001. I only have these
figures as a paper version and they are at work
Finally, although the CDC claims that this is an independent publication,
co-author Dr. Poul Thorsen was in residence at the CDC at the time of the
study. In addition, Dr. Thorsen made a specific request that Dr. Jose
Cordero, then director of the NCBDDD write a letter to the editor of the
journal Pediatrics for expedited review and publication of the Madsen et al.
2003 study. Dr. Thorsen in April, 2011 was indicted by the U.S.
Attorney in Atlanta, Georgia for embezzlement of funds from a CDC grant to
his institution, the North Atlantic Neuro-Epidemiology Alliance.
This paper is more of a “ecological review” of autism prevalence data obtained from California, Sweden and Denmark to deny a causal relationship between thimerosal containing vaccines and autism. The treatment of the California data was more of a critique of the Blaxill 2001 presentation to the Institute of Medicine Immunization Safety Review committee, where it was shown that increased uptake of thimerosal containing vaccines in California during the 1990’s resulted in a corresponding increase in autism diagnoses. Here the authors criticized the reliability of the autism prevalence data, citing that the California data included autism spectrum disorder diagnoses such as Pervasive Development Disorder, which could account for the increase.
The treatment of Sweden autism prevalence data showed an increase in autism rates from 5-6 cases per 100,000 to a peak of 9.2 cases per 100,000 in 1993. Thimerosal was removed from vaccines in Sweden in 1987. The treatment of Denmark autism prevalence data was identical to that done in the Madsen et al. 2003 paper critiqued previously. The authors reported an astounding 20-fold increase in autism prevalence between 1990 and 1999, despite the removal of thimerosal from vaccines in 1992. The most glaring flaws of this paper are the treatment of the Denmark prevalence data, which is discussed previously. In addition, the data from Sweden were based on inpatient (Hospital) visits only. This limitation (counting a minority of the total number of cases) likely accounted for the erratic swings in the annual numbers of autism cases reported in that country. Also, the thimerosal exposure level based on the Sweden vaccination schedule during this time period was much less than that seen in California and the United States as a whole. Finally, concerning the California prevalence data, the study authors erred by citing PDD data inclusion. In fact, the California prevalence data reported by Blaxill in 2001 included only cases of “full blown” autism. The increase in autism prevalence in California has been since shown to be real by two separate peer reviewed studies.
Emails obtained from the CDC via the FOIA show that study co-authors Dr. Paul Stehr-Green (CDC consultant) and Dr. Diane Simpson (acting Deputy Director of the NIP) were scouring other countries from autism prevalence data to counter the October 2001 IOM ISR committee report citing that the relationship between thimerosal containing vaccines and autism is biologically plausible. Dr. Stehr-Green and Dr. Simpson traveled in Denmark and Sweden in August 2001 and very hastily formed collaborations with institutions in these countries that stewarded autism prevalence data. In an August 7, 2001 email prior to the trip, Dr. Simpson wrote, "I don't have any new data at the moment and am frantically trying to see what is available and how best to get it in time for the expected IOM report release (we have given up trying to submit it in time for the report as they are in the process of writing it)." In a separate email to Dr. Stehr-Green and Dr. Roger Bernier (Science Director of the NIP), Simpson writes “It is possible that the data won’t help us at all, but we won’t know until we see it.” By this, she is inferring that “helpful” data would oppose the IOM ISR committee report and counter a causal relationship between thimerosal containing vaccines and autism. Thus, Dr. Simpson had a bias prior to writing the publication and demonstrated a vested interest in exonerating thimerosal using the Sweden and Denmark autism prevalence data.
This is a population-based cohort study comparing rates of autism prevalence among individuals who received thimerosal free vaccines versus those receiving thimerosal containing vaccines. The authors report that there was no evidence of increased autism prevalence with thimerosal exposure and that thimerosal seemed to have a “protective effect” against autism.
Criticisms of this study include the fact that the Denmark registry that holds the data allows 10-25% of diagnosed autism cases to be lost from its records each year. Thus, the effect of this loss is such that the records will disappear from older age groups to a much greater degree than from younger age groups in any given registry year. This is seen in the study, which is skewed towards younger children that did not receive thimerosal containing vaccines (i.e., they were vaccinated after 1992). When a correction was applied (Safeminds, 2004), an increase in autism prevalence was 2.3 times greater in the group that received thimerosal containing vaccines.
This study comprised a comprehensive analysis of medical databases for three HMOs in a central data repository, the Vaccine Safety Datalink. This particular study was done in five separate phases. In the final phase (i.e., that reported in the publication), the authors claim there was no relationship between thimerosal exposure in vaccines and autism incidence. However, no data is reported to support this assertion.
Data from the first 4 phases of the study have been obtained (either via the FOIA or where the CDC directly reported the data). The first phase of the study (results obtained via FOIA) showed that infants that were exposed to 25 micrograms (ug) of mercury in their infant vaccines by age one month were 7.62 times more likely to have an autism diagnosis than those not exposed to any mercury. The study author, Thomas Verstraeten (then at the CDC) said of the correlation in an internal email, “It just won’t go away”.
In the second phase of the study, a different approach was taken: exposure was compared at 3 months of age, rather than one month. However, like the first phase, children exposed to the maximum amount of mercury in infant vaccines (62.5 ug) were 2.48 times more likely to have autism diagnosis compared to those not exposed to mercury in vaccines.
In the third phase of the study, more data stratification methods and exclusion criteria were applied to the analysis and the increase in risk for children at three months dropped to 1.69 times. At this point, it is evident that Verstraeten is receiving pressure within the CDC to apply methods to deny a causal relationship between thimerosal and autism. In an email written to a colleague outside of the CDC, Verstraeten states, “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 an unpleasant theory.”
The fourth and fifth phase of the study incorporated a third HMO, Harvard Pilgrim, into the analysis. Some critics of the study questioned the use of Harvard Pilgrim as the HMO was riddled with questionable record keeping practices, 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 Phases 1 through 3. Other criticisms include that the study used younger children, from 0 to 3 years of age, even though the average age for an autism diagnosis at the time was at 4.4 years.
Finally, Dr. Verstraeten, who left the CDC and spent most of the two years prior to publication of the study as an employee of vaccine manufacturer GlaxoSmithKline, made a statement in 2004 that appeared in the journal Pediatrics 9 months after the publication of his study. In this statement, he says, ““The perception of the study changed from a positive to a neutral study,” and continues “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.”
This is a retrospective cohort study completed using records from the United Kingdom, where autism prevalence rates were compared for children receiving thimerosal containing DTaP and DT vaccines. The study authors report no correlation between the number of doses of vaccine and the incidence of autism and reported that thimerosal exposure had a protective effect against autism.
The main technical problem with this study is that the authors used a non-transparent, multi-variate regression technique to analyze vaccine uptake and autism prevalence data. The study included one dependent variable (autism), and multiple independent variables, including two independent variables (thimerosal exposure levels, and year of birth) that were “correlated” with each other, since thimerosal exposures went up with time. This creates a well-known problem in regression known as "multicollinearity". It is illogical to include both variables unless you believe the increases over time are only due to improved awareness. If there is no logic to including a variable in a regression model, it simply doesn’t belong there. In this case, since the time variable and the vaccine exposure variable are correlated, they actually compete to explain the outcome effect. Inclusion of the time variable reduces the significance of the exposure variable. Yet the authors never explained why they included a time variable that correlates and competes with the exposure variable. Instead, the Andrews model assumes implicitly that increased autism rates are due to time trends alone. Unfortunately, the authors of this study have refused to release their raw data. Accordingly, a single variable analysis cannot be completed.
Interestingly, emails obtained via FOIA indicate that Dr. Thomas Verstaeten at the CDC had decision authority as to whether this study would receive funding. Thus, this study, like the prior 4, may be tied directly to the CDC. In an email exchange with Dr. Robert Chen (also of the CDC), Verstraeten states the following about the UK study, “"The maximum exposure [in Britain] is indeed relatively low...my estimate is that you need at least >50 [mcg of mercury] by 3 months or >100 by 6 months to see an effect if there is one which you barely make...I hate to say this, but given these concerns, it may not be worth doing this after all. On the other hand, maybe the grant can be given to Harald in Sweden..." In response to this, Elizabeth Miller (GPRD – UK), the study lead author, replies, “If this is true, then do we have sufficient exposure to ethyl Hg (i.e., thimerosal) by 4-6 months of age to pick up an effect? Do I have to give my GPRD money from WHO back???”
Again, this shows that Verstraeten and Chen of the CDC exerted financial control over the UK study. Also, this belies the fact that the UK thimerosal exposure was not comparable to that in the United States and that this study should not be extrapolated to autism-thimerosal correlation based on the US vaccination schedule.
This study is comprised of the evaluation of the thimerosal exposure levels
in a small study set of autistic children versus similar exposure in a
control group of “neurotypical” children. The study was stratified
into 4 exposure categories: prenatal, birth to one month, birth to seven
months and birth to 20 months. No statistically significant difference
was seen in the likelihood of receiving an autism diagnosis based on the
level of mercury exposure within these categories.
The authors erroneously report that this is a study of the relative risk of
autism with increasing levels of prenatal and postnatal thimerosal exposure.
Instead, this is a study that determines the relative amount of thimerosal
exposure between a group of autistic children and neurotypical children.
This answers the wrong question. The question isn’t whether autistic
children received greater exposure to thimerosal. Instead, the
question should be “does the risk of receiving an autism diagnosis increase
with increasing thimerosal exposure.” Such an analysis was not
completed in this study.
Additionally, the study size is very limited (256 autistic and 752 control individuals). Within this group, further stratification is completed based on pre- and postnatal thimerosal exposure, further limiting the statistical power of the study. The data from this study were taken from the Vaccine Safety Datalink (VSD), which has been deemed inappropriate for this type of study by the 2006 National Institute for Environmental Health Studies 2006 committee “Thimerosal Exposure in Pediatric Vaccines: Feasibility of Studies Using the Vaccine Safety Datalink.” This is due to problems with case ascertainment via administrative data which may lead to both false positives and missed cases, heterogeneity in business practices across the managed care organizations (MCOs) comprising the VSD (there were 3 different MCOs represented in the Price et al 2010 study), difficulties in linking children’s records to their mothers’ and poor estimation of total mercury burden.
Also, by considering prenatal and postnatal thimerosal burden separately, the study authors have not accounted for mercury exposure outside of the parameter study period. In other words, prenatal cohort analyses were not evaluated for postnatal exposures and vice versa. Finally, the covariate analysis completed on the cohort sets is ill conceived and runs the risk of introducing errors due to “multicollinearity”. With these additional variables (birth weight, maternal age, birth order, breastfeeding duration, family income, maternal health care–seeking behavior, maternal exposures during pregnancy with study child, and early childhood health conditions), it becomes much easier to “fit” data to the desired outcome.
http://www.bolenreport.com/Mark%20Geier/critique_of_the_6_epidemiologica.htm
Brian Hooker's Testimony From Congressional Autism Hearing
Brian Hooker is the father of a son with autism and he holds a PhD in Biochemical Engineering, in addition to being a dedicated member of the autism community. He also played a role in how the House autism hearing came to be.
My initial thanks go to Dr. Mark Geier and David Geier, who strategically linked me up with a friend of theirs, who in turn has become my good friend as well. Through the work of this individual, Dr. Andrew Wakefield and I were invited to meet with Rep. Darrell Issa, Rep. Vern Buchanan and their wives in early May, 2012 to discuss malfeasance in the CDC regarding autism and vaccines. Andy discussed the MMR vaccine and the vaccine schedule. I talked specifically about thimerosal and the cover-up of CDC data that affirm a causal relationship between thimerosal and neurodevelopmental disorders including autism. Rep. Issa was concerned regarding the CDC information and stated that this was the type of government misconduct that his committee (Oversight and Government Reform) specifically addressed.
I was in DC for a National Science Foundation function later the same month and had the opportunity to meet with Reps. Issa and Buchanan again, this time with Rep. Dan Burton. Rep. Issa affirmed his commitment to hold a hearing at that time. Rep. Burton detailed his valiant efforts to get the CDC and large pharma to remove mercury from vaccines and indicated that they wouldn’t listen to him.
I’ve worked very diligently since May with the Oversight committee staff to convey what I had found via the FOIA and to get additional information from CDC relevant to thimerosal. Along the way, I gained the support of Barry and Dolly Segal, through Focus Autism and they have become pivotal to this entire effort. In addition, I received a very significant amount of assistance from Dawn Loughborough, Bob Krakow, Bobbie Manning and Louise Habakus. They are all amazing sources of insight and have advised me throughout the process. I also need to acknowledge my friends at EBCALA, especially Louis Conte, Rolf Hazlehurst, Becky Estepp and Kevin Barry, who have been working with the committee staff very effectively regarding NVICP reform.
I was able to meet with the Oversight committee staff several times between May and November, up to the day before the hearing, to discuss the pertinent details. I also was corresponding with Beth Clay from SafeMinds who was working very diligently on the issue as well. When the committee staff finally indicated the participants in the panel, I was disappointed because there was only one participating organization (Safeminds) that included the relationship of vaccines (specifically thimerosal) to autism causation within their mission.The rest of the panel would either avoid the issue or deny any causal relationship. Given the importance of autism causation, this was just not a balanced panel.
I asked Brian about his efforts to gather information about the actions of the CDC.
What kind of information were you seeking from the CDC with your FOIA requests?
All kinds. I have made over 100 FOIA requests to the CDC over the last 8 years and received thousands of pages of information. This has been a very thorough compilation of work. David Geier, who is my mentor regarding the FOIA, got me started doing FOIA requests back in 2004. David has also reviewed nearly everything I have received.
I have specifically requested information for the 5 CDC studies on thimerosal and autism prior to 2004 that led to the IOM Immunization Safety Review Committee report “Vaccines and Autism” released in May 2004. In this report, primarily due to committee chairperson Dr. Marie McCormick (Harvard University) and study director Dr. Kathleen Stratton (IOM), causation was denied between thimerosal containing vaccines and autism (as well as the MMR vaccine and autism). This report also effectively shut down government funding for any further "independent" research on vaccines and autism. This information is crucial, given the constant reference that the CDC and others make to the 2004 IOM report. Most of the key components of the FOIAed information have been completely redacted by the CDC.
I also requested information on PoulThorsen and his connection to CDC, obviously because of his co-authorship in studies that bolstered the body of evidence denying vaccine causation in autism and his known culpability and fraud indictments, being on the DHHS OIG Most Wanted Fugitive list. The majority of this information has been withheld by the CDC.
Finally, I have requested information on two of the latest CDC studies again denying causation between neurodevelopmental disorders (NDDs) and thimerosal exposure including Thompson et al. 2007 (NEJM 357:1281) and Price et al. 2010 (Pediatrics 126:656). These two publications are indiscernible from an epidemiology standpoint. This information has yet to be released from the CDC.
For years the CDC has acted as though they’ve seriously addressed the question of a link between vaccines and autism and according to their research; there simply isn’t any. How would you characterize what the CDC has done?
I would challenge anyone who would rely in the veracity of the CDC studies. They've repeatedly, purposefully withheld data that clearly show a link between thimerosal and autism (among other NDD's). They've obfuscated the main issue via obviously biased statistical manipulation. Clearly, the CDC's conflicted role of vaccine advocate and vaccine safety guardian has contributed to this whole problem.
How did the agency charged with the oversight of our children’s health instead become complicit in covering up a disaster?
Several reasons. I believe the physicians and scientists who have
controlled the agenda for CDC for many years have a fear of infectious
disease that is unsupported by science. As a good friend reminded me
recently, the United States by far has the most recommended vaccinations
given to children than any other nation in the world (49 by age 6 years
old), yet we have some of the sickest children. We rank 34th in infant
mortality based on 2009 data. The fear of epidemics of infectious disease
drummed by U.S. public health officials and pharmaceutical manufacturers is
extremely heightened. However, in other countries where they vaccinate less
and had banned thimerosal use many years ago, we do not see evidence of mass
infectious disease spread.
I also believe that thimerosal has not been removed from U.S. vaccines due
to various issues in a concerted effort towards the globalization of
vaccines. This is heavily influenced by three things: (1) perceived
manufacturing and cold chain distribution problems, (2) the influence of the
GAVI Alliance and the World Health Organization involving the preceding
factors and (3) international political considerations because of the
perception in developing nations about distributing thimerosal containing
vaccines there when there is removal of thimerosal here.
Unfortunately we have seen a lack of integrity in other industries, and we can’t assume CDC employees are not immune to falling into this vicious cycle. Many vaccine scientists and other officials look forward to very lucrative careers with pharmaceutical manufacturers after they have worked professionally at CDC. Two rather dubious examples are Dr. Julie Gerberding, former Director of CDC during the last decade who was recently appointed as head of the vaccine division of Merck and Dr. Thomas Verstraeten, who was the lead author of the Verstraeten et al. 2003 study on thimerosal and neurodevelopmental disorders and left CDC for a career at GlaxoSmithKline in July 2001. This revolving door between CDC and pharma is fostered by an incestuous relationship between the two entities, as we have been exposed to many “government-industry” partnerships that are supposed to help provide the U.S. with effective, safe vaccines but instead seem to only help vaccine manufacturers with their bottom line. Also, the pharmaceutical industry is bolstered by the fact that it cannot be sued for vaccine design defects.
This adds up to more and more vaccines given to our most vulnerable citizens. Some of these vaccines still contain thimerosal and are now given to pregnant women, exposing very tiny unborn children to this potent neurotoxin. Both of these factor into the current autism epidemic.
Finally, I hate to even think about it, but I believe that CDC officials are truly afraid of the consequences of completely removing thimerosal and/or revising the current vaccine schedule, limiting the exposure of infants and children to the many vaccine antigens their immune systems now have to endure. What if autism rates do go down? J.B. Handley sent me a T-shirt several years ago with the saying, “If you caused a 6000% increase in autism, wouldn’t you try to cover it up too.”
What difference has your work with Chairman Issa, the committee and creation of this hearing made?"
Well, the coordinated effort to expose malfeasance has enabled our
community, after years of watching the prevalence rising, to have the
hearings and start to get to the bottom of this enormous concern for our
society. With the material I have compiled via the FOIA and other
sources, I present a clear distinction between what the CDC has claimed
publicly and what goes on behind closed doors. In addition, I have
collaborative insight and support from a team of advisors, medical
professional resources and government agency members conferring with me on a
significant body of “evidence of malfeasance” case studies.
My FOIAed documents focus on thimerosal in vaccines so I’ll limit my
comments here to that issue.
As I stated earlier, 2004 IOM Immunization Safety Review Committee report was bought by CDC specifically to say that vaccines don't cause autism and no more government research should be funded regarding that issue. The committee made their "decision" in this regard based solely on 5 epidemiological studies. The scientific merit of these studies is poor and the results have been critiqued very accurately by me and others in our community many times. Quite frankly, challenging the science presented in these papers is like sandblasting a soup cracker.
My goal was to shed light on the malfeasance by the CDC and others around these studies and the 2004 IOM report. This is crucial! Coleen Boyle of the CDC invoked the 2004 IOM report several times when she tried to sidestep questions asked in the hearing. The report has led to grant funds denied for solid research from top universities specifically to address the autism-vaccine question. And, the report was quoted many times by Special Master Hastings in his decision regarding the Cedillo test case of the Autism Omnibus in the National Vaccine Injury Compensation Program in order to deny compensation. This paved the way for the dismissal of the majority of over 5000 cases involving "autism", most without any type of hearing.
I also wanted to drive home the intertwined nature of the relationship between Dr. Poul Thorsen (who was indicted in Federal court on April 14, 2011 for fraud and embezzlement of CDC grant funds) and the National Center for Birth Defects and Developmental Disabilities (NCBDDD). Dr. Thorsen wrote 36 papers in collaboration with NCBDDD scientist Dr. Diana Schendel, many as "cover" to deflect the issue of autism causation from vaccines. It is unclear whether CDC continues to work with Thorsen, but four papers, co-authored by Thorsen and Schendel, have appeared in the scientific literature since his Federal indictment. Why is this happening?
Shouldn't the veracity of all 36 publications be investigated by CDC? Thorsen received the majority of his grant funds from CDC after the Madsen et al. 2003 Pediatrics publication. Thorsen co-authored the paper and coordinated (with Dr. Boyle) the CDC review and recommendation of publication to Pediatrics. It is perhaps the most blatantly fraudulent of the 5 studies quoted in the 2004 IOM report, as the Madsen et al. authors claimed that autism rates went up after the removal of thimerosal from vaccines in Denmark in 1992. I really want to know why CDC paid Thorsen so handsomely after this paper was published, given the fact that the original Madsen manuscript was rejected by the Journal of the American Medical Association and the Lancet, prior to finally being accepted in the journal Pediatrics.
How did it happen that you weren’t allowed to speak at the hearing?
I had been told by Oversight committee staff prior to Thanksgiving that I would not be testifying and I was not on the original list of speakers that appeared on the Oversight committee website on Monday, November 26, prior to the hearing. However, on Tuesday after I arrived in DC, I was notified that Chairman Issa had added me to panel. I stayed up until 3:00 a.m. preparing my testimony. Later, on Wednesday, the Oversight committee staff informed me that someone from the minority side of the committee had been blocking me from testifying and that the Rules of Order did not allow for Chairman Issa’s last minute addition. I don't know who specifically kept me off of the panel or why at this time. Chairman Issa kindly recognized my involvement at the start of the hearing and provided great, front-row seats for me and my good friends Barry and Dolly Segal and Dawn Loughborough, all who contributed immensely to the success of the hearing.
Since you did attend the hearing, what are your feelings about what was said?
First of all, Mark Blaxill of Safeminds did a great job highlighting the connection between environmental factors and autism, and included a slide in his testimony that showed the connection between thimerosal and autism. He also was able to address the complete lack of effectiveness of IACC as well as Mr. Michael Carley's erroneous assertions about diagnostic substitution and the current autism epidemic.
Dr. Boyle and Dr. Alan Guttmacher (NIH) were evasive in their testimony and the committee members were very concerned about this. Many statements by Dr. Boyle from the CDC are not supported by the information I have via the FOIA. This is a matter of great concern to the committee and it’s a bipartisan issue. Although Boyle invoked the 2004 IOM report to deflect questions regarding vaccines and autism, she omitted the fact that even this report could not exclude that a significant portion of new autism cases were caused by vaccines in a genetically susceptible subset.
The questions regarding vaccines and autism posed by the committee members were extremely encouraging. Rep. Bill Posey and Rep. Vern Buchanan (my heroes) really were able to drill down to the heart of the issue by challenging Dr. Boyle on the current state of the science regarding causation and the lack of a vax/unvax study. It was like listening to Dr. Dave Weldon (former rep. from Florida) in stereo. In addition, Rep. Burton's call for the removal of mercury from all vaccines was extremely powerful. Also, Rep. Cummings (ranking minority member of the committee), Rep. Maloney and Rep. Smith all highlighted the connection between vaccines and autism within their questions, stemming from a decade of mounting verbal evidence of vaccine causation from their constituents, and requested common sense from the CDC to review the vaccine schedule and thimerosal. Undeniably, the door has been opened for future investigation and better outcomes for our children.
Of the 8 panelists that spoke, only one (Mark Blaxill) spoke about autism
causation related to vaccination, when specifically questioned by the
committee members. Of the remaining panelists, Autism Speaks co-founder Bob
Wright in his opening remarks, mentioned that his daughter, Katie Wright was
concerned that vaccines were involved in his grandson’s autism. Four
panelists did not speak to the issue and two actually denied a connection
between vaccines and autism. In my opinion, this is not a balanced
panel. If it weren't for the many questions raised by the committee
members (due in large part to many great parents in our community that
visited, called or wrote these representatives), the vaccine autism issue
would have been woefully underrepresented.
What do you hope the federal government will do next?
In his remarks to me after the hearing, Chairman Issa indicated that the committee will continue to investigate the connection between autism and vaccines. This needs to include the thimerosal issue as well as the expanding vaccine schedule where infants are given up to nine vaccines in one day.
The CDC needs a comprehensive, independent investigation, obviously. It shouldn't stop there - the entire Department of Health and Human Services (including CDC, NIH, FDA, the Health Resources Services Administration, etc.) has shown bias against even researching the connection between vaccines and autism and continues to suppress any science that would suggest a link. The National Vaccine Injury Compensation Program should also be investigated, with an emphasis on the whole Omnibus Autism Proceeding. The Oversight committee members need to know that they have the power to stop the autism epidemic by getting to the bottom of this issue.
Posted by Age of Autism at December 06, 2012 at 5:45 AM in Anne
Dachel, Vaccine Safety | Permalink |Comments
(20)