An Overview of the Fourteen Vaccine Studies
Part 4 in the 14 Studies Series
By Julie Obradovic
By now, I hope many of you have downloaded the studies from the 14 Studies website (HERE) , put them in a binder and have started to read them. If not, please consider doing so. This series is meant to prepare our community to best counter the common notion that “science has spoken” and vaccines have nothing to do with Autism. The more of us there are to do that, the more effectively we can change the trajectory of our children’s lives.
At this point we have established the true issue of the debate (should those who will be held accountable for Autism be able to investigate themselves); the context of the debate (the history of why and how they are allowed to); and the positions of those involved (whether or not Autism is a whole body disease with an environmental cause or a purely genetic disorder that is rooted in psychology, and what the implications of those positions mean for research).
We will now begin to examine the results of their internal investigation.
For this article, I will be giving a broad overview of the studies based on 3 categories: the studies as a whole, the Thimerosal studies, and the MMR studies. It isn’t necessary to have read all of the studies just yet, and I will be offering a final summary at the end of the series with much of the same information. Following this article I will analyze each study individually.
To make things a little easier to write, I will be referring to the studies by a letter and a number. For example, if I mention study T5, that means Thimerosal study number 5, just as M5 would mean MMR study number 5. The numbers correlate with the order in which they are presented on the 14 Studies website as well as at the end of this article.
Finally, as I mentioned in my first article, it is not my intention to criticize specific statistical methods, for example. On the contrary, I want to make it simple. I want to have a discussion in lay men’s terms, coupling it with common sense. I want to point out flaws in logic, conflicts of interest, and to analyze the study’s true results. I want to educate the world about what these studies do and do not say so that we can change our children’s future for the better. I hope you’ll join me.
A Collective Overview of What Has and Has Not Been Studied
First of all, and perhaps most important, every single study investigating whether or not vaccines have a causal role in the development of Autism (with the possible exception of M5) was completed and/or funded by someone who manufacturers, patents, endorses, promotes, administers, defends in a court of law, and/or profits from vaccines.
Given that, here is what they have studied about vaccines and Autism:
• Only 1 vaccine ingredient (Thimerosal) out of dozens (HERE) and 1 injection (given sometimes twice) out of 35 (36 if you include the prenatal flu shot) recommended (HERE).
Moreover, of the 19 studies completed, only 6 use US children exclusively, the most vaccinated children in the world (T1, 3, 7, 9, 11 and M1), but 2 of those are irrelevant due to either the question they pose (T3) or because they didn’t assess Autism as a health outcome (T7).
This means there are only 4 studies looking at the role of vaccines in the development of Autism in US children that have been completed: 3 on Thimerosal (1 epidemiological study which came to a neutral outcome T1; 1 somewhat biological study that assumes rapid excretion equals absence of harm T9; and 1 that looks only at the role of the Rhogam shot which not all pregnant women receive, T11) and 1 on the MMR (which replicated Dr. Wakefield’s findings, M1).
And here is what they haven’t studied about vaccines and Autism:
• No study has ever looked at never-vaccinated children and compared them to vaccinated children for different health outcomes including Autism.
• No study of vaccines the way they are currently administered to American children has ever been done (meaning the effect of giving 2, 3, 4 or even more injections at one time). In fact, a CDC document released in April of 2008 states on page 33, “Usually simultaneous vaccination is incompletely studied at time of licensure.” (HERE)
• No study of children who received Thimerosal in their vaccines versus those who did not has ever been done.
• No study has looked exclusively at the children who have regressed following vaccinations for evidence of Thimerosal poisoning. In fact, no study on what Thimerosal poisoning via injection looks like exists (although I think we have a pretty good idea).
• No study has looked at the combination of vaccine ingredients for synergistic properties or toxicities (such as the highly cautioned-against combination of aluminum and Thimerosal, which is something we will look at in more detail next time).
To emphasize: We have studied 1 ingredient and 1 injection a total of 4 times on US children exclusively. All of those studies were funded and/or completed by someone who manufactures, patents, endorses, administers, promotes, profits from or defends in a court of law, vaccines. All of them came to different conclusions: 1 reported we don’t know if Thimerosal is a problem, 1 reported in 1 specific shot it is not, and 1 reported it probably isn’t because it appears to be excreted quickly.
We have never compared rates of Autism among children who have been vaccinated versus those who have not, and we have never done the same among children who received Thimerosal and those who have not. We have also never studied our current recommended childhood vaccination schedule for safety, as "Usually simultaneous vaccination is incompletely studied at time of liscensure."
(And this is what is repeatedly touted as proof vaccines don’t cause Autism.)
Thimerosal Studies Overview
• Again, no study has ever looked at children who received Thimerosal versus those who did not.
• Of the 11 studies looking at Thimerosal, only 10 of them consider Autism (T7 does not), and only 4 of those (T1, 3, 9, 11) were done using US children exclusively.
T1 found a neutral association between Thimerosal and Autism (maybe it causes it, maybe it doesn’t); T3 looks at the rate of Autism in California after thimerosal was no longer used in vaccines and concludes because the rate of Autism rose afterwards, Thimerosal isn’t causal (implying thimerosal prevents Autism), but is actually irrelevant because there was never a time during the study period where thimerosal was no longer used; T9 assumes that what appears to be the rapid excretion of Thimerosal in most of the children studied equates with absence of harm; and T11 only assesses the role of the Rhogam shot given to pregnant women, which not all receive (and the study was funded by the makers of the Rhogam shot).
• Of the 10 studies on Thimerosal and Autism, only 9 of them are studies.
1 of them (T10) is an opinion piece that concludes because the manifestation of ethyl mercury poisoning via injection we are seeing in Autism does not precisely match that of the more well known manifestation of ethyl mercury poisoning via ingestion we have seen in Japan and Iraq, Autism cannot be mercury poisoning.
• 5 studies (T1, 4, 6, 7, 11) compared children who received thimerosal to those who also received thimerosal, studying only if different amounts were associated with specific health outcomes.
2 of those studies (T6, 7) found an association between higher levels of Thimerosal (a known neurotoxin) and higher IQ’s and better fine motor coordination (among other positive outcomes). (Yes, they actually published that kids who got more Thimersoal appear to have higher IQs and that it is a positive health outcome for Thimerosal.)
Yet, 3 of those studies (T1, 6, 7) also found an association between tics, poor fine motor skills in girls, and/or speech delay and Thimerosal. (So in spite of what anyone says about Autism, our medical community acknowledges in 3 different studies looking only at kids who got Thimerosal, that it is in fact associated with the development of tics, poor fine motor skills in girls, and speech delay. The studies, however, are all careful to state “more study of the association is needed” to really know if there is a problem.)
• 4 studies (T2, 3, 5, 8), present that as Thimerosal (again, a known neurotoxin) was reduced in vaccines, Autism rates went up, implying it is protective against the development of Autism.
• Only 1 of the studies (T9) is biologically based; it concludes that because Thimerosal (ethyl mercury) appears to be excreted quickly (in smaller amounts than what was injected) and does not appear to raise all of the children’s blood levels of mercury above what we think are safe levels of methyl mercury (even though it does for 1 child), it is not dangerous for any children. And we now know that ethyl mercury while leaving the blood faster than methyl mercury goes to the brain faster (Burbacher, 2005).
It is fair to say the science we have thus far on Thimerosal is woefully inadequate and borderline ridiculous. It is the equivalent of Phillip Morris studying people who smoke 1, 2, or 3 packs of cigarettes a day and concluding that cigarettes don’t cause lung cancer, and furthermore, that those who smoke 3 packs a day are actually healthier and less likely to get lung cancer than those who smoke only 1 pack (but then at the same time quietly acknowledging it may increase lung cancer in girls and they need to study it more). Even better, then reporting that as the smoking rate dropped, the rate of lung cancer skyrocketed, allowing them to exonerate cigarettes as a causal factor.
MMR Overview
• 4 of the 8 studies done on the possible relationship between the MMR and Autism were done by either Eric Fombonne (M2, 3, 4), a vaccine patent holder and an expert witness for the government in MMR litigation, or by the UK’s expert witness for MMR litigation (M6). This means half of the MMR studies were done by expert witnesses for the government.
• 1 study did show Autism is associated with the MMR (M5) and a detailed report of how that is was recently posted on Age of Autism HERE.
• Only 1 study used children from the US exclusively (M1).
This study found 20% of the children with Autism they looked at did indeed regress into Autism in this order: MMR-GI Disturbance-Autism, but concludes because the other 80% did so in a different order such as GI Disturbance-MMR-Autism, the MMR isn’t a problem. It also replicated the findings of Dr. Wakefield and found MMR vaccine strain Measles Virus RNA in the small intestine of one child with Autism.
• No study compared children who received the MMR to those who have never been vaccinated at all.
• No study looked at the children who were affected by the MMR immediately following their reaction to look for evidence of a problem.
The studies we have thus far on the MMR are the equivalent of looking at people who were all exposed to the flu virus and trying to determine whether or not it causes diarrhea by looking at what percentage of them got that symptom, and then concluding that because there wasn’t a statistically significant amount of them that did, no one got diarrhea because of the flu. Or determining that because they had an upset stomach before they got the flu, the diarrhea wasn’t caused by the flu. Or determining that because 12 years after the people who got diarrhea from the flu didn’t all have the flu virus RNA in their gastrointestinal tract still (even though 1 of them did), no one got diarrhea from the flu.
What Must Be Studied Instead
To adequately assess the role of Thimerosal, the MMR, and/or Vaccines in Autism, we must insist on honest and independent science that involves true control groups, and more important, addresses the unique medical issues our children have and how they could possibly have been caused by vaccines. We can start with the following:
• Assume parents are telling the truth when they tell you their child was adversely affected by vaccines, and rather than relying on the above biased, inadequate, and contradictory science, use the child as your science. What evidence is that child showing you the parents could be right?
• Collectively study those children who got sick for evidence of vaccine injury.
• Study the biological mechanisms by which vaccines can cause harm, especially in vulnerable subsets of people who might have predisposing conditions.
• Define and document exactly what Thimerosal poisoning via injection looks like in a person. (It is a poison. It will do something. The Material Safety Data Sheet (HERE) tells us what it will do if you come in contact with it externally. What about internally, like when it's injected into you?)
• Compare the vaccinated to the never vaccinated for specific health outcomes including Autism.
• Study the combination of vaccines and their ingredients as they are given in a real world setting in the US. The idea that "usually simulatneous vaccination is incompletely studied at time of liscensure" is unacceptable and outrageous given that is how they are administered.
• Compare the health outcomes of those who have received Thimerosal versus those who have not.
• Demand this science be conducted independently and free of conflicts of interest, if that is even possible anymore.
Anything less than this at this point in time is unacceptable and frankly, immoral. The studies we have so far are embarrassingly and unethically inadequate. Our children deserve better.
The Studies
Thimerosal
T1: Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases (Verstateen, Pediatrics Nov. 2003)
T2: Thimerosal and the Occurrence of Autism: Negative Ecological Evidence from Danish Population-Based Data (Madsen, Pediatrics Sept. 2003)
T3: Continuing Increases in Autism Reported to California’s Developmental Services System (Schecter, Arch Gen Psychiatry Jan. 2008)
T4: Neuropsychological Performance 10 Years after Immunization in Infancy with Thimerosal Containing Vaccines (Tozzi, Pediatrics Feb.2009)
T5: Autism and Thimerosal-Containing Vaccines: Lack of Consistent Evidence for an Association (Stehr-Green, American Journal of Preventative Medicine 2003)
T6: Thimerosal Exposure in Infants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Support a Causal Association (Heron, Pediatrics Sept. 2004)
T7: Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 years (Thompson, The New England Journal of Medicine, 2007)
T8: Association between Thimerosal-Containing Vaccine and Autism (Hviid, Journal of the American Medical Association 2004)
T9: Mercury Concentrations and Metabolism in Infants Receiving Vaccine Containing Thimerosal: A Descriptive Study (Pinchichero, The Lancet Nov. 2002)
T10: Thimerosal and Autism? (Nelson and Bauman, Pediatrics 2003)
T11: Lack of Association between Rh Status, Rh Immune Globulin in Pregnancy and Autism (Miles and Takahashi, American Journal of Medical Genetics April 2007)
MMR
M1: Lack of Association between Measles Virus Vaccine and Autism with Enteropathy; A Case-Control Study (Hornig, PLoSONE 2008)
M2: MMR Vaccination and Pervasive Developmental Disorders: A Case-Control Study (Smeeth, The Lancet 2004)
M3: Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links with Immunizations (Fombonne, Pediatrics 2006)
M4: No Evidence for a New Variant of Measles-Mumps-Rubella-Induced Autism (Fombonne, Pediatrics 2001)
M5: No Effect of MMR Withdrawal on the Incidence of Autism: A Total Population Study (Honda, Journal of Child Psychology and Psychiatry 2005)
M6: Measles Vaccination and Antibody Response in Autism Spectrum Disorders (Baird, Arch.Dis.Child 2008)
M7: Neurological Disorders after Measles-Mumps-Rubella Vaccination (Makela, Pediatrics 2002)
M8: Association of Autistic Spectrum Disorder and the Measles, Mumps, and Rubella Vaccine: A Systematic Review of Current Epidemiological Evidence (Wilson, article from Arch.Pediatric and Adolescent Medicine 2003)
Julie Obradovic is a Contributing Editor to Age of Autism.
Julie,
I had the pleasure of meeting you at the NAA-NWI seminar on Saturday July 25, 2009 in Merrillville.
Your presentation was outstanding. I learned so much and you touched my heart also.
Thank you for sharing this information to all of us. I now will pass along this article and the handouts that you gave us too.
Keep up the fight and you have a lot of Northwest Indiana mom's there with you.
Thank You,
Tracy Blaney
Posted by: Tracy Blaney | July 27, 2009 at 10:35 PM
Julie, I was surprised to read the lack of comments on your article. Admittedly, I had "put off" reading your post for personal reasons...eagerly anticipating the opportunity to read your excellent analysis of "scientific studies" that have gone scientifically "astray". And, more importantly...with serious..."unintended consequeces"... to this generation of American children.
I have printed out your two previous "14 Studies" articles, as I did this "six page" wealth of information...because they are chock full of information that ANYONE who engages the numerous "scientific experts" who troll various internet sites, whether Huffington Post, AOA or major media outlets...constantly spew the end of a "widespread and growing vaccine controversy debate".
You have done a tremendous job, God bless you and I will be eternally grateful for the "scientific ammunition" that I need to fire back from my grandpa, "uneducated", foxhole.
Posted by: Bob Moffitt | July 17, 2009 at 05:05 PM
Hi Julia
Thank you very much for your presentation.
I simply don´t understant why a cross- link with reserachers in the immunology of development and disorders of the immune system are not more involved in the Autism research related to Vaccines and Infections-Co infections. When the last year or so is analyzed in terms of importance of the environment in brain immune activation, there are plenty of new findings- related even to gene expression and the role of amygdala and hyppocampus in behavior.
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2693090
Autism is a severe disorder that involves both genetic and environmental factors. Expression profiling of the superior temporal gyrus of six autistic subjects and matched controls revealed increased transcript levels of many immune system related genes. We also noticed changes in transcripts related to cell communication, differentiation, cell cycle regulation and chaperone systems. Critical expression changes were confirmed by qPCR (BCL6, CHI3L1, CYR61, IFI16, IFITM3, MAP2K3, PTDSR, RFX4, SPP1, RELN, NOTCH2, RIT1, SFN, GADD45B, HSPA6, HSPB8 and SERPINH1). Overall, these expression patterns appear to be more associated with the late recovery phase of autoimmune brain disorders, than with the innate immune response characteristic of neurodegenerative diseases. Moreover, a variance-based analysis revealed much greater transcript variability in brains from autistic subjects compared to the control group, suggesting that these genes may represent autism susceptibility genes and should be assessed in follow-up genetic studies.
And
The majority of neuroimmune genes found activated in the autistic brains overlap with mouse genes that are activated during the late recovery or “repair” phase in experimental autoimmune encephalomyelitis (Baranzini et al., 2005). This suggests a presence of an innate immune response in autism. However, the altered IL2RB, TH1TH2, and FAS pathways suggest a simultaneously occurring, T cell-mediated acquired immune response. Based on these combined findings we propose that the expression pattern in the autistic brains resembles a late stage autoimmune event rather than an acute autoimmune response or a non-specific immune activation seen in neurodegenerative diseases. Furthermore, the presence of an acquired immune component could conceivably point toward a potential viral trigger for an early-onset chronic autoimmune process leading to altered neurodevelopment and to persistent immune activation in the brain. Interestingly, recently obtained gene expression signatures of subjects with schizophrenia (Arion et al., 2007) show a partial, but important overlap with the altered neuroimmune genes found here in autism. These commonly observed immune changes may represent a long-lasting consequence of a shared, early life immune challenge, perhaps occurring at different developmental stages and thus affecting different brain regions, or yielding distinct clinical phenotypes due to different underlying premorbid genetic backgrounds.
Beyond of course of the studies of Dr Ashwood and others in the MIND Institute.
a-Now, with the lack of knowledge about how thimerosal is managed once injected- why then the conclussion is that is quickly excreted- when this of course has not been even tested properly?And this new one
J Pediatr. 2009 Jun 25.
Mercury Levels in Premature and Low Birth Weight Newborn Infants after Receipt of Thimerosal-Containing Vaccines.
Pichichero ME et al
OBJECTIVE: We conducted a population-based pharmacokinetic study to assess blood levels and elimination of mercury after vaccination of premature infants born at >/=32 and /=2000 but <3000 g. STUDY DESIGN: Blood, stool, and urine samples were obtained before vaccination and 12 hours to 30 days after vaccination from 72 premature newborn infants. Total mercury levels were measured by atomic absorption. RESULTS: The mean +/- standard deviation (SD) birth weight was 2.4 +/- 0.3 kg for the study population. Maximal mean +/- SD blood mercury level was 3.6 +/- 2.1 ng/mL, occurring at 1 day after vaccination; maximal mean +/- SD stool mercury level was 35.4 +/- 38.0 ng/g, occurring on day 5 after vaccination; and urine mercury levels were mostly nondetectable. The blood mercury half-life was calculated to be 6.3 (95% CI, 3.85 to 8.77) days, and mercury levels returned to prevaccination levels by day 30. CONCLUSIONS: The blood half-life of intramuscular ethyl mercury from thimerosal in vaccines given to premature infants is substantially shorter than that of oral methyl mercury in adults. Because of the differing pharmacokinetics, exposure guidelines based on oral methyl mercury in adults may not be accurate for children who receive thimerosal-containing vaccines.
Now, with then known differences in prematures and low birth weight newborns and without one (1) measurement on xenobiotics biochemistry and management and differences of xenobiotics impact this is presented as if thimerosal is safe?
b-Where are the studies on the liver impact in terms of enzymes, ammonia levels, Krebs and urea cycle impact of vaccines in combination?Where are the studies on inflammation biomarkers impact of vaccinations? Where are the studies on immune status before and after vaccines- IgA-IgG-IgM-IgE•? And of autoantibodies after vaccines? and of mitochondria impact and antioxidation status- oxidative stress- after vaccines?
c-What are the roles of the previous infections with herpes of the safety of vaccines- CMV-EB-Herpes 6-HVS1 for example?
d-What is the role of the gut microbiota status and gut /GI status in the answer to vaccines- especially if antibiotics are given near to vaccines?
Posted by: María Luján | July 16, 2009 at 02:42 PM
great article (as usual Julie) I think what you're doing is awesome and I really appreciate your help on the show as well! If everybody becomes aware of the actual studies, they will learn that we've been lied to time and time again by the medical establishment and then we can change things! Keep up the good work!
Posted by: curt linderman sr | July 16, 2009 at 02:26 PM