SafeMinds Review of Autism-Like Outcomes from Vaccinations in a Non-Human Primate Model.

October 19, 2015

SafeMinds Review of Autism-Like Outcomes from Vaccinations in a Non-Human Primate Model.
Findings identify distortion in public reporting and argue need for full disclosure of study documents.

truth

Does published research always reflect the truth? A research paper came out last month in the prestigious Proceedings of the National Academy of Sciences with this title: Administration of thimerosal-containing vaccines to infant rhesus macaques does not result in autism-like behavior or neuropathology. The paper, by Bharathi Gadad, Laura Hewitson and colleagues, concluded that “administration of TCVs and/or the MMR vaccine to rhesus macaques does not result in neuropathological abnormalities, or aberrant behaviors, like those observed in ASD.”

This paper was preceded earlier this year by another based on the same primate model of vaccine administration and autism and was led by the same primary investigators. It too was published in a prestigious journal, Environmental Health Perspectives. It also “provided no consistent evidence of neuro-developmental deficits or aberrant behavior in vaccinated animals.”

Pretty strong conclusions. Case closed, no? Well, not so fast. The Medical literature is rife with misreported investigations and selective reporting. What is published in journals is only a small piece of the entire body of any investigation’s work, and some investigations are not published at all, so a large part of the evidence base may remain largely invisible to the scientific community or to the public. What’s ultimately published may reflect bias, intentional or not.

SafeMinds partially funded this investigation of vaccine administration and autism-like outcomes in a non-human primate model. We have been following it since its inception in 2003, have had regular internal updates from and interaction with various investigators, and have read all the public documents that have appeared from this decade-long, complex placebo-controlled experiment. Based on our knowledge, SafeMinds has serious concerns about the validity of the conclusions of the two most recent papers.

Because the publication record, if distorted, can lead to false conclusions about autism etiology and safety of medical products, in this case vaccinations, SafeMinds conducted an in-depth review of the vaccine-autism primate model research. This review, Primate Model of Effects of Vaccination on Autism-Like Behaviors and Neuropathology: A Review of the Data from Phases I & II, is available online here .

SafeMinds is dedicated to resolving the autism epidemic by identifying the environmental factors underlying autism causality and promoting development and uptake of effective treatments. We are interested in a variety of potential agents hypothesized to increase autism risk. Among these are the vaccine components thimerosal and the vaccine schedule as a whole. Our supporters, most of whom are impacted by autism, rely on us to communicate or support credible science on this topic and to follow the science even on controversial topics. This primate model is an important component of our efforts to examine this potential contributor to some cases of autism.

The vaccine-autism primate study consisted of two phases. The initial phase found a series of negative effects in infant reflexes, learning, brain growth and gastrointestinal function among those exposed to vaccines. The second phase found inconsistent effects and concluded that vaccines and the vaccine component thimerosal do not lead to autism-like behaviors or neuropathology.

SafeMinds became concerned about distortion of the autism-vaccine primate research as presented in the most recent publications of the second phase. These papers ignore the initial phase findings, and they contradict findings from earlier reports of the same, second phase.

For any science project we fund, besides a high quality study design which should be followed rigorously, SafeMinds asks for regular updates from investigators, as is standard procedure for grant administration. In comparing a funding proposal submitted to SafeMinds in 2012, the investigators said they had found alterations in two brain areas relevant to autism (Purkinje cells and CA1 hippocampal cells) between the animals exposed to the 1990s vaccine schedule (1990s Primate) and the unexposed group: “Based on our preliminary studies, we have found a significant decrease in Purkinje cell number and CA1 hippocampal cell size in monkeys given the 1990s vaccination schedule”. A year later, when an abstract was submitted to the 2013 Society for Neuroscience conference, they were still reporting significance: “Significant reductions in Purkinje cell number (7%) and CA1 cell size (11%) were observed in animals in the 1990’s vaccination group,” and “these data from 1990’s vaccine/Hg treated macaques are consistent with Purkinje cell and limbic abnormalities reported in the brains of people with ASDs.” At the end of 2013 they presented a poster at the same Society for Neuroscience conference where the conclusions were not consistent with the update of findings written in the funding proposal to us nor with the findings of the conference abstract. When the findings were next presented, as abstracts at the 2014 and 2015 Neurobehavioral Teratology Society conferences, no brain differences were reported and any behavioral differences were deemed inconsequential, leading to conclusions of no adverse effects from the 1990s vaccine schedule. The 2014 and 2015 published papers made the same conclusions as these conference abstracts.

When SafeMinds questioned the discrepancies, we were asked to be patient as the findings were still preliminary or were told the disappearance of significance was due to the larger size of the final sample. Although our funding contract stipulates that we receive notification and advance copies of accepted manuscripts, this requirement was not followed for either of the two recent papers. We have been unable to provide an assessment of the published work until now.

The SafeMinds Review represents an examination of the details of the entire vaccine-autism primate research effort,unnamed launched due to the discrepancies noted above and the reasons given by the principle investigators to explain them. This examination has identified potential bias, lack of transparency and clarity, questionable statistical arguments and inconsistency in the study protocols, reporting and conclusions. Our goals are (a) to share the concerns identified directly with our supporters, the wider public, the investigators, the publication journals, the supporting research institutions and the wider scientific community, and (b) to take steps to make the study data and related documentation publicly available in order to secure independent reanalysis of the data and additional publications.  Only through full transparency, the spirit of cooperation, and a common desire to understand the environmental underpinnings of autism can we resolve the autism epidemic and restore health to our children.


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