1. Two challenges threatened vaccine orthodoxy, galvanizing vaccine stakeholders to mobilize
  • Wakefield lent validity to that distrust in government assurances that all childhood vaccines and vaccination schedules are proven safe.
  • CDC’s first large-scale scientifically sound CDC epidemiological study, analyzed the medical records of 400,000 infants born between 1991 and 1997, and assessed the relative risk of autism for the children at different ages. The evidence documented an increased 7.6 relative risk of autism[83] from exposure to thimerosal. “Increased Risk Of Developmental Neurologic Impairment After High Exposure To Thimerosal-Containing Vaccine In First Month Of Life, Abstract, 1999
  • This CDC study finding had the potential of blowing the lid off the entire CDC children’s vaccination schedule.

From this case forward, studies that could document scientifically valid evidence of a vaccine safety hazard are avoided. In June 2000, CDC epidemiologist, Dr. Frank DeStefano (a co-author of the concealed 1999 CDC study findings) expressed enthusiasm for the initial proposal of CDC’s Danish study project, which he thought, provided “a good opportunity” to conduct research using clinical data, to examine whether there is an autism MMR relationship.

Dr. Frank DeStefano

“The availability of data from pregnancy, as well as blood specimens, is particularly attractive. The blood spot component would be very valuable just by itself to try to confirm the exciting findings from the small NIH study. If these are true biomarkers for autism, it would be great to see if they identify high risk groups of kids for a vaccine-autism association. In addition to MMR, the study should include all infant and childhood vaccines to look at issues of multiple antigens, vaccine additives, etc. Serologies for measles and rubella in the maternal and cord blood might also be worth considering.” (June 1, 2000 email)[84]

However, CDC never funded the kind of clinical study that Dr. DeStefano anticipated “would be very valuable”. CDC has not funded such a clinically valuable study, precisely because such a study could “identify high risk groups of kids for a vaccine-autism association”—thereby undermining vaccine orthodoxy and CDC’s industry-influenced Childhood Vaccination Schedule. Thus, clinical studies focused on detailed, biological examinations that could identify vaccine risk factors, are not approved or funded, neither by UK nor US government research funding sources. [Appendix 9 provides details of how those disturbing CDC findings were concealed, and the data underwent four years of manipulation until the risk vanished.]

Andrew Wakefield continues to be crucified for having conducted a clinical investigation of the intestine whose results (a) identified the presence of inflammation in the intestine unique to children with autism; and (b) finding measles virus RNA in biopsies of the small intestine (ileum) of these children.

The most recent corroboration of Dr. Wakefield’s finding (a) was published October 2017 in PLoS One:

“As many as 91% of children with ASD may be affected by debilitating GI symptoms such as constipation, diarrhea, or food allergy and/or intolerance [13, 14]. Developmental delays associated with ASD do not account for these symptoms, as GI symptoms are significantly more common in children with ASD as compared to children with developmental delays without ASD [15]. Many GI abnormalities reported may be unique to individuals with ASD. For example, dysfunction in enterocytes carbohydrate transportation [16], inflammation that is not fully consistent with a classic GI disorder [13, 14] and imbalances in the enteric microbiome [1719] have all been reported.”[85]

In 2000, the Brighton Collaboration , an international network of public health officials, vaccine manufacturers, and a coterie of academics funded by them – was launched to provide authoritative, uniform definition standards[86] for the determination of what adverse events following vaccination are defined as AEFIs. In 2005, the Brighton Collaboration acknowledged:

“With the increase in vaccine coverage in both developed and developing countries, the reduction in target vaccine-preventable diseases, has also come a growing concern for the safety of immunizations. This is due to an increase in the absolute number of adverse events following immunizations (AEFIs).”

“Unfortunately, unlike efficacy, the “safety” of a vaccine cannot be measured directly. Safety can only be inferred indirectly from the relative absence of multiple, likely adverse events following immunization. To then best address concerns about real or perceived risks of immunization in a scientific manner, several components need to be in place. For example, regulatory agencies need to ensure that adequate trials for safety and efficacy are conducted prior to licensure of new vaccines (and that good manufacturing practices are in place and maintained).

However, due to practical limitations of prelicensure trials, such as limited sample size and study duration, the principal focuses for collection of data on rare events are postlicensure studies by various stakeholders (e.g., the public health and clinical care communities, regulators, and manufacturers).”[87]

Post-licensure studies avoid scientifically recognized methods for detecting drug/vaccine safety hazards

  • Challenge/Dechallenge/Rechallenge is scientifically recognized as providing scientific proof of causality of adverse events following exposure to a pharmaceutical product. [88]

The literature about drug development refers to positive re-challenges as one of the most effective, most persuasive, most cost-effective means, for determining rare but serious adverse side effects of drugs. It is an especially powerful tool, for detecting rare adverse effects that go undetected in epidemiological studies.

“In pharmacology, the most powerful proof of causation is a single well-documented challenge-dechallenge-rechallenge case report that shows event A caused adverse event B. Unlike evidence from RCTs [randomized clinical trials] and systematic reviews, the evidence from a single well documented spontaneous report of a Challenge-Dechallenge-Rechallenge (CDR) case is often the strongest form of proof of causation if not irrefutable.[89]

“A major omission in all of the papers published as purported evidence of no link between MMR, autism and other ailments is the absence of any attention at all on rechallenges as a drug research and development tool. If this were to be applied to the MMR children, then each and every one of them could well be recognised as the conclusive living scientific proof of a causal connection between their ailments and the MMR vaccine.” [90]

Vaccine stakeholders also avoid studies that compare the health of vaccinated vs. unvaccinated children.
CDC official Coleen Boyle testified before a Congressional hearing (Rising Autism Rates, 2012) at which she acknowledged: “We have not studied vaccinated versus unvaccinated [children]”. At the same hearing Dr. Alan Guttmacher, Director of the National Institute of Child Health & Human Development (NICHD) refused to answer.

  • If studies are not designed to investigate adverse effects following vaccination (challenge), and do not document the effects following revaccination (rechallenge) – in accordance with childhood vaccination schedules – those rare but serious hazards will not be detected.
  • Furthermore, if no studies are designed to document the difference in the rate of neurological disorders, including autism, between vaccinated and unvaccinated children, it ensures that no evidence will be detected linking MMR or thimerosal to autism.
  • However, the failure to document the risk – by avoiding studies designed to reveal the risk – does not mean that no evidence exists. It means that more children will be put in harm’s way, while the evidence connecting harm to vaccines remains undetected.

[Appendix 9 details how vaccine safety assessments are controlled, manipulated, and redefined by an international consortium of vaccine stakeholders who control the channels of information in both scientific journals and the media to ensure high utilization of vaccines.]

Recently, Dr. John Ioannidis, the foremost proponent of evidence-based medicine, raised a provocative question in his article, “Does Evidence-Based Hearsay Determine the Use of Medical Treatments?” (2017) If the question is applied to vaccines, the answer is a resounding, yes, because there is no authentic evidence base, to support the widely publicized claims made about vaccine safety, merely conjecture. Therefore, the basis for those safety claims can be characterized as hearsay.