A daunting 667-page report was released last week by the Institute of Medicine (IoM) in the USA, looking at the evidence for and against causal relationships between vaccines and adverse events. In certain cases, such as vaccine-strain infection leading to pneumonia, meningitis or hepatitis following Varicella zoster (chickenpox virus) vaccination, the authors conclude that convincing evidence of a causal relationship exists. However, they found that evidence for the great majority of the adverse events was "inadequate to accept or reject a causal relationship" – which is already being interpreted by mainstream news sources as saying "vaccines are mostly safe". Don’t be influenced in your vaccination decisions by what appears to be a biased and flawed report!
Entitled Adverse Effects of Vaccines: Evidence and Causality, the report's authors stressed that the document "Is not intended to answer the question “Are vaccines safe?”...Other bodies make that determination and contribute to ongoing safety monitoring, including governmental agencies, care providers, and industry". In such a context, the media's interpretation of the study is certainly optimistic.
The authors looked at the chickenpox vaccine, influenza vaccines, hepatitis A and B vaccines, human papillomavirus (HPV) vaccine, tetanus toxoid-containing vaccines other than those containing the whole-cell pertussis component, measles, mumps, and rubella (MMR) vaccines and meningococcal vaccines. As a quasi-governmental body, the IoM was contracted to produce this report by the Health Resources and Services Administration (HRSA), who provided the authors with a specific list of adverse events for examination.
Two forms of evidence were considered: mechanistic evidence, taken from biological and clinical studies in animals and individual humans, and epidemiological evidence based on studies of populations. The authors then assigned weightings to the mechanistic and epidemiological evidence, by assessing the strengths and weaknesses of each literature article comprising the evidence base and combining the results. The weightings thus synthesised allowed the authors to draw conclusions on causal relationships between vaccines and adverse events.
The table below shows the vaccines considered by the authors of the IoM report to be causally linked to adverse events. The final column gives the strength of the authors' conclusions, where CS = convincingly supports a causal relationship and FA = favours acceptance of a causal relationship.
In addition to the relationships shown in the table, deltoid bursitis and syncope, (fainting) occurred in association with the trauma of injection, and were not thought to be associated with the vaccine contents themselves. The conclusion level was CS in both cases. Evidence for the vast majority of relationships was found to be "inadequate to accept or reject a causal relationship", so how that relates to vaccines being "mostly safe", as per Reuters, is anyone's guess bearing in mind the list of adverse events noted above.
Unsurprisingly, the authors were at pains to reject a causal relationship between the MMR vaccine and autism, dismissing Dr Andrew Wakefield's 1998 Lancet case series because it "did not provide evidence beyond temporality". According to the IoM committee, the gap between MMR administration and appearance of behavioural symptoms was too long to rule out other possible causes. However – and we realise here that we are discussing a paper that was retracted by the Lancet in February 2010 – this seems to skirt the issue somewhat. Wakefield and colleagues' 1998 case series did not set out to prove any connection between MMR and autism, but instead merely described the clinical features observed in a group of children with a similar diagnosis, in this case chronic enterocolitis and regressive developmental disorder. Regardless of the content of the Lancet paper, it is disingenuous of the IoM authors to use it as evidence against an association between MMR and autism, when the paper set out to prove no such thing!
Dr Andrew Wakefield
In the process, the IoM authors also quietly ignored the 5,000 or so other autism/MMR cases that have been brought together as the Omnibus Autism Proceeding in the US vaccine court, which were also dismissed on the basis of just three carefully selected test cases on grounds of insufficient causal evidence. Neither does the IoM mention the remarkable lengths to which the court went to avoid describing as autism the lifelong side effects experienced by 10 year-old Bailey Banks, which manifested days after his MMR jab.
In Table 4-5 on page 169, the IoM authors provide a list of epidemiological papers that look into the MMR–autism link. Several of these are described as having "negligible" methodological limitations, among them a 2002 Danish paper by Madsen et al . One of the authors of that paper, Poul Thorsen, disappeared earlier in 2011, along with nearly $2 million, after officials discovered huge fraud involving the theft of millions of US taxpayers' dollars. Thorsen was indicted by the US Centers for Disease Control and Prevention (CDC) in April this year. Of course, such circumstantial evidence says nothing about the science of the matter – but there is, in fact, plenty to say.
An analysis of Danish data by Goldman and Yazbak in the Journal of American Physicians and Surgeons  came to the opposite conclusion to Madsen: that "Prevalence of autism among children aged 5–9 years increased from a mean of 8.38/100,000 in the pre-[MMR] era (1980–1986) to 71.43/100,000 in 2000 and leveled off during 2001–2002. The relative risk (RR) is therefore 8.5 (95% CI, 5.7 to 12.7)." One significant flaw of Madsen's 2002 paper according to these authors was that, "Because autism is usually diagnosed at age 5 or older in Denmark, many children born in 1994 and thereafter would not have been diagnosed by the end of the study period." And the problems don't end there: "Additional flaws in the Madsen study included the unusual distribution of ages in the cohorts, censoring rules applied to cases, and failure to separate autism into regressive and classical cohorts."
These are hugely significant methodological problems with a paper the IoM describes as being of unimpeachable quality. That the IoM authors fail to acknowledge the existence of these flaws, let alone of the Goldman and Yazbak analysis itself, must surely bring their conclusions into question. We wonder whether the IoM analysis is as apparently superficial in terms of other vaccine–adverse event relationships, especially given that it is funded by the CDC and the National Vaccine Program Office, via the contract with HRSA. Both of these bodies have a highly vested interest in maintaining the current US vaccination schedule, a major plank of which is a positive public perception of vaccine safety. After its recommendation of ridiculously low maximum daily intake levels for vitamin D, maybe it's too late to expect any unbiased reports from the IoM?
The IoM report will probably serve its intended purpose: providing the US medical establishment with continued justification to administer the absurd vaccine schedule, the safety of which has never been studied in its entirety. For those who have concerns over the safety of vaccines, however, especially concerning their administration to young children with highly sensitive and immature immune systems, the report will likely have little effect. Most of us who have concerns have learned to recognise the manipulation and distortion that emanates from vaccine interests and proponents.
We can observe that one particular element of medical science, namely the requirement for proof of a causal relationship, has fast become the primary mechanism used to justify a status quo that maintains steady – and huge! – profits for some of the world’s largest businesses. Here, we see the difficulty of establishing proof of a causal relationship between vaccines and side effects being used to justify continued use of those vaccines. In another field, the same criterion is used for an opposite end: the difficulty of establishing proof of a causal relationship between the health benefits of foods and food ingredients is given as the main reason by the European Food Safety Authority for its rejection of some 80% of health-claim applications.
It is a strange and ironic world in which we live. We have a situation where governments are telling the public that drugs like vaccines are mostly safe, because of a lack of the right type of evidence proving they are dangerous. Simultaneously, they also tell us that certain supplements, foods and herbal ingredients are unsafe – because there is a lack of the right type of evidence proving they are safe!
We call this scientific manipulation; the governments try to persuade us that it is all in the interests of protecting consumers. Ho hum.
A question to ponder: will the IoM report influence your decisions and views over vaccination? In our office the answer is a resounding “no chance”.
 Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, Olsen J, Melbye M. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med 2002;347(19):1477–82.
 Goldman GS, Yazbak FE. An investigation of the association between MMR vaccination and autism in Denmark. J Am Phys Surg 2004;9(3):70–5.
Updated: 8 Sep 2011
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