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IOM Hosts Live Webcast on 9/1 for Vaccine Adverse Effects Report

Listen The Institute of Medicine will host a live audio webcast for the report Adverse Effects of Vaccines: Evidence and Causality on Thursday, September 1, 2011 at 11:00 am EDT. Committee chair, Ellen Wright Clayton, and two members of the committee, S. Claiborne Johnston and Douglas Barrett, will discuss the report and be available for questions.

A link to the webcast will be available at 10:30 am at www.iom.edu/vaccineadverseeffects or www.nationalacademies.org . Beginning at 11:00 am, listeners will be able to email questions to the committee via an additional link on the same webpage.

The report and summary material are available for free download at www.iom.edu/vaccineadverseeffects.

Registered participants will receive an email reminder 15 minutes prior to the start of the audio webcast on September 1st. Please note that registration is not required to participate in the event. If you have not already registered, you can do so here.

Comments

Jim Moody

The IOM report is a stunning admission of ignorance, deliberate on the Government's part, of the true nature and extent of AE's, especially autism. In today's briefing, the panel seemed to accept the need for much more research and research funding, especially the vax-unvax comparison. This has been called for by so many people, including CDC, now Merck, Dr. Gerberding, that its continued absence reflects the moral bankruptcy of our vaccine safety policy and our moral and legal obligation to generously compensate all "veterans" in the war against infection. The 1986 Congressional Mandate for Safer Childhood Vaccines has yet to be implemented. My questions for the panel today were:


The Program has paid hundreds of millions since 1990 in to compensate children with vaccine injuries, from MMR or DTP alone or a combination of vaccines, often encephalopathy or seizures, leading to a diagnosis on the autism spectrum, most recently one of the test cases in the OAP, Poling. These cases have been reviewed in an article published in the Pace Law Review, Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury, 28 Pace Envtl. L. Rev. 480 (2011). This is perhaps the best evidence that vaccines cause autism or what IOM may refer to as “secondary” autism because the Program can only pay compensation when justified by science and medicine presented in particular cases. Did the Committee review this evidence, in the form of actual Program compensation, and if not, why not?

The Committee has made a profound contribution by documenting the profound lack of adequate evidence to resolve most causation questions. What role should a comprehensive and ongoing comparison of acute and chronic illness in unvaccinated children vs. partially and fully vaccinated children (and animals) play in assessing – and reducing – the true rate of vaccine-caused adverse events?

Without baseline data on unvaccinated children, and the ethical duty of each pediatrician to each individual patient, how can the Committee claim that “vaccines are safe?”


Opinion

IOM Report - SIDS

Epidemiolo­gic Evidence

The committee reviewed one study to evaluate the risk of sudden infant death syndrome (SIDS) after the administra­tion of DTaP vaccine. This one study (Geier and Geier, 2004) was not considered in the weight of epidemiolo­gic evidence because it provided data from a passive surveillan­ce system and lacked an unvaccinat­ed comparison population­.

Weight of Epidemiolo­gic Evidence

The epidemiolo­gic evidence is insufficie­nt or absent to assess an associatio­n between
diphtheria toxoid-, tetanus toxoid-, or acellular pertussis-­containing vaccine and SIDS.

Mechanisti­c Evidence

The committee identified three publicatio­ns reporting SIDS after the administra­tion of
vaccines containing diphtheria toxoid, tetanus toxoid, and acellular pertussis antigens alone or in combinatio­n. The publicatio­ns did not provide evidence beyond temporalit­y (Balci et al., 2007; Pollock et al., 1984; Schmitt et al., 1996).

In addition, Balci and colleagues (2007) reported the administra­tion of additional vaccines making it difficult to determine which, if any, vaccine could have been the precipitat­ing event.

Also, Schmitt et al. (1996) reported that the incidence of SIDS after administra­tion of Infanrix was not higher than expected based on the incidence of SIDS in the general population­. The publicatio­ns did not contribute to the weight of mechanisti­c evidence.

Weight of Mechanisti­c Evidence

The committee assesses the mechanisti­c evidence regarding an associatio­n between
diphtheria toxoid-, tetanus toxoid-, or acellular pertussis-­containing vaccine and SIDS
as lacking.

Causality Conclusion

Conclusion 10.25: The evidence is inadequate to accept or reject a causal
relationsh­ip.

------------------------------------------

Take Home Message

1. There are no epidemiolo­gical studies undertaken to examine this question.

2. Three studies show a clear temporal relationsh­ip that needs to be investigat­ed further.

3. Balci - additional vaccines were administer­ed thus opening up further hypotheses in regards to vaccine scheduling­.

4. The IOM disregarde­d evidence undertaken to study DTap and Non Specific Effects.

----------­----------­----------­----------­----------­-----

Not one study made it through the IOM filter. Conclusion - The science has not been undertaken­.

I don't think that the general public should be inadverten­tly misled when clearly the conclusion should have read -

Further scientific research needs to be undertaken to investigat­e the hypothesis that DTaP either on its own or in conjunctio­n with other factors including the administra­tion of other vaccines has a causal role in Sudden Infant Death.

Opinion

Somebody ask them why the IOM epidemiological evidence shrank from 22 studies to 5 as most had serious methodological flaws.

Left were five studies -

Mrozek-Bud­zyn et al., 2010 - was rated as having serious limitations and addressed Vaccines in Poland

http://journals.lww.com/pidj/Abstract/2010/05000/Lack_of_Association_Between_Measles_Mumps_Rubella.3.aspx

So that's 4 studies

---------------------------------------------

Smeeth et al., 2004 - included senior co-author Eric Fombonne who had at least two studies eliminated on 'serious methodological flaws"

http://www.sciencedirect.com/science/article/pii/S0140673604170207

Doubtful then ......?

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Madsen et al. (2002) which studied Danish children undertaking a different vaccine and vaccine schedule
http://www.ncbi.nlm.nih.gov/pubmed/12421889
and finally

two studies using the same data and essentially by the same researchers Brent Taylor and Elizabeth Miller

noted as -

Taylor et al., 1999 and Farringto­n et al., 2001

http://www.sciencedirect.com/science/article/pii/S0140673699012398

http://www.sciencedirect.com/science/article/pii/S0264410X01000974


Sort of a two for one .... using the same data.
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Ask this simple question -


Where are the epidemiological studies that directly address the conditions relating to the United States of America ? The vaccines used , the vaccine schedule used and the US population data.

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