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                                                           Safe Minds’

                              Rebuttal to Senator Frist and Gramm’s Comments

                                                  on Senate Floor 11-18-02

According to Senator Frist, the thimerosal riders Sections 1714-1717 added to the Homeland Security Bill do not in any way take away from an individuals right to file claim for a vaccine injury.  It only adds clarity to the process, that claims must first be filed under the Vaccine Compensation Act before a civil case is filed.

Response: This is not true.  The Vaccine Compensation Act has three-year statute of limitations from the time of the first symptom.  Unfortunately, for a majority of parents who have claims currently pending in state courts, this is their only recourse because by the time they were even aware that the vaccines that their children received exposed them to levels of mercury in excess of Federal Safety Guidelines, the statute had already expired for them to be able to file a claim under the act.  Also, symptoms of mercury toxicity are typically delayed and may not be present until months or years after the exposure occurred and are often times not attributed to mercury.  Additionally, claims related to thimerosal were not previously covered under the Vaccine Compensation Act, which the rider now graciously includes.

According to Senator Gramm, the thimerosal rider is necessary to protect the manufacturers of the current smallpox vaccine and the previously stockpiled smallpox vaccine.

Response:  Smallpox vaccine is a live virus vaccine and neither the current nor previously stockpiled doses of vaccine contain thimerosal.  In fact thimerosal is not a necessary component of any vaccine.  The FDA requires a preservative only in the case of multi-dose vials of vaccine where there may be the chance of bacterial contamination of the vial of vaccine during repeated injections into the vial to withdraw the individual doses.  The fact is there are other approved vaccine preservatives beside thimerosal and the process of packaging each dose as a “unit-dose” or in a single dose container does away with the need for a preservative altogether.  Also, is very unlikely that any new vaccines would contain thimerosal since the FDA asked manufacturers to reduce or elimination the use of thimerosal for vaccine preparations in 1999.  

According to Senator Frist, there is no evidence that thimerosal causes autism and a recent investigation by the Institute of Medicine did not find any convincing evidence of this association.

Response:  Senator Frist is referring to an investigation conducted by the Institute of medicine released in October of 2001 titled Thimerosal containing vaccines and neurodevelopmental disorders.  The actual report reads and I quote, Pg. 3 “The committee concludes that although the hypothesis that exposure to thimerosal containing vaccines could be associated with neurodevelopmental disorders is not established,... the hypothesis is biologically plausible.”  Senator Frist conveniently left out the end of the quote in his statement.  Acknowledging biological plausibility is the first step in establishing a causal relationship.  The report goes on to state that “The evidence (at present) is inadequate to either accept or reject a causal relationship between thimerosal containing vaccines and the neurodevelopmental disorders of autism, ADHD, and speech and language delays.” It is not surprising that the large case controlled studies that are necessary according to IOM standards to either prove or disprove causality have not yet been done.  This issue just surfaced just over 2 years ago at FDA and there has not yet been enough time or resources allocated to complete the much-needed investigations.

Senator Frist also must not be aware of CDC’s recent investigation into thimerosal containing vaccines, which found statistically significant associations between exposure to these vaccines and the later development of ADD/ADHD, speech and language delays and neurodevelopmental delays in general.

Senator Gramm stated that the ability of the Federal Government and its agencies to grant immunity from liability to manufacturers that produce products needed in time of war have been in place since the civil war.

Response:  Indeed he is correct and they are in place now by an executive order.  President Bush has already granted immunity from liability to smallpox vaccine manufacturers for injuries and death related to their products.  Moreover, the Department of Defense may do the same if the need arises, making these additional riders adding liability protection to manufacturers of smallpox completely unnecessary.  As stated previously, smallpox vaccine has not and does not contain thimerosal and has no relevance to the concerns regarding bioterrorism threats or homeland security in this context.   

Lyn Redwood, RN, MSN, CRNP

Pres. SAFE MINDS    

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