Freedom of Information Act Documents

FOIA: Peter Patriarca – Asleep at the Switch Email

Peter Patriarca, an FDA employee, admitted back in 1999, in a confidential e-mail obtained through FOIA, that, “… the greatest point of vulnerability on this issue is that the systematic review of thimerosal in vaccines by the FDA could have been done years ago and on an ongoing basis as the childhood immunization schedule became more complex.  The calculations done by FDA are not complex. I’m not sure if there will be an easy way out of the potential perception that the FDA, CDC and immunization policy bodies may have been “asleep at the switch” re: thimerosal until now”.

Read More: FDA’s CBER – Asleep at the Switch Again – An Ongoing Saga

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Ball Request to Search MedWatch Database for Mercury in Biologics with 7,000 Hits

We’re working on a FDAMA project involving mercury in drugs and biologics and need to query the MedWatch database for reports involving biologics containing mercury. We’ve already done this for vaccines in the VAERS database, using the search terms mercury, thimerosal, thimersal and merthiolate. Our CDER colleagues on the FDAMA committee have performed a MedWatch query for drugs but specifically excluded biologics.

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FDA Ball – Mercury Exposure Assessment of Vaccines and Environment

Powerpoint slides regarding thimerosal in vaccines, maximum potential ethyl mercury exposure from thimerosal in vaccines, mercury exposure assessment and thimerosal toxicity: gaps in knowledge.

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FDA Email Regarding Thimerosal Ineffectiveness and USP Guideline Not Necessary to Follow

(As you recall, thimerosal did not prevent the occurrence of abscesses following DTP vaccine from multi dose vials.) At the time Dr. Halsey wasn’t even considering the advantage of unicode vials if thimerosal is removed. Bill Egan has checked with mark Raza on whether the FDA is compelled to follow USP standards for preservation and it appears we are not.

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Rumack Email to FDA Regarding Thimerosal Mercury Modeling

Now, let’s debate the burden vs. blood level information. I realize that most of the work being reported relates to blood levels but that does not mean it is correct. The blood levels simply reflect some of the body burden and we do not really know the distribution. The actual toxicity of Hg is not from the amount in blood but rather the amount in tissue. In my work with Hg and other heavy metals I have been impressed with the need to understand that burden.

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CDC and FDA private discussions regarding thimerosal in vaccines

I still don’t think we are using the data on “permissible” methyl mercury exposure levels to property assess risk. The whole Issue of relating what we’re giving in vaccines to their impact on blood and tissue levels of Hg rather than relating them to the chronic exposure standards of ATSDR, EPA, etc. seems to have not been something that we have been able or willing to delve into. Until we do that, I don’t think we’re analyzing the situation appropriately.

“The risks of not vaccinating high-risk children far outweigh the unknown and probably much smaller risk, If any, of neurodevelopmental effects posed by exposure to thimerosal-containing vaccines.” How can you say this if it is unknown? While the risks of not immunizing children may be clear, the risks of thimerosal are uncertain – your statement is too strong. (Sinks)

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Leslie Ball, FDA – No Safe Level of Mercury

Above all, it is important to emphasize the odglnal intent of the FDA calculations. The purpose of these calculations was to determine whether infant exposure to ethyl mercury exceeds established guidelines for exposure to methyl mercury. They were not intended to serve as maximum exposure limits, the manner in which the CDC is now using them. These were meant to be preliminary calculations based on the most conservative assumptions (meaning maximum possible exposure to thimerosal in the first 6 months of life). We appreciated that there would be alternate (and perhaps better) approaches.

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Mercury Modeling Conducted by Barry Rumack

Graph and Tables: Ethyl mercury body burden after thimerosal injections vs. methyl mercury oral suggested limits.

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Email from Ruth Etzel, USDA, to Her Colleagues

As you know, Public Health Services informed us that they were planning to conduct business as usual, and would probably indicate no preference for either product. While the Public Health Service may think their “product” is immunizations, I think their “product” is recommendations. If the public loses faith in PHS recommendations, then the immunizations battle will falter. To keep faith we must be open honest now and move forward quickly to replace these products. Short-term shortages may occur.

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