Freedom of Information Act Documents
Memorandums of Agreement (MOA) for the 2011 IOM Report
These are the memoranda of understanding between the CDC, FDA/CBER and HRSA which led to the IOM 2011 report on adverse events associated with eight vaccines. Thimerosal was not addressed and the final report found that 125 of 158 associations the IOM investigated had “inadequate evidence to accept or reject a causal relationship,” between the vaccine and the adverse event.
Generation Zero: Thomas Verstraeten’s First Analyses of the Link Between Vaccine Mercury Exposure and the Risk of Diagnosis of Selected Neuro-Developmental Disorders
Between February 2000 and November 2003 Thomas Verstraeten and his supervisors at the National Immunization Program produced four separate generations of an analysis designed to assess the impact of vaccine mercury exposures on neuro-developmental disorders in children. With each generation, elevated and statistically significant risks were reduced and/or eliminated.
1999 EIS Conference Abstract Presentation, Verstraeten et. al.
Increased risk of developmental neurologic impairment after high exposure to thimerosal-containing vaccine in first month of life. Background: Concern has risen on the presence of the ethylmercury containing preservative thimerosal in vaccines. We assessed the risk for neurologic and renal impairment associated with past exposure to thimerosal-containing vaccine using automated data from the Vaccine Safety Datal ink (VSD). VSD is a large linked database from four health maintenance organizations in Washington, Oregon and California, containing immunization, medical visit and demographic data on over 400,000 infants born between ’91 and ’97. Methods: We categorized the cumulative ethylmercury exposure from thimerosal containing vaccines after one month of life and assessed the subsequent risk of degenerative and developmental neurologic disorders and renal disorders before the age of six.
National Institute of Environmental Health Sciences – Thimerosal Exposure in Pediatric Vaccines
“The conferees urge NIEHS to work with CDC and expert independent researchers on research that could identify or rule out any association between thimerosal exposure in pediatric vaccines and increased rates of autism. The conferees believe that the Vaccine Safety Datalink (VSD), a CDC-constructed database that follows 7 million immunized children from 1990 to present, could be helpful in the research, especially regarding pre-2001 VSD data and post-2000 VSD data, since thimerosal was removed from most childhood vaccines in 2001. The conferees urge NIEHS and CDC to organize a workshop by May 2006 to explore the research possibilities and scientific feasibility of such a study and report back to the House and Senate Appropriations Committees soon after.” (House report No. 109-337, page 75)
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”.
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.
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.
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.
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.
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)
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.
Mercury Modeling Conducted by Barry Rumack
Graph and Tables: Ethyl mercury body burden after thimerosal injections vs. methyl mercury oral suggested limits.
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.