Federal & State Agency Documents (CDC, FDA, NIH, NTP)

Vaccine Technology Outpacing Ability To Predict Adverse Events, FDAer Says

Advances in vaccine technology may be outpacing researchers’ ability to predict potential vaccine-related adverse events, Center for Biologics Evaluation & Research Viral Products Division Director Peter Patriarca, MD, said at a recent forum on immunization issues.

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ORI VSD Investigation Request

In 2004 SafeMinds (Sensible Action For Ending Mercury Induced Neurological Disorders) reviewed the above referenced article and voiced concerns regarding data analysis and related conclusions put forth in this investigation in a letter to the editor of the journal Pediatrics and to the “Post Publication Peer Review” (P3R) website. At that time we called for an external audit of the research ethics and supervisory protocols involved in preparing sequential versions of the Vaccine Safety Database (VSD) for public review and ultimate publication. (Exhibit # 1) We did not receive a response to our request. Since this time additional concerns have come to light which call into question the studies conclusion of “no consistent significant associations between thimerosal containing vaccines (TCVs) and neurodevelopmental outcomes.”

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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)

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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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Thimerosal’s Nomination to the National Toxicology Program

In 2001, Thimerosal was nominated to the NTP for further study to assess gaps in knowledge regarding toxicokinetics and the potential for neurodevelopmental toxicity. These gaps included comparative toxicity of ethyl- and methylmercury, the metabolism and elimination of ethylmercury compared with methylmercury, the effect of intermittent intramuscular doses of thimerosal from vaccines compared with chronic low dose oral exposure to methylmercury, and the susceptibility of the infant compared with the fetus to adverse effects from organic mercurials. In order to provide a more complete assessment of the toxicity of thimerosal during the critical period of neurodevelopment, well-designed studies were needed to address these gaps in knowledge in appropriate animal model(s). Many of these studies were never done and thimerosal’s nomination was rejected.

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Thimerosal is recognized as a reproductive toxicant in the state of California

Outlined below is a review by the California Environment Protection Agency regarding the use of thimerosal as it relates to Proposition 65 in California. Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted in November 1986. The proposition protects the state’s drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals. Proposition 65 requires the state to maintain and update a list of chemicals known to the state to cause cancer or reproductive toxicity.

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Thimerosal – MSDS

Exposure to methylmercury most commonly occurs when people eat kinds of fish and shellfish that have high levels of methylmercury in their tissues. Almost all people have at least small amounts of methylmercury in their bodies, reflecting the widespread presence of methylmercury in the environment. U.S. Centers for Disease Control and Prevention (CDC) data show that most people have blood mercury levels below levels associated with possible health effects. Methylmercury, however, is a powerful neurotoxin, and people exposed to high levels may experience adverse health effects. If you are concerned about your exposure to methylmercury, you should consult your physician.

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Simpsonwood Documents

My name is Walter Orenstein. I’m Director of the National Immunization Program at CDC and I want to thank all of you for coming here and taking time out of your very busy schedules to spend the next day and a half with us. Not only do we thank you for taking time out, but for taking the time out on such short notice, and also putting up with what I gather those of us who are townies here didn’t realize, but apparently the biggest meeting in Atlanta which has taken up all the hotel space and all of the cars, so I think many of you have had to take taxis here. We appreciate you putting up with this, but at least we did arrange the weather nicely and you can look out occasionally and see some beautiful trees.

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