Uncovered documents show that the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) knew that infant vaccines were exposing American children to mercury far in excess of all federal safety guidelines since 1999. The documents, created by a FDA consulting toxicologist, show how federal regulators concealed the dangerous impacts and lied to the public.
In 1997, Congress passed the FDA Modernization Act. A provision of that statute required the FDA to "compile a list of drugs that contain intentionally introduced mercury compounds, and provide a quantitative and qualitative analysis of the mercury compounds on the list." In response, manufacturers reported the use of the mercury-based preservative, thimerosal, in more than 30 licensed vaccines.
FDA's Center for Biologics Evaluation and Research (CBER) was responsible for adding up the cumulative exposure to mercury from infant vaccines, a simple calculation that, astonishingly, had never been performed by either the FDA or the CDC. When the agency finally performed that basic calculation, the regulators realized that a six month-old infant who received thimerosal-preserved vaccines following the recommended CDC vaccine schedule would have received a jaw dropping 187.5 micrograms of mercury.
Instead of immediately ordering the removal of thimerosal, FDA officials circled the wagons treating the public health emergency as a public relations problem. Peter Patriarca, then director of the FDA Division of Viral Products, warned his fellow bureaucrats that hasty removal of thimerosal from vaccines would:
" … raise questions about FDA being 'asleep at the switch' for decades by allowing a potentially hazardous compound to remain in many childhood vaccines, and not forcing manufacturers to exclude it from new products. It will also raise questions about various advisory bodies regarding aggressive recommendations for use. We must keep in mind that the dose of ethylmercury was not generated by "rocket science." Conversion of the percentage thimerosal to actual micrograms of mercury involves ninth grade algebra. What took the FDA so long to do the calculations? Why didn't CDC and the advisory bodies do these calculations when they rapidly expanded the childhood immunization schedule?"
The agency consulted with experts in the field of toxicology to better understand the potential impact of these exposure levels. One consultant was Barry Rumack, MD. Dr. Rumack, at the time, had a private consulting practice, Rumack Consulting, where he offered "toxicologic and pharmacologic evaluation of drugs, biological and potentially toxic or hazardous agents for government and industry." After creating several scenarios based on infants' ages and weights, Dr. Rumack modeled blood and body burden levels in 1999.
The models predicted sharp peaks of mercury concentrations in both blood and tissue, in a stair-step sequence following each of the new thimerosal-containing vaccines given during the first six months of life. Based on these models, Rumack predicted exposure to thimerosal-containing vaccines was dosing American children with mercury levels far exceeding all three federal safety guidelines established by the U.S. Environmental Protection Agency (EPA), FDA, and Agency for Toxic Substances and Disease Registry (ATSDR). There was no point in time from birth to approximately 16-18 months of age that infants were below the EPA guidelines for allowable mercury exposure. In fact, according to the models, blood and body burden levels of mercury peaked at six months of age at a shockingly high level of 120ng/liter. To put this in perspective, the CDC classifies mercury poisoning as blood levels of mercury greater than 10 ng/L.
After receiving this alarming news from its toxicological consultant, the FDA chose to conceal these acute exposures using a deceptive statistical trick. Instead of honestly reporting the dangerous spikes in pediatric blood levels, FDA's public documents averaged the exposures over a six month period despite the fact that the exposures only occurred on four days during that six month period: at birth, and at two, four and six months of age.