As part of its mission, the Informed Consent Action Network (ICAN) ensures products mandated for injection into American children go through property safety testing. ICAN asked the FDA for all clinical trial reports relied upon to license Merck’s chicken pox vaccine. After 14 months of stonewalling by the FDA, ICAN sued and was given 10,796 pages of data. Upon reviewing the documents provided, it was found that this experimental vaccine was licensed without the use of an inert placebo, that serious adverse events observed were considered ‘unrelated’ by the manufacturer’s investigators, the studies used were woefully underpowered, and all study participants were given the vaccine after the study concluded, thus hiding any potential long term health effects.
ICAN will be taking additional formal legal action regarding the lack of safety relied upon to license this product.