are the only pharmaceutical or medical products that do not need to be rigorously safety tested. To win an FDA license, companies must safety test virtually every other drug for years in randomized comparisons against an inert placebo. Yet, not a single vaccine currently on the CDC’s childhood schedule was tested against an inert placebo before licensing. Without placebo testing, regulators have no capacity to assess a medicine’s risks. During a January 2018 deposition, Dr. Stanley Plotkin, the world’s most influential vaccinologist, acknowledged that researches who try to ascertain vaccine safety without a placebo are in “La La land”. According to Dr. Drummond Rennie, Deputy Editor of the Journal of the American Medical Association, “It is the marketing department, not the science, that is driving the research.” It seems plain wrong to me that Democratic-controlled legislatures across the country are frantically passing coercive mandates for pharmaceutical products for which no one knows the risks.
Furthermore, safety testing, which typically requires five or more years for other medical products, often lasts only a few days with vaccines—not nearly long enough to spot cancers or chronic conditions like autoimmune disease (e.g., juvenile diabetes, rheumatoid arthritis, multiple sclerosis), allergic illnesses (e.g., food allergies, allergic rhinitis, eczema, asthma), or neurological and neurodevelopmental injuries (e.g., ADD, ADHD, narcolepsy, epilepsy, seizure disorders, and autism). Manufacturers’ inserts accompanying every vial of mandated vaccines include warnings about these and over 400 other injuries including many serious immune, neurological, and chronic illnesses for which FDA suspects that vaccines may be the cause. Federal law requires that the package insert for each vaccine include “only those adverse events for which there is some basis to believe that there is a causal relationship between the drug and the occurrence of the adverse event.”
Many of these illnesses became epidemic in American children after 1986, coterminous with the exploding vaccine schedule. For American kids born in 1986, only 12.8% had chronic diseases. That number has grown to 54% among the vaccine generation (those born after 1986) in lockstep with the expanding schedule. Evidence including HHS’s own surveillance reports, manufacturers’ inserts, and peer-reviewed studies link all of these injuries to vaccines. However, the associations are not definitive because CDC has failed to conduct the necessary randomized studies to prove or disprove causation.
HHS has directed the Institute of Medicine (IOM, now the National Academy of Medicine) to oversee the CDC’s vaccine safety science. IOM has repeatedly rebuked the agency for failing to study whether vaccines are causing these epidemics. In my experience, vaccine proponents rarely cite specific peer-reviewed studies to support their assertions that all vaccines are safe, relying instead on appeals to authority; CDC, FDA, WHO, or the AAP. My relatives, for example, argue that vaccines are safe because WHO, HHS, CDC, and FDA say so. But HHS designated the IOM as the ultimate arbiter of vaccine safety. And IOM says that the existing scientific literature does not support these claims. Despite requests by the IOM, CDC has steadfastly refused to perform safety studies.
In total, three IOM reports (1991, 1994, and 2011/2012) investigated 231 adverse events associated with vaccines. For 34 conditions, IOM found that the evidence supported a causal connection between the vaccine and the adverse event. But for 184 adverse events, fully 80% of the conditions reviewed, the IOM found that HHS’s evidence was inadequate to accept or reject vaccine causation. How can our public health officials claim safety when there is no follow-up research on reported adverse events?