In 1986, Congress passed one of the most troubling pieces of legislation in modern history, the National Childhood Vaccine Injury Act (NCVIA), which shields vaccine manufacturers from almost all state-law tort liability. See 42 U.S.C 300aa–22 as interpreted by Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011). One feature of the bill that gave at least some hope to vaccine safety advocates was the inclusion of a stipulation titled “Mandate for Safer Childhood Vaccines,” which placed responsibility for vaccine safety directly in the hands of the Secretary of the U.S. Department of Health and Human Services (HHS). See 42 U.S.C. §300aa–27. Part of this “Mandate” required that HHS submit a report to Congress every two years detailing the agency’s research and other efforts to improve the safety of vaccines given to children.
In May 2017, Robert F. Kennedy Jr. invited Del Bigtree, Aaron Siri and Lyn Redwood to a meeting with Dr. Anthony Fauci, Dr. Francis Collins and several other public health officials at the Executive Office of the National Institutes of Health (NIH). For many years, Kennedy had been loudly pointing out that the Department of Health and Human Services (HHS) had not only neglected to conduct large-scale vaccinated versus unvaccinated research, but they had also failed to test the seventy-one doses of vaccines on the childhood schedule against inert placebos. Kennedy directly asked Fauci and Collins for evidence of true placebo controlled studies — using inert placebos — which neither could produce. During the meeting, Kennedy and his team became concerned that HHS might not be fulfilling the obligations placed upon the agency under 42 U.S.C. § 300aa-27.
The Informed Consent Action Network (ICAN) filed a Freedom of Information Act request in Aug. 2017 seeking the biennial reports that HHS was to have submitted to Congress starting in 1989 as stipulated by the Mandate for Safer Childhood Vaccines. In April of 2018, having still heard nothing as a result of the FOIA request, Kennedy and attorney Aaron Siri filed a complaint on behalf of ICAN against the HHS for the agency’s failure to produce any of the reports to have been supplied to Congress. As a result of this complaint, in June 2018, HHS admitted that the agency had no records of any such reports.
In Oct. 2017, before receiving HHS’s ultimate admission of negligence in not reporting to Congress on vaccine safety efforts, Mr. Bigtree submitted a series of relevant questions to HHS, to which the agency replied on Jan. 18, 2018. One of Mr. Bigtree’s questions focused on the lack of inert placebo controlled studies for vaccines prior to being licensed. As stated previously, the absence of true placebo controlled vaccine studies, which would have provided clinical evidence of health outcomes in vaccinated vs. unvaccinated children, has been an issue of great concern among vaccine safety advocates since the passage of the NCVIA.
The paucity and tone of the HHS reply to Mr. Bigtree’s main question spotlight the cavalier attitude towards the health of our nation’s children on the part of federal health officials:
- Please explain how HHS justifies licensing any pediatric vaccine without first conducting a long-term clinical trial in which the rate of adverse reactions is compared between the subject group and a control group receiving an inert placebo?
Inert placebo controls are not required to understand the safety profile of a new vaccine, and are thus not required. In some cases, inclusion of placebo control groups is considered unethical. Even in the absence of a placebo, control groups can be useful in evaluating whether the incidence of a specific observed adverse event exceeds that which would be expected without administration of the new vaccine. Serious adverse events are always carefully evaluated by the FDA to determine potential association with vaccination regardless of their rate of incidence in the control group. In cases where an active control is used, the adverse event profile of that control group is usually known and the findings of the study are reviewed in the context of that knowledge.
Despite a complete lack of scientific justification for not requiring the same safety testing procedures as those conducted for other industry products, the HHS is telling Mr. Bigtree, in essence, that inert placebo controlled studies aren’t required for vaccines “because we said so.” The mention of giving placebos to children enrolled in clinical trials as being “unethical” implies that the vaccines being tested are already known to be safe and prevent disease, which is preposterous given that they are still in the pre-licensure, safety-testing stage of development.
The response also fails to provide any scientific literature to support or explain HHS’s claim that even in the absence of a placebo, “control groups can be useful” or to present any data, charts, graphs or other material to substantiate the agency’s assertion that serious adverse events are “always carefully evaluated by FDA…”
The HHS reply is devoid of any real answers to Mr. Bigtree’s and Mr. Kennedy’s reasonable questions regarding the failure to conduct placebo controlled vaccine safety studies. Perhaps had the agency actually performed the vaccine safety research as mandated by Congress in 1986, we would now have meaningful answers, backed by science, to crucial questions such as these.
The post RFK Jr. Proves HHS is in Violation of Vaccine Safety Requirements Under the Law — “Mandate for Safer Childhood Vaccines” appeared first on Children’s Health Defense.
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