
Barbara Loeppke
377 posts






Dr. Offit, your revised definition of "placebo" as "immunologically inert" would focus on testing efficacy, not safety, which is precisely the substantive concern raised by @RobertKennedyJr and others when explaining that childhood vaccines are virtually never licensed based on trials that included a control group receiving an inert substance. In addition, it is categorically false to claim that "all vaccine trials" included an "immunologically inert" control. This is because most childhood vaccine trials used other vaccines as a control, which, by definition, are immunologically active. The use of vaccines as controls is highly concerning because the control vaccines were virtually never licensed based on a placebo-controlled trial – meaning "inert" per CDC/FDA. This is true even for trials of the first vaccine for a target disease. Hence, the safety of the subject or control vaccine was virtually never properly assessed in any clinical trial. For example, Prevnar-13 was licensed based on a trial comparing it to Prevnar-7, and Prevnar-7 was licensed based on a trial comparing it to another experimental vaccine. "Serious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients and 7.2% among Prevnar 7 recipients." Meaning, equally safe by FDA standards. But equally unsafe by any other standard. As another example, in Gardasil’s trial, 2.3% of the Gardasil group and 2.3% of the control group (which received an injection of a proprietary adjuvant which can cause autoimmune issues) had a suspected autoimmune disorder. Again, meaning equally safe by FDA standards. But equally unsafe by any other standard. I trust you agree that the safety of products injected repeatedly into babies is very important. Without an inert comparator, harm can be obfuscated. While you label it "absurd" to define a placebo as having "no effect on living beings," that is, verbatim, the CDC’s definition of "placebo" in its Vaccine Glossary. What is "absurd" is to define a "placebo" as a vaccine or an adjuvant. As this is a critically important issue, I gladly welcome a respectful in-person discussion where we each present our evidence regarding clinical trials for childhood vaccines to best understand each other’s position for the common goal of protecting children. Would you agree to have that discussion? Sources: CDC definition of “Placebo”: cdc.gov/vaccines/terms… Lack of placebo controls, pp. 3 - 7; even when no vaccine exists for target pathogen, including discussing Gardasil, pp. 7 - 11; using other vaccines as control, including discussing Prevnar, pp. 11 - 15; and trial conduct, pp. 17 - 31: icandecide.org/wp-content/upl…




























