When Placebos are Not Inert

Dr. Tenpenny discusses the use of "comparators" in randomized controlled drug trials, rather than inert placebos.  Comparators are substances, such as FDA/EMA-approved vaccines, that are used in clinical trials for new vaccines.  This practice can be traced back to 2013, when a panel of experts, citing ethical concerns, recommended that the World Health Organization (WHO) require this change to the traditional gold standard testing of new vaccines, which involved double-blind, inert placebo-controlled trials. When using comparators, the new vaccine's true effects and risks cannot be determined. WHO, however, deemed it unethical to deny protections to trial participants if a vaccine could be used instead of a placebo in a vaccine trial.

Dr. Tenpenny asserts that using a comparator undermines the purpose of the placebo-controlled trial.  It takes away the chances of detecting the full range of adverse events associated with a new vaccine.  And because the comparator is usually a different vaccine, it undermines any knowledge of how effective the new vaccine is against a specific disease.