Many vaccine safety and efficacy trials do not use a saline placebo (a true placebo) but an “excipient placebo”, which consists of all the adjuvants of the studied vaccine minus the viral ingredient(s). The said adjuvants (Alu-hydrogel, Aluminumhydroxyphosphate sulfate, polysorbate 80 surfactant/emulsifier, for example) are known or suspected of causing severe adverse reactions, as stated on the Vaccine Inserts and flagged in in vitro studies.
People who are given the excipient placebo are not gaining any medicinal benefit from the injection but are nonetheless exposed to the risk of severe adverse reactions, it seems therefore that this practice is a breach of medical ethics, especially since a saline placebo would not compromise the study but make it more meaningful for assessing the safety of the overall product. I am looking for input from specialists in medical ethics and others for arguments that could either justify this practice on ethical grounds or confirm my doubts about it being unethical.
ideally a placebo should not cause any harmful effects. In addition to that, ideally it should not also cause any pain. It is definitely quite unethical if any potentially harmful substance is used as placebo.
Hi
The question is painful or harmful must means unethical .... especially vaccines are very specific because a placebo has an important role in immune response after vaccination it's not only let say a "carrier" or "filler".
Very nice example suggestion of regulations in this field are proposed in paper from 2020 by Bishop and colleagues:
Article TIDieR-Placebo: A guide and checklist for reporting placebo ...
I think it would be unethical to give a placebo that does not allow obtaining true information about the safety profile of drug product.
Administration of the placebo in the form of (drug product without vaccine only) enables the definition of a panel of adverse reactions resulting from the use of the specific components of the placebo- formulation. This approach allows increasing knowledge about the ingredients included in the drug product formulation and future optimization of the next formulations.
Rather, the lack of detailed information on the composition of the placebo in a particular study may be considered unethical. This approach conflicts with the basic principles of GxP because it makes it impossible to reproduce the study.
Moreover, it would be considered unethical to "whiten" the ADR panels of drug product versus placebo (formulation). Especially in a situation where the formulation generates a very high number of ADR's, however, there is no information that a placebo is in fact a formulation. In this situation, the conclusions from the study may indicate that the number of ADR's after administration of the drug is only slightly different from the number of ADR's after administration of placebo. However, such information cannot be considered fully ethical without information about what the placebo was. For example:
Conclusion based on points 1 and 2 could be:
there is no meaningful difference between the drug and placebo groups.....
or
Conclusion based on points 1 and 3 could be:
the number of ADRs after drug injection is 10 fold higher than after placebo .....
Best regards
Tomasz
Hello,
Perhaps I'm not understanding your question fully, but a placebo should not cause any effect, good nor bad. It is a control, and should be inactive, otherwise you'd confound the study. Does this make sense?
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