Is edaravone harmful? (A placebo is not a control)
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Edaravone is delivered by long-term daily intravenous infusions, yet the risk of infusion was not considered in the design or analysis of studies examining the efficacy of edaravone in ALS. A reappraisal of the pivotal edaravone study (Study 19) on which claims of efficacy are based suggests that this risk cannot be dismissed, that the efficacy of edaravone may be over-estimated, and that some differences between edaravone and placebo may not implicate the ALS disease process. When trial conditions may be harmful to both arms of a placebo-controlled trial, not only is it necessary that treatment prove superior to placebo, but also that treatment is better than no intervention. In Study 19, edaravone performed better than placebo, but both placebo and edaravone likely did worse than no intervention, an interpretation more in keeping with previous trial experience of drugs with similar mechanisms of action, and with previous trial experience with edaravone. Edaravone, as presently delivered, may be both ineffective and harmful.
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