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Statisticians stated the lack of compelling evidence in the drug’s favour and dementia experts who participated in the trial were unconvinced. Three members of the FDA advisory panel resigned, one branding it the “worst drug approval decision in recent US history”. The FDA conceded there were “residual uncertainties regarding clinical benefit”. Nonetheless, the drug was approved at the cost of USD$56,000 per year. Patients who receive it will require frequent scans and symptom monitoring as well as monthly travel to an infusion centre, which itself can be a disorienting event in dementia. Although the trial was conducted on people with early dementia, a specific cohort, the approval label does not specify this. If the required post-marketing trials do not show benefit, the FDA can – but doesn’t have to – rescind approval. Experts say such trials are even harder to conduct because patients who can obtain the drug are reluctant to take a placebo.

Ranjana srivastavaAustralian therapeutic goods administrationDrug administrationரஞ்சனா சிரிவாஸ்தவ