On June 7, 2021, the FDA approved aducanumab, an amyloid beta-directed monoclonal antibody indicated for the treatment of Alzheimer’s disease.
However, most analysts describe this decision as controversial since the FDA overruled the near-unanimous negative recommendation put forward by the FDA advisory committee in November 2020.  And there is a general agreement in the field that the amyloid hypothesis was based on correlations with no real evidence regarding causal relationships between presence of the amyloid and the disease.
Why has the FDA made this decision?
The answer is simple – aducanumab is the first new Alzheimer’s drug since 2003 and the pressure on the regulator must have been enormous.
What do we have to do with that?
For us, this is yet another example for the power of positive results. No matter how tiny the positive signal is, one only needs to be under sufficiently great pressure to ignore all other less supportive or even contradictory signals.
FDA employees are humans like us and they can get biased in the same way as we are. Aducanumab’s approval is not FDA’s failure. It is our failure since we still base decisions on exploratory preclinical evidence, allow positive results to be selectively reported, cherry-pick or inflate results via creative post hoc analyses. We have not been vocal enough and thus allowed to build an illusion that blinded the FDA.