From Scott Alexanders new blog.
Yesterday the FDA approved aducanumab, an anti-amyloid antibody developed by Biogen, for the treatment of Alzheimer’s disease. This was based on post hoc interpretation of clinical trials that were stopped early due to futility, and against the strong recommendation of the FDA’s own advisory committee. Aducanumab will be priced at $56,000 per patient per year. Since Alzheimer’s patients are usually covered by Medicare, this cost will be paid by the American public. I estimate that it could be over $100 billion per year.1 This is excluding indirect costs, such as those of monitoring for brain swelling that is a known effect of this drug.
Putting this in context, for $56,000/year you could hire a graduate student or postdoc to work on Alzheimer’s research full-time. Imagine the opportunity cost!
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Writing at In the Pipeline, Derek Lowe called this a tragedy.3 I want to go further. This is not just a tragedy, but a travesty. The FDA has become a sadistically distorted mockery of what medical regulation should look like. There can be no excuses for the level of statistical incompetence required to approve aducanumab based on the flimsy efficacy data from the trials.