Back in November 2020, a federal panel of medical experts refused to endorse a new drug for Alzheimer’s disease, saying that the evidence wasn’t persuasive enough. However, half a year later, in June 2021, the FDA went ahead and approved this same drug, aducanumab. Even if you pay little attention to pharmaceutical current events, you may have heard the uproar over this decision and how members of the expert committee have resigned as a result. Even if you aren’t prone to believing conspiracy theories, it’s hard not to wonder what motivated the FDA to make this choice that goes strongly against both expert opinions and common sense.
Treatment with aducanumab is expected to cost patients over $50,000 a year. In theory the drug will slow progression of Alzheimer’s disease by clearing amyloid plaques from the brain. For years, the accepted theory has been that these plaques disrupt cognition. Prior drugs developed to clear amyloid plaque have not improved symptoms or slowed the disease and have not been approved by the FDA. Biogen, the company behind aducanumab, claims that the drug was useful in high doses for late-stage disease. Biogen reworked data from previously discounted studies in which the drug was ineffective to show slight possible improvements. “The average degree of improvement on a 0-18 point cognitive scale was just 0.39 points relative to placebo, far smaller than the 1 or 2 point threshold typically used to define a clinically important difference…”1
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