F-10 · How to Read a Regulatory Document
On November 6, 2020, a panel of outside experts convened by the FDA was asked a direct question about an Alzheimer’s drug called aducanumab: did the central study, EMERGE, give strong evidence that the drug worked? The vote was not close. One member said yes. Eight said no. Two were uncertain. No one on that committee clearly endorsed approving the drug.
Seven months later, on June 7, 2021, the FDA approved it anyway.
If you only read the press release, you would see a new Alzheimer’s treatment reaching patients. If you only read the company’s published trial results, you would see a carefully built case for benefit. But neither of those documents tells you about the eight noes, or about how the agency got from there to a yes. That information exists, in writing, available to anyone. You just have to know it is a different kind of document — and know how to read it.
