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Photo: Sarah Silbiger/Getty Images

FDA statisticians did not believe experimental Alzheimer's treatment Aduhelm proved that it could slow down the cognitive disease, but the top brass at the agency thought there was enough evidence to approve the drug anyway, according to internal documents released by the FDA today.

Why it matters: Outside experts almost unanimously voted down the drug, and the scientific community has blasted the FDA's approval of Aduhelm. But FDA leaders repeatedly cited "the urgent and unmet medical need" for Alzheimer's treatments.

The big picture: The conditional approval of Aduhelm is based on the theory "brain amyloid plaques" are major contributors to Alzheimer's, and therefore reducing those plaques will fight the disease. That theory is controversial and unproven.

  • Memos from top FDA neurology officials and Peter Stein, director of FDA's Office of New Drugs, highlighted how Aduhelm reduced amyloid plaques in one of the main clinical trials, and that marker "is reasonably likely to predict clinical benefit."
  • However, as Zach Brennan of Endpoints News pointed out, FDA officials are contradicting their own agency's 2018 guidance on Alzheimer's drug development, which says "there is unfortunately at present no sufficiently reliable evidence that any observed treatment effect on such biomarker measures," like lowering amyloid levels, "would be reasonably likely to predict clinical benefit."
  • In a meeting this past April, five top FDA officials thought Aduhelm met the criteria for "accelerated approval," an option that FDA leaders told its outside expert panel was not up for consideration.
  • Sylva Collins, the FDA's director of the Office of Biostatistics, "dissented on the approach, stating her belief that there is insufficient evidence to support accelerated approval or any other type of approval," according to one of the memos.

The bottom line: The FDA's decision to approve a drug that has not proven to work and has side effects like brain bleeds — and on a theory that goes against the agency's own guidance for evaluating Alzheimer's drugs — will have lasting financial and scientific repercussions.

Go deeper

Sep 22, 2021 - Health

FDA approves Pfizer boosters for high-risk individuals, people 65 and up

Photo: Paul Hennessy/SOPA Images/LightRocket via Getty Images

The Food and Drug Administration on Wednesday approved Pfizer-BioNTech coronavirus booster shots for people at high risk of severe COVID-19 and people 65 years and older.

Driving the news: The approval comes just days after an FDA advisory panel recommended boosters for the two groups but overwhelmingly voted against the third shots for younger Americans.

Sep 23, 2021 - Health

CDC director approves Pfizer boosters, adds eligibility for high-risk workers

Photo: Marco Bello/Anadolu Agency via Getty Images

A key panel at the Centers for Disease Control and Prevention on Thursday recommended the Pfizer-BioNTech coronavirus booster shots for people 65 years old and older, as well as those at high risk of severe COVID-19.

Driving the news: But in an unusual move, CDC director Rochelle Walensky late Thursday overruled part of the advisory committee's decision and said that workers in high-risk jobs should also be eligible for booster shots.

Updated 19 mins ago - Economy & Business

Janet Yellen co-opts Reaganomics phrase for new Davos speech

Treasury Secretary Janet Yellen at a speech this week. Photo: Alex Wong/Getty Images

The U.S. needs to focus on increasing its productive potential, Treasury Secretary Janet Yellen told world leaders Friday, calling for what she terms "modern supply side economics."

Why it matters: She co-opted a phrase traditionally used by political conservatives to describe low-tax and deregulatory policies — and framed the Biden administration's initiatives as the best path forward to achieve greater national prosperity.