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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

Updated Sep 10, 2021 - Axios Events

Watch: A conversation on what's working to get Americans vaccinated

On Friday, September 10, Axios health care reporter Caitlin Owens and health care editor Tina Reed hosted a virtual conversation on what strategies are working to get Americans vaccinated, featuring former FDA Commissioner Dr. Scott Gottlieb and Walgreens Chief Medical Officer Dr. Kevin Ban.

Dr. Scott Gottlieb spoke about reducing vaccine hesitancy, an increase of COVID-19 cases in conjunction with the return to school, and how to ensure the effective distribution of booster shots when the time comes.

  • On why reducing hesitancy is more difficult in the later stages of vaccine rollout: “We’re at that point right now where every vaccine is harder to administer, because you’re probably trying to entice a consumer who is more reluctant to take the vaccine or finds it less accessible for a variety of reasons.”
  • On the recent rise in cases in younger populations returning to school: “Studies have looked at what are the most effective interventions—keeping kids in defined social pods within the school so you’re not having the entire grade commingling...and also implementing routine testing of asymptomatic children, ideally twice a week.”

Dr. Kevin Ban explained Walgreens’ decision to mandate vaccination for some employees, what has been working to increase vaccination, and the potential hurdles of administering booster shots.

  • On Walgreens’ thought process behind implementing an employee vaccine mandate: “Collectively as a group, we have followed the science since the beginning of this epidemic. And along with the effectiveness of these vaccines, we’ve noted the safety. And so collectively, as a leadership team, we thought that the right thing to do here was to, in fact, mandate vaccines.”
  • On the effectiveness of local outreach in vaccination efforts: “Meeting people where they are and listening to them and trying to understand what is it that’s preventing you, and then addressing that, is powerful. It’s hard to do across the country, but you can do it locally.”

In a final Why It Matters segment, Axios' Caitlin Owens and Tina Reed echoed similar curiosities about the impending rollout of booster shots, and raised the question of how the process may mirror or differ from that of the initial vaccine distribution.

Tune in next month for October's Vitals Check-Up.

Sep 10, 2021 - Health

FDA "will follow the science" to approve COVID vaccine for kids under 12

A nurse gives a boy a dose of the Pfizer vaccine at a clinic. Photo: Paul Hennessy/SOPA Images/LightRocket via Getty Images

The FDA said on Friday that it is "working around the clock" to support the process of making the coronavirus vaccine available for children under the age of 12.

Why it matters: The number of children getting hospitalized due to the virus is increasing, with some infectious disease doctors worrying that the Delta variant could be causing more serious illness in kids.

Brazil's health minister tests positive for COVID during UN summit in N.Y.

President of Brazil Jair Bolsonaro (L) and Health Minister Marcelo Queiroga in Brasilia, Brazil, in May. Photo: Andressa Anholete/Getty Images

Brazil's Health Minister Marcelo Queirog has tested positive for COVID-19 while in New York City for the United Nations General Assembly (UNGA), he confirmed Tuesday night.

Why it matters: Hours earlier, Queirog had accompanied Brazilian President Jair Bolsonaro to the UNGA. The Biden administration expressed concern last week that the gathering of world leaders could become a coronavirus "superspreader event."