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New memos show how top FDA officials thought slim evidence was enough for Alzheimer drug approval

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.

Vaccine mandates are suddenly much more popular

State governments, private businesses and even part of the federal government are suddenly embracing mandatory coronavirus vaccinations for their employees.

Why it matters: Vaccine mandates have been relatively uncommon in the U.S. But with vaccination rates stagnating and the Delta variant driving yet another wave of cases, there's been a new groundswell of support for such requirements.

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American Carissa Moore wins first-ever women's Olympic gold in surfing

Team USA's Carissa Moore won gold in the first-ever Olympic women's surfing final, at the Tokyo Games on Tuesday.

The big picture: Brazil's Italo Ferreira won the gold medal in the inaugural men's Olympic surfing contest. The finals were brought forward a day due to the threat of Tropical Storm Nepartak.

Editor's note: This a breaking news story. Please check back for updates.

Activist Tong Ying-kit found guilty of terrorism in first Hong Kong security law trial

Tong Ying-kit, the first person to be charged and tried under Hong Kong's national security law was found guilty of terrorism and inciting secession by three judges Tuesday, per Bloomberg.

Editor's note: This a breaking news story. Please check back for updates.

Naomi Osaka eliminated from Olympic tennis tournament in Tokyo

Tennis superstar Naomi Osaka was eliminated from the Olympics after losing her Tokyo tennis tournament match 6-1, 6-4 in the third round to Czech Marketa Vondrousova on Tuesday.

Editor's note: This a breaking news story. Please check back for updates.

Extreme drought pushes 2 major U.S. lakes to historic lows

Two significant U.S. lakes, one of which is a major reservoir, are experiencing historic lows amid a drought that scientists have linked to climate change.

What's happening: Lake Powell, the second largest reservoir in the U.S., has fallen 3,554 feet in elevation, leaving the crucial reservoir on the Colorado River, at 33% capacity — the lowest since it was filled over half a century ago, new U.S. Bureau of Reclamation data shows.

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North and South Korea restart hotline and pledge to improve ties

North and South Korea's leaders have pledged to improve relations and resumed previously suspended communication channels between the two countries, per Reuters.

Details: South Korean President Moon Jae-in and North Korean leader Kim Jong-un agreed to "restore mutual confidence and develop their relationships again as soon as possible," South Korea's Blue House spokesperson Park Soo Hyun said in a televised briefing, AP notes.

  • This followed an exchange of letters between the two leaders since April.

Go deeper: Kim Jong Un says prepare for "dialogue and confrontation" with U.S.

Editor's note: This a breaking news story. Please check back for updates.

U.S. teen Lydia Jacoby wins Olympic gold medal in 100m breaststroke at Tokyo Games

Team USA's 17-year-old swimmer Lydia Jacoby has won the Olympic gold medal in the women's 100-meter breaststroke at the Tokyo Games.

Of note: The Alaskan is the first American woman to win an Olympic gold medal in Tokyo, and she beat Lilly King into second place.

Editor's note: This a breaking news story. Please check back for updates.

Pelosi expected to extend proxy voting as Delta variant surges

House Speaker Nancy Pelosi (D-Calif.) is expected to extend proxy voting through the fall — and potentially until the end of the year — Democratic lawmakers and aides tell Axios.

Why it matters: The spread of the Delta variant has alarmed both members and staffers anxious about interacting with the unvaccinated. Pelosi’s anticipated move — continuing an emergency COVID-19 measure enacted last year so lawmakers could vote remotely — is aimed at allaying those concerns.

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