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Illustration: Annelise Capossela/Axios

Following the FDA's approval of Biogen's Alzheimer's treatment Aduhelm, experts fear the approval — based on weak scientific data — is a sign the agency is putting speed over rigor.

The big picture: "A general signal being sent to the rest of the drug industry is: If you can get uncertain, maybe suggestive data and a post-hoc analysis — get that threshold to us — we may approve your drug," said Peter Bach, a drug researcher at Memorial Sloan Kettering Cancer Center.

Where things stand: The FDA has not been shy in recent years about touting the quantity of drugs it approves.

  • But Alzheimer's has been different. So many drugs have failed, and patients and families are desperate for any treatment.
  • In 2018, the FDA issued guidance to ease standards and definitions for clinical trials involving potential Alzheimer's treatments. The agency encouraged companies to "discuss their plans with FDA early in development."
  • The Aduhelm decision within the policy community was nearly unanimously panned as a mistake. But it had support among patient advocates and some physicians, most of whom have financial ties to Biogen and Eisai, a company that also developed the drug.
  • "There are very compelling arguments about the magnitude of unmet need [for Alzheimer's], but these shouldn't trump regulatory standards," said Caleb Alexander, a drug researcher at Johns Hopkins who sat on the FDA's advisory committee for this drug and argued it should not be approved.

The bottom line: The FDA is green-lighting an IV drug that has not proven to be better than a placebo, carries a risk of brain swelling and hemorrhages, requires patients to undergo a lifetime routine of imaging scans and doctor visits, and is based on a hypothesis of brain plaques that is losing scientific credence.

  • The FDA also did not limit the drug to Alzheimer's patients who have mild dementia, even though those were the patients who were studied in trials.

Looming concerns: Experts believe opening the door to unproven treatments like Aduhelm could water down the FDA's standards for other serious conditions that similarly lack drug options.

  • Biogen must run a confirmatory trial at some point to test the drug's effectiveness, but mandating post-approval trials also has pitfalls, as companies have no incentive to run them.
  • Biogen's CEO told CNBC the company has "up to nine years to deliver the final results of the study."

Our thought bubble: The FDA said in its approval that, "hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm."

  • Typically, America's drug regulator would have that evidence instead of saying it will "hopefully" pan out.

Go deeper

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.

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

Democrats' health care plans are taking shape

Illustration: Aïda Amer/Axios

Democrats' ambitious health plans are slowly transitioning from bullet point proposals to more fleshed-out policies, inching the legislative process forward and shedding more light on who stands to win or lose.

Yes, but: Some of these proposals put the House and Senate in conflict with one another, emphasizing just how far Democrats still have to go.