An update to our reporting on two recently-approved Alzheimer’s drugs: aducanumab and Lecanemab. FDA advisers and many independent watchdogs said there’s no good evidence the hugely expensive shots make a meaningful difference, and they could cause serious side effects. But the FDA approved them anyway. Recently, the FDA approved a third controversial Alzheimer’s drug, Donanemab, sold as Kisunla, given as a monthly I-V infusion.
The following is a transcript of a report from “Full Measure with Sharyl Attkisson.”
Watch the video by clicking the link at the end of the page.
The watchdog group Public Citizen says that like the 2 other controversial Alzheimer’s drugs the FDA approved in the last couple of years, Kisunladoesn’t prevent or reverse Alzheimer’s, isn’t much better than a placeboand has substantial safety risks, including bleeding in the brain and brain swelling, that can be fatal and outweigh any supposed benefits.
In a statement, Public Citizen calls FDA approval of Kisunla “very disappointing.” “The prescribing information includesthe strongest warning the FDA requires, about these serious risksDonanemab should not have been approved.”
Dr. Caleb Alexander was one of the FDA advisors who voted against approval of the first Alzheimer’s injection, aducanumab. He’s an epidemiologist, internist, and professor at the Johns Hopkins Bloomberg School of Public Health.
Alexander: The advisory committee there was near consensus among the advisory panel that there just wasn’t the evidence to warrant approval.
Sharyl:Did they really want advice from the advisors?
Caleb Alexander: Well, it’s a fair question. And in fact, three advisory committee members of the 10 or 11 or whoever many were on the committee, three resigned in protest of the FDA’s decision.
Sharyl: Aducanumab has since been pulled from the market. The FDA says Lecanemab and the newest one, Kisunla (kiss-SUN’-lah) or Donanemab are safe and effective.
Watch video here.
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