NICK EICHER, HOST: Coming up next on The World and Everything in It: a new drug for Alzheimer’s disease. The Food and Drug Administration recently approved the drug, but it’s not without critics. WORLD science reporter Heather Frank is here to explain the controversy.
MARY REICHARD, HOST: Welcome, Heather.
HEATHER FRANK, REPORTER: Good morning, Mary!
REICHARD: Well Heather, let’s start with what Alzheimer’s disease is and how this new drug treats it.
FRANK: So many people have experience with Alzheimers disease. It’s a neurological disorder that slowly destroys memory and thinking skills. In time, the person can no longer do simple tasks. And decades of research into a cure hasn’t turned up anything.
As for the new drug, it’s called lecanemab. Lecanemab. And it’s for early onset Alzheimer’s. The clinical trial showed it slows cognitive decline, and by quite a lot: 27 percent over an 18-month period.
What happens in Alzheimer’s is that plaques form in the brain called amyloid plaques. They seem to interfere with memory and other cognitive functions. Lecanemab is the second of two newer drugs that seems to reduce the build-up of those plaques in the brain.
REICHARD: This sounds like good news for patients with Alzheimer’s, so why is this new drug getting pushback?
FRANK: Well, some experts are concerned about safety and how well it works. There’s also a growing number of scientists who believe the build-up of amyloid plaques is not the main cause of Alzheimer’s.
REICHARD: So safety and efficacy concerns. Let’s start with the safety concerns.
FRANK: There’re a few. One is brain swelling, reported in about a tenth of participants taking lecanemab. The second is brain swelling or bleeding. These show up in about a fifth of patients. Finally, and most concerning, two patients taking the drug died. Now, the manufacturers claim the deaths are unrelated, but some Alzheimer’s researchers think it’s likely they are linked.
REICHARD: Those are the safety concerns. What about efficacy concerns - whether the drug actually works.
FRANK: Experts say the slowing of cognitive decline may not align with claims the drug manufacture makes. One issue is that the clinical trial excluded over half of Alzheimer’s patients because they didn’t fit the inclusion criteria. Like secondary illnesses, heart problems, kidney disease, things like that. And then the other issue is the large disparity between men and women. Almost half of the men in the study experienced an improvement in Alzheimer’s symptoms. But for women, that number was only 12 percent. And researchers say we can’t assume these improvements will last long-term as the trial was only a year and a half.
REICHARD: And do we even know the true cause of Alzheimer’s?
FRANK: Well, it IS called an “amyloid hypothesis.” The idea that amyloid plaque build up in the brain causes Alzheimer’s was accepted for decades. But more scientists are questioning it due to a lack of sufficient evidence. Before this drug, none of the other treatments targeting amyloid plaque did much for Alzheimer’s patients. One expert told me some elderly people never develop Alzheimer’s symptoms even with amyloid build up in their brains. At best, it’s unclear whether we understand how Alzheimer’s disease works and therefore how to treat it.
REICHARD: So upsides and downsides to any new drug. I’m assuming patients are still excited about the possibilities with some experts on-board.
FRANK: Well, Alzheimer’s patients want access to lecanemab because the trial data showed the disease progressed more slowly. While it’s not a cure, it’s better than nothing. After all, there aren’t many alternatives.
It’s true that some experts are optimistic about the new drug. I spoke to a former FDA employee about it. He thinks the agency’s decision to approve lecanemab shows FDA’s commitment to innovation. If the FDA were overly cautious, companies would be less likely to develop new drugs.
REICHARD: How might Christians approach this issue?
FRANK: I spoke with a Christian family practice doctor. His name is Cheyn Onarecker. He’s experienced in treating Alzheimer’s patients. He was sympathetic to the FDA’s decision, but he cautioned that its use should be limited until moren safety studies are done.
Dr. Onarecker said that Alzheimer’s patients don’t lose their dignity, even when they can’t clothe or feed themselves. He said our dignity lies in our identity as God’s image bearers.
He also recommended a couple of books to help caregivers dealing with the day-to-day experience of a person with dementia or Alzheimer’s: The 36-Hour Day by Nancy Mace and Peter Rabins, and Finding Grace in the Face of Dementia by John Dunlop.
REICHARD: Heather Frank is a science reporter for WORLD. Thanks for explaining the controversy here, Heather.
FRANK: I’m happy to help.
REICHARD: You can read more of this story at wng.org.
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