Alzheimer’s drug has experts divided; rising ICE use in Australia; the disappointing results of a study aimed at improving ovarian cancer survival rates
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What is the main topic discussed in this episode?
Hello and welcome to this week's Health Report podcast. I'm Norman Swan.
And I'm Tegan Taylor.
Today on the Health Report, the first of a new series on substance use. This week, what you need to know about ice, crystal meth. Whether early diagnosis of ovarian cancer through screening makes a difference. And the search for an Alzheimer's disease treatment is as controversial as ever. The US Food and Drug Administration has approved the first drug for Alzheimer's disease in nearly two decades. It's called educanumab. But not everyone is welcoming the decision. While some clinicians, patients and their families think the drug, which costs tens of thousands of dollars a year, provides hope to those living with disease. Others are worried there is not enough evidence to prove it benefits patients and that putting it on the market will only stall the development of other drugs and potentially waste enormous amounts of money.
Amongst those concerned are actually scientists who advise the FDA. And here in Australia, authorities are considering whether to also give aducanumab the green light, as Sarah Seji reports.
For people living with Alzheimer's disease, there are few options they can turn to in medicine, and those can only help manage some of the symptoms. So the promise of a drug that can also target the disease process itself is welcome news. But the decision of the US health regulator, the FDA, To approve the drug aducanumab came as a surprise to some. Dr. Jason Karlawish is a professor of medicine at the University of Pennsylvania and a director of the Penn Memory Center. He was also a site investigator for the drug's clinical trials.
It's a very terrible disease for a number of very unique ethical and social reasons. to discover a therapy to try and slow the disease or even prevent developing in the first place. But desperation is what's needed to motivate funding and all the other social and political things we need to do. But desperation ought not to guide the way we interpret the results of science.
What is the FDA’s controversial decision on the new Alzheimer’s drug aducanumab?
Aducanumab is an antibody that's given to patients intravenously. It targets beta-amyloid plaques in the brain with the aim of triggering an immune response to reduce the buildup of the amyloid. The buildup is a feature of Alzheimer's disease. The FDA approved this drug in the US through an accelerated pathway that can be used if the drug has an effect on a surrogate of the disease that they think could benefit the patient. In this case, the surrogate is the reduction in amyloid. But if you're living with Alzheimer's disease or have a loved one affected, you want to know their memory and thinking is clearer and their quality of life is improving. Dr. Karlawish says it's not certain reducing amyloid in the brain can deliver that.
The FDA's decision was a surprise because there's not been a discussion with an advisory board or with their own statisticians about whether the reduction in brain amyloid is an adequate surrogate to represent clinical benefit to patients. I do think and many do feel that this is a leap. It's a leap of inference that reducing amyloid translates into benefit to patients.
Aducanumab showed early potential but two phase three trials were stopped in 2019 because it didn't appear to be effective. But later the developers of the drug Biogen added more data and found that the Alzheimer's disease-related decline of a number of patients in one of the trials was slowed. But reanalysing data at a later stage is not considered best practice among most clinicians. In the second trial, which was identical in design, patients didn't experience a significant improvement, regardless of what dose of the drug they were on. In November, an independent advisory panel to the FDA overwhelmingly agreed the evidence for aducanumab so far falls short. The FDA's decision to approve the drug despite their objections has led to three of those members resigning.
The argument that Biogen and selected members of the FDA made was based on analyses that required selective exclusion of certain participants, namely people who were, quote, rapid decliners.
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Chapters
4 chapters
1
What is the main topic discussed in this episode?
0:00–2:02
2
What is the FDA’s controversial decision on the new Alzheimer’s drug aducanumab?
2:02–5:18
3
Why do some clinicians and scientists doubt aducanumab’s clinical benefit?
5:18–26:34
4
How does aducanumab work and what are its known side‑effects?
26:34–35:08
Speakers
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