Canadian calls U.S. approval of Alzheimer's drug a 'light at the end of the tunnel,' but scientists skeptical
Biogen says its drug slowed some patients’ mental decline, but not everyone is convinced of the findings
An 82-year-old Ontario man with mild dementia says he's excited the United States has approved a new drug that could help treat Alzheimer's disease, because tackling people's symptoms isn't enough.
"We can't keep building beds to take care of people. They have to stop people from getting to that stage, and that's what this drug will do — maybe," Seaforth resident Bob Murray, who was diagnosed in 2013, told The Current's Matt Galloway.
"But if we don't try it, how do we find out?"
Dementia is a general term for the inability to remember or think clearly, but is not a specific disease, according to the U.S. Centres for Disease Control. Alzheimer's disease is the most common form of dementia.
In early June, the U.S. Food and Drug Administration approved a medication from Biogen called aducanumab, which will be sold under the brand name Adulhelm, despite questions around its efficacy.
It's the first new drug for Alzheimer's in 20 years, and the only therapy U.S. regulators say can likely treat the underlying disease, rather than just manage its symptoms.
The FDA said Aduhelm's ability to reduce harmful clumps of plaque in the brain is expected to help slow dementia. But some experts have questioned the effectiveness of the newly approved drug.
Biogen says some patients who took Aduhelm saw their thinking skills decline 22 per cent more slowly than patients taking a placebo.
However, two studies in 2019 suggested the drug wasn't working to slow mental decline in Alzheimer's patients. The company later said a new analysis of one of those studies found that Aduhelm was effective in higher doses, raising confusion and concern among experts.
Dr. Caleb Alexander, an FDA adviser who recommended against the drug's approval, said he was "surprised and disappointed" by the decision, according to the Associated Press.
The FDA is requiring Biogen to conduct a followup study to confirm its benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though it rarely does so. The company recently submitted an application for review to Health Canada.
Hearing about Aduhelm was like knowing there's a "light at the end of the tunnel," said Murray, who writes a newspaper column about his experiences living with dementia.
"And then I read about all the controversy and I go, 'Come on, guys. Do something. Do it now.'"
'This isn't a home run,' says neurologist
Dr. Howard Chertkow, a senior scientist and neurologist at the Baycrest Centre in Toronto, said that while it's important for Alzheimer's patients to have hope, he worries Aduhelm may raise false expectations.
"This isn't a home run. This is barely getting onto first base, or maybe being tagged out and the umpire calls you safe," he told Galloway.
"People get desperate, but the fact is that we're talking about a drug that … may or may not work."
The drug is also expected to be expensive. Biogen has said the drug would cost about $56,000 US a year.
Chertkow, who is also the scientific director of the Canadian Consortium on Neurodegeneration in Aging, argued that the most effective strategy to combat the brain disorder is to take preventative measures.
"Frankly, we don't actually understand the cause of Alzheimer's disease," he said.
Managing other health issues, such as diabetes, obesity or high blood pressure, for example, can help decrease dementia, Chertkow said.
Last Thursday, Global News reported that Biogen and Japan's Esai Co., which helped develop Aduhelm, submitted a marketing authorization application for the Alzheimer's drug to Health Canada. The government department would be responsible for deciding whether the drug is safe for use in this country.
Health Canada told The Current it is reviewing the submission, but did not specify when the Aduhelm might be authorized or rejected for use here. The department's website on how drugs are reviewed in Canada states that review times depend on the product being submitted, the size and quality of the submission, and the department's available human resources.
In a statement, the Alzheimer Society of Canada said last week it "is urging Health Canada to complete its required reviews swiftly, while maintaining the highest safety standards, so that aducanumab can be made available as quickly as possible to people living with dementia in Canada."
But Canada would be better off spending its money on Alzheimer's research than on Aduhelm, according to Chertkow.
"If we … end up in Canada spending $3-4 billion a year on this treatment, which is what the price tag will be, that's about 100 times as much as all the money that goes into research [for] dementia," Chertkow said.
"The government will be diverting funds from research, which is what we need, to a treatment which in fact may or may not work."
Written by Kirsten Fenn, with files from CBC News and the Associated Press. Produced by Alison Masemann and Alex Zabjek.
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