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alzheimer's disease

resignations keep alzheimer's drug in spotlight

aducanumab's approval has prompted research worry and resignations, but it's the first breakthrough in alzheimer's disease in 20 years.

by lisa machado

jun 11 2021

4 minute read

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new alzheimer's drug sheds light on funding, research need

a new fda-approved medication to treat alzheimer's is generating some controversy. getty

when my father was diagnosed with dementia 19 years ago, the best his neurologist could offer was an antidepressant to calm his temper and something to help him sleep so he didn’t keep my mom up during the night with his incessant wandering. he died in 2018, in a coma, after years of being unable to move his body, speak and finally, to swallow. i hope there wasn’t even a little part of him that knew what was happening — he would have hated it.

so when earlier this week, news came out about a treatment for alzheimer’s, i felt a pang of jealousy. if only. the fact that the drug — aducanumab — may slow the rate of cognitive decline was exciting enough. but that it’s the first treatment for this devastating brain disease in almost two decades, well, that’s positively happy-dance worthy.

except that the controversy around its approval is casting shadows on the hope held by today’s patients, caregivers and advocates that this just might be the key to unlocking not only the mysteries of dementia, but also the millions of minds that are being slowly stolen away.

the news around aducanumab — pronounced add-you-can-you-mab and marketed as aduhelm — has mostly focused on concerns that the treatment was given the green light despite having shown little benefit. but for dr. saskia sivananthan, the real story is how long patients and their families have waited for something to help slow or prevent the deadly disease.

“we haven’t had a breakthrough in [alzheimer’s disease] in twenty years,” says sivananthan. “twenty years! so before we talk about whether or not it should have been approved, let’s talk about why that is.”

sivananthan, a n euroscientist and the chief of research & kte at the alzheimer society of canada, says that canada’s investment in dementia has been dismal at best, especially considering the numbers of canadians who are currently affected — about half a million. it’s a number that’s expected to double in less than ten years.

“ we lag in every country in the g7 in terms of how much money we put towards research in this area,” she says. “globally, the funding is so little … it’s unacceptable.”

it’s no surprise, then, that sivananthan is watching the developments closely.

the drug came under scrutiny after it won fda approval despite warnings from the peripheral and central nervous system drugs advisory committee. it took seven hours for the committee, which provides the fda with recommendations on the safety and efficacy of treatment of neurologic disease treatments, to vote against the suggestion that the treatment had any benefit for patients.

but despite the doubts of the independent advisors, the agency decided that the drug, which is given by infusion every four weeks at a doctor’s office or hospital, showed enough promise of helping patients, and submitted aducanumab for accelerated approval — a process designed to provide earlier access to therapies where there is unmet need.

the move prompted the resignation of two committee members, dr. joel s. perlmutter, a neurologist at washington university, and dr. david s. knopman, a neurologist with the mayo clinic. in an email to the washington post , knopman, called the review and approval process “a sham.”

just days before knopman’s resignation, dr. patrizia cavazzoni, director of the fda’s center for drug evaluation and research , issued a statement noting the “residual uncertainties” surrounding the effectiveness of aducanumab, but also acknowledged the “cumulative devastation” experienced by patients, calling the need for treatment “urgent.”

research impact
the decision has also caught the attention of those in the research community, many of whom worry that the approval may hamper research efforts by causing patients to withdraw from trials to take aducanumab.

there’s also the issue of the clinical pathway of the drug. aducanumab is designed to pull amyloid — one of the hallmark signs of alzheimer’s according to some experts — out of the brain. but not everyone agrees on whether amyloid is a cause or symptom of the brain disease, which has researchers concerned that the swift approval may push drug makers to shift focus to anti-amyloid drugs, rather than looking at other toxic proteins that may play a role, such as tau.

“this is going to set the research community back 10 to 20 years,” george perry, a neurobiologist at the university of texas, told nature .

while sivananthan understands the swirling controversy, she cautions against being too quick to write off the potential of the new treatment.

“the drug has followed the rigours of a proper trial,” she says. “it wasn’t just a straight approval. plus, don’t forget that there is a stipulation that [biogen] must run another trial to prove effectiveness.”

as for what this means for canadians, sivananthan says that, for now, patients and their families will have to wait for health canada to weigh in on the drug’s safety and efficacy. she also points out that despite the controversy, the approval highlights the importance and need for treatment options for people living with the devastating brain disease and gives patients and their families reason for optimism — something that the long drought in research and funding has not left a lot of room for.

you just have to see dementia in action and it’s impact on families to understand what this drug means, sivananthan explains, even if effectiveness is uncertain. “we are hopeful,” she says.

lisa machado is the executive producer of healthing.ca.

lisa machado

lisa machado began her journalism career as a financial reporter with investor's digest and then rogers media. after a few years editing and writing for a financial magazine, she tried her hand at custom publishing and then left to launch a canadian women's magazine with a colleague. after being diagnosed with a rare blood cancer, lisa founded the canadian cml network and shifted her focus to healthcare advocacy and education.

resignations keep alzheimer's drug in spotlight

aducanumab's approval has prompted research worry and resignations, but it's the first breakthrough in alzheimer's disease in 20 years.

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resignations keep alzheimer's drug in spotlight

aducanumab's approval has prompted research worry and resignations, but it's the first breakthrough in alzheimer's disease in 20 years.

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