Many red flags raised by the FDA approval of aducanumab

Health Canada must stick to science

MONTREAL, Aug. 12, 2021 /CNW Telbec/ - Researchers and clinicians from six leading Canadian organizations working in the dementia research and care field, came to the conclusion that aducanumab ? the treatment (or disease-modifying therapy) for Alzheimer's disease (AD) recently approved conditionally by the FDA and undergoing evaluation at Health Canada ? requires further testing before approval and widespread use in patients with AD in Canada. This group of eminent health research professionals produced a consensus statement that was presented to Health Canada and other Canadian health regulatory bodies; it has also been made available to the public. They also offered to form a working committee, which would provide guidance and advice to Health Canada on the approval of any treatment or disease-modifying therapies for neurocognitive disorders.

Alzheimer's disease, one of the many causes of dementia, affects more than 650,000 Canadians, and this number is expected to double within the next ten years. The annual cost attributed to dementia care is estimated at 10 to 12 billion dollars in Canada. People with AD show an increase of a protein called amyloid in their brain. Aducanumab is an anti-amyloid medication. However, the presence of amyloid in the brain is not the only important factor in AD, and it is unclear if amyloid reduction leads to dementia reversal. 

"As researchers, we are all very dedicated towards finding a cure for Alzheimer's disease; we know that there was no treatment breakthrough in the last 20 years for dementia", explained Dr. Howard Chertkow,  Scientific Director of the Canadian Consortium on Neurodegeneration in Aging. "Patients and advocacy groups quickly applauded the accelerated approval of this drug in the U.S. It was the first ray of hope for a cure in a very long while. But scientific evidence must prevail, and actually, there are too many red flags raised. People have to understand that introducing a medication which may not have clinically relevant benefits could have detrimental effects", Dr Chertkow added.

In their statement, health research professionals commented that the available evidence presented by Biogen, the pharmaceutical company that developed the medication, suggests that aducanumab (ADUHELM^TM) does not meet accepted criteria for clinical efficacy, safety, and risk-benefit ratio for a disease-modifying therapy for AD that would justify regulatory approval in Canada. Moreover, major questions about costs and benefits were raised and must be evaluated thoroughly.

"The Canadian health care system is very different from its counterpart in the U.S., and the benefits of an expensive disease-modifying therapy will need to be balanced against other potential uses of limited public financial resources, said Dr Tarek Rajji, Executive Director of the Toronto Dementia Research Alliance. "Adding new costs to an already overloaded health care system will just force the authorities to make difficult decisions. We know that preventable dementia risk factors (such as hypertension, smoking, diabetes, and untreated mid-life hearing loss) can be responsible for up to 40% of dementia cases. Investing more in highly effective prevention programs would turn out to be cost saving, and would reduce number of individuals with dementia" Dr Rajji added.

The consensus statement was prepared by members of the Canadian Consortium on Neurodegeneration in Aging (CCNA), the Consortium of Canadian Centres for Clinical Cognitive Research (C5R), the Canadian Academy of Geriatric Psychiatry (CAGP), the Canadian Geriatric Society (CGS), the Ontario Neurodegenerative Disease Research Initiative (ONDRI), and the Toronto Dementia Research Alliance (TDRA), and endorsed by those organizations. The complete statement, a summary, and the list of signatories are available at www.ccna-ccnv.ca/aducanumab. 

SOURCE Canadian Consortium on Neurodegeneration in Aging