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As academics, researchers, patient and consumer advocates with no ties to the pharmaceutical industry, IVSED can speak directly and without bias about a new dementia drug, aducanumab (Aduhelm), recently approved by the FDA. We are extremely disturbed by the FDA’s recent approval of aducanumab, and were this drug to be submitted to Health Canada for approval, we expect Health Canada will consider the following in its deliberations, including: the FDA's independent Advisory Committee, created to evaluate this drug, voted overwhelmingly against approval due to a lack of evidence; serious side effects were reported in the two Phase III clinical trials; and, the cost of the Aducanumab is prohibitive.
Understandably, people with the disease and their families are terribly desperate. However, desperation is not a basis on which to grant drug approval. Evidence is the cornerstone of our drug approval process and Canadians rely on Health Canada to uphold scientific integrity. We are troubled that the Alzheimer Society is actively pressing for the approval of aducanumab, and worry that their position could be that they receive funding from Biogen, the company that wants Health Canada to approve this drug. Should Health Canada receive an application requesting approval for aducanumab, we implore that it insists on the presentation of actual evidence.
The credibility of science is at stake and high standards must be upheld. Scarce Canadian taxpayer dollars cannot be wasted on snake oil. These dollars are direly needed to fund new avenues of Alzheimer’s research and support for home and long term care for persons with Alzheimer’s disease. Drug approvals are for drugs that hold promise, not false hope. Canadians deserve the best decisions, based on science, and aducanumab does not pass.