Experts: FDA approves much-debated Alzheimer's drug panned by experts

U.S. government health officials approved the first new drug for Alzheimer's disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn't been shown to help slow the brain-destroying disease. The Food and Drug Administration (FDA) said it granted approval to the drug from Biogen based on results that seemed “reasonably likely” to benefit Alzheimer's patients. (CTV News)

Here are some experts from McGill University that can provide comment on this issue:

Simon Ducharme, Associate Professor, Department of Psychiatry

“As the first FDA-approved disease-modifying drug in Alzheimer’s disease, this is a very positive step. However, the excitement is tempered by the questions that remain about the true extent of the efficacy of aducanumab given the discrepancy between the two major studies. A follow-up study will be required to confirm the clinical benefits and keep the FDA approval. If approved in Quebec, while it may present a significant challenge for the healthcare system for various reasons, it finally brings much needed hope for patients suffering from this devastating disease.”

Simon Ducharme is an Associate Professor in the Department of Psychiatry. His research uses advanced structural brain imaging techniques to study the longitudinal changes in brain development from childhood to old age, and how it impacts behavior across health and psychopathology.

simon.ducharme [at] mcgill.ca (English, French)

Maiya Geddes, Assistant Professor, Department of Neurology and Neurosurgery

"It is our job as clinicians to provide patients with evidence-based care. The FDA's decision to approve this drug is surprising, given the inconclusive data supporting its clinical effectiveness. Clinicians and hospital systems in the U.S. will have to scramble to fill the gaps left by the FDA, including defining important criteria for treatment, such as contraindications, stage of disease, and the need for Alzheimer's biomarker data."

Maiya Geddes is an Assistant Professor in the Department of Neurology and Neurosurgery and a clinician-scientist at the Montreal Neurological Institute-Hospital. Her research aims to determine the brain mechanisms underlying the interaction between motivation and cognition in aging. She is currently leading a team of clinicians working on remote assessment of cognition in cognitively impaired adults.

maiya.geddes [at] mcgill.ca (English)

Jonathan Kimmelman, James McGill Professor, Department of Social Studies of Medicine and Director, Biomedical Ethics Unit

“For decades, the FDA has been a beacon for how policy-makers can join science to regulation to improve patient access to life saving drugs. This decision, which overruled independent scientific advice sought by the agency, suggests that beacon is now extinguished. Strong FDA regulations, combined with intellectual property protections, provide powerful incentives for companies to develop drugs and prove they are safe and effective. This decision sends a clear signal to pharmaceutical companies and biotechnology firms that they do not need to worry so much about the efficacy part.”

Jonathan Kimmelman is a James McGill Professor in the Biomedical Ethics Unit and Department of Social Studies of Medicine. His research centers on the ethical, social, and policy challenges in testing novel medical technologies in human beings ("translational clinical research"). Current projects are investigating risk, prediction, validity and knowledge value across the trajectory of drug development.

jonathan.kimmelman [at] mcgill.ca (English)

Gerhard Multhaup, Full Professor and Chair, Department of Pharmacology and Therapeutics

“As a long-term Alzheimer’s researcher, it is fascinating to see that the FDA, after nearly two decades, has approved the first treatment targeting the associated disease pathology. The drug developed by Biogen, an anti-amyloid antibody called aducanumab (Aduhelm), effectively reduces amyloid deposits in the brain. Such amyloid removal will likely lead to improved clinical outcomes for patients who are diagnosed at early stages of the disease. As the socioeconomic impact for patients and their caregivers continues to rapidly escalate world-wide, I expect that the FDA approval will inspire more investments in Alzheimer’s research to deliver improved diagnostics and treatments in the near future.”

Gerhard Multhaup is a Full Professor and the Chair of the Department of Pharmacology and Therapeutics. He is a world-renowned Alzheimer’s disease researcher, mainly known for his pioneering work that has advanced our mechanistic understanding of Alzheimer’s disease at the molecular level.

gerhard.multhaup [at] mcgill.ca (English, German)

Vasavan Nair, Full Professor, Department of Psychiatry

“This new treatment, while not a cure, is significant as is it the first approved drug that modifies one of the biological contributors to Alzheimer’s disease. It is important to acknowledge that it slows progression in a limited population of mild cognitive impairment caused by Alzheimer’s and dementia. It does not stop the decline or improve cognition, but it represents an important step and progress in Alzheimer’s disease science.”

Vasavan Nair is a Ful Professor in the Department of Psychiatry and the Medical Director of the Moe Levin Memory Clinic at the Douglas Mental Health University Institute. The focus of his research is on the prevention and treatment of Alzheimer’s disease in the preclinical, prodromal and early clinical stages, using new pharmacological (e.g. drug trials), and non-pharmacological (e.g. yoga and meditation) tools.

vasavan.nair [at] douglas.mcgill.ca (English)

Judes Poirier, Full Professor, Department of Psychiatry

"The effect of this drug on memory remains quite modest. It should be noted that the FDA has conditionally accepted the drug to proceed with a third study, which will have to clearly demonstrate efficacy and benefit for the patient."

Judes Poirier is a Full Professor in the Department of Psychiatry and the Director of the Molecular Neurobiology Unit at the Douglas Research Centre. He has made key contributions to the advancement of scientific research on Alzheimer's and Parkinson's disease and is internationally renowned for his works on the role of apolipoprotein E in the normal and injured brain and in the genetics of Alzheimer's disease.

judes.poirier [at] mcgill.ca (English, French)