An article published yesterday in MedPage Today illuminates the importance of stringent drug trials and the analysis of findings BEFORE FDA approval. [All of the capitalized words in my article are mine to emphasize critical points.] While the world collectively seeks an Alzheimer’s cure, the most recent investigational treatment medication developed, Aducanumab, was rejected by the FDA expert review panel (George, 2020). Why? There is no evidence the drug works.
As an aging expert, I completely agree that patients with Alzheimer’s Disease [AD] have an urgent need. However, it is impossible to develop and approve a drug without first finding the CAUSE of AD. Developing a medication for prevention or progression of it is working backward. The mindset, “Let’s inject this medication into people with AD and see what happens” is not how drugs are developed because it is not ethical.
The experimental drug Aducanumab is an anti-amyloid agent. However, because we do not know the CAUSE of AD, scientists cannot ethically approve it it to curtail AD without knowing what causes it. It is THOUGHT TO BE CAUSED by an abnormal build-up of proteins in and around brain cells known as amyloid. However, that is not a fact. All we know right now is that AD changes the brain starting with shrinkage in the hippocampus. Scientists are studying a wide array of AD causes including genetic, environmental, lifestyle, toxins, bacteria, and viruses. The resources below from both the NIA and NIH explain AD in easily understood language. I recommend starting with the NIA video first. Finally, THANK YOU for the research participants who are enrolled in trials. You are my heroes! AgeDoc
Resources:
George, J. MedPage Today. 9 November 2020. Alzheimer’s Drug Debate Continues After Negative FDA Panel Review.
NIH. Alzheimer’s Scientific Images and Video. Retrieved on 10 November 2020 from https://www.nia.nih.gov/alzheimers/alzheimers-scientific-images-and-video
NIA. What Causes Alzheimer’s Disease?
Retrieved on 10 November 2020 from
https://www.nia.nih.gov/health/what-causes-alzheimers-disease
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