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  • Meera Patel

Limitations of Hope: Lessons Learned from the Aducanumab Controversy

A year ago, the FDA fast-tracked a brilliant new therapy for Alzherimer’s disease. Alzheimer’s is a devastating neurological illness which causes slow cognitive decline over time, characterized by beta-amyloid plaques which surround neurons in the brain. This new drug, known as aducanumab, removed the plaques linked to the neurological devastation caused by Alzheimer’s disease. The only problem? There was no proof that aducanumab actually treated Alzheimer’s.

Aducanumab looked promising at first. After all, it had been shown to remove beta amyloid plaques, a key hallmark of Alzheimer’s disease. However, in clinical trials, Aducanumab hadn’t been shown to reduce the symptoms of Alzheimer’s, nor slow down the progression of the disease significantly. In other words, the FDA had fast-tracked a therapy that wasn’t actually proven to treat Alzheimer’s.

How did this happen? Pharmaceutical companies, Alzheimer’s patients, and advocates began a lobbying process for the approval of the drug, regardless of its efficacy, and once on the market, Aducanumab was marketed for $56,000 a year. After public outrage, the price was cut down to $28,000 annually. So was the other $28,000 just an upcharge by pharmaceutical companies because they could? For a therapy that wasn’t even proven to be effective? As demonstrated by the motivation of patients to approve the drug, hope must’ve been the factor they were taxing.

And yet, what would’ve happened had the FDA chosen not to approve Aducanumab, one of the more promising therapies in recent years? The lack of significant progress in the realm of Alzheimer’s therapies is causing funding for research in the field to dry up, a problem made worse by the FDA’s refusal to approve or fast-track drugs for Alzheimer’s due to lack of data demonstrating efficacy. This is a pressing problem for Alzheimer’s patients as well, many of whom see their hopes for a better future disappearing just like the potential for new treatments.

While the final approval decision for aducanumab lies squarely on the FDA, it’s also true that the drug likely would not have been approved at all had it not been for the Alzheimer’s advocates pushing for more potential treatments. It’s easy to push blame onto patients, their families, and their caregivers, or wonder why they would push for approval for a therapy that likely wouldn’t succeed anyways. But when you’ve been fighting for so long and the road ahead just keeps getting darker, it’s difficult not to reach for that tiny spark of light, no matter how faint it is. The approval of aducanumab is a lesson both on the limitations of science and the limitations of hope.


Edited by: Olivia Ares

Graphic Designed by: Sofia DiFulvio


References

  1. https://www.dukehealth.org/blog/what-you-need-know-about-aducanumab

  2. https://n.neurology.org/content/98/9/e968

  3. https://investors.biogen.com/news-releases/news-release-details/biogen-announces-reduced-price-aduhelmr-improve-access-patients



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