On Aduhelm (aducanumab) : Bioethics: July 12, 2021
- bjmears1
- Jul 12, 2021
- 2 min read
On Aduhelm (aducanumab)
The approval of aduhelm was, in my opinion, a mistake.
Against the drug:
The side effects of the drug are concerning,
Hemorrhages and swelling in the brain can occur.
Evidence for its benefit is lacking,
The drug was tested only in patients with early symptoms and only one arm in the 2 studies showed a possible slowing of decline of cognitive ability.
The drug does appear to help the amyloid plaques but it is not at all clear this will in any way help slow the progression of the disease. At best, it may slow deterioration?
It will be difficult to give and manage:
The drug must be given as an infusion and follow up scans for hemorrhages and swelling are necessary. How feasible is this for patients who have trouble with memory already?
the costs are unreasonable.
The company plans to charge about $56,000 /year. This doesn’t cover costs for pet scans, MRIs, other lab tests. Even if insurance covers part of the costs, there will be copays.
This approval is under the accelerated program and appears to be for anyone with the diagnosis, not just the patients with mild symptoms who were tested.
For the approval:
perhaps pet scans will now be covered by insurance for diagnosis/monitoring?
This is a terrible disease for which we do not have good treatments to slow and nothing to reverse the disease. The families may become desperate for any glimmer of hope. This drug is not the answer to this problem. We need more knowledge about this problem and drug before we make it available to patients when there is no evidence they will benefit.
Here is a link to a discussion about the drug. https://www.thehastingscenter.org/breakthrough-or-breakdown-should-the-fda-have-approved-the-new-alzheimers-drug-should-patients-take-it/
Here is a link to the Dena Davis article on the drug. https://www.thehastingscenter.org/would-i-give-aducanumab-to-my-mother/
More from The Hastings Center. https://www.thehastingscenter.org/centerreports/alzheimers-and-aducanumab-unjust-profits-and-false-hopes/
The Penn Memory Center has an information page. https://pennmemorycenter.org/aduhelm/
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